Bleeding Academic Research Consortium Classification Research Articles

Predictive Value of HAS-BLED and HEMORR2HAGES Bleeding Risk Scores After Percutaneous Coronary Intervention.

Various scoring systems have been developed to assess the risk of bleeding in medical settings. HAS-BLED and HEMORR2HAGES risk scores are commonly used to estimate bleeding risk in patients receiving anticoagulation for atrial fibrillation, but data on their predictive value in patients undergoing percutaneous coronary intervention (PCI) are limited. This study evaluated and compared the predictive abilities of the HAS-BLED and HEMORR2HAGES bleeding risk scores in all-comer patients undergoing PCI. The PARIS score, specifically designed for patients undergoing PCI, was used as a comparator. The scores were calculated at baseline and compared with the occurrence of events during a 2-year clinical follow-up period. Between 2015 and 2017, all consecutive patients undergoing PCI we re prospectively enrolled and divided into risk tertiles based on bleeding risk scores. The primary end points were hierarchical major bleeding events, defined by Bleeding Academic Research Consortium types 3 through 5, and patient-oriented composite end points according to Bleeding Academic Research Consortium classification, which were assessed during the 2-year follow-up period. A total of 1,080 patients completed the follow-up period. Two years after index, 189 patients (17.5%) had experienced any bleeding, with 48 events (4.4%) classified as Bleeding Academic Research Consortium types 3 to 5. All bleeding risk scores showed statistically significant predictive ability for bleeding events. The HEMORR2HAGES score (C statistic, 0.73) was more effective than the HAS-BLED score (C statistic, 0.66; P = .07) and the PARIS score (C statistic, 0.66; P = .06) in predicting risk of major bleeding. Patients in high-risk bleeding groups also experienced a higher incidence of patient-oriented composite end points. The HEMORR2HAGES, HAS-BLED, and PARIS risk scores exhibited good predictive abilities for bleeding events following PCI. Patients at high risk of bleeding also demonstrated increased ischemic risk and higher mortality during the 2-year follow-up period.

Ultrasound-guided venipuncture of femoral veins vs standard palpation approach in patients undergoing pulmonary veins isolation

Abstract Introduction Complications related to vascular access frequently arise during transcatheter atrial fibrillation (AF) ablation. Vascular access related complications remain the main cause of procedure related adverse events. In the literature, there is no clear evidence supporting the benefit of ultrasound-guided (USG) vascular access. Purpose We hypothesized that USG venipuncture could reduce vascular complication rates and reduce the need for additional interventions due to complications related to vascular access. Methods We conducted a single-center retrospective study. The primary endpoint was the rate of major complications, defined as arteriovenous fistula, pseudoaneurysm, and groin hematoma with Bleeding Academic Research Consortium (BARC) classification ≥ 2 requiring interventions such as transfusions or surgical/percutaneous repair and/or resulting in hospital prolongation or readmission). The secondary endpoints were the rate of minor complications, defined as groin hematoma with BARC classification = 1 or bleeding without sequelae, and the composite rate of additional non-scheduled exams and procedures due to vascular complications. The study included all patients who underwent atrial fibrillation ablation with radiofrequency (RF) between January 2020 and December 2022 in our center, performed by two expert operators: one utilizing a classic palpation (BLIND) approach and the second one employing the USG approach. Identical materials were used for access in both groups, and the choice of protamine administration or closure method was decided by the operator on a case by case basis. In total, there were 946 patients, 352 in USG group and 594 in BLIND group. For patients in both groups who were on vitamin K antagonists (VKAs), uninterrupted administration with an international normalized ratio (INR) ratio between 2.0 and 3.0 was required. Results Major complications were significantly reduced in the USG group compared to the BLIND group (0 (0%) in USG vs. 9 (1.5%) in BLIND, P = 0.02). No significant difference was observed in minor complications between the two groups (3 (0.8%) in USG vs. 6 (1.0%) in BLIND, P = 0.809). During hospitalization or readmission, 3 additional non-scheduled exams/procedures were required (3 vascular echos) in the USG group, while 33 were needed in the BLIND group (23 vascular echos, 6 thrombin injections, 2 surgical procedures and 2 CT-Angio) with a significative reduction (P 0.034). Conclusions USG venipuncture was associated with a reduction in major complication rates and a decrease in additional exams required during hospitalization or readmission. However, it did not lead to a reduction in minor complications. These findings support the use of ultrasound in AF ablation procedures to avoid access related complications requiring intervention.Baseline CharacteristicsSummary

Bleeding complications, coagulation disorders, and their management in acute myocardial infarction-related cardiogenic shock rescued by veno-arterial ECMO: A retrospective cohort study

PurposeManagement of dual antiplatelet therapy (DAPT) in patients on venoarterial-extracorporeal membrane (VA-ECMO) after acute myocardial infarction (AMI) is challenging. Our objective was to describe the frequency, management and outcomes of severe bleeding complications and determine their occurrence risk factors. Material and methodsWe conducted a retrospective observational cohort study including post-AMI cardiogenic shock patients requiring VA-ECMO. Severe bleeding was defined based on the Bleeding Academic Research Consortium classification. We calculated multivariable Fine–Gray models to assess factors associated with risk of severe bleeding. ResultsFrom January 2015 to July 2019, 176 patients received VA-ECMO after AMI and 132 patients were included. Sixty-five (49%) patients died. Severe bleeding occurred in 39% of cases. Severe thrombocytopenia (< 50 G/L) and hypofibrinogenemia (<1,5 g/L) occurred in respectively 31% and 19% of patients. DAPT was stopped in 32% of patients with a 6% rate of stent thrombosis. Anticoagulation was stopped in 39% of patients. Using a multivariate competing risk model, female sex, time on ECMO, troponin at admission and Impella® implantation were independently associated with severe bleeding. ConclusionsBleeding complications and coagulation disorders were frequent and severe in patients on VA-ECMO after AMI, leading of antiplatelet therapy withdrawal in one third of patients.

Safety and efficacy of NOAC vs. VKA in patients treated by PCI: a retrospective study of the FRANCE PCI registry.

Dual antithrombotic therapy (DAT) combining oral anticoagulation (OAC), preferentially Non-vitamin K antagonist OAC (NOAC) and single antiplatelet therapy (SAPT) for a period of 6-12 months is recommended after percutaneous coronary intervention (PCI) in patients with an indication for OAC. To compare outcomes between vitamin K antagonist (VKA) and NOAC-treated patients in the nation-wide France PCI registry. All consecutive patients from the France PCI registry treated by PCI and discharged with OAC between 2014 and 2020 were included and followed one-year. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) classification ≥3 and major adverse cardiac events (MACE) as the composite of all-cause mortality, myocardial infarction (MI), and ischemic stroke. A propensity-score analysis was used. Of the 7,277 eligible participants, 2,432 (33.4%) were discharged on VKA and 4,845 (66.6%) on NOAC. After propensity-score adjustment, one-year major bleeding was less frequent in NOAC vs. VKA-treated participants [3.1% vs. 5.2%, -2.1% (-3.6% to -0.6%), p = 0.005 as well as the rate of MACE [9.2% vs. 11.9%, -2.7% (-5.0% to -0.4%), p = 0.02]. One-year mortality was also significantly decreased in NOAC vs. VKA-treated participants [7.4% vs. 9.9%, -2.6% (-4.7% to -0.5%), p = 0.02]. The area under ROC curves of the anticoagulant treatment propensity score was estimated at 0.93, suggesting potential indication bias. NOAC seems to have a better efficacy and safety profile than VKA. However, potential indication bias were found.

Meta-analysis of 3-month vs 12-month dual anti-platelet therapy after percutaneous coronary intervention

Abstract Background The optimal duration of dual antiplatelet therapy (DAPT) in the era of second generation drug-eluting stents is a matter of debate as increasing evidence suggests that shorter periods of DAPT are feasible and reduce bleeding events. However, the non-inferiority design of the published trials regarding ischemic events still raises doubt on its effectiveness. Methods We performed a meta-analysis to evaluate short-term (≤ 3 months) vs long-term (≥ 12 months) DAPT after percutaneous coronary intervention (PCI). PubMed, Embase and Cochrane Central were searched from inception to February 2023 to identify randomized controlled trials that compared outcomes of patients between these two regimens. Primary outcome of interest included a composite of ischemic events (cardiovascular death, myocardial infarction, re-revascularization and stroke) and secondary outcome was major bleeding as assessed by Bleeding Academic Research Consortium (BARC) classification ≥ 3 after 1 year of follow up. Event rates were extracted and Mantel-Haenszel fixed-effects model was used to perform the meta-analysis. Results We identified a total of 5 trials with 18.682 randomized patients. The use of short-term DAPT was not associated with increased risk of ischemic events (0.90 [0.75-1.08], p=0.250; Figure 1) and was associated with reduced risk of major bleeding (0.74 [0.65-0.84], p&amp;lt;0.001; Figure 2). Conclusion The present meta-analysis provides an updated data on the use of DAPT duration. Short-term DAPT appears to be equivalent to long-term DAPT regarding ischemic risk and a superior strategy in optimizing bleeding risk reduction.Forest plot of ischemic outcomesForest plot of bleeding outcomes

The contributionof genotype-guided selection of P2Y12 inhibitor on prognosis in ACS /CCS patients undergoing percutaneous coronary intervention: aretrospective cohort study.

We aimed to explore the contribution of genotype-guided selection of P2Y12 inhibitors on prognosis in Chinese patients with acute coronary syndromes (ACS) or chronic coronary syndromes (CCS) undergoing percutaneous coronary intervention (PCI). Totally, 2063 patients were included. They were divided into empiric treatment group (n = 1025) and individualized treatment group (n = 1038) depending on whether taken CYP2C19 genetic testing. The incidences of clinical endpoint events were compared in two groups at 1-year follow-up. The effective endpoint events were major adverse cardiovascular events (MACEs), including all-cause mortality, in-stent restenosis, nonfatal myocardial infarction, nonfatal stroke and severe recurrent ischemia. Meanwhile, the safe endpoint was bleeding events defined by the Bleeding Academic Research Consortium (BARC) criteria. Finally, 66.83% patients were diagnosed with ACS and 33.17% patients were diagnosed with CCS in empiric group. 68.11% patients were diagnosed with ACS and 31.89% patients were diagnosed with CCS in individualized group. At 1-year follow-up, individualized group showed lower MACEs rate than empiric group (19.61% vs. 10.69%, HR: 1.915; 95% CI: 1.534 to 2.392; P < 0.0001, log-rank test; adjusted HR: 1.983; 95% CI: 1.573 to 2.501; P = 0.000, cox proportional hazards regression models), while bleeding events were significantly less common in empiric group than in individualized group (7.32% vs. 10.40%, HR: 0.693; 95% CI: 0.519 to 0.926; P = 0.0132, log-rank test; adjusted HR: 0.695; 95% CI: 0.518 to 0.933; P = 0.016, cox proportional hazards regression models). It was mainly manifested in BARC class 1 bleeding, which did not warrant the interruption of antiplatelet therapy (ITA). Further, subgroup analyses illustrated that no significant difference existed in cumulative MACEs-free survival rate between all treatment arms of individualized group (P = 0.6579 by log-rank test), and CYP2C19 intermediate metabolizer (IM) genetype appeared to be significantly associated with bleeding events for patients treated with ticagrelor (clopidogrel vs. ticagrelor: 6.80% vs. 14.88%; adjusted HR:0.440; 95% CI: 0.246 to 0.787; adjusted P = 0.006). Genotype-guided selection of P2Y12 inhibitor made a very positive contribution on the prognosis in Chinese ACS/CCS patients undergoing PCI. Instead of intensifying antiplatelet strategies, conventional-dose clopidogrel could be recommended as P2Y12 inhibitor after weighing MACEs and bleeding events in CYP2C19 IM patients.

PO-01-140 ATRIAL FIBRILLATION AND SEPTIC SHOCK: A FIVE-YEAR RETROSPECTIVE OBSERVATIONAL STUDY OF ANTICOAGULATION USAGE, BLEEDING AND STROKE RATES

Anticoagulation (AC) for atrial fibrillation (AF) is a cornerstone of management, and the benefit of mitigating stroke risk is accompanied by an increased risk of bleeding. The risk and benefit of AC in septic shock remains unclear as this disruptive hyperinflammatory state leads to multi-organ dysfunction, which can include coagulopathies. To further understand the risk of bleeding and stroke in patients with AF and septic shock, we aimed to study the rates of these events in addition to AC usage for this population between 2016 and 2020. In this retrospective observational study, we used ICD-10 coding to identify patients with AF and septic shock. Initial query found 604 patients. 52 were excluded for the absence of AF and 24 were excluded for requiring AC for other reasons. Admission for septic shock and evidence of AF on electrocardiogram were confirmed through chart review. Bleeding was defined using the Bleeding Academic Research Consortium (BARC) classification system. For 528 patients, mean age was 64.8 years, 325 (61.6%) were male, and 203 (38.4%) were female. 314 died (59.5%) and 227 (43%) had new-onset AF. Mean CHA2DS2-Vasc and HAS-BLED scores were 3.2 and 2.6, respectively. AC was started for 195 patients (36.9%), not started for 289 (54.7%), and continued for 43 (8.1%). AC was stopped for 74/195 (38.3%) patients after starting AC and for 20/43 (46.5%) patients after continuing AC. 157 had bleeding episodes (29.7%): 9 BARC 1 (1.7%), 46 BARC 2 (8.7%), 63 BARC 3a (11.9%), 20 BARC 3b (3.8%), 6 BARC 3c (1.1%), 5 BARC 4 (0.9%), 3 BARC 5a (0.6%), and 5 BARC 5b (0.9%). After starting AC, 70/195 (35.9%) patients bled, and this included all fatal bleeding cases. Bleeding occurred in 11/43 (25.6%) patients after continuing AC and 76/289 (26.3%) patients after not starting AC. 8 (1.5%) patients had a stroke: 4 hemorrhagic and 4 ischemic. 3 hemorrhagic strokes occurred after starting AC and 1 occurred after not starting AC. 1 ischemic stroke occurred after starting AC and 3 after not starting AC. In patients with AF and septic shock, we found that bleeding occurred more often and with the highest severity after starting AC. The rate of bleeding when not starting AC may indicate an increased baseline risk associated with sepsis. Notably, the rate of ischemic stroke was relatively low, which may suggest that bleeding risk may outweigh the benefit of stroke prevention in this population. Further studies are needed to optimize AC strategies for these patients.

Percutaneous coronary intervention with Impella support with and without intra-aortic balloon in cardiogenic shock patients

ObjectiveTo assess the clinical characteristics and in-hospital bleeding complications and major adverse cardiac and cerebrovascular events (MACCE) associated with the use of Impella alone or the combination of an intra-aortic balloon pump (IABP) with Impella in cardiogenic shock (CS) patients undergoing percutaneous coronary intervention (PCI). MethodsAll CS patients who underwent PCI and were treated with an Impella mechanical circulatory support (MCS) device were identified. Patients were divided into two groups: having MCS support with Impella alone or with both, IABP and Impella simultaneously (dual MCS group). Bleeding complications were classified by a modified Bleeding Academic Research Consortium (BARC) classification. Major bleeding was defined as BARC≥3 bleeding. MACCE was the composite of in-hospital death, myocardial infarction, cerebrovascular events and major bleeding complications. ResultsBetween 2010 and 2018 a total of 101 patients were treated at six tertiary care New York hospitals with either Impella (n = 61) or dual MCS with Impella and IABP (n = 40). Clinical characteristics were similar for both groups. Dual MCS patients presented more often with a STEMI (77.5 % vs. 45.9 %, p = 0.002) and had left main coronary artery intervention (20.3 % vs. 8.6 %, p = 0.03). Major bleeding complications (69.4 % vs. 74.1 %, p = 0.62) and MACCE rates (80.6 % vs. 79.3 %, p = 0.88) were very high but similar in both groups, however access site bleeding complications were lower in patients treated with dual MCS. In-hospital mortality was 29.5 % for the Impella group and 25.0 % for the dual MCS group (p = 062). Access site bleeding complications were lower in in patients treated with dual MCS (5.0 % vs. 24.6 %, p = 0.01). ConclusionIn CS patients undergoing PCI with either the Impella device alone or with Impella and IABP, major bleeding complications and MACCE rates were high but not significantly different between the two groups. In hospital mortality was relatively low in both MCS groups despite the high-risk characteristics of these patients. Future studies should assess the risks and benefits of the simultaneous use of these two MCS in CS patients undergoing PCI.

Feasibility and efficacy of delayed pharmacoinvasive therapy for ST-elevation myocardial infarction.

ST-elevation myocardial infarction (STEMI) refers to a clinical syndrome that features symptoms of myocardial ischemia with consequent ST-elevation on electrocardiography and an associated rise in cardiac biomarkers. Rapid restoration of brisk flow in the coronary vasculature is critical in reducing mortality and morbidity. In patients with STEMI who could not receive primary percutaneous coronary intervention (PCI) on time, pharmacoinvasive strategy (thrombolysis followed by timely PCI within 3-24 h of its initiation) is an effective option. To analyze the role of delayed pharmacoinvasive strategy in the window period of 24-72 h after thrombolysis. This was a physician-initiated, single-center prospective registry between January 2017 and July 2017 which enrolled 337 acute STEMI patients with partially occluded coronary arteries. Patients received routine pharmacoinvasive therapy (PCI within 3-24 h of thrombolysis) in one group and delayed pharmacoinvasive therapy (PCI within 24-72 h of thrombolysis) in another group. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) within 30 d of the procedure. The secondary endpoints included major bleeding as defined by Bleeding Academic Research Consortium classification, angina, and dyspnea within 30 d. The mean age in the two groups was comparable (55.1 ± 10.1 years vs 54.2 ± 10.5 years, P = 0.426). Diabetes was present among 20.2% and 22.1% of patients in the routine and delayed groups, respectively. Smoking rate was 54.6% and 55.8% in the routine and delayed groups, respectively. Thrombolysis was initiated within 6 h of onset of symptoms in both groups (P = 0.125). The mean time from thrombolysis to PCI in the routine and delayed groups was 16.9 ± 5.3 h and 44.1 ± 14.7 h, respectively. No significant difference was found for the occurrence of measured clinical outcomes in the two groups within 30 d (8.7% vs 12.9%, P = 0.152). Univariate analysis of demographic characteristics and risk factors for patients who reported MACCE in the two groups did not demonstrate any significant correlation. Secondary endpoints such as angina, dyspnea, and major bleeding were non-significantly different between the two groups. Delayed PCI pharmacoinvasive strategy in a critical diseased but not completely occluded artery beyond 24 h in patients who have been timely thrombolyzed seems a reasonable strategy.

Apixaban in Patients With Post-Myocardial Infarction Left Ventricular Thrombus: A Randomized Clinical Trial

BackgroundDirect oral anticoagulants are frequently used to treat post-myocardial infarction (MI) left ventricular thrombus (LVT). This study was conducted to evaluate the efficacy and safety of use of apixaban, compared to the standard warfarin therapy, in post-MI LVT. MethodsThis open-label, randomized controlled trial included patients with post-acute or recent anterior wall MI with transthoracic echocardiography-confirmed LVT. Patients were randomized to receive either apixaban 5 mg twice daily or warfarin to achieve an international normalized ratio of 2-3, in addition to dual antiplatelet therapy. The primary endpoint was LVT resolution at 3 months, with a noninferiority margin of 95% for apixaban compared to warfarin. The secondary endpoint was major adverse cardiovascular events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification. ResultsFifty patients were enrolled from 3 centres. The use of dual or single antiplatelet agents was similar in the 2 groups. The number of 1-, 3-, and 6-month LVT resolutions were 10 (40.0%), 19 (76.0%), and 23 (92.0%) in the apixaban group, and 14 (56%), 20 (80.0%), and 24 (96.0%) in the warfarin group, respectively, without significant differences (P < 0.036 for noninferiority at 3 months). Patients taking warfarin required longer hospital stays and more outpatient visits. Multivariate adjustment analysis revealed left ventricular aneurysm, larger baseline LVT area and lower left ventricular ejection fraction to be independent predictors of LVT persistence at 3 months. No MACE occurred in either group; 1 BARC-2 bleeding event occurred with warfarin. ConclusionsApixaban was not inferior to warfarin in the resolution of post-MI LVT.

Abstract 14328: The Impact of Peripheral Arterial Disease in Major Bleeding and Major Cardiac and Cerebrovascular Events in Patient Undergoing Percutaneous Coronary Intervention: A Contemporary Assessment

Introduction: Peripheral arterial disease (PAD) has been associated with adverse outcomes in patients undergoing percutaneous coronary intervention (PCI). However, there are controversial reports regarding its impact in the current era of radial interventions. Hypothesis: We assessed the hypothesis that patients with PAD and patients without PAD undergoing PCI have similar major bleeding complications and major adverse cardiac and cerebrovascular events (MACCE). Methods: This was a retrospective analysis of data collected from 6 New York metropolitan area tertiary care hospitals and submitted to the NCDR between 2010 and 2018. Major bleeding events were classified using Bleeding Academic Research Consortium (BARC) classification. Severe bleeding was defined as a BARC ≥3. Hierarchical logistic regression was utilized to assess the association of PAD with post-PCI adverse outcomes, as appropriate. Results: A total of 2,933 PAD patients (9.4%) underwent PCI (without PAD, n = 28,172). Results are shown in the Table. PAD patients had a significantly higher odds of MACCE and major bleeding complications, including blood transfusions and in-hospital mortality. Access site bleeding and the need for post PCI dialysis did not reach statistical significance. A multivariable analysis will be presented. Conclusions: In conclusion, PAD continues to be a major risk factor for patients undergoing PCI. When compared with patients without PAD, these patients are at an increased risk of major adverse outcomes, including a 67% increase in mortality risk and a 44% in major bleeding complications risk.

Are There Differences in the Demographics and Clinical Outcomes Between Asian and European Patients Treated With the COMBO Dual Therapy Stent in the REDUCE Trial Populations?

Background: This study aimed to assess differences in clinical characteristics and outcomes between Asian and European patients treated with the COMBO dual therapy stent in the REDUCE trial. Methods: In the REDUCE trial, 1,496 patients who underwent successful COMBO stent implantation were randomised to 3- or 12-month dual antiplatelet therapy groups. Of these, 449 (30%) were Asian and 1,047 (70%) were European. Given that no significant differences were observed between the 3- and 12-month dual antiplatelet therapy cohorts for both sites, the overall data of Asian patients were compared with those of European patients in terms of clinical characteristics and outcomes. Results: The Asian cohort was younger and comprised fewer women than the European cohort. They also had more cases of type 2 diabetes (33.0% versus 15.1%), hypercholesterolaemia (54.6% versus 41.7%) and hypertension (55.7% versus 48.5%) but had fewer previous interventions compared with European patients. Regarding procedures, Asian patients had more cases of infarct-related vessel in the left anterior descending artery. The primary endpoint indices among Asian patients at 90, 180, 360 and 720 days were lower than those among European patients, which can be attributed to the lower number of cases of target-vessel revascularisation, bleeding (Bleeding Academic Research Consortium classification II, III or V) and MI among the Asian cohort. Conclusion: Despite having a higher incidence of cardiovascular risk factors, more ST-elevation MI cases and more cases of culprit lesion located at the proximal left anterior descending artery, Asian patients in the REDUCE trial showed lower trends of target-vessel revascularisation, bleeding and MI than European patients in the REDUCE trial.

A pilot randomised trial of catheter-directed thrombolysis or standard anticoagulation for patients with intermediate-high risk acute pulmonary embolism.

Intermediate-high risk acute pulmonary embolism (PE) remains associated with substantial mortality despite anticoagulation therapy. The aim of this randomised pilot study was to compare catheter-directed thrombolysis to standard anticoagulation therapy. Intermediate-high risk acute PE patients were admitted to a tertiary care centre (November 2019 to April 2021) and randomised in a 1:1 ratio to catheter-directed thrombolysis (CDT) or standard anticoagulation. Two catheters were used for the infusion of alteplase (1 mg/hr/catheter; total dose 20 mg) in the CDT group. The primary efficacy endpoint targeted improvement of right ventricular (RV) function, a decrease in pulmonary pressure, and a reduction of thrombus burden. Twenty-three patients were included (12 in the CDT group and 11 in the standard care group). The primary efficacy endpoint was achieved more frequently in the CDT group than in the standard care group (7 of 12 patients vs 1 of 11 patients, p=0.0004). An RV/left ventricular ratio reduction ≥25% (evident on computed tomography angiography) was achieved in 7 of 12 patients in the CDT group vs 2 of 11 patients in the standard care group (p=0.03). A systolic pulmonary artery pressure decrease of ≥30% or normotension at 24 hrs after randomisation was present in 10 of 12 patients in the CDT group vs 2 of 11 patients in the standard care group (p=0.001). There was no intracranial or life-threatening bleeding (type 5 or 3c bleeding, according to the Bleeding Academic Research Consortium classification). CDT for intermediate-high risk acute PE appears to be safe and effective. Further research is warranted to assess clinical endpoints.

Reduction of Gastrointestinal Bleeding in Patients With Heyde Syndrome Undergoing Transcatheter Aortic Valve Implantation.

Background:Heyde syndrome is the co-occurrence of aortic stenosis and gastrointestinal bleeding secondary to angiodysplasias. Surgical aortic valve replacement effectively reduces bleeding, but the effects of transcatheter aortic valve implantation (TAVI) are largely unknown. This study aimed to describe the reduction of gastrointestinal bleeding in patients with Heyde syndrome after TAVI and to identify the factors associated with rebleeding.Methods:We enrolled patients with Heyde syndrome from a prospective TAVI registry. Gastrointestinal bleeding episodes were assessed by the Bleeding Academic Research Consortium classification, and cumulative incidence functions were used to calculate cessation rates. Factors potentially associated with rebleeding were analyzed using logistic regression. Differences between Heyde and non-Heyde patients were assessed through a case-cohort study.Results:Between December 2008 and June 2020, 1111 patients underwent TAVI. There were 70 patients with Heyde syndrome (6.3%). In the first year following TAVI, gastrointestinal bleeding ceased in 46 of 70 patients (62% [95% CI, 50%–74%]). Bleeding episodes decreased from 3.2 (95% CI, 2.5–4.2) to 1.6 ([95% CI, 1.2–2.2] P=0.001) and hemoglobin levels increased from 10.3 (95% CI, 10.0–10.8) to 11.3 (95% CI, 10.8–11.6) g/dL (P=0.007). Between 1 and 5 years after TAVI (35 [interquartile range, 21–51] months), 53 of 62 patients (83% [95% CI, 72%–92%]) no longer experienced gastrointestinal bleeding. Paravalvular leakage (≥mild) was associated with rebleeding risk (odds ratio, 3.65 [95% CI, 1.36–9.80]; P=0.010). Periprocedural bleeding was more common in Heyde than in control patients (adjusted odds ratio, 2.55 [95% CI, 1.37–4.73]; P=0.003).Conclusions:Patients with Heyde syndrome are at increased risk for periprocedural bleeding. Post-TAVI, gastrointestinal bleeding disappears in the majority of patients. Paravalvular leakage may curtail these clinical benefits.

Dual versus triple antithrombotic therapy after percutaneous coronary intervention: the prospective multicentre WOEST 2 Study.

For patients on oral anticoagulants (OAC) undergoing percutaneous coronary intervention (PCI), European guidelines have recently changed their recommendations to dual antithrombotic therapy (DAT; P2Y12 inhibitor and OAC) without aspirin. The prospective WOEST 2 registry was designed to obtain contemporary real-world data on antithrombotic regimens and related outcomes after PCI in patients with an indication for OAC. In this analysis, we compare DAT (P2Y12 inhibitor and OAC) to triple antithrombotic therapy (TAT; aspirin, P2Y12 inhibitor, and OAC) on thrombotic and bleeding outcomes after one year. Clinically relevant bleeding was defined as Bleeding Academic Research Consortium classification (BARC) grade 2, 3, or 5; major bleeding as BARC grade 3 or 5. Major adverse cardiac and cerebrovascular events (MACCE) was defined as a composite of all-cause mortality, myocardial infarction, stent thrombosis, ischaemic stroke, and transient ischaemic attack. A total of 1,075 patients were included between 2014 and 2021. Patients used OAC for atrial fibrillation (93.6%) or mechanical heart valve prosthesis (4.7%). Non-vitamin K oral anticoagulants (NOAC) were prescribed in 53.1% and vitamin K antagonists in 46.9% of patients. At discharge, 60.9% received DAT, and 39.1% TAT. DAT was associated with less clinically relevant and similar major bleeding (16.8% vs 23.4%; p<0.01 and 7.6% vs 7.7%, not significant), compared to TAT. The difference in MACCE between the two groups was not statistically significant (12.4% vs 9.7%; p=0.17). Multivariable adjustment and propensity score matching confirmed these results. Dual antithrombotic therapy is associated with a substantially lower risk of clinically relevant bleeding without a statistically significant penalty in ischaemic events.

Adherence to guidelines improves outcomes in coronary artery surgery

The present study in the current issue of the EJCTS addressed the highly relevant issue of prognostic impact of secondary prevention after coronary artery bypass grafting (CABG) [1, in this issue]. Unfortunately, disparities in the adherence to guideline recommended therapies after CABG still exist even though different guidelines have emerged as easily available tool to conduct the best evidence-based clinical practice. In the present analysis [1, in this issue], authors included all participants of the TiCAB study [2] aiming to evaluate the effect of guideline-adherent medical secondary prevention on 1-year outcome after CABG [1, in this issue]. TiCAB study enrolled coronary artery disease patients who were scheduled for CABG [2]. The primary outcome was the composite of cardiovascular death, myocardial infarction, repeat revascularization and stroke 12 months after CABG [2]. The main safety end-point was based on the Bleeding Academic Research Consortium classification [2, 3]. The need for dual antiplatelet therapy (DAPT) after surgery was considered as one of the major exclusion criteria [2]. About 25% of patients scheduled for CABG are expected to present with an Acute Coronary Syndrome (ACS) [2]. Thus, patients requiring DAPT after CABG were unfortunately not analysed in this study [1, in this issue]. It would be valuable to elucidate how would the inclusion of the aforementioned subgroup of patients influence the adherence to the guidelines [4]. Furthermore, it would be even more interesting how this adherence in the DAPT subgroup would reflect the clinical outcomes, be it the composite main outcome or the main safety end-point as defined in TiCAB [2].

In-Hospital Bleeding in Elderly Patients With Acute Coronary Syndrome: Are Potent Antiplatelet Agents Safe?

Despite implementation of new interventional techniques and therapeutic advances, elderly patients with acute coronary syndrome (ACS) continue to be susceptible to in-hospital bleeding compared with younger ones. Thus, we investigated the incidence of in-hospital bleeding events and associated risk factors in elderly (≥ 75°years) ACS patients. We also wanted to define the bleeding sites, characteristics, and associated mortality. Bleeding Academic Research Consortium (BARC) classification type 2, 3, or 5 was used to define bleeding events. Overall, 539 patients were included in the study (mean age: 82.5 ± 4.8°years; 282 (52.3%) females). Of these patients, 69 (12.8%) developed in-hospital bleeding. Factors that were independently related with in-hospital bleeding were age (odds ratio (OR): 1.08; 95% confidence interval (CI): 1.011.14, P = .01), acute kidney injury (OR: 3.66; 95% CI: 2.016.69; P < .01), tirofiban (OR: 4.43; 95% CI: 1.7810.99; P < .01), and ticagrelor (OR: 1.93; 95% CI: 1.013.73; P = .04) administration. The urinary tract was the most frequent bleeding site, followed by femoral arteries. In conclusion, ticagrelor and tirofiban should be used with caution in elderly ACS patients.

Predictive performance of different bleeding risk scores in patients with atrial fibrillation and acute coronary syndrome or undergoing percutaneous coronary intervention

Abstract Background Standard scoring system for bleeding risk assessment has not been developed in patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). The study aims to evaluate the predictive value of the HAS-BLED, ORBIT, ARTIA, PARIS, and PRECISE-DEAPT score in patients with AF and ACS/PCI who received both anticoagulant and antiplatelet therapy. Methods A total of 930 patients with AF and ACS/PCI receiving both anticoagulant and antiplatelet therapy were consecutively recruited and followed up for 1 year. The primary endpoint was defined according to the bleeding academic research consortium (BARC) criteria as major (BARC 3a, 3b, 3c, and 5) and any bleeding (BARC 2, 3a, 3b, 3c, and 5). The secondary endpoints included major or minor bleeding according to TIMI criteria. Univariate and multivariate logistic regression were performed to evaluate the association between bleeding risk scores and outcomes. Receiver operating characteristic (ROC) curves were constructed and c-statistics were calculated to evaluate the predictive performance of different bleeding risk scores. Results BARC class ≥2 bleedings occurred in 36 patients (3.9%), while BARC class ≥3 bleedings were seen in 134 patients (14.4%). The HAS-BLED, ORBIT, ARTIA, PARIS, and PRECISE-DEAPT score were significantly associated with incidences of BARC class ≥2 and ≥3 bleedings during 1-year follow-up (all p&amp;lt;0.05). The ROC analysis showed that the predictive performance of the five bleeding risk scores for BARC class ≥3 bleedings were low-to-moderate [c-statistic: HASBLED 0.584 (0.552–0.616), ATRIA 0.624 (0.592–0.655), ORBIT 0.623 (0.591–0.654), PARIS 0.633 (0.601–0.664), PRECISEDAPT 0.616 (0.584–0.647)]. Multivariable logistic regression indicated that previous bleeding history and hemoglobin were independent predictors of BARC class ≥3 bleedings. Compared to the HAS-BLED score, the model constructed by previous bleeding history and hemoglobin displays a significant improvement in bleeding risk prediction (0.704 vs. 0.584, p=0.013). Conclusions In patients with AF and ACS/PCI receiving both anticoagulant and antiplatelet therapy, the HAS-BLED, ORBIT, ARTIA, PARIS, and PRECISE-DEAPT score displayed low-to-moderate performance for predicting BARC class ≥3 bleedings during 1-year follow-up. More accurate scoring systems for bleeding risk evaluation should be developed for these patients in the future. Funding Acknowledgement Type of funding sources: None. Receiver operating characteristic curve

Utility of a pharmacogenetic-driven algorithm in guiding dual antiplatelet therapy for patients undergoing coronary drug-eluting stent implantation in China

The POPular Risk Score (PRiS), a pharmacogenetic-driven algorithm consisting of CYP2C19 genotype, platelet reactivity, and clinical risk factors, is developed to evaluate ischemic risk and guide dual antiplatelet therapy (DAPT). This study aimed to evaluate the efficacy and safety of DAPT in accordance with the PRiS in patients undergoing drug-eluting stent (DES) implantation. A total of 1757 patients recruited in this cohort study were divided into four groups according to the PRiS and type of P2Y12 receptor inhibitor treatment at discharge. The primary endpoint was major adverse cardiovascular events (MACE, a composite of cardiovascular death, myocardial infarction, stroke, definite or probable stent thrombosis, and target vessel revascularization) during 1-year follow-up. The safety endpoints were defined by Bleeding Academic Research Consortium (BARC) criteria as major bleeding (BARC 3a, 3b, 3c, and 5) and clinically relevant bleeding (BARC 2, 3a, 3b, 3c, and 5). Among 1046 patients with PRiS < 2 and 711 patients with PRiS ≥ 2, 34.2% and 38.3% of them were treated with ticagrelor, respectively. The PRiS ≥ 2 was an independent predictor for the 1-year incidence of MACE (HR(95%CI): 2.09 (1.37-3.20), p = 0.001). Multivariable Cox regression indicated that in the PRiS ≥ 2 group, ticagrelor was superior to clopidogrel in reducing the risk of MACE (HR(95%CI): 0.53 (0.29-0.98), p = 0.042), without increasing the bleeding risk. On the other hand, in the PRiS < 2 group, clopidogrel treatment was related to a remarkably lower rate of BARC class ≥ 2 bleeding (HR(95%CI): 0.39 (0.20-0.72), p = 0.003), but comparable incidences of MACE and BARC class ≥ 3 bleeding during 1-year follow-up. Similar associations between P2Y12 receptor inhibitors and 1-year endpoints in the PRiS < 2 and PRiS ≥ 2 group could also be identified in propensity score-weighted analysis and propensity score-matched analysis. Tailored DAPT based on the PRiS could assist in improving the prognosis of patients undergoing DES implantation. Further randomized controlled trials are required to provide more evidence for PRiS-guided DAPT.

Is platelet function testing at the acute phase under P2Y12 inhibitors helpful in predicting bleeding in real-life patients with acute coronary syndrome? The AVALANCHE study

In patients with acute coronary syndrome (ACS), current international guidelines recommend newer potent and predictable P2Y12 inhibitors as first-line treatment despite a greater bleeding risk compared with clopidogrel. To determine if platelet function testing can predict bleeding in real-life patients with ACS treated with newer P2Y12 inhibitors. In this retrospective study, all consecutive adults admitted to the Lariboisière University Hospital for ACS, whatever the P2Y12 inhibitor prescribed, who had platelet function testing (vasodilator-stimulated phosphoprotein phosphorylation [VASP] index and aggregation tests) during the initial hospital stay were included. Follow-up was performed to record bleeding events according to the Bleeding Academic Research Consortium (BARC) classification. A total of 364 patients were included, treated with ticagrelor (n=123), prasugrel (n=105) or clopidogrel (n=136); 42.3% after an ST-segment elevation myocardial infarction, 27.1% after a non-ST-segment elevation myocardial infarction and 30.6% with unstable angina. Mean age was 64±11 years. Median VASP index was significantly lower with the newer P2Y12 inhibitors (14% under ticagrelor, 14% under prasugrel) than with clopidogrel (42%). Despite these differences in the degree of platelet inhibition, the occurrence of bleeding (BARC 2-5) during follow-up was 7.7% overall, and was similar for all P2Y12 inhibitors (ticagrelor 8.9%; prasugrel 6.6%; clopidogrel 7.4%). For each P2Y12 inhibitor, it was impossible to determine a VASP index threshold under which bleeding was significantly greater during follow-up. Similarly, ADP-induced aggregation was more profoundly inhibited by ticagrelor and prasugrel than by clopidogrel, but this did not allow a threshold to be set for increased haemorrhagic risk. Despite the substantial occurrence of bleeding in patients with ACS during follow-up, neither the VASP index nor platelet aggregation test results measured at the acute phase were helpful in predicting bleeding risk. Whether platelet function testing could be helpful later in the course of treatment remains to be evaluated.