Triple or Dual Antithrombotic Therapy After Percutaneous Coronary Intervention in Patients With Non-valvular Atrial Fibrillation. Real-world Italian Multicenter Registry

INTRODUCTION The optimal antithrombotic therapy (combination of anticoagulants and antiplatelets drugs) for patients with non valvular atrial fibrillation (NVAF) after coronary stenting is unknown. In the last years, four randomized controlled trials compared double antithrombotic therapy with Direct Oral Anti-Coagulants (DOACs) and antiplatelet agent versus antithrombotic therapy including warfarin in patients with NVAF undergoing percutaneous coronary intervention (PCI).1-4 However, none of these trial reported the angiographic features of treated coronary lesions nor other PCI details (as stent location, stent number, stent length, type of bifurcation etc). All these characteristics are established determinants of PCI related thrombotic risk. Moreover, all trials were underpowered for the evaluation of stent thrombosis, instead were powered and focused on major bleeding events. Finally, different antithrombotic regimens with DOACs and antiplatelet agent (triple or dual therapy) have not been compared yet.

3. STUDY RATIONALE: Double platelets suppressive agents combined with oral anticoagulation (triple antithrombotic therapy) was the gold standard after PCI with stent implantation in patients with NVAF. Dual antiplatelet therapy (DAPT) is recommended to reduce the risk of ischaemic complications in patients undergoing PCI and the combination of anticoagulant with DAPT, a strategy generally called triple antithrombotic therapy, increases the bleeding risks compared with the use of anticoagulant or DAPT alone. Therefore, research has focused on choosing a treatment strategy that provides the optimal balance between ischaemic and bleeding occurrences.1,2 The use of Direct Oral Anti-Coagulants (DOACs) instead of traditional anticoagulants (warfarin and acenocumarol) is expanding, but their proper management in patients PCI with stent implantation and concomitant indication for antiplatelet therapy is still not completely clear. Current European guidelines are still based on weak data. Recently, 4 randomized controlled trials compared double antithrombotic therapy with DOACs and antiplatelet agent versus antithrombotic therapy including warfarin in patients with NVAF undergoing PCI.1-4 None of these studies reported the angiographic features of treated coronary lesions nor other PCI details (stent location, stent number, stent length, type of bifurcation etc). All these are established determinants of PCI-related thrombotic risk. Moreover, all RCTs were underpowered for the evaluation of stent thrombosis, instead were powered and focused on major bleeding events. Finally, different antithrombotic regimens with DOACs and antiplatelet agent (triple or dual therapy) have not been compared yet. Therefore, the aim of this investigator's driven trial, retrospective, multicenter Italian registry is to describe clinical and procedural characteristics of a real-world large population initiated, on the basis of the local practice, the triple or double antithrombotic therapy after PCI, comparing different anticoagulant regimens (DOACs or warfarin/acenocumarol) in terms of efficacy (coronary stent thrombosis and myocardial infarction) and safety (major bleeding or clinically relevant non-major bleeding).

4. DETAILED DESCRIPTION This Italian, multicenter, retrospective observational study is aimed to evaluate the management of antithrombotic therapy with antiplatelet therapy (single or dual) and concomitant anticoagulant therapy (with direct oral anticoagulants, DOACs, or warfarin/acenocumarol) in patients with NVAF undergoing elective or urgent PCI with stent implantation and the adverse events (coronary stent thrombosis, myocardial infarction and major bleeding) associated with. The registry include all consecutive patients with NVAF treated in the last 5 years by PCI with stent (drug-eluting stent and/or bare metal stent).

The aim of the study is to evaluate the safety and efficacy of triple or dual antithrombotic therapy in patients taking Triple antithrombotic therapy (aspirin and a P2Y12 inhibitor, in addition to either a DOACs or warfarin/acenocumarol) or Dual antithrombotic therapy (aspirin or P2Y12 inhibitor in addition to either a DOACs or warfarin/acenocumarol) for the prevention of adverse events after PCI in patients with NVAF (or atrial flutter).

Adenosine diphosphate (ADP) receptor antagonists (or P2Y12 inhibitors) therapy include: