The annual Transcatheter Cardiovascular Therapeutics conference ended Sept. 25, with a few more companies touting clinical trial results and Boston Scientific Corp. (NYSE:BSX), which took another beating from competitors this year, trying one last time to regain ground for its Taxus drug-eluting stent.

The Natick, Mass.-based medical device maker released three-year follow-up data from its Horizons-AMI trial, comparing the Taxus Express2 DES with bare-metal stents. The company touts the 3,006-patient trial as the world’s largest randomized study comparing DES use with bare-metal stents in patients with acute myocardial infarction — or heart attack.

The study, comparing the paclitaxel-eluting Taxus Express with an otherwise identical Express BMS, showed that ischemia-driven target lesion revascularization was 9.4 percent for the DES group and 15.1 percent for the BMS group after three years. Ischemia-driven target vessel revascularization was 12.4 percent for the Taxus group and 17.6 percent for the Express group. The incidence of major adverse cardiac events was 13.6 percent for the DES group and 12.9 percent for the bare-metal group, consistent with the study’s one- and two-year results.

"Individual rates of death, repeat heart attack, stroke and stent thrombosis between the two groups through three years of follow-up were also comparable," according to a press release.

Two other companies also touted their clinical data on the symposium’s final day:

• OrbusNeich
  E-Healing registry update: OrbusNeich presented 12-month follow-up data from a study of its Genous bio-engineered R stent and endothelial progenitor cell capture device in elderly patients and patients who stopped dual anti-platelet therapy after 30 days and six months. Data from 339 elderly patients over age 80, compared with 4,584 younger patients, showed that the older subjects had higher rates of target vessel failure driven mainly by cardiac death. Late stent thrombosis was 0.3 percent in the elderly cohort and 0.2 percent in the younger group.

  Patients who stopped DAP therapy at 30 days showed a TVF rate of 6.3 percent, compared with 6.5 percent in patients who stopped DAP therapy after six months. Patients who stopped at six months and those that continued on the therapy also showed similar TVF rates, at 2.8 percent for the six-month group and 2.4 percent for the ongoing therapy group.

  "Both patient subgroups showed a low definite or probable stent thrombosis similar to the corresponding control groups," according to a press release.
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• InspireMD
  • Master trial of the MGuard stent: InspireMD announced the launch of a 406-patient study of its MGuard coronary stent, which incorporates a polymer mesh sleeve around the stent designed to help prevent embolisms. Dr. Gregg Stone, director of cardiovascular research and education at Columbia University, will be the study’s chairman.
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  • Two-year data on the MGuard: Two-year data from a study of 100 patients implated with the MGuard device showed that in non-cardiogenic shock subjects the MACE rate was 7.9 percent, compared with 13.3 percent for the total group.

    "When we performed a meta analysis of all our STEMI trials, the results reveal that with MGuard it may be possible to reduce MACE by up to an astonishing 50 percent,” InspireMD CEO Ofir Paz said in prepared remarks.
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