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


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 (> or =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.


CONCLUSIONS
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.
Pfisterer
Matthias
M
Department of Cardiology, University Hospital Basel, Petersgraben, Basel, Switzerland. pfisterer@email.ch
Brunner-La Rocca
Hans Peter
HP
Rickenbacher
Peter
P
Hunziker
Patrick
P
Mueller
Christian
C
Nietlispach
Fabian
F
Leibundgut
Gregor
G
Bader
Franziska
F
Kaiser
Christoph
C
D000368:Aged; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D002317:Cardiovascular Agents / Q000008:administration & dosage / Q000627:therapeutic use; D023921:Coronary Stenosis / Q000188:drug therapy / Q000601:surgery*; D003331:Coronary Vessels / Q000601:surgery*; D054855:Drug-Eluting Stents; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular; D006801:Humans; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D018570:Risk Assessment / Q000379:methods; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents