Oral anticoagulant monotherapy vs oral anticoagulant/antiplatelet therapy for the management of atrial fibrillation and stable coronary artery disease

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
A Abdul Razzack ◽  
T Saeed ◽  
R Gulzar ◽  
S Pothuru ◽  
S Adeel Hassan ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background- The efficacy and safety of oral Anticoagulation (OAC)with either Warfarin or Direct oral anticoagulants (DOACs) as compared with combination therapy of oral anticoagulant and antiplatelet (OAC + APT) in patients with atrial fibrillation and stable coronary artery disease more than 1 year after stenting is not known.  Methods-Electronic databases ( PubMed, Embase, Scopus) were searched from inception to December 28th, 2020. Unadjusted odds ratios (OR) were calculated from dichotomous data using Mantel Haenszel (M-H) random-effects with statistical significance to be considered if the confidence interval excludes 1 and p < 0.05. The primary efficacy end point was MACCE definied as composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis; this end point was analyzed for superiority. Results- A total of seven studies with 81,303(OAC = 56,633; OAC + APT = 24670) participants were included. There was no statistically significant differences in MACCE among patients treated using OAC monotherapy compared with those treated with OAC + APT (HR 1.09; 95% CI 0.93-1.29; p = 0.28). OAC + APT was associated with a significantly higher risk of major bleeding compared with OAC monotherapy (HR 1.65; 95% CI 1.30-2.11; p < 0.0001) Conclusion- Amongst patients with atrial fibrillation and concomitant stable coronary artery disease, OAC monotherapy is non-inferior to combination therapy with OAC and single antiplatelet agent. OAC monotherapy reduced the risk for major or life-threatening bleeding events, while not increasing the risk for major adverse cardiovascular events. Abstract Figure.

Circulation ◽  
2014 ◽  
Vol 129 (15) ◽  
pp. 1577-1585 ◽  
Author(s):  
Morten Lamberts ◽  
Gunnar H. Gislason ◽  
Gregory Y.H. Lip ◽  
Jens Flensted Lassen ◽  
Jonas Bjerring Olesen ◽  
...  

Author(s):  
Koichi Kaikita ◽  
Satoshi Yasuda ◽  
Masaharu Akao ◽  
Junya Ako ◽  
Tetsuya Matoba ◽  
...  

Background: Early bleeding after percutaneous coronary intervention is associated with increased risk of death and myocardial infarction; however, the association between bleeding and subsequent major adverse cardiac and cerebrovascular events (MACCE) remains unclear in patients with atrial fibrillation and stable coronary artery disease. We thus aimed to investigate this association. Methods: The AFIRE trial (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) was a multicenter, open-label trial conducted in Japan. This post hoc analysis included 2215 patients with atrial fibrillation and stable coronary artery disease treated with rivaroxaban or rivaroxaban plus an antiplatelet agent. MACCE was defined as a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause. The association of bleeding with subsequent MACCE risk was investigated using time-adjusted Cox multivariate analysis after adjusting for baseline characteristics and time from bleeding. Bleeding events were classified according to the International Society on Thrombosis and Haemostasis criteria. Results: Among the 2215 patients, 386 (17.4%) had bleeding during follow-up, of whom 63 (16.3%) also experienced MACCE; MACCE incidence was higher in patients with bleeding than in those without (8.38% versus 4.20% per patient-year; hazard ratio, 2.01 [95% CI, 1.49–2.70]; P <0.001). The proportion of patients with both bleeding and MACCE (developed after bleeding) was 73.0% (46 of 63); 27.0% (17 of 63) experienced MACCE before bleeding. Time-adjusted Cox multivariate analysis revealed a temporal association between major bleeding and subsequent MACCE, with particularly high MACCE risks within 30 days after major bleeding (hazard ratio, 7.81 [95% CI, 4.20–14.54]). Conclusions: In patients with atrial fibrillation and stable coronary artery disease, major bleeding was strongly associated with subsequent MACCE. Thus, it is important to prevent major bleeding to avoid cardiovascular events and death. Registration: URL: https://www.umin.ac.jp/ctr ; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02642419.


Author(s):  
Yasushi Matsuzawa ◽  
Kazuo Kimura ◽  
Satoshi Yasuda ◽  
Koichi Kaikita ◽  
Masaharu Akao ◽  
...  

Background Among patients with atrial fibrillation and stable coronary artery disease, those with histories of atherothrombotic disease are at high‐risk for future ischemic events. This study investigated the efficacy and safety of rivaroxaban monotherapy in patients with atrial fibrillation, coronary artery disease, and histories of atherothrombotic disease. Methods and Results This was a post hoc subanalysis of the AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial. Patients with non‐valvular atrial fibrillation and coronary artery disease were recruited and randomized to receive the rivaroxaban monotherapy or combination therapy with rivaroxaban plus antiplatelet drug. For the purpose of this sub‐study, participants were divided into 2 subgroups, including the atherothrombosis group (those with histories of myocardial infarction, stroke, and/or peripheral artery disease; n=1052, 47.5%) and non‐atherothrombosis group (n=1163, 52.5%). The efficacy end point included cardiovascular events or all‐cause death, while the safety end point was major bleeding. Net adverse events consisted of all‐cause death, myocardial infarction, stroke, or major bleeding. In the atherothrombosis group, rivaroxaban monotherapy was significantly associated with a lower risk of net adverse events when compared with combination therapy (hazard ratio [HR], 0.50; 95% CI, 0.34–0.74; P <0.001), with a decrease in both efficacy (HR, 0.68; 95% CI, 0.47–0.99; P =0.044) and safety (HR, 0.37; 95% CI, 0.19–0.71; P =0.003) end points. By contrast, there were no differences between treatment outcomes for the non‐atherothrombosis group. Conclusions Rivaroxaban monotherapy significantly reduced net adverse events as compared with combination therapy for patients with atrial fibrillation, coronary artery disease, and prior atherothrombotic disease. Registration URL: https://www.umin.ac.jp/ctr/ ; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02642419.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 904-904
Author(s):  
Francesco Dentali ◽  
Wendy Lim ◽  
James D. Douketis

Abstract Background: Deciding between combined aspirin and oral anticoagulant (OAC) therapy compared to OAC therapy alone in patients with chronic atrial fibrillation who also have coronary artery disease or are at high risk for stroke is a common clinical problem. Individual trials do not address the benefits and risks of these two treatment strategies. Purpose: To perform a systematic review and meta-analysis of randomized controlled trials comparing combined aspirin-OAC therapy and OAC alone with respect to bleeding complications and overall mortality. Data Sources: Randomized trials published up to December 2004 in MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases. Study Selection: Included studies satisfied the following criteria: randomized trial involving patients, age ≥18 years, with chronic atrial fibrillation, a mechanical heart valve or coronary artery disease that compared treatment with OAC and aspirin to treatment with OAC alone; OAC therapy was the same in all treatment arms; patient follow-up for at least 3 months; the study documented at least 2 of 3 study outcomes. Data Extraction: Two reviewers independently extracted data on thromboembolic, major bleeding and mortality outcomes. Authors were contacted if the required information was not available. Data Synthesis: Fifteen studies were included, totalling 8984 patients with a mechanical heart valve, chronic atrial fibrillation or coronary artery disease. The risk for thromboembolic outcomes was significantly lower in patients receiving aspirin-OAC therapy compared to OAC therapy alone (OR = 0.62; 95% CI: 0.51, 0.77; P &lt;0.001). In patients receiving aspirin-OAC therapy or OAC therapy alone, there was no difference in the risk for major bleeding (OR = 1.14; 95% CI: 0.90, 1.45; P = 0.27), intracranial bleeding (OR = 0.84; 95% CI: 0.51, 1.39), or fatal bleeding (OR = 1.36; 95% CI: 0.71, 2.61). There was no significant difference in all-cause mortality in patients receiving aspirin-OAC therapy compared to OAC therapy alone (OR = 0.93; 95% CI: 0.78, 1.10; P = 0.38). In patients receiving aspirin-OAC therapy compared to OAC therapy alone, there was no significant difference in the case-fatality rate for thromboembolism (12.1% vs. 12.2%; P = 0.99), or major bleeding (13.2% vs. 11.5%; P = 0.66). Conclusions: Aspirin may be added to OAC in patients at high risk of thromboembolic complications since it appears to be effective with a similar bleeding risk as therapy with OAC alone. However, does not appear to reduce the risk of death.


Heart ◽  
2021 ◽  
pp. heartjnl-2021-319321
Author(s):  
Hidehira Fukaya ◽  
Junya Ako ◽  
Satoshi Yasuda ◽  
Koichi Kaikita ◽  
Masaharu Akao ◽  
...  

ObjectivePatients with coronary artery disease (CAD) and atrial fibrillation (AF) can be treated with multiple antithrombotic therapies including antiplatelet and anticoagulant therapies; however, this has the potential to increase bleeding risk. Here, we aimed to evaluate the efficacy and safety of P2Y12 inhibitors and aspirin in patients also receiving anticoagulant therapy.MethodsWe evaluated patients from the Atrial Fibrillation and Ischaemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial who received rivaroxaban plus an antiplatelet agent; the choice of antiplatelet agent was left to the physician’s discretion. The primary efficacy and safety end points, consistent with those of the AFIRE trial, were compared between P2Y12 inhibitors and aspirin groups. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularisation or death from any cause. The primary safety end point was major bleeding according to the International Society on Thrombosis and Haemostasis criteria.ResultsA total of 1075 patients were included (P2Y12 inhibitor group, n=297; aspirin group, n=778). Approximately 60% of patients were administered proton pump inhibitors (PPIs) and there was no significant difference in PPI use in the groups. There were no significant differences in the primary end points between the groups (efficacy: HR 1.31; 95% CI 0.88 to 1.94; p=0.178; safety: HR 0.79; 95% CI 0.43 to 1.47; p=0.456).ConclusionsThere were no significant differences in cardiovascular and bleeding events in patients with AF and stable CAD taking rivaroxaban with P2Y12 inhibitors or aspirin in the chronic phase.Trial registration numberUMIN000016612; NCT02642419.


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