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BACKGROUND: Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its three-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischaemic events. AIMS: We sought to evaluate the impact of DAPT duration on ischaemic and bleeding outcomes following BRS implantation. METHODS: We conducted an individual patient data pooled analysis from four ABSORB randomised trials and one prospective ABSORB registry. Study endpoints were MI, ST, bleeding, and death up to three-year follow-up. Propensity score-adjusted Cox regression analysis was used to account for baseline differences related to DAPT duration. RESULTS: The five ABSORB studies included 2,973 patients. DAPT use was 91.7%, 53.2%, and 48.0% at 1, 2, and 3 years, respectively. DAPT use within the first year after BRS implantation was associated with markedly lower risks of MI (adjusted hazard ratio [aHR] 0.17, 95% CI: 0.10-0.32; p

Background The long-term prognostic impact of IVUS findings following Absorb BVS implantation remains uncertain. This study aimed to identify the IVUS predictors of long-term clinical outcomes following ABSORB bioresorbable vascular scaffold (BVS) implantation from the pooled IVUS substudy cohorts of the ABSORB III and Japan trials. Methods A total of 298 lesions in 286 patients were enrolled with 2:1 randomization to ABSORB BVS vs. cobalt-chromium everolimus-eluting stents. This sub-analysis included 168 lesions of 160 patients in the Absorb arm whose post-procedural quantitative IVUS were available. The primary endpoint of this analysis was device-oriented composite endpoint (DOCE) of target lesion failure, including cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The median follow-up duration was 4.9 [3.1–5.0] years. Results During follow-up, DOCE occurred in 10.1% of lesions treated with Absorb BVS. Among several post-procedural IVUS indices associated with DOCE, non-uniform device expansion (defined as uniformity index = minimum / maximum device area) (hazard ratio 0.47 per 0.1 increase [95%CI 0.28 to 0.77]; p = 0.003) and residual reference plaque burden (hazard ratio 4.01 per 10% increase [95%CI 1.50 to 10.77]; p = 0.006) were identified as independent predictors of DOCE by Cox multivariable analysis. Conclusions Nonuniform device expansion and substantial untreated residual plaque in reference segments were associated with long-term adverse events following BVS implantation. Baseline imaging to identify the appropriate device landing zone and procedural imaging to achieve uniform device expansion if possible (e.g. through post-dilatation) may improve clinical outcomes of BVS implantation. Clinical trial registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT01751906 (ABSORB III); NCT01844284 (ABSORB Japan).

Guidelines suggest differential management of diabetics and nondiabetics with coronary artery disease (CAD) referred for revascularization, but pre-diabetics, who now comprise up to 20% to 30% of CAD patients, have been excluded from the diabetic group. To address this, we studied long-term cardiac outcomes in 1,323 consecutively drug-eluting stent (DES)-stented patients from prespecified local zip codes, dividing patients into normal-glycemic patients, prediabetics and diabetics, based upon conventional definitions. Patient age was 63±11 years, 65.5% male, mean baseline SYNTAX score of 10.2±6.8 and residual SYNTAX score=3.0±4.6. Only 2.9% of patients were lost to follow up at 10 years. Duration of follow up for alive patients was 124±33 mos. Major adverse cardiac events (MACE) by Kaplan Meier (KM) was similar for normal glycemics and prediabetics (42.9±2.5% vs 38.6±3.1% at 10 years, p=0.35), whereas that for diabetics was worse (56.7±2.6% at 10 years, p

Objectives The objective of this study is to identify and model risk factors for major adverse cardiac events (MACE) and all-cause mortality among patients with ESRD treated with PCI using DES. Background Patients with end-stage renal disease (ESRD) have poor long-term outcomes after percutaneous coronary intervention (PCI) compared with non-ESRD patients. However, there is a paucity of literature regarding risk factors associated with outcomes of ESRD patients after PCI with drug-eluding stents (DES). Methods This retrospective cohort study includes all patients with ESRD who underwent first-time PCI with DES at a single, high-volume hospital between 1/1/2005 and 12/31/2015, with follow-up through 9/1/2019. Primary outcomes were MACE (cardiac death, myocardial infarction, or unplanned revascularization) and all-cause mortality. Results Five-year MACE was 83.0% and five-year morality was 77.9% in patients with ESRD (n = 285). Among ESRD patients, factors independently associated with MACE were C-reactive peptide level, SYNTAX score, peripheral vascular occlusive disease, hemoglobin, and treatment of a restenotic lesion (c-index = 0.66). Factors independently associated with mortality in ESRD patients were age, SYNTAX score, non-use of statins at baseline, insulin-dependent diabetes, chronic obstructive pulmonary disease (COPD), peripheral vascular occlusive disease, and platelet count (c-index = 0.65). Conclusions Despite relatively poor 1-and 5-year outcomes among ESRD patients after PCI, risk of MACE and mortality among this cohort can be successfully modelled, which meaningfully informs clinicians regarding management of ESRD patients with coronary artery disease (CAD). Further investigations are necessary to determine whether or not outcomes might be improved through risk profile modification.

Excimer laser coronary atherectomy (ELCA) during percutaneous coronary intervention (PCI) has been in use for more than twenty years. While early experiences were not favorable over balloon angioplasty alone, with improvement in operator technique, patient selection and technology, ELCA has established its own niche in contemporary PCI as a safe and effective atherectomy strategy. With growing experience in complex coronary interventions worldwide, ELCA has become one of the essential atherectomy tools offering unique advantages over other atherectomy devices. In the modern era, ELCA is commonly used for patients with in-stent restenosis, stent under expansion, balloon uncrossable lesions and chronic total occlusions. Technical success rates are reported to be >80% in most situations while procedural complication rates such as vessel dissection and perforation among others are reported to average 9% over the past 25 years with improvement over time. In this review, we provide a comprehensive systematic review of the ELCA system, its practical use, indications, and procedural techniques in the contemporary PCI era.

Mortality in patients with STEMI-associated cardiogenic shock (CS) is increasing. Whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol (CSP) can improve their care delivery and mortality is unknown. We evaluated the impact of a CSP on incidence and outcomes in patients with STEMI-associated CS. We implemented a 4-step CSP including: (1) Emergency Department catheterization lab activation; (2) STEMI Safe Handoff Checklist; (3) immediate catheterization lab transfer; (4) and radial-first percutaneous coronary intervention (PCI). We studied 1,272 consecutive STEMI patients who underwent PCI and assessed for CS incidence per National Cardiovascular Data Registry definitions within 24-hours of PCI, care delivery, and mortality before (January 1, 2011, to July 14, 2014; n = 723) and after (July 15, 2014, to December 31, 2016; n = 549) CSP implementation. Following CSP implementation, CS incidence was reduced (13.0% vs 7.8%, p = 0.003). Of 137 CS patients, 43 (31.4%) were in the CSP group. CSP patients had greater IABP-Shock II risk scores (1.9 ± 1.8 vs 2.8 ± 2.2, p = 0.014) with otherwise similar hemodynamic and baseline characteristics, cardiac arrest incidence, and mechanical circulatory support use. Administration of guideline-directed medical therapy was similar (89.4% vs 97.7%, p = 0.172) with significant improvements in trans-radial PCI (9.6% vs 44.2%, p < 0.001) and door-to-balloon time (129.0 [89:160] vs 95.0 [81:116] minutes, p = 0.001) in the CSP group, translating to improvements in infarct size (CK-MB 220.9 ± 156.0 vs 151.5 ± 98.5 ng/ml, p = 0.005), ejection fraction (40.8 ± 14.5% vs 46.7 ± 14.6%, p = 0.037), and in-hospital mortality (30.9% vs 14.0%, p = 0.037). In conclusion, CSP implementation was associated with improvements in CS incidence, infarct size, ejection fraction, and in-hospital mortality in patients with STEMI-associated CS. This strategy offers a potential solution to bridging the historically elusive gap in their care.

Although it is well established that adding early revascularization to optimal medical therapy reduces mortality and recurrent myocardial infarction in acute coronary syndrome, there is less convincing evidence to guide intervention in stable ischemic heart disease. This review summarizes the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial, which investigated whether there is benefit from initial catheterization and possible revascularization in addition to optimal medical therapy in patients with at least moderate ischemia on stress testing.

OBJECTIVES We sought to compare in-hospital outcomes between patients with and without end-stage renal disease (ESRD) undergoing coronary drug-eluting stent (DES) placement and to model risk of in-hospital adverse postpercutaneous coronary intervention (PCI) events in ESRD patients. BACKGROUND The effect of ESRD on the risk of in-hospital complications after DES PCI is relatively unclear, as is the ability to prospectively stratify risk in this population. METHODS Consecutive patients undergoing first-time DES between April 1, 2003 and June 30, 2018 at a single tertiary care hospital were included in a prospective registry. Outcomes in those with ESRD were compared to those without ESRD. The primary endpoint was in-hospital all-cause mortality; secondary endpoints included in-hospital major adverse cardiac events (MACE)-defined as cardiac death, myocardial infarction, or unplanned revascularization-and major bleeding. Multivariate logistic regression modeling was used to identify factors associated with each outcome and to generate risk scores. RESULTS Among 18,134 patients in the study population, 382 (2.1%) had ESRD. ESRD was associated with increased risk of in-hospital mortality (7.1 vs. 2.9%, p

Aims To determine whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol is associated with reduced sex disparities over 5 years. Methods and results This was an observational cohort study of 1833 consecutive STEMI patients treated with percutaneous coronary intervention (PCI) before (1 January 2011–14 July 2014, control group) and after (15 July 2014–15 July 2019, protocol group) implementation of a protocol for early guideline-directed medical therapy (GDMT), rapid door to balloon time (D2BT), and use of trans-radial PCI. In the control group, females had less GDMT (77.1% vs. 68.1%, P = 0.03), similarly low trans-radial PCI (19.0% vs. 17.6%, P = 0.73), and longer D2BT [104 min (79, 133) vs. 112 min (85, 147), P = 0.02] corresponding to higher in-hospital mortality [4.5% vs. 10.3%, odds ratio (OR) 2.44 (1.34–4.46), P = 0.004], major adverse cardiac and cerebrovascular events [MACCE, 9.8% vs. 16.3%, OR 1.79 (1.14–2.84), P = 0.01], and net adverse clinical events [NACE, 16.1% vs. 28.3%, OR 2.06 (1.42–2.99), P < 0.001]. In the protocol group, no significant sex differences were observed in GDMT (87.2% vs. 86.4%, P = 0.81) or D2BT [85 min (64–106) vs. 89 min (65–111), P = 0.06], but trans-radial PCI was used less in females (77.6% vs. 71.2%, P = 0.03). In-hospital mortality [2.5% vs. 4.4%, OR 1.78 (0.91–3.51), P = 0.09] and MACCE [9.0% vs. 11.1%, OR 1.27 (0.83–1.92), P = 0.26] were similar between sexes, but higher NACE in females approached significance [14.8% vs. 19.4%, OR 1.38 (0.99–1.92), P = 0.05] due to higher bleeding risk [7.2% vs. 11.1%, OR 1.60 (1.04–2.46), P = 0.03]. Conclusions A comprehensive STEMI protocol was associated with sustained reductions for in-hospital ischaemic outcomes over 5 years, but higher bleeding rates in females persisted.

BackgroundLong‐term outcomes of percutaneous coronary intervention (PCI) based on patients’ decision‐making ability have not been studied. Our objective was to assess long‐term outcomes after PCI in patients who provided individual versus surrogate consent.Methods and ResultsData were collected retrospectively for patients who underwent PCI at Cleveland Clinic between January 1, 2015 and December 31, 2016. Inclusion criteria consisted of hospitalized patients aged ≥20 years who had PCI. Patients with outpatient PCI, or major surgery 30 days before or 90 days after PCI, were excluded. Patients who underwent PCI with surrogate consent versus individual consent were matched using the propensity analysis. Kaplan–Meier, log rank,t‐statistic, and χ2tests were used for statistical analysis. The study was approved by the Institutional Review Board at Cleveland Clinic, Ohio. Of 3136 patients who underwent PCI during the study period, 183 had surrogate consent. Propensity matching yielded 149 patients from each group. Two‐year all‐cause mortality was significantly higher in the surrogate consent group (38 [25.5%] versus 16 [10.7%] deaths, log‐rankχ2=10.16,Pχ2=8.36,P=0.003).ConclusionsPatients with surrogate consent had significantly higher all‐cause mortality and higher major adverse cardiac events when compared with patients with individual consent. This study emphasizes the fact that patients with an inability to give consent are at high risk and may need special attention in postprocedural and postdischarge care.

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]; P int =0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02–2.87] versus 3.23 [95% CI, 1.25–8.30]; P int =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.

Patients of different racial backgrounds may have socioeconomic, cultural, or genetic differences that impact outcomes after percutaneous coronary intervention (PCI). There are limited data beyond 2 to 3 years for Blacks to inform discussions and perhaps improve outcomes. We studied consecutive limus-stent treated patients, having their first PCI at our institution January 2003 to March 2010 in 2 cohorts; Cohort 1: standard 3-year follow-up (n = 3,782, 12.4% Blacks) and Cohort 2: from nearby zip codes with intended detailed follow-up through 8 to 13 years (n = 616, 31.8% Blacks). The primary outcomes of interest were mortality and death/MI/revascularization (DMIR) (Cohort 1) or major adverse cardiac events (cardiac DMIR) (Cohort 2). In all cohorts, Blacks had a higher prevalence of many risk factors. In Cohort 1, 3-year mortalities were 14.6% and 9.6% (p = 0.001) and DMIR were 32.1% and 25.0% (p = 0.001), for Blacks and Whites, respectively. In Cohort 2, over 9.5 ± 2.0 years, treatment intensity was as high or higher for Blacks, but they continued to have higher low-density lipoprotein-cholesterol and blood pressure values. Major adverse cardiac events and mortality at 10 years were higher for Blacks (59.0% vs 48.1%, p = 0.024 and 44.3% vs 23.0%, p0.001). Differences in outcomes, except 10 year mortality, were not significantly different after adjustment for baseline characteristics. Blacks have a higher risk profile at the time of PCI and worse long-term outcomes after drug-eluting stent, most of which is explained by baseline differences.

OBJECTIVES This study aimed to evaluate the incidence, treatment, and outcomes of acute myocardial infarction (AMI) following transcatheter or surgical aortic valve replacement (TAVR or SAVR). BACKGROUND Coronary artery disease is common in patients who undergo aortic valve replacement. However, little is known about differences in clinical features of post-TAVR or post-SAVR AMI. METHODS We retrospectively identified post-TAVR or post-SAVR (including isolated and complex SAVR) patients admitted with AMI using the Nationwide Readmissions Database 2012-2017. Incidence, invasive strategy (coronary angiography or revascularization), and in-hospital outcomes were compared between post-TAVR and post-SAVR AMIs. RESULTS The incidence of 180-day AMI was higher post-TAVR than post-SAVR (1.59% vs. 0.72%; p

Background: To risk stratify patients undergoing single-photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) in accordance with appropriate use criteria for referral to coronary angiography, we developed a risk classification algorithm incorporating appropriate use criteria–defined risk features. We evaluated the association between this algorithm with downstream angiography, revascularization, and all-cause mortality. Methods: We studied consecutive patients who underwent SPECT-MPI from January 1, 2015, to December 31, 2017, and assigned a scan risk of low, intermediate, high, or indeterminate. With this stratification, we assessed referral for angiography and revascularization within 3 months of SPECT-MPI and intermediate-term mortality. Results: Among 12 799 patients, the mean age was 66 years, and a majority were men (56.8%). Most patients were low risk (83.6%) followed by intermediate (9.9%) and high risk (5.2%). Compared with low-risk patients, intermediate- and high-risk patients were more frequently referred for angiography (14.8% and 13.6% versus 2.0%; P P P P =0.008) and high scan risk (hazard ratio, 1.98 [95% CI, 1.53–2.56]; P Conclusions: This appropriate use criteria–derived risk classification algorithm for SPECT-MPI guided referral for coronary angiography and revascularization and was significantly associated with mortality. This algorithm may serve as an important tool to reaffirm appropriate use criteria and direct management of patients with stable ischemic heart disease undergoing stress testing.

Coronavirus disease 2019 (COVID-19) causes significant morbidity and mortality for a proportion of infected patients, and our knowledge and understanding of its clinical, radiological and histopathological features are still evolving. An association between COVID-19 and pneumothorax has been described in an increasing number of case reports and series in the literature, which have largely focused on clinical and imaging features. We report the case of a patient who developed COVID-19 complicated by pneumothorax, requiring surgical intervention. We describe the histopathological features seen in the thorascopically resected bullectomy specimen-this is, to our knowledge, the first reported description of the morphological features of pneumothorax in this important clinical setting.

Background: Although most drug-eluding stent (DES) patients live longer than 10 years, there is no generally accepted clinical tool to predict risk of major adverse cardiac events (MACE) after DES over that period of time. Methods: Local consecutive patients receiving their first limus-eluting DES from 6/04-6/12 were characterized at baseline and prospectively followed. Patients were randomly allocated to a training or validation cohort, and a predictive Cox model using pre-procedural variables was developed in the training set. This model was then retested in a validation cohort. The primary endpoint was the c-index in the validation cohort. CIF and Fine-Gray were used for sensitivity analysis. Results: Patients (n=1321) had mean follow up of 10±3 years (3% were lost to follow up). Baseline characteristics included age=63±11 years, 65% male, SYNTAX Score=10±7, 1st/2nd Gen DES (%)=42.8/57.2, DES length (mm)=33±22. In the training set, MACE was independently correlated with renal insufficiency (p Conclusions: Ten year risk of MACE can be accurately modeled using this simple model, with risk ranging from about 30% to nearly 100%.

Background We sought to determine (1) long‐term outcomes in patients presenting with documented Takotsubo syndrome (TS), (2) whether left ventricular global longitudinal strain (LV‐GLS) provides incremental prognostic value, and (3) prognostic cutoffs of LV ejection fraction (LVEF) and LV‐GLS during an acute TS episode. Methods and Results We studied 650 patients with TS (aged 66±14 years, 88% women) who were diagnosed clinically and angiographically between 2006 and 2018. Baseline LVEF and LV‐GLS (using velocity vector imaging) were recorded. The primary end point was all‐cause mortality. TS triggers were unknown (34%), emotional (16%), physical (41%), and neurologic (10%). Mean LVEF and LV‐GLS were 36±10% and −11.6±0.4%; in addition, 94% patients had LVEF P P P Conclusions Patients with TS with a neurologic or physical trigger had significantly worse survival than those without such a trigger, with baseline LVEF and LV‐GLS providing incremental prognostic value.

AIMS The Absorb bioresorbable vascular scaffold (BVS) has high rates of target lesion failure (TLF) at three years. Low wall shear stress (WSS) promotes several mechanisms related to device TLF. We investigated the impact of BVS compared to XIENCE V (XV) on coronary WSS after device deployment. METHODS AND RESULTS In the prospective, randomised, controlled ABSORB III Imaging study (BVS [n=77] or XV [n=36]), computational fluid dynamics were performed on fused angiographic and intravascular ultrasound (IVUS) images of post-implanted vessels. Low WSS was defined as

Background Early coronary ischemic events are uncommon after cardiac surgery, with little known about their management or associated outcomes. We evaluated clinical outcomes of patients undergoing coronary angiography ± percutaneous coronary intervention or redo coronary artery bypass grafting for suspected coronary ischemia within 3 weeks after index cardiac surgery. Methods This is a retrospective observational study based on data from 53,287 patients who underwent cardiac surgery at our institution (1996-2017); 180 patients (0.34%) satisfied the inclusion criteria. The primary outcome was 1-year all-cause mortality. Statistical evaluation involved χ2, analysis of variance, Kaplan-Meier, and receiver operating characteristic curve analyses. Results Most coronary angiography ± percutaneous coronary intervention and redo coronary artery bypass grafting procedures occurred in the first 2 weeks after index cardiac surgery. Patients presenting with ST elevation myocardial infarction (STEMI)/non-STEMI had the lowest 1-year mortality (13.5%), followed by patients with ventricular tachycardia/fibrillation (28.1%), and patients with non–ventricular tachycardia/fibrillation arrest or hemodynamic instability alone the worst (38.6%) (χ2 = 17.3, P = .001). Peak troponin T level after cardiac surgery was strongly predictive of 1-year mortality (area under the curve, 0.74; 95% confidence interval, 0.65-0.84; P Conclusions Although suspected myocardial ischemia requiring coronary angiography or intervention early after cardiac surgery was rare, mortality was high, particularly in presentations other than STEMI/non-STEMI. In patients with overt signs and symptoms of myocardial ischemia after index cardiac surgery, troponin T was not a reliable marker of underlying coronary or graft obstruction but was a robust predictor of 1-year mortality.

Summary 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 p non-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 p non-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 p non-inferiority =0·0008; two-sided p superiority =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.

Objectives The aim of this study was to identify independent correlates of very late scaffold thrombosis (VLST) from an analysis of consecutively treated patients from 15 multicenter studies. Background Recent analyses suggest an increased risk for VLST with the Absorb Bioresorbable Vascular Scaffold compared with drug-eluting stents, but insights as to correlates of risk are limited. Methods A total of 55 patients were identified with scaffold thrombosis. They were matched 2:1 with control subjects selected randomly from patients without thrombosis from the same study. Quantitative coronary angiography was available for 96.4% of patients. Multiple logistic and Cox regression analysis were used to identify significant independent outcome correlates from 6 pre-specified characteristics. Results Patients had scaffold thrombosis at a median of 20 months (interquartile range: 17 to 27 months). Control subjects were followed for 36 months (interquartile range: 24 to 38 months). For the combined groups, reference vessel diameter (RVD) was 2.84 ± 0.50 mm, scaffold length was 26 ± 16 mm, and post-dilatation was performed in 56%. Univariate correlates of thrombosis were smaller nominal scaffold/RVD ratio (linear p = 0.001; ratio 2.72 mm; odds ratio: 3.4; p = 0.001). Post-dilatation at ≥16 atm, post-dilatation balloon/scaffold ratio, final percentage stenosis, and dual antiplatelet therapy were not correlated with VLST. Only scaffold/RVD ratio remained a significant independent correlate of VLST (p = 0.001), as smaller ratio was correlated with RVD (p Conclusions In the present analysis, the largest to date of its type, relative scaffold undersizing was the strongest determinant of VLST. Given current understanding of “scaffold dismantling,” this finding likely has ramifications for all bioresorbable scaffolds.

OBJECTIVES To determine if fractional flow reserve guided percutaneous coronary intervention (FFR-guided PCI) is associated with reduced ischemic myocardium compared with angiography-guided PCI. BACKGROUND Although FFR-guided PCI has been shown to improve outcomes, it remains unclear if it reduces the extent of ischemic myocardium at risk compared with angiography-guided PCI. METHODS We evaluated 380 patients (190 FFR-guided PCI cases and 190 propensity-matched controls) who underwent PCI from 2009 to 2014. Clinical, laboratory, angiographic, stress testing, and major adverse cardiac events [MACE] (all-cause mortality, recurrence of MI requiring PCI, stroke) data were collected. RESULTS Mean age was 63 ± 11 years; the majority of patients were males (76%) and Caucasian (77%). Median duration of follow up was 3.4 [Range: 1.9, 5.0] years. Procedural complications including coronary dissection (2% vs. 0%, P = .12) and perforation (0% vs. 0%, P = 1.00) were similar between FFR-guided and angiography-guided PCI patients. FFR-guided PCI patients had lower unadjusted (14.7% vs. 23.2%, P = .04) and adjusted [OR = 0.58 (95% CI: 0.34-0.98)] risk of repeat revascularization at one year. FFR-guided PCI patients were less likely (23% vs. 32%, P = .02) to have ischemia and had lower (5.9% vs. 21.1%, P

Background: The Absorb bioresorbable vascular scaffold (BVS) completely resorbs within 3 years after coronary artery implantation. The safety and effectiveness of BVS through this critical 3-year period have not been characterized. Methods: We performed an individual-patient-data pooled meta-analysis of the 4 randomized ABSORB trials in which 3389 patients with coronary artery disease were randomly assigned to everolimus-eluting Absorb BVS (n=2164) or cobalt-chromium everolimus-eluting stents (n=1225). The primary efficacy outcome measure was target lesion failure (cardiac mortality, target vessel myocardial infarction, or ischemia-driven target lesion revascularization), and the primary safety outcome measure was device thrombosis. Results: BVS compared with cobalt-chromium everolimus-eluting stents resulted in higher 3-year rates of target lesion failure (11.7% versus 8.1%; risk ratio [RR], 1.38; 95% confidence interval [CI], 1.10–1.73; P =0.006), driven by greater target vessel myocardial infarction (7.8% versus 4.2%; RR, 1.72; 95% CI, 1.26–2.35; P =0.0006) and ischemia-driven target lesion revascularization (6.6% versus 4.4%; RR, 1.44; 95% CI, 1.05–1.98; P =0.02), with comparable cardiac mortality (1.1% versus 1.1%; RR, 0.93; 95% CI, 0.47–1.88; P =0.85). Device thrombosis rates through 3 years were also higher with BVS (2.4% versus 0.6%; RR, 3.71; 95% CI, 1.70–8.11; P =0.001). Between 1 and 3 years, target lesion failure rates (6.1% versus 3.9%; P =0.02) and device thrombosis rates (1.1% versus 0.0%; P Conclusions: In the present individual-patient-data pooled meta-analysis of the ABSORB trials, BVS was associated with increased rates of target lesion failure and device thrombosis between 1 and 3 years and cumulatively through 3 years of follow-up compared with everolimus-eluting stents. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

Background: Cardiac arrest (CA) complicating ST-elevation myocardial infarction (STEMI) is associated with a disproportionately higher risk of mortality. We described the contemporary presentation, management, and outcomes of CA patients in the era of primary percutaneous coronary intervention (PCI). Methods: We reviewed 1,272 consecutive STEMI patients who underwent PCI between 1/1/2011-12/31/2016 and compared characteristics and outcomes between non-CA (N = 1,124) and CA patients (N = 148), defined per NCDR definitions as pulseless arrest requiring cardiopulmonary resuscitation and/or defibrillation within 24-hr of PCI. Results: Male gender, cerebrovascular disease, chronic kidney disease, in-hospital STEMI, left main or left anterior descending culprit vessel, and initial TIMI 0 or 1 flow were independent predictors for CA. CA patients had longer door-to-balloon-time (106 [83,139] vs. 97 [74,121] minutes, p = 0.003) and greater incidence of cardiogenic shock (48.0% vs. 5.9%, p < 0.001), major bleeding (25.0% vs. 9.4%, p < 0.001), and 30-day mortality (16.2% vs. 4.1%, p < 0.001). Risk score for 30-day mortality based on presenting characteristics provided excellent prognostic accuracy (area under the curve = 0.902). However, over long-term follow-up of 4.5 ± 2.4 years among hospital survivors, CA did not portend any additional mortality risk (HR: 1.01, 95% CI: 0.56–1.82, p = 0.97). Conclusions: In a contemporary cohort of STEMI patients undergoing primary PCI, CA occurs in >10% of patients and is an important mechanism of mortality in patients with in-hospital STEMI. While CA is associated with adverse outcomes, it carries no additional risk of long-term mortality among survivors highlighting the need for strategies to improve the in-hospital care of STEMI patients with CA.

Significant progress has been made in the percutaneous coronary intervention technique from the days of balloon angioplasty to modern-day metallic drug-eluting stents (DES). Although metallic stents solve a temporary problem of acute recoil following balloon angioplasty, they leave behind a permanent problem implicated in very late events (in addition to neoatherosclerosis). BRS were developed as a potential solution to this permanent problem, but the promise of these devices has been tempered by clinical trials showing increased risk of safety outcomes, both early and late. This is not too dissimilar to the challenges seen with first-generation DES in which refinement of deployment technique, prolongation of dual antiplatelet therapy, and technical iteration mitigated excess risk of very late stent thrombosis, making DES the treatment of choice for coronary artery disease. This white paper discusses the factors potentially implicated in the excess risks, including the scaffold consideration and deployment technique, and outlines patient and lesion selection, implantation technique, and dual antiplatelet therapy considerations to potentially mitigate this excess risk with the first-generation thick strut Absorb scaffold (Abbott Vascular, Abbott Park, Illinois). It remains to be seen whether these considerations together with technical iterations will ultimately close the gap between scaffolds and metal stents for short-term events while at the same time preserving options for future revascularization once the scaffold bioresorbs.

Objectives The study sought to investigate the incidence, characteristics, predictors, and possible mechanisms of early and 3-year coronary scaffold thrombosis (ScT). Background An increased incidence of both early and late ScT has been shown in randomized trials. Methods Consecutive patients were enrolled in a single-center registry. Quantitative coronary angiography was performed. Incidence and predictors of ScT were assessed with Kaplan-Meier and Cox regression analyses. Results A total of 657 patients (63 ± 12 years of age, 79% men, 21% diabetic, 64% acute coronary syndrome) who received 925 coronary bioresorbable scaffolds (BRS) (Abbott Vascular, Santa Clara, California) between May 2012 and January 2015 were enrolled. Clinical and procedural characteristics and outcome data at 1,076 (interquartile range: 762 to 1,206) days (3-year follow-up rate 93%) were collected. Twenty-eight ScTs were recorded: 14 early (Kaplan-Meier estimate: 2.2%), 5 late (Kaplan-Meier estimate: 0.9%), and 9 very late (Kaplan-Meier estimate: 1.7%). The incidence of ScT followed a U-shaped curve with highest incidence at the extremes of the distributions of reference vessel diameter (RVD) and the ratio of BRS nominal diameter to RVD. At quantitative coronary angiography, RVD (hazard ratio [HR]: 0.14; 95% confidence interval [CI]: 0.04 to 0.49) and BRS oversizing (ratio of BRS nominal diameter to RVD >1.15; HR: 107.40; 95% CI: 9.20 to 1,261.30) emerged as potent predictors of early ScT. RVD (HR: 9.55; 95% CI: 3.90 to 23.42) and BRS undersizing (ratio of BRS nominal diameter to RVD Conclusions Different mechanisms underlie early and late ScT: although incomplete BRS deployment was a predictor of the former, the latter was associated with large vessel size and BRS undersizing. However, both phenomena are significantly less frequent with an optimized implantation technique. (Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178)

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 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)

Background Procedural technique may affect clinical outcomes after bioresorbable vascular scaffold (BVS) implantation. Prior studies suggesting such a relationship have not adjusted for baseline patient and lesion characteristics that may have influenced operator choice of technique and outcomes. Objectives This study sought to determine whether target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) and scaffold thrombosis (ScT) rates within 3 years of BVS implantation are affected by operator technique (vessel size selection and pre- and post-dilation parameters). Methods TLF and ScT rates were determined in 2,973 patients with 3,149 BVS-treated coronary artery lesions from 5 prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend). Outcomes through 3 years (and between 0 to 1 and 1 to 3 years) were assessed according to pre-specified definitions of optimal technique (pre-dilation, vessel sizing, and post-dilation). Multivariable analysis was used to adjust for differences in up to 18 patient and lesion characteristics. Results Optimal pre-dilation (balloon to core laboratory-derived reference vessel diameter ratio ≥1:1), vessel size selection (reference vessel diameter ≥2.25 mm and ≤3.75 mm), and post-dilation (with a noncompliant balloon at ≥18 atm and larger than the nominal scaffold diameter, but not by >0.5 mm larger) in all BVS-treated lesions were performed in 59.2%, 81.6%, and 12.4% of patients, respectively. BVS implantation in properly sized vessels was an independent predictor of freedom from TLF through 1 year (hazard ratio [HR]: 0.67; p = 0.01) and through 3 years (HR: 0.72; p = 0.01), and of freedom from ScT through 1 year (HR: 0.36; p = 0.004). Aggressive pre-dilation was an independent predictor of freedom from ScT between 1 and 3 years (HR: 0.44; p = 0.03), and optimal post-dilation was an independent predictor of freedom from TLF between 1 and 3 years (HR: 0.55; p = 0.05). Conclusions In the present large-scale analysis from the major ABSORB studies, after multivariable adjustment for baseline patient and lesion characteristics, vessel sizing and operator technique were strongly associated with BVS-related outcomes during 3-year follow-up. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281; ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906; A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population—ABSORB CHINA Randomized Controlled Trial [RCT] [ABSORB CHINA]; NCT01923740; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND]; NCT01023789; AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284)

Cardiovascular disease remains the most common cause of mortality. We studied the change in outcomes for anterior ST-elevation myocardial infarction (STEMI) between 1995 and 2014. Over the past 20 years, 1,658 patients presenting to our center with anterior STEMI underwent primary percutaneous coronary intervention within 12 hours of presentation. We divided these into 4 quartiles, 1995 to 1999 (n = 312), 2000 to 2004 (n = 408), 2005 to 2009 (n = 428), and 2010 to 2014 (n = 510). Across the 4 quartiles, mean age decreased (64.4, 62, 60.3, and 60 years, p 0.01). In all groups, there was a significant rise in prevalence of smoking, hypertension, and obesity. The median length of hospital stay decreased (6, 4.4, 4.2, and 3.6 days, p 0.01), as did the median door-to-balloon time (DBT) (217, 194, 135, and 38 minutes, p 0.01). Thirty-day and 1-year mortality improved over time (14.4%, 11.8%, 8.4%, and 7.8%; and 20.5%, 16.4%, 15.9%, and 13.9%) (p = 0.01 both). Also, 3-year mortality improved (25.3%, 21.6%, 21.3%, and 16.5%, p = 0.02). After adjusting for age, gender, co-morbidities, ejection fraction, clinical shock, and mitral regurgitation, shorter DBT was associated with lower long-term mortality (compared with DBT60 minutes; 60 to 90 minutes hazard ratio [HR] 1.67, 95% confidence interval [CI] 0.93 to 3.00, p = 0.084; 90 to 120 minutes, HR 1.74, 95% CI 1.02 to 2.95, p = 0.04;120 minutes, HR 1.91, 95% CI 1.23 to 2.96, p = 0.004). In conclusion, over the past 2 decades, long-term outcomes improved in patients presenting with anterior STEMI associated with shortening of DBT.

Objectives Because females are under-represented in coronary trials, this study sought to assess the relative safety and efficacy of Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) and the Xience everolimus-eluting stent in females compared with males. Background The Absorb everolimus-eluting BVS provides drug delivery and mechanical support similar to a metallic drug-eluting stent, followed by resorption and restoration of more normal vascular structure with the potential to improve late clinical outcomes. Methods The ABSORB II, ABSORB III, ABSORB Japan, and ABSORB China trials were pooled. Baseline clinical, angiography, procedural variables, and 2-year outcomes were analyzed by sex and device. Results Among 3,384 randomized patients, 932 (27.5%) were female. Females were older, more often had diabetes and hypertension, but had less everolimus-eluting stent, 3-vessel disease, and smoking compared with males (all p≤0.001). The 2-year rates of target lesion failure with BVS versus everolimus-eluting stent in females were 8.9% versus 6.2% (study-level adjusted hazard ratio: 1.47; 95% confidence interval [CI]: 0.88 to 2.46) and 8.9% versus 6.4% in males (HR: 1.40; 95% CI: 1.02 to 1.92; pinteraction = 0.85). There were no significant interactions between sex and device type for any of the components of target lesion failure. Conclusions The relative treatment effects of BVS and everolimus-eluting stent for the 2-year rates of target lesion failure and other cardiovascular outcomes were consistent in females and males.

Objectives The aim of this study was to develop a hybrid approach–specific model to predict chronic total coronary artery occlusion (CTO) percutaneous coronary intervention success, useful for experienced but not ultra-high-volume operators. Background CTO percutaneous coronary intervention success rates vary widely and have improved with the “hybrid approach,” but current predictive models for success have major limitations. Methods Data were obtained from consecutively attempted patients from 7 clinical sites (9 operators, mean annual CTO volume 61 ± 17 cases). Angiographic analysis of 21 lesion variables was performed centrally. Statistical modeling was performed on a randomly designated training group and tested in a separate validation cohort. The primary outcome of interest was technical success. Results A total of 436 patients (456 lesions) met entry criteria. Twenty-five percent of lesions had prior failed percutaneous coronary interventions at the site. The right coronary artery was the most common location (56.4%), and mean occlusion length was 24 ± 20 mm. The initial approach was most often antegrade wire escalation (70%), followed by retrograde (22%). Success was achieved in 79.4%. Failure was most closely correlated with presence of an ambiguous proximal cap, and in the presence of an ambiguous proximal cap, specifically defined collateral score (combination of Werner and tortuosity scores) and retrograde tortuosity. Without an ambiguous proximal cap, poor distal target, occlusion length >10 mm, ostial location, and 1 operator variable contributed. Prior failure, and Werner and tortuosity scores alone, were only weakly correlated with outcomes. The basic 7-item model predicted success, with C statistics of 0.753 in the training cohort and 0.738 in the validation cohort, the later superior (p Conclusions Success can be reasonably well predicted, but that prediction requires modification and combination of angiographic variables. Differences in operator skill sets may make it challenging to create a powerful, generalizable, predictive tool.

Objectives The purpose of this study was to evaluate the economic impact of the Absorb bioresorbable vascular scaffold compared with the Xience everolimus-eluting stent in patients undergoing percutaneous coronary intervention. Background The ABSORB III trial (Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease) demonstrated that the Absorb scaffold was noninferior to the Xience stent with respect to target lesion failure at 1 year. Whether health care costs differ between the Absorb scaffold and the Xience stent is unknown. Methods We performed a prospective health economic study alongside the ABSORB III trial, in which patients undergoing percutaneous coronary intervention for stable or unstable angina were randomized to receive the Absorb scaffold (n = 1,322) or Xience stent (n = 686). Resource use data were collected through 1 year of follow-up. Costs were assessed using resource-based accounting (for procedures), MedPAR data (for other index hospitalization costs), and Medicare reimbursements (for follow-up costs and physician fees). Results Initial procedural costs were higher with the Absorb scaffold than the Xience stent ($6,316 ± 1,892 vs. $6,103 ± 1,895; p = 0.02), driven mainly by greater balloon catheter use and the higher cost of the scaffold in the Absorb group. Nonetheless, index hospitalization costs ($15,035 ± 2,992 for Absorb vs. $14,903 ± 3,449 for Xience; p = 0.37) and total 1-year costs ($17,848 ± 6,110 for Absorb vs. $17,498 ± 7,411 for Xience; p = 0.29) were similar between the 2 groups. Conclusions Although initial procedural costs were higher with the Absorb scaffold, there were no differences in total 1-year health care costs between the 2 cohorts. Longer term follow-up is needed to determine whether meaningful cost savings emerge after scaffold resorption. (A Clinical Evaluation of Absorb™ BVS, the Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT01751906 )

Percutaneous coronary intervention (PCI) for coronary artery chronic total occlusion (CTO) is an important treatment to be used in conjunction with non-CTO PCI, coronary artery bypass grafting, and optimal medical therapy to achieve complete revascularization in patients with coronary artery disease.

Ischemic mitral regurgitation (IMR) has been associated with worse outcome myocardial infarction. However, severity of mitral regurgitation (MR) and its impact on patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) remains unknown. We sought to determine impact of increasing severity of IMR on outcomes in patients with STEMI undergoing primary PCI. All patients presenting with STEMI who underwent primary PCI within 12 hours of symptoms from 1994 to 2014 were included. IMR was graded from 0 to 4+ within 3 days of index myocardial infarction by echocardiography. Overall, 4,005 patients with STEMI were included. None, 1+, 2+, 3+, and 4+ MR were present in 3,200 (79.9%), 427 (10.7%), 260 (6.5%), 91 (2.3%), and 27 (0.7%) patients, respectively. On multivariate logistic regression analysis, more severe MR was associated with older age, female gender, lower body mass index, anemia, inferior STEMI, and longer door-to-balloon time. The 30-day mortality rates were 6.8%, 7.3%, 8.8%, 19.8%, and 26.1%, respectively, with increasing grade of MR. The 1-year mortality rates were 10.8%, 12.4%, 20.8%, 37.4%, and 37.1%, whereas 5-year mortality rates were 16.2%, 23.1%, 36.5%, 53.8%, and 63%, respectively (p0.001 all), for none to 4+ MR. After adjusting for age, gender, co-morbidities, ejection fraction, and shock by multivariate analysis, severity of IMR was associated with incremental effect on long-term mortality (hazard ratios of 1.42, 1.83, 2.41, and 2.95 for 1+ to 4+ MR respectively, p0.01 for all). In conclusion, higher grades of MR in patients with STEMI undergoing primary PCI are associated with worse short- and long-term outcomes.

Bioresorbable vascular scaffolds (BVS) offer the potential to improve long-term outcomes of percutaneous coronary intervention after their complete bioresorption. Randomised trials have shown non-inferiority between BVS and metallic drug-eluting stents at 1 year in composite safety and effectiveness outcomes, although some increases in rates of target vessel-related myocardial infarction and device thrombosis were identified. Outcomes of BVS following the first year after implantation are unknown. We sought to ascertain whether BVS are as safe and effective as drug-eluting stents within 2 years after implantation and between 1 and 2 years.We did a systematic review and meta-analysis of randomised trials in which patients were randomly assigned to everolimus-eluting Absorb BVS or metallic everolimus-eluting stents (EES) and followed up for at least 2 years. We searched MEDLINE, the Cochrane database, TCTMD, ClinicalTrials.gov, Clinical Trial Results, CardioSource, and abstracts and presentations from major cardiovascular meetings up to April 1, 2017, to identify relevant studies. The primary efficacy outcome measure was the device-oriented composite endpoint (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation) and the primary safety outcome measure was definite or probable device thrombosis. Individual patient data from the four ABSORB trials were used for landmark and subgroup analysis and multivariable modelling.We identified seven randomised trials in which 5583 patients were randomly assigned to Absorb BVS (n=3261) or metallic EES (n=2322) and followed up for 2 years. BVS had higher 2-year relative risks of the device-oriented composite endpoint than did EES (9·4% [304 of 3217] vs 7·4% [169 of 2299]; relative risk [RR] 1·29 [95% CI 1·08-1·56], p=0·0059). These differences were driven by increased rates of target vessel-related myocardial infarction (5·8% [187 of 3218] vs 3·2% [74 of 2299]; RR 1·68 [95% CI 1·29-2·19], p=0·0003) and ischaemia-driven target lesion revascularisation (5·3% [169 of 3217] vs 3·9% [90 of 2300]; 1·40 [1·09-1·80], p=0·0090) with BVS, with non-significant differences in cardiac mortality. The cumulative 2-year incidence of device thrombosis was higher with BVS than with EES (2·3% [73 of 3187] vs 0·7% [16 of 2281]; RR 3·35 [95% CI 1·96-5·72], p0·0001). Landmark analysis between 1 and 2 years also showed higher rates of the device-oriented composite endpoint (3·3% [69 of 2100] vs 1·9% [23 of 1193]; RR 1·64 [95% CI 1·03-2·61], p=0·0376) and device thrombosis (0·5% [11 of 2085] vs none [0 of 1183], p0·0001) in BVS-treated patients than in EES-treated patients.BVS was associated with increased rates of composite device-oriented adverse events and device thrombosis cumulatively at 2 years and between 1 and 2 years of follow-up compared with EES.Abbott Vascular.

Objectives The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus. Background Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population. Methods In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year following Absorb BVS compared with a performance goal of 12.7%. Results Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF. Conclusions The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.

IMPORTANCE: Bioresorbable scaffolds were designed to provide clinical benefits after their complete bioresorption. Prior studies demonstrated early risks with the Absorb polymeric bioresorbable vascular scaffold (BVS). Whether this risk profile changes over time during the course of its bioresorption is unknown. OBJECTIVE: To examine outcomes of the first-generation BVS before and after 3 years, the point of its complete bioresorption in animals. DATA SOURCES: We searched MEDLINE and the Cochrane database, conference proceedings, and public websites for relevant studies. STUDY SELECTION: Eligible studies were randomized clinical trials of BVS vs metallic drug-eluting stents in patients with coronary artery disease with at least 5-year follow-up. Four trials of BVS vs everolimus-eluting stents (EES) with 3384 patients met criteria. DATA EXTRACTION AND SYNTHESIS: Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed. MAIN OUTCOMES AND MEASURES: The major effectiveness and safety measures were target lesion failure (TLF; cardiac death, target vessel–related myocardial infarction, or ischemia-driven target lesion revascularization) and device thrombosis. Outcomes were examined through 5-year follow-up and between 0 to 3 and 3 to 5 years. RESULTS: Mean age for the 3384 patients was 62.8 years; 2452 patients were men (72.5%), and diabetes was present in 1020 patients (30.2%). Through 5-year follow-up, treatment with BVS compared with EES was associated with higher rates of TLF (14.9% vs 11.6%; HR, 1.26; 95% CI, 1.03-1.54; P = .03) and device thrombosis (2.5% vs 0.8%; HR, 2.87; 95% CI, 1.46-5.65; P = .002). Target lesion failure occurred in 11.6% of BVS-treated patients vs 7.9% of EES-treated patients between 0 to 3 years (HR, 1.42; 95% CI, 1.12-1.80), and 4.3% of BVS-treated patients vs 4.5% of EES-treated patients between 3 to 5 years (HR, 0.92; 95% CI, 0.64-1.31) (P for interaction = .046). Device thrombosis occurred in 2.4% of BVS-treated patients vs 0.6% of EES-treated patients between 0 to 3 years (HR, 3.86; 95% CI, 1.75-8.50) and 0.1% of BVS-treated patients vs 0.3% of EES-treated patients between 3 to 5 years (HR, 0.44; 95% CI, 0.07-2.70) (P for interaction = .03). These results were consistent by spline analysis and after multiple imputation and multivariable analysis. CONCLUSIONS AND RELEVANCE: The period of excess risk for the first-generation Absorb BVS ends at 3 years. These data provide mechanistic insights into the timing of adverse events after BVS and identify the hurdles to be overcome for bioresorbable technology to be accepted as a valid alternative for patients with coronary artery disease. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281

Background: Systems to improve ST-segment–elevation myocardial infarction (STEMI) care have traditionally focused on improving door-to-balloon time. However, prompt guideline-directed medical therapy and transradial primary percutaneous coronary intervention (PCI) are also associated with reduced STEMI mortality. The incremental prognostic value of each facet of STEMI care on clinical outcomes within a STEMI system of care is unknown. Methods and Results: We implemented systems-based strategies at our hospital to improve 3 STEMI care metrics: (1) prompt guideline-directed medical therapy before sheath insertion for PCI, (2) use of transradial primary PCI, and (3) door-to-balloon time. We assessed the incremental association of metrics achieved with in-hospital adverse events and 30-day mortality. Of 1272 consecutive patients with STEMI treated with PCI at our hospital (January 1, 2011, to December 31, 2016), the percentage with achievement of zero, 1, 2, or 3 STEMI care metrics was 7.1%, 24.1%, 43.8%, and 25.1%; and 30-day mortality was 15.6%, 8.6%, 3.6%, and 3.2%, respectively (log-rank P P =0.041). Each metric provided incremental prognostic value when modeled in stepwise order of their occurrence in clinical practice (final model C statistic, 0.677; P Conclusions: Prompt guideline-directed medical therapy before sheath insertion for PCI, transradial primary PCI, and door-to-balloon time add incremental prognostic value in STEMI care. Expanding STEMI systems of care from a singular focus on door-to-balloon time to a comprehensive focus on multifaceted STEMI care offers an opportunity to further improve STEMI outcomes.

Objectives Determine the outcomes of polytetrafluoroethylene (PTFE) covered stents for coronary artery perforation (CAP) and coronary artery aneurysm (CAA). Background PTFE covered stents have been used for treatment of potentially life-threatening CAP and CAA. The short and long-term outcomes of the PTFE covered stent for CAP and CAA have not been well studied. Methods We performed a retrospective study of PTFE covered stents that were placed in the patients from 2003 to 2017. Short term outcomes included in-hospital mortality, pericardial effusion, cardiac tamponade, and length of stay. Long-term outcomes included target lesion revascularization (TLR), in-stent restenosis (ISR), and long-term mortality. Results Fifty-three PTFE covered stents were placed in 32 patients of which there were 24 patients with a CAP with a mean age of 75 ± 8 years. Two patients died in-hospital, with no additional deaths at 30 days. The rate of ISR was 25%, with estimated rates of TLR of 2.6% (3 years) and 17.8% (5 years). The median survival was 55.6 months, with survival at 10 years estimated to be 30.9%. Eight patients received a PTFE covered stent for CAA with a mean age of 59 ± 15 years with no in-hospital or 30-day mortality. Median follow-up of 49 months showed no evidence of TLR. The all-cause mortality was 12% at 1 year and 38% at 3 years. Conclusions PTFE covered stents is an effective option in patients with CAP and CAA. The long-term outcomes may be related to the pathology of the disease rather than the stent itself.

Purpose: Patients with recurrent high-grade gliomas (HGG) are usually managed with alkylating chemotherapy ± bevacizumab. However, prognosis remains very poor. Preclinically, we showed that HGGs are a target for arginine depletion with pegargiminase (ADI-PEG20) due to epimutations of argininosuccinate synthetase (ASS1) and/or argininosuccinate lyase (ASL). Moreover, ADI-PEG20 disrupts pyrimidine pools in ASS1-deficient HGGs, thereby impacting sensitivity to the antifolate, pemetrexed. Patients and Methods: We expanded a phase I trial of ADI-PEG20 with pemetrexed and cisplatin (ADIPEMCIS) to patients with ASS1-deficient recurrent HGGs (NCT02029690). Patients were enrolled (01/16–06/17) to receive weekly ADI-PEG20 36 mg/m2 intramuscularly plus pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 intravenously once every 3 weeks for up to 6 cycles. Patients with disease control were allowed ADI-PEG20 maintenance. The primary endpoints were safety, tolerability, and preliminary estimates of efficacy. Results: Ten ASS1-deficient heavily pretreated patients were treated with ADIPEMCIS therapy. Treatment was well tolerated with the majority of adverse events being Common Terminology Criteria for Adverse Events v4.03 grade 1-2. The best overall response was stable disease in 8 patients (80%). Plasma arginine was suppressed significantly below baseline with a reciprocal increase in citrulline during the sampling period. The anti–ADI-PEG20 antibody titer rose during the first 4 weeks of treatment before reaching a plateau. Median progression-free survival (PFS) was 5.2 months (95% confidence interval (CI), 2.5–20.8) and overall survival was 6.3 months (95% CI, 1.8–9.7). Conclusions: In this recurrent HGG study, ADIPEMCIS was well tolerated and compares favorably to historical controls. Additional trials of ADI-PEG20 in HGG are planned.

Objectives To determine procedural predictors of long-term outcomes for patients with radiation associated coronary artery disease (CAD) treated with percutaneous coronary intervention (PCI). Background Patients who develop CAD after external beam radiation therapy (XRT) for cancer are at high-risk for adverse events following PCI. It is unknown if specific angiographic features can predict outcomes in this population. Methods This is an observational study of 157 patients with malignancy who received XRT prior to PCI. Rates of major adverse cardiovascular and cerebrovascular events (MACCEs; all-cause mortality, myocardial infarction, repeat revascularization, or stroke) were compared across patient characteristics over time with the Cox proportional hazards and Kaplan-Meier's analyses. Results During follow-up of 5.4 ± 4.5 years, 91 (58%) patients had MACCE. On Kaplan-Meier's analysis of angiographic characteristics, MACCE was more frequent in patients with at least moderate target vessel calcification (P = 0.023), ostial stenosis (P = 0.049), target vessel diameter ≥ 3.0 mm (P = 0.018), a SYNTAX score ≥ the median of 11 (P = 0.014), or bare metal stenting (BMS)/balloon angioplasty (BA) compared to drug-eluting stenting (DES) (P = 0.006). Cardiac death was more frequent in patients with SYNTAX score ≥ 11 (P = 0.028) or BMS (P = 0.043). After multivariable adjustment for both angiographic and clinical characteristics, independent predictors of MACCE were BMS placement (P = 0.013), chronic kidney disease ≥ stage 3 (P = 0.019), New York Heart Association (NYHA) heart failure class ≥3 (P = 0.034), and SYNTAX score ≥ 11 (P = 0.041). Conclusions In patients previously exposed to XRT treated with PCI, independent angiographic predictors of MACCE include SYNTAX score ≥ 11 and BMS placement, suggestive that DES should be preferred in this population.

Item does not contain fulltext BACKGROUND: Change in albuminuria as a surrogate endpoint for progression of chronic kidney disease is strongly supported by biological plausibility, but empirical evidence to support its validity in epidemiological studies is lacking. We aimed to assess the consistency of the association between change in albuminuria and risk of end-stage kidney disease in a large individual participant-level meta-analysis of observational studies. METHODS: In this meta-analysis, we collected individual-level data from eligible cohorts in the Chronic Kidney Disease Prognosis Consortium (CKD-PC) with data on serum creatinine and change in albuminuria and more than 50 events on outcomes of interest. Cohort data were eligible if participants were aged 18 years or older, they had a repeated measure of albuminuria during an elapsed period of 8 months to 4 years, subsequent end-stage kidney disease or mortality follow-up data, and the cohort was active during this consortium phase. We extracted participant-level data and quantified percentage change in albuminuria, measured as change in urine albumin-to-creatinine ratio (ACR) or urine protein-to-creatinine ratio (PCR), during baseline periods of 1, 2, and 3 years. Our primary outcome of interest was development of end-stage kidney disease after a baseline period of 2 years. We defined an end-stage kidney disease event as initiation of kidney replacement therapy. We quantified associations of percentage change in albuminuria with subsequent end-stage kidney disease using Cox regression in each cohort, followed by random-effects meta-analysis. We further adjusted for regression dilution to account for imprecision in the estimation of albuminuria at the participant level. We did multiple subgroup analyses, and also repeated our analyses using participant-level data from 14 clinical trials, including nine clinical trials not in CKD-PC. FINDINGS: Between July, 2015, and June, 2018, we transferred and analysed data from 28 cohorts in the CKD-PC, which included 693 816 individuals (557 583 [80%] with diabetes). Data for 675 904 individuals and 7461 end-stage kidney disease events were available for our primary outcome analysis. Change in ACR was consistently associated with subsequent risk of end-stage kidney disease. The adjusted hazard ratio (HR) for end-stage kidney disease after a 30% decrease in ACR during a baseline period of 2 years was 0.83 (95% CI 0.74-0.94), decreasing to 0.78 (0.66-0.92) after further adjustment for regression dilution. Adjusted HRs were fairly consistent across cohorts and subgroups (ie, estimated glomerular filtration rate, diabetes, and sex), but the association was somewhat stronger among participants with higher baseline ACR than among those with lower baseline ACR (pinteraction

BackgroundCoronary artery aneurysms (CAAs) are increasingly diagnosed on coronary angiography; however, controversies persist regarding their optimal management. In the present study, we analysed the long-term outcomes of patients with CAAs following three different management strategies.MethodsWe performed a retrospective review of patient records with documented CAA diagnosis between 2000 and 2005. Patients were divided into three groups: medical management versus percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We analysed the rate of major cardiovascular and cerebrovascular events (MACCEs) over a period of 10 years.ResultsWe identified 458 patients with CAAs (mean age 78±10.5 years, 74.5% men) who received medical therapy (N=230) or underwent PCI (N=52) or CABG (N=176). The incidence of CAAs was 0.7% of the total catheterisation reports. The left anterior descending was the most common coronary artery involved (38%). The median follow-up time was 62 months. The total number of MACCE during follow-up was 155 (33.8%); 91 (39.6%) in the medical management group vs 46 (26.1%) in the CABG group vs 18 (34.6%) in the PCI group (p=0.02). Kaplan-Meier survival analysis showed that CABG was associated with better MACCE-free survival (p log-rank=0.03) than medical management. These results were confirmed on univariate Cox regression, but not multivariate regression (OR 0.773 (0.526 to 1.136); p=0.19). Both Kaplan-Meier survival and regression analyses showed that dual antiplatelet therapy (DAPT) and anticoagulation were not associated with significant improvement in MACCE rates.ConclusionOur analysis showed similar long-term MACCE risks in patients with CAA undergoing medical, percutaneous and surgical management. Further, DAPT and anticoagulation were not associated with significant benefits in terms of MACCE rates. These results should be interpreted with caution considering the small size and potential for selection bias and should be confirmed in large, randomised trials.

Background Few studies have explored percutaneous coronary intervention (PCI) in perioperative myocardial infarction (PMI), even though PMI is a major cause of mortality in patients undergoing urgent/emergent noncardiac surgery. Objectives This study sought to describe the angiographic characteristics and outcomes in patients presenting to the cardiac catheterization laboratory for myocardial infarction sustained after undergoing noncardiac surgery, with a detailed analysis of those undergoing PCI. Methods We included all patients presenting to the catheterization laboratory at our institution after PMI from 2003 to 2012, who had noncardiac surgery within the previous 7 days. Data from patients who underwent PCI were analyzed using both standard regression and time-to-event survival analysis. Results From 2003 to 2012, 1,093 patients with 3,832 person-years of follow-up underwent diagnostic coronary angiography, of whom 281 (40 ST-segment elevation myocardial infarction [STEMI] and 241 non-ST-segment elevation myocardial infarction [NSTEMI] cases) underwent PCI. Using Kaplan-Meier survival analysis, we found 30-day mortality was 5.2% and 1-year mortality was 15% in the overall population. In the PCI subpopulation, we estimated 30-day mortality to be 11.3%. The 30-day death rate in the STEMI cohort was 31.2% and 8.5% in the NSTEMI cohort of the PCI subpopulation. Stepwise logistic regression revealed the following factors as strong predictors of 30-day mortality after PCI: bleeding event after PCI (odds ratio [OR]: 4.33; 95% confidence limits (CL): 1.52 to 12.30), peak troponin T level (OR: 1.20; 95% CL: 1.08 to 1.34), and underlying peripheral vascular disease (OR: 4.86; 95% CL: 1.66 to 14.22). Cox proportional hazard analysis of survival data showed that increasing age (hazard ratio [HR]: 1.03; 95% CL: 1.01 to 1.04), bleeding after PCI (HR: 2.31; 95% CL: 1.61 to 3.32), renal insufficiency (HR: 2.26; 95% CL: 1.51 to 3.39]), and vascular surgery (HR: 1.48; 95% CL: 1.02 to 2.15]) were all significant predictors of long-term mortality after PCI. Conclusions Perioperative MI has a markedly high mortality rate, despite PCI. Bleeding event, peak troponin T level, and peripheral vascular disease predict mortality within 30 days of PCI in this patient population. Similarly, older age, vascular surgery, bleeding event, and renal dysfunction strongly predict long-term mortality after PCI in the setting of PMI.

Current guidelines emphasize timely coronary intervention with a door to balloon time of ≤90min for favorable survival impact after STEMI. Efforts to achieve these targets may result in unnecessary emergent angiography for inappropriate activations.Evaluate the frequency, trend and factors which are significantly associated with inappropriate for intervention cardiac catheterization laboratory (CCL) activation.We analyzed 1764 consecutive emergent CCL activation for possible ST segment elevation myocardial infarction (STEMI) between 7/2005 and 8/2013. Inappropriate for intervention activation was defined as negative STEMI (incorrect diagnosis: insignificant coronary lesion, not requiring any intervention) and inappropriate patients (true STEMI but poor CCL candidacy).Inappropriate for intervention CCL activation occurred in 317 patients (17.9%): 292 incorrect diagnosis (negative STEMI diagnosis), 25 inappropriate patients, with no difference in the frequency based on time of the day (18.6% regular hours vs. 17.6% off-hours, p=0.6). On multivariable analysis, female gender (OR 1.9 [1.2-3.0]), African American race (OR 1.9[1.3-2.7]), and prior coronary artery bypass graft surgery (OR 3.6 [2.3-5.5]) were significantly associated with incorrect diagnosis (negative STEMI diagnosis) (all p0.005) and hyperlipidemia (OR 0.2 [0.1-0.3]), tobacco use (OR 0.2 [0.1-0.3]), and stroke/TIA (OR 0.2 [0.1-0.4]) had a significant inverse association (all p0.001). ST Elevation with no reciprocal depression and pericarditis/myocarditis were the most common ECG finding and etiology respectively.Inappropriate for intervention CCL activation is not uncommon and should be closely monitored to maximize resource utilization. Females, African American patients with few or no risk factors and patients presenting ST elevation but no reciprocal depression constitute a population that may require attention.