An analysis of 5-year clinical outcomes from two major clinical trials revealed that sirolimus-eluting stents have a safety record similar to coronary artery bypass grafting and superior to bare-metal stenting.

In addition, the 5-year major adverse cardiac and cerebrovascular event rate among patients who had sirolimus-eluting stents (SES) was higher compared with those treated with coronary artery bypass grafting (CABG) and lower compared with those treated with bare-metal stenting (BMS), researchers led by Dr. Patrick W. Serruys of Erasmus Medical Center, Rotterdam, the Netherlands, reported online Feb. 17 in the Journal of the American College of Cardiology.

The findings come from an analysis that set out to compare the 5-year clinical outcomes, safety, and efficacy of the Arterial Revascularization Therapies Study I (ARTS I), a randomized trial comparing CABG and BMS in 1,205 patients with multivessel disease, with ARTS II, a nonrandomized trial of SES use in 607 patients, at least one-third of whom had multivessel disease. The mean baseline ages of patients in ARTS I and ARTS II cohorts were 61 and 63 years, respectively.

The current analysis is unique to previous studies comparing arterial revascularization procedures because the ARTS II trial population “clearly represents off-label use of [SES], with a mean of 3.7 stents implanted per patient, and a mean total stent length of 72.5 mm per patient,” the researchers explained (J. Am. Coll. Cardiol. 2010 Feb. 17 [doi:10.1016/j.jacc.2009.11.049]). “Therefore, although a nonrandomized trial, ARTS II can address important issues regarding the safety of [drug-eluting stents] implantation in patients with complex multivessel disease.”

At 5 years, the composite safety and end point of death, stroke, and myocardial infarction was similar in the two groups: 87% in the ARTS II cohort compared with 82% in the ARTS I cohort. Meanwhile, the 5-year major adverse cardiac and cerebrovascular event rate in ARTS II was 28%, which was significantly higher than the subset of ARTS I patients who underwent CABG (21%) and significantly lower than the subset of ARTS I patients who underwent BMS (42%).

Dr. Serruys and his associates went on to report that 32% of adverse events which occurred during the 5-year follow-up could be explained “and potentially prevented” by eliminating stent thrombosis. “These results emphasize the importance of optimal stent implantation, development of less thrombogenic devices such as [drug-eluting stents] with biocompatible or bioabsorbable coatings, or fully bioabsorbable [drug-eluting stents], and in addition, more effective antithrombotic therapies,” they wrote.

The researchers acknowledged certain limitations of the study, including the fact that it was not randomized and that there was a 5-year time lag between the enrollment periods for the ARTS I and II cohorts. “With recent improvements in surgical techniques and concomitant medication (statins), it is more than likely that the clinical results of a true randomized trial would have come out more in favor of surgical treatment,” they concluded.

Two of the study authors disclosed that they are employees of Cordis Clinical Research, a Johnson & Johnson company that manufactured the SES used in ARTS II.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

两项大型临床试验的5年临床结果分析表明，西罗莫司洗脱支架(SES)的安全性记录与冠状动脉旁路移植术(CABG)相似，且优于金属裸支架(BMS)。

 

在《美国心脏病学会杂志》(Journal of the American College of Cardiology)2月17日在线发表的一篇文章中，由荷兰鹿特丹Erasmus医学中心的Patrick W. Serruys博士领导的研究者报告称，而且，接受SES的患者5年内重大心脏和脑血管不良事件的发生率高于接受CABG的患者，但却低于接受BMS的患者。

 

以上结果源自这项旨在比较动脉血运重建治疗研究I (ARTS I)与ARTS II的5年临床结果、安全性及疗效的分析。其中，ARTS I是一项在1,205例多血管病变患者中比较CABG与BMS的随机试验；ARTS II则是一项在607例患者中评价SES疗法的非随机试验，至少1/3的受试者存在多血管病变。ARTS I和ARTS II患者队列的基线平均年龄分别为61和63岁。

 

研究者解释道：“这项分析有别于之前开展的其他比较动脉血运重建术的研究，因为ARTS II的受试人群“明显代表了SES标识适应证以外的用途，每例患者平均植入3.7个支架，每例患者的支架总长度平均为72.5 mm。”(J. Am. Coll. Cardiol. 2010 Feb. 17 [doi:10.1016/j.jacc.2009.11.049])。“因此，虽然ARTS II是一项非随机试验，但它解答了药物洗脱支架植入术用于复杂性多血管病变患者的安全性这一重要问题。”

 

5年后，两组安全性及死亡、卒中和心肌梗死的复合终点相似：ARTS II队列为87%，ARTS I队列为82%。此外，ARTS II队列5年内重大心脏和脑血管不良事件的发生率为28%，显著高于ARTS I队列中接受CABG的患者亚集(21%)，但却显著低于ARTS I队列中接受BMS的患者亚集(42%)。

 

Serruys博士及其助手继续报告称，在这5年的随访期内出现的不良事件有32%都可以用清除了支架血栓来解释，支架血栓的清除也“可能预防” 这些不良事件。研究者写道：“分析结果强调了最佳支架植入、研发出不易形成血栓的器械，如带有生物相容性或生物可吸收涂层的药物洗脱支架或完全生物可吸收的药物洗脱支架，以及寻找更加有效的抗血栓治疗的重要性。”

 

研究者承认该研究存在一定的局限性，包括这是一项非随机试验以及ARTS I和II队列的患者招募期存在5年的时间间隔的事实。研究者总结道：“随着近年来外科技术以及伴随用药(他汀类药物)的不断发展，一项真正的随机试验的临床结果很可能会提示手术治疗更佳。”

 

2名作者声明受聘于强生公司Cordis临床研究部，该公司为ARTS II试验所用SES支架的生产商。

 

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