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.
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Bikdeli Behnood, Talasaz Azita H, Bakhshandeh Hooman, Hassanvand Mohammad Sadegh, Kakavand Hessam, Jamalkhani Sepehr, Rashedi Sina, Tayyebi Sara, Babaei Mohammadreza, Kohansal Erfan, Ghoshouni Hamed, Mohtasham Kia Yasmin, Nikkhoo Mahsa, Mohebbi Bahram, Aghakouchakzadeh Maryam, Alipour-Parsa Saeed, Elahifar Armin, Khalilipur Ehsan, Omidvar Razieh, Mehrpooya Maryam, Sezavar Seyed Hashem, Jimenez David, Jara Palomares Luis, Mazloomzadeh Saeideh, Hadavand Naser, Ansari Dogaheh Mehdi, Maleki Majid, Noohi Feridoun, Ortega-Paz Luis, Raikhelkar Jayant K, Steg Philippe Gabriel, Lopes Renato D, De Caterina Raffaele, Shishehbor Mehdi H, Laine Loren, Angiolillo Dominick J, Rajagopalan Sanjay, Kirtane Ajay J, Piazza Gregory, Lip Gregory Y H, Mehran Roxana, Krumholz Harlan M, Ridker Paul M, Sadeghipour Parham, COATED-AIR investigators
Аннотация
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.