A randomized, multicenter trial comparing a new, low-pressure stent versus a conventional stent: Primary results from the CONSERVE trial

Sorin J. Brener, Mark G. Midei, E. Dean Nukta, Dean J. Kereiakes, David G. Rizik, Donel Murphy, Danielle Brennan, David J. Moliterno, Eric J. Topol

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Because it is uncertain whether high-pressure stent deployment may contribute to more exuberant neointimal proliferation, a new stent, the LP™, was constructed to allow full expansion at ≤ 10 atmospheres (atm). We compared in a randomized trial the 6-month target vessel revascularization (TVR) and other clinical outcomes of the LP™ stent with the most commonly used Food and Drug Administration-approved stent (Guidant Duet™ and Tristar™ stents) in 1,003 patients without a recent myocardial infarction. The first 150 patients assigned the LP™ stent also underwent repeat angiography at 6 months. Baseline characteristics for the two groups were balanced, except for an excess of unstable angina in the LP™ group. There was slight excess in failure to deliver the LP™ stent (3.4% versus 1.4%; p = 0.04), and similar 7-day rates of procedural success without ischemic complications (92% versus 93%; p = 0.53). More patients in the LP™ group had pre-dilation (72% versus 58%; p < 0.001) and post-dilatation (61% versus 50%; p = 0.001). The stent deployment pressure was significantly lower, as expected, in the LP™ group (10 ± 2 ATM versus 13 ± 4 atm; p < 0.001). At 30 days, the incidence of major adverse cardiac events was similar. At 6 months, the incidence of TVR was 10% and 7.8%, respectively (p = 0.28), hazard ratio was 0.79 (0.52-1.21), and absolute difference was 2.2% (-2.3% to 6.7%), well within the range of equivalency set at 7.5%. Patients without post-dilatation had a significantly higher rate of revascularization with the LP™ stent than with the Guidant® stent (p = 0.02). Thus, the new LP™ stent achieves rates of revascularization that are not inferior to the Guidant® stent, but this effect cannot be linked to lower-pressure deployment.

Original languageEnglish
Pages (from-to)128-132
Number of pages5
JournalJournal of Invasive Cardiology
Volume15
Issue number3
StatePublished - Mar 1 2003

Keywords

  • Clinical outcome
  • Restenosis
  • Stent

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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