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Impact of Revascularization Completeness on Cardiovascular Outcomes in STEMI With Multivessel Disease

Madanchi, Mehdi; Pinilla-Echeverri, Natalia; Wood, David A; Sheth, Tej; Storey, Robert F; Kunadian, Vijay; Campo, Gianluca; Moreno, Raul; Mehran, Roxana; Rao, Sunil V; Bainey, Kevin R; Cieza, Tomas; Nguyen, Helen; Mani, Thenmozhi; Cairns, John A; Mehta, Shamir R
BACKGROUND/UNASSIGNED:Complete revascularization is superior to culprit lesion-only percutaneous coronary intervention (PCI) in reducing ischemic events in patients with ST-segment-elevation myocardial infarction and multivessel disease. However, the relationship between the extent of revascularization and the benefits of a complete revascularization strategy remains unclear. The aim of this substudy of the COMPLETE trial was to evaluate how the degree of anatomic completeness of revascularization, measured by the core laboratory-derived modified residual SYNTAX score (R'SS), relates to major cardiovascular events. METHODS/UNASSIGNED:We conducted an exploratory post hoc analysis of the COMPLETE trial (n=3738), stratifying patients randomized in the complete revascularization group based on the R'SS assessed after staged nonculprit lesion-PCI. Complete revascularization was defined by an R'SS=0, whereas incomplete revascularization was defined by an R'SS>0. A stratified Cox proportional hazards model was used, with the culprit-only PCI arm designated as the reference group for comparison. The first coprimary outcome was a composite of cardiovascular death or new myocardial infarction. The second coprimary outcome was a composite of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. RESULTS/UNASSIGNED:Among patients randomized to a complete revascularization strategy, 90% achieved complete revascularization (R'SS=0), whereas 10% did not (R'SS>0). In patients with R'SS=0, the first coprimary outcome occurred less frequently (6.6%) compared with those randomized to the culprit lesion-only PCI strategy (10.7%; adjusted hazard ratio, 0.61 [95% CI, 0.47-0.78]). Among patients with an R'SS>0, the first coprimary outcome was similar (10.7%) to those in the culprit lesion-only PCI group (10.7%; adjusted hazard ratio, 1.01 [95% CI, 0.61-1.67]). A similar result was observed for the second coprimary outcome. CONCLUSIONS/UNASSIGNED:This exploratory analysis of the COMPLETE trial suggests that the benefit of a complete revascularization strategy in patients with ST-segment-elevation myocardial infarction and multivessel disease may be related to the extent of anatomic completeness of revascularization. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01740479.
PMID: 42233186
ISSN: 1941-7632
CID: 6043982

Association Between Hospital Ownership Type and ST-Segment Elevation Myocardial Infarction Outcomes: Insights from the National Readmission Database, 2016-2022

Liu, Olivia C; Billings, John; Katz, Jason N; Rao, Sunil V; Alviar, Carlos; Bangalore, Sripal; Leiva, Orly
BACKGROUND:Hospital ownership type may influence acute cardiovascular disease disparities that persist across the U.S. We examined associations between hospital ownership type and in-hospital and readmission outcomes for STEMI hospitalizations. METHODS:We performed a retrospective cohort study of hospitalizations for STEMI using the National Readmissions Database (2016-2022). Hospitals were categorized as nonprofit, for-profit, or public. Outcomes included in-hospital mortality and 90-day readmission for acute coronary syndrome, heart failure, cardiovascular, and all causes. Associations were assessed using multivariable logistic and Cox proportional hazards regression, adjusting for patient, hospitalization, and hospital-level characteristics. RESULTS:Of 610,427 STEMI hospitalizations, 460,451 (75.4%) were at nonprofit, 88,965 (14.6%) at for-profit, and 61,011 (10.0%) at public hospitals. Compared with nonprofit hospitals, for-profit hospitals (aOR 1.09, 95% CI 1.05-1.13) and public hospitals (aOR 1.17, 95% CI 1.12-1.22) were each associated with higher odds of in-hospital mortality. For-profit hospitals were associated with higher risk of 90-day readmission for acute coronary syndrome (aHR 1.15, 95% CI 1.10-1.21), heart failure (aHR 1.08, 95% CI 1.03-1.13), cardiovascular (aHR 1.08, 95% CI 1.05-1.12), and all causes (aHR 1.13, 95% CI 1.10-1.16) relative to nonprofit hospitals. Public hospitals were associated with higher risk of 90-day readmission for heart failure (aHR 1.08, 95% CI 1.02-1.13) relative to nonprofit hospitals. CONCLUSIONS:For-profit and public hospitals were associated with higher in-hospital mortality and 90-day readmission for various causes compared with nonprofit hospitals. These findings suggest that hospital-level factors may contribute to disparities in STEMI outcomes and warrant further investigation.
PMID: 42034270
ISSN: 1097-6744
CID: 6033342

Design and Rationale of the Radial Access Insertion Sheath Evaluation via the Electronic Medical Record (RAISE-EMR) Study

Shah, Binita; Lerner, Johanna; Martin, Jacob; Patrick Crane, B; Andrade, Orwell; Li, Xiyue; Xia, Yuhe; Yu, Chang; Testa, Paul A; Rao, Sunil V; ,
BACKGROUND:Decisions involving the purchase of procedural equipment at the health system level require balancing efficacy, safety, physician preference, and cost. The application of efficient and low-cost pragmatic study designs has the potential to rapidly generate data to inform health system operations. METHODS:The aim of the pragmatic RAISE-EMR study is to determine physician preference between two commercially available radial artery introducer sheaths, one of which has a higher acquisition cost, to guide inventory selection in the hospital system's catheterization laboratories. Patients undergoing coronary angiography using 6-French radial artery access were prospectively identified and randomized through the health system's electronic medical record (EMR). Among 1696 eligible unique patients, 554 patients (32.7%) were randomized over 37 days across three hospitals. Randomization took place through the EMR after the attending interventional cardiologist signed a mandated pre-procedure note. The study was deemed non-human subject research and approved by the NYU Langone Health Quality Improvement Oversight Committee. The primary endpoint, a physician satisfaction score, will be ascertained by a mandated semi-quantitative survey within the electronic procedure note. All data, including co-variables and clinical outcomes, will be ascertained using structured data within the EMR. CONCLUSIONS:The RAISE-EMR study is designed to determine physician preference of two commercially available radial artery introducer sheaths and potentially reduce supply costs using an entirely EMR-based randomized study design. Pragmatic study designs leveraging structured data within an EMR can be used to rapidly provide data to inform operational decision-making and have implications for the future of evidence generation.
PMID: 42106091
ISSN: 1097-6744
CID: 6031762

Predictive Utility of EROA/LVEDV Ratio in Mitraclip Outcomes: Retrospective Multicenter Cohort Study

Varughese, Vivek Joseph; Richardson, Chandler; Pollock, James; Czyzewski, Patryk; Lyons, Ashley; Mujadzic, Hata; Hurley, Deborah M; Cryer, Michael; Rao, Sunil V; Kumar, Akshay
PMCID:13117757
PMID: 42075666
ISSN: 1648-9144
CID: 6030782

Contemporary Trends, Characteristics, and Outcomes of Patients Undergoing Percutaneous Coronary Intervention for Stent Thrombosis

Elbadawi, Ayman; Chen, Angel; Wojdyla, Daniel; Kaltenbach, Lisa A; Abdelazeem, Mohamed; Shah, Binita; Gilchrist, Ian C; Brilakis, Emmanouil S; Rao, Sunil V; Swaminathan, Rajesh V; Elgendy, Islam Y
BACKGROUND:inhibitors, newer generation drug-eluting stents, and intracoronary imaging. OBJECTIVES/OBJECTIVE:The aim of this study was to examine the trends, characteristics, and outcomes of patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) for ST in the United States. METHODS:Patients undergoing PCI for AMI between April 2018 and June 2023 were identified from the National Cardiovascular Data Registry CathPCI registry. The rates of PCI for ST were evaluated over time using linear regression. In-hospital outcomes of PCI for ST vs no ST were compared using multivariable logistic regression. RESULTS:Among 2,023,032 patients undergoing PCI for AMI, 57,268 (2.8%) procedures were for ST. The timing of ST was early (18,189 of 55,351 [31.8%]), late (8,825 of 55,351 [15.4%]), very late (28,337 of 55,351 [49.5%]), or unknown (1,917 of 55,351 [3.4%]). There was no temporal change in the frequency of PCI for ST during the study period. PCI for ST was associated with a higher incidence of major adverse cardiac events (adjusted OR [aOR]: 1.24; 95% CI: 1.19-1.29), all-cause mortality (aOR: 1.17; 95% CI: 1.12-1.22), recurrent myocardial infarction (aOR: 1.80; 95% CI: 1.63-1.98), and major bleeding (aOR: 1.18; 95% CI: 1.15-1.22) compared with PCI for non-ST. CONCLUSIONS:In this contemporary, nationwide, real-world analysis, there was no temporal change in the frequency of PCI for ST. Most STs were early or very late. PCI for ST was associated with a higher rate of in-hospital adverse outcomes.
PMID: 41813273
ISSN: 1876-7605
CID: 6015672

Choosing Between CABG and PCI for 3-Vessel Coronary Disease: What's Cost Got to Do With It? [Editorial]

Mark, Daniel B; Rao, Sunil V
PMID: 41670563
ISSN: 1558-3597
CID: 6002182

The Role of Intra-aortic Balloon Pump Therapy at Resource-Limited Institutions: A Bridge to Care Escalation

Patil, Ricky; Chuang, Eric; Cheema, Fareed; Rao, Sunil V; Vaynblat, Mikhail
Despite providing relatively modest circulatory support, the intra-aortic balloon pump (IABP) remains the most utilized mechanical support device. IABP therapy specifically provides utility in transferring critically ill patients from resource-limited hospital settings. In a single-center series, 71 patients who received IABP were identified from 2018 to 2023. In this group, 66 (93%) patients presented with acute myocardial infarction (AMI), of which 40 (61%) patients presented with STEMI. Sixty-three (89%) patients presented in cardiogenic shock. In total, 15 (21%) patients died during their hospital stay. In-hospital death was found to be associated with higher age (p < 0.001), female sex (p = 0.004), and chronic heart failure (p = 0.009). Serologic markers of end-organ perfusion, such as lactate, creatinine, and hepatic enzymes, were associated with increased mortality risk. Thirty (41%) patients were successfully transferred to a hub institution for care escalation, including 17 (57%) patients receiving cardiac surgery, five (17%) receiving advanced PCI, and 12 (40%) receiving more robust mechanical support. Therefore, in the real-world setting, IABP therapy provides an accessible form of circulatory support at resource-limited institutions, especially when patient transfer is required within a larger hospital system.
PMCID:12874184
PMID: 41658851
ISSN: 2168-8184
CID: 6001612

Radiation Safety in Chronic Total Occlusion Percutaneous Coronary Intervention

Devkota, Lorna; Razzouk, Louai; Rao, Sunil V
Chronic total occlusion percutaneous coronary intervention (CTO-PCI) is a complex, high-radiation procedure that requires careful radiation management to protect both patients and health care providers. This review outlines the biological risks of radiation exposure, differentiating deterministic and stochastic effects, and highlights key safety thresholds and regulatory guidelines. It presents a range of mitigation strategies across procedural phases, including advanced shielding systems, low-dose imaging platforms, and real-time monitoring tools. Institutional protocols and a culture of shared accountability are emphasized to support the ALARA principle. Emerging technologies offer promising solutions to reduce operator exposure and improve safety outcomes in modern CTO-PCI practice.
PMID: 41276395
ISSN: 2211-7466
CID: 5967742

Radial vs femoral access for percutaneous coronary intervention: temporal trends and outcomes in the USA

Fazel, Reza; Rao, Sunil V; Cohen, David J; Secemsky, Eric A; Swaminathan, Rajesh V; Manandhar, Pratik; Rymer, Jennifer A; Wojdyla, Daniel M; Yeh, Robert W
BACKGROUND AND AIMS/OBJECTIVE:Radial access site for percutaneous coronary intervention (PCI) is recommended by clinical practice guidelines because of superior outcomes compared with femoral access site. Historically, the adoption of radial access site in the USA has lagged behind much of the rest of the world, but contemporary data on access site selection across the spectrum of clinical presentations and its association with outcomes are lacking. METHODS:A retrospective cohort study from the National Cardiovascular Data Registry's CathPCI Registry was conducted including PCIs performed between 1 January 2013 and 30 June 2022. The comparative safety of radial vs femoral access site for PCI was evaluated with instrumental variable analysis, a technique that can be used to support causal inference, exploiting operator variation in access site preferences as the instrumental variable. RESULTS:Overall, 6 658 479 PCI procedures were performed during the study period, of which 40.4% (n = 2 690 355) were performed via radial access site, increasing from 20.3% in 2013 to 57.5% in 2022. This increase was seen in all geographic regions and across the full spectrum of presentations, with the largest relative increase seen in patients with ST-elevation myocardial infarction. Overall, 2 420 805 PCIs met inclusion criteria for the comparative safety analysis. In instrumental variable analyses, radial access site was associated with lower in-hospital mortality [absolute risk difference (ARD) -.15%, 95% confidence interval (CI) -.20 to -.10], major access site bleeding (ARD -.64%, 95% CI -.68 to -.60), and other major vascular complications (ARD -.21%, 95% CI -.23 to -.18) but a higher risk of ischaemic stroke (ARD .05%, 95% CI .03-.08). There was no association with the falsification endpoint of gastrointestinal or genitourinary bleeding (ARD .00%, 95% CI -.03-.03). CONCLUSIONS:Over the past decade, use of radial access site for PCI has increased 2.8-fold in the USA and now represents the dominant form of access site across all procedural indications. Based on instrumental variable analyses, PCI with radial access site had lower rates of in-hospital mortality, major access site bleeding, and other major vascular complications compared with femoral access site but a slightly higher risk of ischaemic stroke in contemporary practice.
PMID: 40614078
ISSN: 1522-9645
CID: 5888512

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