John Mandrola, MD

Disclosures

April 05, 2016

The art of medicine consists in amusing the patient while nature cures the disease.
—Voltaire

Surgeons, once again, have led the way in the field of electrophysiology. By a wide margin, the most practice-changing trial released at the American College of Cardiology (ACC) 2016 Scientific Sessions comes from a group of heart surgeons who call themselves the Cardio-Thoracic Surgical Network (CTSN).

The results of the Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery trial will end the decades-long futile endeavor of stopping AF after heart surgery.[1]

Led by Dr A Marc Gillinov (Cleveland Clinic, Cleveland), the CTSN investigators set out to compare the strategies of rate vs rhythm control for postop AF.

The Study

Steve Stiles from heartwire on Medscape has full coverage of the trial.

In brief, the National Institutes of Health–funded study took place in 23 sites in the US and Canada. They enrolled more than 2100 patients before they had heart surgery.

They then randomized 523 patients who developed stable postop AF to either rate control with AV-node–blocking drugs (n=262), or rhythm control with amiodarone and/or cardioversion (n=261). Anticoagulation was recommended if AF persisted for more than 48 hours.

Researchers chose total days in the hospital within 60 days of randomization as their primary end point. They recorded many other secondary outcomes, including serious adverse events; mortality; readmissions; time to stable non-AF rhythm; AF status at discharge, day 30, and day 60; and anticoagulation status.

Importantly, the types of heart surgery included both bypass and valve operations; nearly 40% were bypass alone and the other 60% were either valve or combined valve and bypass surgery.

Results

The total number of days in the hospital did not differ. Rate-control patients averaged 5.1 days vs 5.0 for rhythm control.

Mortality and adverse events were low and did not differ between the two arms.

Overall readmissions were nearly identical; even cardiovascular and AF readmissions were also not significantly different.

At discharge, warfarin was prescribed to 42.7% of the patients in the rate-control group and 43.3% of those in the rhythm-control group.

The percentage of patients with sinus rhythm at discharge was 89.9% for rate-control and 93.5% for rhythm-control patients.

At 60 days, 93.8% of the rate-control group had sinus rhythm while 97.9% of those in the rhythm control group had sinus rhythm (P=0.02).

Patients in the rhythm-control group achieved sinus rhythm slightly faster than rate-control patients.

Nonadherence to the regimens occurred in equal proportions. In the rate-control arm, 70 patients did not adhere to the regimen, mostly because of inadequate rate control. In the rhythm-control arm, 62 patients did not stay with the regimen, including 40 (64.5%) because of amiodarone intolerance.

In the New England Journal of Medicine paper, the researchers concluded by saying "neither treatment strategy showed a net clinical advantage over the other."

Comments

This trial was presented in the morning at ACC. Later that day, I heard experts calling this a negative trial. Their take was that rhythm control didn't help. They were glum.

I disagree strongly with that way of thinking. This study is a classic example of a negative trial having immensely positive results. Any ablation doctor will testify to the benefits of knowing what is not working.

Since the CAST trial,[2] electrophysiologists have understood the dangers of membrane-active antiarrhythmic drugs. Then the AFFIRM trial taught us that rhythm-control strategies don't reduce hospitalizations, stroke, or mortality in asymptomatic older patients with AF.[3]

Yet, for decades, we've persisted with the fantasy that drugs (or procedures) would stop AF after the heart has been cut on and inflamed.

Dr Gillinov and his colleagues have now allowed us to stop the madness.

I know postoperative AF associates with readmissions, increased outcomes, and higher rates of death. It should be treated. What this trial teaches us is that rate control with inexpensive medications and patience gets us to the same place at hospital discharge and at 60 days.

In an interview I did with Gillinov after his presentation, he said something that made me want to hug the famous surgeon. (I almost did.)

He said the best way to treat AF after heart surgery is to give it time to go away.

Therein lies the true contribution of this trial. Heart surgeons, through this elegant study, have taught cardiologists to embrace the timely wisdom of Voltaire.

Thank you, I say. You should too.

JMM

Comments

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