Cardiovascular Revascularization Medicine最新文献

{"title":"High-risk percutaneous coronary intervention with or without mechanical circulatory support: Will Impella show superiority in the PROTECT IV randomized trial?","authors":"Kalyan R. Chitturi ,&nbsp;Cheng Zhang ,&nbsp;Waiel Abusnina ,&nbsp;Vaishnavi Sawant ,&nbsp;Avantika Banerjee ,&nbsp;Shaan Ahmed ,&nbsp;Ilan Merdler ,&nbsp;Dan Haberman ,&nbsp;Abhishek Chaturvedi ,&nbsp;Lior Lupu ,&nbsp;Pavan Reddy ,&nbsp;Brian C. Case ,&nbsp;Toby Rogers ,&nbsp;Hayder D. Hashim ,&nbsp;Itsik Ben-Dor ,&nbsp;Nelson L. Bernardo ,&nbsp;Lowell F. Satler ,&nbsp;Ron Waksman","doi":"10.1016/j.carrev.2024.07.003","DOIUrl":"10.1016/j.carrev.2024.07.003","url":null,"abstract":"<div><h3>Background</h3><div>PROTECT IV is a current enrolling randomized controlled trial<span> evaluating high-risk percutaneous coronary intervention (HR-PCI) with prophylactic Impella versus no Impella to reduce the composite primary endpoint of all-cause death, stroke, myocardial infarction (MI), or cardiovascular hospitalization. In a PROTECT IV-like cohort of patients who underwent HR-PCI without Impella, we aimed to report the rate of major adverse events to determine whether the trial is adequately powered.</span></div></div><div><h3>Methods and results</h3><div>A total of 700 patients meeting similar inclusion/exclusion criteria of PROTECT IV who underwent HR-PCI without Impella at a single tertiary center from 2008 to 2022 were included in the analysis. The composite rates of all-cause death, MI, target lesion revascularization<span>, and target vessel revascularization<span> at 1, 2, and 3 years were estimated using the Kaplan-Meier method, and the results were used to calculate the sample size under the constant hazard ratio assumption and expected number of events to be observed used in planning PROTECT IV. The primary endpoint occurred in 30.8 % of patients at 2 years. PROTECT IV assumes a hazard ratio of 0.75 using a multivariate Cox regression, which, under a 5 % level and 90 % power, yields 516 events. This implies a 2-year primary outcome rate of 50 % for the non-Impella arm.</span></span></div></div><div><h3>Conclusion</h3><div>Therefore, PROTECT IV estimates that a sample size of 1252 patients is required for Impella to be declared superior to the non-Impella group. Using our observed 2-year outcome of 30.8 %, we estimate that PROTECT IV requires 1966 patients, demonstrating that PROTECT IV is probably underpowered.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"73 ","pages":"Pages 59-63"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141628030","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":"Relationships between sex and in-hospital outcomes of patients with acute cardiogenic shock receiving mechanical circulatory support","authors":"Nadhem Abdallah ,&nbsp;Abdilahi Mohamoud ,&nbsp;Talal Almasri ,&nbsp;Meriam Abdallah","doi":"10.1016/j.carrev.2024.07.017","DOIUrl":"10.1016/j.carrev.2024.07.017","url":null,"abstract":"<div><h3>Background</h3><div>Cardiovascular disease is the leading cause of mortality in women. Despite this there is a paucity of data on the impact of sex on utilization and outcomes of temporary mechanical circulatory support (tMCS) in patients hospitalized with Acute Myocardial Infarction (AMI) Cardiogenic Shock (CS).</div></div><div><h3>Methods</h3><div>We examined the 2016–2019 National Inpatient Sample database to identify cases of AMI-CS. Men were used as our control group, while women comprised our cohort. The primary outcome was in-hospital mortality. Secondary outcomes included the use of tMCS including; left ventricular assist device (LVAD) use, Impella use, and Intra-Aortic Balloon Pump (IABP) use, length of stay (LOS) and total hospitalization cost (THC). Multivariate linear and logistic regression models were used to adjust for confounders.</div></div><div><h3>Results</h3><div>Among patients hospitalized for AMI (<em>N</em> = 2,622,939), 37.7 % were Female. A Female sex was associated with a higher inpatient mortality (adjusted OR [aOR] 1.06, <em>p</em> &lt; 0.001), a lower likelihood of LVAD use (2.3 % vs. 2.9 % and <em>p</em> &lt; 0.001), IABP use (3.0 % vs. 4.4 % and <em>p</em> &lt; 0.001), Impella use (1.0 % vs. 1.5 % and <em>p</em> &lt; 0.001), a longer mean LOS (4.4 vs 4.3 days and p &lt; 0.001) and lower THC ($88,097 vs. $104,101, p &lt; 0.001) compared to male patients for AMI-CS.</div></div><div><h3>Conclusion</h3><div>Female patients admitted for AMI-CS were less likely to receive tMCS despite a higher mortality rate and a slightly longer LOS compared to male patients. Further studies are necessary to confirm these findings and elucidate clearer causality for such disparities.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"73 ","pages":"Pages 76-80"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761685","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":"Peripheral intravascular lithotripsy to facilitate transfemoral transcatheter aortic valve replacement – Defining optimal treatable peripheral arterial disease burden","authors":"Stephanie Tom ,&nbsp;Andy Tully ,&nbsp;Yuta Kikuchi ,&nbsp;Kaylyn Crawford ,&nbsp;José Binongo ,&nbsp;Jane Wenjing Wei ,&nbsp;Patrick Gleason ,&nbsp;Joe Xie ,&nbsp;Chandan M. Devireddy ,&nbsp;Kendra J. Grubb","doi":"10.1016/j.carrev.2024.07.005","DOIUrl":"10.1016/j.carrev.2024.07.005","url":null,"abstract":"<div><h3>Background</h3><div>Transfemoral transcatheter aortic valve replacement (TF-TAVR) has proven superior to alternative access. However, some patients evaluated for TF-TAVR are unfit secondary to peripheral arterial disease (PAD). Peripheral intravascular lithotripsy (IVL) can facilitate femoral access. This study aimed to characterize optimal lesions that can be treated with IVL.</div></div><div><h3>Methods</h3><div>Single-center, retrospective analysis of an institutional database, queried from 1/2018 through 7/2023 for all patients who underwent TAVR. Patients who received IVL-facilitated transfemoral access were analyzed.</div></div><div><h3>Results</h3><div>Of 2862 TAVR cases identified, 92 (3.2 %) underwent lithotripsy. The IVL-facilitated cohort had a mean age of 78 ± 9.2 years and 45 % were female. The right common iliac artery was most treated (47). Most IVL was performed with 7-mm balloons (73.9 %). All cases were successful. 30-day mortality was 1.1 % (1/92).</div></div><div><h3>Conclusions</h3><div>In our cohort, complications after IVL-facilitated TF-TAVR were more common with small vessel diameter (≤4.7 mm), significant luminal loss (&gt;50 % stenosis), and heavy calcium burden (arc calcification &gt;180°). The findings support the use of IVL to expand the population of patients who can undergo TF-TAVR without the increased risks associated with the various forms of alternative access.</div></div><div><h3>Summary for annotated table of contents</h3><div>IVL-facilitated TF-TAVR is safe and feasible. Despite its introduction to TAVR clinical practice in 2018, IVL-facilitated TF-TAVR is not regularly performed and could increase the population of patients eligible for TF-TAVR.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"73 ","pages":"Pages 31-37"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141846726","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":"Left ventricular reverse remodeling and reduction of interstitial fibrosis in patients with severe aortic stenosis who underwent transcatheter aortic valve implantation","authors":"Teruaki Wada ,&nbsp;Shingo Ota ,&nbsp;Kentaro Honda ,&nbsp;Takashi Tanimoto ,&nbsp;Akira Taruya ,&nbsp;Takahiro Nishi ,&nbsp;Jumpei Takeda ,&nbsp;Ryo Hikida ,&nbsp;Yoshinori Asae ,&nbsp;Masahiro Takahata ,&nbsp;Yuichi Ozaki ,&nbsp;Manabu Kashiwagi ,&nbsp;Yasutsugu Shiono ,&nbsp;Akio Kuroi ,&nbsp;Takashi Yamano ,&nbsp;Kazushi Takemoto ,&nbsp;Hironori Kitabata ,&nbsp;Yoshiharu Nishimura ,&nbsp;Atsushi Tanaka","doi":"10.1016/j.carrev.2024.06.022","DOIUrl":"10.1016/j.carrev.2024.06.022","url":null,"abstract":"<div><h3>Background</h3><div><span><span><span>Left ventricular (LV) structural and functional changes have been reported in patients with aortic stenosis (AS) who have undergone </span>transcatheter aortic valve implantation (TAVI); however, the relationship between change in LV structure and </span>systolic function and tissue characteristics assessed via </span>cardiovascular magnetic resonance imaging (CMRI) post-TAVI has been not fully elucidated. This study aimed to investigate this relationship in patients with severe AS who underwent TAVI and CMRI.</div></div><div><h3>Methods</h3><div>In this retrospective study, 65 patients who underwent TAVI and CMRI at the 6-month follow-up were analyzed. The relationship between percent changes in LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), LV ejection fraction (LVEF), and LV mass (LVM) (⊿LVEDV, ⊿LVESV, ⊿LVEF, and ⊿LVM) and those in the native T1 value (⊿native T1) was analyzed using a correlation analysis. Moreover, extracellular volume fraction (ECV) value changes were analyzed.</div></div><div><h3>Results</h3><div>The ⊿native T1 significantly decreased from 1292.8 (1269.9–1318.4) ms at pre-TAVI to 1282.3 (1262.6–1310.2) ms at the 6-month follow-up (<em>P</em> = 0.022). A significant positive correlation between ⊿LVEDV, ⊿LVESV, and ⊿LVM and ⊿native T1 (<em>r</em> = 0.351, <em>P</em> = 0.004; <em>r</em> = 0.339, <em>P</em> = 0.006; <em>r</em> = 0.261, <em>P</em> = 0.035, respectively) and a tendency toward a negative correlation between ⊿LVEF and ⊿native T1 (<em>r</em> = −0.237, <em>P</em> = 0.058) were observed. The ECV value increased significantly from 26.7 % (25.3–28.3) to 28.2 % (25.7–30.5) (<em>P</em> = 0.002).</div></div><div><h3>Conclusions</h3><div>The decrease in native T1 might be associated with LV reverse remodeling. Evaluating structural and functional changes using CMRI may be useful for patient management.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"73 ","pages":"Pages 38-43"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141535670","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":"Outcomes of aortic stenosis in patients with cardiac amyloidosis: A systematic review and meta-analysis","authors":"Soban Ahmad ,&nbsp;Muhammad Junaid Ahsan ,&nbsp;Morgan Newlun ,&nbsp;Mitchell Sand ,&nbsp;Anan Abu Rmilah ,&nbsp;Amman Yousaf ,&nbsp;Muhammad Asim Shabbir ,&nbsp;Shahbaz A. Malik ,&nbsp;Andrew M. Goldsweig","doi":"10.1016/j.carrev.2025.02.005","DOIUrl":"10.1016/j.carrev.2025.02.005","url":null,"abstract":"<div><h3>Background</h3><div>Cardiac amyloidosis (CA) results from the deposition of abnormally folded protein fibrils, leading to restrictive cardiomyopathy, valvular heart disease, and arrhythmias. Up to 15 % of patients with severe aortic stenosis (AS) have concomitant CA (AS-CA). We conducted this systematic review and meta-analysis to compare medical management, transcatheter aortic valve replacement (TAVR), and surgical AVR (SAVR) in AS-CA.</div></div><div><h3>Methods</h3><div>A comprehensive literature search was conducted for relevant studies from inception through January 20, 2024. Studies exploring outcomes in adult AS patients with and without CA receiving medical therapy, TAVR, or SAVR were included in this analysis.</div></div><div><h3>Results</h3><div>Fifteen studies including 253,334 patients (AS-CA 6704; AS alone 246,630) were identified. AS-CA patients had significantly higher all-cause mortality (RR = 2.60, 95 % CI 1.48–4.57, <em>P</em> = 0.0009) compared to AS alone. Among patients with AS-CA, TAVR was associated with lower all-cause mortality compared to both medical therapy (RR = 0.50, 95 % CI 0.29–0.89, <em>P</em> = 0.02) and SAVR (RR = 0.41, 95 % CI 0.22–0.78, <em>P</em> = 0.007). AS-CA patients undergoing TAVR were more likely to have paradoxical low-flow, low-gradient AS (RR = 1.56, 95 % CI 1.15–2.12, <em>P</em> = 0.04) at baseline and had a higher risk of post-TAVR acute kidney injury (RR = 1.95, 95 % CI 1.35–2.80, <em>P</em> = 0.0003) compared to patients undergoing TAVR for AS alone. There were similar risks of other post-TAVR complications, including major bleeding, vascular complications, stroke, and new pacemaker implantation between AS-CA and AS alone.</div></div><div><h3>Conclusion</h3><div>CA is associated with a higher mortality in patients with severe AS. In patients with concomitant AS and CA, TAVR is safe and associated with better survival than medical therapy or SAVR.</div></div><div><h3>Social media abstract</h3><div>#Meta-Analysis: Cardiac amyloidosis is associated with increased mortality in severe AS. #TAVR is safe in amyloidosis &amp; improves survival more than medical therapy or SAVR.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"73 ","pages":"Pages 98-106"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426484","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":"Impact of left bundle branch block or permanent pacemaker after transcatheter aortic valve replacement on mid-term left ventricular ejection fraction","authors":"Ilan Merdler ,&nbsp;Brian C. Case ,&nbsp;Itsik Ben-Dor ,&nbsp;Kalyan R. Chitturi ,&nbsp;Heather Fahey ,&nbsp;Fatima Hayat ,&nbsp;Imad Isaac ,&nbsp;Lowell F. Satler ,&nbsp;Toby Rogers ,&nbsp;Ron Waksman","doi":"10.1016/j.carrev.2024.06.021","DOIUrl":"10.1016/j.carrev.2024.06.021","url":null,"abstract":"<div><h3>Background</h3><div>Conduction disturbances have uncertain implications for long-term left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR). We aimed to examine LVEF changes in patients up to two years post-TAVR.</div></div><div><h3>Methods</h3><div>We examined patients who underwent TAVR between 2012 and 2020 and underwent echocardiography follow-up. Patients were categorized into four groups: 1) Those without a permanent pacemaker (PPM) or left bundle branch block (LBBB) pre- or post-TAVR; 2) Patients with pre- and post-TAVR LBBB; 3) Individuals with preexisting PPM; and 4) Patients requiring new PPM after TAVR. LVEF was assessed at the outset of TAVR, at 30 days, 1-year, and 2-years post-TAVR.</div></div><div><h3>Results</h3><div>The study included 730 patients: 421 (57.6 %) without conduction abnormalities, 151 (20.7 %) with post-TAVR LBBB (48 pre-existing, 103 new-onset), 63 (8.6 %) with pre-existing PPM, and 95 (13.1 %) requiring new PPM. At discharge, patients without conduction abnormalities exhibited the highest LVEF (57.4 ± 11.5 %), whereas those with pre-existing PPM had the lowest (48.1 ± 15.5 %). Over two years, LVEF remained constant in patients without conduction issues and in those with pre-existing PPM. However, patients with new LBBB experienced a 6.3 % decrease in LVEF, and those requiring new PPM showed a 4.1 % reduction.</div></div><div><h3>Conclusion</h3><div>New conduction abnormalities, such as LBBB or the need for PPM, induce a decline in LVEF post-TAVR. It is imperative to focus on the long-term monitoring of left ventricular function in patients experiencing new conduction disturbances post-TAVR.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"73 ","pages":"Pages 8-14"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113446","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":"Angiographic and clinical impact of balloon inflation time in percutaneous coronary interventions with sirolimus-coated balloon: A subanalysis of the EASTBOURNE study","authors":"Filippo Luca Gurgoglione ,&nbsp;Dario Gattuso ,&nbsp;Antonio Greco ,&nbsp;Davide Donelli ,&nbsp;Giampaolo Niccoli ,&nbsp;Bernardo Cortese","doi":"10.1016/j.carrev.2024.07.021","DOIUrl":"10.1016/j.carrev.2024.07.021","url":null,"abstract":"<div><h3>Introduction</h3><div>Percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) is an attractive strategy for the treatment of obstructive coronary artery disease (CAD). The implantation technique strongly influences the outcome of DCB PCI: accurate and adequate lesion preparation, short delivery time and sufficient DCB inflation time are deemed crucial to warrant adequate drug transfer and mitigate the risk of immediate vessel recoil and flow-limiting dissections. However, the optimal DCB inflation time is unclear, current consensus documents suggesting 30–60 s based on Experts' opinion. However, clinical studies comparing the prognostic role of different inflation times are scarce and mainly involve paclitaxel-coated balloons. In this study we aimed to assess the impact of different inflation times in patients undergoing PCI with a sirolimus-coated balloon (SCB).</div></div><div><h3>Methods</h3><div>We conducted a post-hoc analysis of the prospective, multicenter, EASTBOURNE study, classified into two study groups according to balloon inflation time: long (&gt;30 s) versus short (≤30 s). The primary endpoint was target lesion revascularization (TLR) at 24-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, non-fatal myocardial infarction (MI), and BARC 2–5 bleedings. Furthermore, angiographic endpoints (the rate of bailout stenting and post-procedural TIMI flow &lt;3) were also addressed.</div></div><div><h3>Results</h3><div>A total of 2289 lesions (2092 in the long inflation group, 197 in the short inflation group) were included in the analysis. Median balloon inflation time was 60 s in the long inflation and 30 s in the short inflation group. The two study groups experienced a similar rate of TLR [6.2 % in the short versus 6.3 % in the long inflation group, <em>p</em> = 1.00] as well MACE (<em>p</em> = 0.683), death (<em>p</em> = 0.102), non-fatal MI (<em>p</em> = 0.822), and BARC 2–5 bleedings (<em>p</em> = 0.252). These results were consistent when considering subpopulations with different target lesion phenotypes (in-stent restenosis, de-novo lesions, large and small vessels). Interesting, the rate of bailout stent implantation and post-procedural TIMI flow &lt;3 was higher in the short SCB inflation time, as compared to the standard strategy.</div></div><div><h3>Conclusions</h3><div>Short vs. long SCB inflation time is associated with a higher need of bailout stenting after PCI with SCB, with similar clinical outcomes at 24-month follow-up.</div></div>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":"73 ","pages":"Pages 70-75"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141851288","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":"Revascularization strategies for coronary artery aneurysms: A systematic review.","authors":"Magdi Zordok, Kevin G Buda, Muhammad Etiwy, Mir B Basir, Khaldoon Alaswad, Erik Beckmann, Emmanouil S Brilakis, Michael Megaly","doi":"10.1016/j.carrev.2025.03.022","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.022","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144021337","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":"Comparison of drug-coated versus conventional balloons for the side branch of the bifurcation lesion - multicenter randomized controlled study - (OCVC-BIF): Design and rationale.","authors":"Tomoharu Dohi, Takayuki Ishihara, Hirota Kida, Daisuke Nakamura, Atsushi Kikuchi, Tsutomu Kawai, Naoki Mori, Naotaka Okamoto, Yasunori Ueda, Ryu Shutta, Minoru Ichikawa, Toshiaki Mano, Tetsuya Watanabe, Yoshiharu Higuchi, Masami Nishino, Eisuke Hida, Tomoharu Sato, Shungo Hikoso, Daisaku Nakatani, Yohei Sotomi, Yasushi Sakata","doi":"10.1016/j.carrev.2025.03.024","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.024","url":null,"abstract":"<p><strong>Background: </strong>Although several clinical trials have suggested the usefulness of drug-coated balloons (DCB) for side-branch lesions, their efficacy and safety have not yet been established.</p><p><strong>Methods and study design: </strong>The Osaka Cardiovascular Conference (OCVC) will conduct a multicenter, randomized, open-label, controlled trial aiming to examine whether additional DCB treatment for the side branch after main vessel stenting followed by kissing balloon inflation (KBI) is superior to only KBI by conventional balloons in PCI patients with coronary bifurcation lesions. The primary endpoint is restenosis of side branches documented by scheduled or symptom-driven coronary angiography during 9-month follow-up period after the index PCI. The key secondary endpoints include major adverse cardiac event which consists of cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis, and optical coherence tomography findings. A total of 300 patients will be enrolled and followed up to 1 year.</p><p><strong>Summary: </strong>The OCVC-BIF trial is a randomized controlled trial designed to assess whether additional DCB treatment for side branch is superior to only KBI by conventional balloons in patients with coronary bifurcation lesions undergoing PCI with main vessel stenting.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788932","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":"Anticoagulation alone versus large-bore mechanical thrombectomy in acute intermediate-risk pulmonary embolism.","authors":"Robert S Zhang, Eugene Yuriditsky, Peter Zhang, Hannah P Truong, Yuhe Xia, Muhammad H Maqsood, Allison A Greco, Vikramjit Mukherjee, Radu Postelnicu, Nancy E Amoroso, Thomas S Maldonado, Carlos L Alviar, James M Horowitz, Sripal Bangalore","doi":"10.1016/j.carrev.2025.03.023","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.023","url":null,"abstract":"<p><strong>Background: </strong>Patients with intermediate-risk pulmonary embolism (PE) have outcomes worse than uncomplicated ST elevation myocardial infarction. Yet, no large-scale study has compared the outcomes of large-bore mechanical thrombectomy (LBMT) with anticoagulation alone (AC). The aim of this study was to compare the clinical outcomes among patients receiving LBMT vs AC alone.</p><p><strong>Methods: </strong>This was a two-center retrospective study that included patients with intermediate-risk PE from October 2016 - October 2023 from the institution's Pulmonary Embolism Response Team (PERT) database. The primary outcome was a composite of 30-day mortality, resuscitated cardiac arrest or hemodynamic decompensation. Inverse probability of treatment weighting (IPTW) was used to balance covariates; Kaplan Meir curves and IPTW multivariable Cox regression were used to assess the relationship between treatment groups and outcomes.</p><p><strong>Results: </strong>Of the 273 patients included in the analysis, 192 (70 %) patients received AC alone and 81 (30 %) patients received LBMT and AC. A total of 30 (10.9 %) patients experienced the primary composite outcome over a median follow-up of 30 days. The primary composite outcome was significantly lower in the group that received LBMT compared to those on AC alone (1.2 % vs 15.1 %, log-rank p < 0.001; adjusted HR: 0.02; 95 % CI: 0.002-0.17, p < 0.001) driven by a lower rate of 30-day all-cause mortality (0 % vs 7.3 %, log-rank p = 0.01), resuscitated cardiac arrest (0 % vs 6.8 %, log-rank p = 0.016) and new or worsening hemodynamic instability (4 % vs 11.1 %, log-rank p = 0.007).</p><p><strong>Conclusion: </strong>In this largest cohort to date comparing LBMT versus AC alone in acute intermediate-risk PE, LBMT had a significantly lower rate of the primary composite outcome including a lower rate of all-cause mortality when compared to AC alone. Ongoing randomized trials will test these associations.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024723","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}