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Restrictive vs Liberal Transfusion Strategy After Myocardial Infarction: A Post Hoc Analysis of the MINT Randomized Clinical Trial
Bertolet, Marnie; Carrier, Francois Martin; Glynn, Simone; Abbott, J Dawn; Defilippis, Andrew P; Simon, Tabassome; Fordyce, Christopher B; Senaratne, Janek; Potter, Brian J; Herbert, Brandon M; Rao, Sunil V; Caixeta, Adriano; Tessalee, Meechai; Cooper, Howard A; Beraldo de Andrade, Pedro; Dall'Orto, Frederico Toledo Campo; Silvain, Johanne; Carson, Jeffrey L; Brooks, Maria Mori; ,
IMPORTANCE/UNASSIGNED:The decision to transfuse a patient with myocardial infarction (MI) and anemia at a higher vs lower hemoglobin threshold must consider the potential benefit of reduced risk of 30-day death or MI and the potential risk of heart failure. OBJECTIVES/UNASSIGNED:To estimate bayesian posterior risk differences and posterior probabilities that a liberal vs restrictive transfusion strategy is associated with reduced risk of 30-day death or MI and whether the probabilities exceed predefined thresholds. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:The Myocardial Ischemia and Transfusion (MINT) trial recruited adults from April 26, 2017, to April 14, 2023, who were hospitalized with MI and anemia at 144 sites in 6 countries. Statistical analysis was performed from July 31, 2024, to February 18, 2026. INTERVENTION/UNASSIGNED:The MINT trial randomized participants to a restrictive (transfuse if hemoglobin is <7 to 8 g/dL) or liberal (maintain hemoglobin at >10 g/dL) transfusion strategy. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Bayesian posterior risk differences were estimated for 30-day death or MI and for heart failure using 3 prior beliefs regarding the treatment strategies: noninformative, liberal strategy superiority, or restrictive strategy superiority. RESULTS/UNASSIGNED:The mean (SD) age of the 3504 participants was 72.1 (11.6) years and 1911 (54.5%) were men. Compared with the restrictive strategy, the risk of 30-day death or MI with the liberal strategy was 1.4% (95% credible interval, -0.8% to 3.5%) to 2.4% (95% credible interval, 0.3%-4.6%) lower, depending on prior beliefs. The probability that the liberal strategy was associated with a lower risk of 30-day death or MI ranged from 89.1% to 98.8%, and the probability that a liberal strategy was associated with at least 1 less death or MI per 100 treated was between 62.7% and 90.4%. Conversely, the risk of heart failure with the liberal strategy was 0.2% (95% credible interval, -1.6% to 1.2%) to 0.6% (95% credible interval, -2.0% to 0.8%) higher compared with the restrictive strategy, depending on prior beliefs. The probability that the liberal strategy was associated with a higher risk of heart failure ranged from 60.6% to 80.0%, and the probability that a liberal strategy was associated with at least 1 more heart failure event per 100 treated was between 13.3% and 29.3%. CONCLUSIONS AND RELEVANCE/UNASSIGNED:This post hoc analysis of a randomized clinical trial of patients with MI and anemia suggests that a liberal transfusion strategy was associated with a lower risk of 30-day death or MI, outweighing the increased risk of heart failure. Consistent with guideline recommendations and according to patients' values and clinician risk assessment, a liberal transfusion strategy may be reasonable. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT02981407.
PMCID:13409005
PMID: 42507445
ISSN: 2574-3805
CID: 6070390
SCAI/ASE/HRS/SIR/SVS Expert Consensus Statement on Enhanced Radiation Protection: Time for Mandatory and Urgent Action
Rizik, David G; Sutton, Nadia R; Lansky, Alexandra J; Alasnag, Mirvat; Bartal, Gabriel; Brady, Mary Beth; Coylewright, Megan; Goldstein, James A; Firestone, Scott M; Goldsweig, Andrew M; Kereiakes, Dean J; Kirkwood, Melissa; Madder, Ryan D; Mehran, Roxana; Nicholson, William J; Paulo, Graciano; Rao, Sunil V; Rosenfield, Kenneth; Schultz, Cheryl C; Tamirisa, Kamala P; Tuozzo, Kristin A; Velagapudi, Poonam; Vora, Amit N; Yong, Celina M; Hermiller, James B
Health care professionals in fluoroscopic laboratories face significant occupational hazards, including cancer, cataracts, and reproductive concerns due to prolonged exposure to iodizing radiation, and orthopedic injuries stemming from long-term use of heavy aprons as protection from radiation. Despite substantial advancements in radiation protection technology, adoption of these advancements has been slow, hindered by the high upfront costs of implementation and the lag in revising institutional and regulatory radiation exposure thresholds to reflect the capabilities of contemporary enhanced radiation protection devices (ERPDs). This multisociety statement, endorsed by the Society for Cardiovascular Angiography & Interventions, American College of Cardiology, the American Society of Echocardiography, the Heart Rhythm Society, the Society of Interventional Radiology, and the Society for Vascular Surgery, calls for mandatory implementation of ERPDs to meet as low as reasonably achievable standards. This expert consensus statement outlines the ethical and legal responsibilities of government, fluoroscopy laboratory manufacturers, and health care institutions to protect all health care professionals from avoidable workplace hazards and the urgent need to implement ERPDs. The document does not promote or recommend any single ERPD system, and the choice of protection technology is left to department preference. It also addresses the importance of training, monitoring, and continuous research to optimize radiation safety practices. The document advocates for updated regulations and standardized practices across states to ensure comprehensive protection for all fluoroscopy laboratory personnel.
PMID: 42446441
ISSN: 1876-7605
CID: 6066672
Aspirin Withdrawal in Patients With Coronary Artery Disease
Galli, Mattia; Capodanno, Davide; Berg, Jurrien Ten; Cavallari, Larisa H; Rao, Sunil V; Lemos, Pedro A; Valgimigli, Marco; Gaudino, Mario; Kastrati, Adnan; Steg, P Gabriel; Lopes, Renato D; Gibson, C Michael; Mehran, Roxana; Angiolillo, Dominick J
In patients with coronary artery disease (CAD), aspirin has long represented the cornerstone of antiplatelet therapy for secondary prevention. In patients with an acute coronary syndrome (ACS) and undergoing percutaneous coronary intervention (PCI), oral P2Y12 inhibitors have traditionally been used as adjuncts to aspirin, a strategy known as dual antiplatelet therapy (DAPT). Although DAPT reduces the risk of ischemic recurrences, it carries a risk of bleeding. In CAD patients with a concomitant indication for oral anticoagulation (OAC)-who account for approximately 15% of patients--the combination of aspirin and OAC is associated with an increased risk of bleeding without ischemic benefit. The adverse impact of bleeding on prognosis has prompted investigations aimed at identifying antithrombotic treatment regimens associated with reduced bleeding without compromised ischemic protection. Among these, a strategy of aspirin withdrawal after a brief period of combination therapy has emerged as an attractive option. The efficacy and safety of aspirin withdrawal, however, vary substantially according to clinical setting, patient profile (eg, age, sex, ethnicity, genetic background, and comorbidities), timing of discontinuation after ACS or PCI, and alternative adjunctive antithrombotic therapy, including use of OAC and choice of P2Y12 inhibitor. After reviewing the pharmacologic rationale for aspirin withdrawal, the clinical trial evidence, and guideline recommendations, we provide practical considerations for the implementation of this strategy in patients with CAD, with and without an indication to be on OAC.
PMID: 42455105
ISSN: 1558-3597
CID: 6066872
SCAI/ASE/HRS/SIR/SVS Expert Consensus Statement on Enhanced Radiation Protection: Time for Mandatory and Urgent Action
Rizik, David G; Sutton, Nadia R; Lansky, Alexandra J; Alasnag, Mirvat; Bartal, Gabriel; Brady, Mary Beth; Coylewright, Megan; Goldstein, James A; Firestone, Scott M; Goldsweig, Andrew M; Kereiakes, Dean J; Kirkwood, Melissa; Madder, Ryan D; Mehran, Roxana; Nicholson, William J; Paulo, Graciano; Rao, Sunil V; Rosenfield, Kenneth; Schultz, Cheryl C; Tamirisa, Kamala P; Tuozzo, Kristin A; Velagapudi, Poonam; Vora, Amit N; Yong, Celina M; Hermiller, James B
Health care professionals in fluoroscopic laboratories face significant occupational hazards, including cancer, cataracts, and reproductive concerns due to prolonged exposure to iodizing radiation, and orthopedic injuries stemming from long-term use of heavy aprons as protection from radiation. Despite substantial advancements in radiation protection technology, adoption of these advancements has been slow, hindered by the high upfront costs of implementation and the lag in revising institutional and regulatory radiation exposure thresholds to reflect the capabilities of contemporary enhanced radiation protection devices (ERPDs). This multisociety statement, endorsed by the Society for Cardiovascular Angiography & Interventions, American College of Cardiology, the American Society of Echocardiography, the Heart Rhythm Society, the Society of Interventional Radiology, and the Society for Vascular Surgery, calls for mandatory implementation of ERPDs to meet as low as reasonably achievable standards. This expert consensus statement outlines the ethical and legal responsibilities of government, fluoroscopy laboratory manufacturers, and health care institutions to protect all health care professionals from avoidable workplace hazards and the urgent need to implement ERPDs. The document does not promote or recommend any single ERPD system, and the choice of protection technology is left to department preference. It also addresses the importance of training, monitoring, and continuous research to optimize radiation safety practices. The document advocates for updated regulations and standardized practices across states to ensure comprehensive protection for all fluoroscopy laboratory personnel.
PMID: 42446437
ISSN: 1535-7732
CID: 6066662
Efficacy and Safety of Prasugrel, Ticagrelor, or Clopidogrel After Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis
Maqsood, M Haisum; Feit, Frederick; Kaul, Upendra; Rao, Sunil V; Giacoppo, Daniele; Kastrati, Adnan; Bangalore, Sripal
IMPORTANCE:The relative efficacy and safety of oral P2Y purinergic receptor 12 (P2Y12) inhibitors (clopidogrel, ticagrelor, or prasugrel) after percutaneous coronary intervention (PCI) are not well defined. OBJECTIVE:To assess the efficacy and safety of oral P2Y12 inhibitors in patients who underwent PCI. DATA SOURCES AND STUDY SELECTION:PubMed and Embase were searched until November 15, 2025, for randomized clinical trials comparing at least 2 of the 3 agents. DATA EXTRACTION AND SYNTHESIS:Data were abstracted by 2 independent authors according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines. Random-effects odds ratios (ORs) and 95% confidence intervals were calculated. Data were analyzed in December 2025. MAIN OUTCOMES AND MEASURES:The primary efficacy outcome was major adverse cardiovascular events (MACE), while the primary safety outcome was major bleeding. The primary analysis compared prasugrel and ticagrelor in reference to clopidogrel using a mixed treatment comparison meta-analysis. RESULTS:Data were analyzed from 15 randomized clinical trials that included 48 904 patients (mean [SD] age, 63.2 [4.21] years; 13 330 female patients [27.3%]). Compared with clopidogrel, there was a lower risk of MACE (OR, 0.80; 95% CI, 0.69-0.93) driven by lower myocardial infarction (OR, 0.71; 95% CI, 0.62-0.82) and stent thrombosis (OR, 0.48; 95% CI, 0.37-0.62) with prasugrel. MACE was not reduced with ticagrelor compared with clopidogrel, although there was lower stent thrombosis (OR, 0.73; 95% CI, 0.59-0.91). Furthermore, there was lower risk of MACE with prasugrel compared to ticagrelor (OR, 0.83; 95% CI, 0.70-0.98) driven by lower myocardial infarction (OR, 0.78; 95% CI, 0.65-0.94) and stent thrombosis (OR, 0.66; 95% CI, 0.49-0.88). There was a higher risk of major bleeding with ticagrelor vs clopidogrel (OR, 1.24; 95% CI, 1.01-1.52) driven by higher intracranial hemorrhage (OR, 1.89; 95% CI, 1.08-3.33). Prasugrel ranked first, followed by ticagrelor and clopidogrel, for MACE, myocardial infarction, and stent thrombosis. CONCLUSIONS AND RELEVANCE:In this systematic review and meta-analysis of 15 randomized clinical trials in patients who underwent PCI, prasugrel provided the optimal balance between efficacy and safety compared with ticagrelor and clopidogrel.
PMID: 42201709
ISSN: 2380-6591
CID: 6062712
Incidence and prognostic value of electrocardiographic changes in patients with myocardial injury after elective PCI
LaRaja, Alexander; Chakraborty, Ashish; Talmor, Nina; Graves, Claire; Kozloff, Sam; Major, Vincent J; Shah, Binita; Babaev, Anvar; Razzouk, Louai; Rao, Sunil V; Attubato, Michael; Feit, Frederick; Slater, James; Smilowitz, Nathaniel R
BACKGROUND:Myocardial injury after percutaneous coronary intervention (PCI) is common and associated with adverse outcomes. Contemporary definitions of periprocedural myocardial infarction require biomarker elevation with or without ischemic electrocardiographic (ECG) findings. However, the incremental prognostic value of ECG beyond biomarker-defined injury alone remains uncertain. OBJECTIVES/OBJECTIVE:To determine the incidence and independent prognostic value of ischemic ECG changes after elective PCI. METHODS:Consecutive adults age ≥ 18 years undergoing elective PCI at NYU Langone Health between 2011 and 2020 were included. Creatine kinase-myocardial band (CKMB) concentrations were measured at 1 and 3 h post-PCI. Among patients with myocardial injury, baseline and post-PCI ECGs (within 24 h) were reviewed to identify development of ischemic ECG changes (ST segment abnormalities, T wave abnormalities, and Q waves). Relationships between ischemic ECG findings and mortality were evaluated in Cox proportional hazards models adjusted for age, sex, and assay-normalized CKMB. RESULTS:Among 10,735 patients, 1741 (16.2%) developed post-PCI myocardial injury. New ischemic ECG changes occurred in 18.4% of patients with myocardial injury and increased stepwise with higher concentrations of CKMB. New T wave abnormalities were most common (11%), followed by ST depressions (4.9%), Q waves (3.0%), and ST elevations (1.5%). Over a median follow-up of 5.3 years, new ischemic ECG changes were not independently associated with increased mortality among patients with myocardial injury (aHR 1.27, 95% CI 0.82-1.96). CONCLUSIONS:Among patients with myocardial injury after elective PCI, new ischemic ECG changes were uncommon and did not confer independent prognostic value for long-term mortality.
PMID: 42399161
ISSN: 1878-0938
CID: 6063822
The Effect of Restrictive vs Liberal Blood Transfusion Strategy on Subsequent Myocardial Infarction Type
DeFilippis, Andrew P; Abbott, J Dawn; Herbert, Brandon M; Bertolet, Marnie H; Chaitman, Bernard R; White, Harvey D; Goldsweig, Andrew M; Polonsky, Tamar S; Gupta, Rajesh; Alsweiler, Caroline; Silvain, Johanne; de Barros E Silva, Pedro G M; Hillis, Graham S; Daneault, Benoit; Tessalee, Meechai; Menegus, Mark A; Rao, Sunil V; Lopes, Renato D; Hébert, Paul C; Alexander, John H; Brooks, Maria M; Carson, Jeffrey L; Goodman, Shaun G; ,
BACKGROUND:Data on the differential impact of interventions on subsequent myocardial infarction (MI) type are limited. OBJECTIVES/OBJECTIVE:This post-hoc analysis was done to evaluate the 30-day rate of subsequent MI by type (ie, type 1 and 2) among patients enrolled in the MINT (Myocardial Ischemia and Transfusion; NCT02981407) trial. METHODS:Subdistribution HRs and cumulative incidences of subsequent MI types were computed using Fine-Gray subdistribution models that accounted for the competing risk of death and other MI types, if applicable. Effect modification of treatment strategy by index MI type was tested using log-binomial regression models. RESULTS:Among 3,504 MINT trial patients, 275 (7.8%) had a 30-day subsequent MI, of which 118 (43%) were type 2 MI, 79 (28%) were uncertain MI type, 40 (15%) were type 4 MI, and 38 (14%) were type 1 MI. The rate of subsequent type 2 MI in patients randomized to the restrictive vs liberal transfusion was 3.5% (n = 61) vs 3.2% (n = 57) (HR: 1.07; 95% CI: 0.74-1.53) as compared with a subsequent type 1 MI rate of 1.3% (n = 23) vs 0.9% (n = 15) (HR: 1.53; 95% CI: 0.80-2.94). CONCLUSIONS:Among patients with MI and anemia, subsequent MI occurred within 30 days in 7.8% of patients, with type 2 MI occurring 3 times more often than type 1 MI. A differential effect of the restrictive vs liberal transfusion strategy on the type of subsequent MI (eg, type 1 vs type 2) was not observed.
PMID: 42312774
ISSN: 2772-963x
CID: 6050142
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