Gennaro Giustino1, Alaide Chieffo2, Tullio Palmerini3, Marco Valgimigli4, Fausto Feres5, Alexandre Abizaid5, Ricardo A Costa5, Myeong-Ki Hong6, Byeong-Keuk Kim6, Yangsoo Jang6, Hyo-Soo Kim7, Kyung Woo Park7, Martine Gilard8, Marie-Claude Morice9, Fadi Sawaya9, Gennaro Sardella10, Philippe Genereux11, Bjorn Redfors12, Martin B Leon13, Deepak L Bhatt14, Gregg W Stone11, Antonio Colombo15. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Cardiovascular Research Foundation, New York, New York; San Raffaele Scientific Institute, Interventional Cardiology Unit, Milan, Italy. 2. San Raffaele Scientific Institute, Interventional Cardiology Unit, Milan, Italy. Electronic address: chieffo.alaide@hsr.it. 3. Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Bologna, Italy. 4. Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands. 5. Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil. 6. Severance Cardiovascular Hospital and Science Institute, Yonsei University College of Medicine, Seoul, South Korea. 7. Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. 8. Department of Cardiology, Brest University, Brest, France. 9. Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. 10. Department of Cardiovascular, Respiratory, Nephrologic and Geriatric Sciences, "Sapienza" University of Rome, Policlinico Umberto I, Rome, Italy. 11. Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York. 12. Cardiovascular Research Foundation, New York, New York. 13. San Raffaele Scientific Institute, Interventional Cardiology Unit, Milan, Italy; Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York. 14. Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. 15. San Raffaele Scientific Institute, Interventional Cardiology Unit, Milan, Italy.
Abstract
BACKGROUND: Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. OBJECTIVES: This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. METHODS: The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. RESULTS: Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; pinteraction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (pinteraction = 0.96). Results were consistent by per-treatment landmark analysis. CONCLUSIONS: Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.
BACKGROUND: Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. OBJECTIVES: This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. METHODS: The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. RESULTS: Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; pinteraction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (pinteraction = 0.96). Results were consistent by per-treatment landmark analysis. CONCLUSIONS: Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.
Authors: Mariusz Tomaniak; Ply Chichareon; Yoshinobu Onuma; Efthymios N Deliargyris; Kuniaki Takahashi; Norihiro Kogame; Rodrigo Modolo; Chun Ching Chang; Tessa Rademaker-Havinga; Robert F Storey; George D Dangas; Deepak L Bhatt; Dominick J Angiolillo; Christian Hamm; Marco Valgimigli; Stephan Windecker; Philippe Gabriel Steg; Pascal Vranckx; Patrick W Serruys Journal: JAMA Cardiol Date: 2019-11-01 Impact factor: 14.676