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.
RCT Entities:
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.
Authors: Catherine Chirouze; François Alla; Vance G Fowler; Daniel J Sexton; G Ralph Corey; Vivian H Chu; Andrew Wang; Marie-Line Erpelding; Emanuele Durante-Mangoni; Nuria Fernández-Hidalgo; Efthymia Giannitsioti; Margaret M Hannan; Tatjana Lejko-Zupanc; José M Miró; Patricia Muñoz; David R Murdoch; Pierre Tattevin; Christophe Tribouilloy; Bruno Hoen Journal: Clin Infect Dis Date: 2014-11-10 Impact factor: 9.079
Authors: Tahaniyat Lalani; Christopher H Cabell; Daniel K Benjamin; Ovidiu Lasca; Christoph Naber; Vance G Fowler; G Ralph Corey; Vivian H Chu; Michael Fenely; Orathai Pachirat; Ru-San Tan; Richard Watkin; Adina Ionac; Asuncion Moreno; Carlos A Mestres; José Casabé; Natalia Chipigina; Damon P Eisen; Denis Spelman; Francois Delahaye; Gail Peterson; Lars Olaison; Andrew Wang Journal: Circulation Date: 2010-02-16 Impact factor: 29.690
Authors: Carlos Ortiz; Javier López; Héctor García; Teresa Sevilla; Ana Revilla; Isidre Vilacosta; Cristina Sarriá; Carmen Olmos; Carlos Ferrera; Pablo Elpidio García; Carmen Sáez; Itziar Gómez; José Alberto San Román Journal: Medicine (Baltimore) Date: 2014-12 Impact factor: 1.889