Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Thromb Haemost. 2019 Feb;119(2):328-339. doi: 10.1055/s-0038-1676816. Epub 2019 Jan 7.
The optimal antithrombotic therapy after surgical bioprosthetic aortic valve replacement (BAVR) is uncertain. We conducted a systematic review and meta-analysis of observational studies and randomized controlled trials (RCTs) comparing antiplatelet therapy and anticoagulation in patients with surgical BAVR.
We searched Cochrane CENTRAL, MEDLINE and EMBASE from inception to 3 November 2017 for studies evaluating antiplatelet therapy versus anticoagulation early after surgical BAVR. We performed title and abstract screening, full-text review, risk of bias evaluation and data collection independently and in duplicate. We evaluated overall quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework, and pooled data using a random effects model.
We identified 2 RCTs ( = 397) and 5 observational studies ( = 2,012) meeting our eligibility criteria. The mean follow-up for all outcomes was 3 months in RCTs, and 10 months for observational studies. Antiplatelet compared with anticoagulant therapy demonstrated a trend towards fewer major bleeds in RCTs (relative risk [RR], 0.34; 95% confidence interval [CI], 0.11-1.04, = 0.06, = 0%, low quality evidence), and significantly fewer major bleeds in observational studies (RR, 0.34; 95% CI, 0.20-0.58, ≤ 0.0001, = 0%, very low quality evidence), but stroke, thromboembolism and mortality did not show a significant difference in either RCTs or observational studies.
Antiplatelet therapy demonstrated reduced bleeding risk with no negative effects on stroke, thromboembolism or mortality compared with anticoagulation therapy after surgical BAVR. Our confidence in the results is reduced by the low quality of the available evidence.
心脏外科生物瓣主动脉瓣置换术后(BAVR)的最佳抗栓治疗方案仍不明确。我们进行了一项系统评价和荟萃分析,纳入了比较心脏外科 BAVR 术后抗血小板治疗与抗凝治疗的观察性研究和随机对照试验(RCT)。
我们检索了 Cochrane 中心、MEDLINE 和 EMBASE 数据库,检索时间截至 2017 年 11 月 3 日,以评估心脏外科 BAVR 术后早期抗血小板治疗与抗凝治疗的研究。我们独立且重复地进行标题和摘要筛选、全文评价、偏倚风险评估和数据收集。我们使用推荐评估、制定与评价(GRADE)框架评估证据质量总体级别,并采用随机效应模型进行数据合并。
我们纳入了 2 项 RCT( = 397 例)和 5 项观察性研究( = 2012 例),均符合纳入标准。所有结局的平均随访时间在 RCT 中为 3 个月,在观察性研究中为 10 个月。与抗凝治疗相比,抗血小板治疗在 RCT 中显示出大出血风险降低的趋势(相对风险 [RR],0.34;95%置信区间 [CI],0.11-1.04, = 0.06, = 0%,低质量证据),在观察性研究中显著降低大出血风险(RR,0.34;95% CI,0.20-0.58, ≤ 0.0001, = 0%,极低质量证据),但在 RCT 和观察性研究中,卒中、血栓栓塞和死亡率均无显著差异。
与抗凝治疗相比,心脏外科 BAVR 术后抗血小板治疗可降低出血风险,且不增加卒中、血栓栓塞或死亡率。由于现有证据质量较低,我们对结果的信心有所降低。