RESUMO
OBJECTIVES: This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. BACKGROUND: There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. METHODS: The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. RESULTS: Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). CONCLUSIONS: Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern.
Assuntos
Angioplastia Coronária com Balão , Reestenose Coronária/prevenção & controle , Stents Farmacológicos/estatística & dados numéricos , Imunossupressores/uso terapêutico , Sirolimo/uso terapêutico , Reestenose Coronária/mortalidade , Bases de Dados Factuais , Stents Farmacológicos/efeitos adversos , Europa (Continente) , Feminino , Indicadores Básicos de Saúde , Humanos , Internacionalidade , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Vigilância de Produtos Comercializados , Sistema de Registros , Estatística como AssuntoRESUMO
Objectives This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher SelectPlus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of baremetalstents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients.Background There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR.Methods The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenterand international registry encompassing virtually all subsets of patients and lesions treated with atleast 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis allpatients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint wasmajor adverse cardiac events and stent thrombosis rate at 1 year.Results Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n 1,235,DES group, n 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%,p 0.001), renal insufficiency (5.8% vs. 2.3%, p 0.003), and prior coronary artery bypass graft(20.5% vs. 11.8%, p 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p 0.3) and myocardialinfarction (2.4% for BMS and 3.3% for DES, p 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher inpatients with DES ISR (6.9% vs. 3.1%, p 0.003, and 1.8% vs. 0.5%, p 0.04, respectively).Conclusions Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesionrevascularization recurrence and no apparent safety concern. (J Am Coll Cardiol Intv 2012;5:6471) © 2012by the American College of Cardiology Foundation.