|
Cardiac Interventions Today News
|
| REGULATORY UPDATE |
FDA Approves Effient for ACS Treatment
July 10, 2009—Daiichi Sankyo, Inc. (Parsippany, NJ) and Eli Lilly and Company (Indianapolis, IN) announced that the US Food and Drug Administration approved Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with percutaneous coronary intervention (PCI). Daiichi Sankyo and Eli Lilly codeveloped Effient, which was discovered by Daiichi Sankyo and its research partner, Ube Industries, Ltd. (Tokyo, Japan). The companies noted that Effient should be initiated with a loading dose of 60 mg followed by a maintenance dose of 10 mg once daily. In addition, for those patients who weigh less than 132 lbs (60 kg), physicians should consider lowering the maintenance dose to 5 mg once daily. Patients taking Effient should also take 75 to 325 mg of aspirin orally once daily, as instructed by their doctors.
According to the companies, the approval was based on results from the pivotal phase 3 TRITON-TIMI 38 clinical trial, which compared Effient with clopidogrel bisulfate (Plavix, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, New York, NY) in reducing cardiovascular events in 13,608 acute coronary patients managed with PCI. The study showed that Effient taken with aspirin had a 19% relative risk reduction of the combined endpoint of cardiovascular death, nonfatal heart attack, or nonfatal stroke versus Plavix taken with aspirin. This benefit was driven predominantly by a reduction in heart attacks. The benefit of Effient compared with Plavix was seen as early as 3 days and continued during the 15 months of the trial. In addition, there were fewer incidents of stent thrombosis in patients treated with Effient compared to Plavix, with a relative risk reduction of approximately 50%.
"The data from the TRITON-TIMI 38 phase 3 pivotal trial provide compelling evidence that treatment with prasugrel significantly reduced the combined risk of cardiovascular death, heart attack, or stroke over the current standard of care, clopidogrel, across a wide variety of patient types," commented the trial's lead investigator, Elliott Antman, MD. "Prasugrel is an important new option for patients with acute coronary syndromes who are managed with PCI."
Dr. Antman noted that prasugrel was associated with a significantly higher risk of serious bleeding events compared with clopidogrel, but that appropriate patient selection may help reduce this risk. The risk of bleeding was highest in patients treated with Effient who were 75 years of age or older, weighed less than 132 pounds (60 kg), or had a history of transient ischemic attacks or stroke. Effient is contraindicated in patients with a history of transient ischemic attack/stroke. It is generally not recommended in patients 75 years of age or older, except for patients in high-risk situations, such as those with diabetes or a history of heart attack.
FDA Clears Ziehm's Vision RFD Mobile Imaging System
June 10, 2009—Ziehm Imaging, Inc. (Orlando, FL) announced that the US Food and Drug Administration has granted 510(k) marketing clearance for the Ziehm Vision RFD, a mobile C-arm imaging system that is designed for use in endovascular, interventional radiology, and interventional cardiology procedures.
According to the company, the Ziehm Vision RFD combines flat-panel technology with object-detected, dose-control software and specially designed anatomical programs for enhanced image quality with a minimal dose of radiation. The 30- X 30-cm flat-panel detector allows for fully digital, distortion-free imaging and better access to the patient due to the larger C-arm opening and the 165° orbital rotation. With pulse technology at up to 25 frames per second, the system provides sharp, high-contrast images of vasculature, bone, and soft tissue structures. The 1,500- X 1,500-pixel resolution provides extended dynamic range and 49% greater anatomical viewing compared to 12-inch image intensifier systems delivering comprehensive information about the patient's anatomy. The Ziehm Vision RFD's VisionCenter touchscreen user interface simplifies workflow and improves day-to-day clinical efficiency, the company stated.
Abbott Vascular's Xience Prime DES Receives CE Mark
June 23, 2009—Abbott Vascular (Santa Clara, CA) announced that it has received CE Mark approval for its Xience Prime everolimus-eluting coronary stent system for the treatment of coronary artery disease. The company plans to launch the device in a broad size matrix with lengths up to 38 mm in Europe in the third quarter of 2009.
According to Abbott Vascular, Xience Prime uses the same drug and biocompatible polymer as the company's Xience V everolimus-eluting coronary stent system but incorporates a novel stent design and a modified delivery system for greater flexibility and improved deliverability. Cobalt-chromium technology allows for very thin struts while maintaining strength to support the vessel, as well as excellent visibility under x-ray during the stent implantation procedure. Its design is based on the company's Multi-Link family of stents.
The Xience Prime is an investigational device in the United States and is not available for sale, the company advised. On June 16, Abbott Vascular announced the initiation of SPIRIT PRIME, a clinical trial to study the performance of the device for the treatment of coronary artery disease. The results will be used to support the regulatory filing for Xience Prime in the United States.
Cardiva's Catalyst III Cleared
May 19, 2009—Cardiva Medical, Inc. (Mountain View, CA) announced that its Catalyst III drug-coated vessel-closure device has received clearance from the US Food and Drug Administration. According to the company, the Catalyst III is coated with protamine sulfate, a drug that neutralizes heparin in the tissue adjacent to the device. Local heparin reversal by the Catalyst III system facilitates vessel closure as an adjunct to manual compression in patients undergoing anticoagulation with heparin. Catalyst III's protamine coating contacts the tissue tract from the arteriotomy site to the point of percutaneous entry in the skin.
"We believe that localized protamine in the tissue tract makes a big difference," commented Craig Walker, MD. "Not only can we accomplish rapid, natural vessel closure for our patients, but we can also improve our efficiency while utilizing a more cost-effective and time-tested anticoagulant."
Spectranetics' ThromCat XT Approved in Europe
June 23, 2009—Spectranetics Corporation (Colorado Springs, CO) announced that it has received CE Mark approval for its ThromCat XT thrombus removal system. The ThromCat XT is a single-use, disposable device indicated for mechanical removal of thrombus from native coronary arteries and infrainguinal arteries. The launch of the product will commence immediately within the European Union. The company stated that the next-generation ThromCat XT system has enhanced thrombus removal and several advancements in ease-of-use. The device generates a consistent vacuum pressure at the tip of the catheter to draw thrombus into the extraction ports where it is then macerated by an internal helix. Without further contact with the blood stream, the thrombus is then transported to an external collection bag. The ThromCat XT is completely disposable and is offered in a 150-cm length to treat vessels 2.5 to 7 mm in diameter.
"In contrast to the previous version of the ThromCat, the setup time was significantly shortened, and the device was easy to use," commented Danny Nguyen, MD, and Michael Haude, MD, who collaborated on the first use of the device. "In addition, this new version of the ThromCat provides better pushability and trackability within the vessel. The device was able to remove virtually all thrombus from a 100% occluded vessel that contained significant thrombus burden."
Taxus Liberté Long and Atom Stents Approved by FDA
July 16, 2009—Boston Scientific Corporation (Natick, MA) announced that it has received US Food and Drug Administration (FDA) approval to market the Taxus Liberté Long paclitaxel-eluting coronary stent system. On May 27, Boston Scientific announced it has received FDA approval to market its Taxus Liberté Atom paclitaxel-eluting coronary stent system for the treatment of coronary vessels as small as 2.25 mm in diameter. The Taxus Liberté Long will be launched in August and the the Taxus Liberté Atom was launched in June in the United States.
According to the company, at 38 mm, the Taxus Liberté Long stent is designed for treating long lesions and can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs.
Boston Scientific stated that in the TAXUS ALTAS Long Lesion trial, the Liberté Long stent met its primary endpoint of noninferiority to the trial control stent (Taxus Express), in 9-month percent diameter stenosis (31.7% vs 32.6%; P = .71) and reported a 36% reduction in major adverse coronary events (9.4% vs 14.8%; P = .16). The trial reported a significant 79% in the rate of 9-month myocardial infarction for the Liberté Long as compared to the Express (1.3% vs 6.3%; P = .026). At 2 years, the composite measure of cardiac death or myocardial infarction showed a significant 63% reduction for the Liberté Long compared to the Express (3.5% vs 9.4%; P = .0426). The rate of stent thrombosis at 2 years was 0% for the Liberté Long stent and 0.8% for the Express stent.
The company said that the Liberté Atom stent is approved for treating small vessels (< 2.5 mm). The device features thin struts for improved deliverability and conformability and uniform stent geometry for consistent lesion coverage and drug distribution.
Stentys Platform Approved in Europe to Treat Bifurcations
July 8, 2009—Stentys, Inc. (Princeton, NJ) announced that it has received CE Mark approval of its disconnectable and self-expanding platform for treating coronary artery bifurcations. The company also announced that 6-month follow-up data from its OPEN I clinical study demonstrated safety and efficacy of the platform in treating coronary lesions close to a bifurcation.
According to the company, the Stentys platform's self-expanding feature insures optimal apposition in the critical initial hours and days after an acute myocardial infarction procedure by being constantly applied to the vessel surface during thrombus and vessel spasm relief, therefore avoiding malapposition. The disconnectability feature is designed to treat lesions close to a bifurcation, by ensuring safe main branch provisional stenting and optimal side branch access when needed. The Stentys platform is implanted by usual stenting techniques requiring no additional training, the company noted.
Coherex FlatStent Cleared in EU for PFO Closure
July 8, 2009—Coherex Medical, Inc. (Salt Lake City, UT) announced that the Coherex FlatStent EF patent foramen ovale (PFO) closure system has been granted CE Mark clearance for use in Europe and other countries. The company has initiated efforts for the commercial launch of the device. This clearance follows successful PFO closure procedures during the company's COHEREX-EU clinical trial, which was conducted at sites in Germany, Switzerland, New Zealand, and Australia. Professor Horst Sievert, MD, was the COHEREX-EU study's principal investigator.
According to the company, the Coherex FlatStent EF is similar in use and function to self-expanding vascular stents. However, the device combines a planar nitinol structure with a polyurethane substrate in a fusion of PFO closure mechanisms designed with the intent to naturally seal PFO tunnels. The device is cleared for use to close a PFO from within the PFO tunnel, which is done by using the body's natural defenses to enclose its polyurethane foam and nitinol metal structure.
Dr. Sievert commented, "The most common approach taken today for repairing a PFO is to use a device that clamps two metal mesh-like disks on either side of the PFO opening, with these disks exposed inside the left and right atria of the heart. This approach works; however, anytime you insert any foreign object into the heart, there are several risks, including blood clot formation, damage, or erosion of the septal wall separating the left and right atria, and even the potential for interfering with the electrical signals within the heart muscle itself.
"These risks appear to be reduced with the Coherex FlatStent EF. Its rapid exchange system allows a physician to deliver the FlatStent EF quickly and easily to the PFO, where it can easily be maneuvered within the PFO tunnel before its anchors secure it into place. As a result, there is very little exposed surface area within the left atrium, little or no damage to the septal wall, and significantly less metal mass than current devices. The rapid exchange design also reduces the risk of introducing an air embolism into the left atrium by eliminating the need for a large-bore delivery catheter common to other devices."
Occlutech's Figuella Flex Occluders Approved in EU
May 12, 2009—Occlutech AB (Jena, Germany) announced that it has obtained CE Mark approval for the Figulla Flex occluding devices for the treatment of atrial septal defects (ASD) and patent foramen ovale (PFO). The Figulla Flex ASD and Figulla Flex PFO occluders' new delivery system is designed to make the use of a threaded hub unnecessary. The implantation of the occluder is facilitated by the ability of the delivery system to allow a 45° angle before release, stated Occlutech.
|
| INDUSTRY NEWS |
Societies Object to NCCI and CMS Proposed Changes
June 18, 2009—The Society for Cardiovascular Angiography and Interventions (SCAI) has posted on its Web site (www.scai.org) a letter to Niles R. Rosen, MD, Medical Director of the National Correct Coding Initiative (NCCI) in response to the Centers for Medicaid & Medicare Services (CMS) and NCCI's April 16 letter proposing coding changes that relate to coverage for angioplasty procedures.
SCAI, with the American College of Cardiology (ACC), American College of Radiology, American Roentgen Ray Society, Radiological Society of North America, Society for Vascular Surgery, and Society of Interventional Radiology, wrote to oppose the edits and revisions to the NCCI Policy Manual for Medicare Services that would disallow percutaneous catheter-based angioplasty from being reported with atherectomy when performed in the same noncoronary vessel at the same setting. The societies stated that the proposed edits are in direct conflict with the American Medical Association's currently established national coding conventions for correct coding of percutaneous catheter-based therapeutic interventions. The April 16 letter also addressed NCCI edits for simultaneous open and percutaneous angioplasty, as well as simultaneous open and percutaneous atherectomy. Current coding conventions state that multiples of the same intervention (angioplasty, atherectomy, etc.) are only reported once per vessel. However, there are situations when bilateral procedures may be performed or separate vessels are treated within either leg, the societies stated.
On July 1, CMS announced its proposal for payment and policy changes for physicians' service to Medicare beneficiaries in 2010. According to the ACC, the 2010 proposed Medicare physician payment rule would slash payments for cardiovascular-related services. CMS projected that the proposed changes would reduce total Medicare payments to cardiology by 11%. The projected payment cut would result from changes to practice-expense calculation, equipment utilization rates, malpractice rate calculation, and payment for consultations. In addition, CMS proposed a 21.5% reduction in the Medicare conversion factor due to the flawed sustainable-growth-rate formula. Practices could face cuts ranging from 20% to 40%, the ACC noted.
In a statement released by the ACC, its President Alfred Bove, MD, commented, "The ACC is shocked that CMS has proposed to cut payments to cardiology services by 11% in a single year. These proposed cuts are based on the incorporation of a few esoteric pieces of data into a complex formula. The focus on this formula completely ignores the very important issues of access that are certain to be created by these huge slashes in payment. Services that have improved countless lives by diagnosing and treating cardiovascular disease are scheduled to have payment cuts in the range of 25% to 42%....Given the extensive discussion of previous surveys in previous rules, the ACC is concerned about the very brief discussion of the new survey in this proposal. In previous rules, CMS has stated its strong concerns about wild swings in payments for services and has chosen not to implement significant changes in payments in a single year. The ACC questions why they would propose to do so this time."
E-Tryton 150 Registry Begins
June 30, 2009—Tryton Medical, Inc. (Durham, NC) announced enrollment of the first patient in E-Tryton 150, a registry study of the company's Tryton Side Branch stent system.
According to the company, E-Tryton 150 is one of four registries in Europe evaluating the Tryton Side Branch stent system in real-world clinical settings. The registry will enroll 150 patients in several European sites. The primary endpoint of the study is the overall rate of major adverse cardiac events at 6 months after the procedure. Major adverse cardiac events is defined as cardiac death, myocardial infarction, and target lesion revascularization (main and/or side branch). The study will also assess the technical success of the Tryton stent, procedural success, and the rate of target lesion revascularization at 6 months after the procedure.
The company stated that the Tryton Side Branch stent system is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. The cobalt-chromium stent is deployed in the side branch artery using a standard single-wire, balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel. The company noted that in a first-in-man study of 30 patients, the Tryton Side Branch stent system demonstrated excellent 6-month clinical results with no restenosis occurring in the side branch artery. The stent system received CE Mark approval in Europe in February 2008. It is not yet approved in the United States.
Abbott Vascular Initiates SPIRIT PRIME Trial
June 16, 2009—Abbott Vascular (Santa Clara, CA) announced the initiation of SPIRIT PRIME, a clinical trial to study the performance of the company's next-generation Xience Prime everolimus-eluting coronary stent system for the treatment of coronary artery disease. Results from SPIRIT PRIME will be used to support the regulatory filing for Xience Prime in the United States.
The company stated that the SPIRIT PRIME study is a prospective, multicenter, nonrandomized trial designed to study the Xience Prime device in 500 patients at 75 hospital centers. Patients may receive a maximum of two stents in separate vessels. SPIRIT PRIME will have two arms: the Core Size arm will follow 400 patients who will be treated with a stent from 2.25 to 4 mm in diameter and from 8 to 28 mm in length, and the Long Lesion arm will follow 100 patients who will receive a stent from 2.5 to 4 mm in diameter and either 33 or 38 mm in length. The primary endpoint is major adverse cardiac events, which is a composite measure of cardiac death, myocardial infarction, and target lesion revascularization at 1 year.
Volcano to Distribute Lumen's Xtract Thrombus Aspiration Device
May 18, 2009—Volcano Corporation (San Diego, CA), announced an exclusive worldwide distribution agreement to initiate the formal launch of the Xtract thrombus aspiration catheter, manufactured by Lumen Biomedical (Plymouth, MN). The device is available in the United States and Europe. It has been cleared by the US Food and Drug Administration and is CE Mark approved for use in coronary vessels, as well as in some peripheral vascular applications. The device incorporates a single-lumen design to maximize cross-sectional area and, in turn, thrombus suction; a circular, right angle tip for close-up access to clots; and a curved, directional tip to enable full sweep of the vessel, the company stated.
Atrium Announces COCTAIL Study Data for ClearWay RX
July 15, 2009—Atrium Medical Corporation (Hudson, NH) has announced that Francesco Prati, MD, presented interim results from the COCTAIL study on the performance of the company's ClearWay RX local therapeutic infusion catheter at the C3/Capital Cardiovascular Conference held June 14-17 in Baltimore, Maryland and at the EuroPCR 2009 meeting held May 17-22 in Barcelona, Spain. ClearWay RX is indicated for localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature.
Atrium stated that the COCTAIL study is a multicenter, randomized, controlled clinical trial comparing local coronary administration of abciximab (ReoPro, Eli Lilly and Company, Indianapolis, IN) through a guide catheter, with local coronary administration of abciximab using the ClearWay RX. The primary objective is to verify whether intracoronary (IC) ClearWay infusion of abciximab is capable of reducing thrombus burden by optical coherence tomography (OCT) as compared to traditional IC guide catheter infusion. The secondary objective is to address whether the administration of abciximab by IC ClearWay RX, as compared to IC guide catheter delivery, can improve macro- and microcirculation postintervention by measuring corrected TIMI frame count (cTFC) and myocardial blush grade.
The current interim results are for the first 48 patients. The study will enroll a total of 50 patients. Of the first 48 patients, 39 had evaluable OCT scans, 19 in the ClearWay RX group and 20 in the guide catheter group. The interim results demonstrated that super selective intracoronary infusion of abciximab through the ClearWay RX catheter significantly reduced thrombus burden as measured by OCT, whereas local guide catheter infusion did not.
According to the company, the primary endpoint demonstrated that ClearWay RX significantly reduced the thrombus score by over 35% (P = .0015), whereas local guide catheter infusion only reduced the thrombus burden by 3.7% (P = NS). There was a statistically significant improvement in the cTFC in the ClearWay RX infusion group compared to the guide catheter infusion group. The ClearWay RX infusion group had an average cTFC of 15.75 versus 20.75 for the guide catheter infusion group (P < .05). The ClearWay RX infusion group had more patients reach a myocardial blush grade of 3, whereas the overall myocardial blush grade showed a trend toward improvement in the ClearWay RX group that was not statistically significant. Additionally, the interim results postintervention showed that the ClearWay RX group had a diameter stenosis of 5.9% versus 11.9% for the guide catheter group (P = .015).
First Use of Edwards'18-F Valve System Shows Success
May 14, 2009—Edwards Lifesciences Corporation (Irvine, CA) announced the successful completion of the first human implants of its next-generation transcatheter aortic heart valve used with its new 18-F delivery system. The 18-F system features the Edwards Sapien XT valve and a new, smaller NovaFlex transfemoral delivery system. The valve has a cobalt-chromium-alloy, balloon-expandable frame, which allows for a significant reduction in its profile, and bovine pericardial tissue leaflets processed in the same stringently controlled manner as Edwards' surgical heart valves.
While the Sapien XT valve is being evaluated in the PREVAIL EU trial for CE Mark approval, the company is launching the RetroFlex 3 delivery system to be used with the Sapien valve in Europe. The RetroFlex 3 delivery system is designed to optimize physician control of valve navigation and facilitate crossing of the patient's native calcified aortic valve. The Edwards Sapien valve is approved for commercial sale in Europe. In the United States, it is being studied as part of a randomized, pivotal clinical trial, the company advised.
|
| LITERATURE HIGHLIGHTS |
Study Demonstrates Efficacy of Paclitaxel-Coated Balloons
June 16, 2009—In a study published in Circulation, Martin Unverdorben, MD, et al concluded that treatment of coronary in-stent restenosis with the paclitaxel-coated balloon was at least as efficacious and as well tolerated as a paclitaxel-eluting stent, and that inhibition of re-restenosis does not require a second stent implantation for the treatment of in-stent restenosis (2009;119:2986-2994).
According to the investigators, treatment of in-stent restenosis with a paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. In this study, the investigators compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care.
In the study, 131 patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 µg/mm²) or a paclitaxel-eluting stent. The main inclusion criteria encompassed diameter stenosis of 70% and 22 mm in length, with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic in-segment late lumen loss. Quantitative coronary angiography revealed no differences in baseline parameters. At 6-month follow-up, in-segment late lumen loss was 0.38 ± 0.61 mm in the drug-eluting stent group versus 0.17 ± 0.42 mm (P = .03) in the drug-coated balloon group, resulting in a binary restenosis rate of 12 of 59 (20%) versus four of 57 (7%; P = .06). At 12 months, the major adverse cardiac events rates were 22% and 9%, respectively (P = .08). This difference was primarily due to the need for target lesion revascularization in four patients (6%) in the coated-balloon group, compared with 10 patients (15%) in the stent group (P = .15), reported the investigators in Circulation.
BARI 2D Trial Published
June 11, 2009—In the New England Journal of Medicine, Robert L. Frye, MD, et al published findings from the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D), which was sponsored by the National Institutes of Health (2009;360:2503-2515). The BARI 2D findings were also presented at the American Diabetes Association's 69th annual scientific sessions, which were held June 5 to 9 in New Orleans, Louisiana.
According to the BARI 2D group investigators, optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established. In the study, the investigators randomly assigned 2,368 patients with both type 2 diabetes and heart disease to undergo either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy. The primary endpoints were the rate of death and the rate of major cardiovascular events (a composite of death, myocardial infarction, or stroke). Randomization was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) as the more appropriate intervention.
The investigators reported in the New England Journal of Medicine that at 5 years, rates of survival did not differ significantly between the revascularization group (88.3%) and the medical therapy group (87.8%; P = .97) or between the insulin-sensitization group (88.2%) and the insulin-provision group (87.9%; P = .89). The rates of freedom from major cardiovascular events also did not differ significantly among the groups: 77.2% in the revascularization group and 75.9% in the medical-treatment group (P = .7); and 77.7% in the insulin-sensitization group and 75.4% in the insulin-provision group (P = .13). In the PCI stratum, there was no significant difference in primary endpoints between the revascularization group and the medical therapy group. In the CABG stratum, the rate of major cardiovascular events was significantly lower in the revascularization group (22.4%) than in the medical therapy group (30.5%; P = .01; P = .002 for interaction between stratum and study group). Adverse events and serious adverse events were generally similar among the groups, although severe hypoglycemia was more frequent in the insulin-provision group (9.2%) than in the insulin-sensitization group (5.9%; P = .003).
Overall, there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision, the investigators concluded.
On June 8, the Society for Cardiology and Angiographic Interventions (SCAI) commented on the BARI 2D trial findings. The complete statement is available on the SCAI Web site, www.scai.org.
SCAI stated that BARI 2D is a useful and focused trial that builds on the body of scientific knowledge physicians use to provide the best possible care for diabetic patients with chronic stable angina and to evaluate their treatment options. The society encourages health care providers to apply the findings of BARI 2D, when appropriate, to their patients, as studied in this trial. BARI 2D specifically applies to those with carefully controlled diabetes, multivessel but stable coronary artery disease (CAD), and few heart disease symptoms. This trial does not answer the question of whether all patients with diabetes and multivessel CAD might be better treated with optimal medical therapy plus either PCI or CABG. Because the BARI 2D study enrolled a very small subset of CAD patients with diabetes, SCAI stated that it looks forward to additional data from the upcoming FREEDOM trial, which may shed more light on revascularization options for this growing patient population.
"Physicians should understand the patients in the BARI 2D study are highly selected and represent only a very small slice of diabetes and heart disease patients. More research is needed on the larger diabetic population," stated SCAI President Steven R. Bailey, MD. "Unfortunately, the majority of the BARI 2D patients did not receive drug-eluting stents, which have been shown to be superior to bare-metal stents for diabetic patients. The standard of care has evolved since BARI 2D was initiated, and many of the early patients in the trial did not receive the care we now know to be most effective."
"It's important to note that in a real-world setting, patients' blood sugar levels are not so closely monitored to maintain optimal levels as in this study," added Robert Chilton, DO. "The patients I see with diabetes and heart disease frequently have difficulty complying with a drug regimen that includes upwards of 10 pills per day, often coupled with insulin injection. Not surprisingly, noncompliance can quickly lead to deteriorating health and should be carefully considered for patients who may be candidates for revascularization."
Transfemoral and Transapical Valve Implantation Studied
July 14, 2009—In the Journal of the American College of Cardiology, Dominique Himbert, MD, et al published findings from a study that sought to describe the results of a strategy offering either transfemoral or transapical aortic valve implantation in high-risk patients with severe aortic stenosis (2009;54:303-311). Results of transfemoral and transapical approaches have been reported separately, but rarely after a uniform assessment to select the procedure, the investigators noted.
In the study, 75 of 160 consecutive patients who were at high risk or who had contraindications to surgery (referred between October 2006 and November 2008) were treated with transcatheter aortic valve implantation. The transfemoral approach was used as the first option, and the transapical approach was chosen when contraindications to the former were present. The device used was the Edwards Sapien transcatheter heart valve (Edwards Lifesciences, Irvine, CA).
As detailed in the Journal of the American College of Cardiology, the patients were aged 82 ± 8 years (mean ± SD), and were in the New York Heart Association functional classes III/IV, with predicted mean surgical mortalities of 26 ± 13% using the European System for Cardiac Operative Risk Evaluation and 16 ± 7% using the Society of Thoracic Surgeons Predicted Risk of Mortality. Fifty-one patients were treated via the transfemoral approach, and 24 were treated via the transapical approach. The valve was implanted in 93% of the patients. Hospital mortality was 10%. Mean (± SD) 1-year survivals were 78 ± 6% in the whole cohort, 81 ± 7% in the transfemoral group, 74 ± 9% in the transapical group (P = .22), and 60 ± 10% in the first 25 patients versus 93 ± 4% in the last 50 patients treated (P = .001). In multivariate analysis, early experience was the only significant predictor of late mortality.
The investigators concluded that being able to offer either transfemoral or transapical aortic valve implantation within a uniform assessment expands the scope of the treatment of aortic stenosis in high-risk patients and provides satisfactory results at 1 year in this population. The results are strongly influenced by experience, they noted.
Longer-Term REACT Follow-Up Supports Rescue PCI
June 29, 2009—Amanda Carver, RN, et al published follow-up findings of patients recruited to the REACT (Rescue Angioplasty Versus Conservative Treatment or Repeat Thrombolysis) trial in the July 7 issue of the Journal of the American College of Cardiology (2009;54:118-126). The investigators' objective was to evaluate the longer-term outcomes for rescue percutaneous coronary intervention (R-PCI). The background of the study is that thrombolysis remains an important, commonly used reperfusion therapy, but failure to achieve complete reperfusion occurs relatively frequently. A number of recent trials have focused on the management of patients with thrombolytic failure, including the REACT trial, which demonstrated a significant 6-month benefit favoring R-PCI. However, longer-term maintenance of benefit for R-PCI has not been demonstrated, the investigators stated.
The REACT investigators analyzed rates of the primary composite endpoint (major adverse cardiac and cerebrovascular events) to 1 year and mortality to a median of 4.4 years in 427 patients included in the REACT trial's three randomized arms (repeat lysis, conservative therapy, and R-PCI). One-year event-free survival for patients randomized to R-PCI was 81.5%, compared with 64.1% for repeat thrombolysis and 67.5% for conservative therapy (overall P = .004). The adjusted hazard ratio was 0.44 (95% confidence interval [CI], 0.28 to 0.71; P = .0008) for R-PCI versus repeat thrombolysis and 0.51 (95% CI, 0.32 to 0.83; P = .007) for R-PCI versus conservative therapy. The adjusted hazard ratio for longer-term (median, 4.4 years) overall mortality for R-PCI versus repeat thrombolysis was 0.41 (95% CI, 0.22 to 0.75; P = .004) and 0.43 (95% CI, 0.23 to 0.79; P = .006) for R-PCI versus conservative therapy. There was no difference in either analysis between repeat thrombolysis and conservative strategies, the investigators reported.
These findings indicate that R-PCI, which has previously been shown to be superior in the short-term to both repeat thrombolysis and conservative therapy, maintains its benefits in terms of long-term mortality. The REACT investigators concluded that this strategy for failed lysis should be mandated as part of thrombolytic-based ST-segment elevation myocardial infarction protocols.
Large-Scale Analysis Supports Use of PES in Elderly Patients
June 2, 2009—In Circulation: Cardiovascular Interventions, Daniel E. Forman, MD, et al published findings from an analysis of long-term paclitaxel-eluting stent (PES) outcomes in approximately 10,000 elderly patients that concluded that percutaneous coronary intervention with PES is a safe and effective treatment option that should not be withheld based on age (2009;2:178-187).
According to the investigators, information about drug-eluting stent outcomes in elderly patients has been limited. Data from the PES trials and registries were pooled to assess PES benefits relative to advancing patient age, including comparison with bare-metal stents (BMS).
In the analysis, data from five randomized trials (2,271 patients with PES, 1,397 patients with BMS) and from two postmarket registries (7,492 patients with PES) were pooled separately. For each dataset, patients were stratified into age groups: < 60, 60 to 70, and > 70 years. At baseline, patients aged > 70 years in both datasets had significantly more adverse characteristics than younger patients. Through 5 years, trial data showed that patients aged > 70 years had higher death rates, but rates of myocardial infarction (MI), stent thrombosis, and target lesion revascularization (TLR) were comparable with those of younger patients. Compared with patients with BMS, patients with PES > 70 years had comparable rates of death, MI, and stent thrombosis but a significantly lower TLR rate (22.2% vs 10.2%; P < .001). These findings were also found in the registry data through 2 years, and showed that PES patients > 70 years had significantly higher death rates but lower MI, stent thrombosis, and TLR rates compared with younger patients. Although the mortality rates of patients > 70 years were higher than those of younger patients, they were comparable with those of age- and gender-matched norms in the general population, the investigators reported.
Study Supports Routine Early Angioplasty After Fibrinolysis
June 25, 2009—Warren J. Cantor, MD, et al for the TRANSFER-AMI (Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction) investigators have published their findings in the New England Journal of Medicine (2009;360:2705-2718).
According to the investigators, patients with ST-segment elevation myocardial infarction (STEMI) who present to hospitals that do not have the capability of performing percutaneous coronary intervention (PCI), often cannot undergo timely primary PCI and therefore, receive fibrinolysis. The role and optimal timing of routine PCI after fibrinolysis have not been established.
As detailed in the New England Journal of Medicine, the investigators randomly assigned 1,059 high-risk STEMI patients who were receiving fibrinolytic therapy at centers that did not have the capability of performing PCI to either standard treatment (including rescue PCI, if required, or delayed angiography) or a strategy of immediate transfer to another hospital and PCI within 6 hours after fibrinolysis. All patients received aspirin, tenecteplase, and heparin or enoxaparin; concomitant clopidogrel was recommended. The primary endpoint was the composite of death, reinfarction, recurrent ischemia, new or worsening congestive heart failure, or cardiogenic shock within 30 days.
The investigators reported that cardiac catheterization was performed in 88.7% of the patients assigned to standard treatment at a median of 32.5 hours after randomization and in 98.5% of the patients assigned to routine early PCI at a median of 2.8 hours after randomization. At 30 days, the primary endpoint occurred in 11% of the patients who were assigned to routine early PCI and in 17.2% of the patients assigned to standard treatment (relative risk with early PCI, 0.64; 95% confidence interval, 0.47–0.87; P = .004). There were no significant differences between the groups in the incidence of major bleeding.
The TRANSFER-AMI investigators concluded that among high-risk patients who had a STEMI and who were treated with fibrinolysis, transfer for PCI within 6 hours after fibrinolysis was associated with significantly fewer ischemic complications than was standard treatment.
Secondary Source of Right-to-Left Shunt in PFO Studied
June 26, 2009—In the Journal of the American College of Cardiology: Cardiovascular Interventions, Jill T. Jesurum, PhD, et al published findings from a study that sought to assess the prevalence of secondary right-to-left circulatory shunt (RLS) in patients undergoing transcatheter closure of patent foramen ovale (PFO) as detected by power M-mode transcranial Doppler (TCD) and intracardiac echocardiography (2009;2:561-567). The investigators stated that the background of the study is that prevalence of residual RLS in late follow-up after PFO closure may be as high as 34%. Other cardiac and noncardiac sources of RLS may coexist and obscure PFO closure evaluation.
As detailed by the investigators, 88 patients in the study who underwent transcatheter PFO closure to prevent recurrent paradoxical cerebral embolism between June 2005 and December 2006 were evaluated for a secondary source of RLS. Before device deployment, a sizing balloon was inflated in the PFO tunnel and agitated saline contrast was injected into the inferior vena cava. Clinically significant secondary RLS was defined as > 10 embolic tracks on TCD at rest or immediately after calibrated (40 mm Hg), sustained (10 s) respiratory strain, with corresponding negative color-flow Doppler. Late residual RLS was evaluated in all patients with TCD and transthoracic echocardiography (mean, 192 days; 95% confidence interval, 161 to 223 days). The sample (n = 84) was 59% female, aged 49 ± 14 years. Seventeen patients (20%; 95% confidence interval, 11.7 to 28.8) had secondary RLS during balloon occlusion. At late follow-up (n = 66), 13 of 14 (93%) patients with secondary RLS and 23 of 52 (44%) patients without secondary RLS had residual RLS (P = .002).
According to the investigators' conclusions, this is the first report to systematically assess the prevalence of secondary RLS in patients undergoing PFO closure, and residual RLS detected by TCD may be due to secondary RLS, which may have implications for clinical outcomes.
OCT Results Published for CeloNova's Catania Stent
June 1, 2009—Alessio La Manna, MD, et al have published optical coherence tomography (OCT) results from 6-month follow-up in the Assessment of the Latest Nonthrombogenic Angioplasty Stent (ATLANTA) trial. The findings were published in the American Journal of Cardiology (2009;103:1551-1555). The ATLANTA registry enrolled 55 patients to a first-in-man study of the Catania coronary stent system (CeloNova BioSciences, Inc., Newnan, GA). The Catania rapid-exchange, cobalt-chromium stent incorporates CeloNova's NanoThin Polyzene-F surface, which is a 35- to 40-µm-thin synthesized, inorganic, biocompatible polymer.
ATLANTA was the first clinical human study addressing the short-term follow-up results of the Catania stent with Polyzene-F. As a part of the study protocol, 15 patients were randomly assigned to OCT examination at 6-month follow-up.
According to the investigators, drug-eluting stents were devised as an answer to restenosis, but research has shown that the eluting drug can interfere with the blood vessel's healing process, thus increasing the risk of stent thrombosis. The study was designed to evaluate if the Catania device might address this problem. OCT data were obtained using a Lightlab M2 system (LightLab Imaging Inc., Westford, MA) with a motorized pull-back at 2 mm/s. A total of 1,904 cross-sectional images with 19,028 struts were analyzed. The rate of covered struts was 99.5%, whereas malapposed struts accounted for 0.15%. Area measurements were performed in 476 cross sections. Neointimal hyperplasia (NIH) area and percent NIH area were 3.2 ± 1.4 mm² and 38 ± 17%, respectively. Percent NIH area was comparable between diabetics and nondiabetics. Qualitative assessment of OCT images demonstrated neither occurrence of stent fractures nor thrombus. The investigators concluded that OCT assessment of the Polyzene-F–covered stent at follow-up showed a small percentage of neointima. Also, almost complete stent strut coverage was revealed by OCT. These figures indicate that the Catania stent with Polyzene-F is a promising solution for decreasing late stent restenosis and preventing thrombosis, the investigators stated in the American Journal of Cardiology.
CCTA Radiation Dose-Reduction Techniques Studied
June 10, 2009—In the Journal of the American Medical Association, Gilbert L. Raff, MD, et al published a study that concluded that in a statewide cardiac computed tomography angiography (CCTA) registry, consistent application of currently available dose-reduction techniques was associated with a marked reduction in estimated radiation doses without impairment of image quality (2009;301:2340-2348).
According to the Advanced Cardiovascular Imaging Consortium investigators, the study was based on knowledge that CCTA can accurately diagnose coronary artery disease but radiation dose from this procedure is of concern. This study's objective was to determine whether a collaborative radiation dose-reduction program would be associated with reduced radiation dose in patients undergoing CCTA in a statewide registry over a 1-year period and to define its effect on image quality.
The investigators conducted a prospective, controlled, nonrandomized study during a control period (July–August 2007), an intervention period (September 2007–April 2008), and a follow-up period (May–June 2008) at 15 hospital imaging centers participating in the Advanced Cardiovascular Imaging Consortium in Michigan, which included small community hospitals and large academic medical centers. A total of 4,995 sequential patients undergoing CCTA for suspected coronary artery disease were enrolled; 4,862 patients (97.3%) had complete radiation data for analysis.
A best-practice CCTA scan model was used, which included minimized scan range, heart rate reduction, electrocardiographic-gated tube current modulation, and reduced tube voltage in suitable patients. Primary outcomes included dose-length product and effective radiation dose from all phases of the CCTA scan. Secondary outcomes were image quality assessed by a 4-point scale (1 indicated excellent; 2, good; 3, adequate; and 4, nondiagnostic) and frequency of diagnostic-quality scans.
The investigators found that compared with the control period, patients' estimated median radiation dose in the follow-up period was reduced by 53.3% (dose-length product decreased from 1493 mGy X cm [interquartile range {IQR}, 855-1823 mGy X cm] to 697 mGy X cm [IQR, 407–1163 mGy X cm]; P < .001) and effective dose from 21 mSv (IQR, 12–26 mSv) to 10 mSv (IQR, 6–16 mSv) (P < .001). The greatest reduction in dose occurred at low-volume sites. There were no significant changes in median image quality assessment during the control period compared with the follow-up period (median image quality of 2 [images rated as good] vs median image quality of 2; P = .13) or frequency of diagnostic-quality scans (554/620 patients [89%] vs 769/835 patients [92%]; P = .07), reported the investigators in the Journal of the American Medical Association.
|
| CONFERENCE COVERAGE: EuroPCR |
Edwards SOURCE Registry Presented for Sapien Valve
May 20, 2009—At the EuroPCR conference in Barcelona, Spain, Edwards Lifesciences Corporation (Irvine, CA) announced the results from the SOURCE serial registry, its first postmarket study of consecutively enrolled Edwards Sapien transcatheter aortic valve patients. The data demonstrated high device success and low 30-day mortality.
According to Edwards, the SOURCE registry reported results on 1,038 patients (100%) treated with the Edwards Sapien valve at 32 European centers from November 2007 to January 2009. The data showed a 30-day survival rate of 93.7% in transfemoral procedures and 89.7% in transapical procedures. The company said that these rates are better than the predicted surgical survival in this high-risk patient cohort. Implant procedure safety with the Sapien valve was demonstrated with low rates of valve malposition (1.5%), coronary obstruction (0.6%), stroke (2.5%), conversion to surgery (2.7%), need for permanent pacemaker (7%), and significant aortic regurgitation (4.7%).
"In order to preserve the integrity of the study data, each adverse event was individually reviewed by the SOURCE study's principal investigators," commented Martyn Thomas, MD. "Additionally, to avoid patient selection bias, those centers unable to provide all data on all patients were excluded from the report. This approach provided the opportunity to accurately evaluate both the effectiveness of training and the commercial launch experience of the Edwards Sapien valve, and will guide clinical practice."
Also at EuroPCR, Edwards announced the presentation of the first complete 6-month data set of the 130 patients enrolled in the PARTNER EU clinical trial. The data demonstrated strong hemodynamics and valve performance through measurements including effective orifice area and ejection fraction, as well as 100% freedom from structural valve deterioration. PARTNER EU was designed to evaluate the Edwards Sapien valve in a setting where an interventional cardiologist and cardiac surgeon partnered to screen and determine the correct treatment approach for each patient. The study was conducted in Europe from April 2007 through January 2008 and provided data about patient selection that were incorporated into SOURCE and the PARTNER investigational device exemption trial in the United States. The Edwards Sapien transcatheter aortic heart valve is approved for commercial sale in Europe. In the United States, it is an investigational device being studied as part of the PARTNER randomized, controlled clinical trial.
Data Presented From Pivotal Trial of Cordis' Nevo Stent
May 19, 2009—Cordis Corporation (Warren, NJ) announced that 6-month study results suggest the company's Nevo sirolimus-eluting coronary stent, incorporating RES reservoir technology, was superior to the Taxus Liberté stent (Boston Scientific Corporation, Natick, MA) in reducing tissue growth within the stent that can potentially lead to repeat procedures. In addition, no reports of stent thrombosis were reported in patients treated with Nevo through 6 months. The results of the NEVO RES I study comparing these two drug-eluting stents were presented at the EuroPCR conference in Barcelona, Spain.
According to the company, the Nevo stent had significantly lower in-stent late lumen loss, the primary endpoint of this prospective, randomized clinical trial. Specifically, late lumen loss was reduced by 64% in the Nevo arm as compared to the Taxus Liberté arm (0.13 mm vs 0.36 mm; P < .001). Nevo also showed angiographic results superior to the Taxus Liberté stent in reducing restenosis at 6 months. Angiographic restenosis was reduced 86% in Nevo compared to Taxus Liberté (1.1% vs 8%; P < .002). The incidence of major adverse coronary events (MACE) was reduced in the Nevo arm by more than 40% compared to the Taxus Liberté arm (4.1% vs 7%; P = .226). MACE occurring between hospital discharge and 6 months were reduced 67% with the Nevo compared to the Taxus Liberté (1.6% vs 4.8%; P = .08).
NEVO RES I was not designed to show differences in clinical outcomes; however, patients treated with Nevo compared to the Taxus Liberté had numerically lower rates of events with respect to target lesion revascularization (1.6% vs 3.2%; P = .33) and the composite of death or heart attack (2.6% vs 4.3%; P = .26). Based on the Academic Research Consortium definitions of stent thrombosis, there were no reports of stent thrombosis in the 202 patients receiving Nevo and two reports of stent thrombosis in the 192 patients receiving the Taxus Liberté stent, both of whom were on dual-antiplatelet therapy at the time.
In a prespecified subset analysis of the 65 patients with diabetes completing 6-month follow-up to date, there was a 60% reduction in in-stent late lumen loss with Nevo compared to the Taxus Liberté stent (0.17 mm vs 0.42 mm; P < .03). The difference seen in favor of Nevo compared to Taxus Liberté was similar to the 65% reduction seen in 277 nondiabetic patients (0.12 mm vs 0.34 mm; P < .001).
The NEVO RES I study is a randomized, multicenter comparison of the Nevo sirolimus-eluting coronary stent to the Taxus Liberté stent in de novo native coronary artery lesions. Key secondary endpoints include target lesion failure, target vessel failure, MACE, stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at 6 months. A subset of patients in each treatment arm was evaluated via intravascular ultrasound at 6 months. The study involved 394 patients at 40 sites throughout Europe, South America, Australia, and New Zealand. Patients received clinical follow-up at 30 days and 6 months and will be followed annually through 5 years. Data from this trial will support a regulatory filing for a CE Mark in countries outside the United States. The Nevo sirolimus-eluting coronary stent is an investigational device and is not yet approved or available for sale in any market, the company advised.
According to Cordis, upcoming clinical trials for the device are planned. NEVO II will be a global, randomized, noninferiority trial comparing the Nevo stent to the Xience V everolimus-eluting coronary stent (Abbott Vascular, Santa Clara, CA). The study will enroll several thousand patients with coronary artery disease and will include expanded enrollment in multiple patient subgroups. The primary endpoint of the study is target lesion failure at 12-months. Patrick Serruys, MD, Stephen Windecker, MD, and Manual Sabate, MD, will lead the study. Results from this trial will provide long-term data in support of a premarket approval application with the US Food and Drug Administration. NEVO III will be a nonrandomized, single-arm trial evaluating clinical outcomes in approximately 1,200 patients throughout the United States and Canada. The primary endpoint will be target lesion failure at 12 months. In NEVO III, led by Dan Simon, MD, and David Kandzari, MD, the Nevo stent will be compared to the Cypher stent control arm of Cordis' CYPHER Stent/DAPT (dual-antiplatelet therapy) trial. The trial will enroll approximately 2,000 patients and will compare clinical outcomes in a broad range of patients receiving dual-antiplatelet therapy for 12 months versus 30 months after receiving a Cypher stent.
Evalve's EVEREST II High-Risk Registry Data Presented
May 20, 2009—Evalve, Inc. (Menlo Park, CA) announced results showing that percutaneous mitral repair using the company's MitraClip system in symptomatic high-risk surgical patients with either functional mitral regurgitation (FMR) or degenerative mitral regurgitation (DMR) improves patient clinical status. The results from the 78-patient EVEREST II High Risk registry demonstrated improvement in left ventricular function and reduced hospitalization for congestive heart failure for both mitral regurgitation groups at 12 months. Additionally, a reduction in mortality compared to the predicted mortality risk of surgery was reported for the registry. Lead investigator Saibal Kar, MD, presented the High-Risk Registry results at the EuroPCR conference in Barcelona, Spain.
According to the company, the High Risk Registry data showed similar 30-day mortality, as well as improved 12-month mortality among patients treated with the MitraClip therapy compared to a concurrent control group who was managed medically or underwent mitral valve surgery. At 12 months, 74% of FMR patients with matched data were in New York Heart Association functional class I or II compared to 9% at baseline. At 12 months, 75% of DMR patients with matched data were in New York Heart Association functional class I or II compared to 15% at baseline. This sustained improvement in functional class was accompanied by improved left ventricular function for both groups. The rate of hospitalization for congestive heart failure in the year after treatment with the MitraClip system was reduced by 55% and significantly lower compared to the year before treatment.
"The High Risk Registry data support our belief that the MitraClip therapy is a safe and clinically beneficial treatment alternative for select patients suffering from significant functional or degenerative mitral regurgitation," commented Dr. Kar. "Patients otherwise unable to withstand more invasive treatments can benefit from the MitraClip therapy while avoiding the risk of increased morbidity and mortality often associated with surgical treatment."
Abbott Vascular's SPIRIT V Data Presented
May 21, 2009—Abbott Vascular (Santa Clara, CA) announced that data from the company's international, postapproval, single-arm SPIRIT V study were presented at the EuroPCR conference in Barcelona, Spain. The SPIRIT V study evaluated the Xience V in a diverse, real-world population of patients and lesion types, including diabetics, patients with multivessel disease, and patients with highly complex lesions. Also at EuroPCR, Abbott Vascular presented 5-year results from the SPIRIT FIRST trial, which was a 60-patient, first-in-man study comparing Xience V to the company's Multi-Link Vision coronary stent system. Xience V continued to demonstrate an excellent long-term safety profile with no major adverse cardiac events or stent thrombosis events between 1 and 5 years, the company stated.
According to the company, the SPIRIT V investigators enrolled 2,663 patients at approximately 100 clinical sites in Europe, Asia-Pacific, and Canada for a patient population composed of multiple ethnic groups. The patient and lesion types studied in SPIRIT V include patients with diabetes (n = 794; 30%), patients with multivessel disease (n = 1,107; 42%), patients with highly complex lesions (lesion type B2 or C; n = 2,307 patients; 82% of lesions), patients with moderately or severely calcified lesions (n = 809 patients; 29% of lesions), patients with longer lesions (≥ 20 mm; 28% of lesions; n = 911 patients) that need treatment, and patients with smaller vessels (reference vessel diameter ≤ 2.75 mm; 35% of lesions; n = 1,068 patients).
The primary endpoint of the study is a composite rate of all death, myocardial infarction, and target lesion revascularization (TLR) at 30 days, in which Xience V had a rate of 2.7%. At 1 year, the SPIRIT V results for the Xience V demonstrated a 1.8% rate of TLR, a 0.7% cumulative rate of definite/probable stent thrombosis (to 1 year), a 0.2% rate of definite/probable late stent thrombosis (between 30 days and 1 year), a 5.1% rate of major adverse cardiac events (defined as cardiac death, myocardial infarction attributed to the target vessel, and ischemia-driven TLR), and a 1.1% rate of cardiac death. An independent clinical events committee adjudicated all events according to the Academic Research Consortium definitions.
Abbott Vascular supplies a private-label version of Xience V to Boston Scientific Corporation (Natick, MA) called the Promus everolimus-eluting coronary stent system. Promus is designed and manufactured by Abbott and supplied to Boston Scientific Corporation as part of a distribution agreement between the two companies. The company advised that the safety and efficacy of Xience V has not been established in the United States for patients with multivessel disease, patients with highly complex lesions (lesion type B2 or C), or patients with severely calcified lesions.
"The data from real-world studies are valuable because they reflect a broad patient population that is more representative of the spectrum of disease seen in a typical interventional cardiology practice," commented the study's principal investigator Eberhard Grube, MD. "The 1-year results from SPIRIT V indicate that even in a patient population with a high percentage of complex lesions, Xience V exhibits remarkably low event rates, similar to what was seen when Xience V was studied in controlled, randomized SPIRIT studies."
Medtronic's Endeavor DES Approved in EU to Treat ACS
May 19, 2009—At the EuroPCR conference in Barcelona, Spain, Medtronic, Inc. (Minneapolis, MN) announced CE Mark approval of an expanded indication for the Endeavor drug-eluting stent (DES). In Europe and in all countries that accept the CE Mark, the device is now available for the treatment of acute coronary syndrome (ACS), including unstable angina and acute myocardial infarction (MI). The Endeavor stent originally received CE Mark approval in August 2005 for the treatment of coronary artery disease.
At EuroPCR, Martin Rothman, MD, presented new 12-month data from the company's international real-world registry E-Five study (n = 8,314) showing comparable outcomes for Endeavor DES patients with and without ACS. The E-Five study demonstrated no statistically significant difference in the primary endpoint—the rate of major adverse cardiac events at 1 year—between ACS patients (7.8%; n = 3,973) and non-ACS patients (7.2%; n = 4,341). Rates of death, MI, and late stent thrombosis (LST) at 1 year were similarly low and comparable between the two groups:
- All-cause mortality: 2.7% for ACS, 2.2% for non-ACS
- Cardiac death: 2% for ACS, 1.5% for non-ACS
- MI: 1.8% for ACS, 1.5% for non-ACS
- Cardiac death + MI: 3.4% for ACS, 2.7% for non-ACS
- LST (ARC definite/probable): 0.5% for ACS, 0.3% for non-ACS
Low and similar rates of standard efficacy measures were also observed, including target lesion revascularization (TLR), target vessel revascularization, and target vessel failure. On all these measures, there were no statistically significant differences between the ACS and non-ACS groups.
Also on May 19 at EuroPCR, Medtronic announced that David Kandzari, MD, presented 5-year clinical data from the company's ENDEAVOR II trial (n = 1,197), a randomized controlled trial comparing the Endeavor DES to Medtronic's Driver bare-metal stent. The Endeavor DES demonstrated a low and durable plateau in the rate of TLR. The 7.5% TLR rate at 5 years is a 0.3% difference from the rate at 3 and 4 years. Medtronic noted that this long-term data would be submitted in a premarket approval application to the US Food and Drug Administration.
According to the company, the TLR rate is lower than expected based on the results of other trials with comparable designs and may challenge the assumptions on the long-term efficacy of DES. The Endeavor stent has shown low rates of complications including very late stent thrombosis to 5 years across various geographies, patient subsets, and trial designs. These latest results confirm that the Endeavor stent's long-term safety is complemented by long-term efficacy, stated Medtronic.
|