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.

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.

Long-Term Outcomes in ST Elevation Myocardial Infarction Patients Undergoing Coronary Artery Bypass Graft Versus Primary Percutaneous Coronary Intervention.

BACKGROUND: Coronary artery bypass grafting (CABG) for primary reperfusion in patients with ST elevation myocardial infarction (STEMI) has largely been superseded byf primary percutaneous coronary intervention (PCI) and is estimated to be performed in ≤ 5% of STEMI cases. OBJECTIVES: To compare early CABG (within 30 days following admission) and primary PCI outcomes following STEMI. METHODS: We analyzed a retrospective cohort of patients hospitalized with acute STEMI for early reperfusion therapy between January 2008 and June 2016. Short- and long-term outcomes were assessed for patients with STEMI undergoing primary PCI vs. early CABG as reperfusion therapy. RESULTS: The study comprised 1660 STEMI patients, 38 of whom (2.3%) underwent CABG within 30 days of presentation. Unadjusted 30-day mortality was more than twice as high in the CABG group (7.5%) than in the PCI group (3.3%); however, it did not reach statistical significance. Similar results were demonstrated for mortality rates beyond 30 days (22% vs. 14%, P = 0.463). All patients undergoing CABG beyond 72 hours following admission survived past 2 years. Multivariate analysis found no differences between the two groups in long-term mortality risk. propensity score matched long-term mortality comparison (30 days-2 years) yielded a 22% mortality rate in the CABG groups compared with 14% in the PCI group (P < 0.293). CONCLUSIONS: Early CABG was performed in only a minority of STEMI patients. This high-risk patient population demonstrated worse outcomes compared to patients undergoing PCI. Performing surgery beyond 72 hours following admission may be associated with lower risk.

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.

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.

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.

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.

Immediate and early percutaneous coronary intervention in very high-risk and high-risk non-ST segment elevation myocardial infarction patients.

BACKGROUND: The European Society of Cardiology (ESC) guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation (non-ST-segment elevation myocardial infarction [NSTEMI]) has recommended immediate (<2 h) percutaneous coronary intervention (PCI) in very-high risk patients and early (<24 h) PCI in high-risk patients. HYPOTHESIS: To examine the ESC NSTEMI guidelines adherence in a nationwide survey in Israel using the Acute Coronary Syndrome Israeli Survey (ACSIS). We hypothesized that adherence to the guidlines' recommnded PCI timing in NSTEMI pateints will be inadequate, partly due to the inconsistent evidence regarding its effect on clinical outcomes. METHODS: All NSTEMI patients who underwent PCI during the ACSIS surveys in 2016 and 2018 were included in the analysis. RESULTS: Out of 1793 NSTEMI patients, 1643 (92%) patients underwent PCI, and door to balloon time was documented in 1078 of them. One hundred and fifty-six (14.5%) patients and 922 (85.5%) patients were defined as very high-risk and high-risk NSTEMI patients, respectively. Of the very high-risk NSTEMI patients, only 10 (6.4%) underwent immediate coronary angiography, and 50 (32.1%) underwent early coronary angiography. Acute heart failure 139 (89.1%) was the main reason for including NSTEMI patients in the very high-risk category. Of the high-risk patients, early coronary angiography was performed in only 405 (43.9%) patients. Patients in whom coronary angiography was postponed were older and had more comorbidities. CONCLUSIONS: Despite guidelines recommendations for immediate and early PCI in very high-risk and high-risk NSTEMI patients, respectively, most patients do not undergo immediate or early PCI according to contemporary guidelines. Further studies are needed to better understand the reasons for guidelines' nonadherence in those high-risk patients.