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European Heart Journal Advance Access originally published online on November 25, 2008
European Heart Journal 2009 30(1):16-24; doi:10.1093/eurheartj/ehn516
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org

Long-term benefit–risk balance of drug-eluting vs. bare-metal stents in daily practice: does stent diameter matter? Three-year follow-up of BASKET

Matthias Pfisterer1,*,{dagger}, Hans Peter Brunner-La Rocca1,{dagger}, Peter Rickenbacher3, Patrick Hunziker2, Christian Mueller2, Fabian Nietlispach1, Gregor Leibundgut1, Franziska Bader1, Christoph Kaiser1,{ddagger} for the BASKET Investigators{ddagger}

1 Department of Cardiology, University Hospital Basel, Petersgraben 4, CH-4031 Basel, Switzerland
2 Department of Internal Medicine, University Hospital Basel, Basel, Switzerland
3 Bruderholzspital, Bruderholz, Switzerland

Received 16 June 2008; revised 29 September 2008; accepted 23 October 2008; online publish-ahead-of-print 25 November 2008.

* Corresponding author. Tel: +41 265 5214, Fax: +41 265 4598, Email: pfisterer{at}email.ch

Aims: To assess the long-term benefit–risk ratio of drug-eluting (DES) vs. bare-metal stents (BMS) relative to stent size.

Methods and results: All 826 consecutive BASKET (BAsel Stent Kosten-Effektivitäts Trial) patients randomized 2:1 to DES vs. BMS were followed after 3 years. Data were analysed separately for patients with small stents (<3.0 mm vessel/<4.0 mm bypass grafts, n = 268) vs. only large stents (≥3.0 mm native vessels, n = 558). Clinical events were related to stent thrombosis. Three-year clinical target-vessel revascularization rates remained borderline reduced after DES [9.9 vs. 13.9% (BMS), P = 0.07], particularly in patients with small stents (10.7 vs. 19.8%, P = 0.03; large stents: 9.5 vs. 11.5%, P = 0.44). Cardiac death/myocardial infarction (MI) rates (12.7 vs. 10.0%, P = 0.30) were similar, however, death/MI beyond 6 months was higher after DES [9.1 vs. 3.8% (BMS), P = 0.009], mainly due to increased late death/MI in patients with large stents (9.7 vs. 3.1%, P = 0.006). The results paralleled findings for stent thrombosis.

Conclusion: The clinical benefit of DES was maintained at no overall increased risk of death or death/MI up to 3 years. However, death/MI rates were increased in DES vs. BMS patients beyond 6 months, particularly in patients with large stents, paralleling findings for stent thrombosis. Thus, stent size seems to influence the 3-year benefit–risk ratio after DES implantation.

Key Words: Drug-eluting stents • Bare-metal stents • Stent thrombosis • Outcome • Coronary artery disease

{dagger} The first two authors contributed equally to this paper.

{ddagger} The BAsel Stent Kosten-Effektivitäts Trial (BASKET) Investigators are listed in Ref. 14.

Trial Registration number: ISRCTN75663024 [controlled-trials.com] – BAsel Stent Kosten-Effektivitäts Trial (Basel stent cost-effectiveness trial).


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