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RAFT: CRT, ICD plus medical therapy beneficial in patients with mild-to-moderate HF
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American Heart Association Scientific Sessions 2010
CHICAGO — Rates of mortality and hospitalization were lower in patients with mild-to-moderate HF who were treated with cardiac resynchronization therapy, implantable cardioverter defibrillators and medical therapy compared with those treated with implantable cardioverter defibrillators and medical therapy alone, new study data suggested.
The RAFT was a parallel, randomized control trial featuring patients with NYHA class II or III HF, left ventricular ejection fraction ≤30% and wide QRS duration. In addition to medical therapy, patients received either an ICD (n=904) or an ICD with cardiac resynchronization therapy (CRT; n=894).
After a mean follow-up of 40 months, the primary outcome of composite of all-cause mortality or hospitalization for HF was observed in 33.2% of patients in the ICD-CRT arm and 40.3% of those in the ICD arm (ICD-CRT HR=0.75; 95% CI, 0.64-0.87). The secondary outcomes all favored the ICD-CRT group, including rates of death from any cause (6.1% vs. 20.8%; P=.003), death from CV cause (17.9% vs. 14.5%; P=.019) and rates of hospitalization for HF (26.1% vs. 19.5; P≤.0001).
Among patients in this study, Anthony S.L. Tang, MD, with the Royal Jubilee Hospital, Victoria, British Columbia, Canada, and trial researcher concluded in a news conference, "The addition of CRT to ICD reduces death and hospitalization for HF, and reduces all-cause mortality with an absolute reduction of 6% over a treatment period of 5 years. This translates to 14 patients needing to be treated for 5 years to prevent one death. We also demonstrated that [CRT plus ICD] reduces hospitalization for HF, translating to 11 patients needing to be treated for 5 years to prevent one hospitalization for HF."
Dr. Tang has received research support MedTronic, St. Jude Medical and Boston Scientific. - by Brian Ellis
For more information:
- Tang ASL. LBCT I, Abstract 21768 . Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17; Chicago.
The first statement that can be made is that there is no longer any need for equipoise. It is very clearly evident that the ICD-CRT combination works and works well in patients with mild-to-moderate HF.
The next thing that represents a take home [message] is that we will have to revisit our clinical practice guidelines and understand that we will need to expand the indications from those with class III or ambulatoryclass IV HF to those that have lesser degrees of HF with regards to severity. Importantly, we should then anticipate that to a certain extent clinical practice should change. But we also need to be somewhat circumspect. We're waiting for the cost-effectiveness data from this investigation. We have to understand there is a finite risk of certain morbid events that are important to patients, and we increasingly struggle with how be best characterize the phenotype of patient that responds to CRT.
– Clyde W. Yancy, MD
Medical Director,
Baylor Heart and Vascular Institute, Dallas
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