Coated or chewable Aspirin and a hybrid air pollution mitigation strategy in patients with atherosclerotic disease: Rationale and Design of the COATED-AIR Randomized Trial.
Abstract
BACKGROUND: Although enteric-coated aspirin is widely used instead of chewable formulations in patients with atherosclerotic cardiovascular diseases (ASCVD), its effects on cardiovascular and gastrointestinal outcomes remain uncertain. Separately, air pollution is a driver of cardiovascular risk, yet individual-level interventions have not been tested in outcomes trials. METHODS AND RESULTS: The Coated Or Chewable Aspirin in Patients with Established AThErosclerotic Disease and a Hybrid Strategy to Mitigate the Adverse Effects of AIR Pollution (COATED-AIR) is a randomized trial with a 2x2 factorial design planned to address these knowledge gaps. Patients with ASCVD receiving low-dose aspirin are considered for inclusion. Major exclusion criteria consist of being within 72 hours of acute/unstable ASCVD or revascularization, triple antithrombotic therapy, active/recent bleeding, life expectancy <1 year, or other barriers or unwillingness for enrollment. Eligible consenting patients are randomized, in a double-blind fashion, to enteric coated vs chewable aspirin 81mg daily, and (via factorial randomization) to a hybrid strategy to mitigate the adverse effects of air pollution vs usual care. The hybrid strategy includes 1. an educational flashcard, 2. real-time air quality alerts via cellular text messages, and recommendations to 2a. limit outdoor activity or 2b. to use a KN-95 facemask when outdoors, and 2c. to increase citrus fruit intake on days with elevated pollution levels. The primary efficacy outcome for the aspirin randomization is a composite of fatal/nonfatal ischemic stroke, thrombotic/thromboembolic myocardial infarction, and acute limb ischemia. For the AIR randomization, other forms of cardiovascular death are additionally included in the primary composite outcome. The median planned duration of follow-up is 2 years. Enrollment was completed on 01/28/2026. Clinical follow-up and blinded event adjudications are ongoing. CONCLUSION: COATED-AIR will determine whether aspirin coating affects its safety or effectiveness, and whether individual-level strategies can mitigate cardiovascular risks from air pollution in patients with ASCVD.
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Authors: Behnood Bikdeli, Azita H. Talasaz, Hooman Bakhshandeh, Mohammad Sadegh Hassanvand, Hessam Kakavand, Sepehr Jamalkhani, Sina Rashedi, Sara Tayyebi, Mohammadreza Babaei, Erfan Kohansal, Hamed Ghoshouni, Yasmin Mohtasham Kia, Mahsa Nikkhoo, Bahram Mohebbi, Maryam Aghakouchakzadeh, Saeed Parsa, Armin Elahifar, Ehsan Khalilipur, Razieh Omidvar, Maryam Mehrpooya, Seyed Hashem Sezavar, David Jiménez, Luis Jara‐Palomares, Saeideh Mazloomzadeh, Naser Hadavand, Mehdi Ansari Dogaheh, Majid Maleki, Feridoun Noohi, Luis Ortega-Paz, Jayant K Raikhelkar, Philippe Gabríel Steg, Renato D Lopes, Raffaele De Caterina, Mehdi H. Shishehbor, Loren Laine, Dominick J Angiolillo, Rajagopalan Sanjay, Ajay Jayant Kirtane, Gregory Piazza, Gregory Y H Lip, Roxana Mehran, Harlan M Krumholz, Paul M Ridker, Parham Sadeghipour
Institutions: Brigham and Women's Hospital, University of Florida, Florida College, Icahn School of Medicine at Mount Sinai, Harvard University, University of Liverpool, Duke University, Case Western Reserve University, Medical University of Białystok, Inserm, Iran University of Medical Sciences, Virginia Commonwealth University, Yale University, Tehran University of Medical Sciences, Université Paris Cité, Assistance Publique – Hôpitaux de Paris, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Instituto Ramón y Cajal de Investigación Sanitaria, Columbia University Irving Medical Center, Kerman University of Medical Sciences, NewYork–Presbyterian Hospital, Shahid Beheshti University of Medical Sciences, University Hospitals of Cleveland, Universidad de Alcalá, Aalborg University, Imam Khomeini Hospital, Instituto de Biomedicina de Sevilla, Paris Cardiovascular Research Center, VA Connecticut Healthcare System, Hôpital Bichat-Claude-Bernard, Shaheed Rajaei Cardiovascular Medical and Research Center, Alliance nationale pour les sciences de la vie et de la santé, New York Hospital Queens