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Acute coronary syndrome represents a significant part of the global burden of cardiovascular disease, with approximately more than 3 million people expected to die each year.1 2 Percutaneous coronary intervention initially consisted only of inflating a balloon at the site of a blockage of the coronary artery, which did not seem to achieve lasting results.3–5 Metallic scaffolds called stents were then developed to prevent elastic recoil and to keep the lumen open longer.3 Still, restenosis occurred over time, which is why drug-eluting stents including bioresorbable stents were developed.6–12 Preventing restenosis with drug-eluting stents is thought to improve clinical outcomes and drug-eluting stents are now generally recommended and used as first choice over bare-metal stents.13 But is there convincing evidence for this change of practice? Several meta-analyses have previously assessed the subject, but no previous systematic review has used Cochrane methodology and used methods to assess if enough data have been accumulated to confirm or reject drug-eluting stents’ superiority (or inferiority) compared with bare-metal stents. We conducted a Cochrane systematic review with meta-analysis and Trial Sequential Analysis to compare drug-eluting stents with bare-metal stents.14
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, SCI-EXPANDED and BIOSIS from their inception to January 2017. In addition, we also searched clinical trial registers and pharmaceutical company websites.
Our methodology was based on the recommendations of Cochrane and we used meta-analysis, Trial Sequential Analysis and an eight-step procedure to assess if the thresholds for significance were crossed.15 16 Before conducting the review, we published a protocol with a detailed description of the methodology. The primary outcomes were all-cause mortality, major cardiovascular events (a composite of cardiovascular mortality and myocardial infarction), serious adverse events (defined as any untoward medical occurrence that resulted in death, was life-threatening, …
Contributors JF: drafted the protocol, extracted data, co-ordinated the review, conceived the review, designed the review, interpreted the data by providing a methodological view and revised the review. EEN: drafted the protocol, extracted data, drafted the review, interpreted the data by providing a methodological view and revised the review. CG: revised the protocol, interpreted the data by providing a methodological and clinical view, and commented on and revised the review. JCJ: revised the protocol, analysed the data, interpreted the data by providing a methodological and clinical view, and commented on and revised the review.
Funding This study was funded by Cochrane Review Support Program.
Competing interests CG is a member of the Copenhagen Trial Unit task force for developing Trial Sequential Analysis methods, manuals and software.
Patient consent Not required.
Provenance and peer review Commissioned; internally peer reviewed.