| Literature DB >> 35159964 |
Leonardo De Luca1,2, Raffaella Mistrulli3, Francesco Antonio Veneziano4, Francesco Grigioni4, Massimo Volpe3, Francesco Musumeci1, Domenico Gabrielli1.
Abstract
Patients with atrial fibrillation (AF) are at increased risk for coronary artery disease (CAD). After percutaneous coronary intervention (PCI), the antithrombotic therapy consists of a combination of anticoagulant and antiplatelet agents to reduce the ischemic and thromboembolic risk, at the cost of increased bleeding events. In the past few years, several randomized clinical trials involving over 12,000 patients have been conducted to compare the safety of vitamin K antagonist (VKA) and direct-acting oral anticoagulants (DOACs) in association with a single- or double-antiplatelet agent, in the so-called dual- (DAT) or triple-antithrombotic therapy (TAT). These studies and several meta-analyses showed a consistent benefit for reducing bleeding events of DAT over TAT and of DOAC over VKA, without concerns about ischemic endpoints, except for a trend for increased stent thrombosis risk. The present paper examines current international guidelines' recommendations and reviews clinical trials, meta-analyses, and observational studies conducted on AF patients treated with DAT or TAT after PCI for acute coronary syndromes.Entities:
Keywords: acute coronary syndrome; atrial fibrillation; dual antithrombotic therapy; triple antithrombotic therapy
Year: 2022 PMID: 35159964 PMCID: PMC8836736 DOI: 10.3390/jcm11030512
Source DB: PubMed Journal: J Clin Med ISSN: 2077-0383 Impact factor: 4.241
Design of major trials comparing TAT vs. DAT.
| Design, Randomization | Patients ( | Treatment Arms | AF (%) | Maximum Days in ASA in DAT Group | ACS (%) | Follow Up (mo) | Primary Outcome | |
|---|---|---|---|---|---|---|---|---|
| WOEST | RCT open label, 1:1 | 573 | VKA + P2Y12i for 1 or 12 mo vs. VKA + aspirin + P2Y12i for 1 or 12 mo | 69 | <1 | 28 | 12 | Any bleeding events (TIMI and GUSTO criteria) |
| ISAR-TRIPLE | RCT open label, 1:1 | 614 | 6 we of VKA + clopidogrel + aspirin vs. 6 mo of VKA + clopidogrel + aspirin | 84 | / | 32 | 9 | A composite of death, MI, ST, stroke, or major bleeding |
| PIONEER-AF | RCT open label, 1:1:1 | 2124 | rivaroxaban (15 mg/od) + P2Y12i vs. rivaroxaban (2.5 mg/bid) + aspirin + P2Y12i vs. VKA + aspirin + P2Y12i | 100 | 3 | 52 | 12 | Clinically significant bleeding (TIMI major, minor bleeding, or bleeding requiring medical attention) |
| RE-DUAL PCI | RCT open label, 1:1:1 | 2725 | dabigatran (110 mg/bid) + P2Y12i vs. dabigatran (150 mg/bid) + P2Y12i vs. VKA + aspirin (1–3 months) + P2Y12i | 100 | 5 | 51 | 14 | Clinically significant bleeding (ISTH major bleeding or clinically relevant nonmajor bleeding event) |
| AUGUSTUS | RCT open label, | 4614 | apixaban (5 mg/bid) + P2Y12i vs. apixaban (5 mg/bid) + aspirin + P2Y12i vs. VKA + P2Y12i vs. VKA + aspirin + P2Y12 | 100 | 14 | 60 | 6 | Clinically significant bleeding (ISTH major or clinically relevant nonmajor bleeding) |
| ENTRUST-AF PCI | RCT open label, 1:1 | 1506 | Edoxaban (60 mg/od) + P2Y12i vs. VKA + aspirin (1–12 mo) + P2Y12 | 100 | 5 | 52 | 12 | Major or clinically relevant nonmajor bleeding (according to ISTH criteria) |
RCT = randomized controlled trial; MI = myocardial infarction; ST = stent thrombosis; ISTH = International Society on Thrombosis and Haemostasis; GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries.
Figure 1Antithrombotic therapy duration: differences across guidelines. ACS, acute coronary syndrome; AF, atrial fibrillation; CCS, chronic coronary syndrome; DAT, dual-antithrombotic therapy; OAC, oral anticoagulant; TAT, triple-antithrombotic therapy.
Figure 2Risk factors associated with an increased risk of bleeding and an increased risk of ischemic coronary outcomes. ARB-HBR = The Academic Research Consortium for High Bleeding Risk; CKD = Chronic kidney disease; DM = Diabetes mellitus; PAD = Peripheral arterial disease; MI = Myocardial infarction; PCI = Percutaneous coronary intervention.