Pieter C Smits, Pim A L Tonino, Sjoerd H Hofma, Jan-Peter van Kuijk, Fabrizio Spano, Amar Al Mafragi, Ron Pisters, Jawed Polad, Kris Bogaerts, Rohit M Oemrawsingh, Valeria Paradies
{"title":"Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 HBR Trial: An Open-Label, Randomized, Controlled Trial.","authors":"Pieter C Smits, Pim A L Tonino, Sjoerd H Hofma, Jan-Peter van Kuijk, Fabrizio Spano, Amar Al Mafragi, Ron Pisters, Jawed Polad, Kris Bogaerts, Rohit M Oemrawsingh, Valeria Paradies","doi":"10.1161/CIRCINTERVENTIONS.123.014042","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.014042","url":null,"abstract":"<p><strong>Background: </strong>No randomized data exist on ultrathin-strut stents in patients at high bleeding risk (HBR) undergoing an abbreviated dual antiplatelet therapy after coronary stenting. The aim of this study was to compare the safety and effectiveness of the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent with the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent in patients at HBR with abbreviated dual antiplatelet therapy after stenting.</p><p><strong>Methods: </strong>In the investigator-initiated, randomized, open-label COMPARE 60/80 HBR trial (Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in HBR Percutaneous Coronary Intervention Population), 741 patients at HBR according to the Academic Research Consortium HBR criteria were randomized to receive either the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent or thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. Dual antiplatelet therapy was recommended according to the applicable guidelines and trial data for patients at HBR. The primary outcome was net adverse clinical events, the composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke, and major bleeding, and was powered for noninferiority with an absolute margin of 4.0% at 1-sided 2.5% alpha.</p><p><strong>Results: </strong>Between September 2020 and August 2022, 371 patients were randomized to the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent and 370 patients to the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent at 11 sites in the Netherlands. At 1 year, the primary outcome was observed in 56 (15.4%) patients in the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent group and 61 (17.1%) in the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent group (risk difference, -1.65%; upper boundary of the 1-sided 95% CI, 3.74; <i>P</i>=0.02 for noninferiority at a 0.025 significance level and <i>P</i>=0.55 for 2-sided superiority at a 0.05 significance level).</p><p><strong>Conclusions: </strong>Among patients at HBR with abbreviated dual antiplatelet therapy post-stenting, the use of an ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent was noninferior compared with the use of a thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500912.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014042"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Unconscious After Arrest and Primary PCI in STEMI: Hold or Go?","authors":"Anna E Bortnick","doi":"10.1161/CIRCINTERVENTIONS.124.014689","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014689","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e014689"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lars Kjøller-Hansen, Akiko Maehara, Henning Kelbæk, Mitsuaki Matsumura, Michael Maeng, Thomas Engstrøm, Ole Fröbert, Jonas Persson, Rune Wiseth, Alf Inge Larsen, Lisette Okkels Jensen, Jan Erik Nordrehaug, Elmir Omerovic, Claes Held, Stefan James, Gary S Mintz, Ziad A Ali, Gregg W Stone, David Erlinge
{"title":"Impact of Lipidic Plaque on In-Stent and Stent Edge-Related Events After PCI in Myocardial Infarction: A PROSPECT II Substudy.","authors":"Lars Kjøller-Hansen, Akiko Maehara, Henning Kelbæk, Mitsuaki Matsumura, Michael Maeng, Thomas Engstrøm, Ole Fröbert, Jonas Persson, Rune Wiseth, Alf Inge Larsen, Lisette Okkels Jensen, Jan Erik Nordrehaug, Elmir Omerovic, Claes Held, Stefan James, Gary S Mintz, Ziad A Ali, Gregg W Stone, David Erlinge","doi":"10.1161/CIRCINTERVENTIONS.124.014215","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014215","url":null,"abstract":"<p><strong>Background: </strong>Lipid content in untreated nonobstructive coronary artery lesions is associated with adverse clinical outcomes, and residual in-stent or stent edge lipid may worsen outcomes after percutaneous coronary intervention (PCI).</p><p><strong>Methods: </strong>Near-infrared spectroscopy-intravascular ultrasound was performed before and after PCI in patients with myocardial infarction. We evaluated the impact of lipid assessed by near-infrared spectroscopy (maximal lipid core burden index over 4 mm [maxLCBI<sub>4mm</sub>]) along with intravascular ultrasound information including residual plaque burden on in-stent or edge-related major adverse cardiac events (MACE) in de novo PCI-treated culprit coronary artery lesions. The primary end point was culprit lesion-related MACE (CL-MACE), defined as cardiac death, myocardial infarction, or unstable or progressive angina either requiring revascularization or with rapid lesion progression and classified as in-stent or stent edge-related.</p><p><strong>Results: </strong>During a median follow-up of 3.8 years, 25 CL-MACE (11 stent edge-related, 13 in-stent, and 1 in-lesion without a stent) occurred in 1041 PCI-treated lesions in 768 patients. Pre-PCI or post-PCI measures of lipid content were not related to in-stent CL-MACE. However, stent edge-related CL-MACE was increased if both the post-PCI stent edge maxLCBI<sub>4mm</sub> was greater than the upper quartile (108.7) and the stent edge plaque burden was >50% (adjusted odds ratio, 4.11 [95% CI, 1.12-15.2]; <i>P</i>=0.03).</p><p><strong>Conclusions: </strong>In PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree), CL stent implantation leaving behind greater stent edge-related lipid and uncovered plaque burden was associated with an increased risk of stent edge-related CL-MACE during follow-up. In contrast, CL lipid content was not related to in-stent CL-MACE.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02171065.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014215"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
David E Hamilton, Daniel S Kobe, Milan Seth, Manoj Sharma, Thomas LaLonde, Ibrahim Shah, Hitinder S Gurm, Devraj Sukul
{"title":"Association Between Neurological Status and Outcomes in Cardiac Arrest Patients Undergoing PCI in Contemporary Practice: Insights From BMC2.","authors":"David E Hamilton, Daniel S Kobe, Milan Seth, Manoj Sharma, Thomas LaLonde, Ibrahim Shah, Hitinder S Gurm, Devraj Sukul","doi":"10.1161/CIRCINTERVENTIONS.124.014189","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014189","url":null,"abstract":"<p><strong>Background: </strong>Coronary artery disease remains the largest contributor to cardiac arrests worldwide; yet, long-term outcomes are often driven by neurological status after resuscitation. We examined the association between pre-percutaneous coronary intervention (PCI) level of consciousness (LOC) and outcomes among patients with cardiac arrest who underwent PCI.</p><p><strong>Methods: </strong>The study cohort included patients undergoing PCI after cardiac arrest between April 2018 and March 2022 at 48 hospitals in the state of Michigan. Pre-PCI LOC was categorized as mentally alert, partially responsive, unresponsive, and unable to assess. In-hospital outcomes included mortality, bleeding, and acute kidney injury.</p><p><strong>Results: </strong>Among 3021 patients who underwent PCI after cardiac arrest, 1394 (49%) were mentally alert, 132 (5%) were partially responsive, 698 (24%) were unresponsive, and 631 (22%) were unable to assess. The mentally alert cohort had lower mortality (4.59%) compared with the partially responsive (17.42%), unresponsive (50.14%), and unable to assess cohorts (38.03%; <i>P</i><0.001). After adjusting for baseline differences, compared with mentally alert patients, the odds of mortality were markedly elevated in patients who were partially responsive (adjusted odds ratio, 4.63 [95% CI, 2.67-8.04]; <i>P</i><0.001), unable to assess (adjusted odds ratio, 13.95 [95% CI, 9.97-19.51]; <i>P</i><0.001), and unresponsive (adjusted odds ratio, 24.36 [17.34-34.23]; <i>P</i><0.001). After adjustment, patients with impaired LOC also had higher risks of acute kidney injury and bleeding compared with mentally alert patients.</p><p><strong>Conclusions: </strong>Pre-PCI LOC is a strong predictor of in-hospital outcomes after PCI among cardiac arrest patients. A patient's pre-PCI LOC should be considered an important factor when weighing treatment options, designing clinical trials, and counseling patients and their families regarding prognosis after PCI.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e014189"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adam C Bland, William Meere, Philopatir Mikhail, Eunice Chuah, Eleanor Redwood, David Ferreira, Nicklas Howden, Adam Perkovic, Samantha L Saunders, Amy Kelty, Tony Kull, Andrew Hill, Roberto Spina, Kiran Sarathy, Austin May, Michael Parkinson, Mark Ishak, Nicholas Collins, Andrew Boyle, Maged William, Prajith Jeyaprakash, Tom J Ford
{"title":"Enhancing Guidewire Efficacy for Transradial Access: The EAGER Randomized Controlled Trial.","authors":"Adam C Bland, William Meere, Philopatir Mikhail, Eunice Chuah, Eleanor Redwood, David Ferreira, Nicklas Howden, Adam Perkovic, Samantha L Saunders, Amy Kelty, Tony Kull, Andrew Hill, Roberto Spina, Kiran Sarathy, Austin May, Michael Parkinson, Mark Ishak, Nicholas Collins, Andrew Boyle, Maged William, Prajith Jeyaprakash, Tom J Ford","doi":"10.1161/CIRCINTERVENTIONS.124.014529","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014529","url":null,"abstract":"<p><strong>Background: </strong>The 1.5 mm Baby J hydrophilic narrow J-tipped wire is a development of the standard 0.035\" 3-mm J-tipped peripheral guidewire, designed to improve efficiency of transradial coronary procedures by safely navigating small caliber radial arteries to the aorta. There is currently a lack of evidence comparing the procedural success and safety of different peripheral guidewires used in transradial cardiac procedures. We compared the efficacy and safety of a narrow J-tipped hydrophilic 0.035\" wire (intervention, Radifocus Baby J guidewire; TERUMO Co, Tokyo, Japan) versus a standard fixed-core 0.035\" J wire (control).</p><p><strong>Methods: </strong>Investigator-initiated, blinded, Australian, multicenter randomized trial in patients undergoing clinically indicated coronary angiography or percutaneous coronary intervention. Patients were randomized 1:1 to use either the control guidewire or the intervention guidewire. The primary end point (technical success) was defined as gaining aortic root access with the randomized guidewire.</p><p><strong>Results: </strong>In all, 330 patients were randomized between October 2022 and June 2023 (median age was 69 years, 36% were female, and body mass index was 29 kg/m<sup>2</sup>). The primary end point was achieved more frequently in the intervention group (96% versus 84%; absolute risk reduction 12% [95% CI, 5.7-18.3]; <i>P</i><0.001). Women assigned to the control wire experienced a higher failure rate compared with men (31% versus 8% in men; <i>P</i><0.001). Fluoroscopy time was significantly lower in the Baby J group (median, 344 versus 491 seconds; <i>P</i>=0.024). The main mechanisms of failure using the control wire were radial artery spasm (15/26; 57%) and subclavian tortuosity (5/26; 19.2%). There were no differences in overall procedure times, major adverse cardiovascular events, or vascular complications between guidewires.</p><p><strong>Conclusions: </strong>A narrow 1.5 mm J-tipped hydrophilic guidewire resulted in greater technical success and reduced fluoroscopy time compared with the standard 3-mm J-tipped nonhydrophilic guidewire. The guidewire is safe and demonstrated key incremental benefits for the transradial approach, particularly in women.</p><p><strong>Registration: </strong>URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12622001557729.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014529"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lianglong Chen, Yuanming Yan, Jiaxin Zhong, Ping Chen, Wei Chen, Chaoxiang Xu, Long Chen, Shengxian Tu, Yukun Luo
{"title":"Prognostic Value of Murray Law-Based QFR (μQFR)-Guided Virtual PCI in Patients With Physiological Ischemia.","authors":"Lianglong Chen, Yuanming Yan, Jiaxin Zhong, Ping Chen, Wei Chen, Chaoxiang Xu, Long Chen, Shengxian Tu, Yukun Luo","doi":"10.1161/CIRCINTERVENTIONS.124.014362","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014362","url":null,"abstract":"<p><strong>Background: </strong>Quantitative flow ratio (QFR)-based virtual percutaneous coronary intervention (PCI) is associated with improved post-PCI physiological results. Murray law-based QFR (μQFR) is a new method for physiological assessment that has higher feasibility and efficiency. The purpose of this study was to investigate the performance of μQFR-guided virtual PCI in improving post-PCI outcomes.</p><p><strong>Methods: </strong>The QUITE RIGHT study (Quantitative Flow Ratio Virtual Stenting and Angiography Guided Percutaneous Coronary Intervention) is a prospective, multicenter, blinded, randomized, controlled superiority study. Eligible patients were randomized 1:1 to either the μQFR-guided virtual PCI group or the angiography-guided PCI group. The primary end point was the proportion of the target vessels with a post-PCI μQFR ≥0.90, accepted as an optimal post-PCI physiological outcome.</p><p><strong>Results: </strong>A total of 622 patients with 666 vessels were enrolled. The optimal physiological outcome was reached more often in the μQFR-guided virtual PCI group (absolute difference, 9.1% [95% CI, 4.53-13.76]; <i>P</i><0.001). The μQFR-guided virtual PCI group had a better QFR value, a lower contrast agent dose and x-ray dose, and a more appropriate stent length than the angiography-guided group.</p><p><strong>Conclusions: </strong>The QUITE RIGHT study showed that the μQFR-guided virtual PCI strategy is superior to angiography-guided PCI in terms of physiological outcomes. The μQFR-guided virtual PCI strategy is associated with lower contrast and x-ray doses and a more appropriate stent length.</p><p><strong>Registration: </strong>URL: https://www.chictr.org.cn/; Unique identifier: ChiCTR2100045452.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014362"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"14-Day DAPT After Coronary Stenting for Patients on Oral Anticoagulants: How Short Is Too Short?","authors":"John A Bittl","doi":"10.1161/CIRCINTERVENTIONS.124.014691","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014691","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e014691"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adel Aminian, Grigorios G Tsigkas, Gregory A Sgueglia
{"title":"Eagerness in Navigating Upper Arm Vasculature During Transradial Access: The Path to Excellence.","authors":"Adel Aminian, Grigorios G Tsigkas, Gregory A Sgueglia","doi":"10.1161/CIRCINTERVENTIONS.124.014692","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014692","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e014692"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Letter by Henry and Widmer Regarding Article, \"Visual Estimates of Coronary Slow Flow Are Not Associated With Invasive Wire-Based Diagnoses of Coronary Microvascular Dysfunction\".","authors":"Timothy D Henry, R Jay Widmer","doi":"10.1161/CIRCINTERVENTIONS.124.014588","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014588","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014588"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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":"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":"10.1161/CIRCINTERVENTIONS.123.013735","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":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}