MADIT-CRT
Trial question
What is the role of CRT 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
75.0% male
N = 1820
1820 patients (453 female, 1367 male).
Inclusion criteria: patients with ischemic or nonischemic cardiomyopathy, an ejection fraction ≤ 30%, a QRS duration ≥ 130 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 MI within 3 months before enrollment; AF within 1 month before enrollment.
Interventions
N=1089 CRT plus ICD implantation (CRT with biventricular pacing plus ICD).
N=731 ICD implantation only (ICD).
Primary outcome
Death from any cause or a nonfatal heart-failure event
17.2%
25.3%
25.3 %
19.0 %
12.7 %
6.3 %
0.0 %
CRT plus ICD
implantation
ICD implantation
only
Significant
decrease ▼
NNT = 12
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 ≥ 130 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.
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