José M de la Torre Hernández1, Juan F Oteo Domínguez2, Felipe Hernández3, Tamara García Camarero4, Omar Abdul-Jawad Altisent5, Fernando Rivero Crespo6, José D Cascón7, Germán Zavala8, Federico Gimeno9, Antonio L Arrebola Moreno10, Leire Andraka11, Antonio Gómez Menchero12, Francisco Bosa13, Xavier Carrillo14, Ángel Sánchez Recalde15, Fernando Alfonso16, Armando Pérez de Prado17, Ramón López Palop18, Juan Sanchis19, José A Diarte de Miguel20, Manuel Jiménez Navarro21, Luz Muñoz22, Antonio Ramírez Moreno23, Helena Tizón Marcos24. 1. Servicio de Cardiología, Hospital Marqués de Valdecilla, Santander, Cantabria, Spain. Electronic address: he1thj@humv.es. 2. Servicio de Cardiología, Hospital Puerta de Hierro, Majadahonda, Madrid, Spain. 3. Servicio de Cardiología, Hospital 12 de Octubre, Madrid, Spain. 4. Servicio de Cardiología, Hospital Marqués de Valdecilla, Santander, Cantabria, Spain. 5. Servicio de Cardiología, Hospital Mútua Terrassa, Terrassa, Barcelona, Spain. 6. Servicio de Cardiología, Hospital Universitario de la Princesa, Madrid, Spain. 7. Servicio de Cardiología, Hospital Santa Lucía, Cartagena, Murcia, Spain. 8. Servicio de Cardiología, Hospital Vall d'Hebron, Barcelona, Spain. 9. Servicio de Cardiología, Hospital Clínico, Valladolid, Spain. 10. Servicio de Cardiología, Hospital Universitario Virgen de las Nieves, Granada, Spain. 11. Servicio de Cardiología, Hospital de Basurto, Bilbao, Spain. 12. Servicio de Cardiología, Hospital Juan Ramón Jiménez, Huelva, Spain. 13. Servicio de Cardiología, Hospital Clínico, Santa Cruz de Tenerife, Spain. 14. Servicio de Cardiología, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain. 15. Servicio de Cardiología, Hospital La Paz, Madrid, Spain. 16. Servicio de Cardiología, Hospital Clínico San Carlos, Madrid, Spain. 17. Servicio de Cardiología, HemoLeon, Fundación Investigación Sanitaria en León, León, Spain. 18. Servicio de Cardiología, Hospital San Juan, San Juan de Alicante, Alicante, Spain. 19. Servicio de Cardiología, Hospital Clínico, Valencia, Spain. 20. Servicio de Cardiología, Hospital Miguel Servet, Zaragoza, Spain. 21. Servicio de Cardiología, Hospital Virgen de la Victoria, Málaga, Spain. 22. Servicio de Cardiología, Hospital Carlos Haya, Málaga, Spain. 23. Servicio de Cardiología, Hospiten Estepona, Marbella, Málaga, Spain. 24. Servicio de Cardiología, Hospital del Mar, Grupo de Investigación Biomédica en Enfermedades del Corazón, IMIM (Instituto Hospital del Mar de Investigaciones Médicas), Barcelona, Spain.
Abstract
INTRODUCTION AND OBJECTIVES: The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. METHODS: A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. RESULTS: The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen.
INTRODUCTION AND OBJECTIVES: The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. METHODS: A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. RESULTS: The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen.