Abstract
Abstract 1156
In the ROCKET-AF trial, rivaroxaban (RX) has been found to be at least as effective and safe as warfarin to prevent stroke in atrial fibrillation (AF) and is approved in many countries. However, patients in RCT‘s present a selected population which is 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 AF 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, 504 patients received RX for atrial fibrillation (demographic data in table 1). Despite similar age (mean 75 years), our real world cohort has lower CHADS2-Scores compared to ROCKET-AF (2.4 vs. 3.5). The preferred dosage in most RX patients (68.8%) was 20mg, but these patients had lower CHADS2-scores than patients receiving 15 mg (2.2 vs. 2.8). 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 112.2 patient years. Five patients (1.0%) experienced major cardiovascular events (3 ACS, 1 ischemic stroke, 1 TIA). Another five patients experienced minor cardiovascular events (syncope). Three patients (0.6%) died within the first month of treatment (one due to sudden cardiac death, possibly related to ventricular fibrillation, two of underlying disease). Bleeding complications were frequent (15.2%) but major bleeding was rare (n=1; 0.2%). At 3 month, 95% of patients were still taking RX.
In unselected patients in daily care, RX is effective and safe with low rates of cardiovascular or major bleeding events and low rates of treatment discontinuation in the first 180 days of treatment.
Baseline data of RX patients
| . | N= 506 . |
|---|---|
| Female/male | 253/253 (50.0%/50.0%) |
| Age (years) | 74.7 ± 9.4 |
| Mean CHADS2-Score all RX patients (n=504) | 2.4 |
| Mean CHADS2-Score RX 1 × 20 mg (n=348) | 2.2 |
| Mean CHADS2-Score RX 1 × 15 mg (n=158) | 2.8 |
| Number of concomitant medication | 5.7 ± 2.8 |
| VKA naive/VKA pretreatment | 312/194 (61.7%/38.3%) |
| VKA-pretreated patients switched to RX due to | |
| Instable INR | 114 (58.8%) |
| Bleeding complications with VKA | 43 (22.2%) |
| Frequent falls | 31 (16.0%) |
| Thromboembolic complications during VKA | 4 (2.1%) |
| Other | 2 (1.1%) |
| . | N= 506 . |
|---|---|
| Female/male | 253/253 (50.0%/50.0%) |
| Age (years) | 74.7 ± 9.4 |
| Mean CHADS2-Score all RX patients (n=504) | 2.4 |
| Mean CHADS2-Score RX 1 × 20 mg (n=348) | 2.2 |
| Mean CHADS2-Score RX 1 × 15 mg (n=158) | 2.8 |
| Number of concomitant medication | 5.7 ± 2.8 |
| VKA naive/VKA pretreatment | 312/194 (61.7%/38.3%) |
| VKA-pretreated patients switched to RX due to | |
| Instable INR | 114 (58.8%) |
| Bleeding complications with VKA | 43 (22.2%) |
| Frequent falls | 31 (16.0%) |
| Thromboembolic complications during VKA | 4 (2.1%) |
| Other | 2 (1.1%) |
Outcomes in 30-day FU, 3-month and 6-month FU (events listed in FU occurred after previous FU). FU = follow-up; RX = rivaroxaban; 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 506 patients . | Events per 100 patient years . |
|---|---|---|---|---|---|
| FU completed | 425 | 241 | 33 | NA | |
| Still on RX | 400 (94.1%) | 228 (94.6%) | 30 (90.9%) | ||
| Switch to otheranticoagulation | 11 (2.6%) | 9 (3.7%) | 2 (6.1%) | ||
| No anticoagulation | 14 (3.3%) | 4 (1.7%) | 1 (3.0%) | ||
| Minor vascular events | 3 | 2 | 0 | 1.0% | 0.9 |
| Major vascular events (stroke, ACS, acute limb ischemia) | 5 * | 0 | 0 | 1.0% | 0.9 |
| Death | 3 ** | 0 | 0 | 0.6% | 0.5 |
| Any bleeding | 62 | 14 | 1 | 15.2% | 13.6 |
| Minor bleeding | 37 | 12 | 1 | 9.9% | 8.8 |
| NMCR bleeding | 24 | 2 | 0 | 5.1% | 4.6 |
| Major bleeding | 1 | 0 | 0 | 0.2% | 0.2 |
| . | 1-month-FU . | 3-month-FU . | 6-month-FU . | Total event rate per 506 patients . | Events per 100 patient years . |
|---|---|---|---|---|---|
| FU completed | 425 | 241 | 33 | NA | |
| Still on RX | 400 (94.1%) | 228 (94.6%) | 30 (90.9%) | ||
| Switch to otheranticoagulation | 11 (2.6%) | 9 (3.7%) | 2 (6.1%) | ||
| No anticoagulation | 14 (3.3%) | 4 (1.7%) | 1 (3.0%) | ||
| Minor vascular events | 3 | 2 | 0 | 1.0% | 0.9 |
| Major vascular events (stroke, ACS, acute limb ischemia) | 5 * | 0 | 0 | 1.0% | 0.9 |
| Death | 3 ** | 0 | 0 | 0.6% | 0.5 |
| Any bleeding | 62 | 14 | 1 | 15.2% | 13.6 |
| Minor bleeding | 37 | 12 | 1 | 9.9% | 8.8 |
| NMCR bleeding | 24 | 2 | 0 | 5.1% | 4.6 |
| Major bleeding | 1 | 0 | 0 | 0.2% | 0.2 |
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.
