Mehran, Roxana

Abstract Since its introduction in 2002, left atrial appendage closure (LAAC) has rapidly expanded as an alternative to anticoagulation in patients with atrial fibrillation at high risk of stroke. Harmonized processes for data collection, analysis, and reporting in LAAC trials are essential to enhance research quality and improve clinical practice. The Left Atrial Appendage Academic Research Consortium (LAARC) initiative is an independent collaboration of academic research organizations, cardiology and neurology experts, clinical trialists, and regulatory authorities from the USA, Europe, and Asia. The consortium engaged clinical experts, regulators—including the US Food and Drug Administration (FDA), European Notified Bodies, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)—and industry leaders to define standardized study elements and endpoints for LAAC trials. Key considerations included alignment with prior Academic Research Consortium initiatives, procedural and mechanistic insights, and clinical relevance. Consensus definitions were proposed for mortality, stroke, bleeding, and device performance, along with composite endpoints for safety and effectiveness. The proposed LAARC consensus definitions aim to standardize endpoint reporting, improve comparability across studies, and support regulatory and clinical trial applications for this evolving therapy through broad dissemination in the peer-reviewed literature.

Antiplatelet therapy is the mainstay of pharmacologic treatment to prevent thrombotic or ischemic events in patients with coronary artery disease treated with percutaneous coronary intervention and those treated medically for an acute coronary syndrome. The use of antiplatelet therapy comes at the expense of an increased risk of bleeding complications. Defining the optimal intensity of platelet inhibition according to the clinical presentation of atherosclerotic cardiovascular disease and individual patient factors is a clinical challenge. Modulation of antiplatelet therapy is a medical action that is frequently performed to balance the risk of thrombotic or ischemic events and the risk of bleeding. This aim may be achieved by reducing (ie, de-escalation) or increasing (ie, escalation) the intensity of platelet inhibition by changing the type, dose, or number of antiplatelet drugs. Because de-escalation or escalation can be achieved in different ways, with a number of emerging approaches, confusion arises with terminologies that are often used interchangeably. To address this issue, this Academic Research Consortium collaboration provides an overview and definitions of different strategies of antiplatelet therapy modulation for patients with coronary artery disease, including but not limited to those undergoing percutaneous coronary intervention, and consensus statements on standardized definitions.

A growing number of patients undergoing percutaneous coronary intervention (PCI) with stent implantation also have atrial fibrillation. This poses challenges for their optimal antithrombotic management because patients with atrial fibrillation undergoing PCI require oral anticoagulation for the prevention of cardiac thromboembolism and dual antiplatelet therapy for the prevention of coronary thrombotic complications. The combination of oral anticoagulation and dual antiplatelet therapy substantially increases the risk of bleeding. Over the last decade, a series of North American Consensus Statements on the Management of Antithrombotic Therapy in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention have been reported. Since the last update in 2018, several pivotal clinical trials in the field have been published. This document provides a focused updated of the 2018 recommendations. The group recommends that in patients with atrial fibrillation undergoing PCI, a non–vitamin K antagonist oral anticoagulant is the oral anticoagulation of choice. Dual antiplatelet therapy with aspirin and a P2Y 12 inhibitor should be given to all patients during the peri-PCI period (during inpatient stay, until time of discharge, up to 1 week after PCI, at the discretion of the treating physician), after which the default strategy is to stop aspirin and continue treatment with a P2Y 12 inhibitor, preferably clopidogrel, in combination with a non–vitamin K antagonist oral anticoagulant (ie, double therapy). In patients at increased thrombotic risk who have an acceptable risk of bleeding, it is reasonable to continue aspirin (ie, triple therapy) for up to 1 month. Double therapy should be given for 6 to 12 months with the actual duration depending on the ischemic and bleeding risk profile of the patient, after which patients should discontinue antiplatelet therapy and receive oral anticoagulation alone.

Abstract Objectives We sought to identify clinical, electrocardiographic (ECG), and angiographic characteristics that are predictive of 3‐year mortality after primary percutaneous coronary intervention (PCI) in patients with non‐anterior ST‐elevation myocardial infarction (NA‐STEMI) from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS‐AMI) trial. Background Which patients with NA‐STEMI undergoing PCI have a poor prognosis is uncertain. Methods NA‐STEMI was defined as ST‐segment elevation in lateral (V5, V6, I, aVL), inferior (II, III, aVF), or inferolateral (I, II, III, aVF, and V5‐V6) ECG leads or posterior myocardial infarction with ST‐segment depression of ≥1 mm in ≥2 contiguous anterior leads. Cox regression was used to identify independent predictors of 3‐year mortality. Missing data were imputed using multiple imputation. Results In HORIZONS‐AMI, 2,578/3,602 patients had no prior coronary artery bypass grafting, underwent single‐vessel PCI, and had baseline ECG data assessed in an independent core laboratory. Among them, 1,495 (58.0%) had NA‐STEMI. Patients with NA‐STEMI had lower 3‐year mortality risk than those with anterior STEMI (4.5% versus 7.1%, P = 0.004). The independent predictors of increased 3‐year mortality in NA‐STEMI were older age (median > 59.0 years), diabetes, reduced LVEF (≤50%), Killip class ≥2, post‐procedure TIMI flow 0–2 versus 3, renal insufficiency, and ST‐resolution <30% at 60 min post‐PCI. Patients with 0, 1, 2, 3, and ≥4 of these risk factors had 3‐year mortality rates of 1.8%, 2.3%, 3.1%, 6.1%, and 36.3%, respectively ( P < 0.0001). Conclusions Although NA‐STEMI carries a better prognosis than anterior STEMI, high‐risk patient cohorts with NA‐STEMI may be identified who have substantial 3‐year mortality.