Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada.
The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands.
Department of Cardiovascular Sciences, University of Leicester and NIHR (National Institute of Heath Research) Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester NHS (National Health Service) Trust, Glenfield Hospital, Leicester, United Kingdom.
Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.
Centre for Cardiovascular Innovation, University of British Columbia, Vancouver, British Columbia, Canada.
Zena and Michael A. Weiner Cardiovascular Institute, Mount Sinai School of Medicine, New York, New York.
Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.
Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.
Importance
Recently, the Complete vs Culprit-Only Revascularization to Treat Multivessel Disease After Early PCI (percutaneous coronary intervention) for STEMI (ST-segment elevation myocardial infarction [MI]) (COMPLETE) trial showed that angiography-guided PCI of the nonculprit lesion with the goal of complete revascularization reduced cardiovascular (CV) death or new MI compared with PCI of the culprit lesion only in STEMI. Whether complete revascularization also reduces CV mortality is uncertain. Moreover, whether the association of complete revascularization with hard clinical outcomes is consistent when fractional flow reserve (FFR)– and angiography-guided strategies are used is unknown.
Objective
To determine through a systematic review and meta-analysis (1) whether complete revascularization is associated with decreased CV mortality and (2) whether heterogeneity in the association occurs when FFR- and angiography-guided PCI strategies for nonculprit lesions are performed.
Data Sources
A systematic search of MEDLINE, Embase, ISI Web of Science, and CENTRAL (Cochrane Central Register of Controlled Trials) from database inception to September 30, 2019, was performed. Conference proceedings were also reviewed from January 1, 2002, to September 30, 2019.
Study Selection
English-language randomized clinical trials comparing complete revascularization vs culprit-lesion-only PCI in patients with STEMI and multivessel disease were included.
Data Extraction and Synthesis
The combined odds ratio (OR) was calculated with the random-effects model using the Mantel-Haenszel method (sensitivity with fixed-effects model). Heterogeneity was measured using the
I
2
statistic. Publication bias was evaluated using the inverted funnel plot approach. Data were analyzed from October 2019 to January 2020.
Main Outcomes and Measures
Cardiovascular death and the composite of CV death or new MI.
Results
Ten randomized clinical trials involving 7030 unique patients were included. The weighted mean follow-up time was 29.5 months. Complete revascularization was associated with reduced CV death compared with culprit-lesion-only PCI (80 of 3191 [2.5%] vs 106 of 3406 [3.1%]; OR, 0.69 [95% CI, 0.48-0.99];
P
= .05; fixed-effects model OR, 0.74 [95% CI, 0.55-0.99];
P
= .04). All-cause mortality occurred in 153 of 3426 patients (4.5%) in the complete revascularization group vs 177 of 3604 (4.9%) in the culprit-lesion-only group (OR, 0.84 [95% CI, 0.67-1.05];
P
= .13;
I
2
= 0%). Complete revascularization was associated with a reduced composite of CV death or new MI (192 of 2616 [7.3%] vs 266 of 2586 [10.3%]; OR, 0.69 [95% CI, 0.55-0.87];
P
= .001; fixed-effects model OR, 0.69 [95% CI, 0.57-0.84];
P
< .001), with no heterogeneity in this outcome when complete revascularization was performed using an FFR-guided strategy (OR, 0.78 [95% CI, 0.43-1.44]) or an angiography-guided strategy (OR, 0.61 [95% CI, 0.38-0.97];
P
= .52 for interaction).
Conclusions and Relevance
In patients with STEMI and multivessel disease, complete revascularization was associated with a reduction in CV mortality compared with culprit-lesion-only PCI. There was no differential association with treatment between FFR- and angiography-guided strategies on major CV outcomes.
中文翻译：
重要性
最近，针对 STEMI（ST 段抬高型心肌梗死 [MI]）的早期 PCI（经皮冠状动脉介入治疗）后多支血管疾病的完全或仅罪犯血运重建 (COMPLETE) 试验表明，血管造影指导的非罪犯病变的 PCI 与与仅在 STEMI 中对罪犯病变进行 PCI 相比，完全血运重建的目标减少了心血管 (CV) 死亡或新的 MI。完全血运重建是否也能降低心血管死亡率尚不确定。此外，当使用血流储备分数 (FFR) 和血管造影指导策略时，完全血运重建与硬临床结果的关联是否一致尚不清楚。
目的
通过系统评价和荟萃分析确定 (1) 完全血运重建是否与降低的 CV 死亡率相关，以及 (2) 当对非罪犯病变执行 FFR 和血管造影指导的 PCI 策略时，这种关联是否存在异质性。
数据来源
对 MEDLINE、Embase、ISI Web of Science 和 CENTRAL（Cochrane Central Register of Controlled Trials）从数据库开始到 2019 年 9 月 30 日进行了系统搜索。会议记录也从 2002 年 1 月 1 日至 2019 年 9 月 30 日进行了审查。
研究选择
英语随机临床试验比较了 STEMI 和多支血管疾病患者的完全血运重建与仅罪犯病变 PCI 的比较。
数据提取和综合
综合优势比 (OR) 是使用 Mantel-Haenszel 方法（具有固定效应模型的敏感性）的随机效应模型计算的。使用
I
2
统计量测量异质性。使用倒漏斗图方法评估发表偏倚。数据分析时间为 2019 年 10 月至 2020 年 1 月。
主要结果和测量
心血管死亡和心血管死亡或新的 MI 的复合。
结果
纳入了涉及 7030 名独特患者的 10 项随机临床试验。加权平均随访时间为 29.5 个月。与仅使用罪犯病变的 PCI 相比，完全血运重建与 CV 死亡率降低相关（3191 次中的 80 次 [2.5%] vs 3406 次中的 106 次 [3.1%]；OR，0.69 [95% CI，0.48-0.99]；
P
= .05 ；固定效应模型 OR，0.74 [95% CI，0.55-0.99]；
P
= .04）。完全血运重建组 3426 名患者中有 153 名 (4.5%) 发生全因死亡率，而仅罪犯病变组 3604 名患者中的 177 名 (4.9%) 发生全因死亡率（OR，0.84 [95% CI，0.67-1.05]；
P
= .13;
I
2
= 0%）。完全血运重建与心血管死亡或新 MI 的复合减少相关（2616 例中的 192 例 [7.3%] vs 2586 例中的 266 例 [10.3%]；OR，0.69 [95% CI，0.55-0.87]；
P
= .001；固定效应模型 OR，0.69 [95% CI，0.57-0.84]；
P
< .001），当使用 FFR 指导的策略进行完全血运重建时，该结果没有异质性（OR，0.78 [95% CI，0.43- 1.44]）或血管造影引导策略（OR，0.61 [95% CI，0.38-0.97]； 相互作用
P
= .52）。
结论和相关性
在 STEMI 和多支血管病变患者中，与仅使用罪犯病变的 PCI 相比，完全血运重建与 CV 死亡率降低相关。FFR 和血管造影指导的策略对主要 CV 结果的治疗没有差异关联。
