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非ST段抬高型急性冠状动脉综合征患者侵入性和保守性策略的时变结局综合评估:一项随机对照试验的荟萃分析

Comprehensive evaluation of time-varied outcomes for invasive and conservative strategies in patients with NSTE-ACS: a meta-analysis of randomized controlled trials.

作者信息

Zhao Yi-Jing, Sun Yangyang, Wang Fan, Cai Yuan-Yuan, Alolga Raphael N, Qi Lian-Wen, Xiao Pingxi

机构信息

State Key Laboratory of Natural Medicines, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, China.

The Clinical Metabolomics Center, China Pharmaceutical University, Nanjing, China.

出版信息

Front Cardiovasc Med. 2023 Sep 8;10:1197451. doi: 10.3389/fcvm.2023.1197451. eCollection 2023.

Abstract

BACKGROUND

Results from randomized controlled trials (RCTs) and meta-analyses comparing invasive and conservative strategies in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) are highly debatable. We systematically evaluate the efficacy of invasive and conservative strategies in NSTE-ACS based on time-varied outcomes.

METHODS

The RCTs for the invasive versus conservative strategies were identified by searching PubMed, Cochrane Central Register of Controlled Trials, Embase, and ClinicalTrials.gov. Trial data for studies with a minimum follow-up time of 30 days were included. We categorized the follow-up time into six varied periods, namely, ≤6 months, 1 year, 2 years, 3 years, 5 years, and ≥10 years. The time-varied outcomes were major adverse cardiovascular event (MACE), death, myocardial infarction (MI), rehospitalization, cardiovascular death, bleeding, in-hospital death, and in-hospital bleeding. Risk ratios (RRs) and 95% confidence intervals (Cis) were calculated. The random effects model was used.

RESULTS

This meta-analysis included 30 articles of 17 RCTs involving 12,331 participants. We found that the invasive strategy did not provide appreciable benefits for NSTE-ACS in terms of MACE, death, and cardiovascular death at all time points compared with the conservative strategy. Although the risk of MI was reduced within 6 months (RR 0.80, 95% CI 0.68-0.94) for the invasive strategy, no significant differences were observed in other periods. The invasive strategy reduced the rehospitalization rate within 6 months (RR 0.69, 95% CI 0.52-0.90), 1 year (RR 0.73, 95% CI 0.63-0.86), and 2 years (RR 0.77, 95% CI 0.60-1.00). Of note, an increased risk of bleeding (RR 1.80, 95% CI 1.28-2.54) and in-hospital bleeding (RR 2.17, 95% CI 1.52-3.10) was observed for the invasive strategy within 6 months. In subgroups stratified by high-risk features, the invasive strategy decreased MACE for patients aged ≥65 years within 6 months (RR 0.68, 95% CI 0.58-0.78) and 1 year (RR 0.75, 95% CI 0.62-0.91) and showed benefits for men within 6 months (RR 0.71, 95% CI 0.55-0.92). In other subgroups stratified according to diabetes, ST-segment deviation, and troponin levels, no significant differences were observed between the two strategies.

CONCLUSIONS

An invasive strategy is superior to a conservative strategy in reducing early events for MI and rehospitalizations, but the invasive strategy did not improve the prognosis in long-term outcomes for patients with NSTE-ACS.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021289579, identifier PROSPERO 2021 CRD42021289579.

摘要

背景

比较非ST段抬高型急性冠状动脉综合征(NSTE-ACS)患者侵入性和保守性策略的随机对照试验(RCT)及荟萃分析结果极具争议性。我们基于随时间变化的结果,系统评价侵入性和保守性策略在NSTE-ACS中的疗效。

方法

通过检索PubMed、Cochrane对照试验中心注册库、Embase和ClinicalTrials.gov识别侵入性与保守性策略的RCT。纳入随访时间至少30天的研究的试验数据。我们将随访时间分为六个不同时期,即≤6个月、1年、2年、3年、5年和≥10年。随时间变化的结果为主要不良心血管事件(MACE)、死亡、心肌梗死(MI)、再住院、心血管死亡、出血、院内死亡和院内出血。计算风险比(RRs)和95%置信区间(Cis)。采用随机效应模型。

结果

该荟萃分析纳入了17项RCT的30篇文章,涉及12331名参与者。我们发现,与保守性策略相比,侵入性策略在所有时间点的MACE、死亡和心血管死亡方面并未为NSTE-ACS带来明显益处。尽管侵入性策略在6个月内降低了MI风险(RR 0.80,95% CI 0.68-0.94),但在其他时期未观察到显著差异。侵入性策略在6个月内(RR 0.69,95% CI 0.52-0.90)、1年内(RR 0.73,95% CI 0.63-0.86)和2年内(RR 0.77,95% CI 0.60-1.00)降低了再住院率。值得注意的是,侵入性策略在6个月内出血风险(RR 1.80,95% CI 1.28-2.54)和院内出血风险(RR 2.17,95% CI 1.52-3.10)增加。在按高危特征分层的亚组中,侵入性策略在6个月内(RR 0.68,95% CI 0.58-0.78)和1年内(RR 0.75,95% CI 0.62-0.91)降低了≥65岁患者的MACE,且在6个月内对男性有益(RR 0.71,95% CI 0.55-0.92)。在根据糖尿病、ST段偏移和肌钙蛋白水平分层的其他亚组中,两种策略之间未观察到显著差异。

结论

侵入性策略在减少MI和再住院的早期事件方面优于保守性策略,但侵入性策略并未改善NSTE-ACS患者的长期预后。

系统评价注册

https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021289579,标识符PROSPERO 2021 CRD42021289579

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/624b/10516546/76420e44467f/fcvm-10-1197451-g001.jpg

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