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最优药物治疗可改善经皮冠状动脉介入治疗或冠状动脉旁路移植术血运重建患者的临床结局:来自经皮冠状动脉介入治疗与紫杉醇洗脱支架和心脏手术(SYNTAX)试验的 5 年随访结果。

Optimal medical therapy improves clinical outcomes in patients undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting: insights from the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial at the 5-year follow-up.

机构信息

From the Thoraxcenter (J.I., Y.-J.Z., A.P.K., P.W.S.) and Department of Public Health (E.W.S.), Erasmus Medical Centre, Rotterdam, The Netherlands; University of Sheffield, UK (J.I., J.P.G.); Mayo Clinic, Rochester, MN (D.R.H.); ICPS, Hopital privé Jacques Cartier, Générale de Santé Massy, France (M.-C.M.); The Heart Hospital, Dallas, TX (M.J.M.); Evanston Hospital, IL (T.F.); University Hospital Uppsala, Sweden (E.S.); Hospital Clínico San Carlos, Madrid, Spain (J.E.); Oxford University Hospitals, UK (A.P.B.); San Raffaele Scientific Institute, Milan, Italy (A.C.); Herzzentrum Universität Leipzig, Germany (F.W.M.); and International Centre for Circulatory Health, Imperial College London, UK (P.W.S.).

出版信息

Circulation. 2015 Apr 7;131(14):1269-77. doi: 10.1161/CIRCULATIONAHA.114.013042. Epub 2015 Feb 24.

Abstract

BACKGROUND

There is a paucity of data on the use of optimal medical therapy (OMT) in patients with complex coronary artery disease undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting (CABG) and its long-term prognostic significance.

METHODS AND RESULTS

The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial is a multicenter, randomized, clinical trial of patients (n=1800) with complex coronary disease randomized to revascularization with percutaneous coronary intervention or CABG. Detailed drug history was collected for all patients at discharge and at the 1-month, 6-month, 1-year, 3-year, and 5-year follow-ups. OMT was defined as the combination of at least 1 antiplatelet drug, statin, β-blocker, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Five-year clinical outcomes were stratified by OMT and non-OMT. OMT was underused in patients treated with coronary revascularization, especially CABG. OMT was an independent predictor of survival. OMT was associated with a significant reduction in mortality (hazard ratio, 0.64; 95% confidence interval, 0.48-0.85; P=0.002) and composite end point of death/myocardial infarction/stroke (hazard ratio, 0.73; 95% confidence interval, 0.58-0.92; P=0.007) at the 5-year follow-up. The treatment effect with OMT (36% relative reduction in mortality over 5 years) was greater than the treatment effect of revascularization strategy (26% relative reduction in mortality with CABG versus percutaneous coronary intervention over 5 years). On stratified analysis, all the components of OMT were important for reducing adverse outcomes regardless of revascularization strategy.

CONCLUSIONS

The use of OMT remains low in patients with complex coronary disease requiring coronary intervention with percutaneous coronary intervention and even lower in patients treated with CABG. Lack of OMT is associated with adverse clinical outcomes. Targeted strategies to improve OMT use in postrevascularization patients are warranted.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00114972.

摘要

背景

在接受经皮冠状动脉介入治疗或冠状动脉旁路移植术(CABG)血运重建的复杂冠状动脉疾病患者中,优化药物治疗(OMT)的使用数据很少,其长期预后意义尚不清楚。

方法和结果

SYNTAX 试验是一项多中心、随机临床试验,共纳入 1800 例复杂冠状动脉疾病患者,随机分为经皮冠状动脉介入治疗或 CABG 血运重建组。所有患者在出院时、1 个月、6 个月、1 年、3 年和 5 年随访时均详细记录药物史。OMT 定义为至少联合应用 1 种抗血小板药物、他汀类药物、β受体阻滞剂和血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂。根据 OMT 和非 OMT 对 5 年临床结局进行分层。接受冠状动脉血运重建的患者,尤其是 CABG 患者,OMT 应用不足。OMT 是生存的独立预测因子。与非 OMT 相比,OMT 显著降低死亡率(风险比 0.64;95%置信区间 0.48-0.85;P=0.002)和死亡/心肌梗死/卒中复合终点(风险比 0.73;95%置信区间 0.58-0.92;P=0.007)。5 年随访时,OMT 的治疗效果(5 年内死亡率降低 36%)大于血运重建策略的治疗效果(5 年内 CABG 与经皮冠状动脉介入治疗相比死亡率降低 26%)。分层分析显示,无论血运重建策略如何,OMT 的所有组成部分对于降低不良结局都很重要。

结论

在需要经皮冠状动脉介入治疗的复杂冠状动脉疾病患者中,OMT 的应用仍然很低,在接受 CABG 治疗的患者中则更低。缺乏 OMT 与不良临床结局相关。有必要针对血运重建后患者制定提高 OMT 应用的靶向策略。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT00114972。

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