ALBERT

Description: Abstract 1156 Background: 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. Objectives: To evaluate the efficacy, safety and management issues of rivaroxaban 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 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. Conclusion: 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. 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.

Description: Abstract 1159 Background: 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. Objectives: To evaluate the efficacy, safety and management issues of rivaroxaban anticoagulation in acute VTE in daily care. Patients and methods: 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, 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. Conclusion: 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. 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.

Description: Abstract 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. 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.

Description: Abstract 1173 Background: Among other side effects, hair loss is a frequent complaint in patients receiving anticoagulant therapy with Vitamin-K antagonists (VKA) and sometimes also found in patients receiving low-molecular weight heparin (LMWH). Novel oral anticoagulants (NOAC) such as apixaban, dabigatran or rivaroxaban have been tested in large prospective phase-III trials including over 100.000 patients. Furthermore, after approval more than one million patients have been treated with these novel drugs in daily care. So far, hair loss has not been reported as a side effect of NOAC therapy. Using data from a large monocentric prospective NOAC registry, we evaluated incidence and risk profile of newly reported hair loss in patients receiving dabigatran or rivaroxaban therapy. Objectives: To evaluate the incidence of newly reported hair loss as a potential side effect of NOAC therapy 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, 730 patients received rivaroxaban for atrial fibrillation (AF) or venous thromboembolism (demographic data in table 1) and 208 received dabigatran for AF. For these patients, current follow up data cumulate to 270.8 patient years of NOAC treatment. During follow-up visits, twelve patients spontaneously reported new hair loss (nine with rivaroxaban, 3 with dabigatran; demographic data in table 1). Therefore, total incidence of newly reported hair loss in our registry is 4.4 per 100 patient years. The mean time between start of NOAC and first report of hair loss was 68±76 days. Despite the fact that all twelve patients were female, uni- and multivariate analysis did not detect any correlation to baseline data including demographic data, co-morbidity or co-medication. Conclusion: In patients receiving long-term NOAC therapy, the incidence of hair loss as a spontaneously reported side effect is around 4.4 per 100 patient years. Before treatment initiation, patients should be informed about this potential side effect. Further data in larger cohorts are necessary to evaluate potential risk factors for hair loss with novel oral anticoagulants. 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.

Description: Key Points In a real-world setting, annualized bleeding rates of major rivaroxaban bleeding are lower than those reported for vitamin K antagonists. Treatment of major rivaroxaban bleeding is simple and rarely requires pro-coagulants; outcome at 90 days is better than that reported for vitamin K antagonists.

Description: Background: Dabigatran is approved for stroke prevention in atrial fibrillation (SPAF) in many countries. However, little is known about the effectiveness and safety of or the persistence with Dabigatran therapy in unselected patients in daily care. Objectives: To evaluate the effectiveness, safety and discontinuation rates of dabigatran anticoagulation in SPAF in daily care. Patients and methods: The prospective NOAC registry was initiated in November 2011. A network of more than 230 physicians in the district of Saxony, Germany, enroll up to 3000 patients in the registry, which are prospectively followed by the central registry office for up to 36 months. Persistence to dabigatran, rates of stroke/TIA/systemic embolism and of NMCR or major bleeding (ISTH definition) during or within 3 days after last intake of dabigatran were assessed using Kaplan-Meier time-to-first-event analysis. Results: Between November 2011 and February 2013, 341 SPAF patients were enrolled with dabigatran (133 with VKA pre-treatment and 208 newly anticoagulated patients). 158 received dabigatran 150 mg BID and 174 received 110 mg BID. Patients on 110 mg BID were significantly older (78 vs. 71 years), more often had diabetes, a history of stroke, a CHADS2 score ≥ 2 and HAS-BLED scores ≥2 (table 1). In the intention-to-treat analysis, stroke/TIA/systemic embolism occurred at a rate of 2.14/100 pt. years. In the valid-for safety analysis (all events during or within 3 days after last intake of dabigatran) stroke/TIA/systemic embolism occurred at a rate of 1.4/100 pt. years, which was numerically lower for patients receiving 150 compared to 110 mg BID (0.7 vs 2.1/100 pt. years; table 2). Major bleeding occurred at a rate of 1.7/100 pt. years and numerically more often in patients receiving 110 instead of 150 mg BID (2.0 vs 1.3/100 pt. years). Similarly, rates of NMCR bleeding (8.9/100 pt. years) were numerically higher in the 110 mg BI cohort (10.3/100 pt. years) compared to the 150 mg BID cohort (7.0/100 pt. years). Treatment discontinuation occurred in a total of 124 patients during follow up, which in a Kaplan-Meier analysis translated into a discontinuation rate of 23.8/100 pt. years. Documented reasons for treatment discontinuation were side effects (40/124; 32.3%), no longer indicated (13/124; 10.5%), worsening of renal function (12/124; 9.7%), bleeding complications (11/124; 8.9%), costs (4/124; 3.2%), inconvenience (13/124; 10.5%); others (31/124; 25%). Conclusion: In unselected patients in daily care, dabigatran is effective and safe with low rates of cardiovascular or major bleeding events. However, within 12 month, about 24.6% (84/341) of patients are switched to other anticoagulants. Disclosures Werth: Bayer: Honoraria. Köhler:Bayer: Honoraria. Beyer-Westendorf:Boehringer Ingelheim: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Bayer: Honoraria, Research Funding.

Description: Abstract 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. 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.