Drug-eluting stents:: an early systematic review to inform policy

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 The search strategy identified published (7) and unpublished (7) randomised controlled trials comparing the use of DES to non-DES.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-anatysis. 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 pactitaxel-eluting stents at 12 months, OR 0.30 (95% CI 0.22, 0.42, n = 1296) for sirolimus-etuting 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. (C) 2004 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved.