6/28/23, 11:16 PM MADIT-CRT Pathway Feedback Search Clinical Topics Home Studies MADIT CRT MADIT CRT Disease Disease Disease Coronary artery disease Dilated cardiomyopathy Heart failu Trial question What is the role of cardiac resynchronization therapy in addition to ICD in patients with mild cardiac symptoms, a reduced ejection fraction, and a wide QRS complex? Study design Multi-center Open label RCT Population Characteristics of study participants 25.0% female N = 1820 75.0% male 1820 patients (453 female, 1367 male) Inclusion criteria: patients with ischemic or nonischemic cardiomyopathy, an ejection fraction 30%, a QRS duration 30 ms, and NYHA class I or II symptoms Key exclusion criteria: existing indication for CRT; NYHA class III or IV symptoms, previous CABG, PCI, or an enzyme-positive myocardial infarction within 3 months before enrollment; AF within 1 month before enrollment Interventions N=1089 CRT plus ICD implantation (cardiac resynchronization therapy with biventricular pacing plus ICD) N=731 ICD implantation only (ICD) https://web.pathway.md/studies/recuJgDvvzF9H6gws 1/2 6/28/23, 11:16 PM MADIT-CRT Pathway Primary outcome Death from any cause or a nonfatal heart-failure event 25.3 % 25.3 19.0 % 17.2 12.7 % Significant decrease 6.3 % NNT = 12 0.0 % CRT plus ICD implantation ICD implantation only Significant decrease in death from any cause or a nonfatal heart-failure event (17.2% vs. 25.3%; HR 0.66, 95% CI 0.52 to 0.84) Secondary outcomes Significant decrease in HF (13.9% vs. 22.8%; HR 0.59, 95% CI 0.47 to 0.74) No significant difference in death (6.8% vs. 7.3%; HR 1, 95% CI 0.69 to 1.44) Safety outcomes No significant differences in serious adverse events, including pneumothorax, infection, and pocket hematoma requiring evacuation. Conclusion In patients with ischemic or nonischemic cardiomyopathy, an ejection fraction 30%, a QRS duration 30 ms, and NYHA class I or II symptoms, CRT plus ICD implantation was superior to ICD implantation only with respect to death from any cause or a nonfatal heart-failure event. Reference Moss AJ, Hall WJ, Cannom DS et al. Cardiac-resynchronization therapy for the prevention of heart- failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. Open reference URL https://web.pathway.md/studies/recuJgDvvzF9H6gws 2/2