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Objective To assess the safety and efficacy of a novel biodegradable polymer and rapamycin-coating stent, the EXCEL stent, in the treatment of coronary artery disease (CAD), as compared with the Cypher?stent. Methods In this prospective, non-randomized study, 60 consecutive patients with symptomatic CAD received either an EXCEL stent (n=32), or a CypherTM stent(n=28),according to their respective treatment intention. Follow-up angiography was performed at a mean of 180±40 days. The primary endpoint of the study was the occurrence of a major adverse cardiac event (MACE), including death, myocardial infarction, or target-vessel revascularization during the 6 months after stenting. The secondary end points included the in-stent late luminal loss (LLL), percentage of in-stent stenosis of the luminal diameter, and the rate of restenosis (luminal narrowing of 50 percent or more) at 6 months. Results There were no significant differences between the two groups in baseline characteristics, including the distribution of target vessel and lesion types. During the follow up period of 6 months, there were no occurrences of MACE in either group. Twenty-seven patients (84%) in the EXCEL group and 10 (36 %) in the Cypher?group underwent quantitative coronary angiography at 6 months. For these patients, no restenosis occurred, and there were no differences in the in-stent stenosis of the luminal diameter (5.98±5.52 % vs 5.21±6.3%, P>0.05) and the LLL (-0.02±0.09 mm vs -0.01±0.07 mm, P>0.05). Conclusions Compared with the CypherTM stent, the EXCEL Stent with biodegradable polymer and rapamycin-coating showed similar efficacy in the prevention of neointimal proliferation, restenosis, and associated clinical events in CAD patients.
Objective To assess the safety and efficacy of a novel biodegradable polymer and rapamycin-coated stent, the EXCEL stent, in the treatment of coronary artery disease (CAD), as compared with the Cypher® stent. Methods In this prospective, non-randomized study , 60 consecutive patients with symptomatic CAD received either an EXCEL stent (n = 32), or a Cypher ™ stent (n = 28), according to each of their respective treatment intention. Follow-up angiography was performed at a mean of 180 ± 40 days. The primary endpoint of the the occurrence of a major adverse cardiac event (MACE), including death, myocardial infarction, or target-vessel revascularization during the 6-month after stenting. The secondary end points included the in-stent late luminal loss ( LLL), percentage of in-stent stenosis of the luminal diameter, and the rate of restenosis (luminal narrowing of 50 percent or more) at 6 months. Results There were no significant differences between the two groups in the baseline characteristics, in During the follow-up period of 6 months, there were no occurrences of MACE in either group. Twenty-seven patients (84%) in the EXCEL group and 10 (36%) in the Cypher ? group underwent quantitative coronary angiography at 6 months. For these patients, no restenosis occurred, and there were no differences in the in-stent stenosis of the luminal diameter (5.98 ± 5.52% vs 5.21 ± 6.3%, P> 0.05) and the LLL (-0.02 ± 0.09 mm vs -0.01 ± 0.07 mm, P> 0.05). Conclusions Compared with the CypherTM stent, the EXCEL Stent with biodegradable polymer and rapamycin-coating showed similar efficacy in the prevention of neointimal proliferation, restenosis, and associated clinical events in CAD patients.