Real Life Efficacy and Safety of Dabigatran for Stroke Prevention in Atrial Fibrillation – First Results of the Prospective Noac Registry (NCT01588119)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 502-502
Author(s):  
Vera Gelbricht ◽  
Sebastian Werth ◽  
Christina Koehler ◽  
Ulrike Haensel ◽  
Luise Tittl ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cardiovascular Events ◽  
Safety Data ◽  
Real Life ◽  
Bleeding Complications ◽  
Efficacy And Safety ◽  
Daily Care ◽  
Short Period

Abstract 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.

Real Life Efficacy and Safety of Rivaroxaban for Stroke Prevention in Atrial Fibrillation – First Results of the Prospective Noac Registry (NCT01588119)

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1156-1156
Author(s):  
Sebastian Werth ◽  
Christina Koehler ◽  
Vera Gelbricht ◽  
Ulrike Haensel ◽  
Luise Tittl ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cardiovascular Events ◽  
Safety Data ◽  
Real Life ◽  
Bleeding Complications ◽  
Efficacy And Safety ◽  
Daily Care ◽  
Short Period

Abstract 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.

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

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2267-2267
Author(s):  
Christina Koehler ◽  
Sebastian Werth ◽  
Vera Gelbricht ◽  
Ulrike Haensel ◽  
Luise Tittl ◽  
...  
Keyword(s):  
Oral Anticoagulants ◽  
Safety Data ◽  
Real Life ◽  
Prolonged Treatment ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Vascular Events ◽  
Daily Care ◽  
Short Period

Abstract 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.

Pattern and Management Of Bleeding Complications With Novel Oral Anticoagulants – Results Of The Prospective Dresden Noac Registry (NCT01588119)

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 214-214
Author(s):  
Kati Förster ◽  
Franziska Ebertz ◽  
Vera Gelbricht ◽  
Denise Röllig ◽  
Luise Tittl ◽  
...  
Keyword(s):  
Gastrointestinal Bleeding ◽  
Major Bleeding ◽  
Research Funding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Safety Data ◽  
Factor Vii ◽  
Bleeding Complications ◽  
Daily Care

Abstract Background The most common side effect of oral anticoagulants are bleeding complications. In large trials, novel direct oral anticoagulants (NOAC) have been shown to reduce the risk of major bleeding compared to warfarin. However, little is known about the distribution pattern, management and outcome of NOAC-related bleeding complications in daily care. Patients and methods Using data from a large regional registry of patients treated with novel direct oral anticoagulants (NOAC) in the district of Saxony, Germany, we evaluated pattern and management of NOAC-related bleeding complications in daily care. In this ongoing registry, a network of 239 physicians enrols up to 2500 daily care NOAC patients who receive central prospective follow up (FU) by the registry office at day 30 day and quarterly thereafter to collect efficacy and safety data. All outcome events are centrally adjudicated using standard scientific definitions. Results Until July 31th 2013, 2249 patients were enrolled into the registry. Of these, 1738 (77.3%) patients received rivaroxaban, 356 (15.8%) received dabigatran and 155 (6.9%) received apixaban. During follow-up (2674.0 patient years), a total of 825 patients reported 1137 bleeding complications (59.1% minor, 33.9% non-major, clinically relevant (NMCR) and 6.9% major bleeding according to ISTH definition). For non-major bleedings, mucosal and skin bleeding were the most common bleeding sites (67.9% of all bleedings), followed by genitourinary (10.9%) and gastrointestinal bleeding (10.9%). For major bleeding, gastrointestinal bleeding was the most common manifestation (2.8%), followed by genito-urinary (0.6%) bleeding. In 93% of all bleeding events, treatment was not necessary or consisted of conservative treatment with compression, tamponade or red blood transfusion. Surgical or interventional treatment was reqired in 7.0% of all bleedings (0.0% of minor, 13.0% of NMCR and 38.0% of major bleedings). Prothrombin complex concentrate was used in 1.3% (24% of all major bleedings). No patient received recombinant factor VII. Bleeding-associated mortality was 0.5% for all and 7.5% for major bleeding. Of the six fatal bleedings observed, three were intracranial bleedings. Conclusion Bleeding complications are common in daily care NOAC patients and are usually managed conservatively. Only 7% of all observed bleedings fulfil the ISTH criteria of major bleeding (mainly for RBC transfusion criterion) and are managed using interventions, FFP or PCC. Overall, only few NOAC-associated bleeding complications in daily care are fatal, indicating that available management strategies are sufficient. For presentation at ASH, updated results including risk assessments will be reported. Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Bayer Healthcare: Research Funding, Speakers Bureau; Boehringer Ingelheim: Research Funding, Speakers Bureau; Pfizer: Research Funding, Speakers Bureau.

Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial

2021 ◽  
pp. ASN.2020111566
Author(s):  
An S. De Vriese ◽  
Rogier Caluwé ◽  
Hans Van Der Meersch ◽  
Koen De Boeck ◽  
Dirk De Bacquer
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cardiovascular Events ◽  
Vitamin K Antagonists ◽  
Vitamin K2 ◽  
Composite Outcome ◽  
End Point ◽  
Life Threatening ◽  
K2 Group

BackgroundIn patients with normal renal function or early stage CKD, the risk-benefit profile of direct oral anticoagulants (DOACs) is superior to that of vitamin K antagonists (VKAs). In patients on hemodialysis, the comparative efficacy and safety of DOACs versus VKAs are unknown.MethodsIn the Valkyrie study, 132 patients on hemodialysis with atrial fibrillation were randomized to a VKA with a target INR of 2–3, 10 mg rivaroxaban daily, or rivaroxaban and vitamin K2 for 18 months. Patients continued the originally assigned treatment and follow-up was extended for at least an additional 18 months. The primary efficacy end point was a composite of fatal and nonfatal cardiovascular events. Secondary efficacy end points were individual components of the composite outcome and all-cause death. Safety end points were life-threatening, major, and minor bleeding.ResultsMedian (IQR) follow-up was 1.88 (1.01–3.38) years. Premature, permanent discontinuation of anticoagulation occurred in 25% of patients. The primary end point occurred at a rate of 63.8 per 100 person-years in the VKA group, 26.2 per 100 person-years in the rivaroxaban group, and 21.4 per 100 person-years in the rivaroxaban and vitamin K2 group. The estimated competing risk–adjusted hazard ratio for the primary end point was 0.41 (95% CI, 0.25 to 0.68; P=0.0006) in the rivaroxaban group and 0.34 (95% CI, 0.19 to 0.61; P=0.0003) in the rivaroxaban and vitamin K2 group, compared with the VKA group. Death from any cause, cardiac death, and risk of stroke were not different between the treatment arms, but symptomatic limb ischemia occurred significantly less frequently with rivaroxaban than with VKA. After adjustment for competing risk of death, the hazard ratio for life-threatening and major bleeding compared with the VKA group was 0.39 (95% CI, 0.17 to 0.90; P=0.03) in the rivaroxaban group, 0.48 (95% CI, 0.22 to 1.08; P=0.08) in the rivaroxaban and vitamin K2 group and 0.44 (95% CI, 0.23 to 0.85; P=0.02) in the pooled rivaroxaban groups.ConclusionsIn patients on hemodialysis with atrial fibrillation, a reduced dose of rivaroxaban significantly decreased the composite outcome of fatal and nonfatal cardiovascular events and major bleeding complications compared with VKA.Clinical Trial registry name and registration number:Oral Anticoagulation in Hemodialysis, NCT03799822

Abstract 14344: Prognostic Factors of Atrial Fibrillation Patients With Coronary Artery Disease: The Fushimi Af Registry

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Nobutoyo Masunaga ◽  
Hisashi Ogawa ◽  
Yuya Aono ◽  
Syuhei Ikeda ◽  
KOSUKE DOI ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Heart Failure ◽  
Atrial Fibrillation ◽  
Prognostic Factors ◽  
Major Bleeding ◽  
Cardiac Death ◽  
Cardiovascular Events ◽  
Factors Associated ◽  
Artery Disease

Background: Atrial fibrillation (AF) patients are likely to have concomitant coronary artery disease (CAD). A new strategy of antithrombotic therapy in AF patients with stable CAD was demonstrated in recent randomized clinical trials. Now that antithrombotic therapy for AF patients with CAD has reached a major turning point, it is important to know the prognostic factors in those patients. Purpose: In this study, we investigated clinical characteristics, cardiovascular events and prognostic factors in AF patients with CAD. Methods: The Fushimi AF Registry, a community-based prospective survey, was designed to enroll all of the AF patients who visited the participating medical institutions in Fushimi-ku, Kyoto, Japan. Follow up data including prescription status were available in 4,441 patients from March 2011 to November 2019. Of 4,441 patients, 645 patients had a history of CAD at enrollment. Results: The mean age was 76.4±8.6 and 65.9% were male. Averages of CHA 2 DS 2 -VASc score and HAS-BLED score were 4.41 and 2.35, respectively. Oral anticoagulant (OAC) was prescribed in 52.9% of those patients and antiplatelet drug (APD) was prescribed in 70.4%. The combination of OAC and APD was prescribed in 36.0%. During follow-up period (median 1,495 days), cardiac death occurred in 51 patients, composite of cardiac death, myocardial infarction (MI) and stroke in 136, and major bleeding in 77 (1.8, 5.1 and 2.9 per 100 person-years, respectively). In multivariate analysis, factors associated with composite of cardiac death, MI and stroke in AF patients with CAD were low body weight (<=50kg) (hazard ratio [95% confidence interval]; 1.62 [1.07-2.47]), previous stroke (1.69 [1.13-2.52]), heart failure (1.47 [1.02-2.11]), hypertension (0.60 [0.41-0.87]) and diabetes mellitus (1.62 [1.13-2.32]). Furthermore, factors associated with major bleeding in AF patients with CAD were anemia (male: hemoglobin<12 g/dl, female: hemoglobin<11 g/dl) (1.82 [1.09-3.04]) and thrombocytopenia (<150,000 /μL) (3.02 [1.29-7.03]). Conclusion: In Japanese AF patients with CAD, low body weight, previous stroke, heart failure, hypertension and diabetes mellitus were associated with cardiovascular events, and anemia and thrombocytopenia were associated with major bleeding.

scholarly journals Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation and cancer a meta-analysis

2020 ◽  
Author(s):  
Marco Valerio Mariani ◽  
Michele Magnocavallo ◽  
Martina Straito ◽  
Agostino Piro ◽  
Paolo Severino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Significant Risk ◽  
Bleeding Complications ◽  
Efficacy And Safety

Abstract Background Direct oral anticoagulants (DOACs) are recommended as first-line anticoagulants in patients with atrial fibrillation (AF). However, in patients with cancer and AF the efficacy and safety of DOACs are not well established. Objective We performed a meta-analysis comparing available data regarding the efficacy and safety of DOACs vs vitamin K antagonists (VKAs) in cancer patients with non-valvular AF. Methods An online search of Pubmed and EMBASE libraries (from inception to May, 1 2020) was performed, in addition to manual screening. Nine studies were considered eligible for the meta-analysis involving 46,424 DOACs users and 182,797 VKA users. Results The use of DOACs was associated with reduced risks of systemic embolism or any stroke (RR 0.65; 95% CI 0.52–0.81; p 0.001), ischemic stroke (RR 0.84; 95% CI 0.74–0.95; p 0.007) and hemorrhagic stroke (RR 0.61; 95% CI 0.52–0.71; p 0.00001) as compared to VKA group. DOAC use was associated with significantly reduced risks of major bleeding (RR 0.68; 95% CI 0.50–0.92; p 0.01) and intracranial or gastrointestinal bleeding (RR 0.64; 95% CI 0.47–0.88; p 0.006). Compared to VKA, DOACs provided a non-statistically significant risk reduction of the outcomes major bleeding or non-major clinically relevant bleeding (RR 0.94; 95% CI 0.78–1.13; p 0.50) and any bleeding (RR 0.91; 95% CI 0.78–1.06; p 0.24). Conclusions In comparison to VKA, DOACs were associated with a significant reduction of the rates of thromboembolic events and major bleeding complications in patients with AF and cancer. Further studies are needed to confirm our results.

scholarly journals Drug Persistence with Rivaroxaban Therapy in Atrial Fibrillation Patients Results from the Dresden NOAC registry

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4264-4264
Author(s):  
Jan Beyer-Westendorf ◽  
Kati Förster ◽  
Franziska Ebertz ◽  
Vera Gelbricht ◽  
Franziska Michalski ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Research Funding ◽  
Treatment Discontinuation ◽  
Baseline Risk ◽  
Bleeding Complications ◽  
Event Analysis ◽  
Daily Care ◽  
Kaplan Meier

Abstract Aims: Worldwide, rivaroxaban is increasingly used for stroke prevention in atrial fibrillation (SPAF) but little is known about the rates of or reasons for rivaroxaban discontinuation in daily care. Using data from a prospective, non-interventional oral anticoagulation (NOAC) registry, we analysed rivaroxaban treatment persistence. Methods and results: Persistence with rivaroxaban in SPAF was assessed in an ongoing, prospective, non-interventional registry of >2600 NOAC patients from daily care using Kaplan-Meier time-to-first-event analysis. Reasons for and management of rivaroxaban discontinuation were assessed. Potential baseline risk factors for treatment discontinuation were evaluated using Cox regression analysis. Between October 2011 and April 2014, 2603 patients were enrolled in the registry. Of these, 1204 (46.3%) received rivaroxaban for SPAF, with 473 (39.3%) switched from VKA pretreatment to rivaroxaban and 731 (60.7%) newly anticoagulated rivaroxaban patients. As of 30 April 2014, follow-up information was available for all 1204 patients (100%). By that date, the median treatment duration with rivaroxaban was 544 days (25th and 75th percentile 444/639d) for all patients. During follow-up, the overall persistence with rivaroxaban therapy was 81.5% (223/1204 patients discontinued rivaroxaban) and similar for patients switched from VKA to rivaroxaban or newly treated rivaroxaban patients (82.0% vs 81.1%). In the intention-to-treat analysis, rates of treatment discontinuation per 100 patient-years were assessed as a Kaplan–Meier time-to-first-event analysis and found to be 13.6 [95% CI 11.8–15.4] for all patients and similar for newly treated rivaroxaban patients (14.1 [95% CI 11.9–16.7]) and patients switched from VKA to rivaroxaban (12.7 [95% CI 10.1–15.7]; p = 0.35; Figure 1a). This finding did not change if only patients with a completed 12-month follow-up were assessed (Figure 1b). Discontinuation rates were highest in the first 6 months of treatment (9.9% [95% CI 7.7–12.1%] for patients newly treated with rivaroxaban and 10% [95% CI 7.3–12.7%] for patients switched from VKA pretreatment to rivaroxaban) and declined similarly in both subgroups over time (for 6–12 months: 6% [95% CI 5.5–6.4%] and 3.9% [95% CI 3.5–4.4%], respectively; after 12 months: 4.4% [95% CI 3.9–5%) and 7.7% [95% CI 6.0–9.2%], respectively). Most common reasons for treatment discontinuations were bleeding complications (30% of all discontinuations), followed by other side-effects (24.2%) and diagnosis of stable sinus rhythm (9.9%). Within the group of 67 bleeding complications, according to the International Society on Thrombosis and Haemostasis bleeding definition, 14 were major and 53 were non-major clinically relevant bleeding events that led to treatment discontinuation. A history of chronic heart failure (HR 1.43; 95% CI 1.09-1.87; p=0.009) or diabetes (HR 1.39; 95% CI 1.06-1.82; p=0.018) were the only statistically significant baseline risk factors for rivaroxaban discontinuation. After discontinuation of rivaroxaban, patients received antiplatelet therapy (31.8%), VKA (24.2%), another NOAC (18.4%), heparin (9.9%) or nothing (15.7%). Conclusion: Our data indicate that overall persistence with rivaroxaban therapy is high, with a discontinuation rate of approximately 15% in the first year of treatment and few additional discontinuations thereafter. Non-major bleeding is the most common reason for riaroxaban discontinuation and nearly 50% of all discontinuing patients receive only antiplatelet or no antithrombotic treatment. Figure 1: Kaplan–Meier analysis of persistence to rivaroxaban treatment for all patients (left diagram) and for all patients who were observed for at least 12 months (right diagram), according to VKA pretreatment Figure 1:. Kaplan–Meier analysis of persistence to rivaroxaban treatment for all patients (left diagram) and for all patients who were observed for at least 12 months (right diagram), according to VKA pretreatment Disclosures Beyer-Westendorf: Bayer: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding. Weiss:Boehringer Ingelheim: Honoraria; Bayer: Honoraria.

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

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1159-1159
Author(s):  
Vera Gelbricht ◽  
Christina Koehler ◽  
Sebastian Werth ◽  
Ulrike Haensel ◽  
Thomas Schreier ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Vascular Event ◽  
Acute Limb Ischemia ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Vein Thrombosis ◽  
Daily Care ◽  
Short Period ◽  
Deep Vein

Abstract 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.

Relation of Renal Dysfunction to Quality of Anticoagulation Control in Patients with Atrial Fibrillation: The FANTASIIA Registry

2018 ◽  
Vol 118 (02) ◽  
pp. 279-287 ◽  
Author(s):  
María Esteve-Pastor ◽  
José Rivera-Caravaca ◽  
Inmaculada Roldán-Rabadán ◽  
Vanessa Roldán ◽  
Javier Muñiz ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cardiovascular Mortality ◽  
Real World ◽  
Cardiovascular Events ◽  
Vitamin K Antagonists ◽  
Major Adverse Cardiovascular Events ◽  
Anticoagulation Control

Background One-third of atrial fibrillation (AF) patients have chronic kidney disease (CKD), a condition that itself increases thromboembolic and major bleeding risks, especially in patients with severe CKD. Bleeding would be accentuated by suboptimal anticoagulation control with vitamin K antagonists (VKA). Purpose This article aimed to investigate the incidence of cardiovascular events, mortality and quality of anticoagulation in relation to CKD in a ‘real-world’ prospective cohort of AF patients included in the FANTASIIA registry. Methods We analysed consecutive AF patients who were prospectively recruited with a year of follow-up. The quality of anticoagulation was estimated by time in therapeutic range (TTR). The annual incidence of events was analysed. Results We studied 1,936 patients (male: 55.7%, mean: 73.8 ± 9.4 years): 445 (22.9%) had normal function, 698 (36.1%) had mild CKD, 713 (36.8%) had moderate CKD and 80 (4.2%) had severe CKD. Patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (severe CKD) had lower TTR (53.3 ± 25.6% vs. 61.8 ± 25.1%, p = 0.007) and higher proportion of poor TTR (67.2 vs. 51.8%; p = 0.014) than patients with eGFR ≥30 mL/min/1.73 m2. Severe CKD was significantly associated with cardiovascular mortality (hazard ratio [HR]: 9.33; p = 0.002), major bleeding (HR: 2.94; p = 0.036) and major adverse cardiovascular events (MACE) (HR: 4.93; p = 0.004). Importantly, 375 patients (21.1%) showed a deteriorating eGFR of ≥10 mL/min during the follow-up, with significantly higher mortality and cardiovascular events. Conclusion In a prospective and real-world AF registry, approximately 67% of patients with severe CKD had poor anticoagulation control while taking VKA. The presence of severe CKD was an independent factor for cardiovascular mortality, MACE and major bleeding. Worsening eGFR of only ≥10 mL/min during follow-up was significantly associated with mortality and major bleeding.

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