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Circulation ; 131(1): 74-81, 2015 Jan 06.
Artículo en Inglés | MEDLINE | ID: mdl-25411159

RESUMEN

BACKGROUND: Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. METHODS AND RESULTS: To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. CONCLUSIONS: In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01166685.


Asunto(s)
Implantes Absorbibles , Antiinflamatorios/uso terapéutico , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Polímeros , Sirolimus/análogos & derivados , Implantes Absorbibles/efectos adversos , Anciano , Antiinflamatorios/efectos adversos , Aspirina/uso terapéutico , Stents Liberadores de Fármacos/efectos adversos , Everolimus , Femenino , Humanos , Estimación de Kaplan-Meier , Estudios Longitudinales , Masculino , Metales , Persona de Mediana Edad , Piperazinas/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Polímeros/efectos adversos , Clorhidrato de Prasugrel , Antagonistas del Receptor Purinérgico P2Y/uso terapéutico , Método Simple Ciego , Sirolimus/efectos adversos , Sirolimus/uso terapéutico , Stents , Suiza , Tiofenos/uso terapéutico , Resultado del Tratamiento
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