Background: Sex-based disparities persist in the management of patients with coronary artery disease undergoing complex percutaneous coronary intervention (PCI). Objectives: The purpose of this study was to evaluate sex differences in early and late outcomes among patients undergoing mechanical circulatory support (MCS)–assisted complex PCI. Methods: We conducted a retrospective analysis of hemodynamically stable patients who underwent complex PCI assisted with either an intra-aortic balloon pump or Impella (Abiomed) at a single center between 2017 and 2022. The primary endpoint was 1-year major adverse cardiovascular events (MACE), defined as a composite of all-cause death, myocardial infarction, and stroke. Secondary endpoints included individual MACE components, target vessel revascularization, bleeding, and procedural complications. Results: Among the 605 included patients, 24% were women (n = 145). Women had a higher comorbidity burden, presented more frequently with non–ST-segment elevation myocardial infarction, and experienced significantly more in-hospital complications, particularly bleeding. At 1 year, women had higher rates of MACE compared with men (25.5% vs 13.8%; P = 0.002), driven largely by excess mortality (20.8% vs 10.2%; P = 0.003), irrespective of MCS device type. After multivariable adjustment, the difference in MACE was no longer statistically significant (adjusted HR: 1.34; 95% CI: 0.74-3.03; P = 0.337). Conclusions: Women undergoing complex PCI with MCS support experienced higher procedural risk and worse early outcomes, yet adjusted 1-year MACE rates were comparable to men. The marked absolute differences in bleeding and mortality highlight the need for sex-specific approaches to patient selection, procedural planning, and post-PCI management in this high-risk population.

Background An enhanced understanding is needed of the clinical trajectories seen in contemporary practice among patients with cardiogenic shock (CS) due to different acute myocardial infarction (AMI) types. Objectives The objective of the study was to compare clinical characteristics, management strategies, and outcomes among patients with CS due to AMI with and without ST-segment elevation. Methods All adults treated for CS due to STEMI or NSTEMI within a multilevel of care health system spanning 11 hospitals from 2016 to 2022 were included. The primary and secondary outcomes were 6-month and in-hospital all-cause mortality. Results We identified 1,375 patients: 57% ST-segment elevation myocardial infarction with CS (STEMI-CS) and 43% non-STEMI-CS (NSTEMI-CS). STEMI-CS patients had more severe shock with more cardiac arrest and higher initial lactate whereas NSTEMI-CS patients were older with more comorbidities and more severe coronary disease. NSTEMI-CS patients received more coronary artery bypass grafting (33% vs 8%) and lower rates of percutaneous coronary intervention (35% vs 73%) in those undergoing left heart catheterization. Management patterns were consistent across hospital levels. Rates of in-hospital and 6-month mortality (STEMI-CS 37.1% vs NSTEMI-CS 34.0%; P = 0.53) were similar in both groups. On multivariable analysis, revascularization was associated with lower 6-month mortality in both groups, whereas intra-aortic balloon pump or percutaneous ventricular assist device use was associated with lower mortality only in STEMI-CS. Venoarterial extracorporeal membrane oxygenation was associated with increased mortality in both AMI types. Conclusions STEMI and NSTEMI patients with CS have distinct clinical profiles and management strategies across all hospital levels. Although they experience similar rates of short and long-term mortality, associations between mechanical circulatory support use and outcomes differ by phenotype. These findings suggest that AMI type should inform management strategies and research design in CS.

BACKGROUND:Women have been underrepresented in peripheral artery disease revascularization trials. We aimed to analyze sex-specific outcomes after endovascular therapy (EVT) with stent implantation versus bypass surgery (BSx) in patients with symptomatic femoropopliteal peripheral artery disease, leveraging data from the REVIVE (Revascularization Strategies in Patients With Peripheral Arterial Disease Involving the Femoropopliteal Arteries) study. METHODS:The REVIVE study pooled individual patient data from 5 randomized controlled trials comparing EVT with stent implantation versus BSx. The primary end point was major adverse limb events, a composite of all-cause death, major amputation, or reintervention. Secondary end points included amputation-free survival, the individual components of major adverse limb events, and primary patency at 2 years. Early complications were defined as a composite of any bleeding, infection, or all-cause death within 30 days. RESULTS:Of 639 patients, 185 (29.0%) were women. At 2 years, there were no significant differences in major adverse limb events between EVT and BSx in women (40.6% versus 42.1%; adjusted hazard ratio [aHR], 0.93 [95% CI, 0.57-1.52]) and men (39.7% versus 34.4%; aHR, 0.98 [95% CI, 0.69-1.39]; P-interaction=0.963). Similarly, there were no differences in secondary end points between EVT and BSx, regardless of sex. EVT, compared with BSx, was associated with lower rates of early complications (8.7% versus 25.9%, P=0.002 in women and 5.9% versus 21.5%, P<0.001 in men; P-interaction =0.77) and shorter hospital stay (3.7±5.7 versus 7.2±4.3 days, P<0.001 in women and 2.8±3.2 versus 7.4±5.1, P<0.001 in men). CONCLUSIONS:Our analysis supports the efficacy and safety of EVT with stent implantation as an alternative to BSx in patients with symptomatic peripheral artery disease involving the femoropopliteal segment, regardless of sex.

Background: Patients with peripheral arterial disease (PAD) or cerebrovascular disease (CeVD) are known to have worse outcomes when undergoing percutaneous coronary intervention (PCI) for coronary artery disease (CAD). Methods: We conducted a retrospective cohort study to investigate the impact of PAD and CeVD, and their various presentation subtypes on the clinical outcomes in patients undergoing PCI. 21,978 patients undergoing PCI at the Mount Sinai Hospital between 2012 and 2022 were stratified by the presence of PAD and/or CeVD and their most common presentation subtypes. Results: Among the cohorts 1,613 (7.3%) patients had PAD, 1,874 (8.5%) had CeVD and 453 (2.1%) had both (polyvascular group) while the CAD only (control group) 18,038 (82.1%) had neither. 1-year risk of MACCE was significantly higher for patients with PAD, CeVD or both where patients presenting with PAD and prior intervention and CeVD with past cerebrovascular accident (CVA) with hemiparesis had the highest risk among the various subgroups. Patients with a history of CVA with/without hemiparesis had a higher risk of stroke post PCI. Bleeding events were more frequent in polyvascular and PAD patients, on subgroup analysis only the PAD with prior intervention subgroup was statistically significant. Conclusion: PAD, CeVD and polyvascular disease demonstrate a higher risk of MACCE in patients undergoing PCI. This increased risk of MACCE appears to be driven by those with prior intervention or CVA with hemiparesis. An increased risk of bleeding is seen in patients with PAD, polyvascular disease and PAD with prior intervention when stratified by subgroup.

AIMS:Platelet function testing (PFT)-guided de-escalation of dual antiplatelet therapy (DAPT) after acute coronary syndrome (ACS) has been shown to reduce bleeding risk without increasing ischaemic events. Patients with high atherothrombotic risk (ATR) remain a challenging subgroup for such strategies. This study evaluated the safety and efficacy of early PFT-guided DAPT de-escalation according to ATR status. METHODS AND RESULTS:In the TROPICAL-ACS trial, 2610 ACS patients were randomized to standard 12-month prasugrel therapy or PFT-guided DAPT de-escalation. For this post hoc analysis, patients were stratified by ATR. High ATR was defined as age ≥ 65 years, polyvascular disease, or ≥2 risk factors (diabetes, smoking, or renal dysfunction). Hazard ratios (HRs) for clinical endpoints were derived using multistate Cox regression. High-ATR patients (n = 990) had a higher incidence of the primary net clinical benefit endpoint-composite of cardiovascular death, myocardial infarction, stroke, or Bleeding Academic Research Consortium 2-5 bleeding-compared with low-ATR patients (n = 1620) (11.0% vs. 6.7%; HR 1.67, 95% confidence interval 1.28-2.18; P < 0.001). Platelet function testing-guided de-escalation showed no significant interaction by ATR status for the primary endpoint [high ATR: 10.5% vs. 11.5%, HR 0.90 (0.61-1.32), P = 0.586; low ATR: 5.6% vs. 7.7%, HR 0.71 (0.48-1.04), P = 0.082; Pinteraction = 0.394] or ischaemic events [high ATR: 3.7% vs. 4.4%, HR 0.83 (0.44-1.56); low ATR: 1.8% vs. 2.6%, HR 0.68 (0.35-1.34); Pinteraction = 0.666]. CONCLUSION:Early PFT-guided de-escalation from prasugrel to clopidogrel was safe across atherothrombotic risk categories, supporting individualized DAPT optimization in ACS patients with both low and high ischaemic risk.

Background:Women with chronic limb-threatening ischemia remain historically underrepresented in peripheral artery disease trials and often exhibit distinct anatomic and clinical profiles. The LIFE-BTK randomized trial demonstrated superiority of an everolimus-eluting resorbable scaffold (DRS) over percutaneous transluminal angioplasty (PTA) for below-the-knee revascularization. This analysis assessed whether sex influenced baseline characteristics, procedural details, or clinical outcomes after DRS compared with PTA. Methods:LIFE-BTK randomly assigned 261 patients (2:1 DRS/PTA) with Rutherford-Becker class 4-5 ischemia across 50 global sites. Sex-stratified outcomes at 1 and 2 years were evaluated using descriptive statistics, multivariate models, and Kaplan-Meier estimates. The primary efficacy end point was freedom from above-ankle amputation, target vessel occlusion, clinically-driven target lesion revascularization (CD-TLR), and binary restenosis. The primary safety end point was freedom from major adverse limb events and perioperative death. Both end points are presented here as event rates. Results:Female patients (32% of cohort) were older and had smaller reference vessel diameters and lower ankle-brachial index values; male patients had higher tobacco use and cardiovascular comorbidities. At 1 year, DRS significantly reduced event rates for the primary efficacy end point vs PTA in both sexes (female: 23.5% vs 57.1%; male: 26.5% vs 56.0%). Benefits persisted at 2 years (female: 34.1% vs 68.4%; male: 40.7% vs 66.7%). Binary restenosis and CD-TLR were lower with DRS. Multivariate analysis showed sex was not significantly associated with outcomes, and no sex-by-treatment interaction was observed. Female patients demonstrated higher restenosis but lower CD-TLR rates, suggesting discordance between anatomic and clinical failure. Conclusions:DRS provided durable benefit over PTA irrespective of sex. Although sex did not modify treatment effect, differences in vessel size, ischemia severity, and restenosis-reintervention patterns highlight the need for sex-specific surveillance and personalized below-the-knee treatment strategies.

Background: Racial and ethnic disparities in cardiovascular disease outcomes, including percutaneous coronary intervention (PCI), are well-documented. However, studies do not stratify certain subgroups, such as separating South Asian and East Asian patients, who exhibit varying burdens of cardiovascular disease and PCI outcomes. Additionally, socioeconomic status (SES) further complicates outcomes, with low SES serving as an independent predictor of adverse outcomes post-PCI. Objectives: This study aimed to analyze PCI outcomes across 5 racial and ethnic groups—White, Black, Hispanic, South Asian, and East Asian populations—while accounting for comorbidities and SES to better understand how race and ethnicity influence cardiovascular outcomes. Methods: We conducted a retrospective cohort study of patients undergoing PCI from 2012 to 2022. Patients were stratified by race/ethnicity and matched to median household income based on U.S. Census Zone Improvement Plan code data. The primary endpoint was 1-year major adverse cardiovascular events (MACE). Multivariable Cox regression models were used to assess outcomes, adjusting for comorbidities and SES. Results: A total of 21,236 patients were included: 47.8% White, 11.3% Black, 18.0% Hispanic, 20.7% South Asian, and 2.2% East Asian. South Asian patients had significantly lower MACE (adjusted HR: 0.62; P < 0.001) compared with White patients. Black patients, in contrast, had a higher risk of MACE (adjusted HR: 1.27; P = 0.032). Conclusions: Significant racial and ethnic disparities exist in 1-year PCI outcomes, with South Asian patients exhibiting favorable outcomes compared with White patients, and Black patients experiencing worse outcomes. Baseline comorbidities and estimated SES do not fully explain these disparities, suggesting that targeted strategies are needed to address the multifactorial influences on PCI outcomes across racial and ethnic groups.

Peripheral arterial disease (PAD) often predicts poor outcomes in patients undergoing percutaneous coronary intervention (PCI). Here we examine the impact of PAD in patients receiving complex PCI (CPCI) and noncomplex PCI. Patients undergoing PCI at the Mount Sinai Hospital between 2012 and 2022 were stratified by the presence of CPCI and PAD. The primary outcome was major adverse cardiovascular events (MACE), a composite of death, myocardial infarction, target vessel revascularization, or stroke within 1 year; secondary endpoints included bleeding events. An adjusted Cox proportional hazard method was used to evaluate risks of each outcome within each subgroup. Among 20,376 patients, 8,200 (40.2%) had CPCI and 1,959 (9.6%) had PAD. PAD patients were older and more likely to be female and have risk factors such as diabetes and smoking and were more commonly discharged with anticoagulants. 1-year risk of MACE was significantly higher for patients with PAD in both CPCI (19.6% vs 14.4%, adj. hazard ratio [HR] 1.31, 95% confidence interval [CI] 1.08 to 1.58, p = 0.006) and no-CPCI strata (13.9% vs 9.2%, adj. HR 1.35, 95% CI 1.12 to 1.64, p = 0.002; p-interaction = 0.349). Bleeding events were also more frequent in PAD patients for CPCI (8.5% vs 5.5%, adj. HR 1.40, 95% CI 1.07 to 1.84, p = 0.014) and no-CPCI (7.1% vs 4.3%, adj. HR 1.52, 95% CI 1.18 to 1.96, p = 0.001; p-interaction = 0.608). In conclusion, presence of PAD is associated with a significantly increased risk of MACE and bleeding after PCI, regardless of procedural complexity.

Background and AimsLarge-bore femoral access is commonly required in transfemoral transcatheter aortic valve replacement (TF-TAVR), but vascular access complications remain prevalent, impacting patient outcomes. Various vascular closure devices (VCDs) are used for hemostasis, including the suture-based Prostar XL, Perclose ProGlide, and ProStyle, and the plug-based MANTA device. However, comprehensive comparative evidence on these VCDs, particularly single Perclose strategies, is lacking.MethodsA systematic review and network meta-analysis were conducted according to PRISMA guidelines. We included randomized and observational studies comparing the safety and efficacy of VCDs for large-bore femoral access closure in TF-TAVR patients. Primary outcomes included major vascular complications; secondary outcomes included major and minor bleeding, minor vascular complications, VCD failure, and all-cause mortality. Frequentist and Bayesian analyses were performed using a random-effects model, with additional subgroup analyses of single Perclose strategies.ResultsThirty-five studies comprising 16,503 patients met inclusion criteria. The single Perclose strategy, with or without adjunct Angio-Seal or FemoSeal, significantly reduced major vascular complications compared to dual Perclose (RR: 1.9, 95% CI [1.2-3.01]), MANTA (RR: 1.89, 95% CI [1.03-3.48]), and Prostar XL (RR: 3.46, 95% CI [1.94-6.18]). Among secondary outcomes, single Perclose also ranked highest in reducing minor complications and bleeding.ConclusionSingle Perclose strategies, especially when combined with Angio-Seal, demonstrated superior safety and efficacy for large-bore femoral access closure following TF-TAVR. These findings support the need for further randomized trials to validate single Perclose as a primary approach in TF-TAVR vascular closure.

Percutaneous coronary intervention (PCI) is an established alternative to coronary artery bypass grafting for the treatment of select patients with unprotected left main (LM) coronary artery disease (CAD). This study evaluates the safety and clinical impact of treating additional coronary arteries during LM-PCI. Consecutive patients undergoing PCI with drug-eluting stents for unprotected LM-CAD between 2010 and 2021 at The Mount Sinai Hospital, New York, USA were eligible for inclusion. Patients were stratified based on whether they underwent treatment of the LM complex alone or had concomitant PCI to an additional vessel outside the LM complex. The primary outcome was major adverse cardiovascular events (MACE), a composite of death, myocardial infarction, or stroke, at 1 year following PCI. Among 869 consecutive patients (mean age 70.9, 33.0% female, 27.9 mean SYNTAX score) undergoing LM-PCI, 479 (55.1%) underwent treatment of the LM complex alone, and 390 (44.9%) had concomitant PCI of an additional non-LM vessel. Compared with LM complex PCI only, there were no significant differences in the rate of MACE at 1 year [HR 12.0% vs 13.3%; HR: 0.95; 95% CI (0.62-1.44), p = 0.797], even after adjustment for potential confounders [HR 12.0% vs 13.3%; HR: 0.87; 95% CI (0.56-1.36), p = 0.550]. In conclusion, in a large, real-world cohort of patients undergoing unprotected LM-PCI, treatment of an additional non-LM vessel did not increase the risk of MACE at 1 year compared to LM complex PCI alone. (c) 2025 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.

BACKGROUND:Multilayer in-stent restenosis (ISR) remains a clinical challenge. Intravascular brachytherapy (IVBT) offers a "metal-free" treatment modality for multilayer drug-eluting stent (DES)-ISR; however, long-term outcome data on IVBT safety and efficacy are lacking. AIMS:We sought to compare 3-year clinical outcomes between patients treated with IVBT and those treated with a non-IVBT strategy. METHODS:Patients treated for multilayer DES-ISR (≥2 layers) at Mount Sinai Hospital (2012-2019) were included for analysis. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, target lesion revascularisation and myocardial infarction, at 3-year follow-up. RESULTS:A total of 647 patients (mean age 66.6±9.9 years, 25.5% female) were included: 453 patients (70%) were treated with IVBT and 194 patients (30%) with a non-IVBT strategy. Baseline characteristics were similar, except for IVBT-treated patients having a higher incidence of prior coronary artery bypass grafting. The IVBT group had a lower mean SYNTAX score (11.9±10.7 vs 14.2±11.3; p=0.028) and were significantly less likely to receive a DES (0.4% vs 25.8%; p<0.001). At 3-year follow-up, the incidence of MACE was lower in the IVBT-treated group compared to the non-IVBT group (propensity score-adjusted analysis: 39.5% vs 47.8%; hazard ratio 0.73, 95% confidence interval: 0.53-0.99; p=0.044). There were no significant differences between the incidence of the individual components of MACE in each group. CONCLUSIONS:Multilayer DES-ISR is associated with a high rate of adverse outcomes at 3-year follow-up. Treatment with IVBT was associated with a lower rate of MACE compared to treatment with a non-IVBT strategy at long-term follow-up.

BACKGROUND:Artificial intelligence (AI) augmentation of ECG assessment has significant potential to improve patient outcomes in acute coronary syndrome. OBJECTIVE:We sought to evaluate the performance of a novel AI device (PMCardio) in assessing angiographic occlusion myocardial infarction (OMI) and predicting clinical outcomes. METHODS:We used a 1-year retrospective cohort of angiographic data from patients presenting with ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI). The device analyzed precatheterization ECGs to identify OMI, defined as a culprit vessel with thrombolysis In myocardial infarction (TIMI) 0-2 flow or TIMI 3 flow and peak cardiac troponin I > 10.0 ng/ml. RESULTS:A total of 217 patients were included: 72 STEMI (32%) and 145 NSTEMI (65%). Angiographic OMI was confirmed in 60 (83%) STEMI and 51 (35%) NSTEMI cases. The AI model achieved a sensitivity of 86.5%, specificity of 82.2%, and an area under the curve of 0.84. Traditional STEMI criteria had a sensitivity of 54.1% and a specificity of 88.7%. The AI model was 100% sensitive in detecting STEMI-OMI. The odds ratio for mortality in AI-detected OMI patients was 12.44 (1.56-98.98), unplanned readmissions 1.15 (0.53-2.51), and reduced ejection fraction at 1 year 0.24 (0.26-2.16). CONCLUSIONS:The AI model demonstrated higher sensitivity and similar specificity compared with traditional STEMI criteria, improving OMI detection while reducing false positives. These findings suggest potential benefits in triage accuracy and resource utilization, but further prospective validation is needed to determine its clinical impact.