Real Life Efficacy and Safety of Dabigatran for Stroke Prevention in Atrial Fibrillation – First Results of the Prospective Noac Registry (NCT01588119)

Abstract

AbstractAbstract 502 Background:In the RE-LY trial, dabigatran (DB) has been found to be at least as effective and safe as warfarin to prevent stroke in atrial fibrillation (AF), which lead to approval in many countries. However, patients in RCT‘s present a selected population treated under a strict protocol and followed for a short period of time. Consequently, efficacy and safety of new oral anticoagulants (NOAC) need to be confirmed in unselected patients in daily care. Objectives:To evaluate the efficacy, safety and management issues of dabigatran anticoagulation in AF in daily care. Patients and methods:In the district of Saxony, Germany, a network of 200 physicians from private practice and hospitals enrol patients in the prospective NOAC registry. Inclusion criteria are: 1) indication for NOAC anticoagulation >3 month; 2) age > 18 years; 3) written informed consent; 4) availability for follow-up. No Exclusion criteria apply. In the registry, up to 2000 patients will receive prospective follow up (FU) by phone visits at day 30 day and quarterly thereafter to collect efficacy and safety data. Results:Until July31th 2012, 938 patients were registered. Of these, 201 received DB for AF (table 1). The population in our registry is older than in RELY (74.2 vs. 71.5 years) and has a higher CHADS2-Score (2.7 vs. 2.1). Interestingly, 110 mg BID was the preferred dosage in DB patients (55.7%) despite the fact that these patients had higher CHADS2-scores than patients receiving 150 mg BID (2.3 vs. 2.9). Two third of patients were newly anticoagulated and one third was switched from Vitamin-K antagonists, mainly due to poor INR control or bleeding complications.Results of 30-day-, 3-month and 6-month FU are shown in table 2. Currently, FU data cumulate to 86.8 patient years. During FU, Three patients (1.5%) experienced major cardiovascular events (xyz) and another two patients (1.0%) minor cardiovascular events (syncope). Until now, no deaths occurred. Bleeding complications were frequent (14.9%) but major bleeding was rare (n=3; 1.5%) none of which was fatal. At 3 month, 93% of patients were still taking DB but switch to other anticoagulants increased between 3 and 6 month, mainly due to side effects or incompliance. Conclusion:In unselected patients in daily care, DB is effective and safe with low rates of cardiovascular or major bleeding events. However, within 6 month, about 20% of patients are switched to other anticoagulants. Long-term data will be reported.Table 1Baseline data of DB patients at inclusion into the registryN = 201Female/male97/104 (48.3%/51.7%)Age (years)74.2 ± 8.0Mean CHADS2-Score all DB patients (n=201)2.7- Mean CHADS2-Score DB 2 × 150 mg (n=89)2.3- Mean CHADS2-Score DB 2 × 110 mg (n=112)2.9Number of concomitant medication5.8 ± 2.9VKA naive/VKA pretreatment122/79 (60.7%/39.3%)VKA-pretreated patients switched to DB due to- Instable INR42 (53.2%)- Bleeding complications with VKA23 (29.1%)- Frequent falls19 (24.1%)- Thromboembolic complications during VKA4 (5.1%)- Other35 (44.3%)Table 2Outcomes in 30-day FU, 3-month and 6-month FU (events listed in FU occurred after previous FU). FU = follow-up; DB = dabigatran; ACS = acute coronary syndrome; NMCR = non-major clinically relevant; NA = not applicable1-month-FU3-month-FU6-month-FUTotal event rate per 201 patientsEvents per 100 patient yearsFU completed18014770NAStill on DB169 (93.9%)137 (93.2%)52 (74.3%)Switch to other anticoagulation8 (4.4%)9 (6.1%)15 (21.4%)No anticoagulation3 (1.7%)1 (0.7%)3 (4.3%)Minor vascular events1101.0%1.1Major vascular events (stroke, ACS, acute limb ischemia)2101.5%1.7Death00000Any bleeding179414.9%17.1Minor bleeding138211.4%13.1NMCR bleeding3012.0%2.3Major bleeding1111.5%1.7 Disclosures:Werth:Bayer Healthcare: Honoraria. Beyer-Westendorf:Bayer Healthcare: Bayer provided a grant to support the NOAC registry in part Other, Honoraria; Boehringer Ingelheim: Boehringer provided a grant to support the NOAC registry in part, Boehringer provided a grant to support the NOAC registry in part Other, Honoraria; Bristol Myers Squibb: Honoraria; Pfizer: Honoraria.