Article type
Year
Abstract
Methods: Study design: Methodological systematic review of Randomized controlled trials (RCT). Data Sources: MEDLINE and the Cochrane Central Register of Controlled Trials. Study selection: Reports of randomized controlled trials assessing stents for cardiovascular disease published between January 2003 and December 2005. Data extraction: A standardized abstraction form was used to extract data.
Results: 80 articles were analyzed; the experimental treatment was a bare metal stent in 45.0% of the reports, a polymer coated stent in 17.5%, a drug eluting stent in 33.8% and a strategy of stent implantation in 3.8%. The generation of allocation sequence was adequate in 38.8% of the reports. The treatment allocation was concealed in only 26.3%. Data on blinding retrieved that patients, care providers and outcome assessors were adequately blinded respectively in 15 reports (18.8%), in 14 reports (17.5%) and in 17 (21.3%). An intent-to-treat analysis was described in 56 reports (70.0%). The main outcome was a surrogate angiographic outcome (i.e. coronary restenosis) in 46.3% of the reports. Although at least some details of the intervention were reported in 90% of the articles, in about 20% of the reports, no information was provided on the stent used. Most trials were multicentric (52.5%); however, the number of centers involved was not reported or unclear in one third of the reports and the setting (i.e. primary, secondary, tertiary, academic) was described in only 5 reports. The volume of interventions performed by each center was never described. Expertise of care providers was reported in 2 reports (2.5%). The quality of reporting was better in high impact factor journals and in journals endorsing the CONSORT Statement.
Conclusions: This study highlights the currently poor reporting of data necessary to appraise the risk of bias and the applicability of the results of RCTs involving stents.
Results: 80 articles were analyzed; the experimental treatment was a bare metal stent in 45.0% of the reports, a polymer coated stent in 17.5%, a drug eluting stent in 33.8% and a strategy of stent implantation in 3.8%. The generation of allocation sequence was adequate in 38.8% of the reports. The treatment allocation was concealed in only 26.3%. Data on blinding retrieved that patients, care providers and outcome assessors were adequately blinded respectively in 15 reports (18.8%), in 14 reports (17.5%) and in 17 (21.3%). An intent-to-treat analysis was described in 56 reports (70.0%). The main outcome was a surrogate angiographic outcome (i.e. coronary restenosis) in 46.3% of the reports. Although at least some details of the intervention were reported in 90% of the articles, in about 20% of the reports, no information was provided on the stent used. Most trials were multicentric (52.5%); however, the number of centers involved was not reported or unclear in one third of the reports and the setting (i.e. primary, secondary, tertiary, academic) was described in only 5 reports. The volume of interventions performed by each center was never described. Expertise of care providers was reported in 2 reports (2.5%). The quality of reporting was better in high impact factor journals and in journals endorsing the CONSORT Statement.
Conclusions: This study highlights the currently poor reporting of data necessary to appraise the risk of bias and the applicability of the results of RCTs involving stents.