CHICAGO (EGMN) – Drug-eluting stents are as safe as bare-mental stents when implanted in patients with large-vessel coronary artery disease, according to results of the BASKET-PROVE trial.

At 2 years of follow-up, the rates of death from cardiac causes or nonfatal myocardial infarction did not differ significantly, at 2.6% for patients implanted with sirolimus-eluting stents, 3.3% for those given everolimus-eluting stents, and 4.8% for those with bare-metal stents. Moreover, there were no significant differences between those groups in the rates of stent thrombosis.

However, the use of drug-eluting stents reduced the need for target vessel revascularization by more than 50%, Dr. Christoph Kaiser reported in a late-breaking clinical trial session at the annual scientific sessions of the American Heart Association.

The BASKET-PROVE data were simultaneously published online by the New England Journal of Medicine (N. Engl. J. Med. 2010 Nov. 16 [doi: 10.1056/NEJMoa1009406]).

Any target-vessel revascularization occurred in 4.3% of patients implanted with sirolimus releasing stents, in 3.7% of patients with everolimus-eluting stents, and in 10.3% of those with bare metal stents in the BASKET-PROVE (Basel Stent Kosten-Effektivitäts Trial-Prospective Evaluation Examination) trial.

The European trial was launched after a retrospective analysis of data from the original BASKET trial suggested that patients who underwent large-vessel stenting with sirolimus-eluting or paclitaxel-eluting stents were at increased risk of cardiac death and myocardial infarction at 6 months and beyond.

The 2,314 patients in BASKET-PROVE were randomized to first-generation sirolimus-eluting stents (Cypher Select) or second-generation everolimus-eluting stents (Xience V) or bare-metal cobalt-chromium stents. All stents were at least 3.0 mm in diameter.

“In patients with large-vessel artery disease, the late safety problems of drug-eluting stents could no longer be confirmed and there was even a trend in the opposite direction,” Dr. Kaiser, head of interventional cardiology at University Hospital Basel, Switzerland, said during a press briefing at the meeting.

Invited discussant Dr. Marco Valgmigli, chair of cardiology, Cardiovascular Institute, Azienda Opedaliero Universitaria di Ferrara, Italy, said the data are highly reassuring, but not conclusive, because “the trial is technically underpowered.” He pointed out that the study was based on a cardiac death/MI event rate of 6% in the bare-metal group and 10.5% in the two drug-eluting arms, with a type II error of 20%. The observed event rate was indeed 20% lower in the bare-metal group and more than 70% lower in the drug-eluting stents.

Dr. Kaiser responded that the confidence intervals observed in the trial rule out the potential for any harm with drug-eluting stents in contemporary stenting.

The different findings from the BASKET and BASKET-PROVE trials could reflect longer clinical experience with drug-eluting stents, technical factors during surgery, and the use of dual antiplatelet therapy with aspirin and clopidogrel for 12 rather than 6 months, as in the original BASKET trial, Dr. Valgmigli suggested.

Press briefing moderator Dr. Elliott Antman, with Harvard Medical School in Boston, said he is less concerned now about placing drug-eluting stents in large vessels with respect to late risks, and that the major benefit for patients will be the reduction in target vessel revascularization.

“What they need to know is that the chance for having to come back to the hospital for target vessel revascularization is clearly higher, about twice as high, with bare-metal stents,” he said in an interview. “What we’re getting from the drug-eluting stent in this situation is reducing target vessel revascularization, which may be very meaningful for patients because they want to travel and don’t want to worry about having to have another procedure in a year or two.”

An unadjusted exploratory analysis revealed no significant differences in the primary end point of cardiac death and MI between patients receiving first- or second-generation drug-eluting stents, Dr. Kaiser reported.

In all, 28 (3.6%) patients with sirolimus-eluting stents died vs. 25 (3.2%) with everolimus-eluting stents and 34 (4.4%) with bare-metal stents. Death from cardiac causes was also similar at 1.7%, 1.7% and 2.9%, respectively.

A nonfatal MI occurred in seven patients with sirolimus-eluting stents, compared with 13 patients with everolimus-eluting stents and 20 with bare-metal stents.

“Since the performance of first- and second-generation drug-eluting stents was similar, both drug-eluting stents may be used in these patients,” he said.

Dr. Valgmigli said that comparison between the first- and second-generation stents should be interpreted as purely exploratory since it was not adjusted for type I or type II errors.

The number of stents per patient was similar at 1.6 vs. 1.7 vs. 1.7, respectively, as was the number of treated segments per patient (1.4 vs. 1.4 vs. 1.5) and total stent length per patient (30 mm vs. 31.1 mm vs. 31.1 mm).

Off-label stent use was high at 78% for sirolimus-eluting stents, 76% for everolimus-eluting stents, and 75% for bare-metal stents.

One-third of patients had unstable angina, and two-thirds presented with acute coronary syndromes, and half of these had MI with ST-segment elevation.

BASKET-PROVE was sponsored by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research. Dr. Kaiser and his coauthors report serving on the speakers bureau or as a consultant/adviser for several companies, including Biotronik, Abbott Vascular, Eli Lilly, Daiichi-Sankyo, and Astra Zeneca.

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

芝加哥(EGMN)——瑞士巴塞尔大学医院介入心脏病科主任Christoph Kaiser博士在美国心脏学会科学年会上报告称，冠状动脉大血管病变患者植入药物洗脱支架与裸金属支架同样安全 (N. Engl. J. Med. 2010 Nov. 16 [doi: 10.1056/NEJMoa1009406])。

                          

此前研究发现，接受西罗莫司洗脱支架或紫杉醇洗脱支架治疗的冠状动脉大血管病变患者，6个月及以后心脏病死亡和心肌梗死风险增加。为进一步评价药物洗脱支架的安全性，研究者将2,314例患者随机植入第一代西罗莫司洗脱支架或第二代依维莫司洗脱支架或钴铬裸金属支架，所有支架直径不小于3.0 mm。各组毎例患者所用支架数量(1.6个、 1.7 个和 1.7个)、治疗部位数量(1.4个、 1.4个和 1.5个)以及支架总长度(30 mm 、 31.1 mm 和 31.1 mm)均相似。支架超说明书使用率分别为78%、76%和75%。1/3患者患有不稳定性心绞痛，2/3患有急性冠脉综合征，半数患有ST段升高的心肌梗死。

 

结果显示，在2年随访期间，西罗莫司洗脱支架、依维莫司洗脱支架和裸金属支架心脏原因或非致命性心肌梗死死亡率分别为2.6%、3.3%和4.8%，无显著差异；组间支架血栓发生率也未见显著差异。靶血管血运重建发生率分别为4.3%、3,7%和10.3%，药物洗脱支架可降低50%以上的靶血管血运重建需求。

 

此外，非调整探索性分析显示，接受第一代和第二代药物洗脱支架治疗的患者，主要终点心脏病死亡和心肌梗死无显著差异。西罗莫司洗脱支架组、依维莫司洗脱支架组和金属裸支架组死亡总例数分别为28 (3.6%)、25 (3.2%)和34 (4.4%)，心脏病死亡率分别为1.7%、1.7% 和2.9%，非致命性心肌梗死发生例数分别为7例、13例和20例。

 

研究表明，药物洗脱支架治疗冠状动脉大血管病变与金属裸支架同样安全，而且还能显著减少患者靶血管血运重建需求。

 

本研究由巴塞尔心血管研究基金和瑞士国家研究基金资助，研究者声称担任多家公司的代言人或顾问。

 

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