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| |  TCT: Neither Phosphorycholine-Coated Stents Nor Abciximab Reduces Restenosis in Small Vessel Disease By M.M. Pennell WASHINGTON, DC -- October 3, 2003 -- Neither use of phosphorylcholine-coated (PC) stents nor abciximab (ReoPro, Centocor) reduced the incidence of restenosis after stenting of small coronary arteries, according to results from the Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries (ISAR SMART-II) trial. "These data strengthen the belief that future studies on prevention of restenosis in small coronary arteries should focus on drug-eluting stents," Adnan Kastrati, MD, Deutsches Herzzentrum, Munich, Germany, said during a late-breaking clinical trials session at the 15th Annual Transcatheter Cardiovascular Therapeutics Symposium. ISAR-SMART-2 was a prospective, randomized, 4-arm trial of 502 patients. The researchers randomized 253 patients to receive a PC-coated BiodivYsio small vessel stent plus glycoprotein (GP) IIb/IIIa inhibition, and 249 patients to undergo percutaneous transluminal coronary angiography (PTCA) plus GP IIb/IIIa inhibition. They also randomized 251 patients to receive abciximab, and 251 patients to placebo. Inclusion criteria were stable or unstable angina without an acute myocardial infarction (MI), a lesion in native vessels up to 2.5 mm in diameter, and no allergy to antiplatelet medications used in the study. The primary end point was incidence of angiographic restenosis at 6 months, which was defined as at least 50% stenosis. The secondary end points were clinical event rates at 1 year, including target vessel revascularization, death, and MI. "Stent coating with phosphorylcholine has been shown to reduce protein absorption and platelet activation, which may reduce the risk of restenosis," Dr. Kastrati said. "Previous non-randomized studies with PC-coated stents had demonstrated favorable long-term results, in particular for lesions in small coronary arteries." Similarly, results from 2 studies -- Evaluation of 7E3 for the Prevention of Ischemic Complications (EPIC), and Evaluation of Platelet IIb/IIIa Inhibitor for Stenting (EPISTENT) -- previously suggested a positive role for abciximab in the prevention of restenosis after PC implantation. Baseline patient characteristics and baseline angiographic characteristics did not differ significantly between the stent and PTCA groups. However, differences were seen in certain procedural characteristics -- the stent group had higher balloon pressure, greater post-procedural minimum lumen diameter (MLD), and less residual stenosis. "The most important thing is that there was a crossover rate of 40% in the PTCA group" he said. The crossover in the stent group was just 3.6%. Procedural success was achieved in 99% of stent patients, and 98% of PTCA patients. There were no significant clinical differences between treatment groups at 30 days. Angiographic results minimal lumen diameter at follow-up and net lumen gain were similarly not significant, and there were no angiographical or clinical differences in restenosis at 6 months. Likewise, the comparison between abciximab and placebo did not show significant clinical differences at 30 days. Again, angiographical and restenosis results were also not significant.
[Study title: ISAR SMART-II: A Prospective, Randomized, 4-arm Trial of Phosphorylcholine-coated Stenting +IIb/IIIa Inhibition vs. PTCA+ IIb/IIIa inhibition in Small Coronary Arteries Undergoing Percutaneous Coronary Intervention.]
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