Abstract
Abstract 2267
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.
To evaluate the efficacy, safety and management issues of rivaroxaban anticoagulation for extended VTE treatment in daily care.
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.
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.
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.
baseline data of patients with extended VTE treatment with rivaroxaban at inclusion into the registry
| . | N = 126 . |
|---|---|
| Female/male | 53/73 (42.1%/57.9%) |
| Age (years) | 64.4 ± 15.1 |
| Rivaroxaban 20 mg OD/15 mg OD | 95/31 (75.4%/24.6%) |
| Proximal DVT and/or PE | 93.3% |
| Distal DVT without PE | 6.7% |
| Treatment for first/recurrent VTE | 65/61 (51.6%/48.4%) |
| Mean duration of anticoagulant pretreatment (month) | 30.4 ± 42.1 |
| Pretreatment with VKA | 94 (74.6%) |
| Pretreatment with low-molecular weight heparin only | 24 (19.0%) |
| Pretreatment with ASS | 1 (0.8%) |
| Pretreatment with blinded Study Drug | 5 (4.0%) |
| No pretreatment | 2 (1.6%) |
| Number of concomitant medication | 3.9 ± 3.5 |
| . | N = 126 . |
|---|---|
| Female/male | 53/73 (42.1%/57.9%) |
| Age (years) | 64.4 ± 15.1 |
| Rivaroxaban 20 mg OD/15 mg OD | 95/31 (75.4%/24.6%) |
| Proximal DVT and/or PE | 93.3% |
| Distal DVT without PE | 6.7% |
| Treatment for first/recurrent VTE | 65/61 (51.6%/48.4%) |
| Mean duration of anticoagulant pretreatment (month) | 30.4 ± 42.1 |
| Pretreatment with VKA | 94 (74.6%) |
| Pretreatment with low-molecular weight heparin only | 24 (19.0%) |
| Pretreatment with ASS | 1 (0.8%) |
| Pretreatment with blinded Study Drug | 5 (4.0%) |
| No pretreatment | 2 (1.6%) |
| Number of concomitant medication | 3.9 ± 3.5 |
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 applicable
| . | 1-month-FU . | 3-month-FU . | 6-month-FU . | Total event rate per 126 patients . | Events per 100 patientyears . |
|---|---|---|---|---|---|
| FU completed | 110 | 86 | 27 | NA | |
| Still on Rivaroxaban | 106 (96.4%) | 81 (94.2%) | 23 (85.2%) | ||
| Switch to other anticoagulation | 2 (1.8%) | 2 (2.3%) | 3 (11.1%) | ||
| No anticoagulation planned discontinuation (end of treatment) unplanned discontinuation | 2 (1.8%) | 3 (3.5%) | 1 (3.7%) | ||
| 1 | 0 | 1 | |||
| 1 | 1 | 0 | |||
| Recurrent VTE | 0 | 0 | 0 | 0 | 0 |
| Minor vascular events | 0 | 0 | 0 | 0 | 0 |
| Major vascular events (stroke, ACS, acute limb ischemia) | 0 | 1 (TIA) | 1 (ACS) | 1.6% | 3.6 |
| Death | 1 | 0 | 1 | 1.6% | 3.6 |
| Any bleeding | 20 | 8 | 3 | 24.6% | 55.9 |
| Minor bleeding | 11 | 7 | 0 | 14.3% | 32.5 |
| NMCR bleeding | 8 | 0 | 3 | 8.7% | 19.8 |
| Major bleeding | 1 | 1 | 0 | 1.6% | 3.6 |
| . | 1-month-FU . | 3-month-FU . | 6-month-FU . | Total event rate per 126 patients . | Events per 100 patientyears . |
|---|---|---|---|---|---|
| FU completed | 110 | 86 | 27 | NA | |
| Still on Rivaroxaban | 106 (96.4%) | 81 (94.2%) | 23 (85.2%) | ||
| Switch to other anticoagulation | 2 (1.8%) | 2 (2.3%) | 3 (11.1%) | ||
| No anticoagulation planned discontinuation (end of treatment) unplanned discontinuation | 2 (1.8%) | 3 (3.5%) | 1 (3.7%) | ||
| 1 | 0 | 1 | |||
| 1 | 1 | 0 | |||
| Recurrent VTE | 0 | 0 | 0 | 0 | 0 |
| Minor vascular events | 0 | 0 | 0 | 0 | 0 |
| Major vascular events (stroke, ACS, acute limb ischemia) | 0 | 1 (TIA) | 1 (ACS) | 1.6% | 3.6 |
| Death | 1 | 0 | 1 | 1.6% | 3.6 |
| Any bleeding | 20 | 8 | 3 | 24.6% | 55.9 |
| Minor bleeding | 11 | 7 | 0 | 14.3% | 32.5 |
| NMCR bleeding | 8 | 0 | 3 | 8.7% | 19.8 |
| Major bleeding | 1 | 1 | 0 | 1.6% | 3.6 |
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.
Author notes
Asterisk with author names denotes non-ASH members.
