A missing coronary guidewire mimicking aortic dissection-a case report.

Background: A retained coronary guidewire following coronary angiography is an extremely rare complication. We present a case of a retained coronary guidewire from a percutaneous coronary intervention done 2 years ago. Case summary: An 80-year-old asymptomatic man with a history of ischemic heart disease and moderate aortic stenosis presented to the echocardiography lab for routine follow-up. Transthoracic echocardiography showed Moderate aortic stenosis and a suspected linear echogenic structure in the ascending aorta. trans-esophageal echocardiography was performed to reveal a mobile and linear echogenic structure originating from the sinuses of Valsalva/Sinotubular junction and extending to the ascending aorta. An electrocardiogram gated cardiac computed tomography was performed and showed A linear well-defined structure originating from the ostium of the left main coronary artery and extending to the ascending aorta-a coronary guidewire from an earlier procedure. A second look at the last invasive coronary angiography record demonstrated the same finding. A multidisciplinary heart team discussion was obtained and concluded that the risk of surgical or endovascular intervention outweighed the potential benefit. The patient was discharged home for a close clinical and echocardiographic follow-up. Discussion: A retained coronary guidewire is a rare complication that operators should be aware of. Management should be case-specific depending on clinical presentation.

Anti PCSK9 Monoclonal Antibody Treatment in Elderly Patients: A Real-world Clinical Experience.

BACKGROUND: The use of proprotein convertase subtilisin/kexin type 9 monoclonal antibodies (PCSK9 mAbs) is emerging for lowering low-density lipoprotein cholesterol (LDL-C). However, real-world data is lacking for their use among elderly patients. OBJECTIVES: To define the characteristics of elderly patients treated with PCSK9 mAbs and to evaluate the efficacy and tolerability compared with younger patients. METHODS: We conducted a retrospective cohort study of elderly patients (≥ 75 years at enrollment) treated with PCSK9 mAbs for primary and secondary cardiovascular prevention. Data were retrieved for demographic and clinical characteristics; indications for treatment; agents and dosages; concomitant lipid lowering treatment; LDL-C levels at baseline, 6, 12 months, and at the end of follow up. Data also included achieving LDL-C target levels and adverse effects. RESULTS: The cohort included 91 elderly patients and 92 younger patients, mean age 75.2 ± 3.76 and 58.9 ± 7.4 years (P < 0.0001). Most patients (82%, 80%) were in high/very high-risk categories. For almost all (98%, 99%), the indication was statin intolerance, with PCSK9 mAb monotherapy the most prevalent regimen. The average follow-up was 38.1 ± 20.5 and 30.9 ± 15.8 months (P = 0.0258). Within 6 months the LDL-C levels were reduced by 57% in the elderly group and by 59% in the control group (P = 0.2371). Only 53% and 57% reached their LDL-C target levels. No clinically significant side effects were documented. CONCLUSIONS: PCSK9 mAbs have similar effects and are well tolerated among elderly patients as in younger patients.

Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk.

BACKGROUND: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR. METHODS AND RESULTS: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% (P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%). CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.

Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

The Clinical SYNTAX score predicts survival better than the SYNTAX score in coronary revascularization.

BACKGROUND: The Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) trial showed that the SYNTAX score (SS) is a useful tool for customizing revascularization treatment for patients with multivessel coronary disease. In the past decade, the Clinical SS (CSS) has emerged as a comprehensive tool. This novel tool considers the SS as well as patient clinical parameters such as age, creatinine clearance, and ejection fraction, which were shown to be relevant for patient prognosis. Thus, in the current work we set out to compare the survival predictive values of the SS versus the CSS and their future application in real-world implementation of the revascularization guidelines. METHODS: This study was a subanalysis of data collected in a prospective national registry in Israel that enrolled consecutive patients with left main and/or 2- to 3-vessel coronary artery disease involving the proximal or mid-left anterior descending artery; the MULTI-vessel Coronary Artery Disease (MULTICAD). The revascularization method was chosen by the physicians taking care of the patients at each hospital and the patients were followed for 5 years. Patients were categorized according to their SS, the CSS, and their revascularization method (primary coronary intervention [PCI] vs coronary artery bypass grafting [CABG]) and patient survival were compared. RESULTS: A total of 585 patients were enrolled in the study and were followed for 5 years. The median CSS was 27, with 288 patients showing a CSS ≥27, with a mean CSS of 47.85 and a mean SS of 29.05. At 3 and 5 years post-treatment, the CSS ≥27 group had a lower survival probability, CSS ≥27 was associated with a lower survival probability among patients who underwent PCI compared with those who underwent CABG. More specifically, the high-CSS CABG group had a 5-year mortality rate of 16.8%, whereas the high-CSS PCI group had a 5-year mortality rate of 32.2%. In a comparison of SS with CSS for the 5-year mortality outcome prediction, CSS was superior to SS with a higher area under the curve. CONCLUSIONS: This prospective registry of real-world revascularization strategies in patients with multivessel disease showed that CSS is a better predictive tool of postrevascularization survival than SS. Moreover, it showed that surgical revascularization in patients with CSS ≥27 is associated with better all-cause mortality outcome after CABG as compared with after PCI. This attests to the need for a score that considers clinical parameters in a real-world scenario.

Ischemic Postconditioning Confers No Benefit to Left Ventricular Systolic Function: A Meta-Analysis of Cardiac Magnetic Resonance Imaging Results.

Ischemic postconditioning (IPoC) is a technique suggested to reduce reperfusion injury in patients suffering acute ST-elevation myocardial infarction (STEMI), although its use is highly controversial. This meta-analysis aimed to evaluate the effect of IPoC with percutaneous coronary intervention in patients with acute STEMI, as measured by follow-up left ventricular ejection fraction (LVEF) on cardiac magnetic resonance imaging. The investigators searched PubMed, Embase, and Web of Science for all randomized controlled trials published during the last 2 decades. After the removal of duplicates, 2,021 articles from online databases had been identified using relevant search criteria. The included randomized controlled trials had studied patients with acute STEMI and Thrombolysis in Myocardial Infarction flow 0 to 1 at presentation and had measured follow-up LVEF using cardiac magnetic resonance imaging. Overall, 11 studies (n = 1,339 patients) qualified for inclusion. In each study, the control group did not differ significantly from the experimental group. The pooled data from included studies were analyzed using standardized mean difference between IPoC and control groups, and the 95% confidence interval for LVEF; the results were visualized using a forest plot. Bivariate regression analyses and 1-way analyses of LVEF coefficient ratios were done to isolate for various clinical and procedural parameters. An analysis of pooled data of the IPoC (n = 674) and control (n = 665) groups showed that IPoC did not significantly impact follow-up LVEF (using standardized mean difference 0.10, 95% confidence interval 0.00 to 0.21). Further analysis showed that IPoC did not improve follow-up LVEF when isolating for relevant clinical and procedural parameters. In conclusion, the use of IPoC as an adjunctive therapy to percutaneous coronary intervention seemingly provides no benefit to left ventricular systolic function, as quantified with cardiac magnetic resonance imaging, in patients with acute STEMI with Thrombolysis in Myocardial Infarction flow 0 to 1.

The Impact of Sex on Cardiogenic Shock Outcomes Following ST Elevation Myocardial Infarction.

BACKGROUND: Cardiogenic shock (CS) remains the leading cause of ST elevation myocardial infarction (STEMI)-related mortality. Contemporary studies have shown no sex-related differences in mortality. METHODS: STEMI-CS patients undergoing primary percutaneous coronary intervention (PPCI) were included based on a dedicated prospective STEMI database. We compared sex-specific differences in CS characteristics at baseline, during hospitalization, and in subsequent clinical outcomes. Endpoints included all-cause mortality and major adverse cardiac events (MACE). RESULTS: Of 3202 consecutive STEMI patients, 210 (6.5%) had CS, of which 63 (30.0%) were women. Women were older than men (73.2 vs. 65.5% y, p < 0.01), and more had hypertension (68.3 vs. 52.8%, p = 0.019) and diabetes (38.7 vs. 24.8%, p = 0.047). Fewer were smokers (13.3 vs. 41.2%, p < 0.01), had previous PCI (9.1 vs. 22.3% p = 0.016), or required IABP (35.3 vs. 51.1% p = 0.027). Women had higher rates of mortality (53.2 vs. 35.3% in-hospital, p = 0.01; 61.3 vs. 41.9% at 1 month, p = 0.01; and 73.8 vs. 52.6% at 3 years, p = 0.05) and MACE (60.6 vs. 41.6% in-hospital, p = 0.032; 66.1 vs. 45.6% at 1 month, p = 0.007; and 62.9 vs. 80.3% at 3 years, p = 0.015). After multivariate adjustment, female sex remained an independent factor for death (HR-2.42 [95% CI 1.014-5.033], p = 0.042) and MACE (HR-1.91 [95% CI 1.217-3.031], p = 0.01). CONCLUSIONS: CS complicating STEMI is associated with greater short- and long-term mortality and MACE in women. Sex-focused measures to improve diagnosis and treatment are mandatory for CS patients.

Effectiveness and Safety of Remote Cardiac Rehabilitation for Patients After Acute Coronary Syndrome.

Cardiac rehabilitation improves cardiovascular outcomes in patients after acute coronary syndrome (ACS). Recently there has been a growing interest in remote cardiac rehabilitation (RCR) programs. We aimed to evaluate the effectiveness of RCR compared with center-based cardiac rehabilitation (CBCR). This is an observational study including patients after hospital admission for ACS. The study group included patients at low-to-moderate risk for cardiovascular complications who were referred for RCR. The control group included patients at similar risk who participated in CBCR. The primary end points were the improvement of at least 10% to 25% in exercise capacity after 6 months of cardiac rehabilitation. Included were 305 patients who completed 6 months of cardiac rehabilitation. Of them, 107 patients participated in RCR and 198 in CBCR. RCR patients were younger and more frequently males. Improvement of ≥10% in exercise capacity after 6 months was achieved more frequently in patients participating in RCR compared with CBCR (69.3% and 55% respectively, p = 0.03). A similar trend was observed for improvement of ≥25% in exercise capacity after 6 months (33.8% and 22.7% in RCR and CBCR, respectively, p = 0.05). While weight reduction and the increase in muscle mass were similar in the 2 groups, fat percent reduction was significantly greater in the RCR compared with the CBCR (2.5% and 1.4% respectively, p <0.005). We conclude that RCR program is an effective and safe option for low-risk patients after hospital admission for ACS. It enables optimizing the utilization of this important service for patients with coronary artery disease.

Eyeball Test for the Assessment of Frailty in Elderly Patients With Cardiovascular Disease: A Prospective Study.

Frailty has been associated with poor outcomes in patients with cardiovascular diseases (CVDs). We aimed to assess the accuracy of the Eyeball test for frailty assessment in elderly patients with CVD. This is a prospective study including stable patients ≥75 years old who were followed-up in a cardiology clinic. Frailty assessment was performed separately through the Eyeball test and the Fried test in a blinded way. Cardiologists were asked to rate the frailty status of participants based on their routine clinical assessment and grade frailty on a Fried-type scale (1 to 5, with frailty defined as a score ≥3). Each patient then underwent formal frailty assessment using the Fried test. Included were 300 consecutive patients with a mean age of 81 ± 6 years. Frailty was diagnosed in 109 (36%) and 125 patients (41%) according to the Fried and Eyeball tests, respectively. The Eyeball test demonstrated 86% sensitivity and 82% specificity for the diagnosis of frailty. A receiver operating characteristics curve analysis demonstrated an area under the curve of 0.82 for the diagnosis of frailty. The Eyeball test demonstrated a very high negative predictive value of 90% and a modest positive predictive value of 73% for frailty assessment. Similar results were observed after subgroup analysis according to age and gender. In conclusion, the Eyeball test is an accurate method to rule out frailty in elderly patients with CVD. However, when frailty is suspected based on the Eyeball test, a formal tool such as the Fried test should be used to confirm the diagnosis.

Percutaneous coronary intervention with ridaforolimus-eluting stents in long lesions: the BIONICS 38†mm prospective trial.

BACKGROUND: The ridaforolimus-eluting stent (RES) system is a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. The aim of this trial was to assess the performance of a 38 mm RES in long coronary lesions. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameters of ≥2.75 mm to ≤4.25 mm. The primary endpoint was combined efficacy (final in-stent residual diameter stenosis <30%) without 30-day major adverse cardiovascular events (MACE) (composite of cardiac death, any myocardial infarction), or ischemia-driven target lesion revascularization. RESULTS: A total of 50 patients were enrolled in the study. Fourteen (28%) had acute coronary syndromes; 17 (34%) had diabetes. The mean lesion length was 32.4 mm ±â€…8.3, reference vessel diameter 2.88 mm ±â€…0.45, minimal lumen diameter 0.80 mm ±â€…0.41, and percent diameter stenosis 72.6% ±â€…13.2. The primary endpoint was achieved in 88% (44/50) of the patients (95% confidence interval: 75.7-95.5%). Thirty-day and 1-year MACE rates were 6% and 8%, respectively. Target lesion failure after 1 year occurred in three patients (6%). Forty-seven lesions (94%) were treated successfully, with final in-stent diameter stenosis of < 30% [95% confidence interval: (84-99%). CONCLUSION: Percutaneous coronary intervention (PCI) of long lesions with a 38 mm RES achieved satisfactory results, and support the safety and efficacy of PCI with RES in patients with long lesions. (ClinicalTrials.gov NCT03702608).

Cardiac Tamponade in Patients Treated with Direct Oral Anticoagulants.

BACKGROUND: Direct oral anticoagulants (DOACs) are the treatment of choice for patients with non-valvular atrial fibrillation; however, bleeding risk remains significant. We reported a single-center experience with 11 patients who presented with hemorrhagic cardiac tamponade while treated with DOACs. OBJECTIVES: To evaluate the characteristics and clinical outcomes of patients under DOACs with cardiac tamponade. METHODS: We retrospectively identified 11 patients treated with DOACs admitted with pericardial tamponade in our cardiology unit during 2018-2021. RESULTS: The mean age was 84 ± 4 years; 7 males. Atrial fibrillation was the indication for anticoagulation in all cases. DOACs included apixaban (8 patients), dabigatran (2 patients), and rivaroxaban (1 patient). Urgent pericardiocentesis via a subxiphoid approach under echocardiography guidance was successfully performed in 10 patients. One patient was treated with urgent surgical drainage with a pericardial window. Reversal of anticoagulation using prothrombin complex concentrate and idarucizumab was given before the procedure to 6 patients treated with apixaban and one patient treated with dabigatran. One patient, initially treated with urgent pericardiocentesis, underwent pericardial window surgery due to re-accumulation of blood in the pericardium. The pericardial fluid analysis demonstrated hemopericardium. Cytology tests were negative for malignant cells in all cases. Discharge diagnoses regarding the cause of hemopericardium included pericarditis (3 patients) and idiopathic (8 patients). Medical therapy included non-steroidal anti-inflammatory drugs (1 patient), colchicine (3 patients), and steroids (3 patients). No patient died during hospitalization. CONCLUSIONS: Hemorrhagic cardiac tamponade is a rare complication of DOACs. We found good short-term prognosis following pericardiocentesis.

Transcatheter Left Atrial Appendage Occlusion: A Multi-Center Real Life Experience.

(1) Background: left atrial appendage occlusion (LAAO) is considered an effective and relatively safe treatment for the prevention of thromboembolic events in patients with atrial fibrillation and a contra-indication for anticoagulation. We present a large multicenter real-world experience of transcatheter LAAO implementation in patients with atrial fibrillation who cannot be treated with chronic anti-coagulation; (2) Methods: included were atrial fibrillation patients who underwent transcatheter LAAO between 1 January 2016 and 30 June 2021. The study was conducted using the electronic health record database of Clalit Health Services (CHS). The primary outcomes included hemorrhagic and ischemic stroke following LAAO; (3) Results: included were 389 atrial fibrillation patients. During a median follow-up of 2.1 years, 13% patients had ischemic cerebrovascular accident (CVA), and 4.4% patients had hemorrhagic CVA. While the risk of ischemic stroke increased gradually over time, the risk of hemorrhagic CVA was highest during the first 3 months following the procedure. Moreover, previous ischemic stroke was the only significant predictor for both hemorrhagic and ischemic stroke following LAAO; (4) Conclusions: while the annual performance rate of transcatheter LAAO has increased significantly over the past years, post procedural long-term prognosis remains poor with a substantial risk of both thrombotic and bleeding events.

The impact of COVID-19 pandemic on cardiac rehabilitation of patients following acute coronary syndrome.

BACKGROUND: Cardiac rehabilitation improves prognosis and symptoms in cardiac patients. In 2020, due to the COVID-19 pandemic, cardiac rehabilitation services were temporarily suspended between April and August. We aimed to investigate the effect of cardiac rehabilitation suspension during the COVID-19 pandemic on patients' exercise capacity and metabolic parameters. METHODS: Included were patients undergoing cardiac rehabilitation following hospital admission for ACS. Exercise capacity, weight and body fat percentage were compared between baseline, pre- and post-lockdown visits. RESULTS: A total of 281 patients participated in the cardiac rehabilitation program prior to its suspension. Of them, only 198 (70%) patients returned to the program on its renewal and were included in the analysis. Exercise capacity improved significantly in the pre-lockdown stress test compared to baseline. However, there was a significant decrease in exercise capacity in the post compared to pre-lockdown test (8.1±6.3 and 7.1±2.1 METs in pre- and post-lockdown measurements, respectively, p<0.001). Of the 99 (50%) of patients that demonstrated at least 10% improvement in exercise capacity in the pre-lockdown test, 48(48.5%) patients returned to their baseline values in the post-lockdown test. Post-lockdown assessment demonstrated a significant weight gain (80.3 and 81.1kg, in pre- and post-lockdown measurements, respectively, p<0.001) as well as an increase in visceral fat level and body fat percentage. CONCLUSIONS: Cardiac rehabilitation suspension for 4 months during COVID-19 pandemic caused a significant reduction in exercise capacity and increased weight and body fat percent. These findings highlight the importance of remote cardiac rehabilitation services that can continue uninterrupted in times of pandemic.

Procedural and long-term outcome among patients undergoing expedited trans-catheter aortic valve replacement.

OBJECTIVE: Patients with rapidly deteriorating clinical status due to severe aortic stenosis are often referred for expedited transcatheter aortic valve replacement (TAVR). Data regarding the outcome of such interventions is limited. We aimed to evaluate the outcome of patients undergoing expedited TAVR. DESIGN AND SETTING: Data were derived from the Israeli Multicenter Registry. SUBJECTS: Subjects were divided into two groups based on procedure urgency: patients who were electively hospitalized for the procedure (N = 3140) and those who had an expedited TAVR (N = 142). Procedural and periprocedural complication rates were significantly higher among patients with an expedited indication for TAVR compared to those having an elective procedure: valve malposition 4.6% versus 0.6% (p < 0.001), procedural cardiopulmonary resuscitation 4.3% versus 1.0% (p = 0.007), postprocedure myocardial infarction 2.0% versus 0.4% (p = 0.002), and stage 3 acute kidney injury 3.0% versus 1.1%, (p < 0.001). Patients with expedited indication for TAVR had significantly higher in hospital mortality (5.6% vs. 1.4%, p = 0.003). Kaplan-Meier's survival analysis showed that patients undergoing expedited TAVR had higher 3-year mortality rates compared to patients undergoing an elective TAVR procedure (p < 0.001). Multivariate analysis found that patients with expedited indication had fourfolds increased risk of in-hospital mortality (odds ratio: 4.07, p = 0.001), and nearly twofolds increased risk of mortality at 3-year (hazard ratio: 1.69, p = 0.001) compared to those having an elective procedure. CONCLUSION: Patients with expedited indications for TAVR suffer from poor short- and long-term outcomes. It is important to characterize and identify these patients before the deterioration to perform TAVR in a fast-track pathway to minimize their procedural risk.

CHA2DS2-VASc Score, Mortality and Acute Myocardial Infarction in Patients With Nonvalvular Atrial Fibrillation.

Patients with atrial fibrillation (AF) are at increased cardiovascular risk. The CHA2DS2-VASc score (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, previous stroke, vascular disease, age 65 to 74 years, female gender) has been used to predict thromboembolic risk in patients with nonvalvular AF. We aimed to evaluate the association between the CHA2DS2-VASc score and the risk of acute myocardial infarction (AMI) and all-cause mortality in patients with AF treated with direct oral anticoagulants (DOACs). The study was based on the Clalit Health Services database. Included were 21,129 patients with nonvalvular AF treated with DOACs. Patients were stratified into four groups according to the CHA2DS2-VASc score.1-9 The primary end point was the occurrence of AMI and all-cause mortality. During 21,129 patient-years, there were 1,253 incidents (5.9%) of AMI. A higher CHA2DS2-VASc score was associated with a significantly increased risk of AMI (7.8, 14.9, 23.9, and 35.3 cases per 1,000 person-years, for patients with CHA2DS2-VASc score of 1 to 2, 3 to 4, 5 to 6, and 7 to 9, respectively, p <0.001). Each 1-point increase in the CHA2DS2-VASc score was associated with a 27% increased risk of AMI. A higher CHA2DS2-VASc score was also associated with a significantly increased ll-cause mortality rate (21.7, 60.2, 103.9, 162.6 cases per 1,000 person-years, for patients with CHA2DS2-VASc score of 1 to 2, 3 to 4, 5 to 6, 7 to 9, respectively, p <0.001). All associations remained statistically significant after a multivariate analysis. In conclusion, among patients with nonvalvular AF treated with DOACs, the CHA2DS2-VASc score was associated with increased risk of AMI and all-cause mortality.

Temporal Trends in the Prevalence, Treatment and Outcomes of Patients with Acute Coronary Syndrome at High Bleeding Risk.

(1) Background: High bleeding risk is associated with adverse outcomes in ACS patients. We aimed to evaluate temporal trends in treatment and outcomes of ACS patients according to bleeding risk. (2) Methods: Included were ACS patients enrolled in ACSIS surveys. Patients were divided into three groups according to enrolment period: early (2002−2004), mid (2006−2010) and recent (2012−2018). Each group was further stratified into three subgroups according to CRUSADE bleeding risk score. The primary endpoints were 30-day MACE and 1-year all-cause mortality. (3) Results: Included were 13,058 ACS patients. High bleeding risk patients were less frequently treated with guideline-based medications and coronary revascularization. They also had higher rates of 30-day MACE and 1-year all-cause mortality regardless of the enrollment period. Among patients enrolled in early period, 30-day MACE rates were 10.8%, 17.5% and 24.3% (p < 0.001) and 1-year all-cause mortality rates were 2%, 7.7% and 23.6% (p < 0.001) in the low, moderate and high bleeding risk groups, respectively. Among patients enrolled in mid period, 30-day MACE rates were 7.7%, 13.4% and 23.5% (p < 0.001) and 1-year all-cause mortality rates were 1.5%, 7.2% and 22.1% (p < 0.001) in low, moderate and high bleeding risk groups, respectively. For patients enrolled in recent period, 30-day MACE rates were 5.7%, 8.6% and 16.2%, (p < 0.001) and 1-year all-cause mortality rates were 2.1%, 6% and 22.4%, (p < 0.001) in low, moderate and high bleeding risk groups, respectively. These differences remained significant following a multivariate analysis. (4) Conclusions: The percentage of patients at high bleeding risk has decreased over the last years. Despite recent improvements in the treatment of ACS patients, high bleeding risk remains a strong predictor of adverse outcomes.

Generational Differences in Outcomes of Self-Expanding Valves for Transcatheter Aortic Valve Replacement.

BACKGROUND: The Medtronic Evolut Pro valve (EPV) is a new-generation self-expanding valve (SEV), particularly designed to reduce paravalvular leak (PVL) rates in transcatheter aortic valve replacement (TAVR). We aimed to compare the safety and efficacy of EPV with older-generation SEVs, in particular, postprocedural PVL and permanent pacemaker (PPM) implantation rates. METHODS: We performed a retrospective, multicenter, propensity-matched analysis of the Israeli TAVR registry between September 2008 and June 2019. Two independent propensity score-matched comparisons were performed comparing EPV with the first-generation CoreValve (CV), and comparing EPV with the second-generation Evolut R valve (ERV). RESULTS: The registry included 2591 patients who were propensity-matched into 3 cohorts: EPV (n = 222), CV (n = 212), and ERV (n = 213). Moderate and above PVL rates were lower for EPV (angiographic PVL [aPVL], 0.6%; echocardiographic PVL [ePVL], 3.0%) as compared with CV (aPVL, 7.8% [P<.001] and ePVL, 11.6% [P<.01]), but not as compared with ERV (aPVL, 6.4% [P<.01] and ePVL, 4.4% [P=.57]). Lower rates of PPM were noted for EPV (16.3%) as compared with both CV (33.5%; P<.001) and ERV (24.4%; hazard ratio, 0.61; 95% confidence interval, 0.37-0.995; P=.046). Other safety and efficacy outcome rates were excellent, with significant improvements as compared with older-generation SEVs. CONCLUSIONS: The EPV demonstrates excellent procedural safety and efficacy outcomes. Moderate and above PVL rates were significantly reduced in comparison with CV; however, not significantly reduced as compared with ERV. The need for PPM implantation was lower as compared with both older-generation valves.

Double-blind, placebo-controlled evaluation of biorest liposomal alendronate in diabetic patients undergoing PCI: The BLADE-PCI trial.

BACKGROUND: Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM. METHODS: Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography. RESULTS: From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups. CONCLUSIONS: Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.