Lower Rate Of Major Adverse Cardiac Events Research Articles

DES Strut Thickness and Clinical Outcomes After CTO Recanalization: Insights From LATAM CTO Registry

BackgroundUltra-thin strut drug-eluting stent (UTS-DES) may improve outcomes after percutaneous coronary intervention (PCI) but have received limited study in chronic total occlusion (CTO) PCI. AimsTo compare of 1-year incidence of major adverse cardiac events (MACE) between patients who underwent CTO PCI with ultrathin (≤ 75 μm) versus thin (>75 μm) strut DES in the LATAM CTO registry. MethodsPatients were considered for inclusion only if successful CTO PCI was performed and when only one type of stent strut thickness (ultrathin or thin) was used. A propensity score matching (PSM) was computed to produce similar groups in relation to clinical and procedural characteristics. ResultsBetween January 2015 and January 2020, 2092 patients underwent CTO PCI, of whom 1466 were included in the present analysis (475 in the ultra-thin and 991 in the thin strut DES). In unadjusted analysis the UTS-DES group had lower rate of MACE (HR: 0.63 95 % CI 0.42 to 0.94, p = 0.04) and repeat revascularizations (HR: 0.50 95 % CI 0.31 to 0.81, p = 0.02) at 1-year follow-up. After adjustment for confounding factors in a Cox regression model there was no difference in 1-year incidence of MACE between groups (HR: 1.15 95 % CI 0.41 to 2.97, p = 0.85). On PSM of 686 patients (343 in each group) the 1-year incidence of MACE (HR 0.68 95 % CI 0.37–1.23; P = 0.22) and individual components of MACE did not differ between groups. ConclusionsOne-year clinical outcomes after CTO PCI were similar with ultrathin and thin strut DES.

Assessment of Major Adverse Cardiac Events (MACE) and Arrhythmias in Patients with Large B-Cell Lymphoma Undergoing Anti-CD19 Chimeric Antigen Receptor T-Cell (CAR-T) Therapy: Impact of Baseline Cardiac Biomarkers

Introduction: Chimeric antigen receptor - T Cell (CAR-T) therapy is widely used for relapsed or refractory (r/r) large B-cell lymphoma (LBL), now with approval for second-line use. Cytokine release syndrome (CRS) is commonly seen after CAR-T therapy and can lead to increased cardiovascular circulatory demand. Additionally, the pro-inflammatory milieu from CAR-T cells can lead to coagulopathy, endothelial damage, and myocardial stunning which may lead to major adverse cardiac events (MACE) and/or cardiac arrhythmias. Recent single center and pharmacovigilance studies have reported increased risk of MACE as well as cardiac arrhythmias after CAR-T cell therapy (Steiner, et al and Goldman, et al), but there are no data describing the predictive value of high sensitivity troponin and NT-proBNP as biomarkers of adverse cardiovascular outcomes after CAR-T therapy. Methods: Data were collected through retrospective chart analysis from a patient registry of 71 r/r LBL patients who received commercial anti-CD19 CAR-T therapy at Cleveland Clinic from May 2018 to October 2020. Baseline serum high sensitivity-troponin and NT-proBNP were collected on the day of but prior to treatment (i.e. day 0). Cardiac toxicity was defined as a decrease in the left ventricular ejection fraction by 10% or occurrence of arrhythmia. MACE was defined as cardiovascular death, myocardial infarction, coronary revascularization, stroke, or hospitalization because of heart failure. Univariate and multivariate logistic analyses were performed to determine the impact of baseline clinical and laboratory parameters on the risk for developing MACE as well as cardiac arrhythmia. Results: Median age was 63 years [interquartile range (IQR): 54 to 69 years]. 68% were male. Full details of baseline characteristics are shown in the attached table. Baseline troponin was elevated above laboratory reference range in 82% of patients and baseline NT-proBNP was elevated in 58% of patients. Median follow up was 326 days from cellular infusion. Three of 71 patients (4%) developed MACE and 11 (15%) developed atrial/ventricular arrhythmias. Baseline troponin was elevated in two of the patients who developed MACE and baseline NT-proBNP was elevated in all three patients who developed MACE. All three occurrences of MACE were within 45 days of CAR-T infusion. In univariate analysis, baseline troponin was associated with a statistically significant increased risk of developing atrial arrhythmia after treatment but other known risk factors such as hypertension, obesity, and congestive heart failure were not. In multivariable analysis, baseline troponin was associated with an increased risk of developing atrial arrhythmia [OR 1.07, 95% CI (1.004-1.145), p=0.039]. Conclusions: In contrast to previous reports, we found a low rate of MACE in our patient population, possibly due to patient selection. However, 15.4% of patients developed atrial fibrillation, consistent with prior reports of elevated risk of arrhythmias. Baseline elevation in troponin was associated with an increased risk of subsequent atrial arrhythmia. Further data are needed to explore the predictive value of baseline NT-proBNP in predicting MACE. As CAR-T cell therapy is likely to increasingly take place in the outpatient setting, future prospective and validation studies may explore the use of baseline troponin to risk stratify patients.

Timing of angiography and outcomes in patients with non-ST-segment elevation myocardial infarction: Insights from the evaluation and management of patients with acute chest pain in China registry.

Although an invasive strategy has been recommended within 24 h for patients with non-ST-segment elevation myocardial infarction (NSTEMI), the optimal timing of the invasive strategy remains controversial. We sought to investigate the association between the different timings of invasive strategies and clinical outcomes in patients with NSTEMI. Patients admitted with NSTEMI from the Evaluation and Management of Patients with Acute ChesT pain in China (EMPACT) registry between January 2016 and September 2017 were included. The primary outcomes were major adverse cardiac events (MACEs) within 30 days. Multivariable logistic regression was performed to assess independent risk factors for MACEs. A total of 969 patients with NSTEMI from the EMPACT Registry were eligible for this study. Coronary angiography (CAG) was performed in 501 patients [<24 h, n = 150 (15.5%); ≥ 24 h, n = 351 (36.2%)]. The rate of MACEs at 30 days in all patients was 9.2%, including 54 (5.6%) deaths. Patients who underwent CAG had a lower rate of MACEs and mortality than those who did not receive CAG (MACEs: 5.6% vs. 13.0%, P < 0.001; mortality: 1.6% vs. 9.8%, P < 0.001). Nonetheless, no statistically significant difference was found in the rates of MACEs and mortality between the early (< 24 h) and delayed (≥ 24 h) CAG groups. Older age (OR: 1.036, 95% CI: 1.007, 1.065, P = 0.014), and acute heart failure (OR: 2.431, 95% CI: 1.244, 4.749, P = 0.009) increased the risk of MACEs and protective factors were underwent CAG (OR: 0.427, 95% CI: 0.219, 0.832, P = 0.012) or PCI (OR: 0.376, 95% CI: 0.163, 0.868, P = 0.022). In the multilevel logistic regression, older age (OR: 0.944, 95% CI: 0.932, 0.957, P < 0.001), cardiogenic shock (OR: 0.233, 95% CI: 0.079, 0.629, P = 0.009), pulmonary moist rales (OR: 0.368, 95% CI: 0.197, 0.686, P = 0.002), and prior chronic kidney disease (OR: 0.070, 95% CI: 0.018, 0.273, P < 0.001) was negatively associated with CAG. This real-world cohort study of NSTEMI patients confirmed that the early invasive strategy did not reduce the incidence of MACEs and mortality within 30 days compared with the delayed invasive strategy in NSTEMI patients.

Pericardial Involvement in ST-Segment Elevation Myocardial Infarction as Detected by Cardiac MRI.

BackgroundPost myocardial infarction pericarditis is considered relatively rare in the current reperfusion era. The true incidence of pericardial involvement may be underestimated since the diagnosis is usually based on clinical and echocardiographic parameters.ObjectivesThis study aims to document the incidence, extent, and prognostic implication of pericardial involvement in ST-segment elevation myocardial infarction (PISTEMI) using cardiac MRI (CMR).MethodsOne hundred and eighty-seven consecutive ST-segment elevation myocardial infarction patients underwent CMR on day 5 ± 1 following admission, including steady-state free precession (SSFP) and late Gadolinium enhancement (LGE) sequences. Late Gadolinium enhancement and microvascular obstruction (MVO) were quantified as a percentage of left ventricular (LV) mass. Late Gadolinium enhancement was graded for transmurality according to the 17 AHA left ventricle (LV) segment model (LGE score). Late pericardial enhancement (LPE), the CMR evidence of pericardial involvement, was defined as enhanced pericardium in the LGE series and was retrospectively recorded as present or absent according to the 17 AHA segments. Late pericardial enhancement was evaluated adjacent to the LV, the right ventricle, and both atria. Clinical, laboratory, angiographic, and echocardiographic data were collected. Clinical follow-up for major adverse cardiac events (MACE) was documented and correlated with CMR indices, including LGE, MVO, and LPE.ResultsLate pericardial enhancement (LPE+) was documented in 77.5% of the study cohort. A strong association was found between LPE and the degree and extent of myocardial injury (LGE, MVO). Both LGE and MVO were significantly correlated with increased MACE on follow-up. On the contrary, LPE presence, either adjacent to the LV or the other cardiac chambers, was associated with a lower MACE rate in a median of 3 years of follow-up HR 0.39, 95% CI (0.21–0.7), p = 0.002, and HR 0.48, 95% CI (0.26–0.9), p = 0.02, respectively.ConclusionsPrognostic implication of pericardial involvement in ST-segment elevation myocardial infarction was documented by CMR in 77.5% of our STEMI cohort. Late pericardial enhancement presence correlated significantly with the extent and severity of the myocardial damage. Unexpectedly, it was associated with a considerably lower MACE rate in the follow-up period.

Meta-Analysis Comparing Outcomes With Bifurcation Percutaneous Coronary Intervention Techniques

There have been mixed results regarding the efficacy and safety of various percutaneous coronary intervention bifurcation techniques. An electronic search of Medline, Scopus, and Cochrane databases was performed for randomized controlled trials that compared the outcomes of any bifurcation techniques. We conducted a pairwise meta-analysis comparing the 1-stent versus 2-stent bifurcation approach, and a network meta-analysis comparing the different bifurcation techniques. The primary outcome was major adverse cardiac events (MACEs). The analysis included 22 randomized trials with 6,359 patients. At a weighted follow-up of 25.9months, there was no difference in MACE between 1-stent versus 2-stent approaches (risk ratio [RR] 1.20, 95% confidence interval [CI] 0.92 to 1.56). Exploratory analysis suggested a higher risk of MACE with a 1-stent approach in studies using second-generation drug-eluting stents, if side branch lesion length ≥10mm, and when final kissing balloon was used. There was no difference between 1-stent versus 2-stent approaches in all-cause mortality (RR 0.95, 95% CI 0.69 to 1.30), cardiovascular mortality (RR 1.07, 95% CI 0.68 to 1.68), target vessel revascularization (TVR) (RR 1.22, 95% CI 0.90 to 1.65), myocardial infarction (MI) (RR 1.04, 95% CI 0.69 to 1.56) or stent thrombosis (RR 1.10, 95% CI 0.68 to 1.78). Network meta-analysis demonstrated that double kissing crush technique was associated with lower MACE, MI, TVR, and target lesion revascularization, whereas culotte technique was associated with higher rates of stent thrombosis. In this meta-analysis of randomized trials, we found no difference between 1-stent versus 2-stent bifurcation percutaneous coronary intervention approaches in the risk of MACE during long-term follow-up. Among the various bifurcation techniques, double kissing crush technique was associated with lower rates of MACE, target lesion revascularization, TVR, and MI.

Clinical significance of myocardial involvement in acute idiopathic pericarditis

Acute idiopathic pericarditis (AIP) is frequently accompanied by myocardial involvement (AIPM). Although in acute myocarditis, the myocardial inflammation can lead to life-threatening complications, the outcome of patients with AIPM has been described as good. It remains unclear if a good prognosis of patients with AIPM reflects mild myocardial involvement or good medical management. A retrospective analysis of life-threatening complications and life-saving interventions in a cohort of 248 consecutive patients admitted to a single medical center between 2006 and 2017 with AIP (n = 169) or AIPM (n = 79). Major adverse cardiac events (MACE) included cardiac tamponade, cardiogenic shock, ventricular tachycardia, pericardiocentesis, pericardiectomy, large pericardial effusion and death. Patients with AIPM were younger than patients with AIP (p < 0.001), and more often had left ventricular dysfunction (31.6% vs. 1.2%, p < 0.001) and less often had large pericardial effusion (1.3% vs. 13.6%, p = 0.002), and MACE (5.1% vs. 14.8%, p = 0.014). Cardiac tamponade occurred in 5.3% of the patients with AIP as opposed to 1.3% of the patients with AIPM (p = 0.176). Severe left ventricular dysfunction with cardiogenic shock occurred exclusively among patients with AIPM but the rate was low (2.5%). Life-saving interventions were used in both groups at comparable rates (2.5% vs. 5.3%, p = 0.510). There were no in-hospital deaths. Myocardial involvement in acute pericarditis is associated with a low rate of severe left ventricular dysfunction and cardiogenic shock and a reduced rate of large pericardial effusion, resulting in a lower rate of MACE. Life-saving interventions were used at comparable rates in patients with and without myocardial involvement having excellent survival rates.

Five-year clinical outcomes of the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.

This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.

Exercise capacity improvement after cardiac rehabilitation following myocardial infarction and its association with long-term cardiovascular events.

Cardiovascular rehabilitation (CR) improves aerobic capacity and quality of life in patients after myocardial infarction (MI). The aim was to examine the associations between exercise capacity improvement and different clinically relevant cardiovascular events. This was a registry-based study of post-MI patients, referred to CR. All patients were submitted to exercise testing before and after CR (36 sessions, 2-3 times/week, and combined exercise). Patients were divided into two groups, based on the difference in exercise capacity before and after the CR programme with the cut-off of two metabolic equivalents (METs) improvement. We assessed the correlation between the extent of exercise capacity improvement and the following cardiovascular events: major adverse cardiac events (MACE), cardiovascular-related hospitalizations, and unplanned coronary angiography. A total of 499 patients were included (mean age 56 ± 10 years, 20% women). Both groups significantly improved in terms of exercise capacity, natriuretic peptide levels, resting heart rate, and resting diastolic pressure; however, lipid status significantly improved only in patients with ≥2 METs difference in exercise capacity. A total of 13.4% patients suffered MACE (median follow-up 858 days); 21.8% were hospitalized for cardiovascular reasons (median follow-up 791 days); and 19.8% had at least one unplanned coronary angiography (median follow-up 791 days). Exercise capacity improvement of ≥2 METs was associated with lower rates of MACE, cardiovascular hospitalizations, and unplanned coronary angiography in all examined univariate and multivariate models. This study has shown that exercise improvement of ≥2 METs is associated with a significant decrease in MACE, cardiac hospitalizations, and unplanned coronary angiography.

Invasive Approaches in the Management of Cocaine-Associated Non-ST-Segment Elevation Myocardial Infarction.

The aim of this study was to determine the impact of invasive approaches and revascularization in patients with cocaine-associated non-ST-segment elevation myocardial infarction (NSTEMI). The role of invasive approaches in cocaine-associated NSTEMI is uncertain. This retrospective cohort study identified 3,735 patients with NSTEMI and history of cocaine use from the Nationwide Readmissions Database from 2016 to 2017. Invasive approaches were defined as coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG). Revascularization was defined as PCI and CABG. The primary efficacy outcome was major adverse cardiac events (MACE), and the primary safety outcome was emergent revascularization. Nonadherence was identified using appropriate International Classification of Diseases-Tenth Revision codes. Two propensity-matched cohorts were generated (noninvasive vs. invasive and noninvasive vs. revascularization) through multivariate logistic regression. In the propensity score-matched cohorts, an invasive approach (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.56 to 0.92; p=0.008) and revascularization (HR: 0.54; 95%CI: 0.40 to 0.73; p<0.001) (compared with a noninvasive approach) were associated with a lower rate of MACE, without an increase in emergent revascularization. On stratification, PCI and CABG individually were associated with a lower rate of MACE. Emergent revascularization was increased with PCI (HR: 1.78; 95%CI: 1.12 to 2.81; p=0.014) but not with CABG. Nonadherent patients after PCI and CABG did not have significant difference in rate of MACE. PCI in nonadherent patients was associated with an increase in emergent revascularization (HR: 4.45; 95%CI: 2.07 to 9.57; p<0.001). Invasive approaches and revascularization for cocaine-associated NSTEMI are associated with lower morbidity. A history of medical nonadherence was not associated with a difference in morbidity but was associated with an increased risk for emergent revascularization with PCI.

Intermittent concurrent use of clopidogrel and proton pump inhibitors did not increase risk of adverse clinical outcomes in Chinese patients with coronary artery disease

BackgroundProton pump inhibitors (PPIs) are frequently prescribed to patients with coronary heart disease (CHD) under antiplatelet therapy to prevent gastrointestinal (GI) bleeding. However, its clinical impact is still under debate, especially in Asian population. This study was undertaken to explore the effects of concurrent use of clopidogrel and PPIs on the clinical outcomes in Chinese patients with CHD in secondary prevention.MethodsA single-center retrospective study was conducted in 638 patients with CHD on consecutive clopidogrel therapy for at least 1 year. After 18-month follow-up, adverse clinical events were collected. Cox regression was used to calculate hazard ratios (HR) and 95% confidence interval (CI) for the effect of PPI use on the outcomes. A total of 638 patients were recruited from 2014 to 2015 in this study, among whom 201 were sustained PPI users, 188 were intermittent PPI users and the remaining 249 were non-PPI users.ResultsCompared with sustained PPI users, intermittent use of PPIs was associated with a lower risk of stroke, major adverse cardiac events (MACE) and net adverse clinical event (NACE) (stroke: adjusted HR: 0.109, 95% CI 0.014–0.878, p = 0.037; MACE: adjusted HR: 0.293, 95% CI 0.119–0.722; p = 0.008; NACE: adjusted HR: 0.357, 95% CI 0.162–0.786, p = 0.011). Subgroup analysis further revealed the benefit of intermittent PPI use was significant in male CHD patients over 60 years old, with hypertension or chronic kidney disease, and undergoing percutaneous coronary intervention during hospitalization.ConclusionThe current findings suggest that the intermittent concurrent use of PPIs and clopidogrel is not associated with an increased risk of 18-month adverse clinical outcomes, and intermittent use of PPIs is associated with a lower rate of MACE and NACE.

Long-Term Risk of Major Adverse Cardiac Events in Atrial Fibrillation Patients on Direct Oral Anticoagulants

ObjectiveTo determine the association between direct oral anticoagulant (DOAC) use and risk of major adverse cardiac events (MACEs) in patients with atrial fibrillation (AF). Patients and MethodsThis study is a single-center prospective observational cohort study including 2366 outpatients with non-valvular AF on treatment with DOACs or vitamin K antagonists (VKAs) from February 2008 for patients on VKA and September 2013 for patients on novel oral anticoagulants. The primary endpoint was the incidence of MACE including fatal and non-fatal myocardial infarction (MI), cardiac revascularization, and cardiovascular death. ResultsThe mean age was 75.1±9.0 years; 44.7% were women. During a mean follow-up of 33.3±21.9 months (6567 patients/years) 133 MACEs occurred (2.03%/year): 79 MI/cardiac revascularization and 54 cardiovascular deaths. Of these, 101 were on VKAs (2.42%/year) and 32 on DOACs (1.34%/year; log-rank test P=.040). This difference was evident also considering MI alone (1.53%/year and 0.63%/year in the VKA and DOAC group, respectively, log-rank test P=.009). At multivariable Cox proportional hazard regression analysis, use of DOACs was associated with a lower risk of MACE (hazard ratio, 0.636; 95% CI, 0.417 to 0.970; P=.036) and MI (hazard ratio, 0.497; 95% CI, 0.276 to 0.896; p=.020). Sensitivity analysis showed that this association was consistent in younger patients (<75 years), in patients with anemia, and in those without chronic obstructive pulmonary disease and heart failure. We also found that both dabigatran and apixaban/rivaroxaban were associated with a lower rate of MACE, with similar efficacy between full and low doses. ConclusionDOACs are associated with a lower risk of MACE in patients with AF independently from dosage.

Abstract 14304: Assessing the Association of Adherence to Fractional Flow Reserve Treatment Thresholds and Outcomes of Patients With Coronary Artery Disease

Background: Although fractional flow reserve (FFR) thresholds have been established to guide the use of percutaneous coronary intervention (PCI) or medical therapy, little is known about the adherence to FFR thresholds for PCI in clinical practice and their association with clinical outcomes. Methods: Adults undergoing FFR assessment in a single vessel (excluding ST-segment elevation myocardial infarction [MI]) from April 1, 2013 to March 31, 2018 in Ontario, Canada were included. Patients were divided into two cohorts based on FFR ≤ 0.80 (ischemic) and &gt; 0.80 (non-ischemic). Inverse probability of treatment weighting was used to balance confounders between patients treated with PCI vs. no PCI in each cohort. The primary outcome was major adverse cardiac events (MACE) defined by death, MI, unstable angina, or urgent revascularization. Results: We identified 9,106 patients who underwent single-vessel FFR measurement. Among the 2,693 patients with an ischemic FFR (mean age 65, 27.0% female), 75.3% of patients received PCI and 24.7% were treated only with medical therapy. Over a median follow-up of 2.6 years in the ischemic cohort, PCI was associated with a 20% lower rate of MACE compared to no PCI (24.0% vs. 31.6%; hazard ratio [HR]: 0.80, 95% CI: 0.66-0.96). However, among 6,413 patients with a non-ischemic FFR (mean age 66, 38.9% female), 12.6% received PCI and 87.4% were treated only with medical therapy. Over a median follow-up of 2.8 years in the non-ischemic cohort, PCI was associated with a 42% higher rate of MACE compared to no PCI (25.6% vs. 17.6%; HR: 1.42, 95% CI: 1.18-1.70). The increased rate of MACE was driven mainly by MI (HR 1.67, 95% CI: 1.20-2.31) but not death (HR 0.99, 95% CI: 0.72-1.35). Conclusions: In routine practice, we found 1 in 4 patients did not receive PCI for ischemic lesions while 1 in 8 received PCI for non-ischemic lesions. Performing PCI procedures according to recommended FFR cutoffs was associated with lower rates of clinical events.

Orbital Atherectomy for Treatment of Severely Calcified Coronary Artery Bifurcation Lesions: A Multicenter Analysis

ObjectiveThis study evaluated the safety and efficacy of orbital atherectomy (OA) for the treatment of severely calcified coronary artery bifurcation lesions. BackgroundPercutaneous coronary intervention (PCI) of severely calcified coronary artery lesions is associated with lower procedural success and higher rates of target lesion failure compared to non-calcified lesions. OA is an effective treatment for calcified coronary artery lesions prior to stent implantation. However, there is little data regarding the safety and efficacy of OA in patients with coronary artery bifurcation lesions. MethodsData were obtained from analysis of patients with severe coronary artery calcification who underwent OA and coronary stent implantation at ten high-volume institutions. Data were pooled and analyzed to assess peri-procedural outcomes and 30-day major adverse cardiac events (MACE). ResultsA total of 1156 patients were treated with OA and PCI. 363 lesions were at a coronary artery bifurcation. There were no statistically significant differences in baseline characteristics between the bifurcation and non-bifurcation groups. In the bifurcation group, treatment involved the left anterior descending artery and its branches more frequently and right coronary artery less frequently. After propensity score matching, the 30-day freedom from MACE was not statistically significant between the two groups. ConclusionIn this multicenter cohort analysis, patients with severely calcified coronary bifurcation lesions had low rates of MACE and target vessel revascularization at 30 days at rates comparable to non-bifurcation lesions. This analysis demonstrates that OA is safe and effective for complex coronary lesions at both bifurcation and non-bifurcation locations.

Development and validation of an ECG-based cardiac syncope risk calculator

Abstract Background The early diagnosis of cardiac syncope is often challenging. We therefore developed an ECG-based risk calculator as an aid for rapid rule-out or rule-in of cardiac syncope and aimed to validate this decision tool. Methods In a prospective diagnostic international multicenter study (derivation cohort), 2007 patients, 40 years or older, presenting with syncope to the emergency department were recruited. The primary diagnostic outcome, cardiac syncope, was centrally adjudicated by two independent cardiologists using all clinical information obtained during syncope work-up including 12-month follow up. 12-lead ECG was recorded at presentation and read by residents blinded to clinical information. Significant ECG predictors of cardiac syncope were identified using penalized backward selection. Findings were validated in an independent US multicenter cohort with 2'269 syncope patients. Results In the derivation cohort (median age 71 years, 40% women), centrally adjudicated cardiac syncope was present in 267 patients (16%). Seven ECG criteria (rhythm, heart rate, corrected QT-interval, ST-segment depression, atrioventricular-block, bundle-branch-block and ventricular extrasystole/non-sustained ventricular tachycardia) were identified as significant predictors for cardiac syncope and combined into the bAseL Ecg Risk calculaTor for Cardiac Syncope (ALERT-CS). Diagnostic accuracy of ALERT-CS for cardiac syncope, as quantified by the area under the receiver-operating characteristics curve (AUC), was high (0.80, 95%-confidence interval (CI) 0.77–0.83) and significantly higher compared to the EGSYS score (0.73, 95% CI 0.70–0.76, p&amp;lt;0.001). In combination, ALERT-CS significantly increased the AUC of BNP (0.82, 95% CI 0.79–0.85 vs 0.77, 95% CI 0.74–0.81, p=0.003), hs-cTnT (0.84, 95% CI 0.0.81–0.87 vs 0.77, 95% CI 0.74–0.80, p&amp;lt;0.001) and integrated clinical judgment in the ED (0.90, 95% CI 0.89–0.92 vs 0.87, 95% CI 0.84–0.90, p&amp;lt;0.001). A predicted probability for cardiac syncope below 5.5% by ALERT-CS identified 138 patients (8%) eligible for triage towards rapid rule-out of cardiac syncope with a sensitivity of 99%. A predicted probability above 37.5% identified 181 patients (11%) eligible for triage towards rapid rule-in of cardiac syncope with a specificity of 95%. Prognostic verification for 30-day major adverse cardiac events (MACE) showed a high rate of MACE in the rule-in group and a very low rate of MACE in the rule-out group (Figure). External validation (median age 72 years, 48% women) showed similar diagnostic accuracy (AUC 0.76, 95% CI 0.73–0.79) and prognostic results. Conclusion Combining seven ECG criteria within the simple ALERT-CS may aid ED physicians in the early rule-out or rule-in of cardiac syncope. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Swiss National Science Foundation, Swiss Heart Foundation

Pregnancy outcomes in women with aortic coarctation

ObjectivePregnancy in women with aortic coarctation (CoA) has an estimated moderately increased risk (mWHO II–III) of adverse cardiovascular, obstetric or fetal events, but prospective data to validate this risk classification...

A high exercise workload of ≥ 10 METS predicts a low risk of significant ischemia and cardiac events in older adults

BackgroundPatients who achieve ≥ 10 METS during exercise SPECT myocardial perfusion imaging (MPI) have very low rates of significant ischemia and major adverse cardiac events (MACE). It is unknown how many older adults can achieve ≥ 10 METS, and if low risk extends to this subgroup. Methods and resultsWe examined the workload achieved, prevalence and predictors of ischemia, and MACE (cardiac death, non-fatal MI, late revascularization) in a cohort of 382 patients ≥ 65 years of age who underwent exercise 99mTc SPECT MPI. The cohort was 64.4% male and 36.9% had known coronary artery disease (CAD). All achieved ≥ 85% of maximum age-predicted heart rate. A workload of ≥ 10 METS was achieved in 25.4%; 50.3% attained 7-9 METS, and 24.4% reached < 7 METS. There was a stepwise decrease in prevalence of any ischemia and significant ischemia (≥ 10% of the left ventricle (LV)) as workload increased (P = 0.037). Patients achieving ≥ 10 METS had a 3.1% prevalence of ≥ 10% LV ischemia (1.2% in those without ST depression). Cardiac death and MACE rates in the ≥ 10 METS subgroup were 0.6%/year and 2.6%/year over a median 7.0 years of follow-up. ConclusionsA substantial proportion of older adults who undergo exercise SPECT MPI can achieve ≥ 10 METS. This subgroup has low rates of significant LV ischemia and MACE. The favorable diagnostic and prognostic implications of achieving a high workload in an older adult population suggest it is feasible, with certain exceptions, to include this subgroup in workload-based strategies of provisional imaging.

Identification and Management of Intermediate Risk Patients in the Chest Pain Unit.

We examined low risk (LR) patients admitted to our chest pain unit (CPU) with negative cardiac injury markers, normal electrocardiogram, and clinical stability. We hypothesized that there is a sub-group of intermediate risk (IR) patients within the larger LR population. Criteria for IR were the aforementioned 3 indicators of LR and ≥1 of the following: (1) known coronary artery disease (CAD), (2) men ≥45 yo, women ≥55 yo, and (3) ≥3 cardiac risk factors. We compared patient characteristics, use of pre-discharge testing (PDT), and major adverse cardiac events (MACE). IR patients numbered 371, whereas LR patients totaled 70. IR patients were older (61 vs 46 years), more had known CAD (28 vs. 0%), had a higher median number of risk factors (2 vs. 1) and were less likely to be women (49 vs. 81%), all P < 0.0001. IR patients received a greater median number of tests compared with LR patients (1 vs. 0, P < 0.0001). Among the IR group, 16 patients (4%) had a cardiac event at the index CPU visit, 2 (0.5%) experienced MACE at 30-day follow-up, and 2 (0.5%) had MACE at 6 months follow-up. No LR patients had MACE at any point in the study. Thus, the majority of CPU patients are IR, have more risk factors than LR group, and are more likely to receive PDT. IR patients were managed safely in a CPU, while maintaining low rates of MACE post-discharge.

First clinical evidence characterizing safety and efficacy of the new CoCr Biolimus-A9 eluting stent: The Biomatrix Alpha™ registry

BackgroundThe biolimus-eluting stent (BES) was the first to elute anti-proliferative drug from a biodegradable polymer. In the randomized LEADERS trial, a stainless steel BES showed non-inferior efficacy compared to a sirolimus-eluting stent and a long-term safety advantage. We report the first clinical efficacy and safety outcomes of a new thin-strut cobalt chromium biolimus-eluting stent (CoCr-BES) from an international multi-centre registry. MethodsWe studied 400 all-comer patients with coronary disease receiving CoCr-BES at 12 centres, with follow-up at 9 months and 2 years. The primary endpoint was incidence of major adverse cardiac events (MACE) at 9 months comprising cardiac death, myocardial infarction (MI), and clinically indicated target vessel revascularization (ci-TVR). Key protocol elements were the same as the randomized LEADERS trial to enable a historical control for propensity-matched comparison. ResultsMean patient age was 65 ± 11 years, 19% had diabetes, and 55% presented with unstable angina or MI. On discharge, 96% of patients were on dual antiplatelet therapy (DAPT) and 69% were on DAPT at 9 months. MACE at 9 months occurred in 3.9% of patients, cardiac death in 0.8%, MI in 1.1% and ci-TVR in 2.7%. One patient (0.25%) experienced definite or probable stent thrombosis (ST). A propensity-adjusted comparison showed similar clinical outcomes to the BES arm in the LEADERS trial for the primary endpoint MACE. ConclusionsThe new CoCr-BES showed low rates of MACE, MI, ci-TVR and ST at 9 months, similar to the BES arm in LEADERS.

P2807Clinical outcomes with cobalt chromium biolimus eluting drug-eluting stents compared with stainless steel biolimus eluting drug-eluting stents in all-comers patients

Abstract Aims Thinner stent struts may improve deliverability, conformability and reduce vessel injury. We report the first clinical outcomes of the thinner strut (84–88um) cobalt chromium biolimus eluting stent from the Biomatrix Alpha registry and compare these with objective performance criteria from the stainless steel BioMatrix Flex arm of the Leaders study. Methods A total of 1257 patients were studied: 400 patients from 12 centres receiving ≥1 Biomatrix Alpha stent were prospectively enrolled into the Biomatrix Alpha registry and then underwent a pre-specified comparison with 857 patients who received a Biomatrix Flex stent in the Leaders study. The primary endpoint was major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or clinically driven target vessel revascularization (TVR) at 9 months. Assuming a 9.2% event rate with BioMatrix Flex, a one-sided type I error (α) of 0.05, and a 4% non-inferiority margin, a sample size of 400 in the Biomatrix alpha registry had &gt;80% power to conclude non-inferiority. Results Baseline characteristics in the Alpha registry were typical of an all-comers population with a mean age of 64.7±11.3, diabetes 19%, current smoking 21%, dyslipidemia 57%, hypertension 57%, total stent length per lesion 25.49±13.45, mean stents per procedure 1.59±0.88 and overlapping stents in 13.4%. Observed MACE at 9 months with Alpha was 3.94% (upper limit 5.98%) vs. 9.28% MACE rate with Flex stents in Leaders, which met pre-specified criteria for non-inferiority (p&lt;0.001) and on post hoc testing for superiority yielded p&lt;0.001 for Alpha vs Flex. Secondary endpoints with Alpha included clinically-driven TVR 2.6%, all-cause mortality rate 1.51% and definite/probable stent thrombosis 0.25%. While both Alpha and Leaders enrolled all-comers, Alpha included longer total stent length per lesion (25.49 vs 23.85mm, p&lt;0.001) and more stents per procedure (mean 1.59 vs 1.34; p&lt;0.001) but fewer patients with diabetes (19% vs 26%; p=0.0087), dyslipidemia (57 vs 65%; p=0.0037), prior MI (18.8% vs 32.2%; p&lt;0.001) or acute coronary syndrome (41% vs 55%; p&lt;0.001). To correct for these imbalances and to assess robustness further, a propensity score at the patient level data was undertaken (total sample size of 1257 patients; 400 from the Alpha registry and 857 from the LEADERS study). A propensity score stratification method was used obtaining 5 quintiles for adjusted analysis (each of the 5, containing 251 or 252 patients, 20%). In each of the strata as well as at the aggregate level, a p valve&lt;0.005 was obtained confirming non-inferiority for the primary endpoint. Conclusion The thinner strut (84–88um) cobalt chromium Biomatrix Alpha stent demonstrated low MACE rates at 9 months which were non-inferior to MACE outcomes with the stainless steel Biomatrix Flex in the Leaders study. The robustness of this finding was further confirmed by a propensity score analysis. Acknowledgement/Funding Biosensors

P6454Antithrombotic therapy and cardiovascular events in patients with left ventricular thrombus

Abstract Background Left Ventricular Thrombus (LVT) is associated with a high risk of thromboembolic complications such as stroke. Contemporary data are lacking on the management, prognosis and treatment of LVT, particularly with the emergence of the non-vitamin K antagonist anticoagulants (NOACs). Purpose To study the time and predictive factors associated with thrombus regression on treatment and its association with survival, embolic and bleeding complications. Methods From January 2011 to January 2018, a computerized case sensitive search of LVT was performed on 90 065 consecutive echocardiogram reports. All patients with a confirmed LVT were included in this analysis after imaging review by two independent experts. Repeated echocardiographic data, treatment management and clinical outcomes were collected during follow-up. Major adverse cardiac events (MACE), defined as the composite of death, ischemic stroke or transient ischemic attack (TIA), myocardial infarction (MI) or embolic peripheral artery occlusion were analyzed as well as major bleeding events (BARC ≥3) and the predictive factors and impact of LVT regression. Results We identified 174 patients with a suspected LVT of whom 159 had confirmed LVT on two different cardiac imaging exams. Ischemic cardiomyopathy was the main cause of LVT (n=125, 78.6%) including 56 (35.2%) patients with an acute ST segment elevation MI. The mean left ventricular ejection fraction was 31.9±12.5% with predominant (98.1%) apical location of the LVT. Anticoagulation therapy was achieved with vitamin K antagonists, NOACs and parenteral heparins in 48.7%, 22.8% and 27.8% of patients, respectively. Concomitant antiplatelet therapy was prescribed in 67.9% of patients. Total LVT regression was reached in two third of patients (62.3%, n=99) within a median time of 103 [32–392] days. Independent predictors of total LVT regression were an ischemic cardiomyopathy (HR: 0.36 [0.19–0.70], p=0.002), a larger baseline thrombus area (HR=0.66 [0.45–0.96], p&lt;0.031) and a prolonged anticoagulation therapy over 3 months (HR=0.11 [0.05–0.22], p&lt;0.0001). During a median follow-up of 632 [187–1126] days, MACE occurred in 59 (37.1%) patients with a 18.9% rate of mortality and 13.2% of major bleeding. Patients with a total LVT regression had a non-significant lower rate of MACE as compared with patients without total LVT regression (35.4% vs. 40.0%; HR=0.71 [0.42–1.21]; p=0.20), and a significant lower rate of mortality (15.2% vs. 25.0%; HR=0.48 [0.23–0.98]; p=0.039). Occurence of mortality (A) and MACE (B) Conclusions The prognosis of LVT remains severe with a high risk of major cardiovascular event and mortality. Total LVT regression, mostly reached in 3 months, can be obtained with both vitamin K antagonists and NOACs and is associated with a better prognosis.