TCT 2010 roundup

TCT2010, stent wars logo

A major battlefield in the stent wars opens again this week, as thousands of cardiologists and other healthcare providers flock to Washington, D.C., for the annual Transcatheter Cardiovascular Therapeutics conference.

Medical device industry players large and small are busy hawking the results of clinical trials and touting new products — or new versions of older products. TCT 2010, which kicked off yesterday, is slated to run through Sept. 25.

Here’s a quick look at some of this year’s offerings from Abbott (NYSE:ABT), Boston Scientific Corp. (NYSE:BSX), Medtronic Inc. (NYSE:MDT), Johnson & Johnson’s (NYSE:JNJ) Cordis Corp.,St. Jude Medical Inc. (NYSE:STJ), Cardiovascular Systems Inc. (NSDQ:CSII) and Corindus Vascular Robotics Inc.:

  • Abbott
    • Absorb bioresorbable stent trial update: Nine-month results from the first 45 patients enrolled in the second stage of Abbott’s Absorb trial, testing its bioresorbable vascular scaffold, were consistent with six-month data from the same cohort. The rate of major adverse cardiac events was the same, 4.4 percent, and there were no reports of blood clots (thromboses). Six-month results from the 101 patients enrolled in the second stage of the trial also showed a "nominal" MACE rate increase, from 4.4 percent at six months in the first 45 patients to 5.0 percent at six months in all 101 patients. There were no reports of blood clots in any of the 101 patients.

      "I am impressed with how consistent the BVS data have been to date, as the nine-month data are compelling and supportive of earlier positive results," said co-prinicipal investigator Dr. John Ormiston of Mercy Hospital in Auckland, New Zealand. "In addition to the positive safety data we’ve seen to date, the late loss rate of 0.19 millimeters reported at six months is comparable to a metallic drug eluting stent, and may address a limitation of metal stents by not leaving metal in the artery. This technology is truly a step forward for the field of interventional cardiology, and I am excited about the prospect of treating patients with this revolutionary product."
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  • Boston Scientific
    • The Platinum QCA study of the Promus Element stent: The 100-patient study examined patients implanted with Boston Scientific’s latest-generation Promus Element stent, which it hope to put up against Abbott’s Xience platform (which BSX sold under the private-label Promus brand). One patient experienced a peri-procedural stent thrombosis and target lesion revascularization during the first 30 days after implantation. There were no adverse events between 31 days and nine months.

      "These results demonstrate the successful transfer of drug and polymer from the Promus Stent to the Promus Element stent," Dr. Keith Dawkins, senior vice president and chief medical officer for Boston Scientific’s cardiology, rhythm and vascular group said in prepared remarks. "The Platinum QCA results further support the performance of the everolimus drug/polymer combination while demonstrating a highly effective platinum chromium Promus Element stent platform.  The Promus Element stent also demonstrates an excellent safety profile in this study with only a single patient experiencing a cardiac event within 30 days and no additional events through nine months."
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    • Perseus Taxus Element diabetes results: This study compares the performance of the Taxus Element paclitaxel-eluting stent in diabetic and non-diabetic patients, looking at clinical outcomes after a year among 314 diabetic patients and 852 non-diabetic patients. The trial showed comparable rates of TLR at one year (5.5 percent for the diabetic cohort vs. 4.1 percent for the un-diabetic group). Rates of MACE, cardiac death, myocardial infraction and stent thrombosis showed no differences between the two populations.

      “The Perseus diabetic subset data showed that the Taxus Element stent mitigated the impact of diabetes as a risk factor for restenosis following stenting procedures in the patients studied,” said co-principal investigator Dr. Louis Cannon of the Cardiac and Vascular Research Center of Northern Michigan. “At one year, no significant differences in measures of stent efficacy were observed between the two patient groups. Diabetic status was not a predictor of re-intervention in patients treated with the Taxus Element Stent.”
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    • Taxus Atlas clinical program update: The Taxus Atlas series of global, prospective, single-arm trials evaluate the Taxus Liberté paclitaxel-eluting stent, compared with BSX’s Taxus Express stent. Five-year results from the main trial and four-year results from the small-vessel and long-lesion trials was presented at the symposium.

      The main arm of the study, examining so-called “workhorse” lesions (a.k.a. de novo coronary lesions) in 871 patients after five years showed TLR rates of 11.0 percent for Liberté and 11.5 percent for the Express. There were comparable rates of cardiac death (5.1 percent for the Liberté and 4.4 percent for the Express Stent) and overall MI (7.6 percent for the Liberté and 8.4 percent for the Express). Stent thrombosis rates were 3.0 percent for the Liberté vs. 2.7 percent for the Express.

      After four years, the study’s small-vessel arm, designed to evaluate the long-term safety and efficacy of the Taxus Liberté Atom 2.25mm stent compared to lesion-matched patients treated with either 2.25mm or 2.5mm bare-metal Express stents or the Taxus Express 2.25mm model. The Liberté 2.25 showed significantly lower rates of TLR (10.8 percent vs. 23.8 percent), target vessel revascularization (16.5 percent vs. 31.7 percent), target lesion failure (15.4 percent vs. 30.2 percent) and MACE (21.6 percent vs. 36.5 percent). All stents showed comparable rates of total death, cardiac death, MI and stent thrombosis.

      Four-year data from the long-lesion arm were also presented. That trial, designed to compare the Taxus Liberté Long 38mm stent with the Taxus Express. A subgroup of patients treated with a single stent, the Liberté Long showed lower rates of target-vessel MI (2.6 percent vs. 12.9 percent) and target-vessel non-Q-wave MI (2.6 percent vs. 11.3 percent). Both groups showed comparable rates of TLR, MACE and stent thrombosis.

      “The Taxus Atlas trials continue to reinforce the long-term safety and efficacy of the Taxus Liberté stent in a variety of complex lesions,” Turco said. “The data showed sustained positive outcomes in workhorse lesions, significantly reduced rates of re-intervention in small vessels and important safety differences in long lesions. The Atlas data suggest that improvements in stent design and a reduction in strut thickness may contribute to improved clinical outcomes for patients treated with the Taxus Liberté stent.”
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  • Medtronic
    • Resolute “all comers” study: This study took all comers, "regardless of disease complexity and comorbidities," examining the performance of the Resolute drug-eluting stent. The study’s international arm, involving 2,349 patients, showed that 4.1 percent of subjects experienced cardiac death or TVMI through one year of follow-up. TLR occurred in 3.4 percent of patients and 0.9 percent experienced stent thrombosis.

      The all-comers arm, with 2,292 subjects, compared the Resolute stent with Abbot’s Xience V drug-eluting stent. Patients implanted with the Resolute DES showed a "statistically equivalent but numerically lower" rate of acute MI from TLF (3.3 percent vs. 7.1 percent). A subset of patients, examined for multi-vessel intervention for TLF, Resolute-implanted patients showed a similar difference from the Xience cohort (9.6 percent vs. 11.3 percent).

      The Resolute feasibility study, a first-in-man trial of the stent, enrolled 130 patients. After four years, the results showed "stable clinical efficacy" with a TLR rate of 2.3 percent and no stent thrombosis.

      "Medtronic is rapidly amassing a compelling body of high-quality evidence to demonstrate the safety and efficacy of the Resolute drug-eluting stent as a treatment for coronary artery disease in all its complexity," said principal investigator Dr. Alan Yeung of Stanford University. "These new data from Resolute International in particular reinforce the strong results that the device showed in Resolute All Comers. We hope to have the opportunity to present the one-year data from Resolute US in March at the annual meeting of the American College of Cardiology."
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  • Cordis Corp.
    • Cypher comparative effectives study: This study compared the cost of using Cypher sirolimus-eluting coronary stent in patients with diabetes against everolimus-eluting, paclitaxel-eluting and zotarolimus-eluting stents — in other words, stents made by Cordis Corp.’s major competitors using different anti-clotting drugs. The cost reduction per diabetic patient treated with the Cypher would range between $733 and $937, depending on which stents are being compared. Extrapolated to an estimated 200,000 U.S. diabetics who undergo stenting procedures annually, annual cost savings with Cypher would exceed $145 million.

      "This study adds to the large body of evidence assessing the economic value of drug-eluting stents," said Dr. Ryan Saadi,the firm’s vice president of health economics and strategic pricing. "It is unique in that it includes all relevant stents and predicts the actual costs for an entire population of patients, in this case diabetic patients that qualify under a fixed fee reimbursement system like Medicare. We look forward to presenting our analysis in other important patient sub-groups in the future."

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  • St. Jude Medical
    • Angio-Seal Evolution device registry update: The registry follows more than 1,000 patients undergoing closure with STJ’s Angio-Seal Evolution vascular closure device after catheterization procedures via femoral artery access. The device was successfully deployed in 99.7 percent of procedures and achieved hemostasis (cessation of bleeding) in 97.8 percent of cases.

      "The Angio-Seal Evolution vascular closure device registry results demonstrate the benefits Angio-Seal Evolution provides for my patients and cath lab staff," said Dr. Robert Applegate of Wake Forest University Baptist Medical Center. "With 51.5 percent of patients in the registry having scar tissue at the vascular access site and 48.6 percent of patients clinically diagnosed with obesity, the registry and subset analysis provide strong clinical data that demonstrate the Angio-Seal Evolution has excellent safety and efficacy in challenging patient subsets."
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  • Corindus
    • CorPath 200 guidewire system trial: This first-in-human clinical study of the CorPath 200 guidewire and stent/balloon system in PCIs.

      "The trial reached its primary endpoint of zero MACE at 48 hours," principal investigator Dr. Juan Granada of the Cardiovascular Research Foundation’s Skirball Center for Cardiovascular Research. "I was impressed by the CorPath 200 System’s ability to precisely control and deliver the guidewire and other angioplasty devices to the target lesion. It definitely helped to perform the procedure in a highly controlled manner. Conducting the procedure while sitting in the system’s cockpit gave me more control and better focus on my patient than I would have achieved standing alongside the procedure table."
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  • Cardiovascular Systems
    • Calcium 360° study: The Calcium 360° study randomized 50 patients with critical limb ischemia, comparing orbital treatment with the Diamondback 360° or balloon angioplasty. The primary endpoint, less than 30 percent residual stenosis, was met in 92.6 percent of the Diamondback cohort and 78.8 percent of the angioplasty group. The Confirm Diamondback registry, a prospective, single-arm study of 728 patients, showed a low rate of procedural events (0.5 percent perforations, 1.2 percent abrupt closure/no flow and 0.7 percent macro-embolization), a final residual stenosis of 10.5 percent and a bailout stent rate due to dissection of 2.2 percent. The Clear 360° study looked at hemolysis, a breakdown of red blood cells, associated with the orbital atherectomy procedure. Results from 31 patients showed "no clinically significant" hemolysis.

      "Creating a new standard of care for patients with [peripheral artery disease] starts with obtaining quality clinical and economic data," president and CEO David Martin said. "Our 360° Clinical Series represents an armada of reproducible evidence giving physicians irrefutable proof of the safety and efficacy of the Diamondback 360° for both above-the-knee and below-the-knee applications. Our commitment to data-driven results will support physicians as they make optimal treatment decisions for their patients with PAD."
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