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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).This study sought to assess clinical outcomes through 3 years following BVS implantation.Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years.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.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).

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.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.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.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 1.18:1; odds ratio: 7.5; p = 0.002) and larger RVD (linear p = 0.001;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 0.001). Post hoc analysis of 8 other potential covariates revealed no other correlates of outcome.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.

Background Obstructive sleep apnea ( OSA ) is an independent risk factor for many cardiovascular conditions such as coronary artery disease, myocardial infarction, systemic hypertension, pulmonary hypertension, and stroke. However, the association of OSA with outcomes in patients hospitalized for ST ‐elevation myocardial infarction remains controversial. Methods and Results We used the nation‐wide inpatient sample between 2003 and 2011 to identify patients with a primary discharge diagnosis of ST ‐elevation myocardial infarction and then used the International Classification of Diseases, Clinical Modification code 327.23 to identify a group of patients with OSA . The primary outcome of interest was in‐hospital mortality, and secondary outcomes were in‐hospital cardiac arrest, length of stay and hospital charges. Our cohort included 1 850 625 patients with ST ‐elevation myocardial infarction, of which 1.3% (24 623) had documented OSA . OSA patients were younger and more likely to be male, smokers, and have chronic pulmonary disease, depression, hypertension, known history of coronary artery disease, dyslipidemia, obesity, and renal failure ( P OSA had significantly decreased in‐hospital mortality (adjusted odds ratio, 0.78 [95% CI , 0.73–0.84]), longer hospital stay (5.00±4.68 versus 4.85±5.96 days), and incurred greater hospital charges ($79 460.12±70 621.91 versus $62 889.91±69 124.15). There was no difference in incidence of in‐hospital cardiac arrest (adjusted odds ratio, 0.93 [95% CI , 0.84–1.03]) between these 2 groups. Conclusion ST ‐elevation myocardial infarction patients with recognized OSA had significantly decreased mortality compared with patients without OSA . Although patients with OSA had longer hospital stays and incurred greater hospital charges, there was no difference in incidence of in‐hospital cardiac arrest.

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.

Rationale: The TIME trial (Timing in Myocardial Infarction Evaluation) was the first cell therapy trial sufficiently powered to determine if timing of cell delivery after ST-segment–elevation myocardial infarction affects recovery of left ventricular (LV) function. Objective: To report the 2-year clinical and cardiac magnetic resonance imaging results and their modification by microvascular obstruction. Methods and Results: TIME was a randomized, double-blind, placebo-controlled trial comparing 150 million bone marrow mononuclear cells versus placebo in 120 patients with anterior ST-segment–elevation myocardial infarctions resulting in LV dysfunction. Primary end points included changes in global (LV ejection fraction) and regional (infarct and border zone) function. Secondary end points included changes in LV volumes, infarct size, and major adverse cardiac events. Here, we analyzed the continued trajectory of these measures out to 2 years and the influence of microvascular obstruction present at baseline on these long-term outcomes. At 2 years (n=85), LV ejection fraction was similar in the bone marrow mononuclear cells (48.7%) and placebo groups (51.6%) with no difference in regional LV function. Infarct size and LV mass decreased ≥30% in each group at 6 months and declined gradually to 2 years. LV volumes increased ≈10% at 6 months and remained stable to 2 years. Microvascular obstruction was present in 48 patients at baseline and was associated with significantly larger infarct size (56.5 versus 36.2 g), greater adverse LV remodeling, and marked reduction in LV ejection fraction recovery (0.2% versus 6.2%). Conclusions: In one of the longest serial cardiac magnetic resonance imaging analyses of patients with large anterior ST-segment–elevation myocardial infarctions, bone marrow mononuclear cells administration did not improve recovery of LV function over 2 years. Microvascular obstruction was associated with reduced recovery of LV function, greater adverse LV remodeling, and more device implantations. The use of cardiac magnetic resonance imaging leads to greater dropout of patients over time because of device implantation in patients with more severe LV dysfunction resulting in overestimation of clinical stability of the cohort. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT00684021.

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.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.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.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; pThe 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.

Background: Since 2006 the Center for Medicare and Medicaid Services has allowed hospitals to exclude public reporting of door to balloon (D2B) time data for STEMI patients with cardiopulmonary arrest (CPA) within 90 minutes after hospital arrival, a high risk group with 30% in-hospital mortality. In July 2014, we implemented a high reliability STEMI process with rapid reperfusion goals for all STEMI patients treated with primary PCI at our center with no patient exclusions (figure). We studied D2B times for patients with and without in-hospital CPA before and after implementation of our high reliability STEMI process to clarify whether exclusion from public reporting on the basis of CPA is justified. Methods: We compared consecutive cases of STEMI treated with primary PCI at our center before (January 2013 to July 15 th , 2014) and after (July 16 th , 2014 to October 2016) implementation of a high reliability STEMI process, and we assessed D2B times in patients with and without in-hospital CPA prior to primary PCI. The primary endpoint was the % of patients treated within guideline D2B times ( < 90 minutes for ED presenting patients or < 120 minutes for inter-hospital transfer patients). Results: Over the study period 795 cases of STEMI were treated with primary PCI at our center. The control group constituted 37.4% (297/795) of patients who were treated prior to July 15 th , 2014, and the high reliability group constituted 62.6% (498/795) of patients treated after July 15 th , 2014. Patients presenting to our primary ED were 27.3% (217/795), inter-hospital transfer patients were 69.1% (549/795), and in-hospital STEMI patients were 3.6% (29/795). CPA within 90 minutes of hospital arrival occurred in 6.3% (50/795) of patients overall, and CPA was more prevalent in the control group vs the high reliability group (8.8% [26/297] vs 4.8% [24/498], P=0.027). In the control group patients with CPA were less likely to achieve goal D2B times compared to patients without CPA (30.8% [8/26] vs 60.5% [164/271], P=0.003), whereas in the high reliability group there was no difference in the rate of achievement of goal D2B times in patients with vs without CPA (75.0% [18/24] vs 81.6% [387/474], P=0.418). Conclusion: High reliability STEMI processes can improve delivery of care for the most vulnerable and highest risk patients.

Item does not contain fulltext OBJECTIVES: The authors sought to identify and verify independent correlates of device thrombosis from an analysis of multicenter trials and registries. BACKGROUND: Recent analyses suggest an increased risk of device thrombosis with Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) implantation compared with metallic drug-eluting stents, and data from moderate size studies suggest a risk relationship to vessel size and technique. METHODS: From 8,771 consecutively treated patients, 105 patients (1.2%) were identified with scaffold thrombosis within 1 year of implantation. They were matched 2:1 with controls selected randomly from nonthrombosis patients. Data-restricted multiple logistic analysis was used to identify significant independent covariates of the outcome. RESULTS: Early (within 1 month) scaffold thrombosis occurred in 69 patients and late (1 to 12 months) thrombosis occurred in 36 patients. Modelling found significant correlations of thrombosis to be final minimal lumen diameter 1.1:1 balloon/scaffold ratio (OR: 2.3; p = 0.022), and reference vessel diameter

Background— In patients with possible acute coronary syndromes, guidelines recommend routine provocative testing after negative cardiac biomarkers. We hypothesized that myocardial perfusion imaging would be low yield with limited short-term value and that early revascularization would not affect mortality. Methods and Results— We identified consecutive patients referred from our emergency department between October 2004 and September 2011 who had myocardial perfusion imaging after negative troponin T tests and nondiagnostic ECGs. We assessed the incidence of abnormal myocardial perfusion imaging, coronary angiography, revascularization, and mortality. In a cohort of 5354 patients (58.7% female, age 59±13, 78.6% thrombolysis in myocardial infarction [TIMI] ≤2), 9% had >5% and 3.6% had >10% ischemic myocardium. Among patients with TIMI scores ≤2, 6.1% had >5% ischemic myocardium compared with 19.6% of patients with TIMI scores ≥3 ( P Conclusions— Routine provocative testing to detect ischemia before emergency department discharge is low yield in patients with negative troponins and TIMI scores ≤2 and modest yield in patients with TIMI scores ≥3. In all patients, 30 days events are rare. Finally, in patients with ischemia, we are unable to demonstrate a mortality benefit with early revascularization.

Background— Diabetes mellitus adversely affects outcomes in patients undergoing percutaneous coronary intervention. The association of baseline hemoglobin A1c (HbA1c) at the time of percutaneous coronary intervention with long-term mortality is unknown. Methods and Results— Consecutive patients with diabetes mellitus undergoing percutaneous coronary intervention between 1998 and 2008 were identified from our institutional database. Characteristics and outcomes of patients were compared based on HbA1c categories (≤7%, 7.1%–8.0%, 8.1%–9.0%, 9.1%–10.0%, and >10.0%). Among 3008 patients, 1321 had HbA1c ≤7%, 782 with HbA1c 7.1% to 8.0%, 401 with HbA1c 8.1% to 9.0%, 229 with HbA1c 9.1% to 10.0%, and 275 with HbA1c >10%. Compared with low HbA1c (≤7%), those with highest HbA1c (>10%) were younger (56.5 versus 67.5 years), had higher total cholesterol (188 versus 157 mg/dL), more insulin use (54% versus 26%), and presented more often with ST-segment–elevation myocardial infarction (10.9% versus 5.6%). Those with lower HbA1c (≤7%) more often had other comorbidities (more hypertension [90.4% versus 82.5%] and chronic renal failure [14.4% versus 7.6%]). On multivariable Cox proportional hazards modeling, survival analysis demonstrated a trend toward higher mortality with higher HbA1c. Compared with the reference group of patients with HbA1c ≤7%, patients with HbA1c >10% had a significantly higher mortality on follow-up (hazard ratio [95% confidence interval], 1.52 [1.17–1.99]; P =0.002). This difference was primarily seen among noninsulin users; however, insulin users had no significant differences in mortality among HbA1c categories. Conclusions— Patients with diabetes mellitus who were not on insulin and had poor glycemic control (HbA1c >10%) had significantly higher long-term mortality after percutaneous coronary intervention as compared with those with well-controlled diabetes mellitus, evidenced by HbA1c ≤7%. Insulin users, however, had similar rates of mortality among different HbA1c categories.

Objectives The study undertook a systematic review to establish and compare the risk of stroke between the 2 widely used approaches (transfemoral [TF] vs. transapical [TA]) and valve designs (CoreValve, Medtronic, Minneapolis, Minnesota vs. Edwards Valve, Edwards Lifesciences, Irvine, California) for transcatheter aortic valve replacement (TAVR). Background There has been a rapid adoption and expansion in the use of TAVR. The technique is however far from perfect and requires further refinement to alleviate safety concerns that include stroke. Methods All studies reporting on the risk of stroke after TAVR were identified using an electronic search and pooled using established meta-analytical guidelines. Results 25 multicenter registries and 33 single-center studies were included in the analysis. There was no difference in pooled 30-day stroke post-TAVR between the TF and TA approach in multicenter (2.8% [95% confidence interval (CI): 2.4 to 3.4] vs. 2.8% [95% CI: 2.0 to 3.9]) and single-center studies (3.8% [95% CI: 3.1 to 4.6] vs. 3.4% [95% CI: 2.5 to 4.5]). Similarly, there was no difference in pooled 30-day stroke post TAVR between the CoreValve and Edwards Valve in multicenter (2.4% [95% CI: 1.9 to 3.2] vs. 3.0% [95% CI: 2.4 to 3.7]) and single-center studies (3.8% [95% CI: 2.8 to 4.9] vs. 3.2% [95% CI: 2.4 to 4.3]). There was a decline in stroke risk with experience and technological advancement. There was no difference in the outcome of 30-day stroke between TAVR and surgical aortic valve replacement. Conclusions Our findings suggest that the risk of 30-day stroke after TAVR is similar between the approaches and valve types. There has been a decline in stroke risk after TAVR with improvements in valve technology, patient selection, and operator experience.

Necropsy studies have outlined the morphological characteristics of high-risk, or “vulnerable,” coronary plaque segments, demonstrating the presence of inflammatory infiltrate and various compositional elements in patients who succumbed to fatal intracoronary thrombosis. However, accumulating evidence in vivo relates the overall burden of atherosclerosis, its rate of progression, and its subsequent ischemic potential with the risk for incident clinical events. These observations, coupled with the efficacy of contemporary medical therapies in reducing clinical event rates, have important implications for trial design of future human in vivo evaluations of vulnerable coronary plaque.

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In the ABSORB randomized trials, XIENCE cobalt-chromium everolimus-eluting stents (EES) resulted in lower rates of target lesion failure (TLF) and device thrombosis through 3 years compared with Absorb BVS. For BVS implantation, data has supported improved outcomes with PSP technique (e.g. pre

The ABSORB III trial demonstrated that following implantation of coronary bioresorbable vascular scaffolds (BVS), an excess of adverse events continued to accrue through 3 years of implantation (the time of their complete bioresorption), compared with metallic everolimus-eluting stents (EES).

The pivotal ABSORB III and Japan trials randomized patients with noncomplex coronary artery disease to Absorb bioresorbable vascular scaffolds (BVS) versus cobalt-chromium Xience everolimus-eluting stents (EES) (both Abbott Vascular, Santa Clara, California). Formal intravascular ultrasound (IVUS)

Acute kidney injury (AKI) following percutaneous coronary intervention (PCI) is associated with significant morbidity and mortality. Several prediction models have been proposed with variable predictive strength, such as the National Cardiovascular Data Registry (NCDR) model, with a C statistic of

The Absorb everolimus-eluting PLLA-based bioresorbable vascular scaffold (BVS) provides 1-year drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in ∼3 years with recovery of vascular structure and function. The large

9097 Background: Pegylated arginine deiminase (ADI-PEG20) targets ASS1-ve tumors, including non–small-cell lung cancer (NSCLC), by potentiating pemetrexed cytotoxicity via arginine depletion. In Beddowes et al (JCO 2017) we showed a 100% disease control rate in thoracic cancers treated with ADI-PEG20, cisplatin and pemetrexed (ADIPemCis). Thus, we tested ADIPemCis in a phase I dose-expansion cohort study of patients (pts) with non-squamous NSCLC. Methods: Good performance (ECOG 0-1) advanced non-squamous NSCLC pts were enrolled at the maximum tolerated dose (MTD) of ADIPemCis, using tumoral ASS1 loss as a selection biomarker. Pem (500mg/m2) and Cis (75mg/m2) were given every 3 weeks with weekly IM ADI-PEG20 (36mg/m2) for up to 4 cycles with maintenance ADI-PEG20 or Pem in responding pts. Primary endpoint was tumor response rate (RR by RECIST 1.1), with secondary endpoints including progression-free survival (PFS), overall survival (OS), and toxicity. We also measured plasma [arginine] and [citrulline], anti-ADI-PEG20 antibodies, and PD-L1 expression. Results: 21 of 70 screened pts (median age 60.1) were enrolled between April 15 and August 17. A confirmed partial response (PR) was observed in 55.6 % (n = 10/18 evaluable pts). Median PFS and OS were 4 months (95% CI 2.9-4.8) and 7.2 months (95% CI 5.1-18.4), respectively. 9% (n = 2/21) remain alive on subsequent therapies. 43% (n = 9/21) experienced grade 3/4 treatment-related toxicities, commonly non-febrile neutropenia. Plasma [arginine] declined rapidly and [citrulline] increased; both changes persisted at 16 weeks. 55% of pts’ tumors (n = 6/11 ) were PD-L1 < 1% by immunohistochemistry. Conclusions: The ADIPemCis regimen is active and safe in ASS1-ve NSCLC pts almost doubling the expected RR. However, the short survival compared with ASS1-agnostic historical controls indicates that ASS1 (and frequent PD-L1) loss selects for a biologically more aggressive and immunorefractory NSCLC phenotype. The iTRAP study opening Q2 of 2019 will assess the safety and tolerability of ADIPemPlatinum(Carbo) with atezolizumab in pts with ASS1-deficient non-squamous NSCLC. Clinical trial information: NCT02029690.

Patients of different racial or ethnic backgrounds may face different socioeconomic or cultural issues, or have genetic differences that impact long-term outcomes after PCI. To date there are very limited data beyond 1-2 years to inform discussions about this issue and perhaps improve outcomes.

Patients admitted with acute myocardial infarction (AMI) have a high risk of readmission within 90 days of discharge, often with another AMI. The readmission risk for AMI over time has not been previously described. We analyzed all hospital admissions for a primary diagnosis of AMI at a single

In patients hospitalized for acute myocardial infarction (AMI), use of evidence-based medicines after discharge is important. The impact of treatment strategy (percutaneous coronary intervention (PCI) vs. medical management) on prescription of specific classes of medication has not been well

Patients admitted with acute myocardial infarction (AMI) have a high risk of readmission within 90 days of discharge, many for another AMI. The factors that influence a patient's risk for 90-day readmission with recurrent AMI are not known. We analyzed all hospital admissions for a primary

Large scale outcomes data in patients with Takotsubo cardiomyopathy (TC) are not available. We sought to assess characteristics and longer-term outcomes of patients presenting with documented TC at a tertiary center. We studied 631 patients (66±14 years, 88% women) who presented to our center

Despite modern advances in care, mortality among patients with STEMI and cardiogenic shock (CS) is increasing. It is unknown whether a comprehensive STEMI protocol (CSP) can improve mortality in these patients. On 7/15/14, we implemented a CSP which included (1) Emergency Department cath lab

The Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) is designed to reduce chronic adverse cardiovascular events that may occur from the permanent presence of a metallic stent and/or durable polymer. The systemic pharmacokinetic (PK) profile of BVS has not been

In this issue of JACC: Cardiovascular Interventions , Lee et al. [(1)][1] present the results of a Bayesian network meta-analysis (NMA) to assess the relative efficacy of drug-eluting stents (DES), drug-eluting balloons (DEB), and plain old balloon angioplasty (POBA) used to treat in-stent

Objectives: The goal of this study was to provide a systematic review comparing the long-term outcomes of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus coronary art...

Introduction The safety and effectiveness of drug-eluting stent (DES) compared with bare metal stents (BMS) for the treatment of saphenous vein graft (SVG) disease is controversial, especially because of the lack of long-term follow-up. The aim of this study was to address the late outcome of DES versus BMS for the treatment of SVG lesions. Methods A matched, case-control study included 82 patients in each group. Patients groups were matched by gender, age, clinical presentation, and diabetes. The primary study end point was occurrence of major adverse cardiovascular events (MACE). Secondary end points included death, cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). Results Clinical and angiographic characteristics were similar between the groups. At 6 months, TVR (hazard ratio [HR] 6.12, 95% confidence interval [CI] 1.39 to 26.93, P = 0.05), and MACE (HR 2.54, 95% CI 1.08 to 5.98, P = 0.04) were higher in the BMS group. At 4 years the risks of MI (P = 0.21), TVR (P = 0.99), and MACE (P = 0.21) were similar between both groups. However, the rates of death (HR 2.74, 95% CI 1.11 to 6.74, P = 0.04) and cardiac death (HR 4.26, 95% CI 1.59 to 11.35, P = 0.01) were significantly higher in the BMS group. Conclusions These results suggest that the use of DES compared with BMS in the treatment of SVG lesions reduces TVR and MACE at 6 months of follow-up, a benefit that was lost over the next 3–4 years. © 2012 Wiley Periodicals, Inc.

Management of coronary artery disease (CAD) in patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR) is posing challenges. Due to limited and heterogeneous data on the prevalence and clinical impact of CAD on the outcomes of TAVR and the management strategies for CAD in patients undergoing TAVR, we performed a comprehensive review of the literature. Significant CAD is present in 40% to 75% of patients undergoing TAVR. The impact of CAD on outcomes after TAVR remains understudied. Based on existing data, not all patients require revascularization before TAVR. Percutaneous coronary intervention (PCI) should be considered for severely stenotic lesions in proximal coronaries that subtend a large area of myocardium at risk. Ongoing studies randomizing patients to surgical or percutaneous management strategies for severe AS will help provide valuable data regarding the impact of CAD on TAVR outcomes, the role of PCI, and its timing in relation to TAVR.

ObjectivesThis study sought to ascertain causes of death and the incidence of percutaneous coronary intervention (PCI)-related mortality within 30 days.BackgroundPublic reporting of 30-day mortality after PCI without clearly identifying the cause may result in operator risk avoidance and affect hospital reputation and reimbursements. Death certificates, utilized by previous reports, have poor correlation with actual cause of death and may be inadequate for public reporting.MethodsAll patients who died within 30 days of a PCI from January 2009 to April 2011 at a tertiary care center were included. Causes of death were identified through detailed chart review using Academic Research Consortium consensus guidelines and compared with reported death certificates. The causes of death were divided into cardiac and noncardiac and PCI and non–PCI-related categories.ResultsOf the 4,078 PCI, 81 deaths (2%) occurred within 30 days. Of these, 58% died of cardiac and 42% of noncardiac causes. However, only 42% of 30-day deaths were attributed to PCI-related complications. Patients with non–PCI-related, compared with PCI-related, death presented with a higher incidence of cardiogenic shock (15 of 47 [32%] vs. 2 of 34 [6%]; p < 0.01) and cardiac arrest (19 of 47 [40%] vs. 1 of 34 [3%]; p < 0.01). Death certificates had only 58% accuracy (95% confidence interval: 45% to 72%) for classifying patients as experiencing cardiac versus noncardiac death.ConclusionsLess than one-half of 30-day deaths are attributed to a PCI-related complication. Death certificates are inaccurate and do not report PCI-related deaths, which may represent a better marker of PCI quality.

Background— Implantation of implantable cardioverter defibrillator for prevention of sudden cardiac death is deferred for 90 days after coronary revascularization, but mortality may be highest early after cardiac procedures in patients with ventricular dysfunction. We determined mortality risk in postrevascularization patients with left ventricular ejection fraction ≤35% and compared survival with those discharged with a wearable cardioverter defibrillator (WCD). Methods and Results— Hospital survivors after surgical (coronary artery bypass graft surgery) or percutaneous (percutaneous coronary intervention [PCI]) revascularization with left ventricular ejection fraction ≤35% were included from Cleveland Clinic and national WCD registries. Kaplan–Meier, Cox proportional hazards, propensity score-matched survival, and hazard function analyses were performed. Early mortality hazard was higher among 4149 patients discharged without a defibrillator compared with 809 with WCDs (90-day mortality post–coronary artery bypass graft surgery 7% versus 3%, P =0.03; post-PCI 10% versus 2%, P P P =0.048) and post-PCI (57%, P P =0.002; 67% post-PCI, P Conclusions— Patients with left ventricular ejection fraction ≤35% have higher early compared to late mortality after coronary revascularization, particularly after PCI. As early hazard seemed less marked in WCD users, prospective studies in this high-risk population are indicated to confirm whether WCD use as a bridge to left ventricular ejection fraction improvement or implantable cardioverter defibrillator implantation can improve outcomes after coronary revascularization.

Twenty percent of patients who experience a myocardial infarction (MI) will be readmitted within 30 days of discharge [(1,2)][1]. Previous studies have suggested that the timing of readmission after MI by cause is relatively uniform [(2)][2]. Because hospital reimbursement and payment structures

Coronary artery disease (CAD) is the leading cause of mortality around the world. We sought to study changes in the risk profile of patients presenting with ST elevation myocardial infarction (STEMI).We retrospectively studied all patients presenting with STEMI to our center between 1995 and 2014. Patients were divided into four quartiles, 5years each. Baseline risk factors and comorbidities were recorded. Sub-analysis was done for patients with established CAD and their household incomes.A total of 3913 patients (67.9% males) were included; 42.5% presented with anterior STEMI and 57.5% inferior STEMI. Ages were 64±12, 62±13, 61±13 and 60±13 in the four quartiles respectively. Obesity prevalence was 31, 37, 38 and 40% and diabetes mellitus prevalence was 24, 25, 24 and 31%, while hypertension was 55, 67, 70 and 77%, respectively, p0.01 for all. Smoking prevalence was 28, 32, 42 and 46, p0.01. When subgroup analysis was done for patients with history of CAD, prevalence of smoking, obesity, diabetes and hypertension significantly increased across the four quartiles. When patients were divided to four groups based on household income (poor, low middle, middle and high income), prevalence of diabetes, hypertension, smoking and obesity were significantly higher in patients with low income.Despite better understanding of cardiovascular risk factors and more focus on preventive cardiology, patients presenting with STEMI over the past 20years are getting younger and more obese, with more prevalence of smoking, hypertension, and diabetes mellitus. This trend is greater in the lower income population.

The introduction of stents has drastically reduced target-lesion restenosis rates associated with percutaneous coronary angioplasty. Bare-metal stents were the first introduced, followed by drug-eluting stents, both of which had significant impacts on the complication rates. Stents, however, have resulted in the emergence of stent thrombosis and stent restenosis, which can cause life-threatening cardiac complications. Three new technological approaches are being investigated to overcome these complications: stents coated with bioresorbable polymers, stents without polymers, and completely bioresorbable stents. Initial results are encouraging, but more data are needed to ascertain their implications for clinical practice.

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.CTO percutaneous coronary intervention success rates vary widely and have improved with the "hybrid approach," but current predictive models for success have major limitations.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.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 length10 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 0.05) to that of the J-CTO (Multicenter CTO Registry of Japan) (0.55) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (0.61) scores.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.

Little literature exists on the risk of performing coronary intervention (PCI) on patients who have had recent gastrointestinal bleeding (GIB), although bleeding after PCI has been identified as a risk factor for long-term mortality.Patients within the Cleveland Clinic PCI database who had acute GIB within 30 days preceding PCI during the same hospitalization (n = 79) were retrospectively compared to those who had PCI without recent GIB (n = 10 979) for mortality and need for revascularization. Baseline characteristics, laboratory values, procedures, morbidities, and mortality were compared using chi-square test for categorical variables and using Wilcoxon rank sum test for continuous variables. Mortality data was obtained using Social Security Death Index and demonstrated using Kaplan-Meier method.The GIB group had more prevalent history of peptic ulcer disease, GIB, gastrointestinal or liver disease (P0.0001), transient ischemic accident (P = 0.017), peripheral vascular disease (P = 0.0002), significant carotid artery occlusion (P = 0.023), and myocardial infarction (P0.0001). 47% of patients had upper GIB with 20% needing endoscopic intervention. This group had more anemia (P0.0001), heart failure (P = 0.0001), cardiogenic shock (10% versus 1.4%, P0.001), cardiac arrest (7.6% versus 1%, P0.001). GIB group had worse in-hospital mortality (P0.0001), long-term mortality (P0.001), and a 7.6% re-bleeding incidence.Overall, the patients who had GIB preceding PCI had higher in-hospital mortality and long-term mortality compared with those without GIB before PCI.

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.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.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).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.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).

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.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.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%.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.The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.

Background— The incidence and predictors of long-term mortality after percutaneous coronary intervention (PCI) for radiation-associated coronary artery disease are unknown. Methods and Results— In this observational study of 314 patients (age, 65.2±11.4 years; 233 [74%] women) treated with PCI, 157 patients with previous external beam radiation therapy (XRT) were matched 1:1 with 157 comparison patients with atherosclerotic coronary artery disease without previous XRT, based on age, sex, lesion artery, and PCI type. The primary end point was all-cause mortality, and the secondary end point was cardiovascular mortality. After follow-up of 6.6±5.5 years, there were 101 deaths; 59 in the XRT group and 42 in the comparison group ( P =0.04). On Cox proportional hazards multivariable survival analysis, previous XRT remained an independent predictor of all-cause mortality (hazard ratio [HR] 1.85; 95% confidence interval [CI], 1.21–2.85; P =0.004) and cardiovascular mortality (HR, 1.70; 95% CI, 1.06–2.89; P =0.03). Additional independent predictors of increased all-cause mortality included balloon angioplasty or bare-metal stent placement compared with drug-eluting stent placement (HR, 2.50; 95% CI, 1.61–3.97; P P P =0.012), history of smoking (HR, 1.88; 95% CI, 1.10–3.09; P =0.022), and age ≥65 years (HR, 1.70; 95% CI, 1.07–2.07; P =0.024). Conclusions— Compared with patients with typical atherosclerotic coronary artery disease, patients with radiation-associated coronary artery disease are at higher risk for mortality after PCI. Previous XRT exposure is independently associated with increased all-cause and cardiovascular mortality in patients treated with PCI.

Summary Background Compared with metallic drug-eluting stents, bioresorbable vascular scaffolds (BVS) offer the potential to improve long-term outcomes of percutaneous coronary intervention. Whether or not these devices are as safe and effective as drug-eluting stents within the first year after implantation is unknown. Methods We did a patient-level, pooled meta-analysis of four randomised trials in which 3389 patients with stable coronary artery disease or a stabilised acute coronary syndrome were enrolled at 301 academic and medical centres in North America, Europe, and the Asia-Pacific region. These patients were randomly assigned to the everolimus-eluting Absorb BVS (n=2164) or the Xience cobalt-chromium everolimus-eluting stent (CoCr-EES; n=1225). The primary endpoints were the 1-year relative rates of the patient-oriented composite endpoint (all-cause mortality, all myocardial infarction, or all revascularisation) and the device-oriented composite endpoint of target lesion failure (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation). All analyses were by intention to treat. The four randomised trials included in our meta-analysis are all registered with ClinicalTrials.gov, numbers NCT01751906, NCT01844284, NCT01923740, and NCT01425281. Findings The summary treatment effect for the 1-year relative rates of the patient-oriented composite endpoint did not differ significantly different between BVS and CoCr-EES (relative risk [RR] 1·09 [0·89–1·34], p=0·38). Similarly, the 1-year relative rates of the device-oriented composite endpoint did not differ between the groups (RR 1·22 [95% CI 0·91–1·64], p=0·17). Target vessel-related myocardial infarction was increased with BVS compared with CoCr-EES (RR 1·45 [95% CI 1·02–2·07], p=0·04), due in part to non-significant increases in peri-procedural myocardial infarction and device thrombosis with BVS (RR 2·09 [0·92–4·75], p=0·08). The relative rates of all-cause and cardiac mortality, all myocardial infarction, ischaemia-driven target lesion revascularisation, and all revascularisation did not differ between BVS and CoCr-EES. Results were similar after multivariable adjustment for baseline imbalances, and were consistent across most subgroups and in sensitivity analysis when two additional randomised trials with less than 1 year of follow-up were included. Interpretation In this meta-analysis, BVS did not lead to different rates of composite patient-oriented and device-oriented adverse events at 1-year follow-up compared with CoCr-EES. Funding Abbott Vascular.

Background— The aim of this analysis was to determine the long-term prognostic value of lower serum chloride in patients with stable chronic heart failure. Electrolyte abnormalities are prevalent in patients with chronic heart failure. Little is known regarding the prognostic implications of lower serum chloride. Methods and Results— Serum chloride was measured in 1673 consecutively consented stable patients with a history of heart failure undergoing elective diagnostic coronary angiography. All patients were followed for 5-year all-cause mortality, and survival models were adjusted for variables that confounded the chloride–risk relationship. The average chloride level was 102±4 mEq/L. Over 6772 person-years of follow-up, there were 547 deaths. Lower chloride (per standard deviation decrease) was associated with a higher adjusted risk of mortality (hazard ratio 1.29, 95% confidence interval 1.12–1.49; P P =0.03) when added to a multivariable model (with a resultant C-statistic of 0.70), in which sodium levels were not prognostic ( P =0.30). In comparison to those with above first quartile chloride (≥101 mEq/L) and sodium (≥138 meq/L), subjects with first quartile chloride had a higher adjusted mortality risk, whether they had first quartile sodium (hazard ratio 1.35, 95% confidence interval 1.08–1.69; P =0.008) or higher (hazard ratio 1.43, 95% confidence interval 1.12–1.85; P =0.005). However, subjects with first quartile sodium but above first quartile chloride had no association with mortality ( P =0.67). Conclusions— Lower serum chloride levels are independently and incrementally associated with increased mortality risk in patients with chronic heart failure. A better understanding of the biological role of serum chloride is warranted.

Antithrombotic management of patients with atrial fibrillation (AF) undergoing coronary stenting is complicated by the need for anticoagulant therapy for stroke prevention and dual antiplatelet therapy for prevention of stent thrombosis and coronary events. Triple antithrombotic therapy, typically comprising warfarin, aspirin, and clopidogrel, is associated with a high risk of bleeding. A modest-sized trial of oral anticoagulation with warfarin and clopidogrel without aspirin showed improvements in both bleeding and thrombotic events compared with triple therapy, but large trials are lacking. The RE-DUAL PCI trial (NCT 02164864) is a phase 3b, a strategy of prospective, randomized, open-label, blinded-endpoint trial. The main objective is to evaluate dual antithrombotic therapy with dabigatran etexilate (110 or 150 mg twice daily) and a P2Y12 inhibtor (either clopidogrel or ticagrelor) compared with triple antithrombotic therapy with warfarin, a P2Y12 inhibtor (either clopidogrel or ticagrelor, and low-dose aspirin (for 1 or 3 months, depending on stent type) in nonvalvular AF patients who have undergone percutaneous coronary intervention with stenting. The primary endpoint is time to first International Society of Thrombosis and Hemostasis major bleeding event or clinically relevant nonmajor bleeding event. Secondary endpoints are the composite of all cause death or thrombotic events (myocardial infarction, or stroke/systemic embolism) and unplanned revascularization; death or thrombotic events; individual outcome events; death, myocardial infarction, or stroke; and unplanned revascularization. A hierarchical procedure for multiple testing will be used. The plan is to randomize similar to 2500 patients at approximately 550 centers worldwide to try to identify new treatment strategies for this patient population.

Objectives: To investigate the characteristics and one-year outcomes following sirolimus-eluting CYPHER Select Plus stent (SES) implantation in small (SmVD) and non-small vessel disease (NSmVD) in the international e-SELECT registry. Background: Large-scale registry data are lacking on DES outcomes in SmVD treatment. Methods: There were 4,700 SmVD (at least one vessel with estimated reference vessel diameter [RVD] < 2.5 mm, excluding 283 patients with unknown RVD vessels) and 10,139 NSmVD only patients. Results: The SmVD population was older, with more women, diabetics, and vessels treated, higher mean Charlson Comorbidity Index score (CCI), shorter lesions, and less STEMI presentation. The 1-year stent thrombosis (ST) rate (primary end-point), was significantly higher (1.3% vs. 0.7%) in SmVD versus NSmVD, mainly driven by early events. One-year major adverse cardiac event (MACE), myocardial infarction (MI), and clinically indicated target-lesion revascularization (TLR) rates were significantly higher in SmVD although death and major bleeding rates were similar in both groups. Complication rates were similar between pure (3,188 patients; only RVD < 2.5 mm) and mixed (1,795 patients; some RVD < 2.5 mm or unknown RVD) SmVD. Multivariate predictors for 1-year MACE in SmVD included saphenous vein graft or bifurcation lesions, major bleeding, any antiplatelet therapy discontinuation within 1 month, age, number of stents implanted, CCI, acute coronary syndrome, and insulin-dependent diabetes mellitus. Conclusion: SES implantation for SmVD occurs more frequently in women, diabetics, and those with multivessel disease and comorbidities. One-year ST, MACE, MI, and clinically indicated TLR rates are higher, although low overall, in SmVD or mixed SmVD patients while death rates are similar to NSmVD. (J Interven Cardiol 2012;**:1–10)

Objectives To assess the influence of race on long-term outcomes following percutaneous coronary intervention (PCI) with paclitaxel-eluting stents (PES). Background Data on the influence of race on long-term outcomes following PCI with drug-eluting stents are limited because of severe underrepresentation of minority populations in randomized trials. Methods We compared 5-year outcomes of 2,301 Whites, 127 Blacks, and 169 Asians treated with PES in the TAXUS IV, V, and ATLAS trials. Outcomes were adjusted using a propensity score logistic regression model with 1:4 matching. Results Blacks were more likely than Whites to be female, have a history of hypertension, diabetes mellitus, congestive heart failure, and stroke, but were less likely to have prior coronary artery disease. Compared with Whites, Asians were younger, more likely to be male, have stable angina, and left anterior descending disease, and less likely to have silent ischemia, previous coronary artery bypass surgery, prior coronary artery disease, diabetes mellitus, peripheral vascular disease, and to receive glycoprotein IIb/IIIa inhibitors. Despite higher antiplatelet compliance, the adjusted 5-year rates of myocardial infarction (15.4% vs. 5.4%, P < 0.001) and stent thrombosis (5.6% vs. 1.1%, P = 0.002) were higher in Blacks than Whites. Despite lower antiplatelet compliance, Asians had no differences in myocardial infarction and stent thrombosis compared with Whites. Mortality and revascularization rates were similar between the three groups. Conclusions The long-term risk of major thrombotic events after PCI with PES was higher in Blacks, but not Asians, compared with Whites. The mechanisms underlying these racial differences warrant further investigation. (J Interven Cardiol 2013;26:49–57)