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Background Potent P2Y12 inhibitors are recommended on top of aspirin in patients presenting with acute coronary syndrome (ACS). However, guideline recommendations suggest that the optimal antithrombotic strategy should be tailored based on patients thrombotic and hemorrhagic risk profile. Purpose It is poorly investigated if the benefits derived from potent P2Y12 inhibition in patients with ACS depend on the individual thrombotic risk profile. Our aim was to evaluate if the benefits associated with prasugrel vs. clopidogrel in patients with ACS undergoing percutaneous coronary intervention (PCI) are similar in case of different thrombotic risk profiles. Methods PROMETHEUS was a multicenter observational study comparing prasugrel vs. clopidogrel in ACS patients undergoing PCI. According to the 2020 ESC guidelines for non-ST elevation-ACS, patients are defined at high thrombotic risk if presenting with a clinical (diabetes mellitus requiring medication, history of recurrent myocardial infarction [MI], multivessel coronary artery disease [CAD], polyvascular [coronary and peripheral] disease, premature (60 mm, complex revascularization [left main PCI, bifurcation or chronic total occlusion]) risk features. The primary endpoint was major adverse cardiac events (MACE), a composite of death, MI, stroke or unplanned revascularization. Hazard ratio (HR) and 95% confidence intervals (CI) were calculated using propensity-stratified analysis to assess the effect of prasugrel vs. clopidogrel and with multivariable Cox regression to evaluate the impact of thrombotic risk. Results Among 16065 patients, 4293 were defined at high thrombotic risk and 11772 at low-to-moderate thrombotic risk. Patients treated with prasugrel had less comorbidities and risk factors than those treated with clopidogrel, both in the high and low-to-moderate thrombotic risk strata. Patients at high thrombotic risk had higher rates of both ischemic and bleeding events at 90 days and at 1 year. Patients treated with prasugrel had a lower adjusted risk of MACE at 1 year (HR 0.86, 95% CI 0.77–0.96), with no significant interaction between effect estimates and thrombotic risk. However, after stratifying the study population by the number of risk factors, there was a significant interaction for a greater reduction in MACE with prasugrel in patients with ≤1 thrombotic risk factor. Conversely, there were no differences in major bleeding among patients treated with prasugrel and clopidogrel. Conclusions Patients with ACS at high thrombotic risk who undergo PCI are at increased risk of adverse events. Prasugrel, although mainly reserved to patients with lower burden of comorbidities, reduced the risk of ischemic events both in patients at high and low-to-moderate thrombotic risk as compared with clopidogrel. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo and Eli Lilly and Company Clinical outcomes at 1 year.Impact of number of risk factors

Introduction Patients undergoing PCI of chronic total occlusions (CTO) are at high risk of both periprocedural and post-procedural adverse events. Whether sex-differences in outcomes exist after PCI of CTO remains unclear. Purpose We sought to investigate sex-differences in outcomes after CTO-PCI among an unselected real-world cohort of patients. Methods In our single-center retrospective study, patients who underwent elective CTO intervention from January 2000 to December 2019 were included. The primary endpoint of interest was major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction (MI), and target vessel revascularization (TVR) at 1 year of follow-up. Results A total 1897 patients were included of which 368 were women (19.4%). Women were older (67±11.3 years vs. 62.6±10.9 years) and had a higher prevalence of comorbidities including diabetes and chronic kidney disease. Women had higher rates of procedure-related complications including increased risk of post-procedural bleeding requiring blood transfusion (3.0% vs 1.1%; p=0.007), and acute vessel closure (1.36% vs 0.2%; p=0.009). In multivariable-adjusted models for baseline confounders, female sex was associated with higher risk of MACE and TVR (Table 1). Conclusion Gender differences in CTO management are observed, with fewer females going for CTO revascularization in contemporary practice. Female sex is associated with procedural-related complications, higher MACE, and TVR even after successful CTO intervention. Funding Acknowledgement Type of funding sources: None.

Background Diabetes mellitus (DM) and chronic kidney disease (CKD) are established risk factors for cardiovascular events, with patients presenting both conditions being at extremely high risk. P2Y12 inhibitor monotherapy with ticagrelor after a short course of dual antiplatelet therapy has emerged as a bleeding avoidance strategy for high-risk patients undergoing percutaneous coronary intervention (PCI). Purpose To investigate ischemic and bleeding outcomes associated with ticagrelor monotherapy versus ticagrelor plus aspirin according to the presence or absence of CKD and DM. Methods The TWILIGHT trial enrolled patients undergoing PCI with a drug-eluting stent who fulfilled at least one clinical and one angiographic high-risk criterion. Both DM and CKD (estimated glomerular filtration rate Results Of the 6273 patients included in the analysis, 8.0% had both CKD and DM (DM+/CKD+), 8.9% had CKD only (DM-/CKD+), 29.0% had DM only (DM+/CKD-), and 52.1% had neither CKD nor DM (DM-/CKD-). At 1-year follow-up, there was a progressive increase in the rates of bleeding and ischemic events according to DM and CKD status (Figure 1). Ticagrelor plus placebo reduced the primary bleeding endpoint as compared with ticagrelor plus aspirin across all study groups, including DM+/CKD+ patients (4.7% vs. 8.7%; HR 0.52, 95% CI 0.25–1.07), with no evidence of heterogeneity (p-interaction=0.68). Similar treatment effects of ticagrelor monotherapy were observed for major BARC type 3 or 5 bleeding (p-interaction=0.17), with DM+/CKD+ patients showing the greatest absolute risk reduction (0.9% vs. 5.1%; HR 0.16, 95% CI 0.04–0.72). The key secondary endpoint was not significantly different between treatment arms across study groups, with the exception of a reduced risk in DM+/CKD- patients receiving ticagrelor monotherapy (p-interaction=0.033). A similar pattern in the DM+/CKD- group was observed for NACE (p-interaction=0.030) (Figure 2). Conclusions Among high-risk patients undergoing PCI, ticagrelor monotherapy reduced the risk of clinically relevant and major bleeding without a significant increase in ischemic events as compared with ticagrelor plus aspirin, irrespective of the presence of DM and CKD. Furthermore, ticagrelor monotherapy seemed to be associated with a more favourable net benefit in patients with DM without CKD. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Investigator-initiated grant from AstraZeneca Figure 1. Event rates according to DM/CKD statusFigure 2. Effects of ticagrelor monotherapy

Aims The aim of this study was to assess the impact of chronic kidney disease (CKD) on the safety and efficacy of ticagrelor monotherapy among patients undergoing percutaneous coronary intervention (PCI). Methods and results In this prespecified subanalysis of the TWILIGHT trial, we evaluated the treatment effects of ticagrelor with or without aspirin according to renal function. The trial enrolled patients undergoing drug-eluting stent implantation who fulfilled at least one clinical and one angiographic high-risk criterion. Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) Conclusion Among CKD patients undergoing PCI, ticagrelor monotherapy reduced the risk of bleeding without a significant increase in ischaemic events as compared with ticagrelor plus aspirin.

Background/Introduction Low levels of high-density lipoprotein (HDL) have been associated with adverse cardiovascular events in multiple epidemiological studies. Evidence regarding the role of HDL in males and females with established coronary artery disease undergoing percutaneous coronary intervention (PCI) with drug eluting stents (DES) is scarce. Purpose We sought to investigate the impact of low HDL levels on 1-year cardiovascular outcomes in males and females undergoing PCI with DES. Methods We screened all patients undergoing PCI in our center from 2012 to 2017. Exclusion criteria were: unavailable baseline HDL measurement, age Results Out of the 10,843 patients included, 7,718 (71.2%) were male and 3,125 (28.8%) were female. Low HDL was noted in 58.5% of males and 63.8% of females. Patients with low HDL were younger and had a higher prevalence of DM, prior MI, smoking and multi-vessel disease. When comparing low to high HDL groups in terms of 1-year MACE a borderline significant difference was shown in males (7.4% vs. 6.0%; p-value=0.08) but not in females (7.7% vs 8.1%; p-value=0.90) [Panel A]. The numerically higher incidence of MACE in males with low HDL was primarily driven by TVR (5.4% vs 3.7%; p-value=0.005) while the rates of Death (1.4% vs. 1.3%; p=0.96) and MI (2.0% vs. 1.8%; p-value=0.89) were similar between the two groups. After adjustment the male low HDL subgroup remained at a higher risk for 1-year TVR but not 1-year MACE compared to the male high HDL subgroup [Panel B]. No difference for any individual component of MACE was shown between low and high HDL subgroups in females [Panel C]. Conclusion(s) High HDL levels were associated with a lower incidence of TVR and borderline reduction of MACE in male but not female patients undergoing PCI with DES. No difference was demonstrated in terms of death or MI between the high and low HDL subgroups at 1-year follow-up. Impact of HDL levels according to gender Funding Acknowledgement Type of funding source: None

Introduction Current clinical guidelines recommend prolonged dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndromes (ACS). However, an extended DAPT duration in high-bleeding risk (HBR) patients amplifies the risk of post procedural complications. Hence, clinicians often face the dilemma of prolonging DAPT duration to prevent recurrent ischaemic events at the expense of increasing the incidence of bleeding in high-risk patients. The actual incidence of ischaemic and bleeding events in this particular population is not well elucidated. Purpose To evaluate one-year ischemic and bleeding outcomes following PCI for ACS in a real-world HBR population as defined by the Academic Research Consortium (ARC) consensus document. Methods We included all patients who presented with ACS to a high-volume single PCI centre from 2012 to 2017 and underwent PCI with 2nd generation drug-eluting stent implantation. Patients were classified as HBR if they met ≥1 major or ≥2 minor criteria according to the recent ARC-HBR consensus. The outcomes of interest were major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), and target lesion revascularization (TLR), and major bleeding events, including both peri-procedural and post-discharge bleeding. All outcomes were assessed at 1-year follow-up. The Kaplan-Meier method was used for time-to-event analyses. Results Out of 6,097 ACS patients included in this analysis, 2,717 (44.6%) fulfilled the ARC-HBR definition. Compared to non-HBR group, HBR patients were more frequently female, older, more likely to have cardiovascular risk factors (e.g., diabetes, hypertension, and hyperlipidemia) and complex coronary artery disease (e.g., multi-vessel disease, bifurcation lesions, and calcification). The 1-year incidence of MACE was significantly higher in HBR patients (16.3% vs. 8.1%, HR 2.16, 95% CI [1.81–2.59], p Conclusions HBR patients undergoing PCI for ACS are not only subject to bleeding complications but are also at an increased risk for ischemic events and all-cause mortality. Figure 1 Funding Acknowledgement Type of funding source: None

Background Stroke represents a potentially calamitous complication among patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) even though its rates are relatively low. Data on the distribution of stroke occurrence over time and its overlap with myocardial infarction (MI) and bleeding after PCI is scarce. Purpose We sought to compare the occurrence and impacts of stroke, MI and bleeding on subsequent mortality in ACS patients undergoing PCI in contemporary clinical practice. Methods A total of 19,914 ACS patients who underwent PCI in the PROMETHEUS multi-center observational study were analyzed. We calculated the cumulative stroke incidence at 30 days and 1 year using Kaplan Meier (KM) method. We also compared the distribution of stroke, myocardial infarction (MI) and bleeding across time and evaluated the overlap between their occurrences. Predictors of 1 year stroke occurrence were identified through multivariable Cox-regression and stroke, MI and bleeding were entered as time-updated covariates to estimate their individual effects on subsequent mortality. Results Of the total number of patients, 244 patients (1.5%) had a stroke within 1 year. 48 of these patients also experienced an MI while another 48 patients experienced a bleeding event. Furthermore, 14 of these overlapping patients experienced a stroke, MI and bleeding event, all within the 1-year follow-up. Patients who sustained a stroke were more likely to have a prior history of cerebrovascular disease, peripheral artery disease, MI and heart failure compared to those who did not have a stroke. Mortality risk was significantly higher among those with stroke versus those without stroke (adjusted HR 4.84, p Conclusion When compared with MI and bleeding, stroke had a substantially stronger impact on mortality that attenuated rapidly over time among ACS patients undergoing PCI. Optimization of modifiable risk factors and medication adherence are essential parts of management of stroke following PCI for ACS.

Purpose: Coronary artery disease (CAD) is a frequent complication of HIV infection and patients with HIV are increasingly referred for percutaneous coronary intervention (PCI). Despite substantial cardiac morbidity, the angiographic pattern or burden of CAD and outcomes following PCI in HIV patients has not been well described. Methods: We followed 112 consecutive patients with HIV who underwent PCI from 1999 to 2011. Quantitative coronary angiographic (QCA) analysis was performed independently in all patients. We determined that the incidence of adverse events including death, myocardial infarction, and revascularization. The mean follow-up period was 2.4 years. Results: We identified 112 HIV patients with 164 lesions undergoing PCI during the study period. Patients with HIV were more frequently male (n=88, 79%) and non-Caucasian (n=79, 71%) with a mean age of 57 years. The majority of patients were treated with DES (n=66, 59%). Most lesions displayed minimal calcification (67%), modest lesion length (16.6 mm±10.6) with a diameter stenosis of 69%, and an overall SYNTAX score of 13.5±8.9. The rate of all-cause mortality, MI or target vessel revascularization at 3 years was 29.5% while 19% of patients were readmitted due to cardiac causes (Figure 1). Similar results were obtained for both BMS and DES treated patients (29.8% vs 29.2%, P=0.95). ![Figure][1] Figure 1 Conclusion: Although the angiographic pattern of CAD in HIV patients suggests a relatively low-risk phenotype, the risk for adverse events after PCI, particularly revascularization, is significant. These findings suggest that atherosclerosis progression and restenosis is altered in the setting of HIV [1]: pending:yes