Atrial fibrillation (Afib) patients who had catheter ablation done in the CABANA trial tended to score higher on quality-of-life questionnaires later on, investigators reported.
Self-reported outcomes on several scales at 12 months favored those who were randomized to catheter ablation instead of standard medical therapy, according to a group led by Daniel Mark, MD, MPH, of the Duke Clinical Research Institute in Durham, North Carolina:
- Atrial Fibrillation Effect on Quality of Life summary score: 86.4 vs 80.9 points (P<0.001)
- Mayo AF-Specific Symptom Inventory frequency score (6.4 vs 8.1 points, P<0.001) and severity score (5.0 vs 6.5 points, P<0.001)
Patients with the worst quality-of-life assessments at baseline reported the greatest improvement after catheter ablation.
For the 2,204 symptomatic patients in CABANA, catheter ablation “led to clinically important and significant improvements in quality of life at 12 months,” the authors concluded. Their findings were published online in JAMA with top-line results previously reported at the European Society of Cardiology meeting last year.
CABANA had missed its primary endpoint, researchers reported last year, as the intention-to-treat analysis of the trial showed no benefit to catheter ablation in terms of hard outcomes such as combined death, disabling stroke, serious bleeding, or cardiac arrest; nor all-cause mortality alone.
In a per-protocol analysis accounting for cross-overs, however, the procedure did appear to improve the primary composite endpoint (7.0% vs 10.9%, P=0.006) and all-cause mortality (4.4% vs 7.5%, P=0.005).
A similar phenomenon was observed in the present quality-of-life study, as treatment benefits with catheter ablation appeared to hit a ceiling at 12 months and decline slowly thereafter; this late attenuation was no longer present in a per-protocol analysis, according to Mark and colleagues.
Study participants went into CABANA at a median age of 68 and comprised a cohort with 63% being men. Paroxysmal Afib accounted for 43% of cases (the rest getting treated for persistent Afib).
Follow-up lasted a median of 48.5 months.
One limitation of the trial was its open-label design: quality-of-life data were collected via phone interviews in which North American patients got blinded interviews but others everywhere else were interviewed by local site coordinators who had access to treatment assignments, Mark’s group said.
CABANA was supported by grants from the National Heart, Lung, and Blood Institute; the St. Jude Foundation and Corporation; Biosense Webster; Medtronic; Boston Scientific; and the Mayo Clinic.
Mark reported receiving grants from the NIH and the Mayo Clinic during the conduct of the study; as well as grants from Merck, Oxygen Therapeutics, Bristol-Myers Squibb, AstraZeneca, the University of Calgary, Eli Lilly & Company, AGA Medical, St. Jude Medical, and Tufts University and personal fees from CeleCor and Novo Nordisk.