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Clinical research

Patient selection to enhance the long-term benefit of first generation drug-eluting stents for coronary revascularisation procedures. Insights from a large multicentre registry

1. Istituto di Cardiologia, Università di Bologna, Policlinico S. Orsola-Malpighi, Italy; 2. Unità Operativa di Cardiologia, Ospedale degli Infermi, Rimini, Italy; 3. Unità Operativa di Cardiologia Interventistica, Ospedale S. Maria Nuova, Reggio Emilia, Italy; 4. Agenzia Sanitaria Regionale Regione Emilia-Romagna Bologna, Italy; 5. Divisione di Cardiologia, Ospedale Maggiore, Parma, Italy; 6. Unità Operativa di Cardiologia, Centro Interventistico, Ospedale S. Maria delle Croci, Ravenna, Italy; 7. Laboratorio di Emodinamica, Hesperia Hospital, Modena, Italy; 8. Casa di cura Villa Maria Cecilia Hospital, Cotignola (Ra), Italy; 9. Laboratorio di Emodinamica, Ospedale di Ferrara, Italy; 10. Nuovo Ospedale S. Agostino, Modena, Italy; 11. Laboratorio di Emodinamica, Ospedale Morgagni, Forlì, Italy

Aims: To evaluate the long-term clinical outcome after drug-eluting stents (DES) implantation, and to test if patient selection could enhance their net clinical benefit.

Methods and results: We assessed the incidence of major adverse cardiac events (MACE=death, acute myocardial infarction, and target vessel revascularisation, TVR) and angiographic stent thrombosis (ST) during 3-year follow-up in a prospective multicentre registry. Propensity-score analysis to adjust for different clinical, angiographic and procedural characteristics was performed. Overall, 14,115 patients enrolled in the registry received solely BMS (n=9,565) or DES (n=4,550). The incidence of definite ST was 0.6% for BMS and 1.3% for DES (p=0.003). The propensity-score adjusted incidence of cardiac death and myocardial infarction was similar between the two groups (DES 11.9% vs. BMS 12.1%, HR 0.90, 95% CI 0.77-1.04), whereas DES were associated with lower rates of TVR (DES 11.6% vs. BMS 15.2%, HR 0.67, 95% CI 0.59-0.76). The efficacy of DES in reducing TVR increased with increasing likelihood of TVR at baseline.

Conclusions: The beneficial effect of DES in reducing new revascularisations compared to BMS extends out to three years without a significantly worse overall safety profile. The benefit seems more evident in patients with the highest baseline risk of clinical restenosis.

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