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Afib Roundup: REHEARSE-AF; RE-DUAL; RACE 3; CASTLE-AF

— New trial evidence on atrial fibrillation management from ESC

Ƶ MedicalToday

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Smartphone screening picks up more atrial fibrillation, multifaceted risk factor management early on helps outcomes, while catheter ablation helps for patients with more advanced disease, a bevy of trials reported at the European Society of Cardiology meeting in Barcelona.

Other trials reported here supported smartphone monitoring to pick up atrial fibrillation (Afib) and a dual therapy regimen that can avoid aspirin triple therapy after revascularization for Afib patients.

RACE 3

Patients with both early stage Afib and early stage heart failure maintained sinus rhythm significantly better with multifaceted risk factor treatment than with standard therapy, the randomized RACE 3 trial showed.

Sinus rhythm at 1 year was achieved by about 75% of patients given the aggressive therapy -- mineralocorticoid receptor antagonists, statins, ACE inhibitors and/or angiotensin receptor blockers, and a protocol of cardiac rehabilitation that included physical activity, dietary restriction, and counselling -- compared with 63% of the patients given standard therapy (P=0.021).

"RACE 3 may contribute to the shift to focus on risk factor modification to improve outcomes in atrial fibrillation patients," said presenter Isabelle Van Gelder, MD, of the University of Groningen, The Netherlands.

CASTLE-AF

In advanced heart failure, treating persistent Afib with catheter ablation cut hospitalization and mortality risk compared with medical treatment alone, the CASTLE-AF trial showed.

Combined mortality and worsening heart failure admissions rates were lower with ablation (28.5% versus 44.6% for controls, HR 0.62, 95% CI 0.43-0.87, P=0.007) during a median follow-up of 37.8 months. Both were statistically significant individually as well:

  • All-cause mortality (13.4% versus 25%, HR 0.53, 95% CI 0.32-0.86)
  • Heart failure hospitalization (20.7% versus 35.9%, HR 0.56, 95% CI 0.37-0.83)

Co-investigator Johannes Brachmann, MD, of Klinikum Coburg in Germany, noted that, "Until now we had no evidence that ablation, arrhythmia medications, or any other treatment was superior to another in saving lives and reducing hospitalization. This study has the potential to change the way physicians manage many patients suffering from heart failure and atrial fibrillation."

RE-DUAL

For Afib patients after percutaneous coronary intervention (PCI), the antithrombotic regimen can safely skip aspirin by combination of dabigatran (Pradaxa) and a P2Y12 inhibitor, the RE-DUAL trial found.

A low 110-mg dose of the non-vitamin K antagonist oral anticoagulant (NOAC) with a P2Y12 inhibitor nearly halved major and clinically-relevant non-major bleeds over 14 months when compared with triple therapy of warfarin, aspirin, and a P2Y12 inhibitor (15.4% versus 26.9%, HR 0.52, 95% CI 0.42-0.63, P<0.001 for superiority).

Higher-dose dual therapy, with 150-mg dabigatran, was associated with fewer bleeds as well (20.2% versus 25.7% with corresponding triple-therapy group, HR 0.72, 95% CI 0.58-0.88, P<0.001 for noninferiority).

"These findings indicate a net clinical benefit of each of the two dual-therapy regimens, and clinicians could potentially select one of these two regimens on the basis of a patient's risk of bleeding and risk of thromboembolic events," Christopher Cannon, MD, of Brigham and Women's Hospital in Boston, and colleagues wrote in the simultaneous publication in the New England Journal of Medicine.

REHEARSE-AF

Regularly looking for Afib with a smartphone device for single-lead electrocardiogram detection finds more of it than usual care, according to the REHEARSE-AF randomized trial, although the implications are unclear.

Twice-weekly screening with the AliveCor Kardia device picked up 3.9-fold more Afib than found in routine care -- 19 versus five cases out of the evenly divided 1,001 participants (P=0.007), Julian Halcox, MD, of Swansea University in Wales, reported here and simultaneously online in Circulation.

As seen in studies with implanted pacemakers, loop recorders and other Afib screening studies, "the more we look for AF, the more we will find it," wrote Albert Waldo, MD, PhD, of UH Case Medical Center in Cleveland, and John Camm, MD, of St. George's University of London, in an accompanying editorial. But it comes without much clue of the duration of the arrhythmia, "and mere identification is not enough," they cautioned.

While the trial was underpowered for hard clinical outcomes, the number of strokes and transient ischemic attacks or systemic embolic events was nominally lower with the intervention (six versus 10, HR 0.61, 95% CI 0.22–1.69). All detected paroxysmal atrial fibrillation was treated with anticoagulation.

That translated to a "quite low" 0.02% adverse event rate, mirroring what has been seen in virtually all the previous studies looking for asymptomatic episodes of so-called subclinical atrial fibrillation, the editorialists noted. And, they pointed out, "of the 16 total strokes, 14 were either causally unrelated to AF or of undetermined origin."