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
Aims: Although enteric-coated aspirin is widely used instead of chewable formulations in patients with atherosclerotic cardiovascular disease (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 2 × 2 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 h of acute/unstable ASCVD or revascularization, triple antithrombotic therapy, active/recent bleeding, life expectancy <1 year, or other barriers or unwillingness for enrolment. Eligible consenting patients are randomized, in a double-blind fashion, to enteric-coated vs. chewable aspirin 81 mg daily and (via factorial randomization) to a hybrid strategy to mitigate the adverse effects of air pollution vs. usual care. The hybrid strategy includes (i) an educational flashcard, (ii) real-time air quality alerts via cellular text messages, and (iii) recommendations to (a) limit outdoor activity or (b) use a KN-95 facemask when outdoors, or (c) increase citrus fruit intake on days with elevated pollution levels. The primary efficacy outcome for the aspirin randomization is a composite of fatal/non-fatal ischaemic stroke, thrombotic/thromboembolic myocardial infarction, and acute limb ischaemia. 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. Enrolment was completed on 28 January 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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BibTeX
@article{bikdeli2026coated,
title = {{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}},
author = {Behnood Bikdeli and Azita H Talasaz and Hooman Bakhshandeh and Mohammad Sadegh Hassanvand and Hessam Kakavand and Sepehr Jamalkhani and Sina Rashedi and Sara Tayyebi and Mohammadreza Babaei and Erfan Kohansal and Hamed Ghoshouni and Yasmin Mohtasham Kia and Mahsa Nikkhoo and Bahram Mohebbi and Maryam Aghakouchakzadeh and Saeed Alipour-Parsa and Armin Elahifar and Ehsan Khalilipur and Razieh Omidvar and Maryam Mehrpooya and Seyed Hashem Sezavar and David Jimenez and Luis Jara Palomares and Saeideh Mazloomzadeh and Naser Hadavand and Mehdi Ansari Dogaheh and Majid Maleki and Feridoun Noohi and Luis Ortega-Paz and Jayant K Raikhelkar and Philippe Gabriel Steg and Renato D Lopes and Raffaele De Caterina and Mehdi H Shishehbor and Loren Laine and Dominick J Angiolillo and Sanjay Rajagopalan and Ajay J Kirtane and Gregory Piazza and Gregory Y H Lip and Roxana Mehran and Harlan M Krumholz and Paul M Ridker and Parham Sadeghipour},
journal = {European Heart Journal. Cardiovascular Pharmacotherapy},
year = {2026},
month = sep,
doi = {10.1093/ehjcvp/pvag071},
url = {https://doi.org/10.1093/ehjcvp/pvag071},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - 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
AU - Behnood Bikdeli
AU - Azita H Talasaz
AU - Hooman Bakhshandeh
AU - Mohammad Sadegh Hassanvand
AU - Hessam Kakavand
AU - Sepehr Jamalkhani
AU - Sina Rashedi
AU - Sara Tayyebi
AU - Mohammadreza Babaei
AU - Erfan Kohansal
AU - Hamed Ghoshouni
AU - Yasmin Mohtasham Kia
AU - Mahsa Nikkhoo
AU - Bahram Mohebbi
AU - Maryam Aghakouchakzadeh
AU - Saeed Alipour-Parsa
AU - Armin Elahifar
AU - Ehsan Khalilipur
AU - Razieh Omidvar
AU - Maryam Mehrpooya
AU - Seyed Hashem Sezavar
AU - David Jimenez
AU - Luis Jara Palomares
AU - Saeideh Mazloomzadeh
AU - Naser Hadavand
AU - Mehdi Ansari Dogaheh
AU - Majid Maleki
AU - Feridoun Noohi
AU - Luis Ortega-Paz
AU - Jayant K Raikhelkar
AU - Philippe Gabriel Steg
AU - Renato D Lopes
AU - Raffaele De Caterina
AU - Mehdi H Shishehbor
AU - Loren Laine
AU - Dominick J Angiolillo
AU - Sanjay Rajagopalan
AU - Ajay J Kirtane
AU - Gregory Piazza
AU - Gregory Y H Lip
AU - Roxana Mehran
AU - Harlan M Krumholz
AU - Paul M Ridker
AU - Parham Sadeghipour
PY - 2026
DA - 2026/09/23
JO - European Heart Journal. Cardiovascular Pharmacotherapy
DO - 10.1093/ehjcvp/pvag071
UR - https://doi.org/10.1093/ehjcvp/pvag071
AB - Aims: Although enteric-coated aspirin is widely used instead of chewable formulations in patients with atherosclerotic cardiovascular disease (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 2 × 2 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 h of acute/unstable ASCVD or revascularization, triple antithrombotic therapy, active/recent bleeding, life expectancy <1 year, or other barriers or unwillingness for enrolment. Eligible consenting patients are randomized, in a double-blind fashion, to enteric-coated vs. chewable aspirin 81 mg daily and (via factorial randomization) to a hybrid strategy to mitigate the adverse effects of air pollution vs. usual care. The hybrid strategy includes (i) an educational flashcard, (ii) real-time air quality alerts via cellular text messages, and (iii) recommendations to (a) limit outdoor activity or (b) use a KN-95 facemask when outdoors, or (c) increase citrus fruit intake on days with elevated pollution levels. The primary efficacy outcome for the aspirin randomization is a composite of fatal/non-fatal ischaemic stroke, thrombotic/thromboembolic myocardial infarction, and acute limb ischaemia. 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. Enrolment was completed on 28 January 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.
SN - 2055-6837
SN - 2055-6845
ER -