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(Circulation. 2008;117:923-930.)
© 2008 American Heart Association, Inc.

Interventional Cardiology

Two-Year Clinical Outcomes With Drug-Eluting Stents for Diabetic Patients With De Novo Coronary Lesions

Results From a Real-World Multicenter Registry

Paolo Ortolani, MD; Marco Balducelli, MD; Paolo Marzaroli, MSc; Giancarlo Piovaccari, MD; Alberto Menozzi, MD; Vincenzo Guiducci, MD; Pietro Sangiorgio, MD; Fabio Tarantino, MD; Giuseppe Geraci, MD; Fausto Castriota, MD; Stefano Tondi, MD; Francesco Saia, MD, PhD; Robin M.T. Cooke, MA; Paolo Guastaroba, MSc; Roberto Grilli, MD; Antonio Marzocchi, MD; Aleardo Maresta, MD

From the Istituto di Cardiologia, Università di Bologna, Policlinico S. Orsola-Malpighi (P.O., F.S., R.M.T.C., A. Marzocchi); Unità Operativa di Cardiologia–Centro Interventistico, Ospedale S. Maria delle Croci, Ravenna (M.B., A. Maresta); Unità Operativa di Cardiologia, Ospedale degli Infermi, Rimini (G.P.); Divisione di Cardiologia, Ospedale Maggiore, Parma (A. Menozzi); Unità Operativa di Cardiologia Interventistica, Ospedale S. Maria Nuova, Reggio Emilia (V.G.); Divisione di Cardiologia, Ospedale Maggiore, Bologna (P.S.); Laboratorio di Emodinamica, Ospedale Morgagni, Forlì (F.T.); Laboratorio di Emodinamica, Policlinico di Modena, Modena (G.G.); Casa di Cura Villa Maria Cecilia Hospital, Cotignola (F.C.); Nuovo Ospedale S. Agostino, Modena (S.T.); and Agenzia Sanitaria Regionale Regione Emilia-Romagna Bologna, Bologna (P.H., P.G., R.G.), Italy.

Correspondence to Paolo Ortolani, MD, Institute of Cardiology, University of Bologna, Azienda Ospedaliera S. Orsola-Malpighi, Via Massarenti 9, 40138, Bologna, Italy. E-mail paortol{at}tin.it

Received July 26, 2007; accepted December 14, 2007.

Background— The long-term effectiveness of drug-eluting stents (DES) in unselected diabetics in routine practice is currently unclear.

Methods and Results— To evaluate the long-term effectiveness of bare metal stents and DES in a real-world setting of diabetic patients, we analyzed 2-year follow-up data from all diabetic patients with de novo lesions enrolled in a prospective Web-based multicenter registry (Registro Regionale Angioplastiche dell’Emilia-Romagna; study period, 2002 to 2004) comprising all 13 hospitals performing percutaneous coronary interventions in the Emilia-Romagna region of Italy. Among the 1648 eligible patients treated with either bare metal stents alone (n=1089) or DES alone (n=559), 27% were insulin dependent and 83% had multivessel coronary disease. At 2 years, use of DES was associated with lower crude incidence of major adverse cardiac advents (all-cause mortality, nonfatal myocardial infarction, and target vessel revascularization) compared with bare metal stents (22.5% versus 28.1%; P=0.01). After propensity score adjustment, only target vessel revascularization appeared significantly lower in the DES group (11.6% versus 15.0%; hazard ratio, 0.66; 95% confidence interval, 0.46 to 0.96; P=0.041). Two-year angiographic stent thrombosis occurred in 1.5% DES patients and 0.7% of the bare-metal-stents patients (P=0.18). At Cox regression analysis, predictors of 2-year major adverse cardiac advents were left ventricular ejection fraction <35%, Charlson comorbidity index, insulin-dependent diabetes, and total lesion length.

Conclusions— In this large, real-world, diabetic population, the use of DES was associated with a moderate reduction in the 2-year risk of target vessel revascularization, a benefit that was limited to non–insulin-dependent diabetic patients. Larger long-term studies are needed to clarify the long-term effectiveness and safety of such devices in diabetic patients.

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