RAFT
Trial question
What is the role of addition of cardiac-resynchronization therapy to an ICD in patients with LV systolic dysfunction and a wide QRS complex?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
17.0% female
83.0% male
N = 1798
1798 patients (308 female, 1490 male).
Inclusion criteria: patients with NYHA (NYHA) class II or III HF, an LVEF ≤ 30%, and an intrinsic QRS duration ≥ 120 msec or a paced QRS duration ≥ 200 msec.
Key exclusion criteria: life expectancy of < 1 year from noncardiac causes, intravenous inotropic agent in the last 4 days, acute coronary syndrome, tricuspid prosthetic valve, severe primary pulmonary disease.
Interventions
N=894 ICD-CRT implantation (ICD plus cardiac-resynchronization therapy and optimal medical therapy).
N=904 ICD implantation alone (ICD and optimal medical therapy).
Primary outcome
Death or hospitalization for heart failure
33.2%
40.3%
40.3 %
30.2 %
20.1 %
10.1 %
0.0 %
ICD-CRT
implantation
ICD implantation
alone
Significant
decrease ▼
NNT = 14
Significant decrease in death or hospitalization for HF (33.2% vs. 40.3%; HR 0.75, 95% CI 0.64 to 0.87).
Secondary outcomes
Significant decrease in death from any cause (20.8% vs. 26.1%; HR 0.75, 95% CI 0.62 to 0.91).
Significant decrease in hospitalization for HF (19.5% vs. 26.1%; HR 0.68, 95% CI 0.56 to 0.83).
Significant decrease in death due to cardiovascular causes (14.5% vs. 17.9%; HR 0.76, 95% CI 0.6 to 0.96).
Safety outcomes
Significant differences in adverse events at 30 after device implantation (118 vs. 61 events, p < 0.001).
Conclusion
In patients with NYHA (NYHA) class II or III HF, an LVEF ≤ 30%, and an intrinsic QRS duration ≥ 120 msec or a paced QRS duration ≥ 200 msec, ICD-CRT implantation was superior to ICD implantation alone with respect to death or hospitalization for HF.
Reference
Tang AS, Wells GA, Talajic M et al. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010 Dec 16;363(25):2385-95.
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