TY - JOUR
T1 - A randomized, multicenter trial comparing a new, low-pressure stent versus a conventional stent
T2 - Primary results from the CONSERVE trial
AU - Brener, Sorin J.
AU - Midei, Mark G.
AU - Nukta, E. Dean
AU - Kereiakes, Dean J.
AU - Rizik, David G.
AU - Murphy, Donel
AU - Brennan, Danielle
AU - Moliterno, David J.
AU - Topol, Eric J.
PY - 2003/3/1
Y1 - 2003/3/1
N2 - 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.
AB - 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.
KW - Clinical outcome
KW - Restenosis
KW - Stent
UR - http://www.scopus.com/inward/record.url?scp=0037341181&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0037341181&partnerID=8YFLogxK
M3 - Article
C2 - 12612386
AN - SCOPUS:0037341181
SN - 1042-3931
VL - 15
SP - 128
EP - 132
JO - Journal of Invasive Cardiology
JF - Journal of Invasive Cardiology
IS - 3
ER -