Robert A Byrne, Róisín Colleran, J J Coughlan, Rajiv Jauhar, Luc Maillard, Axel De Labriolle, Michael Maeng, Charles Croft, Michael Brunner, David Leistner, Bernhard Zrenner, Marc Kollum, Karl-Ludwig Laugwitz, Erion Xhepa, Katharina Mayer, Shqipdona Lahu, Michael Joner, Ajay Kirtane, Roxana Mehran, Mark Barakat, Philip Urban, Donald E Cutlip, Adnan Kastrati
{"title":"COBRA PzF 支架植入术缩短三联疗法时间的随机试验：COBRA-REDUCE试验。","authors":"Robert A Byrne, Róisín Colleran, J J Coughlan, Rajiv Jauhar, Luc Maillard, Axel De Labriolle, Michael Maeng, Charles Croft, Michael Brunner, David Leistner, Bernhard Zrenner, Marc Kollum, Karl-Ludwig Laugwitz, Erion Xhepa, Katharina Mayer, Shqipdona Lahu, Michael Joner, Ajay Kirtane, Roxana Mehran, Mark Barakat, Philip Urban, Donald E Cutlip, Adnan Kastrati","doi":"10.1161/CIRCINTERVENTIONS.123.013735","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients with an indication for oral anticoagulation who undergo percutaneous coronary intervention require a combination of oral anticoagulation and antiplatelet therapy. The use of a coronary stent with a thromboresistant and pro-healing coating may allow an abbreviated duration of dual antiplatelet therapy (DAPT) without an increase in the risk of thromboembolic events.</p><p><strong>Methods: </strong>Patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention were randomized to treatment with the COBRA polyzene F (PzF) stent followed by 14 days of DAPT or a Food and Drug Administration-approved new-generation drug-eluting stent followed by 3 or 6 months of DAPT. The bleeding coprimary end point was Bleeding Academic Research Consortium type ≥2 beyond 14 days (or after hospital discharge) until 6 months. The thromboembolic coprimary end point was the composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischemic stroke at 6 months. The trial hypothesis was that the COBRA PzF stent strategy would be superior with respect to bleeding events and noninferior with respect to thromboembolic events.</p><p><strong>Results: </strong>A total of 996 patients underwent randomization. The bleeding end point occurred in 37 of 475 patients (7.8%) in the COBRA PzF group and 47 of 482 patients (9.8%) in the control group (difference, -2.0 [95% CI, -5.6 to 1.6]; <i>P</i>=0.14). The thromboembolic end point occurred in 37 of 492 patients (7.5%) in the COBRA PzF group and 24 of 490 patients (4.9%) in the control group (difference, 2.6%; prespecified noninferiority margin 5%, upper limit of 1-sided 95% CI of the difference, 5.2%; <i>P</i><sub>noninferiority</sub>=0.07).</p><p><strong>Conclusions: </strong>In patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention, treatment with the COBRA PzF stent plus 14 days of DAPT was not superior with respect to bleeding events and was not noninferior with respect to thromboembolic events at 6 months compared with treatment with standard Food and Drug Administration-approved drug-eluting stent plus 3 to 6 months of DAPT.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02594501.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e013735"},"PeriodicalIF":6.1000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial.\",\"authors\":\"Robert A Byrne, Róisín Colleran, J J Coughlan, Rajiv Jauhar, Luc Maillard, Axel De Labriolle, Michael Maeng, Charles Croft, Michael Brunner, David Leistner, Bernhard Zrenner, Marc Kollum, Karl-Ludwig Laugwitz, Erion Xhepa, Katharina Mayer, Shqipdona Lahu, Michael Joner, Ajay Kirtane, Roxana Mehran, Mark Barakat, Philip Urban, Donald E Cutlip, Adnan Kastrati\",\"doi\":\"10.1161/CIRCINTERVENTIONS.123.013735\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patients with an indication for oral anticoagulation who undergo percutaneous coronary intervention require a combination of oral anticoagulation and antiplatelet therapy. The use of a coronary stent with a thromboresistant and pro-healing coating may allow an abbreviated duration of dual antiplatelet therapy (DAPT) without an increase in the risk of thromboembolic events.</p><p><strong>Methods: </strong>Patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention were randomized to treatment with the COBRA polyzene F (PzF) stent followed by 14 days of DAPT or a Food and Drug Administration-approved new-generation drug-eluting stent followed by 3 or 6 months of DAPT. The bleeding coprimary end point was Bleeding Academic Research Consortium type ≥2 beyond 14 days (or after hospital discharge) until 6 months. The thromboembolic coprimary end point was the composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischemic stroke at 6 months. The trial hypothesis was that the COBRA PzF stent strategy would be superior with respect to bleeding events and noninferior with respect to thromboembolic events.</p><p><strong>Results: </strong>A total of 996 patients underwent randomization. The bleeding end point occurred in 37 of 475 patients (7.8%) in the COBRA PzF group and 47 of 482 patients (9.8%) in the control group (difference, -2.0 [95% CI, -5.6 to 1.6]; <i>P</i>=0.14). The thromboembolic end point occurred in 37 of 492 patients (7.5%) in the COBRA PzF group and 24 of 490 patients (4.9%) in the control group (difference, 2.6%; prespecified noninferiority margin 5%, upper limit of 1-sided 95% CI of the difference, 5.2%; <i>P</i><sub>noninferiority</sub>=0.07).</p><p><strong>Conclusions: </strong>In patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention, treatment with the COBRA PzF stent plus 14 days of DAPT was not superior with respect to bleeding events and was not noninferior with respect to thromboembolic events at 6 months compared with treatment with standard Food and Drug Administration-approved drug-eluting stent plus 3 to 6 months of DAPT.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02594501.</p>\",\"PeriodicalId\":10330,\"journal\":{\"name\":\"Circulation: Cardiovascular Interventions\",\"volume\":\"17 10\",\"pages\":\"e013735\"},\"PeriodicalIF\":6.1000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation: Cardiovascular Interventions\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1161/CIRCINTERVENTIONS.123.013735\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/15 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation: Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCINTERVENTIONS.123.013735","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/15 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Randomized Trial of COBRA PzF Stenting to Reduce the Duration of Triple Therapy: The COBRA-REDUCE Trial.
Background: Patients with an indication for oral anticoagulation who undergo percutaneous coronary intervention require a combination of oral anticoagulation and antiplatelet therapy. The use of a coronary stent with a thromboresistant and pro-healing coating may allow an abbreviated duration of dual antiplatelet therapy (DAPT) without an increase in the risk of thromboembolic events.
Methods: Patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention were randomized to treatment with the COBRA polyzene F (PzF) stent followed by 14 days of DAPT or a Food and Drug Administration-approved new-generation drug-eluting stent followed by 3 or 6 months of DAPT. The bleeding coprimary end point was Bleeding Academic Research Consortium type ≥2 beyond 14 days (or after hospital discharge) until 6 months. The thromboembolic coprimary end point was the composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischemic stroke at 6 months. The trial hypothesis was that the COBRA PzF stent strategy would be superior with respect to bleeding events and noninferior with respect to thromboembolic events.
Results: A total of 996 patients underwent randomization. The bleeding end point occurred in 37 of 475 patients (7.8%) in the COBRA PzF group and 47 of 482 patients (9.8%) in the control group (difference, -2.0 [95% CI, -5.6 to 1.6]; P=0.14). The thromboembolic end point occurred in 37 of 492 patients (7.5%) in the COBRA PzF group and 24 of 490 patients (4.9%) in the control group (difference, 2.6%; prespecified noninferiority margin 5%, upper limit of 1-sided 95% CI of the difference, 5.2%; Pnoninferiority=0.07).
Conclusions: In patients with an indication for oral anticoagulation undergoing percutaneous coronary intervention, treatment with the COBRA PzF stent plus 14 days of DAPT was not superior with respect to bleeding events and was not noninferior with respect to thromboembolic events at 6 months compared with treatment with standard Food and Drug Administration-approved drug-eluting stent plus 3 to 6 months of DAPT.
期刊介绍：
Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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