Cardiovascular Revascularization Medicine最新文献

{"title":"Cutting balloon versus standard balloon for lesion preparation of drug-coated balloon treatment in de-novo coronary artery lesions: Rationale and Design of the Randomized NATURE trial.","authors":"Masafumi Ono, Taku Asano, Masahiko Noguchi, Norihiro Kogame, Raisuke Iijima, Kohei Osakada, Kenji Ando, Takayuki Ishihara, Koji Nishida, Mamoru Nanasato, Kengo Tanabe, Takashi Muramatsu, Atsunori Okamura, Yoshihisa Kinoshita, Kiyoshi Hibi, Satoru Suwa, Nehiro Kuriyama, Kozo Okada, Gaku Nakazawa, Takashi Ashikaga, Yutaka Tadano, Hiroki Shiomi, Masato Nakamura, Akiyoshi Miyazawa, Satoshi Miyata, Kiyoko Uno, Kazushige Kadota, Ken Kozuma","doi":"10.1016/j.carrev.2025.03.009","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.009","url":null,"abstract":"<p><strong>Background: </strong>Drug-coated balloons (DCBs) have emerged as an alternative to drug-eluting stents (DESs) for percutaneous coronary intervention (PCI) in de novo coronary artery diseases (CADs). However, the optimal predilatation strategy prior to DCB dilatation has yet to be validated.</p><p><strong>Methods/design: </strong>The NATURE (Non-stent PCI with an appropriate dilatation by means of cutting balloon and drug-coated balloon in de novo lesion) study is a prospective, multi-center, randomized controlled trial designed to evaluate the safety and efficacy of a cutting balloon compared to standard balloons (semi-compliant or non-compliant balloons) for lesion preparation prior to DCB treatment in normal-sized vessels. The DCB treatment is performed with the guidance of intravascular ultrasound (IVUS) and fractional flow reserve (FFR). The study will enroll 200 patients with a single de novo coronary lesion (reference vessel diameter: 2.5-4.0 mm) at 18 sites. Patients are randomized 1:1 to undergo predilatation with either a cutting or standard balloons, followed by DCB dilatation. The primary endpoint is the success rate of optimal predilatation, as defined by the International DCB Consensus Group: no flow-limiting dissections, residual stenosis ≤30 %, and FFR >0.80. Secondary endpoints include in-segment late lumen loss (LLL) at 9 months, the incidence of bailout stenting, and clinical outcomes at 6 and 12 months.</p><p><strong>Summary: </strong>The NATURE study aims to address the critical gap in evidence regarding optimal predilatation for DCBs in de novo CADs. By utilizing state-of-the-art DCB treatment strategies, including cutting balloons, intravascular imaging, and physiological tools, this study is expected to provide meaningful insights for refining DCB-based PCI strategies.</p><p><strong>Clinical trial registration url: </strong>https://jrct.niph.go.jp/. Unique Identifier: jRCTs032230543.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143659203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Timing of invasive coronary angiography, management, and in-hospital outcomes among patients with non-ST-segment elevation myocardial infarction: A comprehensive nationwide analysis.","authors":"Josip A Borovac, Konstantin Schwarz, Adnan I Qureshi, Domenico D'Amario, Dejan Milasinovic, Maximillian Will, Dino Miric, Jaksa Zanchi, Frane Runjic, Anteo Bradaric, Mislav Lozo, Mihajlo Kovacic, Mladen I Vidovich, Chun Shing Kwok","doi":"10.1016/j.carrev.2025.03.006","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.006","url":null,"abstract":"<p><strong>Background: </strong>The impact of timing of invasive coronary angiography (ICA) and management strategies on in-hospital outcomes among unselected all-comers with non-ST-segment elevation myocardial infarction (NSTEMI) presents an equipoise in clinical practice.</p><p><strong>Methods: </strong>Patients with NSTEMI from the US NIS database during 2016 to 2021 were included in the analysis. In-hospital outcomes were examined according to the timing of ICA - early (<24 h), intermediate (24-72 h), and delayed (>72 h). These outcomes included all-cause death, major adverse cardiovascular and cerebrovascular events (MACCE), major bleeding, reinfarctions, cardiovascular complications, and stroke.</p><p><strong>Results: </strong>A total of 4,238,570 admissions with NSTEMI were screened of which 1,811,545 (42.7 %) received ICA. Most of patients (48.9 %) received ICA during 2nd and 3rd day following admission, whereas 32.5 % and 18.6 % received early and delayed ICA, respectively. Percutaneous coronary intervention (PCI) was performed in 54.7 %, 47.8 %, and 37.1 % of cases among patients that underwent ICA <24 h, 24-72 h, and > 72 h, respectively. Patients receiving delayed ICA were more likely to be older, women, have more comorbidites and high-risk features. Compared to ICA <24 h, ICA performed at 24-72 h was associated with reduced odds of death (OR 0.80), MACCE (OR 0.85), reinfarction (OR 0.63), and cardiovascular complications (OR 0.89) with no difference concerning major bleeding and stroke.</p><p><strong>Conclusions: </strong><50 % of patients with NSTEMI in a contemporary nationwide US cohort receive ICA while 1 in 2 patients out of those receive PCI. ICA timing at 24-72 h appears to provide the optimal safety profile with respect to primary outcomes and complications.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FFR-guided complete or culprit-only revascularization in ST-elevation myocardial infarction: A systematic review and Meta-analysis.","authors":"Luke P Dawson, Christopher C Y Wong, Daniel K Amponsah, William F Fearon","doi":"10.1016/j.carrev.2025.03.008","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.008","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Two-step recanalization of chronic total occlusion with IVUS-guided antegrade fenestration re-entry.","authors":"Marouane Boukhris, Amine Mamoun Boutaleb, Pierre Chenard, Giuseppe Colletti, Claudiu Ungureanu, Lorenzo Azzalini","doi":"10.1016/j.carrev.2025.03.005","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.005","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143665007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparing outcomes of endovascular intervention vs bypass surgery for patients with chronic/critical limb ischemia.","authors":"Prasana Ramesh, Mohamed Zghouzi, Roshan Bista, Neel N Patel, Chidubem Ezenna, Timir K Paul, Aravinda Nanjundappa","doi":"10.1016/j.carrev.2025.02.017","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.02.017","url":null,"abstract":"<p><strong>Background: </strong>Chronic Limb Threat Ischemia (CLTI) is a severe form of peripheral arterial disease characterized by various symptoms including nonhealing wounds, ulcers and gangrene ultimately leading to a possible amputation. Therefore, revascularization either through endovascular intervention (EVI) or surgical bypass (SB) is an important step in management. Literature review of various studies including Randomized clinical trials (RCTs), Meta-analysis and observational studies show varied results with some studies suggesting better outcomes with EVI while majority of the others favors superiority of SB. Our Systematic review and meta-analysis aims to ascertain underlying differences between the approaches.</p><p><strong>Methods: </strong>We performed a Meta-analysis of observational studies and RCTs following the PRISMA guidelines. We searched Pubmed, and Cochrane databases. After removing duplicates and studies that did not meet the inclusion criteria, 9 studies were included which comprised of 4 RCTs and 5 observational studies. Outcomes measured include limb salvage, amputation free survival and Mortality. Random effects were applied to calculate Odds ratio (OR) and 95 % confidence Intervals (CI).</p><p><strong>Results: </strong>A total of 6375 patients from 9 studies were included. The pooled analysis from the meta-analysis comparing Endovascular intervention vs Surgical Bypass showed no statistically significant difference between the outcomes. The Pooled OR was 0.990(95%CI 0.913-1.073). Additionally the heterogeneity among the studies was moderate (i² = 34.7 %) suggesting some variability in the study results but not enough to conclude a significant difference. Additionally subgroup analysis was performed for above-knee and infra popliteal interventions which yielded statistically similar results.</p><p><strong>Conclusions: </strong>Based on the results above, neither endovascular intervention nor bypass surgery showed superiority over the other for outcomes such as limb salvage, mortality and amputation free survival. Therefore, effectiveness of both interventions for revascularization is comparable.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimal timing for percutaneous coronary intervention in patients undergoing transcatheter aortic valve replacement: A network meta-analysis.","authors":"Pedro E P Carvalho, Bruno Ramos Nascimento, Douglas M Gewehr, Andre Rivera, Mariana Clemente, Marcelo A P Braga, Lucas N Pansani, Lara Almeidinha, Nicole Felix, Thiago M A Veiga, Marco Barbanti, Pedro A Lemos, Marcos Antônio Marino, Maurizio Taramasso, Philippe Garot","doi":"10.1016/j.carrev.2025.03.007","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.007","url":null,"abstract":"<p><strong>Background: </strong>The optimal timing for percutaneous coronary intervention (PCI) in patients undergoing transcatheter aortic valve replacement (TAVR) is uncertain.</p><p><strong>Objectives: </strong>To compare different PCI timings in patients with CAD undergoing TAVR.</p><p><strong>Methods: </strong>MEDLINE, Embase, and Cochrane were systematically searched for studies comparing different timings of PCI in patients with aortic stenosis and coronary artery disease (CAD) undergoing TAVR. PCI in a staged procedure to TAVR and PCI concomitantly to TAVR were compared with TAVR alone without PCI. A frequentist random-effects network meta-analysis calculates the odds ratio (OR) with a 95 % confidence interval (CI). Treatments were ranked using P-score analysis.</p><p><strong>Results: </strong>Two randomized controlled trials and 24 observational studies comprising 10,901 patients with aortic stenosis and CAD were included. Compared with PCI and concomitant TAVR, staged PCI was associated with lower rates of stroke (OR 0.54; 95 % CI 0.37-0.78), myocardial infarction (OR 0.54; 95 % CI 0.31-0.91), and all-cause mortality at 30 days (OR 0.62; 95 % CI 0.41-0.95). In addition, a subgroup analysis showed that staged PCI performed after TAVR is associated with the lowest rates of all-cause mortality of all strategies. In P-score analysis, staged PCI presented the highest likelihood of preventing stroke and myocardial infarction.</p><p><strong>Conclusion: </strong>In patients with aortic stenosis and CAD undergoing TAVR, staged PCI is associated with lower rates of stroke, myocardial infarction, and short-term mortality compared with other timings.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143659206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of optimal lesion preparation prior to implantation of a magnesium-based bioresorbable scaffold: 12-month results of the OPTIMIS study.","authors":"Kirstine Nørregaard Hansen, Akiko Maehara, Jens Trøan, Manijeh Noori, Mikkel Hougaard, Julia Ellert, Karsten Tange Veien, Anders Junker, Henrik Steen Hansen, Jens Flensted Lassen, Lisette Okkels Jensen","doi":"10.1016/j.carrev.2025.03.003","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.003","url":null,"abstract":"<p><strong>Background: </strong>Lumen reduction after bioresorbable scaffold implantation has been reported. This study aimed to assess the influence of pre-dilatation with a scoring balloon versus a standard non-compliant balloon prior to implanting a magnesium-based Magmaris bioresorbable scaffold (MgBRS) on lumen measurements using optical coherence tomography (OCT) and on clinical outcomes after 12 months.</p><p><strong>Method: </strong>In the OPTIMIS-study (Optimal lesion preparation before implantation of a MgBRS in patients with coronary artery stenosis), patients were randomly assigned to pre-dilatation with a scoring balloon or a standard non-compliant balloon before MgBRS implantation. OCT was performed before and after scaffold implantation, and at 6- and 12-month follow-up. Clinical 12-month follow-up was performed for all 82 enrolled patients.</p><p><strong>Results: </strong>Serial pre- and post-procedural, 6- and 12-month OCT were available in 33 lesions (scoring: n = 16 vs. standard: n = 17). Minimal lumen area (MLA) (scoring 4.6 ± 0.5 mm² vs. standard 3.6 ± 0.5 mm², p = 0.16) did not differ significantly at 12 months. In both the scoring and standard non-compliant balloon group, MLA changed significantly over time (post-procedure - 6-month - 12-month) (scoring balloon: 7.2 ± 1.8 mm²-5.1 ± 1.7 mm²-5.0 ± 1.9 mm², p < 0.01, and standard non-compliant balloon: 6.2 ± 1.1 mm²-5.2 ± 1.5 mm²-5.3 ± 2.0 mm², p < 0.01). No target lesion revascularizations (TLR) occurred in the scoring balloon group, compared to 7 TLR in the standard non-compliant balloon group within 12 months.</p><p><strong>Conclusion: </strong>In lesions treated with MgBRS, MLA did not differ significantly after 12 months among lesions pre-dilated with a scoring balloon compared to a standard non-compliant balloon. However, only lesions pre-dilated with a scoring balloon were free from TLR.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"10-year follow-up of patients with titanium-nitride-oxide-coated stents versus everolimus-eluting stents in acute coronary syndrome.","authors":"Jussi Sia, Kari Kervinen, Antti Ylitalo, Bernard De Bruyne, Matti Niemelä, Juhani K E Airaksinen, Hannu Romppanen, Fernando Rivero-Crespo, Pasi P Karjalainen","doi":"10.1016/j.carrev.2025.03.001","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.001","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this study was to compare 10-year clinical outcomes of titanium-nitride-oxide-coated (TiNO)-stent versus permanent polymer everolimus-eluting (EES), for the primary endpoint of major adverse cardiac events (MACE) in patients with acute coronary syndrome (ACS).</p><p><strong>Background: </strong>Previous trials with ACS patients have demonstrated non-inferiority of TiNO-stents compared with EES for clinical events up to 5-year follow-up. Long-term data from randomized clinical stent trials are scarce.</p><p><strong>Methods: </strong>BASE-ACS trial randomized 827 ACS patients to receive either TiNO-stent or EES in a 1:1 fashion. The primary endpoint was MACE: a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR).</p><p><strong>Results: </strong>MACE was significantly lower in the TiNO group compared to EES group (19.2 % vs. 28.3 %; HR 0.72; CI 0.53-0.99; p = 0.04), driven mainly by reduction in MI (8.5 % vs. 13.9 %; HR 0.59; CI 0.37-0.93; p = 0.02) and cardiac death (3.4 % vs. 7.2 %; HR 0.55; CI 0.27-1.14; p = 0.09 (NS). The rate of TLR tended to be less frequent in the TiNO group (10.2 % vs. 15.1 %; HR 0.73; CI 0.48-1.12; p = 0.15 (NS). The rate of definite stent thrombosis was significantly less frequent in the TiNO group (1.8 % vs. 5.4 %; HR 0.32; CI 0.13-0.81; p = 0.01.</p><p><strong>Conclusions: </strong>At 10-year follow-up, the rate of MACE was significantly lower in ACS patients treated with TiNO-stents compared to patients treated with EES.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of acute kidney injury after percutaneous coronary intervention with plaque modification.","authors":"Sant Kumar, Kathleen E Kearney, Christine J Chung, David Elison, Zachary L Steinberg, William L Lombardi, James M McCabe, Lorenzo Azzalini","doi":"10.1016/j.carrev.2025.03.004","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.004","url":null,"abstract":"<p><strong>Background: </strong>The use of plaque modification techniques during percutaneous coronary interventions (PCI) has increased. However, these procedures are linked to higher contrast volume and hypotensive episodes, which are risk factors for acute kidney injury (AKI). This study examined the effects of various plaque modification techniques on AKI after PCI.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of patients who underwent PCI at our institution between December 2020 to March 2024, categorizing them into 3 groups based on the plaque modification technique used: atherectomy, intravascular lithotripsy (IVL), or no plaque modification (NPM). The primary endpoint was AKI, and multivariable logistic regression was used to identify independent predictors of AKI. Multivariable analysis and propensity score matching (1:1) were performed to control for confounders.</p><p><strong>Results: </strong>In total, 1758 patients were included. Atherectomy was performed in 268 (15.2 %) patients, IVL in 120 (6.8 %) patients, and 1370 (77.9 %) patients had NPM. Atherectomy patients were older and had worse baseline renal function than the IVL and NPM groups (p < 0.001 for both). Compared with NPM, atherectomy was an independent predictor of AKI (odds ratio [OR] 1.27, 95 % confidence interval [CI] 1.07-1.98, p = 0.037), while IVL was not (OR 1.30, 95 % CI 0.84-2.08, p = 0.209). In a propensity-matched analysis of 101 atherectomy and IVL patient pairs, atherectomy-based PCI remained associated with a higher rate of AKI (11.9 % vs. 2.0 %; p = 0.013).</p><p><strong>Conclusion: </strong>Atherectomy, but not IVL, is associated with a higher risk of AKI after PCI, compared to NPM. This underscores the importance of thoughtfully selecting plaque modification strategies in high-risk patients to reduce renal adverse events following PCI.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long term follow up of patients treated with a polymer coated non drug-eluting stent in the COBRA-REDUCE trial.","authors":"Jola Bresha, Karsten P Hug, Robert A Byrne, Shqipdona Lahu, Salvatore Cassese, Roisin Colleran, Tareq Ibrahim, Erion Xhepa, Isabell Bernlochner, Michael Joner, Karl-Ludwig Laugwitz, Adnan Kastrati, Sebastian Kufner, J J Coughlan","doi":"10.1016/j.carrev.2025.02.014","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.02.014","url":null,"abstract":"<p><strong>Background: </strong>The use of a non-drug eluting coronary stent with a thromboresistant and pro-healing coating may result in long term advantages in comparison to FDA approved drug eluting stents (DES).</p><p><strong>Methods: </strong>In the COBRA REDUCE trial, patients with an indication for OAC undergoing PCI were randomized to treatment with the COBRA-PzF stent followed by 14 days of DAPT or an FDA-approved new generation DES followed by 3- or 6-months of DAPT. In the subset of patients enrolled at the lead site, we collected additional long term follow up. The primary endpoints for the current analysis were a composite thromboembolic endpoint (all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischaemic stroke) and ischemia driven target lesion revascularisation (ID-TLR) through to 4 years follow up.</p><p><strong>Results: </strong>A total of 996 patients underwent randomization in the COBRA REDUCE trial. Of 140 patients randomized in Munich, 71 were randomized to the COBRA PzF stent and 69 to the control group. The primary composite ischemic endpoint occurred in 15/71 patients (21.8 %) in the COBRA PzF group and 15/69 patients (22.4 %) in the control group (hazard ratio [HR], 0.96; 95 % confidence interval [CI], 0.47-1.97, p value = 0.92). ID-TLR occurred in 7/71 patients (10.1 %) in the COBRA PzF group and 3/69 patients (4.5 %) in the control group (HR, 2.30; 95 % CI, 0.60-8.77, p value = 0.22). TLR occurred in 11/71 patients (15.8 %) in the COBRA PzF group and 3/69 patients (4.5 %) in the control group (HR, 3.76; 95 % CI, 1.06 to 13.32, p value = 0.04).</p><p><strong>Conclusion: </strong>Through to 4 year follow up after PCI in patients with an indication for OAC, the COBRA PzF stent did not result in any advantages in comparison to FDA approved DES and was associated with an increased risk of TLR.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143574285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}