High Bleeding Risk Patients Research Articles

P109 INTRAVENOUS CANGRELOR INFUSION IN PATIENTS UNDERGOING COMPLEX VERSUS NON–COMPLEX PERCUTANEOUS CORONARY INTERVENTION: A SUBANALYSIS OF THE ICARUS REGISTRY

Abstract Aims To compare the clinical characteristics and in–hospital outcomes of patients undergoing complex vs. non–complex percutaneous coronary intervention (PCI) with peri–procedural use of cangrelor. Methods Consecutive patients treated with cangrelor in 6 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high–bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results Among 551 patients enrolled in the ICARUS registry and undergoing PCI between January 2019 and August 2022, a total of 534 (97%) patients had complete information on PCI complexity, of whom 173 (32%) underwent complex PCI and 361 (68%) underwent non–complex PCI. In general, patients with complex PCI had similar clinical features compared with non–complex PCI patients, including comparable prevalence of high bleeding risk (HBR) status according to the ARC–HBR definition (35% vs. 30%, p=0.253), but complex PCI patients presented more often with cardiogenic shock (9% vs. 2%, p<0.001). PCI with ≥3 stents implanted was the most frequent criterion of procedural complexity (62%). The incidence of the primary endpoint of 48–hour NACE (10% vs. 7%, p=0.264) and other clinical endpoints occurring at 48 hours or during hospitalization did not differ between complex and non–complex PCI patients. Conclusions Among patients receiving peri–procedural cangrelor, about 30% of cases underwent complex interventions. Notwithstanding higher procedural complexity, short–term clinical outcomes were similar between complex and non–complex PCI patients.

C75 INTRAVENOUS CANGRELOR INFUSION IN ELDERLY PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION: A SUBANALYSIS OF THE ICARUS REGISTRY

Abstract Aims To assess the clinical characteristics and compare in–hospital outcomes of elderly and non–elderly patients receiving cangrelor in the peri–percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high–bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. Elderly patients were defined if age was ≥75 years at the time of PCI. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Independent predictors of the primary endpoint were also assessed. Results Out of 551 patients undergoing PCI with cangrelor between January 2019 and August 2022, 174 (32%) were elderly. Mean age was 81±5 vs. 61±8 years in elderly vs. non–elderly patients (p<0.001). Female sex (32% vs. 21%, p=0.006), atrial fibrillation (20% vs. 5%, p<0.001), chronic kidney disease (30% vs. 6%, p<0.001) and heart failure (14% vs. 8%, p=0.041) were more frequent in the elderly group, whereas presentation with acute coronary syndrome (ACS) was less frequent (69% vs. 83%, p=0.001). Elderly patients received shorter cangrelor infusion (122±25 vs. 134±43 minutes, p=0.001) and were more frequently administered with clopidogrel after PCI (50% vs. 19%, p<0.001). At 48 hours, elderly patients had higher rates of NACE (13% vs. 6%, p=0.006) and BARC 2, 3 or 5 bleeding (11% vs. 5%, p=0.013), whereas the rates of other 48–hour and in–hospital clinical endpoints did not differ. At multivariable analysis, age ≥75 years (odds ratio [OR] 1.07, 95% CI 1.02–1.12, p=0.004), major anemia (OR 1.10, 95% CI 1.005–1.22, p=0.038), ACS at presentation (OR 1.08, 95% CI 1.03–1.14), femoral access (OR 1.13, 95% CI 1.06–1.22) and cardiogenic shock (OR 1.35, 95% CI 1.21–1.50) independently predicted the occurrence of 48–hour NACE. Conclusions Advanced age is a distinctive risk feature among patients receiving intravenous cangrelor in the peri–PCI phase. Elderly patients had higher rates of adverse events at 48 hours, with advanced age (≥75 years) being an independent predictor of NACE.

Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial

BackgroundClinical outcomes and treatment selection after completing the randomized phase of modern trials, investigating antiplatelet therapy (APT) after percutaneous coronary intervention (PCI), are unknown. ObjectivesThe authors sought to investigate cumulative 15-month and 12-to-15-month outcomes after PCI during routine care in the MASTER DAPT trial. MethodsThe MASTER DAPT trial randomized 4,579 high bleeding risk patients to abbreviated (n = 2,295) or standard (n = 2,284) APT regimens. Coprimary outcomes were net adverse clinical outcomes (NACE) (all-cause death, myocardial infarction, stroke, and BARC 3 or 5 bleeding); major adverse cardiac and cerebral events (MACCE) (all-cause death, myocardial infarction, and stroke); and BARC type 2, 3, or 5 bleeding. ResultsAt 15 months, prior allocation to a standard APT regimen was associated with greater use of intensified APT; NACE and MACCE did not differ between abbreviated vs standard APT (HR: 0.92 [95% CI: 0.76-1.12]; P = 0.399 and HR: 0.94 [95% CI: 0.76-1.17]; P = 0.579; respectively), as during the routine care period (HR: 0.81 [95% CI: 0.50-1.30]; P = 0.387 and HR: 0.74 [95% CI: 0.43-1.26]; P = 0.268; respectively). BARC 2, 3, or 5 was lower with abbreviated APT at 15 months (HR: 0.68 [95% CI: 0.56-0.83]; P = 0.0001) and did not differ during the routine care period. The treatment effects during routine care were consistent with those observed within 12 months after PCI. ConclusionsAt 15 months, NACE and MACCE did not differ in the 2 study groups, whereas the risk of major or clinically relevant nonmajor bleeding remained lower with abbreviated compared with standard APT. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020)

Comparison of urgent and early endoscopy for acute non-variceal upper gastrointestinal bleeding in high-risk patients

Comparison of urgent and early endoscopy for acute non-variceal upper gastrointestinal bleeding in high-risk patients

Thirty-Days versus Longer Duration of Dual Antiplatelet Treatment after Percutaneous Coronary Interventions with Newer Drug-Eluting Stents: A Systematic Review and Meta-Analysis.

Abbreviation of the duration of dual antiplatelet therapy (DAPT) (one or three months) has been recently proposed, especially for high bleeding risk patients, after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Three databases were screened for eligible randomized control trials. The primary endpoint was the incidence of net adverse clinical events (NACE). Secondary endpoints consisted of major adverse cardiovascular events (MACE), all-cause and cardiovascular mortality, myocardial infarction, stroke, stent-thrombosis, repeat revascularization and major bleeding. We included four RCTs with a total of 26,576 patients; 13,282 patients were grouped in 30-days DAPT, while the remaining 13,294 were allocated in a longer period of DAPT. One month of DAPT did not significantly reduce NACE (odds ratio [OR]: 0.87, 95% confidence intervals [Cl]: 0.74-1.03); however, major bleedings were significantly reduced by 22% (OR: 0.78, 95% Cl: 0.65-0.94). Mortality or ischemic events (stroke, myocardial infarction, revascularization and stent thrombosis) were not affected. Thus, 30-days DAPT could be considered as safe and feasible after PCI with DES in selected patients, especially those with high bleeding risk. Forthcoming RCTs could shed light on the optimal duration of DAPT.

Differential prognosis of patients that are candidates for standard, short or prolonged dual antiplatelet treatment discharged after an acute coronary syndrome

BackgroundCurrent evidence supports the efficacy of prolonged dual antiplatelet treatment (DAPT) for patients at high-ischemic risk and low bleeding risk as well as the efficacy and safety of short DAPT in high-bleeding risk (HBR) patients. MethodsWe evaluated patterns of DAPT candidates in all patients discharged in 2 hospitals after an acute coronary syndrome (ACS). Patients categorized in 3 groups: 1) short-DAPT candidates if they met 1 major o 2 minor criteria for HBR, by the 2019 ARC-HBR criteria; 2) prolonged-DAPT candidates if were not HBR and had recurrent ACS, complex percutaneous coronary interventions or diabetes; 3) standard 12 months DAPT if were not include in the previous 2 groups. Major bleeding (MB) was registered according to 3 or 5 of the BARC consortium definitions. ResultsWe included 8252 patients and 3215 (39 %) were candidates for abbreviated DAPT, 3119 (37.8 %) for prolonged DAPT, and 1918 (23.2 %) for 12 m DAPT. Relevant differences were observed between the 3 categories beyond the bleeding risk. Median follow-up was 57 months. Multivariate analysis identified higher risk of all-cause mortality (HR: 1.96 95 % CI 1.45–2.67; p < 0.001), cardiovascular mortality (HR: 2.10 95 % CI 1.39–3.19; p < 0.011), MACE (HR: 1.69 95 % 1.50–2.02; p < 0.001) and MB (sHR: 3.41 95 % CI 1.45–8.02; p = 0.005) in candidates to short DAPT. Candidates to prolonged DAPT had higher risk of MACE (HR: 1.17 95 % CI 1.02–1.35; p = 0.027). ConclusionsAlmost two thirds of patients discharged after an ACS would be candidates for short or prolonged DAPT and these patients are at higher risk of MACE and mortality.

330 INTRAVENOUS CANGRELOR INFUSION IN HIGH BLEEDING RISK PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION: PRELIMINARY RESULTS OF THE ICARUS REGISTRY

Abstract Aims To investigate the prevalence of high bleeding risk (HBR) criteria and compare clinical outcomes between HBR and non-HBR patients receiving cangrelor in the peri-percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. HBR status was assessed according to the Academic Research Consortium (ARC-HBR) definition. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results We enrolled 551 patients undergoing PCI with cangrelor between January 2019 and August 2022. HBR definition was met in 33% of cases. HBR patients were older (76±10 vs. 63±10 years, p&amp;lt;0.001), more frequently affected by peripheral arterial disease (16% vs. 8%, p=0.010), atrial fibrillation (24% vs. 2%, p&amp;lt;0.001), chronic kidney disease (35% vs. 3%, p&amp;lt;0.001), active cancer (7% vs. 0%, p&amp;lt;0.001) and heart failure (17% vs. 7%, p&amp;lt;0.001). At 48 hours, HBR patients had a significantly higher rate of NACE (13% vs. 6%, p=0.004), and BARC 2, 3 or 5 bleeding (12% vs. 4%, p=0.001). In the HBR group, the frequency of the primary endpoint increased proportionally to the HBR score. There was no significant difference with respect to other 48-hour and in-hospital endpoints. Conclusions Among consecutive patients treated with cangrelor in the peri-PCI phase, about 30% fulfilled the ARC-HBR definition. In the HBR subpopulation, the incidence of 48-hour adverse events was higher than in the non-HBR subgroup, primarily driven by a higher rate of clinically relevant and major bleeding.

512 ACADEMIC RESEARCH CONSORTIUM HIGH BLEEDING RISK CRITERIA ASSOCIATED WITH ONE-YEAR NACES IN A MULTICENTER COHORT OF OLDEST OLD STEMI PATIENTS

Abstract Introduction The balance between thrombotic and bleeding events after myocardial revascularization is of paramount importance. Patients with higher bleeding risk are at high risk for complications. Age and frailty are also major risk factors for complications. We sought to evaluate the incidence of major bleeding events (BE) and their impact on prognosis in a real life oldest old (i.e. &amp;gt;85 years) ST elevation myocardial infarction (STEMI) patients population. Methods We evaluated all consecutive oldest old STEMI patients hospitalized in two hub-centers between January 2010 and June 2021. Patients were stratified according to Academic Research Consortium for High Bleeding Risk (ARC-HBR) in high bleeding risk (HR) and non-HR (nHR) patients. BE were defined according to the Bleeding Academic Research Consortium (BARC) criteria, BARC 3 or 5. Patients were also divided in groups according to anti-thrombotic therapy (AT) regimens at discharge: single antiplatelet therapy (SAPT), dual antiplatelet therapy (DAPT) or triple therapy (DAPT plus oral anticoagulation) (TT). Net adverse clinical event (NACE) was defined as a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding. Follow-up data were determined from local clinical records during a twelve-months period. Results 340 oldest old (mean age 88.6 ± 2.9 years, 52.6% female) STEMI patients were eligible for the analysis. 161 patients (47.4%) were categorized as nHR and 179 patients (52.6%) as HR. AT regimens at discharge were: 28 patients with SAPT (8.2%), 276 with DAPT (81.2%) and 36 with TT (10.6%). The overall incidence of BE was 4.6% within 12 months, without difference between nHR and HR patients (3.0% vs 5.9%, p=0.16). No BE were found in the SAPT group while the incidence of BE in the HR group was not statistically different between the DAPT and TT regimens (11.2% vs 9.5%; p=0.8). The incidence of NACE was statistically higher in HR than nHR patients (40.9% vs 25.5%, p&amp;lt;0.01) at 1-year. In addition, time-to-NACE was statistically inferior in HR group than nHR group (256.2 days vs 294.2 days, p&amp;lt;0.01) (Figure). Conclusions Our oldest old STEMI population was characterized by a large proportion of HR patients according to ARC-HBR criteria. This population experienced a higher rate of NACE in a shorter time when compared to nHR patients in the same age group.

647 COMPLEX PERCUTANEOUS CORONARY INTERVENTION IN HIGHT BLEEDING AND THROMBOTIC RISK PATIENT: WHICH ANTITHROMBOTIC THERAPY?

Abstract Background Antiplatelet therapy is required in patients with atherosclerotic coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Current European and American guidelines recommend 6 months of DAPT in CCS and 12 months after ACS. However, a shorter duration of DAPT may be considered in high bleeding risk (HBR) patients, and a longer duration in those at higher thrombotic risk (HTR). To minimize the risk of thrombotic and bleeding events of an individual patient and therefore improve the overall outcomes of PCI, risk stratification is essential. In particular, bleeding and thrombotic characteristics must be weighed on a case-by-case basis to tailor antiplatelet therapy strategies and decisions over a patient's individual risk profile. We describe an illustrative case of complex PCI in patient with ACS in which defining the appropriate duration of DAPT is a clinical challenge. Clinical case A 68-year-old man with ACS-NSTEMI and anemia was hospitalized in intensive care unit. His medical history was notable for hypertension, dyslipidemia, diabetes mellitus, diabetic retinopathy, chronic kidney disease (CKD) and paroxysmal atrial fibrillation. A transthoracic echocardiogram showed left ventricular ejection fraction of 30% with diffuse hypokinesia, without relevant valvular disease. He was conducted to the cath-lab for a diagnostic coronary angiogram which showed a three-vessel critical CAD. After Heart Team evaluation coronary artery bypass surgery (CABG) was indicated. However, during the hospitalization in intensive care unit there was a worsening of clinical conditions with cognitive impairment due to mesencephalic stroke leading to a new Heart Team assessment that indicated PCI after stabilization of clinical scenario. After two weeks patient was conducted to the cath-lab to undergoing an IVUS guided PCI. PCI of the right coronary artery was performed with implantation of 1 DES (3.0/30 mm) on the middle segment and 1 DES (4.0/15 mm) on the ostial segment. PCI of the left main bifurcation was performed with implantation of 2 DES (4.0/28 mm) with culotte technique. Patients have both HBR and HTR, therefore, after procedure, the new trade off model score introduced by the Academic Research Consoritum (ARC) was applied. Based on his risk factor, the predicted 1-y risk of BARC type 3 to 5 bleeding (51.41%) was greater than the predicted 1-y risk of myocardial infarction or stroke (25.00%). Based on this result we decided to prescribe Triple antithrombotic therapy for 1 week, dual antithrombotic therapy for 12 months and after only oral anticoagulation. Conclusion In the context of patient with several risk factor undergoing complex PCI the stratification of bleeding and thrombotic individual risk is mandatory to define the appropriate duration of DAPT. The new trade-off model score is an important useful tool to identify patients who might benefit from individualized DAPT durations depending on the balance between HBR and HTR characteristics.

345 INTRAVENOUS CANGRELOR INFUSION IN ELDERLY PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION: A SUBANALYSIS OF THE ICARUS REGISTRY

Abstract Aims To assess the clinical characteristics and compare in-hospital outcomes of elderly and non-elderly patients receiving cangrelor in the peri-percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. Elderly patients were defined if age was ≥75 years at the time of PCI. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Independent predictors of the primary endpoint were also assessed. Results Out of 551 patients undergoing PCI with cangrelor between January 2019 and August 2022, 174 (32%) were elderly. Mean age was 81±5 vs. 61±8 years in elderly vs. non-elderly patients (p&amp;lt;0.001). Female sex (32% vs. 21%, p=0.006), atrial fibrillation (20% vs. 5%, p&amp;lt;0.001), chronic kidney disease (30% vs. 6%, p&amp;lt;0.001) and heart failure (14% vs. 8%, p=0.041) were more frequent in the elderly group, whereas presentation with acute coronary syndrome (ACS) was less frequent (69% vs. 83%, p=0.001). Elderly patients received shorter cangrelor infusion (122±25 vs. 134±43 minutes, p=0.001) and were more frequently administered with clopidogrel after PCI (50% vs. 19%, p&amp;lt;0.001). At 48 hours, elderly patients had higher rates of NACE (13% vs. 6%, p=0.006) and BARC 2, 3 or 5 bleeding (11% vs. 5%, p=0.013), whereas the rates of other 48-hour and in-hospital clinical endpoints did not differ. At multivariable analysis, age ≥75 years (odds ratio [OR] 1.07, 95% CI 1.02-1.12, p=0.004), major anemia (OR 1.10, 95% CI 1.005-1.22, p=0.038), ACS at presentation (OR 1.08, 95% CI 1.03-1.14), femoral access (OR 1.13, 95% CI 1.06-1.22) and cardiogenic shock (OR 1.35, 95% CI 1.21-1.50) independently predicted the occurrence of 48-hour NACE. Conclusions Advanced age is a distinctive risk feature among patients receiving intravenous cangrelor in the peri-PCI phase. Elderly patients had higher rates of adverse events at 48 hours, with advanced age (≥75 years) being an independent predictor of NACE.

902 INCIDENCE, CHARACTERISTICS AND CLINICAL OUTCOMES OF PATIENTS PRESENTING WITH VERSUS WITHOUT CARDIOGENIC SHOCK AND RECEIVING CANGRELOR: AN EXPLORATORY SUBANALYSIS OF THE ICARUS REGISTRY

Abstract Aims To assess the frequency, clinical characteristics, and clinical outcomes of patients presenting with and without cardiogenic shock (CS) among those receiving cangrelor in the peri-percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. Cardiogenic shock was defined as system hypotension (systolic blood pressure &amp;lt; 90 mmHg) despite adequate volume in presence of clinical or laboratory signs of hypoperfusion. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours. Major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, and definite or probable stent thrombosis were evaluated at discharge. Results Out of 551 patients undergoing PCI with cangrelor between January 2019 and August 2022, cardiogenic shock status was available in 550 (99.9%). Among those, 25 (4.5%) presented with CS. Median age was 67 (59-78) vs. 68 (59-77) years in CS vs. non-CS patients (p=0.767). Female sex (44% vs. 24%, p=0.038), presentation with ST-elevation myocardial infarction (84% vs. 42%, p&amp;lt;0.001) and cardiac arrest (46% vs. 4%, p&amp;lt;0.001) were more frequent in the CS group. Likewise, CS patients had higher rates of femoral access (36% vs. 10%, p&amp;lt;0.001), three-vessel PCI (17% vs. 3%, p=0.007), intra-aortic balloon pump implantation (50% vs. 3%, p&amp;lt;0.001) and Gp IIb/IIIa inhibitors use (16% vs. 3%, p=0.005). At 48 hours, CS patients had higher rates of NACE (44% vs. 7%, p&amp;lt;0.001), MACE (12% vs. 1%, p=0.008), cardiovascular death (12% vs. 0.4%, p=0.001), BARC 2, 3 or 5 bleeding (32% vs. 6%, p&amp;lt;0.001), and BARC 3 or 5 bleeding (16% vs. 1%, p=0.001). At multivariable logistic regression, CS independently predicted the occurrence of NACE (odds ratio [OR] 1.29, 95% CI 1.14-1.45, p&amp;lt;0.001) and BARC 3 or 5 bleeding (OR 1.14, 95% CI 1.08-1.21, p&amp;lt;0.001). In-hospital MACE were available in all but one patient, with an event rate that was higher among CS patients (32% vs. 1.3%, log-rank p&amp;lt;0.001). At Cox multivariable analysis, cardiogenic shock was the only independent predictor of in-hospital MACE (hazard ratio [HR] 7.13, 95% CI 1.37-36.8). Conclusions Approximately 5% of patients receiving cangrelor in real-world clinical practice presented with CS. These patients were at higher risk of both ischemic and bleeding events. CS independently predicted the occurrence of 48-hour NACE and major bleeding, as well as in-hospital MACE.

910 PREVALENCE AND PROGNOSTIC IMPACT OF ANAEMIA IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION AND RECEIVING CANGRELOR: A SUBANALYSIS OF THE ICARUS REGISTRY

Abstract Aims To assess the clinical characteristics and compare in-hospital outcomes of patients with and without anaemia receiving cangrelor in the peri-percutaneous coronary intervention (PCI) phase. Methods Consecutive patients treated with cangrelor in 7 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. According to the World Health Organization, anaemia was defined as haemoglobin (Hb) levels &amp;lt; 13 g/dL in men and &amp;lt; 12 g/dL in women; severe anaemia as an Hb value &amp;lt; 11 g/dL irrespective of sex. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours. Major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, myocardial infarction, stroke and definite or probable stent thrombosis were also evaluated at discharge. Results Out of 551 patients undergoing PCI with cangrelor between January 2019 and August 2022, 125 (23%) were anaemic. Mean age was 74±10 vs. 65±11 years in anaemic vs. non-anaemic patients (p&amp;lt;0.001). Baseline haemoglobin significantly differed between the two arms (12±1 vs. 15±1.2 mg/dl, p&amp;lt;0.001); severe anaemia occurred in the 24% of anaemic patients. Atrial fibrillation (20% vs. 6%, p&amp;lt;0.001) and chronic kidney disease (31% vs. 9%, p&amp;lt;0.001) were more frequent among anaemic individuals, in whom clopidogrel was more frequently administered after PCI (42% vs. 25%, p&amp;lt;0.001). At 48 hours, anaemic patients had higher rates of NACE (14% vs. 7%, p=0.019) and BARC 2, 3 or 5 bleeding (12% vs. 5%, p=0.013), whereas the rates of other 48-hour endpoints did not differ. At multivariable analysis, severe anaemia (odds ratio [OR] 1.12, 95% CI 1.02-1.24, p=0.015), acute coronary syndrome at presentation (OR 1.06, 95% CI 1.01-1.12, p=0.013), femoral access (OR 1.12, 95% CI 1.04-1.20, p=0.001) and cardiogenic shock (OR 1.27, 95% CI 1.13-1.44, p&amp;lt;0.001) independently predicted the occurrence of NACE. Complete in-hospital follow-up was available in 549 (99.6%) of patients, with MACE rates being not significantly different between anaemic and non-anaemic patients (2.4% vs. 2.8%, p= 0.593). Conclusions Anaemia is a distinctive risk feature among patients receiving intravenous cangrelor in the peri-PCI phase. Anaemic patients experience higher incidence of adverse events at 48 hours, with severe anaemia being an independent predictor of NACE.

349 INTRAVENOUS CANGRELOR INFUSION IN PATIENTS UNDERGOING COMPLEX VERSUS NON-COMPLEX PERCUTANEOUS CORONARY INTERVENTION: A SUBANALYSIS OF THE ICARUS REGISTRY

Abstract Aims To compare the clinical characteristics and in-hospital outcomes of patients undergoing complex vs. non-complex percutaneous coronary intervention (PCI) with peri-procedural use of cangrelor. Methods Consecutive patients treated with cangrelor in 6 Italian institutions were retrospectively enrolled in the ICARUS (“Intravenous CAngrelor in high-bleeding Risk patients Undergoing percutaneouS coronary intervention”, NCT05505591) registry. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length &amp;gt;60 mm, or chronic total occlusion. The primary endpoint was net adverse clinical events (NACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis and Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding, at 48 hours. Secondary endpoints were assessed at 48 hours and throughout the hospital stay. Results Among 551 patients enrolled in the ICARUS registry and undergoing PCI between January 2019 and August 2022, a total of 534 (97%) patients had complete information on PCI complexity, of whom 173 (32%) underwent complex PCI and 361 (68%) underwent non-complex PCI. In general, patients with complex PCI had similar clinical features compared with non-complex PCI patients, including comparable prevalence of high bleeding risk (HBR) status according to the ARC-HBR definition (35% vs. 30%, p=0.253), but complex PCI patients presented more often with cardiogenic shock (9% vs. 2%, p&amp;lt;0.001). PCI with ≥3 stents implanted was the most frequent criterion of procedural complexity (62%). The incidence of the primary endpoint of 48-hour NACE (10% vs. 7%, p=0.264) and other clinical endpoints occurring at 48 hours or during hospitalization did not differ between complex and non-complex PCI patients. Conclusions Among patients receiving peri-procedural cangrelor, about 30% of cases underwent complex interventions. Notwithstanding higher procedural complexity, short-term clinical outcomes were similar between complex and non-complex PCI patients.

Performance of the HAS-BLED, ORBIT, and ATRIA Bleeding Risk Scores on a Cohort of 399 344 Hospitalized Patients With Atrial Fibrillation and Cancer: Data From the French National Hospital Discharge Database.

Background The association between cancer types and specific bleeding events in patients with atrial fibrillation has been scarcely investigated. Also, the performance of bleeding risk scores in this high-risk subgroup of patients is unclear. We investigated the rate of any bleeding, intracranial hemorrhage, major bleeding, and gastrointestinal bleeding according to cancer types in patients with atrial fibrillation. We also tested the predictive value of HAS-BLED, ATRIA, and ORBIT bleeding risk scores. Methods and Results Observational retrospective cohort study including hospitalized patients with atrial fibrillation and cancer from the French National Hospital Discharge Database (Programme de Medicalisation des Systemes d'Information) from January 2010 to December 2019. Major bleeding was defined according to Bleeding Academic Research Consortium definitions. Patients with HAS-BLED ≥3, ATRIA ≥5, or ORBIT ≥4 were classified as at high bleeding risk. Receiver operating characteristic analysis for each score against any bleeding, major bleeding, gastrointestinal bleeding, and intracranial hemorrhage was performed. Areas under the curve (AUCs) were then compared. We included 399 344 patients. Mean age was 77.9±10.2 years, and 63.2% were men. The highest intracranial hemorrhage rates were found in leukemia (1.89%/year), myeloma (1.52%/year), lymphoma and liver (1.45%/year), and pancreas cancer (1.41%/year). Receiver operating characteristic analysis showed that ORBIT score predicted best for any bleeding. In addition, ORBIT score ≥4 had the highest predictivity for major bleeding (AUC, 0.805), followed by HAS-BLED ≥3 and ATRIA ≥5 (AUCs, 0.716 and 0.700, respectively). HAS-BLED and ORBIT performed best for intracranial hemorrhage (AUCs, 0.744 and 0.742 for continuous scores, respectively), better than ATRIA (AUC, 0.635). For gastrointestinal bleeding, ORBIT ≥4 had the highest predictivity (AUC, 0.756), followed by the HAS-BLED ≥3 (AUC, 0.702) and ATRIA ≥5 (AUC, 0.662). Conclusions Some cancer types carry a greater bleeding risk in patients with atrial fibrillation. The identification and management of modifiable bleeding risk factors is crucial in these patients, as well as to flag up high bleeding risk patients for early review and follow-up.

Real-life trends of anticoagulant prescribing practices for pulmonary embolism – results of a single-center study based on the experience of a multi-profile clinical hospital

Acute pulmonary embolism (APE) is one of the main causes of cardiovascular deaths and anticoagulant treatment plays a key role in preventing recurrent episodes, chronic thromboembolic pulmonary hypertension (CTEPH), and deaths. The aim of this study is to assess the real-life trends and to determine factors associated with the choice of anticoagulation therapy in patients with APE. This is a single center prospective open study. We followed 178 consecutive patients admitted to the tertiary clinical center with APE proven with computed tomography (CT) scan within period of 24 months. A total number of 178 patients with APE were enrolled in the study. 48.9% of subjects were hospitalized in cardiology department. As a prolonged anticoagulant therapy 35.7% of study cohort received direct oral anticoagulants (DOACs), 35.1% LMWH, and 29.2% vitamin K antagonists (VKA), respectively. No statistically significant differences were found between the departments regarding frequency of prescribing anticoagulants (p=0.15). The multivariable analysis showed that oral anti-coagulants (OACs) were less likely to be prescribed than LMWH in patients with malignancy, history of major bleeding, serious medical condition and altered mental status. OACs were preferred over LMWH in symptoms of deep vein thrombosis (DVT). VKA were significantly less likely to be chosen than DOACs in patients with history of orthopaedics procedure. After six months anticoagulation therapy was discontinued in 24.3% of patients. Concluding, the form of anticoagulant therapy was associated with the presence of chronic diseases. LMWH was prescribed in high bleeding risk patients more frequently.

The stent in the high-bleeding risk patient: antiplatelet monotherapy?

Dual antiplatelet therapy (DAPT) is the recommended treatment after percutaneous coronary intervention (PCI). The introduction into clinical practice of new drug-eluting stents (DESs) with significantly improved safety profiles has made it possible to shorten the DAPT. Randomized studies have established the superiority of DES over bare metal stents in high-bleeding risk (HBR) patients treated with antiplatelet monotherapy after 1 month of DAPT from PCI. This regimen has been adopted in randomized trials comparing different DES in patients with HBR. Furthermore, antiplatelet monotherapy after 1 month of DAPT from PCI has been shown to reduce bleeding risk without increasing ischaemic events compared with a conventional DAPT regimen (3-12 months) in a recent randomized study that included HBR patients treated with DES. Parallel to the trend of shortening DAPT, there is growing debate about which antiplatelet monotherapy is optimal after discontinuation of DAPT, with some recent studies exploring the paradigm shift from aspirin monotherapy to P2Y12 inhibitor monotherapy. Finally, future studies are underway to evaluate the clinical effect of monotherapy with ticagrelor or prasugrel directly after implantation of DES thus eliminating DAPT.

High bleeding risk in patients undergoing percutaneous coronary intervention with drug-eluting stent implantation: ReCre8 subanalysis

ObjectivesIn an all-comers cohort undergoing percutaneous coronary intervention (PCI), we aimed to assess prevalence of high bleeding risk (HBR) patients and impact of HBR and dual antiplatelet therapy (DAPT) on clinical events. BackgroundHBR represents a complex subgroup of patients undergoing PCI. MethodsIn the ReCre8 trial, patients undergoing PCI were stratified for troponin status and diabetes and randomized to a permanent polymer zotarolimus-eluting- or polymer-free amphilimus-eluting stent. Patients were treated with 12 months (troponin-positive) or one month (troponin-negative) of DAPT. We evaluated clinical outcomes in patients with and without HBR according to the Academic Research Consortium for High Bleeding Risk criteria. ResultsFrom a total of 1488 patients included in this subanalysis, 406 patients (27.3 %) were identified as being at HBR. Among HBR patients, target-lesion failure (TLF) was similar after one year yet was higher after three years (13.3 % vs. 9.1 %; p = 0.013), compared to non-HBR patients. There was no difference in Bleeding Academic Research Consortium (BARC) 3 to 5 bleeding, however BARC 2 to 5 bleeding was higher after three years with 4.9 % vs. 3.0 % (p = 0.037). There were no differences between troponin-positive (12-months DAPT) and -negative (1-month DAPT) HBR patients with respect to ischemic and bleeding outcomes. ConclusionsIn this all-comers population of PCI patients, a higher TLF rate among HBR patients at long-term follow-up was found, underlining the complexities involving treatment of HBR patients. We did not observe statistically significant differences in BARC 3 to 5 bleeding between HBR and non-HBR patients regardless of DAPT duration. Clinical trial registrationURL: http://www.clinicaltrials.gov, unique identifier: NCT02328898.

Abstract 12805: Incidence and Predictors of Myocardial Infarction or Stent Thrombosis in High-Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention

Introduction: High-bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) are often at high risk for thrombotic complications following coronary stenting. We sought to evaluate the frequency and predictors of myocardial infarction (MI) or stent thrombosis (ST) events in HBR patients at 1 year after PCI. Methods: We included HBR patients undergoing PCI with drug-eluting stent implantation at a tertiary-care center, between 2012 and 2019. HBR status was defined as the presence of ≥1 major or ≥2 minor Academic Research Consortium-HBR criteria. Clinical and angiographic baseline characteristics were analyzed after stratifying patients by the occurrence of MI/ST. Independent predictors of MI/ST at 1-year follow-up were assessed using Cox multivariate regression analysis. Results: Among 7,806 HBR patients undergoing PCI, 245 (3.1%) experienced MI/ST within one year of the index procedure. These patients were more frequently female (42.6% vs. 35.7%, p=0.03), had a higher prevalence of insulin-dependent diabetes mellitus (62.3% vs. 40.5%, p&lt;0.001), peripheral artery disease (18.4% vs. 13.4%, p=0.03), chronic kidney disease (57.1% vs. 52.1%, p=0.006), and a history of prior PCI (57.1% vs. 45.7%, p&lt;0.001). Furthermore, they were more likely to undergo complex PCI (43.3% vs. 32.3%, p&lt;0.001) and had a higher mean syntax score (20.6±12.5 vs. 14.2±10.8, p&lt;0.001). Multivessel disease was the most prevalent and strongest predictor of MI/ST at 1-year follow-up, followed by acute coronary syndrome and diabetes mellitus ( Figure ). Conclusions: MI/ST events frequently occur in HBR patients undergoing PCI. Predictors of MI/ST must be accounted for while deciding on the optimal antithrombotic therapy strategy in these patients.

Abstract 15310: Impact of Peripheral Artery Disease on Outcomes in High-Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention

Introduction: Peripheral artery disease (PAD) has been shown to be related to worse outcomes after percutaneous coronary intervention (PCI). Little is known about the prognostic impact of PAD in patients with concomitant high bleeding risk (HBR) undergoing PCI. Hypothesis: The aim of this study was to assess ischemic and bleeding complications at 1 year after PCI in HBR patients with or without concomitant PAD. We hypothesized that in HBR patients with PAD, the risk of ischemic and, to a lesser extent, bleeding complications would be higher than in non-PAD patients. Methods: Consecutive patients undergoing PCI with drug-eluting stent implantation (DES) at a large tertiary-care center (Mount Sinai Hospital, New York, USA) between 2012 and 2019 and fulfilling the Academic Research Consortium HBR criteria were included. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI) and stroke 1 year after PCI. The key secondary outcome was major bleeding, according to a study specific definition. Results: Out of 7,192 HBR patients, 975 (13.6%) had concomitant PAD. Compared to non-PAD patients, PAD patients were more likely to have cardiovascular risk factors and comorbidities and to undergo a complex PCI. MACE occurred in 93 (11.4%) patients with PAD and 382 (7.3%) without PAD. The increased risk of MACE (HR 1.59, 95% CI 1.27-1.99, p&lt;0.001) was mainly driven by an excess of all-cause death and MI in PAD patients ( Figure 1 ). Bleeding was observed in 80 (8.5%) PAD and 410 (6.9%) non-PAD patients (HR 1.25, 95% CI 0.98-1.59, p=0.066). Conclusions: Among HBR patients undergoing PCI with DES implantation, PAD was associated with a higher risk of MACE and a borderline increase in bleeding events.

Abstract 15084: One- versus Three-Month DAPT in Diabetic Patients With High Bleeding Risk Undergoing PCI: Results From the Xience Short DAPT Global Program

Introduction: In patients at high bleeding risk (HBR), a short dual antiplatelet therapy (DAPT) duration after coronary stenting has been associated with fewer bleeding events and preserved ischemic protection. Whether these effects are maintained in diabetic patients is unclear. Purpose: To assess the safety and efficacy of 1- versus 3-month DAPT after percutaneous coronary intervention (PCI) with stent implantation among HBR patients with or without diabetes. Methods: We included patients from three prospective, international, single-arm studies (XIENCE Short DAPT Program), which enrolled HBR patients successfully treated with a fluoropolymer-based cobalt-chromium everolimus-eluting stent (XIENCE, Abbott). Subjects were eligible for DAPT discontinuation at 1 month (XIENCE 28 USA and Global) or at 3 months (XIENCE 90), if free from ischemic events and adherent to DAPT. The primary endpoint was the composite of all-cause death or any myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding. Outcomes were assessed between 1 and 12 months after index PCI using propensity score adjustment. Results: Out of 3,352 patients, 1,299 (38.8%) had diabetes. The rate of death or MI at 12 months was higher in diabetic than in non-diabetic patients (10.1% vs 6.6%) while the rate of BARC 2-5 bleeding was similar (9.5% vs 9.2%). A one v. three months of DAPT duration resulted in a borderline reduction in death or MI (adj. HR 0.70, 95% CI 0.47-1.05) in diabetic but not in non-diabetic patients (adj. HR 1.24, 95% CI 0.86-1.79; p-interaction=0.016) and fewer BARC 2-5 bleeding in both groups (adj. HR 0.67, 95% CI 0.45-1.01 and adj. HR 0.77, 95% CI 0.56-1.06, respectively; p-interaction=0.950). Conclusions: Among HBR patients undergoing everolimus-eluting stent implantation, diabetic patients derive important benefit in reducing death and MI and bleeding events from a one month compared with three-month DAPT duration.