Circulation: Cardiovascular Interventions最新文献

{"title":"Comparison of Limus and Paclitaxel Drug-Coated Balloons, Second-Generation or Newer Drug-Eluting Stents, and Balloon Angioplasty: A Network Meta-Analysis of Randomized Controlled Trials.","authors":"Yuko Kiyohara, Tadao Aikawa, Tetsuya Saito, Abel Casso Dominguez, Jose Wiley, Dhaval Kolte, Eric A Secemsky, Robert W Yeh, Roger J Laham, Azeem Latib, Deepak L Bhatt, Toshiki Kuno","doi":"10.1161/CIRCINTERVENTIONS.125.016005","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016005","url":null,"abstract":"<p><strong>Background: </strong>It remains unclear whether drug-coated balloons (DCBs) and drug-eluting stents are comparable in the treatment of coronary artery disease (CAD) and whether limus versus paclitaxel DCBs yield similar clinical outcomes. We aimed to assess the clinical efficacy of limus and paclitaxel DCBs in patients with CAD through a network meta-analysis.</p><p><strong>Methods: </strong>We comprehensively searched multiple databases for randomized controlled trials comparing the following 4 strategies: limus DCB, paclitaxel DCB, second-generation or newer drug-eluting stent, and plain old balloon angioplasty. The primary outcome was trial-defined major adverse cardiovascular events (MACEs), typically a composite of death, myocardial infarction, or target lesion revascularization. Secondary outcomes included individual components of MACE. We performed subgroup analyses for in-stent restenosis, small-vessel (<3 mm) CAD, and other de novo CAD, such as large vessel and ST-segment-elevation myocardial infarction.</p><p><strong>Results: </strong>We identified 39 randomized controlled trials including 10 219 patients. There was no significant difference in MACE between limus and paclitaxel DCBs (relative risk, 1.22 [95% CI, 0.86-1.73]). There were no significant differences in MACE between limus or paclitaxel DCB and second-generation or newer drug-eluting stents. Plain old balloon angioplasty had an increased risk of MACE compared with others. These results were consistent across subgroup analyses for in-stent restenosis, small-vessel CAD, and other de novo CAD.</p><p><strong>Conclusions: </strong>No significant differences were observed in MACE or its components between limus and paclitaxel DCBs, albeit with limited statistical power. Furthermore, DCB and second-generation or newer drug-eluting stents yielded similar outcomes though power was limited, especially for other de novo CAD.</p><p><strong>Registration: </strong>URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD420250654276.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016005"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145376232","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":"Calcium Modification After Orbital Atherectomy and Balloon Angioplasty in Severely Calcified Lesions: The ECLIPSE OCT Substudy.","authors":"Akiko Maehara, Ajay J Kirtane, Philippe Généreux, Mitsuaki Matsumura, Bruce E Lewis, Richard A Shlofmitz, Suhail Dohad, Jithendra Choudary, Thom Dahle, Andres M Pineda, Kendrick A Shunk, Alexandra Popma, Bjorn Redfors, Ziad A Ali, Mitchell W Krucoff, Ehrin J Armstrong, David E Kandzari, Kanitha Phalakornkule, Carlye Kraemer, Krista M Stiefel, Denise E Jones, Jana R Buccola, Jeffrey W Chambers, Gregg W Stone","doi":"10.1161/CIRCINTERVENTIONS.125.015588","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015588","url":null,"abstract":"<p><strong>Background: </strong>The treatment of calcified coronary lesions requires optimal lesion preparation to achieve a larger minimal stent area (MSA), the strongest predictor of long-term outcomes. The comparative mechanisms of action of calcium-modifying therapies have not been well defined.</p><p><strong>Methods: </strong>In a prospective, multicenter ECLIPSE trial (Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy Versus Conventional Angioplasty Technique Before Implantation of Drug-Eluting Stents), 2005 patients with severely calcified lesions were randomized to vessel preparation with orbital atherectomy (OA) versus balloon angioplasty (BA) before drug-eluting stent implantation. The primary end point of the optical coherence tomography (OCT) substudy was the MSA at the site of maximal calcification; MSA across the entire stent was also assessed.</p><p><strong>Results: </strong>Postprocedural OCT images were available in 286 lesions in 276 patients treated with OA and 292 lesions in 279 patients treated with BA. By angiographic core laboratory analysis, 567 (98.1%) of lesions were severely calcified. By postprocedural OCT, the maximal calcium arc, maximal calcium thickness, and total calcium length measured 204° (149°-268°), 0.85 mm (°0.69-1.03°), and 22.0 (16.0-31.0) mm. Compared with BA, calcium modification was greater in the OA group (greater number, total length, and maximal depth of calcium fractures), especially in lesions with thicker calcium. Nonetheless, the MSA at the site of maximal calcification was large in both groups and not different (median [interquartile range], 7.44 [6.03-8.94] mm² versus 7.05 [5.78-8.66] mm²; <i>P</i>=0.08). Similar results were observed for the MSA across the entire stent (5.86 [4.60-7.38] mm² versus 5.57 [4.50-6.97] mm²; <i>P</i>=0.10). Among patients in the OCT substudy, 1-year target-vessel failure rates were low and not different between the groups (7.8% with OA and 6.6% with BA, <i>P</i>=0.61).</p><p><strong>Conclusions: </strong>In lesions that are severely calcified by angiography, the extent of calcification by OCT was highly variable. Despite greater calcium modification after OA, the acute MSA and 1-year target-vessel failure rates were not different between OA and BA.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT03108456.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015588"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145660501","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":"Association Between Artificial Intelligence-Detected Features on the ECG and Presence of Microvascular Obstruction.","authors":"Jay H Traverse, Pendell Meyers, Adam Rafajdus, Scott W Sharkey, Sarah Schwager, Larissa Stanberry, Robert Herman","doi":"10.1161/CIRCINTERVENTIONS.125.016104","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016104","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016104"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145487985","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":"Public Reporting and Risk Aversion: Robust Risk Adjustment Is the Cure.","authors":"Rajiv C Patel, David M Shahian, Matthew A Cavender","doi":"10.1161/CIRCINTERVENTIONS.125.016176","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016176","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016176"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145803322","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":"Drug-Coated Balloon Use in Contemporary Coronary Angioplasty: Is the Jury Still Out?","authors":"Fernando Alfonso, Sonya Burgess","doi":"10.1161/CIRCINTERVENTIONS.125.016352","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016352","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016352"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145803171","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":"Correction to \"Intravascular Imaging-Guided Percutaneous Coronary Intervention: A Universal Approach for Optimization of Stent Implantation\".","authors":"Evan Shlofmitz, Ziad A Ali, Akiko Maehara, Gary S Mintz, Richard Shlofmitz, Allen Jeremias","doi":"10.1161/HCV.0000000000000099","DOIUrl":"https://doi.org/10.1161/HCV.0000000000000099","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"19 1","pages":"e000099"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146008922","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":"Zipping Versus Clover Repair in Transcatheter Edge-to-Edge Tricuspid Repair: Insights From the TRI-SPA Registry.","authors":"Julio Echarte-Morales, Manuel Barreiro-Pérez, Xavier Freixa, Dabit Arzamendi, Vanessa Moñivas, Fernando Carrasco-Chinchilla, Manuel Pan, Luis Nombela-Franco, Isaac Pascual, Tomás Benito-González, Ruth Pérez, Iván Gómez-Blázquez, Ignacio J Amat-Santos, Ignacio Cruz-González, Ángel Sánchez-Recalde, Ana Belén Cid Álvarez, Laura Sanchis, Berenice Caneiro-Queija, Chi Hion Li, Maria Del Trigo, José David Martínez-Carmona, Dolores Mesa, Pilar Jiménez, Pablo Avanzas, Pedro Cepas-Guillén, Rodrigo Estévez-Loureiro","doi":"10.1161/CIRCINTERVENTIONS.125.015771","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015771","url":null,"abstract":"<p><strong>Background: </strong>Transcatheter edge-to-edge repair is an established treatment for tricuspid regurgitation (TR) in nonoptimal surgical candidates. Two techniques have been described: zipping (or bicuspidization) and clover (or triple-orifice). This study aimed to compare the echocardiographic and clinical outcomes of these 2 techniques.</p><p><strong>Methods: </strong>This multicenter registry included 288 patients undergoing tricuspid transcatheter edge-to-edge repair from June 2020 to December 2024. Patients were categorized into 2 groups (zipping and clover repairs). The primary study end point was the TR reduction at follow-up. The secondary end point was the composite of all-cause mortality and heart failure hospitalization at follow-up.</p><p><strong>Results: </strong>The median age was 77 years (interquartile range, 73-82), with 203 females (70.5%) and a median TRISCORE of 4.1±1.8. Of these, 197 patients (68.4%) underwent zipping repair, while 91 (31.6%) received the clover repair technique. The median follow-up duration was 11.6 months (interquartile range, 4.5-21.2). Patients treated with the clover technique experienced lower rates of residual TR ≤2+ (76% versus 89%, <i>P</i>=0.006) and higher single-leaflet device attachment in the follow-up, attributed to a higher prevalence of complex tricuspid valve anatomy. Similar rates of the composite end point were observed among the groups without differences in New York Heart Association functional class (<i>P</i>=0.835) and TR reintervention at 1-year (<i>P</i>=0.196).</p><p><strong>Conclusions: </strong>Residual TR was more common in patients treated with the clover technique, owing to the higher prevalence of complex tricuspid valve anatomy. Clinical outcomes were similar between the zipping and clover techniques. Both approaches represent viable and effective treatment options for managing TR.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"19 1","pages":"e015771"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146008961","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":"Response by Maznyczka et al to Letter Regarding Article, \"Patterns of Restenosis After Left Main Bifurcation Single- or Dual-Stenting: An EBC MAIN Trial Subanalysis\".","authors":"Annette Maznyczka, Goran Stankovic, David Hildick-Smith","doi":"10.1161/CIRCINTERVENTIONS.125.016233","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.016233","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e016233"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145667466","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":"Anatomically Directed Lower Extremity Gene Therapy for Ulcer Healing: A Double-Blind, Randomized, Placebo-Controlled Study (LEGenD-1).","authors":"David G Armstrong, Michael S Conte, Joseph L Mills, Matthew T Menard, Dennis P Orgill, Robert D Galiano, Robert S Kirsner, Alik Farber, John C Lantis, Charles M Zelen, Marissa J Carter, Caitlin W Hicks, Richard J Powell","doi":"10.1161/CIRCINTERVENTIONS.125.015648","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015648","url":null,"abstract":"<p><strong>Background: </strong>People with chronic limb-threatening ischemia lack Food and Drug Administration-approved therapies for wound healing, creating an unmet need for novel approaches. Prior studies of biologics in chronic limb-threatening ischemia have largely targeted end-stage patients with amputation-free survival as the primary outcome. This trial evaluated the efficacy of intramuscular administration of AMG0001, a plasmid encoding human HGF (hepatocyte growth factor), to promote ulcer healing in patients with chronic limb-threatening ischemia and neuroischemic ulcers.</p><p><strong>Methods: </strong>LEGenD-1 was a double-blind, randomized, placebo-controlled phase II trial conducted at 22 US sites. Seventy-five participants with neuroischemic ulcers and toe pressure or transcutaneous oxygen pressure between 30 and 59 mm Hg were randomized to receive AMG0001 at 4 mg, 8 mg, or placebo. Injections were administered intramuscularly along an angiographically guided target artery path on days 0, 28, 56, and 84. The 2 coprimary end points were time to complete healing and the proportion of subjects with ulcers healed by 6 months in a pooled AMG0001 analysis. Secondary end points included healing by 12 months, ulcer recurrence, and hemodynamic changes.</p><p><strong>Results: </strong>Baseline characteristics were comparable across groups (mean age 62.6 years; 80.0% male; 70.7% with diabetes). Mean toe pressure was 46.1 mm Hg, and transcutaneous oxygen pressure was 49.8 mm Hg. Median time to healing was significantly shorter with AMG0001 versus placebo (84 versus 280 days; <i>P</i>=0.007); 4 mg: 98 days (<i>P</i>=0.017); 8 mg: 84 days (<i>P</i>=0.022). By 6 months, 63.3% of AMG0001-treated participants healed versus 38.5% of placebo (<i>P</i>=0.053). By 12 months, healing rates were 77.6% versus 46.2% (<i>P</i>=0.010). Adverse events were similar across groups.</p><p><strong>Conclusions: </strong>Anatomically targeted intramuscular delivery of AMG0001 significantly accelerated healing in patients with moderate chronic limb-threatening ischemia and neuroischemic ulcers and may represent a promising nonsurgical therapeutic strategy.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04267640.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015648"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13043276/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145437734","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":"Will a Conservative Case Selection Strategy Improve Hospital-Level TAVR Performance Metrics?","authors":"Ahmed A Kolkailah, Ann Marie Navar, Sreekanth Vemulapalli, Pratik Manandhar, Joseph Leo Brothers, Andrzej Kosinski, Eric D Peterson, Dharam J Kumbhani","doi":"10.1161/CIRCINTERVENTIONS.125.015273","DOIUrl":"10.1161/CIRCINTERVENTIONS.125.015273","url":null,"abstract":"<p><strong>Background: </strong>Current national performance metrics rank transcatheter aortic valve replacement (TAVR) centers based on risk-adjusted outcomes. This could make operators/centers less inclined to offer TAVR in high-risk cases.</p><p><strong>Methods: </strong>We used simulation models based on registry data to explore whether avoiding high-risk TAVR cases would improve the hospitals' comparative risk-adjusted TAVR outcomes. This multicenter, retrospective cohort study included all adults (≥18 years) who underwent TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry in 2021. We evaluated hospital-level, risk-adjusted outcomes, before and after simulating the omission of the top 10% highest-risk patients. The primary outcome was a 30-day composite of death, stroke, VARC major/life-threatening/disabling bleeding, renal failure, or moderate/severe para-valvular leak. The secondary outcome was 30-day death. We used the mean difference±SD in the win ratio and observed/expected ratio for evaluation of the primary and secondary outcomes, respectively.</p><p><strong>Results: </strong>There were 43 907 TAVR cases with available primary outcome data and 56 982 cases with available secondary outcome data. Median age was 79 (73-84) years, 57% were men, and 93% were White race. Our simulation demonstrates that, on average, excluding the top 10% highest-risk patients from centers' case mix would not change their hospital-level, risk-adjusted win ratio (mean difference, 0.002±0.067; <i>P</i>=0.60) or observed/expected ratio (mean difference, -0.003±0.633; <i>P</i>=0.90).</p><p><strong>Conclusions: </strong>Hospital-level, risk-adjusted TAVR outcomes did not consistently improve with simulated strategies of avoiding the highest-risk cases. Operators and centers can be reassured that they can continue to offer TAVR to high-risk patients, as clinically indicated, without the sole focus on being penalized via quality measures.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015273"},"PeriodicalIF":7.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145667411","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}