A randomized multicenter trial comparing a new, low-pressure versus a conventional coronary stent: primary results...

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.