Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial.

BACKGROUND: The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. METHODS: Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years. RESULTS: Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55-1.24] versus 1.35 [95% CI, 1.02-1.78]; Pint=0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02-2.87] versus 3.23 [95% CI, 1.25-8.30]; Pint=0.056) compared with the 0- to 3-year time period. CONCLUSIONS: In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01751906.

Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial.

BACKGROUND: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. METHODS: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. FINDINGS: Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided pnon-inferiority=0·0244). Target lesion failure at 1 year occurred in 98 (7·8%) patients assigned to BVS and 82 (6·4%) patients assigned to EES (difference 1·4%, upper 97·5% confidence limit 3·4; one-sided pnon-inferiority=0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3%) patients assigned to BVS and 274 (20·5%) patients assigned to EES (difference -0·3%, 95% CI -3·4% to 2·9%; one-sided pnon-inferiority=0·0008; two-sided psuperiority=0·8603). Device thrombosis within 1 year occurred in nine (0·7%) patients assigned to BVS and four (0·3%) patients assigned to EES (p=0·1586). INTERPRETATION: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. FUNDING: Abbott Vascular.

Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease.

BACKGROUND: In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes. METHODS: In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year. RESULTS: Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13). CONCLUSIONS: In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.).

Mortality Effect of ICD in Primary Prevention of Nonischemic Cardiomyopathy: A Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: Implantation of an implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death (SCD) is controversial in view of the recent DANISH trial which suggested no benefit with ICD for primary prevention in patients with non-ischemic cardiomyopathy (NICMP). METHODS: We conducted a meta-analysis of randomized control trials studying the role of ICD in primary prevention of SCD in patients with NICMP. Only six studies were identified after the application of inclusion/exclusion criteria. RESULTS: Pooling of these randomized trials showed a statistically significant benefit of using ICDs in patients with NICMP [OR 0.76 (0.64 - 0.91), I2 = 0%]. Sensitivity analysis did not show a statistically significant mortality benefit of ICD in NICMP in trials which had adequate beta blocker, ACE/ARB and aldosterone receptor blocker (ALD-RB) use [OR 0.70 (0.41, 1.19), I2 = 70%]. CONCLUSION: The DANISH trial's failure to show mortality benefit may be due to the significant number of patients who had CRT. Our meta-analysis studied the independent effect of ICDs and showed them to be associated with net mortality benefits in patients who are not on optimal guideline directed medical therapy; especially the patients not on ALD-RB.

A CABG Complication - LIMA Graft to Cardiac Venous System Anastomosis Rescued by Percutaneous Coronary Intervention.

Inadvertent graft anastomosis to the great anterior cardiac vein is a known but rare complication of coronary artery bypass graft surgery (CABG). This is usually managed with percutaneous embolization of the inadvertently anastomosed graft with stenting of underlying atherosclerotic coronary artery disease (CAD) or by surgical correction. We present a similar case of the inadvertent left internal mammary artery (LIMA) graft anastomosis to the cardiac venous system, managed with the less complicated percutaneous coronary intervention of the underlying coronary artery disease due to anginal symptoms without the need for surgical correction or embolization of the graft.

Management of Right Atrial Thrombus During MitraClip Implantation: A Case Report and Review of Literature.

Transcatheter mitral valve repair (TMVR) is a relatively novel approach for treatment of symptomatic severe mitral regurgitation. Intra procedural thrombus formation is a rare but potential complication. Herein, we describe a case of large right atrial thrombus formation after transseptal puncture, that was successfully managed using aspiration thrombectomy.

5-Year Outcomes After Bioresorbable Coronary Scaffolds Implanted With Improved Technique.

BACKGROUND: Bioresorbable vascular scaffolds (BVS) were designed to improve late event-free survival compared with metallic drug-eluting stents. However, initial trials demonstrated worse early outcomes with BVS, in part due to suboptimal technique. In the large-scale, blinded ABSORB IV trial, polymeric everolimus-eluting BVS implanted with improved technique demonstrated noninferior 1-year outcomes compared with cobalt chromium everolimus-eluting stents (CoCr-EES). OBJECTIVES: This study sought to evaluate the long-term outcomes from the ABSORB IV trial. METHODS: We randomized 2,604 patients at 147 sites with stable or acute coronary syndromes to BVS with improved technique vs CoCr-EES. Patients, clinical assessors, and event adjudicators were blinded to randomization. Five-year follow-up was completed. RESULTS: Target lesion failure at 5 years occurred in 216 (17.5%) patients assigned to BVS and 180 (14.5%) patients assigned to CoCr-EES (P = 0.03). Device thrombosis within 5 years occurred in 21 (1.7%) BVS and 13 (1.1%) CoCr-EES patients (P = 0.15). Event rates were slightly greater with BVS than CoCr-EES through 3-year follow-up and were similar between 3 and 5 years. Angina, also centrally adjudicated, recurred within 5 years in 659 patients (cumulative rate 53.0%) assigned to BVS and 674 (53.3%) patients assigned to CoCr-EES (P = 0.63). CONCLUSIONS: In this large-scale, blinded randomized trial, despite the improved implantation technique, the absolute 5-year rate of target lesion failure was 3% greater after BVS compared with CoCr-EES. The risk period for increased events was limited to 3 years, the time point of complete scaffold bioresorption; event rates were similar thereafter. Angina recurrence after intervention was frequent during 5-year follow-up but was comparable with both devices.(Absorb IV Randomized Controlled Trial; NCT02173379).

Mechanical Circulatory Support in Patients With COVID-19 Presenting With Myocardial Infarction.

ST-segment elevation myocardial infarction (STEMI) complicating COVID-19 is associated with an increased risk of cardiogenic shock and mortality. However, little is known about the frequency of use and clinical impact of mechanical circulatory support (MCS) in these patients. We sought to define patterns of MCS utilization, patient characteristics, and outcomes in patients with COVID-19 with STEMI. The NACMI (North American COVID-19 Myocardial Infarction) is an ongoing prospective, observational registry of patients with COVID-19 positive (COVID-19+) with STEMI with a contemporary control group of persons under investigation who subsequently tested negative for COVID-19 (COVID-19-). We compared the baseline characteristics and in-hospital outcomes of COVID-19+ and patients with COVID-19- according to the use of MCS. The primary outcome was a composite of in-hospital mortality, stroke, recurrent MI, and repeat unplanned revascularization. A total of 1,379 patients (586 COVID-19+ and 793 COVID-19-) enrolled in the NACMI registry between January 2020 and November 2021 were included in this analysis; overall, MCS use was 12.3% (12.1% [n = 71] COVID-19+/MCS positive [MCS+] vs 12.4% [n = 98] COVID-19-/MCS+). Baseline characteristics were similar between the 2 groups. The use of percutaneous coronary intervention was similar between the groups (84% vs 78%; p = 0.404). Intra-aortic balloon pump was the most frequently used MCS device in both groups (53% in COVID-19+/MCS+ and 75% in COVID-19-/MCS+). The primary outcome was significantly higher in COVID-19+/MCS+ patients (60% vs 30%; p = 0.001) because of very high in-hospital mortality (59% vs 28%; p = 0.001). In conclusion, patients with COVID-19+ with STEMI requiring MCS have very high in-hospital mortality, likely related to the significantly higher pulmonary involvement compared with patients with COVID-19- with STEMI requiring MCS.

Impact of systemic lupus erythematosus on in-hospital outcomes of peripheral artery disease-insight from the National Inpatient Sample database.

Chronic inflammatory disorders like systemic lupus erythematosus (SLE) and rheumatoid arthritis are associated with worse outcomes in ischemic heart disease. However, there is a paucity of data regarding outcomes in patients with peripheral arterial disease (PAD) with concomitant SLE. The purpose of this study was to compare clinical features and in-hospital outcomes of PAD in patients with and without SLE from the general population using the Healthcare Cost and Utilization Project National Inpatient Sample database. We performed a cross-sectional analysis on 520,665 patients diagnosed with PAD from quarter 4 of 2015 to 2017. The primary endpoint was risk-adjusted in-hospital mortality. Of the total patient population, 3080 patients (0.6%) had SLE compared with 517,585 controls (99.4%). The observed in-hospital mortality was higher in patients with SLE (6.3% vs. 4.6%, P < 0.001). To the best of our knowledge, this is the largest population-based study investigating the impact of SLE in patients with PAD. Our analysis showed higher in-hospital mortality in SLE patients than in those without SLE. Early diagnosis and aggressive management of SLE and its complications in these patients have the potential to improve overall outcomes.

Trends in Clinical Presentation, Management, and Outcomes of STEMI in Patients With COVID-19.

BACKGROUND: We previously reported high in-hospital mortality for ST-segment elevation myocardial infarction (STEMI) patients with COVID-19 treated in the early phase of the pandemic. OBJECTIVES: The purpose of this study was to describe trends of COVID-19 patients with STEMI during the course of the pandemic. METHODS: The NACMI (North American COVID-19 STEMI) registry is a prospective, investigator-initiated, multicenter, observational registry of hospitalized STEMI patients with confirmed or suspected COVID-19 infection in North America. We compared trends in clinical characteristics, management, and outcomes of patients treated in the first year of the pandemic (January 2020 to December 2020) vs those treated in the second year (January 2021 to December 2021). RESULTS: A total of 586 COVID-19-positive patients with STEMI were included in the present analysis; 227 treated in Y2020 and 359 treated in Y2021. Patients' characteristics changed over time. Relative to Y2020, the proportion of Caucasian patients was higher (58% vs 39%; P < 0.001), patients presented more frequently with typical ischemic symptoms (59% vs 51%; P = 0.04), and patients were less likely to have shock pre-PCI (13% vs 18%; P = 0.07) or pulmonary manifestations (33% vs. 47%; P = 0.001) in Y2021. In-hospital mortality decreased from 33% (Y2020) to 23% (Y2021) (P = 0.008). In Y2021, none of the 22 vaccinated patients expired in hospital, whereas in-hospital death was recorded in 37 (22%) unvaccinated patients (P = 0.009). CONCLUSIONS: Significant changes have occurred in the clinical characteristics and outcomes of STEMI patients with COVID-19 infection during the course of the pandemic.

Outcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy.

Background: The Supreme healing-targeted drug-eluting stent (DES) is designed to promote endothelial healing to reduce stent-related adverse events. This may be particularly relevant among complex lesions that have a higher rate of adverse events. We sought to compare 1-year outcomes of percutaneous coronary intervention in complex lesions between the Supreme DES and contemporary durable-polymer, everolimus-eluting stents (DP-EES). Methods: PIONEER III was a multicenter, prospective, single-blind clinical trial, randomizing 1629 patients with either an acute or chronic coronary syndrome in a 2:1 ratio to the Supreme DES or DP-EES. Complex lesions (American College of Cardiology/American Heart Association type B2/C) were found in 1137 patients. Outcomes were also compared for specific parameters of lesion complexity: severe calcification, long length (>20 â€‹mm), and severe tortuosity. The primary end point was target lesion failure at 1 â€‹year. Results: At 1 â€‹year, there was no difference in target lesion failure between the Supreme DES and DP-EES: (5.7% vs 5.6%; hazard ratio 1.00, 95% confidence interval 0.59-1.68, P = .99). Similarly, there were no differences in the secondary end points of lesion success (99.7% vs 99.4%, P = .41), device success (97.0% vs 98.5%, P = .14), target vessel failure (6.5% vs 7.4%, P = .50), major adverse cardiac events (7.8% vs 8.5%, P = .64), or stent thrombosis (0.7% vs 1.1%, P = .48). A trend was observed toward a higher rate of target lesion revascularization with the Supreme DES (2.5% vs 0.9%, P = .06). Conclusions: This study suggests that the Supreme DES is as effective and safe at 1 â€‹year compared with the standard DP-EES across a broad spectrum of lesion complexity.

Initial Findings From the North American COVID-19 Myocardial Infarction Registry.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has impacted many aspects of ST-segment elevation myocardial infarction (STEMI) care, including timely access to primary percutaneous coronary intervention (PPCI). OBJECTIVES: The goal of the NACMI (North American COVID-19 and STEMI) registry is to describe demographic characteristics, management strategies, and outcomes of COVID-19 patients with STEMI. METHODS: A prospective, ongoing observational registry was created under the guidance of 3 cardiology societies. STEMI patients with confirmed COVID+ (group 1) or suspected (person under investigation [PUI]) (group 2) COVID-19 infection were included. A group of age- and sex-matched STEMI patients (matched to COVID+ patients in a 2:1 ratio) treated in the pre-COVID era (2015 to 2019) serves as the control group for comparison of treatment strategies and outcomes (group 3). The primary outcome was a composite of in-hospital death, stroke, recurrent myocardial infarction, or repeat unplanned revascularization. RESULTS: As of December 6, 2020, 1,185 patients were included in the NACMI registry (230 COVID+ patients, 495 PUIs, and 460 control patients). COVID+ patients were more likely to have minority ethnicity (Hispanic 23%, Black 24%) and had a higher prevalence of diabetes mellitus (46%) (all p < 0.001 relative to PUIs). COVID+ patients were more likely to present with cardiogenic shock (18%) but were less likely to receive invasive angiography (78%) (all p < 0.001 relative to control patients). Among COVID+ patients who received angiography, 71% received PPCI and 20% received medical therapy (both p < 0.001 relative to control patients). The primary outcome occurred in 36% of COVID+ patients, 13% of PUIs, and 5% of control patients (p < 0.001 relative to control patients). CONCLUSIONS: COVID+ patients with STEMI represent a high-risk group of patients with unique demographic and clinical characteristics. PPCI is feasible and remains the predominant reperfusion strategy, supporting current recommendations.

Meta-Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Patients With Low Surgical Risk.

Transcatheter aortic valve implantation (TAVI) is the current standard of care for patients with severe aortic stenosis who are at high risk for surgery. However, several recent studies have demonstrated the comparable safety and efficacy of TAVI in low-risk patients as well. We sought to pool the existing data to further assert its comparability. MEDLINE, Cochrane, and Embase databases were evaluated for relevant articles published from January 2005 to June 2019. Studies comparing outcomes of TAVI versus surgical aortic valve replacement in patients who are at low risk for surgery were included. Twelve studies (5 randomized controlled trials and 7 observational studies) totaling 27,956 patients were included. Follow-up ranged from 3 months to 5 years. Short-term all-cause mortality, short-term, and 1-year cardiac mortality were significantly lower in the TAVI group. One-year all-cause mortality, short-term, and 1-year stroke and myocardial infarction were similar in both groups. Rate of acute kidney injury and new-onset atrial fibrillation were lower in the TAVI group, whereas permanent pacemaker implantation and major vascular complications were higher in the TAVI group. Subgroup analysis of randomized controlled trials showed significantly lower 1-year all-cause mortality in the TAVI group. In conclusion, in severe aortic stenosis patients at low surgical risk, TAVI when compared with surgical aortic valve replacement, demonstrated a lower rate of short-term all-cause mortality, short-term, and 1-year cardiac mortality and similar in terms of 1-year all-cause mortality. TAVI is emerging as a safe and efficacious alternative for low surgical risk patients.

Medical therapy vs early revascularization in diabetics with chronic total occlusions: A meta-analysis and systematic review.

BACKGROUND: Management of chronic total occlusions (CTO) in diabetics is challenging, with a recent trend towards early revascularization [ER: Percutaneous coronary intervention (PCI) and bypass grafting] instead of optimal medical therapy (OMT). We hypothesize that ER improves morbidity and mortality outcomes in diabetic patients with CTOs as compared to OMT. AIM: To determine the long term clinical outcomes and to compare morbidity and mortality between OMT and ER in diabetic patients with CTOs. METHODS: Potentially relevant published clinical trials were identified in Medline, Embase, chemical abstracts and Biosis (from start of the databases till date) and pooled hazard ratios (HR) computed using a random effects model, with significant P value < 0.05. Primary outcome of interest was all-cause death. Secondary outcomes included cardiac death, prompt revascularization (ER) or repeat myocardial infarction (MI). Due to scarcity of data, both Randomized control trials and observational studies were included. 4 eligible articles, containing 2248 patients were identified (1252 in OMT and 1196 in ER). Mean follow-up was 45-60 mo. RESULTS: OMT was associated with a higher all-cause mortality [HR: 1.70, 95% confidence interval (CI): 0.80-3.26, P = 0.11] and cardiac mortality (HR: 1.68, 95%CI: 0.96-2.96, P = 0.07). Results were close to significance. The risk of repeat MI was almost the same in both groups (HR: 0.97, 95%CI: 0.61-1.54, P = 0.90). Similarly, patients assigned to OMT had a higher risk of repeat revascularization (HR: 1.62, 95%CI: 1.36-1.94, P < 0.00001). Sub-group analysis of OMT vs PCI demonstrated higher all-cause (HR: 1.98, 95%CI: 1.36-2.87, P = 0.0003) and cardiac mortality (HR: 1.87, 95%CI: 0.96-3.62, P = 0.06) in the OMT group. The risk of repeat MI was low in the OMT group vs PCI (HR: 0.53, 95%CI: 0.31-0.91, P = 0.02). Data on repeat revascularization revealed no difference between the two (HR: 1.00, 95%CI: 0.52-1.93, P = 1.00). CONCLUSION: In diabetic patients with CTO, there was a trend for improved outcomes with ER regarding all-cause and cardiac death as compared to OMT. These findings were reinforced with statistical significance on subgroup analysis of OMT vs PCI.

A meta-analysis of antibacterial envelope use in prevention of cardiovascular implantable electronic device infection.

OBJECTIVES: Cardiac implantable electronic device (CIED) infection has been a major clinical problem in addition to being a major financial burden. In spite of antimicrobial prophylaxis, CIED infection rates have been increasing disproportionately. We therefore conducted this meta-analysis to assess the role of TYRX antibiotic envelope for the prevention of CIED infection. METHODS: Using extensive online search, we conducted a meta-analysis of studies reporting CIED infections with versus without the use of TYRX antibiotic envelope. A random-effect model was used, and between studies heterogeneity was estimated with I2. All analyses were performed with RevMan (version 5.0.20). RESULTS: Five cohort studies were included in this meta-analysis. The pooled odds ratio (OR) of included studies was 0.29 [95% confidence interval (CI): 0.09-0.94; p < 0.004]. There was evidence of heterogeneity with I2 of 58%. There was also evidence of publication bias on funnel plot analysis. On sensitivity analysis, no statistically significant difference was noted when stratified by study design or duration of follow-up. CONCLUSION: The results of our study demonstrate a significant beneficial effect of TYRX antibiotic envelope for the prevention of CIED infections.

Egg Consumption and Incidence of Heart Failure: A Meta-Analysis of Prospective Cohort Studies.

INTRODUCTION: Heart failure (HF) remains a major health problem affecting 5.7 million adults in USA. Data on the association of egg consumption with incident HF have been inconsistent. We, therefore, conducted this meta-analysis of prospective cohort studies to assess the relation of egg consumption with incident HF in the general population. METHODS: Using extensive online search, we conducted a meta-analysis of new onset HF following exposure to egg consumption. A random effects model was used and between studies heterogeneity was estimated with I2. Publication bias was assessed graphically using a funnel plot. All analyses were performed with Comprehensive Meta-Analysis (version 2.2.064). RESULTS: We identified four prospective cohorts for a total of 105,999 subjects and 5,059 cases of new onset HF. When comparing the highest (≥1/day) to the lowest category of egg consumption, pooled relative risk of HF was 1.25 (95% confidence interval = 1.12-1.39; p = 0.00). There was no evidence for heterogeneity (I2 = 0%) nor publication bias. On sensitivity analysis, stratification by gender differences, follow-up duration, and region where study was conducted did not alter the main conclusion. CONCLUSION: Our meta-analysis suggests an elevated risk of incident HF with frequent egg consumption.

First and second generation DESs reduce diabetes adverse effect on mortality and re-intervention in multivessel coronary disease: 9-Year analysis.

BACKGROUND/PURPOSE: Diabetes portends an increased risk of adverse early and late outcomes in patients undergoing PCI. In this study, we aimed to investigate if the adverse effect of diabetes mellitus (DM) on early and late PCI outcomes is reduced with drug-eluting (DES) compared to bare-metal (BMS) stents. METHODS/MATERIALS: We reviewed the Mount Sinai Beth Israel Hospital first PCI experience for multivessel coronary artery disease (CAD, 1998-2009). Patients were excluded if they had single-vessel CAD, emergency, no stent, prior bypass graft or myocardial infarction <24h. Diabetes-effect was derived from 9-year all-cause mortality and re-intervention risk-adjusted hazard ratios [AHR (95% confidence intervals)] for DES (N=2679; 48% three-vessel; 39% DM) and BMS (N=2651; 40% three-vessel; 33% DM) and then stratified based on stent (DES/BMS) and vessel disease (two/three). RESULTS: Diabetes-effect on mortality was lower for DES (AHRDM/NoDM=1.41 [1.14-1.74]) versus BMS (AHRDM/NoDM=1.71 [1.50-2.01]), but this was predominantly driven by two-vessel patients. This diabetes effect was similar for first (DES1: AHRDM/NoDM=1.43 [1.14-1.79]) and second (DES2: AHRDM/NoDM=1.53 [0.77-3.07]) generation DES. Re-intervention comparisons were similarly increased by diabetes in all sub-cohorts. CONCLUSIONS: Our analysis of a large real-world PCI series indicates that diabetes is associated with worse 9-year mortality irrespective of stent type, albeit this is mitigated to varying degrees with DES, particularly in DES2 and in case of 2-vessel disease. A complementary stent-effect analysis confirmed DES-to-BMS and DES2-to-DES1 superiority in both diabetics and non-diabetics.

Risk of Ischemic Heart Disease in Patients With Sjögren's Syndrome.

BACKGROUND: Ischemic heart disease (IHD) has emerged as a major cause of morbidity and mortality in patients with autoimmune conditions such as systemic lupus erythematosus and rheumatoid arthritis, but the risk of IHD in Sjögren's syndrome (SjS) is unknown. To fill this knowledge gap, we estimated the prevalence and risk of IHD with SjS compared to controls from the general population using the Healthcare Cost and Utilization Project National Inpatient Sample 2011 database. MATERIALS AND METHODS: The Healthcare Cost and Utilization Project administrative longitudinal database contains encounter-level information on inpatient stays, emergency department visits and ambulatory surgery in all U.S. hospitals. We conducted a cross-sectional study among the inpatient population diagnosed with SjS and matched 1:4 with controls for age, sex and hospital region. Odds ratio for IHD was calculated as cases compared to controls. The contribution of various risk factors to IHD was also evaluated by logistic regression. RESULTS: Analysis demonstrated that 7,154 of 13,086 cases (54.7%) of SjS had IHD compared to 27,367 of 52,448 controls (52.2%). The adjusted odds ratio for IHD in those with SjS was 0.898 (95% CI: 0.844-0.955). Patients with SjS were significantly more likely to have hypertension, diabetes, apnea and lipid disorders. CONCLUSIONS: To our knowledge, this is the largest population-based study investigating the risk of IHD in patients with SjS. We found a modest, though statistically significant, decrease in the risk of IHD in SjS compared to controls.

Polymer-free Biolimus A9-coated stents in the treatment of de novo coronary lesions with short DAPT: 9-month angiographic and clinical follow-up of the prospective, multicenter BioFreedom USA clinical trial.

BACKGROUND: BioFreedom is a polymer- and carrier-free drug-coated stent that delivers Biolimus A9 to the vessel wall. Our purpose was to evaluate the efficacy and safety of this DCS in patients with short-duration dual antiplatelet therapy. METHODS: The BioFreedom US IDE feasibility trial was a single-arm, open-label, prospective study of patients requiring stenting of de novo lesions. Patients received 3 months of DAPT, repeat angiography at 9 months, and clinical follow-up at multiple intervals. A subgroup also underwent intravascular ultrasound (IVUS) interrogation. The primary safety end point was major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, target lesion revascularization, or stent thrombosis. The primary efficacy end point, in-stent late lumen loss at 9 months, was compared with a historical control from a first-generation paclitaxel-eluting stent. RESULTS: A total of 72 patients from 10 sites received BioFreedom DCS implanted in 83 de novo lesions. At 9 months, the incidence of composite MACE was 8.4%, and TLR was 1.5%. Short DAPT was safe without occurrence of stent thrombosis. The primary end point of LLL was 0.32±0.53 mm. Paired IVUS analyses comparing postprocedural with 9-month measurements showed low in-stent neointimal volume obstruction (5.39±5.28%) and low neointimal hyperplasia (7.43±8.04 mm3). CONCLUSIONS: This study's angiography and IVUS assessments demonstrated that the BioFreedom DCS has anti-restenotic efficacy similar to first-generation DES. In the absence of concerning safety signals, this DCS should be considered effective and safe for patients who require a shorter duration of DAPT.

3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial.

BACKGROUND: The Absorb everolimus-eluting poly-L-lactic acid-based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES). OBJECTIVES: This study sought to assess clinical outcomes through 3 years following BVS implantation. METHODS: Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years. RESULTS: The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter <2.25 mm) was an independent predictor of 3-year TLF and scaffold thrombosis. CONCLUSIONS: In the ABSORB III trial, 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906).