Comparative Effectiveness Research Costs More Than Most Realize
I just finished our first day at the Principle Investigator Meeting for the launch of the Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial in Philadelphia today. The trial is a 3000-patient patient trial performed at 140 centers around the world and jointly sponsored by the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH), and industry (St. Jude Medical and Biosense Webster).
The trial will randomize 3000 previously untreated or incompletely treated patients at high risk of cardiovascular complications in the trial to two arms: 1500 patients to catheter ablation as primary therapy of atrial fibrillation and the other 1500 patients to conventional medical therapy with rate control or rhythm control strategies to determine if catheter ablation is superior to medical therapy at reducing total mortality (the primary endpoint). Secondary endpoints of a composite endpoint of mortality, disabling stroke, serious bleeding, or cardiac arrest will also be studied.
If done properly, this study stands to be a landmark trial for the field of cardiac electrophysiology and has huge ramifications for the treatment of patients with atrial fibrillation. Also, it doesn’t take a lot of rocket science to know that the government will be looking closely at the results of this trial to determine which treatment strategy will receive government funding. Read more »
*This blog post was originally published at Dr. Wes*