Rate Of Major Bleeding Events Research Articles

2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System.

Thirty-day outcomes with the investigational Intrepid transapical (TA) transcatheter mitral valve replacement (TMVR) system have previously demonstrated good technical success, but longer-term outcomes in larger cohorts need to be evaluated. The authors sought to evaluate the 2-year safety and performance of the Intrepid TA-TMVR system in patients with symptomatic,≥moderate-severe mitral regurgitation (MR) and high surgical risk. Patient eligibility was determined by local heart teams and approved by a central screening committee. Clinical events were adjudicated by an independent clinical events committee. Echocardiography was evaluated by an independent core laboratory. The cohort included 252 patients that were enrolled at 58 international sites before February 2021 as part of the global Pilot Study (n=95) or APOLLO trial (primary cohort noneligible+ TA roll-ins, n=157). Mean age was 74.2years, mean STS-PROM was 6.3%, 60.3% were male, and 80.6% were in NYHA functional class III/IV. Most presented with secondary MR (70.1%), and nearly all had≥moderate-severe MR (98.4%). All-cause mortality was 13.1% (30-day), 27.3% (1-year), and 36.2% (2-year). The 30-day≥major bleeding event rate was 22.3%. Heart failure rehospitalization was 9.6% (30-day) and 36.2% (2-year). At 2 years, >50% of patients were alive with improvement in NYHA functional class (82.1%, class I/II), and all patients with available echocardiograms had≤mild MR. This analysis represents the largest reported TA-TMVR experience with the longest follow-up in high-risk≥moderate-severe MR patients. Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years.

Ultrasound-Facilitated, Catheter-Directed Thrombolysis for Acute Pulmonary Embolism.

Acute pulmonary embolism (APE) poses a significant risk to patient health, with treatment options varying in efficacy and safety. Ultrasound-facilitated catheter-directed thrombolysis (USCDT) has emerged as a potential alternative to conventional catheter-directed thrombolysis (CDT) for patients with intermediate to high-risk APE. This study aimed to compare the efficacy and safety of USCDT versus conventional CDT in patients with intermediate to high-risk APE. This observational retrospective study was conducted at the Armed Forces Hospital, Al-Hada, Taif, the Kingdom of Saudi Arabia (KSA), on 135 patients diagnosed with APE and treated with either USCDT or CDT (58 underwent CDT, while 77 underwent USCDT). The primary efficacy outcome was the change in the right ventricle to the left ventricle (RV/LV) diameter ratio.Secondary outcomes included changes in pulmonary artery systolic pressure and the Miller angiographic obstruction index score. Safety outcomes focused on major bleeding events. Both USCDT and CDT significantly reduced RV/LV diameter ratio (from 1.35 ± 0.14 to 1.05 ± 0.17, P < 0.001) and systolic pulmonary artery pressure (SPAP) (from 55 ± 7 mmHg to 38 ± 7 mmHg, P < 0.001) at 48- and 12-hours post-procedure, respectively, with no significant differences between treatments. However, USCDT was associated with a significantly lower rate of major bleeding events compared to CDT (0% vs. 3.4%, P = 0.008). Multivariate logistic regression analysis revealed that USCDT was associated with a 71.9% risk reduction of bleeding (OR = 0.281, 95% CI = 0.126 - 0.627, P = 0.002). USCDT is a safe and effective alternative to CDT for the treatment of intermediate to high-risk APE, as it significantly reduces the risk of major bleeding.

Analysis of appropriateness and safety when discharging patients on triple-antithrombotic therapies.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. To analyze the appropriateness of triple-antithrombotic therapy based on the 2020 American College of Cardiology (ACC) consensus statement while evaluating safety outcomes for patients with respect to adverse events. A single-center, retrospective chart review was conducted using electronic medical records from December 18, 2020, to August 31, 2022. The primary endpoint was the rate of appropriateness for triple-antithrombotic therapy in patients discharged from Ochsner LSU Health Shreveport. Appropriateness was a composite endpoint extrapolated from the 2020 ACC consensus statement. For therapy to be defined as appropriate, patients had to have had the correct therapy indication, medications, dosing, and 30-day duration. Secondary safety endpoints included the percentage of patients rehospitalized at 14 and 30 days, the rate of major bleeding events, and the percentage of patients on gastrointestinal prophylaxis while on triple-antithrombotic therapy. A total of 93 patients were included in the study, of whom 31 (33%) received appropriate triple-antithrombotic therapy. Prolonged duration of triple-antithrombotic therapy was the most common reason that therapy did not meet the primary endpoint. The readmission rate due to bleeding was 2.2% at 14 days and 6.5% at 30 days. Within 30 days of initiation of triple therapy, 4.3% of patients endured major bleeding as defined by the International Society on Thrombosis and Hemostasis and 2 patients died. In this single-center study, triple-antithrombotic therapy appropriately adhered to the 2020 ACC consensus statement for one-third of patients discharged on this therapy.

Twice-daily rivaroxaban after percutaneous left atrial appendage closure for atrial fibrillation.

Background and aim: Rivaroxaban is an emerging oral anticoagulant for postoperative anticoagulation after percutaneous left atrial appendage closure (LAAC). Because a once-daily dosing regimen of rivaroxaban causes fluctuations in the drug plasma concentration, we studied the feasibility and safety of twice-daily rivaroxaban as a postoperative anticoagulation regimen for patients with atrial fibrillation (AF) undergoing LAAC. Methods: This study involved patients with AF who underwent LAAC and took rivaroxaban postoperatively. A total of 326 patients who received a standard total dose (15 or 20mg) of rivaroxaban based on their creatinine clearance rate were divided into the twice-daily (BID) rivaroxaban group (n = 208) and once-daily (QD) rivaroxaban group (n = 118) according to their anticoagulation strategy. Transesophageal echocardiography was recommended at 3-6months postoperatively to check for device-related thrombosis (DRT). Clinical outcomes were evaluated during postoperative anticoagulation. Results: The median CHA2DS2-VASc score (4 [3, 5] vs. 4 [3, 5], p = 0.28) and HAS-BLED score (2 [2, 3] vs. 2 [2, 3], p = 0.48) were not significantly different between the groups. During the anticoagulation period (4.1 ± 0.7 vs. 4.1 ± 0.9 months, p = 0.58), 148 (71.2%) patients in the BID group and 75 (63.6%) in the QD group underwent follow-up transesophageal echocardiography. There were no statistically significant differences between the two groups in terms of DRT (1.4% vs. 2.7%, p = 0.60), minor bleeding (8.2% vs. 11.0%, p = 0.39), thromboembolic events (1.0% vs. 0.8%, p = 1.00), major bleeding (0.5% vs. 0.8%, p = 1.00), or death. Conclusion: A short course of twice-daily rivaroxaban following LAAC is a feasible alternative regimen with a low rate of major bleeding events, DRT, and thromboembolic events for patients with AF.

The Combinations of the Patterns of Non-adherence to Anti-platelet Regimen in Stented Patients (PARIS) and Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) Thrombotic and Bleeding Risk Scores on Clinical Outcomes in Patients with Acute Myocardial Infarction.

Objective The Patterns of Non-adherence to Anti-platelet Regimen in Stented Patients (PARIS) and Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) thrombotic and bleeding risk scores were established to predict ischemic and bleeding events in patients undergoing percutaneous coronary intervention (PCI). However, whether or not the combination of these risk scores is predictive of clinical outcomes is unclear. Methods This bicenter registry included a total of 1,098 patients with acute myocardial infarction (MI) undergoing primary PCI. Patients were divided into three groups according to the PARIS and CREDO-Kyoto thrombotic and bleeding risk scores. The study endpoints included the rates of both ischemic (cardiovascular death, recurrent MI, and ischemic stroke) and major bleeding (Bleeding Academic Research Consortium type 3 or 5) events at two years. Results Two years after primary PCI, ischemic and major bleeding events occurred in 17.3% and 10.2% of patients, respectively. The higher-risk categories of PARIS and CREDO-Kyoto scores were associated with increased risks of ischemic and bleeding events. The rates of ischemic and major bleeding events progressively increased with the increase in risk categories in the two risk scoring systems. In the receiver operating characteristic curve analysis, the addition of CREDO-Kyoto thrombotic and bleeding risk scores to PARIS scores significantly improved diagnostic ability in predicting ischemic (area under the curve: 0.59 vs. 0.63, p=0.01) and bleeding (area under the curve: 0.65 vs. 0.68, p=0.01) events. Conclusion The combinations of the PARIS and CREDO-Kyoto risk scores might be useful for evaluating ischemic and bleeding risks in patients with acute MI undergoing primary PCI.

Efficacy of the bleeding risk scoring system for optimal prophylactic anticoagulation therapy of venous thromboembolism in trauma patients: a single-center, retrospective, observational cohort study

BackgroundWe developed a bleeding risk scoring system (BRSS) using prophylactic anticoagulation therapy to comprehensively assess the risk of venous thromboembolism (VTE) in trauma patients. This study evaluated the usefulness of this system in trauma patients, with a focus on minimizing the rate of bleeding events associated with prophylactic anticoagulation therapy.MethodsWe retrospectively evaluated the efficacy of BRSS in trauma patients who received prophylactic anticoagulation therapy for VTE at the Kitasato University Hospital Emergency and Critical Care Center between April 1, 2015, and August 31, 2020. To compare the incidence of bleeding events, patients were divided into two groups: one group using the BRSS (BRSS group) and another group not using the BRSS (non-BRSS group).ResultsA total of 94 patients were enrolled in this study, with 70 and 24 patients assigned to the non-BRSS and BRSS groups, respectively. The major bleeding event rates were not significantly different between the two groups (BRSS group, 4.2%; non-BRSS group, 5.7%; p = 1.000). However, minor bleeding events were significantly reduced in the BRSS group (4.2% vs.27.1%; p = 0.020). Multivariate logistic regression analysis showed that BRSS was not an independent influencing factor of major bleeding events (odds ratio, 0.660; 95% confidence interval: 0.067-6.47; p = 0.721). Multivariate logistic regression analysis showed that BRSS was an independent influencing factor of minor bleeding events (odds ratio, 0.119; 95% confidence interval: 0.015-0.97; p = 0.047). The incidence of VTE did not differ significantly between groups (BRSS group, 4.2%; non-BRSS group, 8.6%; p = 0.674).ConclusionsBRSS may be a useful tool for reducing the incidence of minor bleeding events during the initial prophylactic anticoagulation therapy in trauma patients. There are several limitations of this study that need to be addressed in future research.

Management of catheter-related upper extremity deep vein thrombosis in patients with cancer: a systematic review and meta-analysis

BackgroundPatients with cancer commonly require a central venous catheter, which is associated with an increased risk of venous thromboembolism (VTE). Despite the frequent occurrence, the optimal anticoagulation management and outcomes for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT) are unclear. ObjectiveWe performed a systematic review and meta-analysis to evaluate the rates of recurrent VTE and bleeding in patients with cancer and catheter-related upper extremity DVT. MethodsWe searched MEDLINE, Embase, Scopus, and CENTRAL from inception to June 2, 2023. The primary efficacy outcome was recurrent VTE, and the primary safety outcome was major bleeding. The incidence rates (with 95% CI) of outcomes were pooled using random effects model. ResultsWe included 29 studies (N = 2,836), among which 5 were prospective. The duration of follow-up and anticoagulation varied considerably. The main long-term anticoagulant used was low molecular weight heparin, followed by direct oral anticoagulants. The pooled 3-month recurrent VTE rate from 14 studies (N = 1,128) was 0.56% (95% CI, 0.10%-3.01%; I2 = 0%). The pooled 3-month major bleeding rate from 10 studies (N = 834) was 2.34% (95% CI, 1.14%-4.76%; I2 = 0%). We were unable to pool event rates beyond 3 months, given high heterogeneity. All studies had serious risk of bias. ConclusionsOur study demonstrated a relatively low rate of recurrent VTE and moderate rate of major bleeding events within the first 3 months in patients with cancer and catheter-related upper extremity DVT. However, there was significant heterogeneity in the management and reporting after 3 months.

Bleeding Risk from Anticoagulant Thromboprophylaxis in Patients with Multiple Myeloma

Introduction: Patients with multiple myeloma (MM) have a high risk of venous thromboembolism (VTE) due to unique disease-related (i.e., vascular inflammation, hyperviscosity) and treatment-related factors (i.e., immunomodulatory drugs [IMiDs], high-dose dexamethasone). Thromboprophylaxis is recommended for most patients starting MM therapy. Anticoagulants are preferred over aspirin except in patients at low risk for VTE. However, compliance with prophylaxis guidelines is low. The risk of bleeding from thromboprophylaxis is not well described in these patients so an excessive perceived risk may influence clinicians' practice. We conducted a real-world analysis of bleeding complications from VTE prophylaxis in MM. Methods: The IBM MarketScan Commercial Claims Database was used to identify MM cases between 2013 and 2021. Cases required MM diagnosis from 1 inpatient or 2 outpatient claims, based on ICD-9 or ICD-10 codes, and MM-specific therapy started between 7 days before and 90 days after index diagnosis code, based on HCPCS codes and prescription records. Those with preexisting VTE, atrial fibrillation or stroke were excluded. Thromboprophylaxis was defined as at least 1 prescription for warfarin, low-molecular weight heparin (LMWH) or direct oral anticoagulants (DOAC) within 30 days of diagnosis. Major bleeding was defined as bleeding requiring hospitalization using inpatient ICD codes previously validated (Cunningham algorithm). Patients were followed from end of prophylaxis exposure window (index MM + 30 days) to first major bleeding event, disenrollment (due to death or other reasons) or December 31, 2021. Descriptive statistics were used to calculate rates of bleeding. Cox regression was used to assess the risk of bleeding from thromboprophylaxis and define risk factors associated with major bleeding. Results: We included 6,656 patients diagnosed and treated for MM, with mean age 62.7 years and 55.3% males. Although over 50% of the population would have had a high thrombotic risk based on consensus guidelines, concurrent anticoagulant prophylaxis was prescribed in only 6.6% (436). Prophylaxis agent of choice was warfarin in 23% (102), LMWH in 39% (169), and DOAC in 38% (165), respectively. There was a trend over time favoring DOAC over other agents (25% increase in DOAC use vs. other agents per year on average, p&amp;lt;0.01). Patients on prophylaxis had a higher rate of IMiD-based therapy (63.8% vs. 46.7%, p&amp;lt;0.01) and lower concomitant anti-platelet use (2.1% vs. 4.7%, p=0.01) than those not receiving prophylaxis. There were no differences in age/sex distribution, Charlson comorbidity index (CCI) or history of bleeding between groups. With a median 1.3 years follow-up, the incidence of major bleeding among MM patients receiving VTE prophylaxis was 1.4% or 7.8 bleeding events per 1,000 person-years. This was numerically but not statistically lower than the incident bleeding rate in patients not receiving prophylaxis: 1.8% or 10.1 events per 1,000 person-years. Table 1 shows risk factors for bleeding in this MM population, adjusting for age and sex, including higher age (per 10-year increase, HR 1.38), higher CCI (per SD increment, HR 1.18), history of bleeding (HR 1.54), hypertension (HR 1.87), and renal disease (HR 1.56). IMiD-based MM therapy was associated with decreased risk of bleeding (HR 0.69). Table 2 shows the estimated bleeding risk associated with prophylaxis across several models. No statistically significant association was identified between major bleeding and anticoagulant prophylaxis. Discussion: In a real-world analysis of commercial claims data, the risk of major bleeding associated with VTE prophylaxis in patients with MM undergoing cancer therapy is low and no significant increase in bleeding risk was identified for concurrent anticoagulant use. The rate of major bleeding events appears to be comparable between patients who receive VTE prophylaxis and those who do not. Nevertheless, underutilization of VTE prophylaxis is frequent. Higher CCI, bleeding history, hypertension, and renal disease were clinical factors associated bleeding risk, which may be included in models to help clinicians assess individual patient's risk and guide clinical decisions.

Anticoagulation for Splanchnic Vein Thrombosis in Patients with Myeloproliferative Neoplasms: A Systematic Review and Meta-Analysis

Introduction: Splanchnic vein thrombosis (SVT) is a common manifestation of myeloproliferative neoplasms (MPN). The optimal anticoagulation strategies in MPN-SVT remain unclear due to the challenge of balancing the concurrent prothrombotic state of MPN with the risk for SVT complications, such as gastrointestinal bleeding. Methods: We conducted a systematic review and meta-analysis to evaluate the safety and efficacy of anticoagulation in patients with MPN following SVT incidence. This study protocol was registered on PROSPERO (#CRD42023414120). On April 07, 2023, we comprehensively searched multiple databases from Cochrane Library, EMBASE, and PubMed/MEDLINE. Retrospective or prospective studies in English with at least ten adult patients with MPN-SVT were included. Study screening by title/abstract, full text, and data extraction were performed in duplicate. Primary outcomes included recurrence of venous thrombosis (SVT and non-SVT), arterial thrombosis, and major bleeding. The risk of bias was assessed with MINORS scale. Pooled risk ratio (RR) of recurrent thrombosis and major bleeding events with respective 95% confidence intervals (CI) were calculated using the Mantel-Haenszel method with random-effects model. Pooled rates of recurrent thrombosis and major bleeding events with respective 95% CI were calculated by DerSimonian and Laird method using random-effects model. Inter study heterogeneity was evaluated using the Cochran Q test and I 2 statistic. Results: Of a total of 4624 studies that were identified on the initial abstract screen, full texts were obtained and reviewed for 192 records. We included five retrospective and one prospective study that provided outcome rates for 387 patients with MPN treated with anticoagulation following SVT. All patients receiving anticoagulation in the six studies included in this analysis were treated with vitamin K antagonists (VKA). Of note, one additional study evaluating MPN-SVT with rivaroxaban was not included in the analysis because of short follow-up compared to the other six studies. Most studies were conducted in Europe (n=4), one was international, and one was done in the United Kingdom. The median follow-up was 3.2 years (follow-up was not reported in one study) and median age of patients at SVT diagnosis was 47.5 years old. JAK2V617F positivity was reported in 311/387 (80.3%). Regarding quality assessment and bias risk, four of the studies had moderate and two high risk of bias by the MINORS scale. Pooled incidence rates showed that subsequent venous thrombosis was the most common complication while on anticoagulation (Pooled rate 9.6%; 95% CI 5.6 - 15.8; I 2=27%), followed by major bleeding (Pooled rate, 9%; 95% CI, 3.7 - 20.3; I 2=72%). Four of the six studies provided data comparing management with anticoagulation vs. no anticoagulation in 288 patients. The rates of venous (SVT and non-SVT) and arterial thrombosis following SVT were similar between the anticoagulation vs. no anticoagulation group (venous: RR 0.90; 95% CI, 0.412 - 1.966; I 2 = 0%, Figure 1 and arterial: RR, 1.01; 95% CI, 0.36 - 2.80; I 2=0%). Similarly, there was no significant difference in the risk of major bleeding between the two groups (RR, 0.52; 95% CI, 0.23- 1.14; I 2=0%). (Figure 2) Conclusion: Risk of recurrent thrombosis and bleeding in patients with MPN-SVT are considerable. Anticoagulation with VKA in MPN patients following SVT was not associated with a reduction in the risk of subsequent venous or arterial thrombosis or increased risk of major bleeding. Further studies with larger populations are warranted to elucidate the optimal medical management for MPN-SVT.

Management of Catheter-Related Upper Extremity Deep Vein Thrombosis in Patients with Cancer: A Systematic Review and Meta-Analysis

Background: Patients with cancer commonly require a central venous catheter (CVC) for delivery of cancer therapies and/or supportive care. The presence of a CVC is associated with an increased risk of venous thromboembolism (VTE). Despite the frequent occurrence, the optimal anticoagulation management and outcomes for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT) are unclear. Objective: We performed a systematic review and meta-analysis to evaluate the rates of recurrent VTE and bleeding complications in patients with cancer and catheter-related upper extremity DVT. Methods: We searched MEDLINE, Embase, Scopus, and CENTRAL (Cochrane) from inception to June 2, 2023. We aimed to include randomized controlled trials (RCTs) (if any), prospective and retrospective cohort studies, and case-control studies (including ≥ 10 patients) evaluating adult patients with cancer and catheter-related upper extremity DVT. The primary efficacy outcome was recurrent VTE, and the primary safety outcome was major bleeding as defined by individual studies. Secondary outcomes included clinically relevant non-major bleeding, total bleeding events, and all-cause mortality. By using R software (version 4.0.3), the incidence rates (with 95% confidence interval [CI]) of recurrent VTE and bleeding outcomes at different time points were pooled using random effects model. Results: After screening 4,264 records, we included 29 studies (N=2,848 patients) in the systematic review. There were no RCTs, 5 prospective cohort studies (including 260 patients), and 24 retrospective cohort studies. Most studies had modest sample size (N&amp;lt;100). Overall from 24 studies with reported tumor types, the most common malignancy was hematological malignancy (50.4%), followed by gastrointestinal (13.6%), breast (10.2%), and lung (5.5%) cancers. The median or mean follow-up duration varied widely from 1 to 20 months. Duration of anticoagulation also varied considerably with median or mean duration of 20 days to 6 months. The main long-term anticoagulant used was low-molecular-weight heparin (58.1%), followed by direct oral anticoagulants (24.3%). Only two studies (N=87 patients) specifically reported the management and associated outcomes after catheter removal. Thirteen studies (N=1105 patients) reported a 3-month recurrent VTE rate, with the pooled rate of 1% (95% CI 0-3%, I 2 = 0%) (Figure 1). Nine studies (N=811 patients) reported a 3-month major bleeding rate, with the pooled rate of 2% (95% CI 1-5%, I 2 = 0%) (Figure 2). We were unable to pool event rates beyond 3 months given high degree of heterogeneity in the follow-up duration, bleeding definition, and duration of anticoagulation. Conclusions: Our systematic review and meta-analysis demonstrated relatively low rates of recurrent VTE and major bleeding events within the first 3 months in patients with cancer and catheter-related upper extremity DVT. However, there was significant heterogeneity in the management and reporting after 3 months, and available data are poor to guide treatment strategies and duration of anticoagulation. The optimal management after catheter removal was also unclear. Future large prospective studies are needed.

Antithrombotic Regimen After Percutaneous Left Atrial Appendage Closure - A Real-World Study.

Antithrombotic therapy after left atrial appendage closure (LAAC) in patients at high risk of bleeding remains controversial. We present real-world clinical outcomes of LAAC.Methods and Results: Data from 74 consecutive patients who received LAAC therapy between January 2020 and June 2022 were analyzed. Patients received 1 of 3 antithrombotic therapies according to the bleeding risk category or clinical event. Regimen 1 was based on a prior study, regimen 2 comprised a lower antiplatelet drug dose without dual antiplatelet therapy, and regimen 3 was antiplatelet drug administration for as long as possible to patients with uncontrollable bleeding who were required to stop anticoagulant drugs. Overall, 73 (98.6%) procedures were successful. Of them, 16 (21.9%) patients were selected for regimen 1, 46 (63.0%) for regimen 2, and 11 (15.1%) for regimen 3. Device-related thrombosis (13% vs. 0% vs. 0%, P=0.0257) only occurred with regimen 1. There was no difference in major bleeding event rates (6% vs. 2% vs. 9%, P=0.53). The post-LAAC antithrombotic regimen was modified without major concerns.

One-year clinical outcomes and the impact of procedural configurations in patients with left atrial appendage occlusion

Abstract Background To evaluate the long-term clinical performance, the impact of procedural configurations and post-procedure medications in atrial fibrillation patients with percutaneous left atrial appendage occlusion (LAAO). Methods The RECORD study was a prospective, all-comers registry conducted in 39 Chinese centers that consecutively enrolling patients who received LAAO between 1st April 2019 and 31st October 2020 with minimum inclusion and exclusion criteria. Events including any death, any stroke, systemic embolism and bleeding event were collected at 1 year and adjudicated by an independent clinical event committee. Cox proportional hazard models with multivariable adjustments were applied to estimate hazard ratios (HRs) for each outcome. Results Of the 3,096 participants, 3,082 successfully received an LAAO implant and 3,013 (97.8%) completed the 1-year follow-up. Participants had a high risk of stroke (mean CHA2DS2-VASc score of 4.0) and a moderate-to-high risk of bleeding (mean HAS-BLED score of 2.4). Local anesthetic was performed in 1,287 (41.6%) patients and fluoroscopy guidance in 492 (16.0%) patients. In 1295 (42.0%) cases, one-stage combination procedures of LAAO and radiofrequency ablation or cryoablation (CA) were performed. At 1 year, the composite ischemic endpoint of death, stroke, and systemic embolism occurred in 133 (4.51%) patients. Any life-threatening, disabling or major bleeding events occurred in 71 (2.36%) patients. There was no significant association between the type of anesthesia (general versus local), modality of image guidance (TEE, ICE, or fluoroscopy) with the ischemic or bleeding events. Combination procedures of LAAO plus CA was associated with a significantly lower rate of death, stroke, or systemic embolism than performing LAAO only (3.5% versus 5.2%, HRadjusted:0.69, 95%CI:0.48-0.98, P=0.041). The commonest antithrombotic strategy was OAC | APT | APT (38.1%; corresponded to medication prescribed at discharge | 45 days | 6 months), followed by OAC | OAC | APT (27.0%). Compared with OAC | APT | APT, the OAC | OAC | APT group was associated with a higher risk of life-threatening, disabling or major bleeding (1.2% versus 2.5%, HRadjusted:0.50, 95%CI: 0.25-0.99, P=0.47); whereas the risk of death, stroke and SE was numerically similar (2.9% versus 3.0%, HRadjusted:1.05, 95%CI: 0.61-1.78, P=0.867). There was no significant difference between OAC | APT | APT and OAC+APT | APT | APT groups regarding ischemic events; however, in patients with HAS-BLED ≥ 3, OAC | APT | APT was associated with lower rates of life-threatening, disabling or major bleeding events (1.1% versus 4.8%, HRadjusted:4.55, 95%CI: 1.31-15.81, P=0.017). Conclusion In Chinese centers, patients with a WATCHMAN LAAO device had low rates of ischemic and bleeding events at 1 year. One-stage combination procedures of LAAO and catheter ablation was associated with a significantly lower rate of ischemic events than performing LAAO only.Procedural configurations to outcomesPost-LAAO antithrombotic medications

Clinical outcomes of physiology-guided coronary revascularization in patients undergoing TAVR

Abstract Background Coronary artery disease frequently coexists with severe aortic valve stenosis (AS). Although an fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) in native coronary artery has been shown to be associated with better clinical outcomes as compared with an angiography-guided PCI, it is unknown whether this applies to severe AS patients. Purpose The purpose of this study was to compare the outcomes of different revascularization strategies between FFR-guided and angiography-guided PCI in AS patients undergoing transcatheter aortic valve replacement (TAVR). Methods In this retrospective analysis, we included 401 patients with severe AS undergoing TAVR who had coexisting coronary artery disease at invasive coronary angiography. A total of 156 patients was considered to have significant coronary artery lesions (&amp;gt;50% of diameter stenosis) due to the visual estimation. Patients were divided into 2 groups: physiology-guided (n=96, PCI performed in case of FFR ≤0.80 or diameter stenosis ≥90%) and angiography-guided PCI (n=60, PCI performed based on angiographic evaluation). Patients were clinically followed up and evaluated for the occurrence of major adverse cardiac and cerebrovascular event (MACCE; defined as a composite of death, non-fatal myocardial infarction, target vessel failure, and cerebrovascular accident) and major bleeding event defined as ≥VARC-3 type 2. Results Most lesions (62/96; 65%) in the physiology-guided group had negative results and were deferred. During a median follow-up of 743 [from 400 to 1,186] days, physiology-guided group had a significantly lower rate of MACCE compared with the angiography-guided groups (adjusted hazard ratio [HR], 0.41; 95% confidence interval [CI], 0.20-0.83; P&amp;lt;0.01). In addition, physiology-guided group showed a lower major bleeding event rate compared with the angiography-guided group (adjusted HR, 0.12; 95% CI, 0.04-0.40; P&amp;lt;0.01). Conclusion Physiology-guided PCI resulted in better clinical outcomes and lower bleeding events than angiography-guided PCI in patients with AS undergoing TAVR.

Abstract 12823: As Anticoagulation Use Increases, Embolic Events Downtrend in Atrial Fibrillation Hospitalizations

Background: Direct oral anticoagulants and Left atrial appendage closure (LAAC) were approved for use in 2010 and 2015, respectively. Data on temporal changes in stroke prevention strategies and rates of embolic complications in atrial fibrillation (AF) in the 2010s decade are limited. Aims: Describe trends in long-term anticoagulation (AC), LAAC use, and in-hospital AF associated ischemic stroke (IS), transient ischemic attacks (TIA), and systemic embolic events (SEE) between 2010 and 2019. Methods: The national inpatient database was used to identify patients with AF from 2010 to 2019. Data were divided into 2 eras: 2010-2014 and 2015-2019. Results: A total of 40,787,136 inpatients with AF were identified: prevalence increased from 18,594,372 in 2010 to 2014 (46%; mean [SD] age 75.5 [12.0] years; 50.3% male) to 22,192,764 in 2015 to 2019 (54%; mean [SD] age 75.1 [11.8] years; 52.5% male). There was a marked increase in long-term AC use (27.2% to 40.2%; P=0.001) and rates of percutaneous LAAC procedures (0.01% to 0.6%; P &lt;0.001) from 2015 to 2019. IS rates among patients with AF increased from 2010 to 2014 (3.5% to 3.8%; P=0.04), with no significant temporal change from 2015 to 2019 (P=0.84). TIA rates declined from 2010 to 2014 (1.2% to 1.0%; P=0.017) and continued a downtrend from 2015 to 2019 (0.9% to 0.7%; P=0.002). There was no temporal change in SEE or the composite outcome of all embolic events from 2010 to 2014, followed by a decline from 2015 to 2019 in SEE (0.5% to 0.4%; P 0.012) and all embolic events (5.1% to 4.8%; P 0.026) ( Figure 1 ). Mean rates of major bleeding events increased from 5.7% in 2010-2014 to 9.1% in 2015-2019 (P &lt;0.001). Conclusion: In an inpatient AF population, the composite outcome of all embolic events and specifically SEE downtrend from 2015 to 2019, likely due to increased AC use. Further data assessing the risk-benefit ratio of available therapies for stroke prevention in inpatients with AF - AC and LAAC - are needed to optimize personalized strategies.

Abstract 12091: Actual Management of Venous Thromboembolism Complicated by Antiphospholipid Antibody Syndrome in Japan. From the Command VTE Registry-2

Background: Venous thromboembolism (VTE) complicated with antiphospholipid antibody syndrome (APS) requires long-term anticoagulation to prevent the recurrent thrombosis. Direct oral anticoagulants (DOACs) have been widely used for VTE, but the guideline recommendations for their use are less favorable for APS-complicated VTE. There are no reports on the actual practice of APS complicated VTE in Japan in the DOAC era. So we investigated the actual practice and prognosis in APS-associated VTE, particulary with regard to the use of DOACs. Methods: COMMAND VTE Registry-2 is a multicenter registry enrolling 5,197 consecutive acute symptomatic VTE patients among 31 centers in Japan between January 2015 and August 2020. In this cohort, we examined the differences in actual VTE practice between patients with and without APS. Results: The current study population consisted of 83 APS-complicated VTE (mean age, 55; 53 male patients [63.9%]), and 5,114 VTE patients without APS (mean age, 68; 3010 male patients [58.9%]). Compared with patients without (w/o) APS, those with (w/) APS were more likely to have proximal deep vein thrombosis (DVT) than distal DVT, but the rate of pulmonary embolism was comparable. There was no difference in the rate DOAC use between patients w/[74.7%] and w/oAPS [79.5%]. All-cause mortality was significantly lower in the APS group (w/APS 6 [7.2%]; w/oAPS 1317 [25.8%]), VTE recurrence rates were similar (w/APS 8 [9.6%]; w/oAPS 275 [5.4%]), and the interval to VTE recurrence was significantly longer in the APS group (median: w/APS, 1050 days; w/oAPS 724 days). Major bleeding event rate was comparable (w/APS 8 [9.6%]; w/oAPS 462 [9.0%]). Conclusions: DOACs were used equally in long-term anticoagulation of VTE complicated with APS compared with VTE without APS, with better outcome.

Abstract 14162: Long-Term Outcomes for Contemporary Mechanical versus Bioprosthetic Surgical Mitral Valve Replacement in Patients Aged 50 to 70 Years

Background: Guidelines are still unclear regarding whether mechanical or bioprosthetic valves should be selected for mitral valve replacement (MVR) in patients aged 50-70 years. Aims: To assess long-term outcomes in patients aged 50-70 years undergoing MVR using contemporary mechanical and bioprosthetic valves. Methods: We performed a retrospective study using the TriNetX global database to identify patients aged 50 to 70 years who had primary isolated surgical MVR from 2014 to 2020. Patients who had concomitant or prior cardiac surgeries were excluded. Patients were stratified into 2 groups: mechanical and bioprosthetic, and a 1:1 propensity-score matching to control for baseline differences between the two groups was performed. The primary endpoint was all-cause mortality and secondary endpoints were stroke, major bleeding, and reoperation over a follow-up period of 8 years. Results: Propensity-score matching yielded 1,130 patients in each group. There were significantly higher rates of all-cause mortality, stroke, and major bleeding events in the mechanical group compared to the bioprosthetic valve. There was no significant difference between the two groups regarding reoperation (Table 1 and Figure 1). Conclusion: At an 8-year follow-up, the use of contemporary bioprosthetic valves for MVR in patients aged 50-70 years shows favorable all-cause mortality and lower rates of strokes and major bleeding with similar reoperation rates compared to mechanical valves.

OC 45.3 Major Bleeding Event Rates in Patients on Hemodialysis and Peritoneal Dialysis: Results from the International DOPPS and PDOPPS

OC 45.3 Major Bleeding Event Rates in Patients on Hemodialysis and Peritoneal Dialysis: Results from the International DOPPS and PDOPPS

Comparisons of drug-eluting balloon versus drug-eluting stent for the treatment of cancer patients presenting with acute myocardial infarction

BackgroundTreatment for cancer patients presenting with acute myocardial infarction (AMI) remains challenging. The objective of the study was to investigate the safety and efficiency of drug eluting balloon (DEB) versus drug eluting stent (DES) in this high-risk group.MethodsBetween 1st January 2017 and 1st January 2022, cancer patients admitted to Beijing Chaoyang Hospital with AMI were retrospectively enrolled. The primary endpoint was major adverse cardiovascular event (MACE). The secondary endpoints included major bleeding events, heart failure and cardiac complications.ResultsA total of 164 cancer patients presenting with AMI were included in the final analysis. Patients treated with DEB had a numerically lower rate of MACE than those treated with DES during a median follow-up of 21.8 months (22.9% vs. 37.1%, p = 0.23). Patients treated with DEB had a trend towards lower rate of major bleeding events than patients treated with DES (6.3% vs. 18.1%, HR 2.96, 95% CI [0.88, 9.92], p = 0.08). There were no significant differences between the two groups with regards to the rate of heart failure (4.2% vs. 9.5%, p = 0.32) and cardiac complications (0.0% vs. 2.6%, p = 0.56).ConclusionsThe present study demonstrated that in cancer patients with AMI, DEB had a trend towards lower rate of major bleeding events and a numerically lower rate of MACE compared with DES.Graphical

5-year stroke rates in nonvalvular atrial fibrillation after watchman compared to direct oral anticoagulants

BackgroundThe WATCHMAN device (Boston Scientific; Marlborough, MA, USA) is noninferior to warfarin in preventing ischemic strokes while reducing bleeding risks associated with long term anticoagulation in nonvalvular atrial fibrillation (AFib). The device's performance compared to direct oral anticoagulants (DOAC) is less well known. ObjectiveTo compare 5-year major bleeding and ischemic stroke rates in patients with nonvalvular AFib who received a WATCHMAN device or DOAC therapy after a major bleeding event. MethodsThis retrospective, multicenter, 1:1 matched cohort study was derived from the PearlDiver Mariner database from 2010 to 2020. Patients with nonvalvular AFib on oral anticoagulation who had a major bleeding event were identified. Those who received either WATCHMAN or DOAC after resolution of the bleeding event were selected. The two groups were exactly matched 1:1 based on various comorbidities. Rates of ischemic stroke, transient ischemic attack (TIA), major bleeding, and hemorrhagic stroke were compared over 5 years. ResultsEach cohort consisted of 2248 patients after 1:1 matching. The mean CHADS2-VASC score was 4.81 ± 1.25. At 5 years, the WATCHMAN cohort had significantly lower rates of major bleeding events [OR 0.24 (0.21, 0.27)], TIAs [OR 0.75 (0.58, 0.95)], and ischemic strokes [OR 0.72 (0.61, 0.86)]. There was no significant difference in hemorrhagic strokes [OR 1.14 (0.83, 1.58)]. ConclusionEven in a high-risk population, the WATCHMAN is comparable to DOAC therapy in the primary prevention of hemorrhagic strokes and may provide benefit in the rates of bleeding events, TIAs, and ischemic strokes.

Early or late initiation of dabigatran versus vitamin-K-antagonists in acute ischemic stroke or TIA: The PRODAST study.

The optimal timing of initiating or resuming anticoagulation after acute ischemic stroke (AIS) or transient ischemic attack (TIA) in patients with atrial fibrillation (AF) is debated. Dabigatran, a non-vitamin K oral anticoagulant (NOAC), has shown superiority against vitamin K antagonists (VKA) regarding hemorrhagic complications. In this registry study, we investigated the initiation of dabigatran in the early phase after AIS or TIA. PRODAST (Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA) is a prospective, multicenter, observational, post-authorization safety study. We recruited 10,039 patients at 86 German stroke units between July 2015 and November 2020. A total of 3,312 patients were treated with dabigatran or VKA and were eligible for the analysis that investigates risks for major hemorrhagic events within 3 months after early (⩽ 7 days) or late (> 7 days) initiation of dabigatran or VKA initiated at any time. Further endpoints were recurrent stroke, ischemic stroke, TIA, systemic embolism, myocardial infarction, death, and a composite endpoint of stroke, systemic embolism, life-threatening bleeding and death. Major bleeding event rates per 10,000 treatment days ranged from 1.9 for late administered dabigatran to 4.9 for VKA. Early or late initiation of dabigatran was associated with a lower hazard for major hemorrhages as compared to VKA use. The difference was pronounced for intracranial hemorrhages with an adjusted hazard ratio (HR) of 0.47 (95% confidence interval (CI): 0.10-2.21) for early dabigatran use versus VKA use and an adjusted HR of 0.09 (95% CI: 0.00-13.11) for late dabigatran use versus VKA use. No differences were found between early initiation of dabigatran versus VKA use regarding ischemic endpoints. The early application of dabigatran appears to be safer than VKA administered at any time point with regards to the risk of hemorrhagic complications and in particular for intracranial hemorrhage. This result, however, must be interpreted with caution in view of the low precision of the estimate.