title: A randomized multicenter trial comparing a new, low-pressure versus a conventional coronary stent: primary results from the CONSERVE trial.
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 Duett  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.
authors.affiliation: The Cleveland Clinic Foundation, OH 44195, USA. breners@ccf.org
authors.forename: Sorin J
authors.initials: SJ
authors.lastname: Brener
authors.forename: Mark G
authors.initials: MG
authors.lastname: Midei
authors.forename: Dean
authors.initials: D
authors.lastname: Nukta
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: David G
authors.initials: DG
authors.lastname: Rizik
authors.forename: Donel
authors.initials: D
authors.lastname: Murphy
authors.forename: Danielle
authors.initials: D
authors.lastname: Brennan
authors.forename: David J
authors.initials: DJ
authors.lastname: Moliterno
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D019917:Blood Vessel Prosthesis Implantation; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000601:surgery; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015607:Stents; D016896:Treatment Outcome