Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention.

Morgane Ethgen,Isabelle Boutron,Philippe Gabriel Steg,Philippe Ravaud,Carine Roy

doi:10.1186/1745-6215-10-29

Abstract

BackgroundThe aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention.MethodsThe study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected.A standardized abstraction form was used to extract data.Results132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke) were reported as primary or secondary outcomes in 107 reports (81%). However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22%) and a definition of expected adverse events was provided in 47 (36%). The length of follow-up was reported in 95 reports (72%). Assessment of adverse events by an adjudication committee was described in 46 reports (35%), and adverse events were described as being followed up for 6 months in 24% of reports (n = 32), between 7 to 12 months in 42% (n = 55) and for more than 1 year in 4% (n = 5). In 115 reports (87%), numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%). The causality of adverse events was reported in only 4 articles.ConclusionSeveral harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention.Trials RegistrationTrials manuscript: 5534201182098351 (T80802P)

Highlights

Since the development of balloon angioplasty and the introduction of stents for percutaneous coronary intervention, stent technology has rapidly evolved [1]
Search strategy and study selection We identified all reports of randomized controlled trial (RCT) assessing stents that were published between January 1, 2003, and September 30, 2008
The experimental treatment was described as a bare metal stent in 31% of reports (n = 41), a polymercoated stent in 14% (n = 19), a drug-eluting stent in 49% (n = 64) and a strategy of stent use in 6% (n = 8)

Summary

Introduction

Since the development of balloon angioplasty and the introduction of stents for percutaneous coronary intervention, stent technology has rapidly evolved [1]. By the end of 2004, drug-eluting stents were used in nearly 80% of percutaneous coronary interventions in the United States, and within 3 years, several million drug-eluting stents had been implanted worldwide [1,2,3]. This widespread dissemination of the technology may have been achieved at the expense of insufficient assessment of harm [4,5,6,7]. The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

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Discussion

Conclusion