Abstract
Abstract 1159
In the EINSTEIN study rivaroxaban (RX) has been found to be at least as effective and safe as warfarin in treatment of acute deep vein thrombosis (DVT), which lead to approval of RX 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 in acute VTE in daily care.
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, 105 patients received RX for acute VTE treatment (demographic data in table 1). In our registry, the population receiving acute VTE treatment is older than the EINSTEIN population (62.2 vs. 55.8 years). Most patients are treated for major VTE (proximal deep vein thrombosis (DVT) pulmonary embolism (PE)), but about 20% are treated for isolated distal DVT.
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 (1.9%) experienced a major vascular event (acute limb ischemia) at the beginning of NOAC therapy and one patient experienced a minor vascular event (tachyarrhythmia). Bleeding events were frequent (22.3%) but only five patients (4.8%) experienced major bleeding events, one of which was a fatal intracranial bleeding. Three patients (2.9%) died during FU (1 intracranial bleed, 2 of underlying diseases). At 6 month, only eight patients (7.8%) were switched to other anticoagulants and one patient (1.0%) had an unscheduled discontinuation of anticoagulant therapy.
In unselected patients in daily care, acute VTE treatment with RX is effective and safe with low rates of cardiovascular or bleeding events during the first 180 days of treatment.
Baseline data of patients with extended VTE treatment with rivaroxaban at inclusion into the registry
| . | N = 105 . |
|---|---|
| Female/male | 58/47 (55.2%/44.8%) |
| Age (years) | 62.5 ± 18.2 |
| proximal DVT and/or PE | 76.3% |
| Distal DVT without PE | 19.7% |
| Other VTE manifestations | 4.0% |
| Treatment for first/recurrent VTE event | 79/26 (75.2%/24.8%) |
| Number of concomitant medication | 3.3 ± 2.7 |
| . | N = 105 . |
|---|---|
| Female/male | 58/47 (55.2%/44.8%) |
| Age (years) | 62.5 ± 18.2 |
| proximal DVT and/or PE | 76.3% |
| Distal DVT without PE | 19.7% |
| Other VTE manifestations | 4.0% |
| Treatment for first/recurrent VTE event | 79/26 (75.2%/24.8%) |
| Number of concomitant medication | 3.3 ± 2.7 |
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; ALI = acute limb ischemia; NMCR = non-major clinically relevant; NA = not applicable
| . | 1-month-FU . | 3-month-FU . | 6-month-FU . | Total event rate per 105 patients . |
|---|---|---|---|---|
| FU completed | 92 | 50 | 12 | NA |
| Still on Rivaroxaban | 85 (92.4%) | 32 (64.0%) | 5 (41.7%) | |
| Switch to other anticoagulation | 6 | 4 | 0 | |
| No anticoagulation planned discontinuation (end of treatment) unplanned discontinuation | 1 | 14 | 7 | |
| 0 | 11 | 2 | ||
| 1 | 0 | 0 | ||
| Recurrent VTE | 0 | 0 | 0 | 0 |
| minor vascular events | 1 (TAA) | 0 | 0 | 1.0% |
| Major vascular events (stroke, ACS, acute limb ischemia) | 2 (ALI) | 0 | 0 | 1.9% |
| Death | 0 | 3 | 0 | 2.9% |
| Any bleeding | 22 | 2 | 0 | 22.9% |
| Minor bleeding | 13 | 2 | 0 | 14.3% |
| NMCR bleeding | 4 | 0 | 0 | 3.8% |
| Major bleeding | 5 | 0 | 0 | 4.8% |
| . | 1-month-FU . | 3-month-FU . | 6-month-FU . | Total event rate per 105 patients . |
|---|---|---|---|---|
| FU completed | 92 | 50 | 12 | NA |
| Still on Rivaroxaban | 85 (92.4%) | 32 (64.0%) | 5 (41.7%) | |
| Switch to other anticoagulation | 6 | 4 | 0 | |
| No anticoagulation planned discontinuation (end of treatment) unplanned discontinuation | 1 | 14 | 7 | |
| 0 | 11 | 2 | ||
| 1 | 0 | 0 | ||
| Recurrent VTE | 0 | 0 | 0 | 0 |
| minor vascular events | 1 (TAA) | 0 | 0 | 1.0% |
| Major vascular events (stroke, ACS, acute limb ischemia) | 2 (ALI) | 0 | 0 | 1.9% |
| Death | 0 | 3 | 0 | 2.9% |
| Any bleeding | 22 | 2 | 0 | 22.9% |
| Minor bleeding | 13 | 2 | 0 | 14.3% |
| NMCR bleeding | 4 | 0 | 0 | 3.8% |
| Major bleeding | 5 | 0 | 0 | 4.8% |
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.
