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冠状动脉搭桥术与支架置入术治疗多支血管病变的比较:以色列ARTS试验结果

Comparison of bypass surgery and stenting for the treatment of multivessel disease: results from the ARTS trial in Israel.

作者信息

Gruberg Luis, Milo Simcha, Ben Tzvi Margalit, Lotan Chaim, Merin Gideon, Braun Shimon, Mohr Rephael, Tzivoni Dan, Bitran Dan, Beyar Rafael

机构信息

Division of Invasive Cardiology, Dept. of Cardiology, Rambam Medical Center, Haifa 31096, Israel.

出版信息

Isr Med Assoc J. 2003 Aug;5(8):539-42.

Abstract

BACKGROUND

The Arterial Revascularization Therapies Study was a multicenter, randomized trial designed to compare percutaneous coronary intervention with stenting versus coronary artery bypass graft surgery in 1,205 patients with multivessel coronary artery disease. The most appropriate type of treatment for these patients is still a matter of considerable debate.

OBJECTIVES

To evaluate the clinical characteristics of patients enrolled in the ARTS trial in Israel in comparison to those worldwide, and to assess the 1 year outcome in these patients.

METHODS

Between April 1997 and June 1998, a total of 1,205 patients with multivessel coronary artery disease, who were considered to be equally treatable with both modalities, were randomized to either stenting (n = 600) or CABG (n = 605) at 67 centers around the world. In Israel, 53 patients at four participating medical centers were randomized to either PCI with stents (n = 27) or CABG (n = 26).

RESULTS

Clinical and angiographic characteristics were similar in the two groups, except for a significantly higher incidence of diabetic patients in Israel who were randomized to CABG, compared to those worldwide (35% vs. 16%, P = 0.01). Also, there were more patients with unstable angina in Israel (63 vs. 37%, P = 0.006). At 1 year follow-up, overall mortality and cerebrovascular accident rates were similar between the two groups and equivalent to results obtained around the world. There was a significantly higher incidence of myocardial infarction rates in patients randomized to stenting in Israel compared to patients worldwide (7.4 vs. 5.3%, P = 0.01) or to patients randomized to CABG in Israel (7.4 vs. 0%, P = 0.006). Similar to the overall ARTS results, there was a higher incidence of repeat revascularization procedures in patients assigned to the PCI with stenting arm (22.2 vs. 3.8%, P = 0.004) compared to those randomized to CABG, respectively.

CONCLUSIONS

The results of this analysis of the Israeli ARTS population indicate that coronary stenting and bypass surgery yield similar findings with regard to mortality and stroke and are comparable to those obtained in the whole study group. Likewise, coronary stenting was associated with an increased incidence of repeat revascularization procedures as compared to CABG. However, patients in Israel randomized to stenting had a higher rate of myocardial infarction as compared to the overall results and to patients who underwent CABG in Israel. The present analysis provides important data for the safety and efficacy of either stenting or bypass surgery in treating patients with multivessel disease in Israel.

摘要

背景

动脉血运重建治疗研究是一项多中心随机试验,旨在比较1205例多支冠状动脉疾病患者接受经皮冠状动脉介入治疗加支架置入术与冠状动脉旁路移植术的效果。对于这些患者,最合适的治疗方式仍是一个备受争议的问题。

目的

评估以色列参加ARTS试验的患者与全球患者相比的临床特征,并评估这些患者的1年结局。

方法

1997年4月至1998年6月期间,共有1205例被认为两种治疗方式均可同等治疗的多支冠状动脉疾病患者,在全球67个中心被随机分为支架置入组(n = 600)或冠状动脉旁路移植术组(n = 605)。在以色列,4个参与医疗中心的53例患者被随机分为支架置入的经皮冠状动脉介入治疗组(n = 27)或冠状动脉旁路移植术组(n = 26)。

结果

两组的临床和血管造影特征相似,但以色列被随机分配到冠状动脉旁路移植术组的糖尿病患者发生率显著高于全球患者(35%对16%,P = 0.01)。此外,以色列不稳定型心绞痛患者更多(63%对37%,P = 0.006)。在1年随访时,两组的总死亡率和脑血管意外发生率相似,与全球获得的结果相当。与全球患者相比,以色列被随机分配到支架置入组的患者心肌梗死发生率显著更高(7.4%对5.3%,P = 0.01),与以色列被随机分配到冠状动脉旁路移植术组的患者相比也更高(7.4%对0%,P = 0.006)。与ARTS总体结果相似,与被随机分配到冠状动脉旁路移植术组的患者相比,被分配到支架置入的经皮冠状动脉介入治疗组的患者再次血运重建手术发生率更高(22.2%对3.8%,P = 0.004)。

结论

对以色列ARTS人群的这项分析结果表明,冠状动脉支架置入术和搭桥手术在死亡率和中风方面产生相似的结果,与整个研究组获得的结果相当。同样,与冠状动脉旁路移植术相比,冠状动脉支架置入术与再次血运重建手术发生率增加有关。然而,与总体结果以及以色列接受冠状动脉旁路移植术的患者相比,以色列被随机分配到支架置入组的患者心肌梗死发生率更高。本分析为以色列多支血管疾病患者进行支架置入术或搭桥手术的安全性和有效性提供了重要数据。

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