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Drug-Coated Balloons for De Novo Non-aorto-ostial and Coronary Bifurcation Lesions: A Systematic Review and Meta-analysis

Mariscal, Enrique Soltero; Slotwiner, Alexander; Karam, Boutros; Bliagos, Dimitrios; Razzouk, Louai; Shah, Binita; Bangalore, Sripal; Rao, Sunil V; Sharma, Atul
BACKGROUND/UNASSIGNED:Stenting of bifurcation and non-aorto-ostial coronary lesions presents significant challenges due to geographic miss and restenosis. Drug-coated balloons (DCBs) offer an attractive alternative to drug-eluting stents in the treatment of these lesions. METHODS/UNASSIGNED:We conducted a systematic review of studies published from 2001 to 2024 comparing DCBs with plain old balloon angioplasty and/or drug-eluting stents (DES) in de novo coronary bifurcation lesions and non-aorto-ostial (NAO) lesions. A meta-analysis was performed with target lesion failure (TLF) as the selected outcome, defined as a composite of target lesion revascularization, target vessel myocardial infarction, or cardiovascular death. RESULTS/UNASSIGNED:= .0015), respectively. CONCLUSIONS/UNASSIGNED:In our meta-analysis, DCBs were associated with a lower rate of TLF compared with plain old balloon angioplasty and DES. These findings suggest that DCBs could be preferred for the treatment of bifurcation and NAO lesions.
PMCID:12766052
PMID: 41498001
ISSN: 2772-9303
CID: 5980912

Contemporary, non-invasive imaging diagnosis of chronic coronary artery disease

van der Bijl, Pieter; Gulati, Martha; Saraste, Antti; Marwick, Thomas; Kwong, Raymond; Blankstein, Ron; Nieman, Koen; Sengupta, Partho P; van Rosendael, Alexander; Knuuti, Juhani; Bangalore, Sripal; Bax, Jeroen J
Coronary artery disease is one of the leading causes of morbidity and mortality worldwide. Although it can present with an acute coronary syndrome, it is often characterised by long periods of stability, known as chronic coronary artery disease. This Review presents a comprehensive overview of the diagnosis of the disease, with a focus on cardiac imaging. We discuss various cardiac imaging modalities, including CT coronary angiography, stress echocardiogram, stress single-photon emission CT, PET, and stress cardiac magnetic resonance. We also compare the roles of anatomical (eg, CT coronary angiography) versus functional (eg, stress echocardiogram) tests and examine the potential utility of artificial intelligence in more detail.
PMID: 41318214
ISSN: 1474-547x
CID: 5969002

Drug-Eluting Stent, Drug-Coated Balloon, or Plain Old Balloon Angioplasty for In-Stent Coronary Restenosis: Insights From a Mixed Treatment Comparison Meta-Analysis of Randomized Trials

Maqsood, M Haisum; Zhang, Robert S; Rawal, Nil; Sella, Gal; Kleiman, Neal S; Bangalore, Sripal
BACKGROUND/UNASSIGNED:Drug-coated balloons (DCBs) are now a Food and Drug Administration--approved treatment option for the management of in-stent restenosis (ISR) based on superior outcomes compared with plain old balloon angioplasty (POBA) alone. However, the efficacy of DCB compared with drug-eluting stent (DES; repeat stenting) for ISR is uncertain, with prior studies showing inferiority of DCB. We aimed to compare the outcomes of DES, DCB, or POBA in patients with coronary ISR. METHODS/UNASSIGNED:We searched PubMed, EMBASE, and clinicaltrials.gov databases (until August 1, 2025) for randomized clinical trials that compared DCB, DES, or POBA alone for ISR. Outcomes included major adverse cardiovascular events, target lesion revascularization, all-cause mortality, cardiovascular mortality, stent thrombosis, late lumen loss, and postprocedure minimum lumen diameter. RESULTS/UNASSIGNED:From 18 randomized clinical trials that randomized 3820 patients with ISR, at mean follow-up of 18 months, compared with POBA, both DCB and DES were associated with reduction in major adverse cardiovascular events (odds ratio, 0.34 [95% CI, 0.24-0.50]; odds ratio, 0.37 [95% CI, 0.25-0.54]) driven by reduction in target lesion revascularization (odds ratio, 0.28 [95% CI, 0.15-0.50]; odds ratio, 0.21 [95% CI, 0.10-0.42]). DCB had a lower postprocedure minimum lumen diameter but lower late lumen loss (mean difference, -0.16 [95% CI, -0.29 to -0.04] mm) compared with DES with no difference in other clinical outcomes. CONCLUSIONS/UNASSIGNED:In patients with ISR, DCB reduced major adverse cardiovascular events/target lesion revascularization compared with POBA. There was no significant difference in clinical outcomes between DCB and DES. REGISTRATION/UNASSIGNED:URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42024598433.
PMID: 41221602
ISSN: 1941-7632
CID: 5966762

Disparities and trends in pulmonary embolism mortality with and without obesity: a nationwide US analysis

Goyal, Aman; Saeed, Humza; Sulaiman, Samia Aziz; Arshad, Muhammad Khubaib; Alexander, Kevin Michael; Bangalore, Sripal; Billings, Liana K; Tafur, Alfonso J; Pareek, Manan; Piazza, Gregory; Qamar, Arman
BACKGROUND/UNASSIGNED:Obesity increases the risk of pulmonary embolism (PE) through multiple mechanisms. OBJECTIVES/UNASSIGNED:This study examined mortality trends in patients with coexisting PE and obesity. METHODS/UNASSIGNED:< .05. RESULTS/UNASSIGNED:< .001). CONCLUSIONS/UNASSIGNED:The analysis reveals a significant rise in mortality from concurrent PE and obesity, with higher rates observed in women, middle-aged adults, non-Hispanic Black individuals, and residents of nonmetropolitan areas. These findings highlight the need for targeted interventions in these high-risk groups.
PMCID:12702333
PMID: 41399430
ISSN: 2475-0379
CID: 5979172

Hemodynamic Super-Response to Mechanical Thrombectomy in Patients With Intermediate-Risk Pulmonary Embolism

Yuriditsky, Eugene; Zhang, Robert S; Zhang, Peter; Truong, Hannah P; Elbaum, Lindsay; Greco, Allison A; Postelnicu, Radu; Horowitz, James M; Bernard, Samuel; Mukherjee, Vikramjit; Hena, Kerry; Alviar, Carlos L; Keller, Norma M; Bangalore, Sripal
BACKGROUND/UNASSIGNED:Among patients with intermediate-risk pulmonary embolism undergoing mechanical thrombectomy, the mean change in cardiac index (CI) is modest. We sought to identify variables associated with a hemodynamic super-response or a CI increase of ≥25% postthrombectomy. METHODS/UNASSIGNED:This was a single-center retrospective study including patients with intermediate-risk pulmonary embolism undergoing mechanical thrombectomy with pulmonary artery catheter-derived hemodynamic indices obtained preprocedure and postprocedure. RESULTS/UNASSIGNED:was associated with a hemodynamic super-response (odds ratio, 3.76 [95% CI, 1.09-13.0]). CONCLUSIONS/UNASSIGNED:Patients with intermediate-risk pulmonary embolism with the more severe hemodynamic derangements had the greatest improvement in CI post thrombectomy. This group can be identified with commonly available noninvasive indices of right ventricular dysfunction.
PMID: 40899246
ISSN: 1941-7632
CID: 5956382

Health Status Outcomes With Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in ISCHEMIA

Huded, Chetan P; Spertus, John A; Jones, Philip G; O'Brien, Sean M; Mark, Daniel B; Bangalore, Sripal; Stone, Gregg W; Williams, David O; White, Harvey D; Boden, William E; Reynolds, Harmony R; Hochman, Judith S; Maron, David J; ,
BACKGROUND/UNASSIGNED:In ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), an invasive strategy demonstrated better health status outcomes than a conservative strategy in patients with chronic coronary disease (CCD). Some previous studies have shown greater health status benefits with coronary artery bypass grafting (CABG) than percutaneous coronary intervention (PCI). Whether the health status benefits of invasive management in ISCHEMIA were driven primarily by participants treated with CABG is unknown. METHODS/UNASSIGNED:The aim of this analysis was to describe the health status outcomes of participants treated with a conservative strategy (n=2232) compared with invasively managed participants treated with PCI (n=1198) or CABG (n=340) in ISCHEMIA. The Seattle Angina Questionnaire-7 summary score (SAQ-SS) and angina frequency score (SAQ-AF) were the primary outcomes, with higher scores indicating better health status. Proportional odds models comparing 1- and 3-year outcomes were fit, adjusting for demographic, clinical, and angiographic characteristics. RESULTS/UNASSIGNED:SAQ-SS in the conservative, PCI, and CABG groups increased by 9.9±18.1, 15.7±19.3, and 16.1±19.1 points at 1 year and 11.5±20.2, 16.5±21.8, and 15.0±19.4 points at 3 years, respectively. Freedom from angina in the conservative, PCI, and CABG groups was noted in 61.4%, 73.3%, and 82.4% at 1 year and 70.4%, 76.1%, 81.4% at 3 years, respectively. In risk-adjusted analyses, PCI and CABG were each associated with a higher SAQ-SS and SAQ-AF at 1 and 3 years compared with conservative management. SAQ-AF was higher with CABG than PCI at 1 year (odds ratio, 1.54 [95% CI, 1.03, 2.31]), but no differences between CABG and PCI were observed in SAQ-SS (odds ratio, 1.11 [95% CI, 0.78, 1.57]) or SAQ-AF (odds ratio, 0.94 [95% CI, 0.58, 1.54]) at 3 years. CONCLUSIONS/UNASSIGNED:In ISCHEMIA, both PCI and CABG were associated with better 3-year health status than conservative management. Better angina relief with CABG than PCI was seen at 1, but not 3, years. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.
PMID: 40910165
ISSN: 1524-4539
CID: 5937562

Outcomes of Percutaneous Mechanical Aspiration in Right-Sided Infective Endocarditis: A Multicenter Registry

El Sabbagh, Abdallah; Hibbert, Benjamin; Bangalore, Sripal; Fong, Pete; Zlotnick, David; El-Sabawi, Bassim; Zhang, Robert; Zwischenberger, Brittany; Mourad, Ahmad; Palatnic, Leonard; Sayfo, Sameh; Gilyard, Shenise; Younes, Stephanie; Younes, Ahmad; Ingrassia, Joseph; Cheema, Mohiuddin; Hammadah, Muhammad; Prasad, Anand; Hamid, Nadira; Voudris, Konstantinos; Villablanca, Pedro; Kaki, Amir; Qintar, Mohammed; Baloch, Zulfiqar; Patton, Marquand; Dominguez, Alejandro; Akhtar, Yasir; Panaich, Sidakpal; Lugo-Fagundo, Nahyr; Yucel, Evin; Hodge, David O; Rosenfield, Kenneth; Baddour, Larry; Sorajja, Paul; Moriarty, John; Parikh, Sahil A; Sethi, Sanjum S
BACKGROUND:Catheter-based percutaneous mechanical aspiration (PMA) is an emerging acute intervention for debulking infective vegetations in right-sided infective endocarditis (RSIE); however, its outcomes and safety remain undefined. OBJECTIVES/OBJECTIVE:The authors sought to assess early clinical outcomes and safety of PMA in patients with RSIE. METHODS:The CLEAR-IE (Cardiac Lesion Extraction and Aspiration Registry for Infective Endocarditis) is a large multicenter retrospective registry of consecutive patients with RSIE who have undergone PMA. Procedural success was defined as a ≥70% reduction in site-reported vegetation size or a residual size ≤1 cm on intraprocedural echocardiography, which included transesophageal echocardiography (TEE), intracardiac echocardiography (ICE), and transthoracic echocardiography (TTE), selected at the operator's discretion to guide the intervention. The primary endpoint was a composite of in-hospital mortality, new pulmonary embolism (PE), or emergency surgery. Secondary endpoints included each component of the primary endpoint and in-hospital worsening tricuspid regurgitation (TR). RESULTS:Between January 2014 and January 2024, 256 patients from 19 institutions were included. Median age was 43 years; 43% were women, and 51% had history of injection drug use. Acute PE (50.8%) and shock (27%) were frequent at presentation. Tricuspid valve involvement was present in 70%, with a median site-reported vegetation size of 2.4 cm (Q1-Q3: 0.6-9 cm). Severe TR was noted in 31.3% at baseline. Staphylococcus aureus was the predominant pathogen (73.8%). Procedural success was achieved in 89.4%, with a median residual vegetation size of 0.7 cm (Q1-Q3: 0.2-1.1 cm). Overall, 86.9% completed the procedure free from procedure-related complications. The primary endpoint occurred in 18% (mortality: 9.8%; new PE: 8.3%; emergency surgery: 3.1%). Among those without baseline severe TR, worsening TR occurred in 16.9%. On univariate analysis, shock (OR: 2.27; 95% CI: 1.15-4.43; P = 0.03) and hypoxia (OR: 3.62; 95% CI: 1.83-7.17; P < 0.001) were significantly associated with the primary endpoint, whereas worsening TR was not. On multivariate analysis, hypoxia (OR: 2.76; 95% CI: 1.34-5.73; P = 0.006) remained significantly associated with the primary outcome. CONCLUSIONS:PMA of RSIE is feasible with high procedural success. Adverse events were acceptable and largely driven by underlying RSIE. Randomized trials are warranted to confirm the clinical impact and safety of PMA in RSIE.
PMID: 40864007
ISSN: 1558-3597
CID: 5910202

Prospective Multicenter IDE Study of the Next-Generation Precision Aspiration Thrombectomy System for Intermediate-Risk Pulmonary Embolism: The SYMPHONY-PE Trial

Bangalore, Sripal; Tomalty, R Dana; Kado, Herman; Sayfo, Sameh; Raskin, Adam; Qamar, Arman; Vargas Estrada, Andres; Garcia-Reyes, Kirema; Lipshutz, H Gabriel; Yallapragada, Srinivas; Butty, Sabah; Gandhi, Sagar; Dexter, David; Trivax, Justin; Ali, Farhan; Knox, Michael; Ramos, Christopher; Al-Saghir, Youssef; Bishay, Vivian
BACKGROUND/UNASSIGNED:Mechanical thrombectomy offers a promising alternative to thrombolytic-based approaches for reducing thrombus burden and right heart strain in acute pulmonary embolism. This pivotal Food and Drug Administration-approval trial evaluated the safety and efficacy of the Symphony Thrombectomy System (Imperative Care, Inc, Campbell, CA) in acute intermediate-risk pulmonary embolism. METHODS/UNASSIGNED:Patients with intermediate-risk pulmonary embolism (systolic blood pressure ≥90 mm Hg; right ventricle-to-left ventricle ratio >0.9) were enrolled without roll-ins. The primary safety end point was the rate of major adverse events within 48 hours, defined as a composite of all-cause major bleeding, device-related mortality, and serious device-related events, adjudicated by an academic independent safety board. The primary efficacy end point was the core laboratory-assessed mean change in right ventricle-to-left ventricle ratio from baseline to 48 hours. Prespecified performance goals were set for both. Exploratory end points included immediate postprocedure change in mean pulmonary artery pressure and change in modified Miller index at 48 hours. Safety was assessed in the intention-to-treat cohort and efficacy in the modified intention-to-treat cohort, excluding patients receiving nonstudy device treatments. RESULTS/UNASSIGNED:<0.001. CONCLUSIONS/UNASSIGNED:These data support the safety and effectiveness of the Symphony Thrombectomy System in patients with acute intermediate-risk pulmonary embolism. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT06062329.
PMID: 40961960
ISSN: 1941-7632
CID: 5935282

Current Concepts in Revascularization for Ischemic Heart Disease With Reduced Ejection Fraction

Mosarla, Ramya C; Hochman, Judith S; Axel, Leon; Ramasamy, Ravichandran; Katz, Stuart D; Bangalore, Sripal
Ischemic heart disease is the leading cause of heart failure with reduced ejection fraction in the developed world. An evolution of background medical therapy over the past decade has spurred improvement in symptoms and a reduction in morbidity and mortality with ischemic cardiomyopathy. However, there is still ongoing debate about the role and impact of revascularization. Much of the societal guidance regarding revascularization with coronary artery bypass grafting in ischemic cardiomyopathy comes from the STICH trial (Surgical Treatment for Ischemic Heart Failure) which predates improvements in medical therapy. More recently, the REVIVED-BCIS2 trial (Revascularization for Ischemic Ventricular Dysfunction-British Cardiovascular Intervention Society) failed to show a benefit of percutaneous coronary intervention on heart failure hospitalization and mortality in ischemic cardiomyopathy over contemporary medical therapy alone. Yet, there are outstanding questions regarding the role and modality of revascularization required to improve outcomes. We review current data and future directions in the management of ischemic cardiomyopathy and the potential role of revascularization.
PMID: 40948139
ISSN: 1941-7632
CID: 5934832

Anticoagulation alone versus large-bore mechanical thrombectomy in acute intermediate-risk pulmonary embolism

Zhang, Robert S; Yuriditsky, Eugene; Zhang, Peter; Truong, Hannah P; Xia, Yuhe; Maqsood, Muhammad H; Greco, Allison A; Mukherjee, Vikramjit; Postelnicu, Radu; Amoroso, Nancy E; Maldonado, Thomas S; Alviar, Carlos L; Horowitz, James M; Bangalore, Sripal
BACKGROUND: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. METHODS: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. RESULTS: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). CONCLUSION/CONCLUSIONS: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.
PMID: 40234154
ISSN: 1878-0938
CID: 5827832