Aims: To provide systematic assessment of the clinical effectiveness of drug-eluting stents (DES) versus non-DES to inform national guidance.
Methods and results: The review was conducted according to internationally recognised methods. The search strategy identified published (7) and unpublished (7) randomised controlled trials comparing the use of DES to non-DES. Outcomes included death, acute myocardial infarction (AMI), revascularisation, event rate (composite of adverse events), and binary restenosis. Data synthesis included descriptive statistics and meta-analysis. Fourteen randomised clinical trials comparing DES to non-DES and involving 5747 patients were identified. There were reductions in event rates between DES and non-DES; odds ratio (OR) 0.63 (95% confidence interval [95% CI] 0.47, 0.84, n = 1978) for paclitaxel-eluting stents at 12 months, OR 0.30 (95% CI 0.22, 0.42, n = 1296) for sirolimus-eluting stents at 12 months. Combined event rates were inconsistently defined across trials and were primarily composed of revascularisations, possibly driven by protocol-required angiograms. DES reduced binary restenosis rates at angiogram compared to non-DES. No significant differences in rates of death or AMI were identified.
Conclusion: The early data available indicate that DES reduce adverse cardiac events, mainly revascularisations. However, these data are limited in terms of patient numbers, length of follow-up, and method of outcome assessment. The evaluation of rapidly evolving technologies requires the inclusion of data not routinely considered for inclusion in systematic reviews of effectiveness.