Watch Dr. Isaac George as he discusses 3 major clinical trials, all New England Journal of Medicine (NEJM) publications. Among them, CTSN and AFFIRM in which patients were randomized to pharmacologic rate vs. rhythm control.
For the hearing impaired members of the AFibSurgeons.org community, we have provided a written transcript below:
Isaac George: How do we treat atrial fibrillation? There’s two strategies. First is rate versus rhythm. This is a concept that’s been well-studied.
The first paper here is the AFFRIM study in 2002 in The New England Journal of Medicine. This is 4,060 patients with atrial fibrillations that were randomized to either pharmacologic rate or rhythm control. However, there was a high crossover rate in these groups as patients were unable to tolerate rhythm control medications. You can see that there was no difference in mortality over a five-year endpoint.
Rate versus rhythm has been studied in heart failure as well. This is another New England Journal study in 2016 that took 1,376 heart failure patients with an average EF of 27% and randomized them again to pharmacologic rate versus rhythm control. There was no difference in mortality. There was again a very high crossover rate in the patients that had rhythm control due to side effects of medications.
Finally, rate versus rhythm control in postoperative atrial fibrillation after cardiac surgery has been studied. This is a CTSN trial in 2016 with over 2,100 patients that underwent post-CABG, valve or CABG-valve operations. Only postoperative AFib was analyzed and randomized to pharmacologic rate versus rhythm control. Coumadin was given for atrial fibrillation greater the 48 hours. There was over a 24% non-compliance rate in the rhythm group. There was no difference in the primary outcome of hospitalization days.
You can see this data here in the rate and rhythm control. Readmission for any cause was no different between the groups. In addition, cardiovascular causes for readmission were no different as well, so it did not meet its primary endpoint.
What’s going on here? We have three major randomized trials that have failed to show rate – rhythm control improves survival. Why is that? We have very poor compliance with medication, one. We have a number of side effects by the rhythm medications that make them intolerable.
We have high crossover rates from the groups. These endpoints may not be appropriate for certain populations, whether it’s mortality versus quality of life. Maybe some of these populations are too sick to be studied like this. At the end of the day, the more
important question, is there a better way to obtain sinus rhythm because the medications really are not working?