BACKGROUND: Dual therapy with sodium-glucose co-transporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) is frequently recommended. We compared rates of medication initiation and disconti...BACKGROUND: Dual therapy with sodium-glucose co-transporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) is frequently recommended. We compared rates of medication initiation and discontinuation between participants assigned to treatment with a single medication class or dual therapy in the feasibility phase of the PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes (PRECIDENTD) pragmatic trial. METHODS: PRECIDENTD randomly assigned participants with type 2 diabetes (T2D) and ASCVD or high ASCVD risk to fill prescriptions for SGLT2i, GLP-1RA, or dual therapy (1:1:1) using their own insurance. Analyses compared medication fill and discontinuation rates of assigned medication(s), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical and Mental Health Scores, and Modified Kansas City Cardiomyopathy Questionnaire (mKCCQ)-12 between the combined monotherapy (SGLT2i or GLP-1RA) and dual therapy (SGLT2i and GLP-1RA) groups. RESULTS: This report includes 173 insured participants [median age 67 years (IQR 62, 72), 46% female, 35% non-White, 67% with ASCVD]; 113 assigned to monotherapy and 60 to dual therapy. Monotherapy vs dual therapy fill rates were 84% vs 53% (P < .001) 4 months after randomization and 87% vs 68% overall (P = .004) during 10-month median follow-up. Of those who filled medication, 22% in monotherapy and 49% in dual therapy discontinued a study medication (P = .002), mostly due to side effects. PROMIS and mKCCQ-12 scores showed no change. CONCLUSIONS: Despite efforts to facilitate medication uptake in the feasibility phase of the PRECIDENTD pragmatic trial, barriers to initiation and ongoing use challenge the use of combination SGLT2i and GLP-1RA in T2D. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05390892, https://clinicaltrials.gov/study/NCT05390892.
BACKGROUND: Catheter-directed therapies are increasingly used to treat acute pulmonary embolism (PE). However, randomized data on reperfusion treatments, including large-bore mechanical thrombectomy (LBMT), for patients...BACKGROUND: Catheter-directed therapies are increasingly used to treat acute pulmonary embolism (PE). However, randomized data on reperfusion treatments, including large-bore mechanical thrombectomy (LBMT), for patients with High-Risk PE are lacking. METHODS: PERSEVERE (NCT06588634) is a multinational randomized controlled trial comparing the FlowTriever LBMT system vs. standard of care (SoC) in patients with High-Risk PE, with the modified intention-to-treat population planned for 200 patients from 40 sites in Europe and the US. Patients are randomized 1:1 to LBMT or SoC (systemic thrombolysis [ST], surgical embolectomy, extracorporeal membrane oxygenation [ECMO], or anticoagulation alone). Key inclusion criteria are the presence of proximal pulmonary thrombus on computed tomography plus ≥1 of the following: (1) systolic hypotension or need for vasopressors, (2) venous lactate ≥4 mmol/L with clinical signs suggesting obstructive shock, (3) need for mechanical circulatory support, (4) resuscitated cardiac arrest. Exclusion criteria include known chronic thromboembolic pulmonary hypertension and key absolute contraindications to ST. Patients are followed for 3 months. The primary endpoint is a composite of events through hospital discharge or 7 days post randomization, whichever occurs first: (1) all-cause death, (2) cardiac arrest requiring cardiopulmonary resuscitation, (3) bailout to rescue treatment, (4) major bleeding, and (5) ECMO in place on day 7. Secondary endpoints include a broad spectrum of functional and patient-reported outcomes (quality of life, functional status and healthcare resource utilization) at 3 months. The trial is funded by Inari. CONCLUSION: The PERSEVERE study will assess the potential superiority of LBMT over SoC for the treatment of High-Risk PE. CLINICALTRIALS: gov Identifier: NCT06588634.
d'Entremont MA, Lee SF, Wijeysundera HC
… +12 more, Tsang MB, Amlani S, Wassef A, Lavi S, So DYF, Betz J, Tyrwhitt J, Graham J, Cantor WJ, Bagherli A, Vijayaraghavan R, Jolly SS
BACKGROUND: Balancing ischemic versus bleeding complications following percutaneous coronary intervention (PCI) remains challenging. However, the optimal dose of unfractionated heparin (UFH) for elective PCI is currently...BACKGROUND: Balancing ischemic versus bleeding complications following percutaneous coronary intervention (PCI) remains challenging. However, the optimal dose of unfractionated heparin (UFH) for elective PCI is currently unclear. METHODS: A Randomized Trial of Higher versus Lower Dose Heparin for PCI (HD-PCI) is a multicenter, randomized, controlled, registry-based, open-label, cluster crossover trial of a lower-dose (70 units/kg) versus higher-dose (100 units/kg) UFH dosing hospital-level policy for elective PCI conducted in 11 centres in Ontario, Canada. The primary efficacy outcome was defined as a composite of all-cause death, myocardial infarction or target vessel revascularization; the key safety outcome was defined as major bleeding; and the key net benefit outcome was defined as the composite of all-cause death, myocardial infarction, target vessel revascularization or major bleeding. All outcomes were evaluated within 30 days of the index PCI. CONCLUSIONS: HD-PCI is a large cluster randomized crossover trial that will inform the ischemic and bleeding effects of lower-dose (70 units/kg) versus higher-dose (100 units/kg) in patients undergoing elective PCI. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04049591.
BACKGROUND: ST-Segment Elevation Myocardial Infarction (STEMI) is considered the main cause of mortality and morbidity for decades globally. Regularly, cardiology-related medical organizations publish clinical practice g...BACKGROUND: ST-Segment Elevation Myocardial Infarction (STEMI) is considered the main cause of mortality and morbidity for decades globally. Regularly, cardiology-related medical organizations publish clinical practice guidelines (CPGs) to support healthcare professionals in the diagnosis, management, and prevention of future cardiovascular events. Nevertheless, the level of evidence (LOE) and classification of recommendations (CORs) endorsing STEMI-associated CPGs recommendations have not been systematically appraised. PURPOSE: This meta-research study evaluated and described the CORs and LOE over time for STEMI guidelines endorsed by the American Heart Association (AHA), American College of Cardiology (ACC), and European Society of Cardiology (ESC), from 1990 to 2023. DATA SOURCES: We initially searched on PubMed and AHA/ACC/ESC electronic repositories to obtain STEMI-related CPGs, published from 1990 to 2023, including their immediate predecessors. STUDY SELECTION: Guidelines related to acute in-hospital STEMI management were included; recommendations related to unstable angina/Non-STEMI were excluded. DATA EXTRACTION: Data management was performed by 2 content experts. Recommendations on pharmacological and nonpharmacological interventions (PI and NPI, respectively) were extracted ipsilaterally, further processed and coded based on thematic analysis fundamentals. Recommendation's recordings associated with each recommendation were maintained as the primary guideline publication without team's specialist judgement. Pharmacological-related recommendations were categorized in accordance with the Anatomical Therapeutic Chemical Classification System by the WHO Collaborating Centre for Drug Statistics Methodology. Changes in the proportion and LOE were evaluated longitudinally, using chi-square test (x). Data visualization included heatmaps, linear plots, and Sankey diagrams. DATA SYNTHESIS: Twenty-six guidelines (2,139 STEMI-specific recommendations) were evaluated. We observed an overall predominance of recommendations relying on moderate (proportion of 30.1% of LOE-B recommendations) or low (proportion of 28.9% of LOE-C recommendations) quality of evidence over the 33-year span. Only 17.7% of processed recommendations were based on high quality of evidence. Pharmacological interventions were more often LOE-A compared with NPI (21.5% vs 13.8%; P-value < 0.05). Most abstracted PI related to anticoagulants and dual anti-platelet therapies, while the most frequent category of NPI were related to percutaneous coronary interventions and implantable cardiac devices. Two consecutive guidelines comparison revealed that LOE and COR assigned to corresponding recommendation were minimal. LIMITATIONS: Restriction to only AHA/ACC/ESC guidelines and primary focus on acute in-hospital management recommendations. CONCLUSIONS: STEMI-related recommendations from foremost cardiology societies worldwide have largely relied on moderate/low-quality evidence, with slight changes over time. Novel ways to generate high quality evidence in a more pragmatic and efficient fashion are warranted. PRIMARY FUNDING SOURCE: None PROTOCOL REGISTRATION: Open Science Frame under OSF.IO/BRD58.
RATIONALE: Hypertension disproportionately affects populations in low- and middle-income countries (LMICs), especially in Latin America and the Caribbean, due to its high prevalence and low control rate. PRIMARY HYPOTHES...RATIONALE: Hypertension disproportionately affects populations in low- and middle-income countries (LMICs), especially in Latin America and the Caribbean, due to its high prevalence and low control rate. PRIMARY HYPOTHESIS: To close the knowledge-practice gap for blood pressure (BP) control, we are assessing the effectiveness and implementation of a team-based care strategy for BP control in primary care clinics in Colombia and Jamaica. DESIGN: The Caribbean and South American Team-based Strategy to Control Hypertension (CATCH) study is a cluster randomized trial using an effectiveness-implementation hybrid type-2 design. Clinics were randomly assigned to a team-based strategy or a provider-training strategy to implement current hypertension guidelines. The team-based strategy includes healthcare team training, care coordination, task sharing, BP audit and feedback, home BP monitoring, health coaching, single-pill combination therapy, and increased medication access. The primary clinical effectiveness outcome is difference in mean change of systolic BP from baseline to 18 months between randomized groups. The primary implementation outcome is a composite fidelity score to key implementation strategy components. SITES: CATCH is conducted in 40 primary care clinics in Jamaica and Colombia. ENROLLMENT: Between February 2023 and August 2024, we recruited 1,707 participants, exceeding our planned enrollment. The planned sample size of 1,680 (42 patients per each of 40 clinics) has 90% statistical power to detect a 6.0 mm Hg difference in mean systolic BP change assuming 85% follow-up and a 2-sided significance level of 0.05. CURRENT STATUS: In follow-up CONCLUSIONS: CATCH will provide evidence on effectiveness and implementation of a team-based care strategy to improve hypertension control in real-world, primary care settings. If proven effective, this approach can be scaled up in primary care throughout low- and middle-income countries (LMICs). CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT05405920 https://clinicaltrials.gov/study/ NCT05405920.
de Ferranti SD, Teng JE, Arslanian SA
… +20 more, Atz AM, Brothers JA, Cartoski MJ, Freemon DR, Magge SN, Mahle WT, Mietus-Snyder M, Peterson A, Raghuveer G, Russell MW, Shah AS, Sponseller CA, Stylianou M, Trachtenberg FL, Urbina EM, Ware AL, Zachariah J, Zadokar VV, McCrindle BW, Pediatric Heart Network Investigators
BACKGROUND: Combined dyslipidemia of obesity (CDO) is a prevalent atherogenic lipid disorder characterized by high TG, low HDL, high non-HDL, and a preponderance of small LDL particles. Lifestyle modification is the main...BACKGROUND: Combined dyslipidemia of obesity (CDO) is a prevalent atherogenic lipid disorder characterized by high TG, low HDL, high non-HDL, and a preponderance of small LDL particles. Lifestyle modification is the mainstay of treatment but is often insufficient; a pharmacologic approach could augment care but has not been rigorously evaluated. METHODS: The dyslipidemia of obesity intervention in teens (DO IT!) Trial was a 2-year randomized controlled double-blind study designed to measure the effect and safety profile of pitavastatin calcium vs placebo on vascular measures of early atherosclerosis, and standard and advanced lipid profiles in children and adolescents with CDO. We present the rationale, design, and study procedures, and share challenges, responses, and lessons learned. RESULTS: Participants were recruited from 17 sites; goal 177, with 122 consented (68.9%). Facilitators to recruitment included familiarity of site investigators with CDO management, relationship with local obesity programs, and study incentives. Barriers included 2-year study duration, number of study visits, and COVID-19 pandemic effects. The research team added recruitment sites, expanded eligibility, shared educational and promotional materials, and bolstered site engagement but enrollment was insufficient, and the trial was stopped early. CONCLUSIONS: The DO IT! Trial was the first to evaluate effects of pitavastatin vs placebo on vascular measures, lipid outcomes and potential adverse effects. Recruitment challenges limited the study sample, but findings may still inform cardiovascular prevention. Future studies are more likely to be more successful with early patient-family input, shorter study duration, and fewer study visits integrated with clinical care close to home. CLINICALTRIALS: gov identifier: NCT02956590.
Bolli R, Tang XL, Hare JM
… +13 more, Mitrani RD, Perin EC, Lima JA, Hurwitz BE, Kalra D, Singh G, Saltzman RG, Caceres LV, Nettina A, Lee YS, Bacallao K, Grant E, Khan A
RATIONALE: To date, almost all studies of cell therapy in chronic heart failure (HF) have delivered cells transendocardially or intracoronarily and all have used a single cell dose, which limits therapeutic efficacy beca...RATIONALE: To date, almost all studies of cell therapy in chronic heart failure (HF) have delivered cells transendocardially or intracoronarily and all have used a single cell dose, which limits therapeutic efficacy because transplanted cells disappear rapidly. Repeated administrations are necessary to replace the cells that disappear, but this is difficult or impossible when cells are delivered invasively. Further, transendocardial delivery is not feasible in many patients, carries risks, and requires specialized training and equipment, thereby limiting its widespread applicability. Intravenous infusion of cells is cheaper, simpler, safer, and less invasive; most importantly, it enables administration of multiple cell doses. PRIMARY GOAL: The CATO trial tests a new strategy-repeated intravenous infusions of cells in chronic HF. The goal is to determine whether intravenous cell therapy is beneficial and whether multiple cell doses are superior to a single dose. This trial is the culmination of a translational journey that began more than a decade ago in animal models of HF. DESIGN: CATO is a Phase IIA randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy of intravenous infusion of umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in patients with ischemic HF. Sixty subjects will be randomized to 3 groups: control (placebo), 1 dose of UC-MSCs, or 4 repeated doses of UC-MSCs, with a comprehensive evaluation of cardiac function and structure, functional capacity, quality of life, and biomarkers over 12 months. ENROLLMENT DATES AND CURRENT STATUS: CATO began enrollment on March 4, 2024. As of November 30, 2025, a total of 47 patients have been enrolled. Enrollment is expected to be completed by March 2026, and follow-up by March 2027. SIGNIFICANCE: CATO is the first trial of UC-MSCs for HF in the US, the first study of intravenous cell therapy for ischemic HF in the US, and the first randomized, double-blind, placebo-controlled trial of repeated cell doses for chronic HF. The 2 strategies tested in CATO (intravenous cell delivery and repeated doses) have the potential to be important advances in the management of HF CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT06145035 https://clinicaltrials.gov/study/ NCT06145035.
PURPOSE: In patients admitted with acute coronary syndrome, invasive coronary angiography (ICA) is performed to determine which patients need revascularization. Coronary computed tomography angiography (CCTA) offers a wi...PURPOSE: In patients admitted with acute coronary syndrome, invasive coronary angiography (ICA) is performed to determine which patients need revascularization. Coronary computed tomography angiography (CCTA) offers a widely available, non-invasive alternative that could reduce patient discomfort, procedural risks, and healthcare costs. The current trial aims to determine whether CCTA is noninferior to ICA in determining the interventional strategy for patients admitted with non-ST elevation acute coronary syndrome (NSTE-ACS)(Central Illustration). METHODS: TRACTION (Team-based Interventional Triage in Acute Coronary Syndrome Based on Noninvasive Coronary Computed Tomography Angiography Versus Invasive Coronary Angiography) is a multicenter, randomized, open-label, noninferiority trial enrolling 2,300 patients. Patients hospitalized with non-ST elevation myocardial infarction or unstable angina with ischemic changes on ECG will be randomized 1:1 to CCTA vs ICA (standard of care). In the CCTA group, a Coronary Team reviews the CCTA and clinical information to determine the interventional strategy. The primary composite endpoint is major adverse cardiac events at 1 year, comprised of all-cause mortality, nonfatal myocardial infarction, hospitalization due to refractory angina, or hospitalization due to heart failure. Secondary outcomes include cardiovascular death, revascularization, symptom status, procedure-related adverse events, and resource utilization. The trial is designed to demonstrate noninferiority if the 95% confidence interval excludes an absolute risk difference of the primary endpoint larger than 5%. PERSPECTIVES: If CCTA is shown to be noninferior to ICA in patients admitted with NSTE-ACS, CCTA could become the preferred management in a large group of patients. This could result in fewer patients exposed to invasive procedures and improved resource utilization. CLINICALTRIALS: gov identifier: NCT06101862.
BACKGROUND: Postoperative bleeding is a major concern in cardiac surgery, often leading to significant transfusion requirements. Despite this high transfusion demand, the use of postoperative autologous blood transfusion...BACKGROUND: Postoperative bleeding is a major concern in cardiac surgery, often leading to significant transfusion requirements. Despite this high transfusion demand, the use of postoperative autologous blood transfusion (PABT) remains underexplored. METHODS AND RESULTS: This large-scale, single-blind randomized controlled trial with a 30-day follow-up enrolls patients undergoing elective on- or off-pump coronary artery bypass grafting. Patients with shed mediastinal blood volumes over 500 mL within the first 6 hours postoperatively are randomly assigned 1:1 to either the PABT group or the standard care group. The PABT group receives postoperative autotransfusion and additional allogeneic RBC transfusions if needed, while the standard care group receives allogeneic RBC transfusions only when clinically necessary, without postoperative autotransfusion. The primary efficacy endpoint is the postoperative allogeneic RBC transfusion volume, defined as the cumulative amount transfused from the day of surgery to discharge. Secondary efficacy endpoints include postoperative allogeneic RBC and non-RBC transfusion rates, perioperative hematologic recovery, drainage volume, mechanical ventilation duration, ICU and hospital length of stay. The primary safety endpoint is the incidence of a composite of postoperative infections (pneumonia, bloodstream infections, and surgical site infections). Secondary safety endpoints include a composite of other postoperative complications (renal dysfunction, myocardial infarction, stroke, deep vein thrombosis, and all-cause mortality), individual components of these composites, and 30-day mortality and morbidity. The estimated sample size is 1,232 participants. Patient recruitment is planned from January 2026 to December 2029 and is currently in the preparatory phase. The study is registered at the Chinese Clinical Trial Registry (ChiCTR2500103269, https://www.chictr.org.cn/) and was registered on May 27, 2025. CONCLUSIONS: The study is designed to identify the efficacy and safety of PABT after cardiac surgery. We hypothesize that PABT has superior efficacy and noninferior safety to the standard care.
BACKGROUND: Supersaturated oxygen (SSO₂) therapy is an emerging intervention to minimize myocardial damage and improve outcomes in patients with ST-segment elevation myocardial infarction (STEMI). This meta-analysis eval...BACKGROUND: Supersaturated oxygen (SSO₂) therapy is an emerging intervention to minimize myocardial damage and improve outcomes in patients with ST-segment elevation myocardial infarction (STEMI). This meta-analysis evaluated the efficacy of SSO₂ therapy to reduce infarct size and microvascular obstruction (MVO). METHODS: PubMed, Embase, and Cochrane databases were systematically searched for studies comparing percutaneous coronary intervention (PCI) plus SSO to PCI alone for STEMI. Outcomes of interest included infarct size, MVO, and subsequent major adverse cardiovascular events (MACE), all-cause mortality, re-infarction, and target vessel revascularization (TVR). Mean differences (MD) with 95% confidence intervals (CIs) were calculated using random-effects models. RESULTS: Six studies (n = 1660) were included with 548 patients (33%) receiving SSO₂ therapy. Pooled analysis showed that PCI plus SSO₂ significantly reduced infarct size (MD -4.31; 95% CI -6.70 to -1.92; P < .01) and MVO (SMD -0.72; 95% CI -1.11 to -0.34; P < .01) compared with PCI alone. MACE, all-cause mortality, re-infarction, and TVR were comparable between the groups. CONCLUSION: SSO₂ therapy significantly reduced infarct size and MVO in patients undergoing PCI for STEMI.
Senman B, Sinha SS, Truesdell AG
… +22 more, Safiriyu I, Drakos S, Dupont AG, Basir MB, Miller PE, Rali AS, Bennett C, Tehrani B, Cowger J, Hall SA, Rosner C, Hackmann AE, Wang DE, Papolos AI, Kadosh BS, Vallabhajosyula S, Ferri M, Kochar A, Gage A, Horowitz JM, Katz JN, Society of Critical Care Cardiology
Cardiogenic shock (CS) remains a high-mortality condition that demands rapid diagnosis, coordinated multidisciplinary management, and timely initiation of mechanical circulatory support. As more institutions implement de...Cardiogenic shock (CS) remains a high-mortality condition that demands rapid diagnosis, coordinated multidisciplinary management, and timely initiation of mechanical circulatory support. As more institutions implement dedicated CS teams, substantial heterogeneity has emerged in how these teams are structured, activated, and sustained. To better characterize this variability and begin defining the components of an optimal CS team, the Society of Critical Care Cardiology (SoCCC), in partnership with the Society for Cardiovascular Angiography and Interventions (SCAI), convened the Inaugural Cardiogenic Shock Teams Think Tank. Held on October 17, 2024, as a preconference program to SCAI SHOCK 2024 in Washington, DC, the meeting brought together national leaders in CS care, mechanical circulatory support, and resuscitation to identify shared challenges and propose practical solutions. This manuscript summarizes key insights from this inaugural Think Tank, which represents the first in an ongoing series of collaborative efforts aimed at informing the standardization and optimization of CS teams nationwide. Specifically, we review the ideal composition and core competencies of a CS team; the rationale and emerging evidence supporting dedicated team-based CS care; activation algorithms and operational workflows; and common barriers to establishing and sustaining such teams. We also outline future directions and opportunities to strengthen collaborative infrastructure, refine clinical pathways, and enhance the reliability, responsiveness, and effectiveness of cardiogenic shock teams across diverse healthcare settings.
BACKGROUND: Malignancy threatens to limit survival in heart transplant recipients. Improved understanding of cancer risk is needed to direct prevention and screening strategies following heart transplantation. This study...BACKGROUND: Malignancy threatens to limit survival in heart transplant recipients. Improved understanding of cancer risk is needed to direct prevention and screening strategies following heart transplantation. This study aims to describe the incidence, demographics, and risk factors associated with de novo malignancy, lymphoproliferative disorders, and solid-organ malignancy subtypes. METHODS: We analyzed the incidence, types, and predictors of malignancy in 50,370 heart transplant recipients from the United Network for Organ Sharing registry. RESULTS: The incidence of de novo post-transplant malignancy at 10 years was 20.6%. The incidence at 10 years by malignancy type was: nonmelanoma skin cancer (9.0%), solid-organ cancer (6.2%), and lymphoproliferative disorder (1.2%). Older age (OR, 1.05; 95%CI, 1.049-1.060), male gender (female vs male; OR, 0.63; 95%CI, 0.58-0.68), induction immunosuppression with OKT3 (OR, 1.47; 95%CI, 1.23-1.76) or >1 induction agent (OR, 1.44; 95%CI, 1.14-1.82), history of cigarette use (OR, 1.19; 95%CI, 1.11-1.28) and hospitalization for infection (OR, 1.26; 95% CI, 1.18-1.34) were associated with increased incidence of de novo malignancy. CONCLUSIONS: De novo malignancy is common, occurring in one-fifth of recipients after heart transplant. Risk factors for de novo malignancy included older age, male gender, induction immunosuppression, and history of cigarette use. Hospitalization for infection is a risk factor that has not been previously described. Improved prevention and personalized screening strategies are needed to reduce the adverse outcome of post-transplant malignancy.
BACKGROUND: In high-bleeding-risk (HBR) patients undergoing percutaneous coronary intervention (PCI), shortening dual antiplatelet therapy (DAPT) is essential, but the optimal approach in those requiring oral anticoagula...BACKGROUND: In high-bleeding-risk (HBR) patients undergoing percutaneous coronary intervention (PCI), shortening dual antiplatelet therapy (DAPT) is essential, but the optimal approach in those requiring oral anticoagulation (OAC) is uncertain. We evaluated a 1-month dual antithrombotic regimen in HBR patients with and without OAC indication in a prespecified sub-analysis of the POEM trial. METHOD: POEM enrolled HBR patients treated with a bioresorbable polymer everolimus-eluting stent. Patients were stratified by OAC indication: the non-OAC group (n = 281) received 1-month DAPT followed by single antiplatelet therapy; the OAC group (n = 158) received 1-month OAC plus a P2Y12 inhibitor followed by OAC monotherapy. Time-to-event outcomes were analyzed using the log-rank test, and hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using Cox regression models. The primary analysis was conducted according to the intention-to-treat principle. A per-protocol analysis, excluding patients with DAPT duration >1 month, was performed as a sensitivity analysis. RESULTS: At 1 year, the primary endpoint, a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis, occurred in 6.1% of the non-OAC group versus 2.6% of the OAC group (HR 0.41, 95% CI 0.14-1.22; P = .097). Secondary ischemic outcomes were similar. BARC type 3-5 bleeding was infrequent (2.6% vs 1.3%; P = .369). The per-protocol analysis showed consistent results. CONCLUSIONS: In HBR patients after PCI, transition to OAC monotherapy at 1 month was associated with low ischemic and bleeding risks, comparable to single antiplatelet therapy. These findings support early OAC monotherapy as a feasible strategy warranting randomized investigation. TRIAL REGISTRATION: EudraCT Number: 2016-004510-99; clinicaltrials.gov: NCT03112707.