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一项比较支架置入术与胸廓内动脉移植术治疗近端孤立性初发左前冠状动脉狭窄的前瞻性随机试验:SIMA试验。支架置入术与胸廓内动脉移植术的比较

A prospective randomized trial comparing stenting to internal mammary artery grafting for proximal, isolated de novo left anterior coronary artery stenosis: the SIMA trial. Stenting vs Internal Mammary Artery.

作者信息

Goy J J, Kaufmann U, Goy-Eggenberger D, Garachemani A, Hurni M, Carrel T, Gaspardone A, Burnand B, Meier B, Versaci F, Tomai F, Bertel O, Pieper M, de Benedictis M, Eeckhout E

机构信息

Division of Cardiology, University Hospital Lausanne, Switzerland.

出版信息

Mayo Clin Proc. 2000 Nov;75(11):1116-23. doi: 10.4065/75.11.1116.

DOI:10.4065/75.11.1116
PMID:11075740
Abstract

OBJECTIVE

To compare coronary artery bypass grafting (CABG) with percutaneous transluminal coronary angioplasty (PTCA) in patients with proximal, isolated de novo left anterior descending coronary artery disease and left ventricular ejection fraction of 45%.

PATIENTS AND METHODS

In the multicenter Stenting vs Internal Mammary Artery (SIMA) study, patients were randomly assigned to PTCA and stent implantation or to CABG (using the internal mammary artery). The primary clinical composite end point was event-free survival, including death, myocardial infarction, and the need for additional revascularization. Secondary end points were functional class, antianginal treatment, and quality of life. Analyses were by intention to treat.

RESULTS

Of 123 patients who accepted randomization, 59 underwent CABG, and 62 were treated with stent implantation (2 patients were excluded because of protocol violation). At a mean +/- SD follow-up of 2.4+/-0.9 years, a primary end point had occurred in 19 patients (31%) in the stent group and in 4 (7%) in the CABG group (P<.001). This significant difference in clinical outcome is due to a higher incidence of additional revascularization in the stent group, the incidence of death and myocardial infarction being similar (7% vs 7%, respectively; P=.90). The functional class, need for antianginal drug, and quality-of-life assessment showed no significant differences.

CONCLUSIONS

Both stent implantation and CABG are safe and highly effective treatments to relieve symptoms in patients with isolated, proximal left anterior descending coronary artery stenosis. Both are associated with a low and comparable incidence of death and myocardial infarction. However, similar to PTCA alone, a percutaneous approach using elective stent placement remains hampered by a higher need for repeated intervention because of restenosis.

摘要

目的

比较冠状动脉旁路移植术(CABG)与经皮腔内冠状动脉成形术(PTCA)治疗近端孤立性初发左前降支冠状动脉疾病且左心室射血分数为45%的患者的疗效。

患者和方法

在多中心支架置入术与乳内动脉(SIMA)研究中,患者被随机分配至PTCA及支架置入组或CABG组(使用乳内动脉)。主要临床复合终点为无事件生存,包括死亡、心肌梗死以及再次血运重建的需求。次要终点为心功能分级、抗心绞痛治疗及生活质量。分析采用意向性治疗。

结果

123例接受随机分组的患者中,59例行CABG,62例接受支架置入治疗(2例因违反方案被排除)。在平均±标准差为2.4±0.9年的随访期内,支架组19例患者(31%)出现主要终点事件,CABG组4例患者(7%)出现主要终点事件(P<0.001)。临床结局的显著差异归因于支架组再次血运重建发生率较高,死亡和心肌梗死发生率相似(分别为7%对7%;P = 0.90)。心功能分级、抗心绞痛药物需求及生活质量评估无显著差异。

结论

支架置入术和CABG均是治疗孤立性近端左前降支冠状动脉狭窄患者症状的安全且高效的治疗方法。两者死亡和心肌梗死发生率均较低且相当。然而,与单纯PTCA类似,因再狭窄导致的再次干预需求较高,限制了使用选择性支架置入的经皮治疗方法。

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