Steroids for Prevention of Restenosis in Bare-metal Stents
Steroids for Prevention of Restenosis in Bare-metal Stents
We searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials for trials that randomized study participants to steroids prior to angioplasty with or without stent placement versus placebo/standard therapy, between 1990 and 2011. The following medical subject heading (MeSH) terms were included for MEDLINE search and adapted for other databases as needed: 'steroids and angioplasty,' 'steroids and PTCA,' 'bare-metal stent and steroids,' 'steroid and prevention of restenosis in bare-metal stents,' and 'prevention of restenosis of bare-metal stents.' In addition to searching these databases, the reference lists of all identified studies, meta-analyses, and reviews were reviewed manually. No language restriction was imposed on the search.
We included trials that studied adult patients (18+ years) who had a recent angioplasty or placement of BMS(s) and received periprocedural corticosteroids (within 72 hours before stent implantation up to 7 days after stent placement). Eligible trials had to be randomized clinical trials comparing restenosis rates with and without periprocedural steroids having a minimum follow-up duration of 6 months. Animal studies as well as pathological analyses were excluded, as were subgroup analyses from trials.
Two authors (SC, PS) reviewed the trials to ensure that they met inclusion criteria and abstracted the data. Disagreements were resolved by consensus (approximately 10% of the time). We performed objective assessment of the trials using the methods specified in the Cochrane Handbook of Systematic Reviews, assessing each study based on randomization, concealment, blinding, intention to treat, baseline comparisons, concomitant interventions, and completeness of follow-up.
The primary endpoint of interest was rate of restenosis at the end of at least 6 months of follow-up. Secondary outcomes of interest were all-cause mortality and rates of target vessel revascularization. The maximum duration of follow-up assessed was 1.2 years. Statistical analysis. Meta-analysis was performed as per the recommendation of the Cochrane collaboration and in line with the PRISMA statement. Pooled treatment effects were estimated by developing risk ratios, using the Mantel-Haenszel random-effects model. Heterogeneity was assessed using chi-square tests and the I statistic; we defined I <50% to be low heterogeneity. We assessed relative risk for data with heterogeneity, and as per Cochrane metrics, publication bias was estimated using funnel plots and the regression test of Egger. For statistical analysis, we used Review Manager Version 5.1 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008).
Methods
Search Strategy
We searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials for trials that randomized study participants to steroids prior to angioplasty with or without stent placement versus placebo/standard therapy, between 1990 and 2011. The following medical subject heading (MeSH) terms were included for MEDLINE search and adapted for other databases as needed: 'steroids and angioplasty,' 'steroids and PTCA,' 'bare-metal stent and steroids,' 'steroid and prevention of restenosis in bare-metal stents,' and 'prevention of restenosis of bare-metal stents.' In addition to searching these databases, the reference lists of all identified studies, meta-analyses, and reviews were reviewed manually. No language restriction was imposed on the search.
Inclusion and Exclusion Criteria
We included trials that studied adult patients (18+ years) who had a recent angioplasty or placement of BMS(s) and received periprocedural corticosteroids (within 72 hours before stent implantation up to 7 days after stent placement). Eligible trials had to be randomized clinical trials comparing restenosis rates with and without periprocedural steroids having a minimum follow-up duration of 6 months. Animal studies as well as pathological analyses were excluded, as were subgroup analyses from trials.
Data Collection and Processing
Two authors (SC, PS) reviewed the trials to ensure that they met inclusion criteria and abstracted the data. Disagreements were resolved by consensus (approximately 10% of the time). We performed objective assessment of the trials using the methods specified in the Cochrane Handbook of Systematic Reviews, assessing each study based on randomization, concealment, blinding, intention to treat, baseline comparisons, concomitant interventions, and completeness of follow-up.
Outcomes Assessment
The primary endpoint of interest was rate of restenosis at the end of at least 6 months of follow-up. Secondary outcomes of interest were all-cause mortality and rates of target vessel revascularization. The maximum duration of follow-up assessed was 1.2 years. Statistical analysis. Meta-analysis was performed as per the recommendation of the Cochrane collaboration and in line with the PRISMA statement. Pooled treatment effects were estimated by developing risk ratios, using the Mantel-Haenszel random-effects model. Heterogeneity was assessed using chi-square tests and the I statistic; we defined I <50% to be low heterogeneity. We assessed relative risk for data with heterogeneity, and as per Cochrane metrics, publication bias was estimated using funnel plots and the regression test of Egger. For statistical analysis, we used Review Manager Version 5.1 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008).
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