Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study.

BACKGROUND: Current guidelines consider vitamin K antagonists (VKA) the oral anticoagulant agents of choice in adults with atrial arrhythmias (AA) and moderate or complex forms of congenital heart disease, significant valvular lesions, or bioprosthetic valves, pending safety data on non-VKA oral anticoagulants (NOACs). Therefore, the international NOTE registry was initiated to assess safety, change in adherence and quality of life (QoL) associated with NOACs in adults with congenital heart disease (ACHD). METHODS: An international multicenter prospective study of NOACs in ACHD was established. Follow-up occurred at 6 months and yearly thereafter. Primary endpoints were thromboembolism and major bleeding. Secondary endpoints included minor bleeding, change in therapy adherence (≥80% medication refill rate, ≥6 out of 8 on Morisky-8 questionnaire) and QoL (SF-36 questionnaire). RESULTS: In total, 530 ACHD patients (mean age 47 SD 15 years; 55% male) with predominantly moderate or complex defects (85%), significant valvular lesions (46%) and/or bioprosthetic valves (11%) using NOACs (rivaroxaban 43%; apixaban 39%; dabigatran 12%; edoxaban 7%) were enrolled. The most common indication was AA (91%). Over a median follow-up of 1.0 [IQR 0.0-2.0] year, thromboembolic event rate was 1.0% [95%CI 0.4-2.0] (n = 6) per year, with 1.1% [95%CI 0.5-2.2] (n = 7) annualized rate of major bleeding and 6.3% [95%CI 4.5-8.5] (n = 37) annualized rate of minor bleeding. Adherence was sufficient during 2 years follow-up in 80-93% of patients. At 1-year follow-up, among the subset of previous VKA-users who completed the survey (n = 33), QoL improved in 6 out of 8 domains (p ≪ 0.05). CONCLUSIONS: Initial results from our worldwide prospective study suggest that NOACs are safe and may be effective for thromboembolic prevention in adults with heterogeneous forms of congenital heart disease.

Sinus rhythm maintenance following DC cardioversion of atrial fibrillation is not improved by temporary precardioversion treatment with oral verapamil.

OBJECTIVE: To evaluate prospectively the effects of pretreatment with verapamil on the maintenance of sinus rhythm after direct current (DC) cardioversion. DESIGN: Randomised, active control, open label, parallel group comparison of verapamil versus digoxin. SETTINGS: Multicentre study in three teaching and three non-teaching hospitals in Sweden. PATIENTS: 100 consecutive patients with atrial fibrillation (AF) of at least four weeks' duration and indications for cardioversion were assigned randomly to two groups, one treated with verapamil (verapamil group) and the other with digoxin (digoxin group) before cardioversion. Fifty patients were assigned randomly to each treatment arm. After dropout of four patients from the digoxin group and seven patients from the verapamil group, data obtained from 89 patients were analysed. INTERVENTIONS: After randomly assigned pretreatment with either verapamil or digoxin for four weeks, DC cardioversion was performed. If sinus rhythm was restored then verapamil treatment was discontinued. MAIN OUTCOME MEASURES: The rate of AF recurrence was assessed one, four, eight, and 12 weeks after cardioversion. RESULTS: 6 patients in the verapamil treated group and none in the digoxin treated group reverted to sinus rhythm spontaneously (p < 0.05). DC cardioversion restored sinus rhythm in 24 of 37 (65%) patients in the verapamil group and 41 of 46 patients (89%) in the digoxin group (p < 0.05). After 12 weeks' follow up 28% (13 of 46) of digoxin pretreated patients versus 9% (four of 43) of verapamil pretreated patients remained in sinus rhythm (p < 0.05). CONCLUSION: Pretreatment with verapamil alone does not improve maintenance of sinus rhythm after DC cardioversion in patients with AF. The rate of spontaneous cardioversion may be improved by verapamil.