Safety Of New Oral Anticoagulants Research Articles

Efficacy and safety of new oral anticoagulants combined with antiplatelet drugs in the treatment of coronary heart disease: Systematic evaluation and meta‐analysis

ObjectiveTo analyze the efficacy and safety of antiplatelet drugs combined with new oral anticoagulants (noac) in the treatment of coronary atherosclerotic heart disease (CAD).MethodsThe randomized controlled trials of noac combined with antiplatelet therapy in Cochrane, CNKI, PubMed, EMBASE, Wanfang, Google Scholar, and Baidu library were searched using the literature database. Two researchers independently searched and screened to ensure the consistency of the results, and the literature was summarized and analyzed by Revman 5.3 software.ResultsFive research results were included. The results showed that the incidence of mace [95% CI 0.75–0.95, or = 0.84,p = .04], the incidence of major and minor bleeding [95% CI 1.25–5.16, or = 2.54,p = .01], the mortality of cardiovascular disease [95% CI 0.78–0.96, or = 0.86, p = .05], the total mortality [95% CI 0.79–0.95, or = 0.87, p = .003], and the incidence of myocardial infarction in patients with CAD treated with noac and antiplatelet drugs [95% CI 0.77–0.95, or = 0.85, p = .004] was lower than that treated with antiplatelet drugs alone, and the difference was statistically significant (p < .05); the incidence of fatal bleeding [95% CI 0.81–2.08, or = 1.30, p = .28], the incidence of stroke [95% CI 0.50–1.03, or = 0.71, p = .07], and the incidence of intracranial hemorrhage [95% CI 1.02–2.56, or = 1.61, p = .06]. There was no significant difference with antiplatelet drugs alone (p > .05).ConclusionNoac combined with antiplatelet drugs can reduce mace, total mortality, the incidence of myocardial infarction, and cardiovascular mortality in patients with CAD, but may increase the risk of bleeding.

Efficacy and Safety of Enoxaparin versus New Oral Anticoagulants to Prevent Venous Thromboembolism after Total Hip Replacement: A Systematic Review and Meta-Analysis.

Prophylactic anticoagulant therapy is recommended for reducing the risk of venous thromboembolism (VTE) after a total hip replacement (THR). However, it is not clear which anticoagulant is preferable. Hence, a systematic review and meta-analysis of randomized double-blind controlled trials (RDBCTs) were conducted to investigate the clinical efficacy and safety of enoxaparin in comparison with newer oral anticoagulants for the prevention of VTE after THR. The Cochrane Library, Scopus, Web of Science, Embase, and PubMed/Medline databases were used for PICO search strategy. Relative risks (RR) of symptomatic VTE, clinically relevant bleeding, mortality, and a net clinical endpoint were estimated employing a random effect meta-analysis. ITC and RevMan software were used for indirect and direct comparisons, respectively. Nine RDBCTs comprising 24,584 patients were included. As compared to enoxaparin, a reduced risk for symptomatic VTE was observed with rivaroxaban (confidence interval [CI]: 0.32–0.77; RR: 0.46%) and comparable with apixaban (0.12–1.26; 0.42%) and dabigatran (0.22–2.20; 0.70%). Contrarily to enoxaparin, a greater risk for clinically relevant bleeding was observed with rivaroxaban (1.03–1.48; 1.23%), comparable with dabigatran (0.96–1.33; 1.10%) and reduced with apixaban (0.19–5.66; 0.96%). In indirect or direct comparisons, the interventions did not differ on the net clinical endpoint. In conclusion, the findings of this meta-analysis revealed no significant difference in the efficacy and safety of new oral anticoagulants as compared to enoxaparin for the prevention of VTE after total hip replacement surgery.

Outpatient Prescription Practices in Patients with Atrial Fibrillation (From the NCDR PINNACLE Registry)

This study sought to evaluate inappropriate prescribing practices in an atrial fibrillation (AF) population, as outlined by the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults with Atrial Fibrillation or Atrial Flutter document. The 2016 AF quality measures document specified medications to avoid in certain AF populations, including aspirin and anticoagulant combination therapy in patients without cardiovascular disease, and non-dihydropyridine calcium channel blockers in patients with reduced ejection fraction. Using data from the NCDR PINNACLE registry, a national outpatient cardiology practice registry, we assessed rates of inappropriate prescription of two types of medications among AF outpatients from 5/1/2008-5/1/2016. Overall rates of inappropriate prescription and variation by practice were calculated. Patient and practice factors associated with inappropriate prescription were assessed in adjusted analyses. A total of 107,759 of 658,250 (16.4%) patients without cardiovascular disease were inappropriately prescribed an antiplatelet and anticoagulant together, and 5,731 of 150,079 (3.8%) patients with reduced ejection fraction were inappropriately prescribed a non-dihydropyridine calcium channel blocker. Overall, 14.8% of AF patients were prescribed medications that were not recommended. Both patient and practice factors were associated with inappropriate prescribing, and the adjusted practice-level median odds ratio for inappropriate prescription was 1.70 (95% CI: 1.61-1.82), indicating a 70% likelihood that 2 random practices would treat identical AF patients differently. In a large registry of AF patients treated in cardiology practices, overall rates of inappropriate prescription practices, as defined by the 2016 AF quality measures, were relatively low, but significant practice variation was present.

The safety of new oral anticoagulants for ischemic stroke and systemic embolism prevention in females with atrial fibrillation

The prevalence of atrial fibrillation is lower in females than in men, but the risk of stroke and systemic thromboembolism is comparable or even higher. Administration of anticoagulant therapy does not modify this difference. Two classes of non-vitamin K antagonist oral anticoagulants were studied in atrial fibrillation: direct thrombin inhibitors, like Dabigatran, and activated factor X inhibitors, like Rivaroxaban, Apixaban and Edoxaban. Response to oral anticoagulants could differ between the gender. This medication was evaluated in phase III randomized controlled trials. Non-vitamin K antagonist oral anticoagulants have been proved more efficacious than Warfarin for stroke and systemic embolism prevention in women, but conclusions regarding the safety and the bleeding are heterogeneous. As in men, before prescribing a NOAC to a female with AF, the stroke and the bleeding risk have to be carefully estimated. It is important that future studies to be targeted on comparison between of non-vitamin K antagonist oral anticoagulants versus Warfarin in females with non-valvular atrial fibrillation.

Meta-analysis comparing impact of age, sex and renal function on the efficacy and safety of new oral anticoagulants vs. vitamin K antagonists for the treatment of acute venous thromboembolisms

Abstract Background New direct oral anticoagulants (NOACs), as a preferable treatment option for acute venous thromboembolism (VTE) have been recommended with practical advantages as compared to Vitamin K antagonists (VKAs) in clinical practice. Purpose In our study, we performed a meta-analysis to determine the efficacy and safety of NOACs vs. VKAs in patients with different age, sex and renal function for the treatment of VTE. Methods Electronic databases (accessed October 2019) were systematically searched to identify RCTs evaluating apixaban, dabigatran, edoxaban, and rivaroxaban versus VKAs for the treatment of acute venous thromboembolism. Results NOACs was associated with a borderline higher efficacy in female (OR 0.79, 95% CI 0.62–1.02), and a significantly higher efficacy in patients with age more than 75 (OR 0.51, 95% CI 0.32–0.80) and creatinine clearance less than 50 mL/min (OR 0.57, 95% CI 0.32–0.99). NOACs also show advantage in terms of major or clinically relevant non-major bleeding in male (OR 0.72, 95% CI 0.60–0.86), and patients with creatinine clearance more than 50 mL/min (OR 0.75, 95% CI 0.67–0.84). Conclusions NOACs have exhibited clinical preference among patients with acute VTE as compared to VKA with significantly decreased thrombosis events and lower bleeding complications, especially in patients with age more than 75 and creatinine clearance less than 50 mL/min. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): This study was supported by the National Natural Science Foundation of China (81800390) and the Natural Science Foundation of Shaanxi province (2018KW067).

Efficacy and safety of new oral anticoagulants as part of triple antithrombotic therapy in patients with atrial fibrillation and acute coronary syndrome. Data from an observational study

Aim To study efficacy and safety of a triple antithrombotic therapy with direct oral anticoagulants (DOAC) versus warfarin in patients with atrial fibrillation after acute coronary syndrome, for 12 months following discharge from the hospital.Materials and methods This single-site cohort, prospective, observational study performed at the Regional Vascular Center 2 of the N.A. Semashko Nizhniy Novgorod Regional Clinical Hospital included 402 patients. It was possible to maintain contacts with 206 patients for 12 months. These patients were divided into two groups, the DOAC treatment (n=105) and the warfarin treatment (n=101) as a part of triple antithrombotic therapy upon discharge. Clinical observation was performed at 1, 3, 6, and 12 months after the discharge by structured telephone interview. Predetermined efficacy endpoints included cardiovascular death, myocardial infarction, stent thrombosis, and ischemic stroke. Safety endpoints included bleeding defined as small, medium (clinically significant), and major in accordance with the TIMI classification.Results At 12 months of follow-up, 80 patients (76.19%) continued taking DOAC and 39 patients (38.61%, p&lt;0.001) continued taking warfarin; in this process, only 25 patients (24.75%) monitored their INR on a regular basis. With a regular INR monitoring and TTR &gt;70%, death rate did not differ in the warfarin and the DOAC treatment groups. However, there was a difference in reaching the composite efficacy endpoint (p=0.048): ischemic events occurred statistically significantly more frequently in the warfarin treatment group than in the DOAC treatment group.Conclusions In 12 months after discharge from the hospital, compliance with the DOAC treatment as a part of the antithrombotic therapy was significantly higher than compliance with the warfarin treatment. The triple antithrombotic therapy with DOAC was safer than the warfarin treatment by the number of hemorrhagic complications and more effective in prevention of ischemic events, primarily due to no need for monitoring of lab test values.

Meta-analysis of efficacy and safety of new oral anticoagulants compared with warfarin in Japanese patients undergoing catheter ablation for atrial fibrillation.

This meta-analysis was designed to evaluate the efficacy and safety of new oral anticoagulants (NOACs) for perioperative anticoagulation of atrial fibrillation (AF) catheter ablation (CA) in Japanese patients with non-valvular atrial fibrillation (NVAF). PubMed, Embase, Web of Science, and the Cochrane Library were searched for articles published up to June 30, 2019. Two reviewers independently screened literature, extracted data, and assessed the methodological quality of the included studies according to the inclusion and exclusion criteria. Then, meta-analysis was performed using RevMan 5.3 software. Nineteen studies with a total of 6827 patients were included in this meta-analysis. The experimental group received dabigatran, rivaroxaban, apixaban, or edoxaban; the control group received warfarin. The safety endpoints were bleeding complications; the efficacy endpoints were thromboembolic complications. Results were as follows: Patients with NOACs had a lower risk of overall bleeding complications (OR = 0.69, 95% CI (0.54, 0.87), P= 0.002), including major bleeding complications (OR = 0.52, 95% CI (0.32, 0.84), P= 0.007) and minor bleeding complications (OR = 0.73, 95% CI (0.56, 0.94), P= 0.02). There was no significant difference in thromboembolic complications between NOACs and warfarin after CA (OR = 0.39, 95% CI (0.14, 1.10), P= 0.08). In Japanese NVAF patients undergoing CA, NOACs have similar effects to warfarin in the prevention of stroke and systemic embolism. Moreover, NOACs were associated with a lower incidence of bleeding complications.

Analysis of efficacy and safety of new oral anticoagulants in the treatment of elderly patients with non-valvular atrial fibrillation

Objective To investigate the efficacy and safety of new oral anticoagulants in the treatment of elderly patients with non-valvular atrial fibrillation. Methods From March 2016 to September 2018, 176 elderly patients with non-valvular atrial fibrillation admitted to Lyucheng Cardiovascular Hospital of Zhejiang Province were selected and divided into warfarin group(56 cases), dabiga group(64 cases) and rivaroxaban group(56 cases) according to the treatment conditions.All three groups were treated for 6 months.The incidence of embolism and bleeding events, the changes of blood sugar and liver, kidney function before and after treatment in three groups were compared. Results The incidence rates of thromboembolism in the warfarin group, dabiga group and rivaroxaban group were 7.14%(4/56), 1.56%(1/64), 3.57%(2/56), respectively, there was no statistically significant difference among the three groups(U=2.457, P>0.05). The incidences of bleeding in the warfarin group, dabiga group and rivaroxaban group were 16.07%(9/56), 3.13%(2/64), 1.79%(1/56), respectively, there was statistically significant difference among the three groups(U=11.090, P 0.05). Conclusion Compared with warfarin, the new oral anticoagulant dapigatron ester and rivaroxaban have similar effects in preventing stroke and thromboembolism in elderly patients with non-valvular atrial fibrillation, while the risk of bleeding events during the administration of dapigatron ester and rivaroxaban is lower, suggesting that the new oral anticoagulant is effective in the treatment of stroke and thromboembolism in elderly patients with non-valvular atrial fibrillation.The therapy has high efficacy and safety, which is worthy of clinical promotion. Key words: Atrial fibrillation; Anticoagulants; Warfarin; Dabicarbonate; Rivaroxaban; Safety; Aged

Safety of New Oral Anticoagulants for Patients with Chronic Kidney Disease.

In daily practice, chemical substances called "direct oral anticoagulants" or DOACs are more convenient to administer when set beside vitamin K antagonists (VKA) due to improved pharmacologic properties, fewer drug interactions and rapid onset of action. The objective of this review was to assess whether DOACs are the alternative for VKA in subjects with mild-to-moderate chronic kidney disease (CKD). An analysis of current DOAC trials and studies was performed focusing on subjects with CKD. This review concludes that although DOACS are not recommended in the course of advanced chronic kidney disease (CrCl<30mL/min) or during dialysis, DOACS are a reasonable choice for individuals with mild to moderate CKD.

Efficacy and safety of new oral anticoagulants: Position of gastroenterologist

The prevention of thromboembolism is the leading goal in the management of atrial fibrillation (AF) patients. Oral anticoagulants (OAC) has been using in the treatment of AF patients for a long time according the modern clinical recommendations. Recently, new direct oral anticoagulants (NOAC) have been increasingly used in the treatment and prevention of thrombo-embolism in AF patients. However, the problem of bleeding prevention in anticoagulated patients (primarily for gastrointestinal tract) is still unresolved. The authors analyzed the results of evidence-based medicine for assessing the risk of gastrointestinal bleeding in anticoagulated patients with NOACs. (For citation: Bakulin GI, Belousova LN, Pakhomova IG, Chizhova OYu. Efficacy and safety of new oral anticoagulants: Position of gastroenterologist. Herald of North-Western State Medical University named after I.I. Mechnikov. 2018;10(2):12-18. doi: 10.17816/mechnikov201810212-18).

Efficacy and Safety of New Oral Anticoagulants in the Prevention of Venous Thromboembolism after Orthopaedic Surgery

Relevance. Despite of a specific prophylaxis, the thromboembolic complications occur in 20-25% of patients after orthopedic surgeries. In those who do not receive the prophylaxis the complications rate is even higher taking up to 45-70% thereby putting the complications into second place after infection complications.&#x0D; Objective. To compare the efficacy and safety of dabigatran etaxilate and rivaroxaban in prophylaxis and treatment of the venous thromboembolism after hip and knee arthroplasty.&#x0D; Materials and methods. An analysis of prophylaxis and treatment of venous thromboembolism in 104 patients who had had hip and knee arthroplasty has been accomplished. All patients were randomized into two groups. 51 patients were enrolled into the first (control) group where 220 mg per day dabigatran etexilat therapy was used. The second (investigated) group included 53 patients who received 10 mg per day rivaroxabane therapy. A year after surgery the quality of life of patients was assessed using CIVIQ-20 and SF-36 questioners.&#x0D; Results and their discussion. Venous thromboembolic complications had occurred in 18 (17,3%) of patients equally in the first and second group. Isolated common femoral vein thrombosis was found in 8 (7,7%), and in 3 (2,9%) patients it was associated with pulmonary embolism. Popliteal and tibial vein thrombosis was detected in 7 (6,7%) patients. Internal bleeding complications were found in 9 (8,6%) patients with venous thrombosis. The complications were more common in a second group (higher by 1,7%). In 7 (6,7%) cases the complications had no clinical significance. Only in 2 (1,9%) patients (one case in each group) were documented severe hemorrhages, that needed hemostatic therapy. A year after surgery the quality of life of patients was assessed using specifically oriented CIVIQ-20 and SF-36 international questioners for chronic venous insufficiency. The evidence based differences between two groups were not discovered.&#x0D; Conclusion. Dabigatran etexilate as well as rivaroxaban can be used for prophylaxis of the venous thromboembolism after orthopedic surgeries.

Utilization of Anticoagulation and Antiplatelet Therapies in Patients with Atrial Fibrillation and Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Utilization of Anticoagulation and Antiplatelet Therapies in Patients with Atrial Fibrillation and Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Treatment of cancer-associated venous thromboembolism by new oral anticoagulants: a meta-analysis

Background: The efficacy and safety of newer oral anticoagulants (NOAs) compared to vitamin K antagonist (VKA) in preventing the recurrence of venous thromboembolism (VTE) is well documented. However, it still needs to be determined whether this pattern holds when compared to the combination of low-molecular-weight heparin (LMWH) and VKA in patients with VTE and malignancy. Methods: For this analysis, the authors searched available databases for randomized controlled trials (RCTs) comparing the NOAs with standard treatment (combination of LMWH and VKA) in patients with VTE and those comparing NOAs with LMWH only for prevention of VTE. All these RCTs included small proportion of patients with cancer. The authors then assessed the pooled treatment effects of VTE recurrence, as well as major and non-major clinically relevant bleeding in the two groups. Results: Twelve studies met our inclusion criteria, yielding 2,054 patients. Five studies with rivaroxaban, three each with dabigatran and apixaban, and one with edoxaban compared NOAs with standard treatment. There was a non-significant reduction in VTE recurrence by the NOAs (3.95%) compared to standard treatment (5.62%) [risk ratio (RR) =0.68; 95% confidence interval (CI) =0.42–1.10; P=0.12]. The major bleeding rate with NOAs was (2.62%) compared to the corresponding rate for standard treatment (3.75%) (RR =0.66; 95% CI =0.36–1.20; P=0.17). The non-major clinically relevant bleeding rate with NOAs was (12.82%) compared to the rate for standard treatment (15.52%) (RR =0.85; 95% CI =0.65–1.10; P= 0.22). However, compared to LMWH only, both higher major (RR =2.18; 95% CI =0.32–14.80; P=0.42) and non-major clinically relevant (RR =2.39; 95% CI =0.75–7.56; P=0.14) bleeding rates were noted with NOAs use in acutely-ill hospitalized patients. Conclusions: NOAs seem to be comparable to standard treatment in both their efficacy and safety in patients with VTE and malignancy. However, increased rates of bleeding were observed with their use compared to LMWH use in acutely-ill hospitalized patients.

Эффективность и безопасность новых оральных антикоагулянтов в профилактике венозного тромбоэмболизма после ортопедических операций и их влияние на последующее качество жизни больных

Эффективность и безопасность новых оральных антикоагулянтов в профилактике венозного тромбоэмболизма после ортопедических операций и их влияние на последующее качество жизни больных

OC11_02 Meta-Analysis of Efficacy and Safety of New Oral Anticoagulants Compared With Uninterrupted Vitamin K Antagonists in Patients Undergoing Catheter Ablation for Atrial Fibrillation

OC11_02 Meta-Analysis of Efficacy and Safety of New Oral Anticoagulants Compared With Uninterrupted Vitamin K Antagonists in Patients Undergoing Catheter Ablation for Atrial Fibrillation

New Oral Anticoagulants in Prophylaxis of Venous Thromboembolic Disease in Major Orthopedic Surgery.

Despite widespread diffusion of pharmacological prophylaxis, deep venous thrombosis (DVT) is still a common cause of morbidity after major orthopedic surgery (total hip replacement--THR--and total knee replacement--TKR). At present, clear evidence has been provided that pharmacological primary prophylaxis with low molecular weight heparin (LMWH) is associated with a significant decrease in the incidence of venous thromboembolism. The main limitation of LMWH prophylaxis however is the need for parenteral administration with a not negligible drop-out of treatment. Newer oral anticoagulants (NAOs) dabigatran, rivaroxaban, apixiban and edoxaban may be valid alternatives in elective surgery. Several studies have demonstrated the efficacy and safety of NAOs after THR and TKR. The research for new compounds and their antidote is under continuous development Aim of this paper was to review the indications and clinical results of DVT prophylaxis with NAO in patients undergoing major orthopaedic surgery.

Safety and Efficacy of New Oral Anticoagulants in Patients with Atrial Fibrillation: A Literature Review

Background: TraditionallyVitamin K antagonists (VKAs), such as warfarin, have been used to reduce the risks of stroke and systemic embolism in patients with atrial fibrillation (AF). However, they are associated with increased risk of haemorrhage. Thus, there is a need for new oral anticoagulant agents that are effective, safe, and convenient to use. Recent, observational and randomized controlled clinical trials, have examined the long-term use and efficacy of new oral anticoagulants. However, their results pertaining to important secondary efi¬cacy end points as well as safety outcomes were inconclusive. Aim: We, therefore, performed a systematic review to examine the long-term efi¬cacy and safety of the new oral anticoagulants namely; dabigatran, rivaroxaban and apixaban in patients with AF. Methods: In total 286 abstracts have been screened and 21 articles have been selected and considered as relevant for this epidemiological review. The primary efi¬cacy endpoint was the incidence of stroke or systemic embolism. The primary safety endpoint was the incidence of major bleeding. Results: We observed that dabigatran and rivaroxaban are more efi¬cacious than warfarin for the prevention of stroke, death and systemic embolism. Also, they decrease the risk for intracranial bleeding and appear to have a favorable safety proi¬le, making them promising alternatives to warfarin. Conclusions: Overall, our results support the use of the new oral anticoagulants as alternatives to warfarin for long-term anticoagulation therapy in patients with AF.

EFFICACY AND SAFETY OF THE ORAL ANTICOAGULANTS IN THE MANAGEMENT OF VENOUS THROMBOEMBOLISM: INDIRECT COMPARISON

Objective. The aim was to perform an indirect comparisons of the effectiveness and safety of new oral anticoagulants (NOACs) in the management of venous thromboembolism (VTE). Material and methods. In the absence of a head-to-head comparisons, indirect comparison was done using the method proposed by Butcher et al. Results. The indirect comparison included 5 RCTs. Apixaban, rivaroxaban and dabigatran were equally effective in preventing recurrent symptomatic VTE, deep vein thrombosis and pulmonary embolism. Dabigatran increased major bleeding risk compared to apixaban RR=2.36; 95% CI 1.15-4.82 and the risk major or clinical relevant non-major (CRNM) bleedings RR=1.43; 95% CI 1.06-1.93. Dabigatran and apixaban were associated with the significant lower risk of major and CRNM bleeding compared with rivaroxaban RR=1.49; 95% CI 1.17-1.91 and RR=2.13; 95% CI 1.66-2.74. Conclusions. There were no statistically significant differences between apixaban, dabigatran and rivaroxaban in effectiveness. Apixaban treatment associated with the most favorable safety profile of the NOACs.

Meta-Analysis of Efficacy and Safety of New Oral Anticoagulants Compared With Uninterrupted Vitamin K Antagonists in Patients Undergoing Catheter Ablation for Atrial Fibrillation

Anticoagulation in catheter ablation (CA) of atrial fibrillation (AF) is of paramount importance for prevention of thromboembolic events, and recent studies favor uninterrupted vitamin K antagonists (VKAs). We aimed to compare the efficacy and safety of new oral anticoagulants (NOACs) to uninterrupted VKAs for anticoagulation in CA by performing a meta-analysis. PubMed, EMBASE, the Cochrane Library, and Clinicaltrials.gov databases were searched for studies comparing NOACs with uninterrupted VKAs in patients who underwent CA for AF from January 1, 2000, to August 31, 2015. Odds ratio (OR) and Peto's OR (POR) were used to report for event rates >1% and <1%, respectively. A total of 11,686 patients with AF who underwent CA in 25 studies were included in this analysis. There was no significant difference between NOACs and uninterrupted VKAs in occurrence of stroke or transient ischemic attacks (POR 1.35, 95% CI 0.62 to 2.94) and major bleeding (POR 0.87, 95% CI 0.58 to 1.31), which were consistent in subgroup analysis of interrupted and uninterrupted NOACs. A lower risk of minor bleeding was observed with NOACs (OR 0.80, 95% CI 0.65 to 1.00), and no major differences were observed for the risk of thromboembolic events, cardiac tamponade or pericardial effusion requiring drainage, and groin hematoma. NOACs, whether interrupted preprocedure or not, were associated with equal rates of stroke or TIA and major bleeding complications and less risk of minor bleeding compared with uninterrupted VKAs in CA for AF.

Early Experience of New Oral Anticoagulants for Stroke Prevention in Octogenarian Patients with Atrial Fibrillation

Background and Objectives: The safety of new oral anticoagulants (NOACs) depends largely on renal function. As renal function deteriorates with aging, the safety of NOACs is clinically important for very old cardiac patients. This study analyzed the efficacy and safety of NOACs prescribed to an octogenarian population in a university hospital. Subject and Methods: A total of 158 consecutive patients aged ≥80 years and who had been prescribed NOACs for non-valvular atrial fibrillation (54 patients on dabigatran, 104 patients on rivaroxaban) were included. Demographic features, laboratory findings, and clinical follow-up results were retrospectively reviewed. Results: Reduced doses were prescribed in 105 (66.2%) patients. The estimated GFR curve in octogenarian patients shifted left compared to that of patients aged <80 years. There were two strokes or systemic embolic events during the follow-up period of 276 days. Major bleeding occurred in 13 patients, where gastrointestinal bleeding and anemia of unknown origin were the major causes. Conclusion: NOACs seem to be highly effective for the prevention of stroke or systemic embolism in octogenarian populations. Bleeding events occurred in a considerable number of the study patients. Further studies on optimum dose ranges are required for very old subjects.