Francesco Costa1, David Van Klaveren2, Fausto Feres3, Stefan James4, Lorenz Räber5, Thomas Pilgrim5, Myeong-Ki Hong6, Hyo-Soo Kim7, Antonio Colombo8, Philippe Gabriel Steg9, Deepak L Bhatt10, Gregg W Stone11, Stephan Windecker5, Ewout W Steyerberg12, Marco Valgimigli13. 1. Department of Clinical and Experimental Medicine, Policlinic "G. Martino," University of Messina, Messina, Italy; Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. 2. Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts. 3. Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil. 4. Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 5. Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. 6. Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea and Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Korea. 7. Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. 8. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy and Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy. 9. FACT, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France; Université Paris-Diderot, Bichat Hospital, Paris, France. 10. Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts. 11. Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York. 12. Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands. 13. Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch.
Abstract
BACKGROUND: Complex percutaneous coronary intervention (PCI) is associated with higher ischemic risk, which can be mitigated by long-term dual antiplatelet therapy (DAPT). However, concomitant high bleeding risk (HBR) may be present, making it unclear whether short- or long-term DAPT should be prioritized. OBJECTIVES: This study investigated the effects of ischemic (by PCI complexity) and bleeding (by PRECISE-DAPT [PREdicting bleeding Complications in patients undergoing stent Implantation and SubsequEnt Dual AntiPlatelet Therapy] score) risks on clinical outcomes and on the impact of DAPT duration after coronary stenting. METHODS: Complex PCI was defined as ≥3 stents implanted and/or ≥3 lesions treated, bifurcation stenting and/or stent length >60 mm, and/or chronic total occlusion revascularization. Ischemic and bleeding outcomes in high (≥25) or non-high (<25) PRECISE-DAPT strata were evaluated based on randomly allocated duration of DAPT. RESULTS: Among 14,963 patients from 8 randomized trials, 3,118 underwent complex PCI and experienced a higher rate of ischemic, but not bleeding, events. Long-term DAPT in non-HBR patients reduced ischemic events in both complex (absolute risk difference: -3.86%; 95% confidence interval: -7.71 to +0.06) and noncomplex PCI strata (absolute risk difference: -1.14%; 95% confidence interval: -2.26 to -0.02), but not among HBR patients, regardless of complex PCI features. The bleeding risk according to the Thrombolysis In Myocardial Infarction scale was increased by long-term DAPT only in HBR patients, regardless of PCI complexity. CONCLUSIONS: Patients who underwent complex PCI had a higher risk of ischemic events, but benefitted from long-term DAPT only if HBR features were not present. These data suggested that when concordant, bleeding, more than ischemic risk, should inform decision-making on the duration of DAPT.
BACKGROUND: Complex percutaneous coronary intervention (PCI) is associated with higher ischemic risk, which can be mitigated by long-term dual antiplatelet therapy (DAPT). However, concomitant high bleeding risk (HBR) may be present, making it unclear whether short- or long-term DAPT should be prioritized. OBJECTIVES: This study investigated the effects of ischemic (by PCI complexity) and bleeding (by PRECISE-DAPT [PREdicting bleeding Complications in patients undergoing stent Implantation and SubsequEnt Dual AntiPlatelet Therapy] score) risks on clinical outcomes and on the impact of DAPT duration after coronary stenting. METHODS: Complex PCI was defined as ≥3 stents implanted and/or ≥3 lesions treated, bifurcation stenting and/or stent length >60 mm, and/or chronic total occlusion revascularization. Ischemic and bleeding outcomes in high (≥25) or non-high (<25) PRECISE-DAPT strata were evaluated based on randomly allocated duration of DAPT. RESULTS: Among 14,963 patients from 8 randomized trials, 3,118 underwent complex PCI and experienced a higher rate of ischemic, but not bleeding, events. Long-term DAPT in non-HBR patients reduced ischemic events in both complex (absolute risk difference: -3.86%; 95% confidence interval: -7.71 to +0.06) and noncomplex PCI strata (absolute risk difference: -1.14%; 95% confidence interval: -2.26 to -0.02), but not among HBR patients, regardless of complex PCI features. The bleeding risk according to the Thrombolysis In Myocardial Infarction scale was increased by long-term DAPT only in HBR patients, regardless of PCI complexity. CONCLUSIONS:Patients who underwent complex PCI had a higher risk of ischemic events, but benefitted from long-term DAPT only if HBR features were not present. These data suggested that when concordant, bleeding, more than ischemic risk, should inform decision-making on the duration of DAPT.
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Authors: Marco Valgimigli; Felice Gragnano; Mattia Branca; Anna Franzone; Usman Baber; Yangsoo Jang; Takeshi Kimura; Joo-Yong Hahn; Qiang Zhao; Stephan Windecker; Charles M Gibson; Byeong-Keuk Kim; Hirotoshi Watanabe; Young Bin Song; Yunpeng Zhu; Pascal Vranckx; Shamir Mehta; Sung-Jin Hong; Kenji Ando; Hyeon-Cheol Gwon; Patrick W Serruys; George D Dangas; Eùgene P McFadden; Dominick J Angiolillo; Dik Heg; Peter Jüni; Roxana Mehran Journal: BMJ Date: 2021-06-16