Rate Of Major Cardiovascular Events Research Articles

Clinical equivalence of generic and brand-name drugs used in cardiology: what do we know?

The problem of using generics in the treatment of patients with cardiovascular diseases remains relevant for more than a decade. The concern of doctors, pharmacists and patients is not diminishing with the constant rise in cardiovascular morbidity and mortality worldwide. Based on a systematic review of 186 publications, physicians identified concerns about the quality, reliability and replaceability of original drugs; pharmacists have shown the highest level of generic approval. Patients distrust of generics was revealed, caused by a lack of information, concerns about packaging, and negative experience of replacing the original drug. Three meta-analyzes compared generic and original drugs of cardiovascular groups in terms of efficacy and safety. A 2008 meta-analysis (47 studies, 9 classes of cardiovascular drugs) assessed the effect on mild outcomes, a 2016 meta-analysis (74 studies, 7 classes of drugs) also assessed side effects. The cumulative effect revealed a small and nonsignificant difference, which indicated that there was no superiority of original drugs over generics; there were no differences in the frequency and severity of side effects between generics and original drugs. A 2020 meta-analysis (72 studies, 9 drug classes) assessed the frequency of hospital admissions (including emergency department consultations, hospitalizations) and found a significant increase in the risk for generics for any reason (14%), but not for cardiac vascular diseases. A review of 8 cohort studies evaluating antihypertensive drugs for long-term cardiovascular outcomes, duration of retention, and substitution effect did not find significant differences between generics and brands. In a systematic review of studies comparing warfarin and generics, there were no significant differences in international normalized ratio and the incidence of thromboembolic and hemorrhagic complications; however, in one study, the frequency of hospital visits was 10% higher for generics. A systematic review of studies comparing clopidogrel versus generics shows drug comparability for major cardiovascular events and mortality. A review of 5 cohort studies evaluating originator statins and generics showed comparable rates of all-cause mortality and major cardiovascular events, except for one study with conflicting results. Meta-analyzes and large observational studies indicate that generics are not the worst efficacy, sometimes even surpass that of original drugs and can be justifiably used in clinical practice.

451 Deferral of coronary revascularization in patients with reduced ejection fraction based on physiological assessment: impact on long-term survival

Abstract Aims Deferring percutaneous coronary intervention (PCI) in patients with non-significant stenoses based on fractional flow reserve (FFR) is associated with favourable clinical outcomes up to 15 years. Whether this holds true in patients with reduced left ventricular ejection fraction (LVEF) is unclear. To investigate whether FFR provides adjunctive clinical benefit compared to coronary angiography in deferring revascularization of patients with intermediate coronary stenoses and reduced LVEF. Methods and results Consecutive patients (n = 4577) with reduced LVEF (≤50%) undergoing coronary angiography between 2002 and 2010 were screened. We eventually included patients with at least one intermediate coronary stenosis (diameter stenosis ≥40%) in whom revascularization was deferred based either on angiography plus FFR (FFR-guided) or angiography alone (angiography-guided). The primary endpoint of the study was the cumulative incidence of all-cause death at 10 years. The secondary endpoint [the incidence of major adverse cardiovascular and cerebrovascular events (MACCE)], was a composite of all-cause death, myocardial infarction, any revascularization and stroke. A total of 840 patients were included (206 in the FFR-guided and 634 in the angiography-guided group). Median clinical follow-up was 7 years [IQR: (3.22–11.08)]. After 1:1 propensity score matching, baseline characteristics between the two groups were similar. All-cause death was significantly lower in the FFR-guided group compared with the angiography-guided group [94 (45.6%) vs. 119 (57.8%), HR: 0.65 (95% CI: 0.49–0.85), P < 0.01]. The rate of major adverse cardiovascular and cerebrovascular events [(MACCE), a composite of all-cause death, myocardial infarction, any revascularization, and stroke) was lower in the FFR-guided group [123 (59.7%) vs. 139 (67.5%), HR: 0.75 (95% CI: 0.59–0.95), P = 0.02]. Conclusions In patients with reduced LVEF, deferring revascularization of intermediate coronary stenoses based on FFR is associated with a lower incidence of death and MACCE at 10 years.

Statin Discontinuation and Cardiovascular Events Among Older People in Denmark

Statin use is common in older persons. Given uncertainties in ongoing benefit, changes in health status, and shifting goals of care and preferences, statin discontinuation may be considered in some older persons, although there is currently little evidence to guide this decision. To evaluate the association between statin discontinuation and the rate of major adverse cardiovascular events (MACE) among people aged 75 years or older who receive long-term statin treatment. This cohort study included all persons in Denmark aged 75 years or older who were treated with statins for at least 5 consecutive years as of January 1, 2011. Participants were followed up until December 31, 2016. Data were analyzed from July to November, 2020. Statin discontinuation. Rate of occurrence of MACE and its components (myocardial infarction, ischemic stroke or transient ischemic attack, coronary revascularization, and death due to myocardial infarction or ischemic stroke) in persons continuing statins compared with those discontinuing statins. Confounding adjustment was done using inverse probability of treatment weighting. Analyses were conducted separately for primary prevention (no history of cardiovascular disease) and secondary prevention (history of cardiovascular disease). The study included 67 418 long-term statin users, including 27 463 in the primary prevention analysis (median age, 79 years [IQR, 77-83 years]; 18 134 [66%] female) and 39 955 in the secondary prevention analysis (median age, 80 years [IQR, 77-84 years]; 18 717 [47%] female). In both primary and secondary prevention analyses, the rate of MACE was higher among persons who discontinued statins compared with those who continued statins. In the primary prevention cohort, the weighted rate difference was 9 per 1000 person-years (95% CI, 5-12 per 1000 person-years) and the adjusted sub-hazard ratio was 1.32 (95% CI, 1.18-1.48), corresponding to 1 excess MACE per 112 persons who discontinued statins per year. In the secondary prevention cohort, the weighted rate difference was 13 per 1000 person-years (95% CI, 8-17 per 1000 person-years) and the adjusted sub-hazard ratio was 1.28 (95% CI, 1.18-1.39), corresponding to 1 excess MACE per 77 persons who discontinued statins per year. In this cohort study, among older adults receiving long-term statin treatment, discontinuation of statins was associated with a higher rate of MACE compared with statin continuation in both the primary and the secondary prevention cohorts. These findings suggest a need for robust evidence from randomized clinical trials.

Standard Modifiable Cardiovascular Risk Factors and Prognosis of Acute Coronary Syndrome in Younger Patients.

To investigate standard modifiable cardiovascular risk factors (SMuRFs) and prognosis of patients with acute coronary syndrome (ACS) aged 50 years or younger. An observational study. Eleven general hospitals in Chengdu, Sichuan Province, China, from January 2017 to June 2019. Patients with ACS were stratified into younger group (≤50 years) and older group (>50 years). The baseline characteristics and prognosis were compared for two groups. Survival analysis was used to assess the long-term prognosis. Among a total of 1982 ACS patients, 322 (16.2%) were of ≤50 years. Compared with older patients, younger patients were more likely to have at least one SMuRFs (90.0% vs. 84.3%, p=0.013). The younger group had a higher prevalence of smoking (62.8% vs. 34.1%, p <0.001) and hypercholesterolemia (36.2% vs. 23.4%, p <0.001) compared with the older group. Younger male patients were more likely to have at least one SMuRFs than younger female patients (91.6% vs. 74.1%, p = 0.011). After the follow-up of 15 (10, 22) months, the cumulative rates of major adverse cardiovascular and cerebrovascular events (MACCE) of the younger patients were significantly lower than those in the older patients [hazard ratio (HR): 0.2661, 95% confidence interval (CI): 0.1932 - 0.3665, p <0.001]. Younger patients with ACS were more likely to have at least one SMuRFs; and were likely to have a better prognosis than older patients. Key Words: Coronary artery disease, Acute coronary syndrome, Middle aged, Risk factors, Prognosis.

Chronic obstructive pulmonary disease in patients with coronary heart disease worsens long-term prognosis after percutaneous coronary interventions.

Aim To evaluate the incidence rate of major adverse cardiovascular events (MACVE) in the long-term following percutaneous coronary interventions (PCCI) in patients with acute and chronic ischemic heart disease (IHD) and the contribution of concurrent chronic obstructive pulmonary disease (COPD) to the long-term prediction.Material and methods This prospective cohort study included 254 patients with IHD and concurrent COPD and 392 patients with IHD without COPD. PCCI was performed in all patients: for acute coronary syndrome in 295 patients and for chronic IHD in 351 patients. The follow-up period lasted for up to 36 months. The outcome was a composite endpoint, MACVE, that included cardiovascular death, myocardial infarction, stroke, repeated unscheduled myocardial revascularization (MR), and the time to the event.Results The age-standardized incidence of MACVE in patients with IHD and COPD was 31.5 vs. 23.2 % in patients with IHD without concurrent COPD (p=0.025), primarily due to an increased frequency of repeated unscheduled MR (20.5 vs. 14.0 %, p=0.041), which was associated with earlier occurrence of adverse events (p&lt;0.001). Repeated unscheduled MR was more frequently performed in patients with moderate COPD; the frequency of MR decreased with increasing severity of COPD, whereas the total incidence of cardiovascular death, myocardial infarction, and stroke was the highest in patients with severe and very severe COPD.Conclusion The presence of concurrent COPD increases the relative risk of MACVE 1.36 times (95 % confidence interval: 1.05-1.75) and facilitates their earlier development. Repeated unscheduled MR makes the major contribution to the increase in the total risk (relative risk, 1.46; 95 % confidence interval: 1.03-2.06). The increase in severity of COPD is associated with the increase in total frequency of MACVE (p=0.005).

Clinical Implications of Nicorandil Combined with Trimetazidine in Patients with Coronary Heart Disease: A Real-World Observational Study.

Coronary heart disease (CHD) remains the leading cause of mortality in China. The treatment strategies, especially for patients with ischemic angina pectoris, are still far from satisfactory. Hence, this study was carried out to evaluate the long-term potential of nicorandil in Chinese patients with CHD. Adult patients with CHD were reviewed retrospectively from three hospitals in Central China to obtain relevant data. The primary outcome was the rate of major adverse cardiovascular events (MACE) which is the composite outcome of stroke, myocardial infarction (MI), and mortality at 3years while the secondary outcomes included rates of MACE, stroke, MI, and mortality at 1 and 2years. The rates of MACE were estimated using Kaplan-Meir survival curves and compared by log-rank test. The association between various treatment regimens and hazards of MACE was estimated using Cox proportional hazards model. All analyses were carried out using SAS9.4. A total of 5504, 1674, and 3923 patients treated with the nicorandil-trimetazidine combination, nicorandil, and trimetazidine were included in the study, respectively. At 3-year follow-up, the rate of MACE [hazard ratio (HR) 0.85; 95%CI 0.74-0.97; P = 0.017] and stroke (HR 0.58, 95%CI 0.48-0.71; P < 0.0001) was lower in the combination group compared to trimetazidine group. Similarly, the rate of stroke was significantly lower (HR 0.69; 95%CI 0.52-0.93; P = 0.0146) at 3years in the nicorandil group compared to the trimetazidine group. The rate of stroke (HR 0.65; 95%CI 0.52-0.83; P = 0.0004) was significantly lower among the combination group compared with the trimetazidine group at 1-year follow-up. Similarly, the rate of stroke was significantly lower at 1year (HR 0.70; 95%CI 0.50-0.97; P = 0.03) but not at2years (HR 0.70; 95%CI 0.52-0.94; P = 0.0177), while the rate of other outcomes, though lower in the nicorandil group than the trimetazidine group, was not statistically significantat 1 and 2 years respectively. Nicorandil in combination with trimetazidine can be considered as an effective and potential treatment strategy in reducing the rate of MACE in patients with CHD in the Chinese population.

Active Versus Conventional Side Branch Protection Strategy for Coronary Bifurcation Lesions.

The side branch (SB) provisional stenting strategy is currently the recommended approach for most coronary bifurcation lesions. However, this strategy may result in SB deterioration, which is associated with an increased incidence of periprocedural myocardial infarction (PMI) and may adversely affect the long-term prognosis. Various techniques for SB protection (SB-P) have been developed to reduce SB occlusion and improve the clinical prognosis. This meta-analysis was performed to compare the outcomes of an active SB-P strategy of jailed balloon technique, balloon-stent kissing technique, and jailed Corsair technique versus the conventional SB-P strategy based on jailed wire technique.This meta-analysis included 5 studies (4 randomized and 1 observational) involving a total of 1,174 patients in whom the active and conventional SB-P strategies were compared. Fixed- and random-effects models were used to calculate summary risk ratios (RRs).The risk of SB occlusion was significantly lower in active SB-P strategy [RR 0.47, 95% confidence interval (CI) 0.30-0.73 in fixed-effect model; RR 0.52, 95% CI 0.31-0.87 in random-effect model]. The risk of PMI was similar between the two strategies (RR 0.63, 95% CI 0.30-1.33 in fixed-effect model; RR 0.71, 95%CI 0.20-2.48 in random-effect model). The rate of long-term major adverse cardiovascular events was similar between the groups (RR 0.48, 95% CI 0.15-1.48 in fixed-effect model; RR 0.49, 95% CI 0.16-1.52 in random-effect model).The active SB-P strategy in coronary bifurcation lesions is associated with reduced SB deterioration, but it does not decrease PMI or improve the long-term prognosis.

Differential importance of endothelial and hematopoietic cell GLP-1Rs for cardiometabolic versus hepatic actions of semaglutide.

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are used to treat diabetes and obesity and reduce rates of major cardiovascular events, such as stroke and myocardial infarction. Nevertheless, the identity of GLP-1R–expressing cell types mediating the cardiovascular benefits of GLP-1RA remains incompletely characterized. Herein, we investigated the importance of murine Glp1r expression within endothelial and hematopoietic cells. Mice with targeted inactivation of Glp1r in Tie2+ cells exhibited reduced levels of Glp1r mRNA transcripts in aorta, liver, spleen, blood, and gut. Glp1r expression in bone marrow cells was very low and not further reduced in Glp1rTie2–/– mice. The GLP-1RA semaglutide reduced the development of atherosclerosis induced by viral PCSK9 expression in both Glp1rTie2+/+ and Glp1rTie2–/– mice. Hepatic Glp1r mRNA transcripts were reduced in Glp1rTie2–/– mice, and liver Glp1r expression was localized to γδ T cells. Moreover, semaglutide reduced hepatic Tnf, Abcg1, Tgfb1, Cd3g, Ccl2, and Il2 expression; triglyceride content; and collagen accumulation in high-fat, high-cholesterol diet–fed Glp1rTie2+/+ mice but not Glp1rTie2–/– mice. Collectively, these findings demonstrate that Tie2+ endothelial or hematopoietic cell GLP-1Rs are dispensable for the antiatherogenic actions of GLP-1RA, whereas Tie2-targeted GLP-1R+ cells are required for a subset of the antiinflammatory actions of semaglutide in the liver.

C24. Cardioembolic Stroke due to LV Thrombus : Very High Risk NSTEMI Complication

Abstract Background Ischemic heart disease is the major cause to the high mortality rate. Ischemic heart disease was responsible for 7 million of the 53 million deaths reported in 2010. Left ventricle thrombus that complicates acute myocardial infarction (AMI) is a major cause of cardioembolic stroke. Case Summary A 69-year-old man presented with typical of infarction chest pain and shortness of breath since 2 days before admission to the hospital. The patient was diagnosed with NSTEMI TIMI 4/7 GS 177, PVC Frequent and history of VT and was planned for immediate PCI. After cannulation in the left coronary artery, the patient developed VT/VF and therefore CPR was performed. The patient was in ROSC then admitted to the CVCU and had improved. After two days of treatment, the patient experienced weakness in right limbs and difficulty of speaking, followed by decreased consciousness and suspected with ischemic stroke. The patient was then immediately treated for cardioembolic stroke. After 1 day of treatment the patient got worsened and was declared dead. Discussion Based on NSTEMI startification, patients was included in very high risk with a major cardiovascular event rate of 40.9%. During the treatment, patients experiencing cardioembolic stroke which causes increased mortality. Management of cardioembolic stroke as soon as possible increases the chances of success in therapy

C24. Cardioembolic Stroke due to LV Thrombus : Very High Risk NSTEMI Complication

Abstract Background Ischemic heart disease is the major cause to the high mortality rate. Ischemic heart disease was responsible for 7 million of the 53 million deaths reported in 2010. Left ventricle thrombus that complicates acute myocardial infarction (AMI) is a major cause of cardioembolic stroke. Case Summary A 69-year-old man presented with typical of infarction chest pain and shortness of breath since 2 days before admission to the hospital. The patient was diagnosed with NSTEMI TIMI 4/7 GS 177, PVC Frequent and history of VT and was planned for immediate PCI. After cannulation in the left coronary artery, the patient developed VT/VF and therefore CPR was performed. The patient was in ROSC then admitted to the CVCU and had improved. After two days of treatment, the patient experienced weakness in right limbs and difficulty of speaking, followed by decreased consciousness and suspected with ischemic stroke. The patient was then immediately treated for cardioembolic stroke. After 1 day of treatment the patient got worsened and was declared dead. Discussion Based on NSTEMI startification, patients was included in very high risk with a major cardiovascular event rate of 40.9%. During the treatment, patients experiencing cardioembolic stroke which causes increased mortality. Management of cardioembolic stroke as soon as possible increases the chances of success in therapy

An Asian Perspective on Gender Differences in In-Hospital and Long-Term Outcome of Cardiac Mortality and Ischemic Stroke after Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction

ObjectivesGender differences historically exist in cardiovascular disease, with women experiencing higher rates of major adverse cardiovascular events. We investigated these trends in a contemporary Asian cohort, examining the impact of gender differences on cardiac mortality and ischemic stroke after primary percutaneous coronary intervention (PPCI) for ST elevation myocardial infarction (STEMI). Materials and MethodsWe analysed 3971 consecutive patients who underwent primary PCI for STEMI retrospectively. The primary outcome was cardiac mortality and ischemic stroke in-hospital, at one year and on longer-term follow up (median follow up 3.62 years, interquartile range 1.03–6.03 years). ResultsThere were 580 (14.6%) female patients and 3391 (85.4%) male patients. Female patients were older and had higher prevalence of hypertension, diabetes, previous strokes, and chronic kidney disease. Cardiac mortality was higher in female patients during in-hospital (15.5% vs. 6.2%), 1-year (17.4% vs. 7.0%) and longer term follow up (19.9% vs. 8.1%, log-rank test: p < 0.001). Similarly, females had higher incidence of ischemic stroke at in-hospital (2.6% vs. 1.0%), 1-year (3.6% vs. 1.4%) and in the longer-term (6.7% vs. 3.1%) as well (log-rank test: p < 0.001). Female gender remained an independent predictor of in-hospital cardiac mortality (HR 1.395, 95%CI 1.061-1.833, p=0.017) and on longer-term follow-up (HR 1.932 95%CI 1.212-3.080, p=0.006) even after adjusting for confounders. ConclusionsFemales were at higher risk of in-hospital and long-term cardiac mortality and ischemic stroke after PPCI for STEMI. Future studies are warranted to investigate the role of aggressive management of cardiovascular risk factors and follow-up to improve outcomes in the females with STEMI.

Evaluating Diuretics in Normal Care (EVIDENCE): protocol of a cluster randomised controlled equivalence trial of prescribing policy to compare the effectiveness of thiazide-type diuretics in hypertension

IntroductionHealthcare systems must use treatments that are effective and safe. Regulators licensed many currently used older medications before introducing the stringent evidential requirements imposed on modern treatments. Also, there has been little encouragement to carry out within-class, head-to-head comparisons of licensed medicines. For commonly prescribed drugs, even small differences in effectiveness or safety could have significant public health implications. However, conventional clinical trials that randomise individual subjects are costly and unwieldy. Such trials are also often criticised as having low external validity. We describe an approach to rapidly generate externally valid evidence of comparative safety and effectiveness using the example of two widely used diuretics for the management of hypertension.Methods and analysisThe EVIDENCE (Evaluating Diuretics in Normal Care) study has a prospective, cluster-randomised, open-label, blinded end-point design. By randomising prescribing policy in primary care practices, the study compares the safety and effectiveness of commonly used diuretics in treating hypertension. Participating practices are randomised 1:1 to a policy of prescribing either indapamide or bendroflumethiazide when clinically indicated. Suitable patients who are not already taking the policy diuretic are switched accordingly. All patients taking the study medications are written to explaining the rationale for changing the prescribing policy and notifying them they can opt-out of any switch. The prescribing policies’ effectiveness and safety will be compared using rates of major adverse cardiovascular events (hospitalisation with myocardial infarction, heart failure or stroke or cardiovascular death), routinely collected in national healthcare administrative datasets. The study will seek to recruit 250 practices to provide a study population of approximately 50,000 individuals with a mean follow-up time of two years. A primary intention-to-treat time-to-event analysis will be used to estimate the relative effect of the two policies.Ethics and disseminationEVIDENCE has been approved by the East of Scotland Research Ethics Service (17/ES/0016, current approved protocol version 5, 26 August 2021). The results will be disseminated widely in peer reviewed journals, guideline committees, National Health Service (NHS) organisations and patient groups.Trial registrationISRCTN46635087. Registered on 11 August 2017 (pre-recruitment).

Worse outcomes of ACS patients without versus with traditional cardiovascular risk factors

IntroductionUp to 20% of patients presenting with acute coronary syndrome (ACS) have no traditional cardiovascular risk-factors (RFs). Data regarding the determinants, management, and outcomes of these patients are scarce. ObjectivesTo evaluate the management, outcomes, and time-dependent changes of ACS patients without RFs. MethodsEvaluation of clinical characteristics, management strategies, and outcomes as well as time-dependent changes [by 3 time periods: early (2000-2006), mid (2008-2013), and late (2016-2018)] of ACS patients without RFs (diabetes mellitus, hypertension, dyslipidemia, family history of ischemic heart disease, and smoking) or known coronary artery disease, enrolled in the biennial ACS Israeli Surveys (ACSIS) between 2000 and 2018. We compared ACS patients without RFs (no-RF group) to those with ≥1 RFs (RF group). ResultsOverall, 554/9,683 (5.7%) eligible ACS patients did not have any RFs [median age 63 (IQR 52-76) years, 25% females]. The no-RF group were older, with lower body mass index and prevalence of other cardiovascular comorbidity and chronic kidney disease compared with the RF group. The in-hospital percutaneous coronary intervention rates were lower among the no-RF vs. the RF group (55% vs. 66%, respectively p<0.001). Furthermore, lower rate of guideline-recommended medical therapy upon discharge was prescribed in the no-RF group. The rate of in-hospital complications was greater in the no-RF vs. RF group (31.6% vs. 26.1%, respectively p=0.005). The rates of 30-day major adverse cardiovascular events (MACE; 17.6% vs.12.8%, respectively, p=0.002) and of 30-day and 1-year all-cause mortality (8.4% vs. 4.2%, p<0.001 and 11.4% vs. 7.7%, p=0.003 respectively) were higher among patients with no-RF vs. RF. Following propensity score matching 30-day MACE, 30-day and 1-year mortality risk remained higher in the no-RF group. The rate of 30-day MACE decreased between the early and the late study period in the no-RF group (21.5% vs. 10.5%, p=0.003, respectively). ConclusionsACS patients without traditional cardiovascular risk-factors comprise a unique group with reduced prevalence of comorbidities yet significantly worse outcomes. Additional research to identify unique risk-factors and targets for interventions to improve outcomes of this group of patients is warranted.

Abstract 10214: Stress Testing Prior to Abdominal Aortic Aneurysm Repair: What is Our Return on Investment?

Introduction: The use of stress testing prior to abdominal aortic aneurysm (AAA) repair is highly variable. We examined the financial implications of this variation and its impact on postoperative cardiac events. Methods: We studied patients who underwent elective endovascular (EVAR) or open AAA repair at Vascular Quality Initiative participating centers from 2015–2019. We grouped centers into quintiles by their frequency of preoperative stress testing. We calculated rates of major adverse cardiovascular events (MACE), a composite of in-hospital myocardial infarction, stroke, heart failure, or death, for each quintile. We applied the charges for electrocardiographic, echocardiographic, and nuclear stress tests at our institution in 2019 to the study population to calculate expected charges per 1,000 patients. Results: We studied 27,978 patients who underwent EVAR (mean age: 73.5 ±8.5 years, 81.7% male) and 4,481 who underwent open AAA repair (mean age: 69.5 ±8.1 years, 75.1% male). Stratifying by quintile, stress test frequency ranged from 13.0% to 68.6% (mean: 37.9%) among EVAR patients and 15.9% to 85.0% (mean: 52.8%) among open AAA repair (Figure). The rate of MACE was 1.4% after EVAR and 10.2% after open AAA repair. MACE after EVAR increased with the frequency of stress testing and was 0.9% at 1 st quintile centers vs 1.7% at 5 th quintile centers (p-trend=0.033). There was no association between MACE and stress testing for open AAA repair (p-trend=0.192). The estimated charges for stress testing prior to EVAR was $125,806 per 1,000 patients at 1 st quintile centers, and $664,975 at 5 th quintile centers, while charges prior to open AAA repair were $153,861 per 1,000 patients at 1 st quintile centers, and $825,473 at 5 th quintile centers. Conclusions: More frequent stress testing is associated with high cost without a reduction in MACE. This lack of return on investment highlights the need for more judicious stress test use prior to AAA surgery.

Elevated Pulse Pressure and Recurrent Hemorrhagic Stroke Risk in Stroke With Cerebral Microbleeds or Intracerebral Hemorrhage.

Background Which type of recurrent stroke is associated with pulse pressure (PP) remains uncertain in ischemic stroke with cerebral microbleeds or intracerebral hemorrhage. Methods and Results The PICASSO (Prevention of Cardiovascular Events in Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage) database involving 1454 subjects was analyzed. Subjects were stratified into quartiles according to the distribution of mean PP (mmHg) during follow-up (mean, 1.9years): <47 (first quartile), 48 to 53 (second quartile), 54 to 59 (third quartile), and ≥60mmHg (fourth quartile). The primary end point was hemorrhagic stroke, and the secondary end points were ischemic stroke, stroke of any type, and major adverse cardiovascular events. Adjusted time-dependent area under the receiver operating characteristic curve analysis was performed to assess the prediction accuracy of mean PP. The mean frequency of visit for blood pressure checkup was 9.4±5.5 times. The stroke incidence rate per 100 person-years was 3.14, 2.24, 5.52, and 6.22, respectively in increasing quartile of mean PP, and the rate of major adverse cardiovascular events was 3.82, 2.84, 6.37, and 7.14, respectively. In the presence of mean arterial pressure, hemorrhagic stroke risk was higher in the highest quartile (adjusted hazard ratio, 6.03; 95% CI, 1.04-34.99) versus the lowest quartile, which was evident at higher mean systolic blood pressure. Higher mean PP as a continuous variable was also a predictor of hemorrhagic stroke (1.09, 1.03-1.15). The time-dependent area under the receiver operating characteristic curve for hemorrhagic stroke was 0.79. Conclusions Long-term elevated PP with higher systolic blood pressure confers a greater risk of subsequent hemorrhagic stroke among stroke patients with cerebral microbleeds or intracerebral hemorrhage. Registration URL: https://www.clinicaltrials.gov; Unique identifier, NCT01013532.

Clinical Characteristics and Outcomes Among Patients Undergoing High-Risk Percutaneous Coronary Interventions by Single or Multiple Operators: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

BackgroundHigh‐risk percutaneous coronary intervention (HR‐PCI) is increasingly common among contemporary patients with coronary artery disease. Experts have advocated for a collaborative 2‐operator approach to support intraprocedural decision‐making for these complex interventions. The impact of a second operator on patient and procedural outcomes is unknown.Methods and ResultsPatients who underwent HR‐PCI from 2015 to 2018 within the Veterans Affairs Healthcare System were identified. Propensity‐matched cohorts were generated to compare the outcomes following HR‐PCI performed by a single or multiple (≥2) operators. The primary end point was the 12‐month rate of major adverse cardiovascular events. We identified 6672 patients who underwent HR‐PCI during the study period; 6211 (93%) were treated by a single operator, and 461 (7%) were treated by multiple operators, with a nonsignificant trend toward increased multioperator procedures over time. A higher proportion of patients treated by multiple operators underwent left main (10% versus 7%, P=0.045) or chronic total occlusion intervention (11% versus 5%, P<0.001). Lead interventionalists participating in multioperator procedures practiced at centers with higher annual HR‐PCI volumes (124±71.3 versus 111±69.2; standardized mean difference, 0.197; P<0.001) but otherwise performed a similar number of HR‐PCI procedures per year (34.4±35.3 versus 34.7±30.7; standardized mean difference, 0.388; P=0.841) compared with their peers performing single‐operator interventions. In a propensity‐matched cohort, there was no significant difference in major adverse cardiovascular events (32% versus 30%, P=0.444) between patients who underwent single‐operator versus multioperator HR‐PCI. Adjusted analyses accounting for site‐level variance showed no significant differences in outcomes.ConclusionsPatients who underwent multioperator HR‐PCI had similar outcomes compared with single‐operator procedures. Further studies are needed to determine if the addition of a second operator offers clinical benefits to a subset of HR‐PCI patients undergoing left main or chronic total occlusion intervention.

Long-term mortality in asymptomatic patients with stable ischemic heart disease undergoing percutaneous coronary intervention

Patients with stable ischemic heart disease (SIHD) may present with a variety of symptoms including typical angina, angina equivalents such as dyspnea or no symptoms. We sought to determine whether symptom status affects periprocedural safety and long-term mortality in patients undergoing PCI. Prospectively enrolled consecutive patients undergoing PCI for SIHD at six hospitals in Australia between 2005 to 2018 as part of the Melbourne Interventional Group registry. Symptom status was recorded at the time of PCI and patients undergoing staged PCI were excluded. Overall, 11,730 patients with SIHD were followed up for a median period of 5 years (maximum 14.0 years, interquartile range 2.2-9.0 years) with 1,317 (11.2%) being asymptomatic. Asymptomatic patients were older, and more likely to be male, have triple-vessel disease, with multiple comorbidities including renal failure, diabetes and heart failure (all P < .01). These patients had significantly higher rates of periprocedural complications and major adverse cardiovascular events at 30-days. Long-term mortality was significantly higher in asymptomatic patients (27.2% vs 18.0%, P < .001). On cox regression for long-term mortality, after adjustment for more important clinical variables, asymptomatic status was an independent predictor (Hazard ratio (HR) 1.39 95% CI 1.16-1.66, P < .001). In a real-world cohort of patients undergoing revascularization for SIHD, absence of symptoms was associated with higher rates of periprocedural complications and, after adjustment for more important clinical variables, was an independent predictor of long-term mortality. As the primary goal of revascularization in SIHD remains angina relief, the appropriateness of PCI in the absence of symptoms warrants justification.

Direct Oral Anticoagulants Combined with Antiplatelet Therapy in the Treatment of Coronary Heart Disease: An Updated Meta-analysis.

Direct oral anticoagulants (DOACs) combined with antiplatelet therapy for acute coronary syndrome (ACS) may reduce ischemic events, but there is no consensus on bleeding risk. Moreover, the effect of DOACs on stable coronary artery disease (CAD) needs to be elucidated. We conducted a meta-analysis to summarize the efficacy and safety of DOACs combined with antiplatelet therapy in the treatment of stable CAD and ACS. We searched PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials, then performed a systematic review of all 17 randomized controlled trials. For patients with stable CAD, DOACs combined with antiplatelet therapy significantly reduced the rate of major adverse cardiovascular events (MACE) (risk ratio; 95% confidence interval: 0.88; 0.81-0.95) and ischemic stroke (0.62; 0.50-0.77), with a relatively low risk of major bleeding (1.72; 1.42-2.07). For patients with ACS, the combination of DOACs reduced the risk of MACE (0.91; 0.85-0.97), myocardial infarction (MI) (0.90; 0.83-0.98), and ischemic stroke (0.75; 0.58-0.97), accompanied by increased non-fatal bleeding events and intracranial hemorrhage (3.42; 1.76-6.65). Results were similar when restricting the analysis to phase III studies except for the rate of stroke in patients with ACS. Combination therapy reduced the incidence of MI in ACS patients, but the risk of bleeding from intracranial hemorrhaging outweighs the benefit of MACE driven by MI. That is due to combination therapy having no positive impact on mortality; thus, the benefit-risk balance may be more favorable in patients with stable CAD.

Predictors of clinical outcome after rotational atherectomy-facilitated percutaneous coronary intervention in hemodialysis patients.

Percutaneous coronary intervention (PCI) in hemodialysis patients with severely calcified and diffused lesions is associated with extremely high rates of major adverse cardiovascular events (MACE), even when facilitated by rotational atherectomy (ROTA). Potential risk factors for MACE with ROTA-facilitated PCI in hemodialysis patients should be identified. We retrospectively analyzed a consecutive cohort of patients from the Sapporo Cardiovascular Clinic database, who were on maintenance hemodialysis with severe calcified lesions and treated with ROTA-facilitated PCI. Clinical and interventional procedure characteristics were collected and compared between patients with and without MACE, defined as all-cause death, hospitalization due to heart failure, definite stent thrombosis, or target lesion revascularization (TLR) at 1-year follow-up. The individual outcomes of MACE and TLR in the cohort were presented as Kaplan-Meier percentages. Cox regression analyses were performed to identify independent predictors of MACE. A total of 138 patients undergoing hemodialysis and followed up for 362.50 (243.75, 382.25) days. Sixty-one patients in the cohort had MACE, most of which were TLR (47.5%, 29/61). Cumulative all-cause death at 30-day and 1-year follow-up were 6.52% and 18.8%, respectively. Patients with right coronary artery (RCA) lesions, in-stent restenosis (ISR) lesions, and were more likely to have MACE, even with larger reference vessel diameter and greater acute gain after PCI. Cox regression analysis demonstrated that ISR lesion was positively associated with both MACE (HR 3.21, 95% CI: 1.59-6.48) and TLR (HR 5.08, 95% CI: 1.78-14.47), latter of which was also proved to be significantly related to greater acute gain (HR 1.95, 95% CI: 1.12-3.39). In subgroup analysis, RCA was found to be positively associated with MACE in de novo lesion (HR 2.83, 95% CI: 1.28-6.28). We found that the overall prognosis of ROTA-facilitated PCI in hemodialysis patients was poor. ISR was a significant risk factor for MACE, especially TLR.

Cardiac and other presentation and clinical outcomes of COVID-19 pandemic among different ethnic and religious populations in the city of Jerusalem

Abstract Background The COVID-19 pandemic is an ongoing global pandemic. Jerusalem with its 919,400 inhabitants has a wide variety of populations, of which 62% are Jews (36% ultra-orthodox; 64% non-ultraorthodox) and 38% Arabs which were largely affected by the pandemic. Objectives The aim of our study was to understand the different presentations, course and clinical outcomes in these different ethnical and cultural groups in Jerusalem in the COVID-19 pandemic. Methods We performed a cohort study of all COVID-19 patients admitted between March 9 - July 16, 2020 to the two university medical centers in Jerusalem. Demographic data, presenting symptoms, comorbid conditions, medications, physical examination, laboratory and imaging data as well as outcome at 30-day were systematically recorded. Patients were divided according to their religion and ethnicity into 3 main groups: 1) Ultra-Orthodox Jews; 2) other (non-Ultra-Orthodox) Jews and 3) Arabs. Results Six hundred and two patients comprised the study population. Of them the 361 (60%) were Ultra-Orthodox Jews; 166 (27.5%) non-Ultra-Orthodox Jews and 75 (12.5%) Arabs. The Arab patients were younger than the Ultra-Orthodox Jews and the non-Ultra-Orthodox Jews (51±18 year-old vs. 57±21 and 59±19, respectively, p&amp;lt;0.01), but suffered from significantly more co-morbidities. Fever, cough, dyspnea and fatigue, were more prominent, as presenting symptoms, in the Jewish patients as compared with the Arab patients. Moreover, hemodynamic shock, ischemic ECG changes and pathological chest x-ray were all more frequent in the Ultra-Orthodox patients as compared the other groups of patients. Being an Ultra-Orthodox was independently associated with significantly higher rate of Major Adverse Cardiovascular Events (MACE) [OR=1.96; 95% CI (1.03–3.71), p&amp;lt;0.05]. Age was the only independent risk factor associated with increased mortality rate [OR=1.10; 95% CI (1.07–1.13), p&amp;lt;0.001]. Conclusions The COVID-19 first phase in Jerusalem, affected different ethnical and cultural groups differently, with the Ultra-Orthodox Jews mostly affected by admission rates, presenting symptoms clinical course and MACE (Acute coronary syndrome, shock, cerebrovascular event or venous thromboembolism). It is conceivable that vulnerable populations need special attention and health planning in time of pandemic, to prevent rapid distribution and severe morbidity. Funding Acknowledgement Type of funding sources: None.