Stroke-free Survival Comparison Between Early Surgery and Conventional Therapy in Left Infective Endocarditis. A Multicenter Partially Randomized Preference Trial (EARLY Study)

Objectives, structure and design of the Study

Study design

Open-label, multicenter, randomized controlled clinical trial to compare early surgery with conventional therapy, in reducing the 1-year mortality or stroke in patients with IE.

Eligible patients will be evaluated by a team including a cardiologist, an infectious diseases expert, and a cardiac surgeon within 24 hours from the initial diagnosis and, if they accept the randomization, then randomized in two arms:

  • early surgical strategy (performed within 72 hours from IE diagnosis)
  • conventional therapy (medical treatment or delayed surgical intervention according to the current guidelines)

Primary objective

Primary objective of the study is to evaluate whether, in patients with IE and no ermengency surgery indication, an early surgical strategy (performed within 72 hours from IE diagnosis) is more effective than conventional therapy in terms of 1-year stroke-free survival.

Secondary objectives

Secondary objectives of the study is to compare effectiveness of early surgery strategy and conventional therapy in terms of:

  • in-hospital mortality
  • overall survival
  • embolic event
  • strokes
  • event-free survival
  • EI relapse
  • length of hospital stay
  • hospital re-admission and hospitalization days
  • quality of life
  • health care costs

Sample size

400 Patients

Number of Centers and location of the Study

16 Centers in Italy

Study duration

3 years based on the following assumptions:

  1. Recruitment: 2 years
  2. Follow-up: 12 months

Study start date

December 2017