scholarly journals Safety and efficacy outcomes of double vs. triple antithrombotic therapy in patients with atrial fibrillation following percutaneous coronary intervention: a systematic review and meta-analysis of non-vitamin K antagonist oral anticoagulant-based randomized clinical trials

2019 ◽  
Author(s):  
Giuseppe Gargiulo ◽  
Andreas Goette ◽  
Jan Tijssen ◽  
Lars Eckardt ◽  
Thorsten Lewalter ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Antithrombotic Therapy ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Vitamin K Antagonist ◽  
Safety And Efficacy ◽  
Percutaneous Coronary ◽  
Triple Antithrombotic Therapy

Abstract Aims To investigate the safety and efficacy of double vs. triple antithrombotic therapy (DAT vs. TAT) in patients with atrial fibrillation (AF) and acute coronary syndrome or who underwent percutaneous coronary intervention (PCI). Methods and results A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials comparing DAT vs. TAT in AF patients undergoing PCI. Four trials encompassing 10 234 patients (DAT = 5496 vs. TAT = 4738) were included. The primary safety endpoint (ISTH major or clinically relevant non-major bleeding) was significantly lower with DAT compared with TAT [risk ratio (RR) 0.66, 95% confidence interval (CI) 0.56–0.78; P < 0.0001; I2 = 69%], which was consistent across all available bleeding definitions. This benefit was counterbalanced by a significant increase of stent thrombosis (RR 1.59, 95% CI 1.01–2.50; P = 0.04; I2 = 0%) and a trend towards higher risk of myocardial infarction with DAT. There were no significant differences in all-cause and cardiovascular death, stroke and major adverse cardiovascular events. The comparison of NOAC-based DAT vs. vitamin K antagonist (VKA)-TAT yielded consistent results and a significant reduction of intracranial haemorrhage (RR 0.33, 95% CI 0.17–0.65; P = 0.001; I2 = 0%). Conclusion Double antithrombotic therapy, particularly if consisting of a NOAC instead of VKA and a P2Y12 inhibitor, is associated with a reduction of bleeding, including major and intracranial haemorrhages. This benefit is however counterbalanced by a higher risk of cardiac—mainly stent-related—but not cerebrovascular ischaemic occurrences.

scholarly journals Safety and efficacy of double vs. triple antithrombotic therapy in patients with atrial fibrillation with or without acute coronary syndrome undergoing percutaneous coronary intervention: a collaborative meta-analysis of non-vitamin K antagonist oral anticoagulant-based randomized clinical trials

2020 ◽  
Author(s):  
Giuseppe Gargiulo ◽  
Christopher P Cannon ◽  
Charles Michael Gibson ◽  
Andreas Goette ◽  
Renato D Lopes ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Percutaneous Coronary Intervention ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Vitamin K Antagonist ◽  
Safety And Efficacy ◽  
Coronary Syndrome ◽  
Percutaneous Coronary ◽  
Triple Antithrombotic Therapy

Abstract Aims Safety and efficacy of antithrombotic regimens in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) may differ based on clinical presentation. We sought to compare double vs. triple antithrombotic therapy (DAT vs. TAT) in AF patients with or without acute coronary syndrome (ACS) undergoing PCI. Methods and results A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials. Data on subgroups of ACS or elective PCI were obtained by published reports or trial investigators. A total of 10 193 patients from four NOAC trials were analysed, of whom 5675 presenting with ACS (DAT = 3063 vs. TAT = 2612) and 4518 with stable coronary artery disease (SCAD; DAT = 2421 vs. TAT = 2097). The primary safety endpoint of ISTH major bleeding or clinically relevant non-major bleeding was reduced with DAT compared with TAT in both ACS (12.2% vs. 19.4%; RR 0.63, 95% CI 0.56–0.71; P &lt; 0.0001; I2 = 0%) and SCAD (14.6% vs. 22.0%; RR 0.68, 95% CI 0.55–0.85; P = 0.0008; I2 = 66%), without interaction (P-int = 0.54). Findings were consistent for secondary bleeding endpoints, including intra-cranial haemorrhage. In both subgroups, there was no difference between DAT and TAT for all-cause death, major adverse cardiovascular events, or stroke. Myocardial infarction and stent thrombosis were numerically higher with DAT vs. TAT consistently in ACS and SCAD (P-int = 0.60 and 0.86, respectively). Findings were confirmed by multiple sensitivity analyses, including a separate analysis on dabigatran regimens and a restriction to PCI population. Conclusions DAT, compared with TAT, is associated with lower bleeding risks, including intra-cranial haemorrhage, and a small non-significant excess of cardiac ischaemic events in both patients with or without ACS.

scholarly journals Safety and Efficacy of Double Antithrombotic Therapy With Non–Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta‐Analysis

2020 ◽  
Vol 9 (16) ◽  
Author(s):  
Davide Capodanno ◽  
Marco Di Maio ◽  
Antonio Greco ◽  
Deepak L. Bhatt ◽  
C. Michael Gibson ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Vitamin K ◽  
Antithrombotic Therapy ◽  
Meta Analysis ◽  
Coronary Intervention ◽  
Vitamin K Antagonist ◽  
Major Adverse Cardiac Events ◽  
Cardiac Events ◽  
Adverse Cardiac Events ◽  
Percutaneous Coronary

Background The optimal antithrombotic therapy for patients with atrial fibrillation undergoing percutaneous coronary intervention is a topic of debate. We aimed at defining the efficacy and safety of double antithrombotic therapy with single antiplatelet therapy (SAPT) plus a non–vitamin K antagonist oral anticoagulant (NOAC) against triple antithrombotic therapy with dual antiplatelet therapy (DAPT) added to a vitamin K antagonist (VKA), illustrating the pooled cumulative distribution of events, the ranking of different NOACs tested in NOAC+SAPT combination strategies, and the state of the current evidence in the field. Methods and Results Randomized controlled trials meeting the inclusion criteria were identified. The primary efficacy end point was the composite of trial‐defined major adverse cardiac events. The primary safety end point was clinically significant bleeding. Secondary end points were the components of primary end points. Trial‐level pairwise and Bayesian network meta‐analyses, reconstructed Kaplan–Meier analyses, and trial sequential analysis were performed. Four randomized controlled trials (10 969 patients) were included. No differences were found in terms of major adverse cardiac events (hazard ratio [HR], 1.07; 95% CI, 0.94–1.22), and the NOAC+SAPT strategy showed a lower rate of clinically significant bleeding compared with VKA + DAPT (HR, 0.56; 95% CI, 0.39–0.80). These results were consistent in reconstructed Kaplan–Meier analyses. In the Bayesian network meta‐analysis, different NOACs displayed diverse risk–benefit profiles. Trial sequential analyses suggest that the evidence for the similarity in major adverse cardiac events compared with VKA + DAPT and the bleeding risk reduction observed with NOAC+SAPT is likely to be conclusive. Conclusions NOAC+SAPT does not increase the risk of major adverse cardiac events and reduces the risk of bleeding compared with VKA + DAPT in AF patients undergoing percutaneous coronary intervention. Various NOACs may have different risk–benefit profiles in combination strategies. Registration URL: https://www.crd.york.ac.uk/prospero/ ; Unique identifier: CRD42020151089.

scholarly journals Antithrombotic Therapy in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention

Circulation ◽  
2018 ◽  
Vol 138 (5) ◽  
pp. 527-536 ◽  
Author(s):  
Dominick J. Angiolillo ◽  
Shaun G. Goodman ◽  
Deepak L. Bhatt ◽  
John W. Eikelboom ◽  
Matthew J. Price ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Percutaneous Coronary Intervention ◽  
Vitamin K ◽  
Oral Anticoagulation ◽  
Antithrombotic Therapy ◽  
Oral Anticoagulant ◽  
Coronary Intervention ◽  
Vitamin K Antagonist ◽  
Percutaneous Coronary ◽  
Antithrombotic Management

The optimal antithrombotic treatment regimen for patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation represents a challenge in clinical practice. In 2016, an updated opinion of selected experts from the United States and Canada on the treatment of patients with atrial fibrillation undergoing percutaneous coronary intervention was reported. After the 2016 North American consensus statement on the management of antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention, results of pivotal clinical trials assessing the type of oral anticoagulant agent and the duration of antiplatelet treatment have been published. On the basis of these results, this focused update on the antithrombotic management of patients with atrial fibrillation undergoing percutaneous coronary intervention recommends that a non–vitamin K antagonist oral anticoagulant be preferred over a vitamin K antagonist as the oral anticoagulant of choice. Moreover, a double-therapy regimen (oral anticoagulant plus single antiplatelet therapy with a P2Y 12 inhibitor) by the time of hospital discharge should be considered for most patients, whereas extending the use of aspirin beyond hospital discharge (ie, triple therapy) should be considered only for selected patients at high ischemic/thrombotic and low bleeding risks and for a limited period of time. The present document provides a focused updated on the rationale for the new expert consensus–derived recommendations on the antithrombotic management of patients with atrial fibrillation treated with oral anticoagulation undergoing percutaneous coronary intervention.

scholarly journals Double Antithrombotic versus Triple Antithrombotic Therapy in Patients with Atrial Fibrillation and Acute Coronary Syndrome

2020 ◽  
Vol 29 (02) ◽  
pp. 081-087
Author(s):  
Surya Dharma
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Vitamin K ◽  
Antithrombotic Therapy ◽  
Randomized Clinical Trials ◽  
Bleeding Event ◽  
Vitamin K Antagonist ◽  
Thromboembolic Complications ◽  
Coronary Syndrome ◽  
Triple Antithrombotic Therapy

AbstractIn atrial fibrillation (AF), oral anticoagulant (OAC) therapy with either vitamin K antagonist or non–vitamin K antagonist is used to prevent thromboembolic complications. In patients who presented with acute coronary syndrome (ACS) and were treated by percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces major adverse cardiac events (MACEs) and stent thrombosis. Consequently, in patients with AF who presented with ACS and were treated by PCI, the combination of OAC and DAPT, the so-called triple antithrombotic therapy (TAT) is needed to improve the outcome of the patients. However, the use of TAT increases the risk of bleeding. Several randomized clinical trials and a meta-analysis evaluated the use of TAT and double antithrombotic therapy (DAT) in this population, and DAT is defined as patients who receive combination of one antiplatelet and OAC. In general, the studies demonstrated a reduction in bleeding event in patients who received DAT as compared with TAT, with similar incidence of thromboembolic complications and MACE. To date, there is no established consensus or guideline for the most appropriate combination of antithrombotic agents in patients with AF and ACS who undergo PCI. Tailoring the treatment for each individual is likely the best approach to determine the balance of bleeding risk and ischemic events before starting antithrombotic therapy. Future trials with adequate sample size are needed to find the most appropriate combination of antiplatelet and OAC in patients with AF who presented with ACS and treated by PCI.

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