The Pharmaceutical Journal
Vol 277 No 7419 p361
23 September 2006

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Safety of drug-eluting stents questioned

Drug-eluting stents are linked to more deaths and Q-wave myocardial infarctions — a clinical surrogate for stent thrombosis — than bare-metal stents, two meta-analyses presented at the World Congress of Cardiology in Barcelona earlier this month suggest.

There has been increasing use of sirolimus (Cypher) and paclitaxel (Taxus) stents by cardiologists since they were introduced around six years ago. Globally about six million people have had a drug-eluting stent fitted.

Edoardo Camenzind, University Hospital Geneva, analysed all randomised trials comparing outcomes with the two drug-eluting stents and bare-metal stents. At four years’ follow-up, in trials involving sirolimus stents, the incidence of death and Q-wave MI was 6.3 per cent in the sirolimus group and 3.9 per cent in the bare-metal stent group (P=0.03), a relative difference of 38 per cent.

With trials involving paclitaxel stents, the rate of death was 2.6 per cent in the paclitaxel group and 2.3 per cent in the bare-metal stent group (P=0.68) at four years.

Alain Nordmann, of the Basel Institute for Clinical Epidemiology, looked at total, cardiac and non-cardiac deaths in his meta-analysis of all patients involved in randomised trials comparing first generation drug-eluting stents and bare-metal stents. The 17 trials included showed overall and non-cardiac mortality was less with bare-metal stents after two to four years’ follow-up. Thirty-five non-cardiac deaths occurred after implantation of sirolimus stents with 15 cancer deaths including those from lung, prostate, pancreas, renal and colon tumours and lymphoma.

“Assessment of cause-specific deaths in patients receiving drug-eluting stents are now mandatory to determine long-term safety of these devices,” Dr Nordmann said and suggested that the cancer deaths could be linked to rapid impairment of patients’ immune systems.