Real Life Efficacy and Safety of Rivaroxaban for Extended VTE Treatment – First Results of the Prospective Noac Registry (NCT01588119).

Abstract

AbstractAbstract 2267 Background:In the EINSTEIN-EXT trial, rivaroxaban (RX) has been found to be at least as effective and safe as warfarin in extended venous thromboembolism (VTE) treatment, 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 rivaroxaban anticoagulation for extended VTE treatment 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 July 31th 2012, 938 patients were registered. Of these, 126 patients received RX for extended VTE treatment (demographic data in table 1). In our registry, the population receiving extended VTE treatment is older than in EINSTEIN-EXT (65.0 vs. 58.2 years). Indication for prolonged treatment is proximal deep vein thrombosis or pulmonary embolism (93.3%). Most patients received 20 mg OD, but a quarter of patients received 15 mg OD due to impaired renal function.Until July 31th, completed FU cumulate to 44.2 patient years. The results of 1-, 3- and 6-months FU are shown in table 2. Until now, no recurrent VTE or VTE-related death occurred. Two patients experienced major vascular events (1 ACS, 1 TIA). Bleeding events were frequent (24.6%) but only 2 patients (1.6%) experienced major bleeding events, none of which were fatal. Two patients died due to underlying diseases. At 3 and 6 month, 94% resp. 85% of patients were still taking RX. Conclusion:In unselected patients in daily care, extended VTE treatment with RX is effective and safe with low rates of events or treatment discontinuation in the first 180 days of treatment. Long-term data will be reported.Table 1:baseline data of patients with extended VTE treatment with rivaroxaban at inclusion into the registryN = 126Female/male53/73 (42.1%/57.9%)Age (years)64.4 ± 15.1Rivaroxaban 20 mg OD/15 mg OD95/31 (75.4%/24.6%)Proximal DVT and/or PE93.3%Distal DVT without PE6.7%Treatment for first/recurrent VTE65/61 (51.6%/48.4%)Mean duration of anticoagulant pretreatment (month)30.4 ± 42.1Pretreatment with VKA94 (74.6%)Pretreatment with low-molecular weight heparin only24 (19.0%)Pretreatment with ASS1 (0.8%)Pretreatment with blinded Study Drug5 (4.0%)No pretreatment2 (1.6%)Number of concomitant medication3.9 ± 3.5Table 2:outcomes in 30-day FU, 3-month and 6-month FU (events listed in FU occurred after previous FU). FU = follow-up; RX = rivaroxaban; VTE = venous thromboembolism; ACS = acute coronary syndrome; NMCR = non-major clinically relevant; NA = not applicable1-month-FU3-month-FU6-month-FUTotal event rate per 126 patientsEvents per 100 patientyearsFU completed1108627NAStill on Rivaroxaban106 (96.4%)81 (94.2%)23 (85.2%)Switch to other anticoagulation2 (1.8%)2 (2.3%)3 (11.1%)No anticoagulation planned discontinuation (end of treatment) unplanned discontinuation2 (1.8%)3 (3.5%)1 (3.7%)101110Recurrent VTE00000Minor vascular events00000Major vascular events (stroke, ACS, acute limb ischemia)01 (TIA)1 (ACS)1.6%3.6Death1011.6%3.6Any bleeding208324.6%55.9Minor bleeding117014.3%32.5NMCR bleeding8038.7%19.8Major bleeding1101.6%3.6 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.