Quality of reporting internal and external validity data from randomized controlled trials evaluating stents for percutaneous coronary intervention

The objective of our study was to evaluate the quality of reporting internal and external validity data in published reports of RCTs assessing the stents for percutaneous coronary interventions.A systematic literature review was conducted. Reports of RCTs assessing stents for percutaneous coronary interventions indexed in MEDLINE and the Cochrane Central Register of Controlled Trials and published between January 2003 and September 2008 were selected. A standardized abstraction form was used to extract data. All analyses were adjusted for the effect of clustering articles by journal.132 articles were analyzed. The generation of the allocation sequence was adequate in 58.3% of the reports; treatment allocation was concealed in 34.8%. Adequate blinding was reported in one-fifth of the reports. An intention-to-treat analysis was described in 79.5%. The main outcome was a surrogate angiographic endpoint in 47.0%. The volume of interventions per center was described in two reports. Operator expertise was described in five (3.8%) reports. The quality of reporting was better in journals with high impact factors and in journals endorsing the CONSORT statement.The current reporting of results of RCTs testing stents needs to be improved to allow readers to appraise the risk of bias and the applicability of the results.In the past decade, stenting has become a routine treatment for many patients with coronary artery disease [1]. Stent design has evolved through various iterations, with the most important advance being the development of drug-eluting stents (DESs). These advances were serially evaluated in randomized clinical trials, often using restenosis as an endpoint.RCTs are widely accepted as the gold standard for the evaluation of new treatments [2]. The design, conduct, analysis, and reporting of RCTs should follow specific guidelines in order to provide valid results and avoid common pitfalls [3]. However, RCTs assessing stents face specific issues related to difficult