Rationale, design, and methods for the early surgery in infective endocarditis study (ENDOVAL 1): A multicenter, prospective, randomized trial comparing the state-of-the-art therapeutic strategy versus early surgery strategy in infective endocarditis - 09/08/11
, Javier López, MD, PhD a, Ana Revilla, MD a, Isidre Vilacosta, MD, PhD, FESC b, Pilar Tornos, MD, PhD, FESC c, Benito Almirante, MD, PhD c, Pedro Mota, MD a, Eduardo Villacorta, MD a, Teresa Sevilla, MD a, Itziar Gómez, BS a, María del Carmen Manzano, MD b, Enrique Fulquet, MD, PhD a, Enrique Rodríguez, MD, PhD b, Alberto Igual, MD cRésumé |
Background |
The prognosis of infective endocarditis is poor and has remained steady over the last 4 decades. Several nonrandomized studies suggest that early surgery could improve prognosis.
Methods |
ENDOVAL 1 is a multicenter, prospective, randomized study designed to compare the state-of-the-art therapeutic strategy (advised by the international societies in their guidelines) with the early-surgery strategy in high-risk patients with infective endocarditis. Patients with infective endocarditis without indication for surgery will be included if they meet at least one of the following: (1) early-onset prosthetic endocarditis; (2) Staphylococcus aureus endocarditis; (3) periannular complications; (4) new-onset conduction abnormalities; (5) new-onset severe valvular dysfunction. A total of 216 patients will be randomized to either of the 2 strategies. Stratification will be done within 3 days of admission. In the early surgery arm, the surgical procedure will be performed within 48 hours of randomization. The only event to be considered will be death within 30 days. The study will be extended to 1 year. In the follow-up substudy, death and a new episode of endocarditis will be regarded as events.
Conclusion |
ENDOVAL 1, the first randomized study on endocarditis, will provide crucial information regarding the putative benefit of early surgery over the state-of-the-art therapeutic approach in high-risk patients with infective endocarditis.
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| This study was financed in part by the Cooperative Network for Cardiovascular Research (Red Cooperativa de Enfermedades Cardiovasculares, RECAVA) of the Spanish National Institute of Health (Instituto de Salud Carlos III). ClinicalTrials.gov identifier: NCT 00624091. |
Vol 156 - N° 3
P. 431-436 - septembre 2008 Retour au numéro
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