The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Optimal Dual Antiplatelet Therapy Duration for Bioresorbable Scaffolds: an Individual Patient Data Pooled Analysis of the ABSORB Trials
Lorenzo Azzalini1; Stephen G Ellis2; Dean J Kereiakes3; Takeshi Kimura4; Runlin Gao5; Yoshinobu Onuma6; Bernard Chevalier7; Ovidiu Dressler8; Aaron Crowley8; Zhipeng Zhou8; Björn Redfors9; Patrick W Serruys10; Gregg Stone11;
1. Division of Cardiology, VCU Health Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, USA 2. Cleveland Clinic, Cleveland, OH, USA 3. The Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, OH, USA 4. Kyoto University Graduate School of Medicine, Kyoto, Japan 5. Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China 6. Erasmus Medical Center, Rotterdam, the Netherlands 7. Institut Cardiovasculaire Paris Sud, Massy, France 8. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA 9. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden 10. Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland; Department of Cardiology, Imperial College of London, London, United Kingdom 11. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, United States
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Background—Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its 3-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischemic events.
Aims—We sought to evaluate the impact of DAPT duration on ischemic and bleeding outcomes following BRS implantation.
Methods—We conducted an individual patient-data pooled analysis from 4 ABSORB randomized trials and 1 prospective ABSORB registry. Study endpoints were MI, ST, bleeding, and death through 3-year follow-up. Propensity score-adjusted Cox regression analysis was used to account for baseline differences related to DAPT duration.
Results—The five ABSORB studies included 2,973 patients. DAPT use was 91.7%, 53.2%, and 48.0% at 1, 2, and 3 years, respectively. DAPT use within the first year after BRS implantation was associated with markedly lower risks of MI (adjusted hazard ratio [aHR] 0.17, 95%CI 0.10-0.32, p<0.0001) and ST (aHR 0.08, 95%CI 0.03-0.19, p<0.0001). Conversely, DAPT use between 1 and 3 years did not significantly affect the risk of MI (aHR 1.04, 95%CI 0.70-1.55, p=0.84) or ST (aHR 0.86, 95%CI 0.42-1.75, p=0.67). DAPT did not have major effects upon bleeding or death in either period.
Conclusion—DAPT use during the first year after BRS implantation was strongly associated with lower risks of ST and MI. However, a benefit of ongoing DAPT use between 1 and 3 years after BRS implantation was not apparent.