Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention.
BACKGROUND
The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention.


METHODS
The 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.


RESULTS
132 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.


CONCLUSIONS
Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention.


BACKGROUND
Trials manuscript: 5534201182098351 (T80802P).
Ethgen
Morgane
M
INSERM, U738, Paris, F-75018 France. morganeethgen@hotmail.com
Boutron
Isabelle
I
Steg
Philippe Gabriel
PG
Roy
Carine
C
Ravaud
Philippe
P
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D002318:Cardiovascular Diseases / Q000209:etiology* / Q000401:mortality; D003257:Consumer Product Safety; D030881:Disclosure; D006801:Humans; D010506:Periodicals as Topic; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D018570:Risk Assessment; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome