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(Circulation. 2007;115:3181-3188.)
© 2007 American Heart Association, Inc.

Interventional Cardiology

Long-Term Safety and Efficacy of Drug-Eluting Stents

Two-Year Results of the REAL (REgistro AngiopLastiche dell’Emilia Romagna) Multicenter Registry

Antonio Marzocchi, MD; Francesco Saia, MD, PhD; Giancarlo Piovaccari, MD; Antonio Manari, MD; Enrico Aurier, MD; Alberto Benassi, MD; Alberto Cremonesi, MD; Gianfranco Percoco, MD; Elisabetta Varani, MD; Paolo Magnavacchi, MD; Paolo Guastaroba, MSc; Roberto Grilli, MD; Aleardo Maresta, MD

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

Correspondence to Francesco Saia, MD, PhD, Catheterization Laboratory, Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi (Pad 21), Via Massarenti, 9, 40138 Bologna, Italy. E-mail francescosaia{at}hotmail.com

Received September 29, 2006; accepted April 13, 2007.

Background— The long-term safety and efficacy of drug-eluting stents (DES) have been questioned recently.

Methods and Results— Between July 2002 and June 2005, 10 629 patients undergoing elective percutaneous coronary intervention with either DES (n=3064) or bare-metal stents (BMS, n=7565) were enrolled in a prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up. A propensity score analysis to adjust for different baseline clinical, angiographic, and procedural characteristics was performed. The 2-year unadjusted cumulative incidence of major adverse cardiac events was 17.8% in the DES group and 21.0% in the BMS group (P=0.003 by log-rank test). Angiographic stent thrombosis was 1.0% in the DES group and 0.6% in the BMS group (P=0.09). After adjustment, the 2-year cumulative incidence of death was 6.8% in the DES group and 7.4% in the BMS group (P=0.35), whereas the rates were 5.3% in DES and 5.8% in BMS for acute myocardial infarction (P=0.46), 9.1% in DES and 12.9% in BMS for target-vessel revascularization (P<0.00001), and 16.9% in DES and 21.8% in BMS for major adverse cardiac events (P<0.0001). Independent predictors of target-vessel revascularization in the DES group were diabetes mellitus (hazard ratio 1.36, 95% confidence interval 1.06 to 1.76), renal failure (hazard ratio 1.69, 95% confidence interval 1.06 to 2.69), and reference vessel diameter (hazard ratio 0.64, 95% confidence interval 0.45 to 0.93).

Conclusions— In this large real-world population, the beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile.

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