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再探吸烟者悖论:18项随机对照试验的患者水平汇总分析

The Smoker's Paradox Revisited: A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials.

作者信息

Yadav Mayank, Mintz Gary S, Généreux Philippe, Liu Mengdan, McAndrew Thomas, Redfors Björn, Madhavan Mahesh V, Leon Martin B, Stone Gregg W

机构信息

Department of Medicine, Division of Cardiology, Bronx Lebanon Hospital Center, New York, New York.

Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.

出版信息

JACC Cardiovasc Interv. 2019 Oct 14;12(19):1941-1950. doi: 10.1016/j.jcin.2019.06.034. Epub 2019 Sep 11.

DOI:10.1016/j.jcin.2019.06.034
PMID:31521646
Abstract

OBJECTIVES

This study examined the smoker's paradox using patient-level data from 18 prospective, randomized trials of patients undergoing percutaneous coronary intervention (PCI) with stent implantation.

BACKGROUND

Studies on the effects of smoking and outcomes among patients undergoing PCI have reported conflicting results.

METHODS

Data from the RAVEL, E-SIRIUS, SIRIUS, C-SIRIUS, TAXUS IV and V, ENDEAVOR II to IV, SPIRIT II to IV, HORIZONS-AMI, COMPARE I and II, PLATINUM, and TWENTE I and II randomized trials were pooled. Patients were stratified by smoking status at time of enrollment. The 1- and 5-year ischemic outcomes were compared.

RESULTS

Among 24,354 patients with available data on smoking status, 6,722 (27.6%) were current smokers. Smokers were younger and less likely to have diabetes mellitus; hypertension; hyperlipidemia; or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting. Angiographically, smokers had longer lesions, more complex lesions, and more occlusions, but were less likely to have moderate or severe calcification or tortuosity. At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization). After multivariable adjustment for potential confounders, smoking was a strong independent predictor of death (hazard ratio [HR]: 1.86; 95% confidence interval [CI]: 1.63 to 2.12; p < 0.0001), cardiac death (HR: 1.68; 95% CI: 1.38 to 2.05; p < 0.0001), MI (HR: 1.38; 95% CI: 1.20 to 1.58; p < 0.0001), stent thrombosis (HR: 1.60; 95% CI: 1.28 to 1.99; p < 0.0001), and target lesion failure (HR: 1.17; 95% CI: 1.05 to 1.30; p = 0.005).

CONCLUSIONS

The present large, patient-level, pooled analysis with 5-year follow-up clearly demonstrates smoking to be an important predictor of adverse outcomes after PCI.

摘要

目的

本研究使用来自18项前瞻性、随机试验的患者水平数据,这些试验涉及接受经皮冠状动脉介入治疗(PCI)并植入支架的患者,以研究吸烟者悖论。

背景

关于吸烟对接受PCI患者的影响及预后的研究报告了相互矛盾的结果。

方法

汇总了来自RAVEL、E-SIRIUS、SIRIUS、C-SIRIUS、TAXUS IV和V、ENDEAVOR II至IV、SPIRIT II至IV、HORIZONS-AMI、COMPARE I和II、PLATINUM以及TWENTE I和II随机试验的数据。患者在入组时按吸烟状况进行分层。比较了1年和5年的缺血性预后。

结果

在24354例有吸烟状况可用数据的患者中,6722例(27.6%)为当前吸烟者。吸烟者更年轻,患糖尿病、高血压、高脂血症或既往心肌梗死(MI)、PCI或冠状动脉搭桥术的可能性更小。在血管造影方面,吸烟者的病变更长、更复杂且闭塞更多,但发生中度或重度钙化或迂曲的可能性更小。在5年时,吸烟者发生MI的比率显著更高(7.8%对5.6%;p<0.0001)以及明确或可能的支架血栓形成比率更高(3.5%对1.8%;p<0.0001);然而,在死亡、心源性死亡、靶病变血运重建或复合终点(心源性死亡、靶血管MI或缺血性靶病变血运重建)的比率方面没有差异。在对潜在混杂因素进行多变量调整后,吸烟是死亡(风险比[HR]:1.86;95%置信区间[CI]:1.63至2.12;p<0.0001)、心源性死亡(HR:1.68;95%CI:1.38至2.05;p<0.0001)、MI(HR:1.38;95%CI:1.20至1.58;p<0.0001)、支架血栓形成(HR:1.60;95%CI:1.28至1.99;p<0.0001)和靶病变失败(HR:1.17;95%CI:1.05至1.30;p=0.005)的强有力独立预测因素。

结论

本项具有5年随访的大型患者水平汇总分析清楚地表明吸烟是PCI后不良预后的重要预测因素。

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