Summary
While this trial had a positive endpoint, it was not a mortality endpoint. A major defect is a lack of a medical therapy alone arm. That said, prevention of heart failure episodes is a laudable goal and given the expense to the US system of CHF, this could be a worthwhile treatment, however the number of patients to benefit will be quite small.
Analysis
As in many modern cardiology trials, a composite endpoint was used and the difference was not that more lives were saved, but other outcomes were prevented. Given this was a low risk population (annual mortality rate of 3%) it was unfortunately there was not a medical treatment arm in the trial. While standard medical therapy was administered to both trial arms, the trial does not show that either arm is superior to medical therapy alone. It is not a given that devices save lives in this low risk population.
The limited message of this trial is that for patients with good clinical status, an EF under 30% and a wide QRS, CRT-ICD is better than ICD alone. The number of patients in the total US CHF population that could benefit from this trial is quite small, and given that one-third to one-half of patients with cardiac indications for these devices have non-cardiac conditions preventing their implantation, the ultimate market is even smaller. This trial may be misrepresented to say that more expensive CRT-ICD devices are needed in these less sick patients, but the trial of ICD-CRT vs. medical therapy alone needs to be done to answer that question.
While Boston Scientific sponsored this trial, the technology available is manufactured by all major US ICD makers (Medtronic, St jude medical and Boston Scientific) and would not benefit Boston as a market differentiator.
This author consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
