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Incidence and Predictors of Very Late (4 Years) Major Cardiac Adverse Events in the DESIRE (Drug-Eluting Stents in the Real World)-Late Registry

Instituto de Ensino e Pesquisa, Hospital do Coração, São Paulo, Brazil

^_* Reprint requests and correspondence: Dr. J. Ribamar Costa Jr., Hospital do Coração, Associação do Sanatório Sírio, Rua Desembargador Eliseu Guilherme, 147, Paraíso, São Paulo 04004-030, SP, Brazil (Email: rmvcosta{at}uol.com.br).

Objectives: Our aim was to access the incidence of late major adverse cardiac events (MACE) and stent thrombosis (ST) in nonselected, complex patients followed for a period 4 years.

Background: Despite the efficacy of drug-eluting stents (DES) in reducing repeated target lesion revascularization, concerns regarding the occurrence of late and very late ST have partially obscured the benefits of this novel technology.

Methods: All consecutive patients treated solely with DES between May 2002 and January 2005 were enrolled into this prospective, nonrandomized, single-center registry. The primary end point was long-term occurrence of MACE up to 7 years. Independent predictors of MACE, cardiac death, target lesion revascularization, and ST were obtained by a multivariate Cox proportional hazards regression model.

Results: A total of 1,010 patients were enrolled. Most of them were men (77%) with a mean age of 63.7 years. Stent/patient rate was 1.4. Patients were kept in dual antiplatelet therapy for 3 and 6 months after Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) and Taxus (Boston Scientific Corp., Natick, Massachusetts) stent implantation, respectively. Follow-up was obtained in 98.2% of the cohort (median 5.01 years). Survival free of MACE and cumulative incidence of definite/probable ST were 84.6% and 1.7%, respectively. Independent predictors of ST were percutaneous coronary intervention in the setting of acute myocardial infarction, DES overlapping, treatment of multivessel disease, presence of moderate-to-severe calcification at lesion site, and in-stent residual stenosis.

Conclusions: The deployment of DES in complex, real-world patients resulted in a low rate of very long-term MACE and ST. However, ST still occurs very long after the index procedure.

Key Words: drug-eluting stents • stent thrombosis • very long-term outcomes

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CI = confidence interval   CK = creatine kinase   DES = drug-eluting stent(s)   DS = diameter stenosis   HR = hazard ratio   MACE = major adverse cardiac events   MLD = minimum lumen diameter   PCI = percutaneous coronary intervention   QCA = quantitative coronary angiography   RD = reference diameter   TVR = target vessel revascularization

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