High Bleeding Risk Patients Research Articles

Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.

Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. This study reports the final 2-year results of the randomized Onyx ONE trial. The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95%CI: -3.1% to 4.2%; P=0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95%CI: -2.5% to 4.8%; P=0.54). Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).

Effectiveness of second-look endoscopy after gastric endoscopic submucosal dissection in patients taking antithrombotic agents: a multicenter propensity score matching analysis.

The risk of bleeding after gastric endoscopic submucosal dissection (ESD) in antithrombotic agent users has increased, and its management remains a problem. Second-look endoscopy (SLE) following gastric ESD in antithrombotic agent users may be effective in preventing delayed bleeding, but this requires elucidation. Therefore, this study aimed to investigate the efficacy of SLE in reducing bleeding after gastric ESD in patients receiving antithrombotic agents. This retrospective cohort study was conducted at 19 referral hospitals in Japan. A total of 1,245 patients who were receiving antithrombotic agents underwent gastric ESD between January 2013 and July 2018. The incidence of delayed bleeding was compared between SLE and non-SLE groups using propensity score matching analysis. Overall, 858 patients (SLE group, 657 patients; non-SLE group, 201 patients) were analyzed. After matching, 198 pairs were created. Delayed bleeding occurred in 10 patients (5.1%) in the SLE group and 16 patients (8.1%) in the non-SLE group [odds ratio (OR) 0.605, 95% confidence interval (CI) 0.23-1.46, p = 0.310]. In the subgroup analysis, SLE reduced the incidence of delayed bleeding in patients receiving heparin bridging therapy (6.3% and 40.0%, respectively; p = 0.004). In the SLE group, prophylactic coagulation did not significantly reduce delayed bleeding compared to the no treatment group (14.6% and 8.6%, respectively; p = 0.140). SLE was ineffective in reducing bleeding after gastric ESD in antithrombotic agent users, overall. A prospective comparative study is warranted to definitively evaluate the effectiveness of SLE in reducing bleeding in high-risk patients.

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

ObjectiveData regarding early (within 24h) and urgent endoscopy (within 12h) in non-variceal upper gastrointestinal bleeding (NV-UGIB) revealed conflicting results. This study aimed to investigate the impact of endoscopy timing on the outcomes of high-risk patients with NV-UGIB. Patients and methodsFrom February 2020 to February 2021, consecutive high-risk (Glasgow–Blatchford score ≥12) adults admitted to the emergency department with NV-UGIB were analyzed retrospectively. The primary composite outcome was 30-day mortality from any cause, inpatient rebleeding, need for endoscopic re-intervention, need for surgery or angiographic embolization. Results240 patients were enrolled: 152 (63%) patients underwent urgent endoscopy (<12h) and 88 (37%) patients underwent early endoscopy (12–24h). One or more components of the composite outcome were observed in 53 (22.1%) patients: 30 (12.5%) had 30-day mortality, rebleeding occurred in 27 (11.3%), 7 (2.9%) underwent endoscopic re-intervention, and 5 (2.1%) required surgery or angiographic embolization. The composite outcome was similar between the groups. Multivariate analysis showed only hemodynamic instability on admission (OR: 3.05, p=0.006), and the previous history of cancer (OR: 2.42, p=0.029) were significant in predicting composite outcome. In terms of secondary outcomes, the endoscopic intervention was higher in the urgent endoscopy group (p=0.006), whereas the number of transfused erythrocyte suspensions and the length of hospital stay was higher in the early endoscopy group (p=0.002 and p=0.040, respectively). ConclusionsUrgent endoscopy leads to a significant reduction in the length of hospitalization and the number of transfused erythrocyte suspensions in NV-UGIB, which can contribute to patient satisfaction, reduce healthcare expenditure, and improve hospital bed availability. The composite outcome and its sub-outcomes were the same among both groups.

In-hospital outcomes of Ticagrelor versus Clopidogrel in high bleeding risk patients with acute coronary syndrome: Findings from the CCC-ACS project

BackgroundThe optimal P2Y12 inhibitor in high bleeding risk (HBR) patients with acute coronary syndrome (ACS) remains unclear. We compared the in-hospital efficacy and safety of ticagrelor versus clopidogrel in ACS patients at HBR. MethodsWe identified 22,120 hospitalized ACS patients with HBR treated with aspirin combined with either clopidogrel (n = 17,420) or ticagrelor (n = 4700) in the Improving Care for Cardiovascular Disease in China-ACS (CCC-ACS) project between November 2014 and December 2019. ResultsThe median length of hospital stay was 10 days (interquartile range, 7–14 days). Compared with clopidogrel, ticagrelor was associated with a higher risk of in-hospital TIMI major or minor bleeding (4.8% vs 3.8%; adjusted OR 1.20; 95% CI 1.03–1.41; P = 0.022). The incidence of TIMI major bleeding (1.7% vs 1.1%, P = 0.005) and intracranial bleeding (0.8% vs 0.5%, P = 0.005) were also higher in the ticagrelor group than in the clopidogrel group. There was no significant difference in the rate of in-hospital major adverse cardiovascular and cerebrovascular event (MACCE) (a composite of all-cause death, myocardial infarction, stent thrombosis, or ischemic stroke) with ticagrelor compared with clopidogrel therapy (4.2% vs 4.3%; adjusted OR 1.08; 95% CI 0.90–1.28; P = 0.411). Outcomes in the propensity-matched cohorts and in sensitivity analyses were consistent with the those of the main analysis. ConclusionsAmong ACS patients with HBR, ticagrelor as compared with clopidogrel was associated with an increased risk of in-hospital major bleeding without a significant reduction in in-hospital MACCE. Clinical trial registrationhttps://www.clinicaltrials.gov. Unique identifier: NCT02306616.

A-19 | Abbreviated Versus Prolonged Dual Antiplatelet Therapy (DAPT) Following Percutaneous Coronary Intervention (PCI) with Drug-Eluting Stents (DES): A Meta-Analysis of Randomized Controlled Trials (RCTs)

The optimal DAPT duration following PCI with DES placement in high bleeding risk (HBR) patients is not well established. This study aimed to compare the hazard ratio (HR) of cardiovascular (CV) mortality, myocardial infarction (MI), definite stent thrombosis, major bleeding (BARC 3-5) and their composite as MACE (major adverse cardiac events) between abbreviated (1 month) and prolonged (6-12 months) DAPT following DES placement.

A-13 | One Month DAPT in High Bleeding Risk ACS Patients: 2-year Subgroup Analysis from Onyx ONE Clear

The safety and efficacy of Resolute Onyx zotarolimus-eluting stents in high bleeding risk (HBR) patients with 1-month dual antiplatelet therapy (DAPT) was previously demonstrated. This subgroup analysis examines 2-year outcomes in ACS and non-ACS patients in the Onyx ONE Clear study.

Ischemic and Bleeding Events in PENDULUM Patients With High Bleeding Risk and High Platelet Reactivity.

The balance between thrombotic and bleeding risk is of great concern in high bleeding risk (HBR) patients. This study evaluated the relationship between perioperative antiplatelet reactivity and thrombotic and bleeding events in patients at HBR undergoing percutaneous coronary intervention (PCI).Methods and Results: In this post hoc analysis of the PENDULUM (Platelet rEactivity in patieNts with DrUg eLUting stent and balancing risk of bleeding and ischeMic event) registry, patients undergoing PCI were categorized as HBR or non-HBR, and stratified as having high platelet reactivity (HPR; P2Y12reaction unit [PRU] >208) or non-HPR (PRU ≤208). Cumulative incidences of cardiovascular and cerebrovascular events (Journal of the American College of Cardiology expert definitions) and bleeding events (Bleeding Academic Research Consortium criteria) were assessed 12 months after index PCI. The incidence of ischemic and bleeding events was ~3-fold higher in HBR vs. non-HBR patients. Thrombotic/ischemic events were significantly more common in the HPR subgroup in HBR patients (hazard ratio [HR]: 1.59; 95% confidence interval [CI]: 1.11-2.28; P=0.012), but there was no difference in non-HBR patients. After adjustment for covariates, HPR in HBR patients remained an independent factor for thrombotic and ischemic events (HR: 1.69; 95% CI: 1.13-2.54; P=0.011), but not for bleeding events (HR: 1.56; 95% CI: 0.78-3.11; P=0.210). Maintaining adequate PRU levels during PCI is an important factor in improving clinical outcomes, especially for HBR patients.

Antiplatelet Therapy After Percutaneous Coronary Intervention - Past, Current and Future Perspectives.

Optimal antiplatelet therapy after percutaneous coronary intervention (PCI) has been changed in parallel with the improvements of coronary stent and antiplatelet therapy. Over the past 25 years, dual antiplatelet therapy (DAPT) with aspirin plus P2Y12inhibitor has been the standard of care used after coronary stent implantation. First-generation drug-eluting stent (DES) appeared to increase the risk of late stent thrombosis, and duration of DAPT was prolonged to 12 months. DAPT duration up to 12 months was the dominant strategy after DES implantation in the subsequent >10 years, although there was no dedicated randomized controlled trial supporting this recommendation. The current recommendation of DAPT duration is getting shorter due to the development of new-generation DES, use of a P2Y12inhibitor as a monotherapy, and the increasing prevalence of high-bleeding risk patients. Furthermore, an aspirin-free strategy is now emerging as one of the novel strategies of antiplatelet therapy after PCI. This review gives an overview of the history of antiplatelet therapy and provides current and future perspectives on antiplatelet therapy after PCI.

Dual antiplatelet therapy duration after percutaneous coronary intervention using drug eluting stents in high bleeding risk patients: A systematic review and meta-analysis

BackgroundOptimal dual antiplatelet therapy (DAPT) duration in patients at high bleeding risk (HBR) is not fully defined. We aimed to compare the safety and effectiveness of short-term DAPT (S-DAPT) with longer duration DAPT (L-DAPT) after percutaneous coronary intervention (PCI) with drug eluting stents (DES) in patients at HBR. MethodsWe searched for studies comparing S-DAPT (≤3 months) followed by aspirin or P2Y 12 inhibitor monotherapy against L-DAPT (6-12 months) after PCI in HBR patients. Primary end points of interest were major bleeding and myocardial infarction (MI). Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs. ResultsSix randomized trials and 3 propensity-matched studies (n = 16,848) were included in the primary analysis. Compared with L-DAPT (n = 8,422), major bleeding was lower with S-DAPT (n = 8,426) [OR 0.68; 95% CI 0.51-0.89] whereas MI did not differ significantly between the 2 groups [1.16; 0.94-1.44]. There were no significant differences in risks of death, stroke or stent thrombosis (ST) between S-DAPT and L-DAPT groups. These findings were consistent when propensity-matched studies were analysed separately. Finally, there was a numerically higher, albeit statistically non-significant, ST in the S-DAPT arm of patients without an indication for OAC [1.98; 0.86-4.58]. ConclusionsAmong HBR patients undergoing current generation DES implantation, S-DAPT reduces bleeding without an increased risk of death or MI compared with L-DAPT. More research is needed to (1) evaluate risks of late ST after 1 to 3 months DAPT among patients with high ischemic and bleeding risks, (2) defining the SAPT of choice after 1 to 3 months DAPT.

Impact of Ticagrelor vs. Clopidogrel in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention After Risk Stratification With the CHA2DS2-VASc Score.

BackgroundsThe clinical benefit of ticagrelor vs. clopidogrel in unselected patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI) remains controversial in the real world. This study was aimed to investigate the impact of ticagrelor vs. clopidogrel in subjects with ACS without atrial fibrillation or flutter (AF) after PCI based on risk stratification using the CHA2DS2-VASc score.MethodsIn 2016–2019, patients who underwent PCI with at least one stent implanted in the General Hospital of Northern Theater Command were classified as low- or high-risk groups according to the CHA2DS2-VASc score. Incidences of 12-month ischemia [cardiac death, myocardial infarction (MI), or stroke], all-cause death, Bleeding Academic Research Consortium (BARC) 2,3,5 bleeding, BARC 3,5 bleeding, and net adverse clinical events (NACEs) (all-cause death, MI, stroke, or BARC 3, 5 bleeding) with aspirin plus different P2Y12 inhibitors (clopidogrel or ticagrelor) were appraised among different risk groups. Propensity score matching (PSM) and Cox multivariate analysis were used to balance the groups.ResultsA total of consecutive 17,037 patients with ACS were enrolled. The optimal cut-off value of the CHA2DS2-VASc score for ischemic events by the Youden test was 3 points. Among patients with high risk (CHA2DS2-VASc ≥ 3, n = 6,151), ticagrelor was associated with slightly lower risks of ischemic events (2.29% vs. 3.54%, P = 0.02) and stroke (0.39% vs. 1.08%, P = 0.01) without excessive risk of BARC 3, 5 bleeding events (2.16% vs. 2.11%, P = 0.92) compared to clopidogrel within 12 months after PCI. For patients with low risk (CHA2DS2-VASc < 3, n = 10,886), a statistically significant difference was seen in the incidence of overall 12-month BARC 2, 3, 5 bleeding events by P2Y12 receptor inhibitor (4.00% vs. 3.26%) with a similar incidence of the ischemic events (1.40% vs. 1.52%). Results in the PSM cohort and the adjustment with Cox multivariate analysis were consistent with the main outcomes.ConclusionHigher CHA2DS2-VASc scores were associated with a higher incidence of 1-year ischemic events for the patients with ACS after PCI. Compared with clopidogrel, ticagrelor was associated with lower ischemic events within 12 months after PCI without excessive risk of bleeding in high-risk patients but shows poor safety with excess bleeding in low-risk patients.

Pulmonary embolism in pediatrics: A 10-year experience from a tertiary center in Brazil

IntroductionAlthough still rare, pulmonary embolism (PE) in children has been increasing over the years. Data regarding this group of patients are still sparse, which contributes to the lack of standardized prophylaxis protocols and the misdiagnosis. This study aimed to determine the incidence of pediatric PE at a Brazilian tertiary hospital, describe clinical characteristics and identify possible risk factors. We also analyzed the diagnosis and management of PE. MethodsThis was a retrospective review of tertiary Brazilian single-center data of all pediatric patients (0 – 18 years) with acute PE, diagnosed radiologically, from September 2009 to May 2019. ResultsThe incidence of PE was 3.3 cases per 10,000 hospitalized children. All the twenty-three cases had some risk factor identified and sixteen of them (69.5%) had more than one risk factor. The most important were central venous catheter (39.1%), malignancy (34.8%) and recent surgery (34.8%). Among the children with identifiable symptoms (69.5%), the most common was dyspnea (56.2%). Only one patient did not receive antithrombotic therapy because of the high bleeding risk and most patients (70.6%) were treated for 3 to 6 months. Among the nineteen patients alive at the end of the six-month follow-up, ten (52.6%) repeated the PE image control. Seven of them (70.0%) had complete or partial resolution of the thrombosis and none had worsening images. ConclusionOur lower incidence than that of the current literature may reflect underdiagnosis due to low suspicion of PE. At least one risk factor was identified in all patients, which emphasizes the importance of increasing awareness of high-risk children.

Dual Loading Antiplatelet Therapy in Patients With Acute Coronary Syndrome and High Bleeding Risk Undergoing Percutaneous Coronary Intervention: Findings From the Improving Care for Cardiovascular Disease in China Project.

ObjectiveLoading dose of dual antiplatelet therapy (LD) is supported by the guidelines for patients with acute coronary syndrome (ACS). However, limited data is provided in the series of high bleeding risk (HBR) patients with ACS and percutaneous coronary intervention (PCI).MethodsUsing data from the Improving Care for Cardiovascular Disease in China—Acute Coronary Syndrome registry, conducted between 2014 and 2019, we stratified all ACS patients with HBR and PCI according to LD used within 24 h of first medical contact or not. Inverse probability of treatment weighting (IPTW) and Cox proportional hazards model with hospital as random effect were used to analyze differences in in-hospital clinical outcomes: the primary efficacy endpoint was mortality, and the primary safety endpoint was bleeding.ResultsOf 21,654 evaluable patients 14,322 (66.2%) were treated with LD, and were on average older, less likely to have comorbidities and higher hemoglobin, more often treated GPI and anticoagulant during hospitalization than those without LD. After IPTW adjustment for baseline differences, LD was associated with significantly increased risk of in-hospital mortality [1.89 vs. 1.02%; hazard ratio (HR): 1.71 (95% confidence interval 1.12, 2.42); p < 0.001] and in-hospital bleeding [3.89 vs. 3.3%; HR: 1.25 (1.03, 1.53); p = 0.03].ConclusionsIn ACS patients with HBR, LD was associated with an increased risk of in-hospital mortality and bleeding complications after PCI. Dedicated randomized trials with contemporary ACS management are needed to confirm these findings.

Early Discontinuation of Antithrombotic Treatment Following Left Atrial Appendage Closure

Although antithrombotic treatment is recommended after left atrial appendage closure (LAAC), some patients require discontinuation of antithrombotic treatment after LAAC without evidence on the safety of such a strategy. We sought to evaluate outcomes of patients who had early antithrombotic treatment discontinuation after LAAC. This is a multicenter study including 1,082 patients who underwent successful LAAC. Early discontinuation of antithrombotic treatment was defined as discontinuation of all antiplatelet/anticoagulant treatment within 6months following the procedure. A propensity-matched analysis was used to compare outcomes of patients with and without early antithrombotic treatment discontinuation. A total of 148 patients (13.7%) had early antithrombotic treatment discontinuation. In the entire population, antithrombotic treatment discontinuation patients exhibited a lower CHA2DS2-VASc score (p <0.001) and a higher rate of previous gastrointestinal bleeding episodes (p=0.01) compared with patients without discontinuation. After a median follow-up of 2.1(1,1-3.1) years after antithrombotic treatment discontinuation, the rates of death, ischemic stroke, and major bleeding were 12.1, 0.6, and 3.3 per 100 patient-years. In 119 matched pairs with similar baseline characteristics, antithrombotic treatment discontinuation patients had a similar risk of death (hazard ratio [HR] 1.06, 95% confidence interval [CI] 0.65 to 1.71, p=0.82), ischemic stroke (HR 0.39, 95% CI 0.04 to 3.79, p=0.42) and major bleeding (HR 1.48, 95% CI 0.56 to 3.88, p=0.43) compared with those without discontinuation. In conclusion, antithrombotic treatment was discontinued in 1 of 7 selected patients within 6months after LAAC, and this was not associated with an increased risk of death or thromboembolic events after a median follow-up of 2years. These data support the safety of shorter periods of antithrombotic therapy after LAAC in high bleeding risk patients based on clinician judgment. Further trials are warranted.

Trends in Arterial Access Site Selection and Bleeding Outcomes Following Coronary Procedures, 2011-2018.

Prior studies of radial access for cardiac catheterization have focused on early adopters of the technique, and some have described a risk/treatment paradox of low radial access use among high bleeding risk patients. This study aimed to determine (1) trends in radial access use over time, (2) if increasing use of radial access is driven by new invasive and interventional cardiologists (operators) or existing operators changing their practice, and (3) if increasing radial rates are associated with lower bleeding rates and elimination of the risk/treatment paradox. In this cross-sectional study using data from the Clinical Assessment, Reporting, and Tracking Program, we calculated radial access rates and risk-adjusted postprocedural bleeding rates of patients undergoing diagnostic angiography or percutaneous coronary intervention (PCI) between 2011 and 2018 in Veterans Affairs hospitals. We used separate bleeding risk models for diagnostic angiography and PCI and assessed temporal trends with the Kendall Tau-b test. Among 253 179 diagnostic angiograms and 93 614 PCIs, radial access rates increased over time for both diagnostic (17.5%-60.4%; P<0.01)) and PCI procedures (14.0%-51.8%; P<0.01). Existing operators and new operators increased their use at similar rates, but new operators entered practice with higher baseline rates. Nearly all operators used radial access at least once in 2018. Overall adjusted rates of bleeding declined, a trend that was significant for diagnostic angiography (2.4%-1.4%, P=0.02) but not PCI (3.4%-2.5%, P=0.20). Femoral access patients had a higher predicted risk for bleeding. A steady rise in radial access for diagnostic angiography and PCI was driven by increasing use among existing operators and high use by new operators. While this was associated with decreasing bleeding rates, a risk/treatment paradox for access site selection persists; patients at higher bleeding risk were still more likely to receive femoral access.

Antiplatelet therapy after percutaneous coronary intervention: current status and future perspectives.

Antiplatelet therapy after percutaneous coronary intervention(PCI) has been changing in parallel with the development of drug-eluting stents (DES) and antiplatelet agents. The recommendation of dual antiplatelet therapy duration is getting shorter due to the decreased risk of stent thrombosis in new-generation DES, the use of a P2Y12 inhibitor as a monotherapy, and the increasing prevalence of high bleeding risk patients. Antithrombotic therapy after PCI has also changed due to the introduction of direct oral anticoagulants. Aspirin-free P2Y12 inhibitor monotherapy is now being evaluated in several prospective studies as a novel strategy of antiplatelet therapy after PCI. This review shows a current status and provides future perspectives for the antiplatelet therapy after PCI.

Prevalence of High Bleeding Risk among Hospitalized Suspected NSTEMI Patients.

In recent years, guidelines for the management of acute coronary syndromes (ACS) have placed more emphasis on identifying patients at high bleeding risk (HBR). We set out to investigate the prevalence of HBR patients according to the Academic Research Consortium for High Bleeding Risk (ARC–HBR) criteria in hospitalized patients with suspected non-ST-segment elevation myocardial infarction (NSTEMI). Consecutive patients were retrospectively enrolled between January and June 2019 from the emergency department (ED) of a tertiary hospital. The discharge diagnosis and baseline data were manually collected using electronic patient records and database searches. Patients with non-cardiac diagnoses were excluded. Overall, 212 patients were included in the study. A total of 146 (68.9%) patients were diagnosed with NSTEMI (Type 1), 47 (22.2%) with unstable angina pectoris (UAP) and 19 (9.0%) with “other.” HBR was detected in 47.6% (n = 101) of all patients. Common criteria for HBR among ACS patients were age (40.4%), chronic kidney disease (33.7%), and the use of oral anticoagulation medicines (20.2%). In conclusion, nearly half of the patients hospitalized for ACS fulfilled HBR criteria. According to contemporary guidelines, the management of HBR patients differs from that of non-HBR patients, and thus, a more comprehensive screening for HBR may be considered in clinical practice.

One-Month Dual Antiplatelet Therapy After Bioresorbable Polymer Everolimus-Eluting Stents in High Bleeding Risk Patients.

BackgroundIt is unknown whether contemporary drug‐eluting stents have a similar safety profile in high bleeding risk patients treated with 1‐month dual antiplatelet therapy following percutaneous coronary interventions.Methods and ResultsWe performed an interventional, prospective, multicenter, single‐arm trial, powered for noninferiority with respect to an objective performance criterion to evaluate the safety of percutaneous coronary interventions with Synergy bioresorbable‐polymer everolimus‐eluting stent followed by 1‐month dual antiplatelet therapy in patients with high bleeding risk. In case of need for an oral anticoagulant, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for 1 month, followed by an oral anticoagulant only. The primary end point was the composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 1‐year follow‐up. The study was prematurely interrupted because of slow recruitment. From April 2017 to October 2019, 443 patients (age, 74.8±9.2 years; women, 29.1%) at 10 Italian centers were included. The 1‐year primary outcome occurred in 4.82% (95% CI, 3.17%–7.31%) of patients, meeting the noninferiority compared with the predefined objective performance criterion of 9.4% and the noninferiority margin of 3.85% (Pnoninferiority <0.001) notwithstanding the lower‐than‐expected sample size. The rates of cardiac death, myocardial infarction, and definite or probable stent thrombosis were 1.88% (95% CI, 0.36%–2.50%), 3.42% (95% CI, 2.08%–5.62%), and 0.94% (95% CI, 0.35%–2.49%), respectively.ConclusionsAmong high bleeding risk patients undergoing percutaneous coronary interventions with the Synergy bioresorbable‐polymer everolimus‐eluting stent, a 1‐month dual antiplatelet therapy regimen is safe, with low rates of ischemic and bleeding events.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT03112707.

Initial practice of left atrial appendage closure device in Japan; single-center experience

BackgroundThe left atrial appendage closure (LAAC) device for patients with nonvalvular atrial fibrillation (NVAF) has recently been introduced in Japan. However, clinical data of Japanese patients are insufficient. MethodsIn this single-center study, 55 consecutive patients (mean age, 74 years) who received LAAC therapy from September 2019 to December 2020 were analyzed. The WATCHMAN implant procedure (Boston Scientific, St. Paul, MN, USA) was performed under transesophageal echocardiography and general anesthesia for all cases. ResultsThe baseline CHA2DS2-VASc score was 4.6 ± 1.4, and the baseline HAS-BLED score was 3.8 ± 0.9. All procedures (98.2%) were successful, except for one, and no procedure-related complications were observed. After the procedures, various antithrombotic regimens were employed according to the bleeding risk of each patient; warfarin was used in 27 patients (49%), direct oral anticoagulants (DOACs) were used in 22 patients (40%), and dual antiplatelet therapy (DAPT) was employed in 6 patients. During a mean follow-up of 360 days, three cases of device-related thrombus (DRT) were detected. One DRT case was related to ischemic stroke. Nine patients had major bleeding during follow-up: two patients received DOACs, six patients received DAPT, and one patient received aspirin. ConclusionsIn this initial Japanese experience, LAAC therapy for high bleeding risk patients with NVAF seems feasible. Optimal antithrombotic regimens are warranted for better clinical outcomes.

DCBs as an adjuvant tool to DES for very complex coronary lesions.

Drug eluting stents (DES) have revolutionised interventional cardiology and currently represent the standard for percutaneous coronary interventions (PCI). However, due to several limitations, new strategies are required, especially in very complex lesions. Drug-coated balloons (DCB) offer an attractive therapeutic alternative, and have already obtained a Class I recommendation for the treatment of in stent restenosis (ISR) with Level A of evidence. Moreover, the role of DCB has been tested in several other settings, such as de novo large vessel disease, multivessel disease or very complex lesions, with promising results regarding safety and effectiveness. In this context, a hybrid strategy consisting in the use of a DES and DCB with the aim of reducing the amount of metal implanted and minimising the risk of ISR and stent thrombosis could become the solution for very complex lesions. Several important studies already demonstrated very good angiographic results in terms of late lumen loss and restenosis for this approach in bifurcation lesions. Moreover, for long diffuse coronary disease similar rates of MACE, TVR, and TLR at 2-year follow-up in comparison to a DES-alone strategy were found. What is more, the use of this strategy in high-bleeding risk patients could safely permit the practitioners to reduce the DAPT duration, as data is suggesting. As our daily practice already strongly incorporated this strategy and with more data expected from important trials, it is our strong believe that the hybrid approach can become a standard treatment choice in the near future.

Ticagrelor Monotherapy After 3-Month Dual Antiplatelet Therapy in Acute Coronary Syndrome by High Bleeding Risk: The Subanalysis From the TICO Trial.

Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs). In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISE-DAPT) score ≥25. The primary outcome was a 3-12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events). Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76-4.69; p<0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92-4.98; p<0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178). In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR. ClinicalTrials.gov Identifier: NCT02494895.