title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  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.affiliation: Institute of Heart Sciences, ICICOR, Universitary Clinic Hospital, Valladolid, Spain. asanroman@secardiologia.es
authors.forename: José Alberto
authors.initials: JA
authors.lastname: San Román
authors.forename: Javier
authors.initials: J
authors.lastname: López
authors.forename: Ana
authors.initials: A
authors.lastname: Revilla
authors.forename: Isidre
authors.initials: I
authors.lastname: Vilacosta
authors.forename: Pilar
authors.initials: P
authors.lastname: Tornos
authors.forename: Benito
authors.initials: B
authors.lastname: Almirante
authors.forename: Pedro
authors.initials: P
authors.lastname: Mota
authors.forename: Eduardo
authors.initials: E
authors.lastname: Villacorta
authors.forename: Teresa
authors.initials: T
authors.lastname: Sevilla
authors.forename: Itziar
authors.initials: I
authors.lastname: Gómez
authors.forename: María
authors.initials: M
authors.lastname: Del Carmen Manzano
authors.forename: Enrique
authors.initials: E
authors.lastname: Fulquet
authors.forename: Enrique
authors.initials: E
authors.lastname: Rodríguez
authors.forename: Alberto
authors.initials: A
authors.lastname: Igual