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Background: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impella-supported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI)., Methods: Patients enrolled in the PROTECT III study were analyzed according to their baseline estimated glomerular filtration rate (eGFR). The primary outcome was 90-day major adverse cardiovascular and cerebrovascular events (the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization)., Results: Of 1237 enrolled patients, 1052 patients with complete eGFR baseline assessment were evaluated: 586 with eGFR ≥60 mL/min per 1.73 m 2 , 190 with eGFR ≥45 to <60, 105 with eGFR ≥30 to <45, and 171 with eGFR <30 or on dialysis. Patients with lower eGFR (all groups with eGFR <60) were more frequently females and had a higher prevalence of hypertension, diabetes, anemia, and peripheral artery disease. The baseline Synergy Between PCI With Taxus and Cardiac Surgery score was similar between groups (28.2±12.6 for all groups). Patients with lower eGFR were more likely to have severe coronary calcifications and higher usage of atherectomy. There were no differences in individual PCI-related coronary complications between groups, but the rates of overall PCI complications were less frequent among patients with lower eGFR. Major adverse cardiovascular and cerebrovascular events at 90 days and 1-year mortality were significantly higher among patients with eGFR <30 mL/min per 1.73 m 2 or on dialysis., Conclusions: Patients with advanced CKD undergoing Impella-assisted high-risk PCI tend to have higher baseline comorbidities, severe coronary calcification, and higher atherectomy usage, yet CKD was not associated with a higher rate of immediate PCI-related complications. However, 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality were significantly higher among patients with eGFR<30 mL/min per 1.73 m 2 or on dialysis. Future studies of strategies to improve intermediate and long-term outcomes of these high-risk patients are warranted., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392., Competing Interests: Dr Bharadwaj reports consulting and speaker fees from Abiomed, Shockwave Medical, and Cardiovascular Systems, Inc. Dr Batchelor reports consulting for Abbott, Medtronic, and Boston Scientific. Dr Grines reports participation on the advisory boards for Philips and Abiomed. Dr Baron reports receiving institutional research support from Boston Scientific Corporation, Acarix, and Abiomed; speaker fees from Medtronic, Edwards Lifesciences, Shockwave, and Zoll Medical; and consulting fees/advisory board membership from Medtronic, Boston Scientific Corporation, Zoll Medical, and Abiomed. Dr Redfors reports consultant fees from Pfizer and Boehringer Ingelheim. Dr Lansky received speaker fees from Abiomed. M.B. Basir has been a consultant/speaker for Abiomed, Boston Scientific, Chiesi, Saranas, and Zoll. Dr O’Neill reports grant/research support from St. Jude Medical, Edwards Life Sciences, and Biomed; consulting fees/honoraria from Medtronic and Abiomed; and major stock shareholder/equity in Synecor, Accumed, Neovasc, Tendyne, and Mitral Align. The other authors report no conflicts.

Background: We investigated the association of insulin resistance (IR) with coronary plaque morphology and the risk of cardiovascular events in patients enrolled in the Providing Regional Observations to Study Predictors of Events in Coronary Tree (PROSPECT) study., Methods: Patients with acute coronary syndromes (ACS) were divided based on DM status. Non-DM patients were further stratified according to homeostasis-model-assessment IR (HOMA-IR) index as insulin sensitive (IS; HOMA-IR ≤ 2), likely-IR (LIR; 2 < HOMA-IR < 5), or diabetic-IR (DIR; HOMA-IR ≥ 5). Coronary plaque characteristics were investigated by intravascular ultrasound. The primary endpoint was major adverse cardiac events (MACE); a composite of cardiac death, cardiac arrest, myocardial infarction, and rehospitalization for unstable/progressive angina., Results: Among non-diabetic patients, 109 patients (21.5%) were categorized as LIR, and 65 patients (12.8%) as DIR. Patients with DIR or DM had significantly higher rates of echolucent plaque compared with LIR and IS. In addition, DIR and DM were independently associated with increased risk of MACE compared with IS (adjusted hazard ratio [aHR] 2.29, 95% confidence interval [CI] 1.22-4.29, p = 0.01 and aHR 2.12, 95% CI 1.19-3.75, p = 0.009, respectively)., Conclusions: IR is common among patients with ACS. DM and advanced but not early stages of IR are independently associated with increased risk of adverse cardiovascular events. Trial Registration ClinicalTrials.gov Identifier: NCT00180466.

Background: Few studies have evaluated if diastolic function could predict outcomes in patients with aortic stenosis., Objectives: The authors aimed to assess the association between diastolic dysfunction (DD) and outcomes in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR)., Methods: Baseline, 30-day, and 1- and 2-year transthoracic echocardiograms from the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registry were analyzed by a consortium of core laboratories and divided into the American Society of Echocardiography DD groups., Results: Among the 1,750 included, 682 (54.4%) had grade 1 DD, 352 (28.1%) had grade 2 DD, 168 (13.4%) had grade 3 DD, and 51 (4.1%) had indeterminate DD grade. Incremental baseline grades of DD were associated with an increase in combined 1- and 2-year cardiovascular (CV) death/rehospitalization (all p < 0.002) and all-cause death at 2 years (p = 0.01) but not at 1 year. Improvement in DD grade/grade 1 DD at 30 days post-TAVR was seen in 70.8% patients. Patients with improvement in ≥1 grade of DD/grade 1 DD had reduced 1-year CV death/rehospitalization (p < 0.001) and increased 2-year survival (p = 0.01). Baseline grade 3 DD was a predictor of 1-year CV death/rehospitalization (hazard ratio: 2.73; 95% confidence interval: 1.07 to 6.98; p = 0.04). Improvement in DD grade/grade 1 DD at 30 days was protective for 1-year CV death/rehospitalizations (hazard ratio: 0.39; 95% confidence interval: 0.19 to 0.83; p = 0.01)., Conclusions: In the PARTNER 2 SAPIEN 3 registry, baseline DD was a predictor of up to 2 years clinical outcomes in patients who underwent TAVR. Improvement in DD grade at 30 days was associated with improvement in short-term clinical outcomes. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128; PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 [PII S3HR/NR7]; NCT03222141)., Competing Interests: Author Disclosures The PARTNER 2 trial was funded by Edwards Lifesciences. Drs. Pibarot, Weissman, Jaber, Douglas, and Hahn have echocardiographic core laboratory contracts with Edwards Lifesciences (no direct financial compensation). Dr. Makkar has received grant funding from Edwards Lifesciences and St. Jude Medical; and has received consulting fees/honoraria from Abbott Vascular, Cordis Corporation, and Medtronic. Dr. Kodali has received consulting fees/honoraria from Abbott Vascular, Merrill Lifesciences, and Claret Medical; and has served on the Scientific Advisory Boards of Thubrikar Aortic Valve Inc., Dura Biotech, and Biotrace Medical. Dr. Thourani serves on Advisory Boards for Edwards Lifesciences, Abbott Vascular, Gore Vascular, Bard Medical, JenaValve, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT) reduced 2-year rates of HF hospitalization and all-cause mortality compared with GDMT alone. Whether the benefits of the MitraClip extend to patients with previously implanted cardiac resynchronization therapy (CRT) is unknown. We sought to examine the effect of prior CRT in patients enrolled in COAPT., Methods: Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only (control arm). Outcomes were assessed according to prior CRT use., Results: Among 614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively). Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%, P =0.32). Death or HF hospitalization at 2 years was lower with TMVr versus control treatment in patients with prior CRT (48.6% versus 67.2%, hazard ratio, 0.60 [95% CI, 0.42-0.86]) and without CRT (42.5% versus 66.9%, hazard ratio, 0.52 [95% CI, 0.39-0.69]; adjusted P interaction =0.23). The effects of TMVr with the MitraClip on reducing the 2-year rates of all-cause death (adjusted P interaction =0.14) and HF hospitalization (adjusted P interaction =0.82) were also consistent in patients with and without CRT as were improvements in quality-of-life and exercise capacity., Conclusions: In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

Background: Percutaneous coronary intervention of severely calcified lesions carries a high risk of adverse events despite the use of contemporary devices. The Classic Crown Orbital Atherectomy System (OAS) was safe and effective for severely calcified lesion preparation in the ORBIT II study (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) but was not optimized for tight lesions. COAST (Coronary Orbital Atherectomy System Study) evaluated the safety and efficacy of calcified lesion preparation before stent implantation with the Diamondback 360 Micro Crown Coronary OAS, designed for use in tighter lesions., Methods: COAST was a prospective, multicenter, single-arm study that enrolled 100 patients with severely calcified de novo coronary lesions at 17 sites in the United States and Japan. The primary effectiveness end point was procedural success, defined as stent delivery with residual stenosis <50% without in-hospital major adverse cardiac events (MACE), and the primary safety end point was freedom from MACE (composite of cardiac death, myocardial infarction, or target vessel revascularization) at 30 days., Results: The OAS Micro Crown was inserted in all patients. A stent was delivered with a residual stenosis <50% in all except one patient (99.0%). Procedural success was achieved in 85 (85.0%) subjects versus 391 (88.9%) in ORBIT II ( P =0.30), and freedom from MACE at 30 days was achieved in 85.0% versus 89.6% in ORBIT II ( P =0.21). Freedom from MACE was 77.8% at 1 year., Conclusions: Prestent preparation of severely calcified lesions using the novel Micro Crown OAS resulted in similar rates of procedural success and freedom from MACE compared with the Classic Crown OAS. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02132611.

Objectives: The aim of this study was to assess race-based differences in patients undergoing percutaneous coronary intervention from a large pooled database of randomized controlled trials., Background: Data on race-based outcomes after percutaneous coronary intervention are limited, deriving mainly from registries and single-center studies., Methods: Baseline characteristics and outcomes at 30 days, 1 year, and 5 years were assessed across different races, from an individual patient data pooled analysis from 10 randomized trials. Endpoints of interest included death, myocardial infarction, and major adverse cardiac events (defined as cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization). Multivariate Cox proportional hazards regression was performed to assess associations between race and outcomes, controlling for differences in 12 baseline covariates., Results: Among 22,638 patients, 20,585 (90.9%) were white, 918 (4.1%) were black, 404 (1.8%) were Asian, and 473 (2.1%) were Hispanic. Baseline and angiographic characteristics differed among groups. Five-year major adverse cardiac event rates were 18.8% in white patients (reference group), compared with 23.9% in black patients (p = 0.0009), 11.2% in Asian patients (p = 0.0007), and 21.5% in Hispanic patients (p = 0.07). Multivariate analysis demonstrated an independent association between black race and 5-year risk for major adverse cardiac events (hazard ratio: 1.28; 95% confidence interval: 1.05 to 1.57; p = 0.01)., Conclusions: In the present large-scale individual patient data pooled analysis, comorbidities were significantly more frequent in minority-group patients than in white patients enrolled in coronary stent randomized controlled trials. After accounting for these differences, black race was an independent predictor of worse outcomes, whereas Hispanic ethnicity and Asian race were not. Further research examining race-based outcomes after percutaneous coronary intervention is warranted to understand these differences., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Hypertension is associated with vascular and endothelial dysfunction that may result in a greater propensity for reactive platelets to cause thrombosis. We sought to assess whether the risk of major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI) in patients with on-clopidogrel residual high platelet reactivity (HPR) varies in patients with versus without hypertension. Assessment of dual antiplatelet therapy with drug eluting stents (ADAPT-DES) was a prospective, multicenter registry of patients successfully treated with coronary drug-eluting stents (DES). HPR was defined as P2Y12 reaction units (PRU) >208, as assessed by the VerifyNow point-of-care assay. Multivariable Cox proportional hazards regression was used to assess whether the adjusted association between HPR and 2-year risk of MACE (cardiac death, myocardial infarction [MI], or stent thrombosis) was different in patients with versus without hypertension. A total of 6833 of 8582 patients (79.6%) had a history of hypertension. Patients with compared with those without hypertension were older, more likely to have other cardiovascular risk factors, and had higher PRU (190.1 ± 97.3 vs 179.5 ± 94.3; p <0.0001). Patients with hypertension had significantly higher 2-year rates of MACE (7.0% vs 4.4%, p <0.001), all-cause death (4.2% vs 2.5%, p = 0.001), and MI (5.2% vs 3.2%, p <0.001), and had nominally higher rates of stent thrombosis (1.0% vs 0.5%, p = 0.059). A significant interaction was present between hypertension and HPR regarding 2-year MACE risk (adjusted hazard ratio for HPR vs no HPR 1.38, 95% confidence interval 1.14 to 1.68 for patients with hypertension vs 0.81, 95% confidence interval 0.50 to 1.33 for patients without hypertension, p = 0.046). In conclusion, following successful PCI with DES, 2-year MACE rates are increased in patients with both hypertension and residual HPR on clopidogrel. HPR had a greater effect on the risk of adverse events among patients with versus without hypertension., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Small vessel diameter and residual platelet reactivity are independent predictors of thrombotic events after percutaneous coronary intervention (PCI). We sought to determine whether an interaction exists between residual platelet reactivity and stent diameter regarding the occurrence of stent thrombosis and other adverse events after PCI. We stratified patients in the prospective ADAPT-DES registry who underwent single-lesion PCI according to if they received a small diameter stent (SDS, defined as a stent with a diameter of 2.25 mm). Patients receiving an SDS were compared with patients receiving a stent ≥2.5 mm using Kaplan-Meier rates and multivariable Cox proportional hazards regression. We defined major adverse cardiac events (MACE) as the composite of cardiac death, myocardial infarction, and stent thrombosis (ST). Among 5,608 patients who underwent single-lesion PCI in ADAPT-DES, 222 (4.0%) patients received an SDS. Patients with an SDS were more likely than patients without an SDS to have 3-vessel disease but received, on average, fewer stents and were less likely to present with a thrombotic lesion. Receiving versus not receiving an SDS was associated with increased risk of ST (adjusted hazard ratio 4.35, 95% confidence interval 1.95 to 9.73, p <0.001) as well as MACE (adjusted hazard ratio 1.75, 95% confidence interval 1.11 to 2.75, p = 0.02). There was no statistical interaction between platelet reactivity and SDS regarding ST (p = 0.12) or MACE (p = 0.51). In conclusion, PCI with small drug-eluting stents is associated with a high risk of thrombotic events, including ST. Further studies should explore whether alternative treatment strategies are appropriate in small vessels., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: Percutaneous coronary intervention (PCI) is often favoured over coronary artery bypass grafting (CABG) surgery for revascularization in patients with chronic obstructive pulmonary disease (COPD). We studied whether COPD affected clinical outcomes according to revascularization in the Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial, in which PCI with everolimus-eluting stents was non-inferior to CABG for the treatment of patients with left main coronary artery disease and low or intermediate SYNTAX scores., Methods: Patients with a history of COPD were propensity score matched to those without COPD. Outcomes at 30 days and 3 years in both groups were compared in patients randomized to PCI versus CABG., Results: COPD status was available for 1901 of 1905 randomized patients (99.8%), 148 of whom had COPD (7.8%). Propensity score matching yielded 135 patients with COPD and 675 patients without COPD. Patients with COPD had higher 3-year rates of the primary composite end point of death, myocardial infarction or stroke (31.7% vs 14.5%, P < 0.0001), death (17.1% vs 7.5%, P = 0.0005) and myocardial infarction (18.3% vs 7.3%, P < 0.0001), but not stroke (3.3% vs 2.9%, P = 0.84). There were no statistically significant interactions in the relative risks of PCI versus CABG for the primary composite end point in patients with and without COPD at 30 days [hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.12-1.21 vs HR 0.55, 95% CI 0.29-1.06; Pinteraction = 0.61] or at 3 years (HR 0.85, 95% CI 0.46-1.56 vs HR 1.28, 95% CI 0.84-1.94; Pinteraction = 0.27)., Conclusions: In the EXCEL trial, COPD was independently associated with poor prognosis after left main coronary artery disease revascularization. The relative risks of PCI versus CABG at 30 days and 3 years were consistent in patients with and without COPD., Clinical Trial Registration Number: http://www.clinicaltrials.gov; NCT01205776., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: The aim of this study was to investigate the impact of pre-diabetes (pre-DM) on coronary plaque characteristics and ischemic outcomes in patients with acute coronary syndromes (ACS)., Background: Pre-DM (i.e., the early stages of glucometabolic disturbance) is common among patients with ACS, but the extent to which pre-DM influences coronary plaque characteristics and the risk for adverse ischemic events is unclear., Methods: In the PROSPECT (Providing Regional Observations to Study Predictors of Events in Coronary Tree) study, patients with ACS underwent quantitative coronary angiography, grayscale intravascular ultrasound, and radiofrequency intravascular ultrasound after successful percutaneous coronary intervention. Patients were divided into 3 groups according to their glucometabolic status, as defined by the American Diabetes Association: normal glucose metabolism (NGM), pre-DM, and diabetes mellitus (DM). These groups were compared with regard to coronary plaque characteristics and the risk for major adverse cardiac events (MACEs) (defined as cardiac death or arrest, myocardial infarction, or rehospitalization for unstable or progressive angina)., Results: Among 547 patients, 162 (29.6%) had NGM, 202 (36.9%) had pre-DM, and 183 (33.4%) had DM. There were no significant differences between the groups with regard to intravascular ultrasound findings indicative of vulnerable plaques. Patients with DM had a higher crude rate of MACEs than those with pre-DM or NGM (25.9% vs. 16.3% and 16.1%; p = 0.03 and p = 0.02, respectively). In an adjusted Cox regression model using NGM as the reference group, DM (hazard ratio: 2.20; 95% confidence interval: 1.25 to 3.86; p = 0.006) but not pre-DM (hazard ratio: 1.29; 95% confidence interval: 0.71 to 2.33; p = 0.41) was associated with increased risk for MACEs., Conclusions: Impaired glucose metabolism is common among patients presenting with ACS. DM but not pre-DM is associated with an increased risk for MACEs. Thus, preventing patients from progressing from pre-DM to DM is important. (PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions; NCT00180466)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to further evaluate clinical outcomes in patients with and without PCS., Background: Prior cardiac surgery (PCS) is associated with increased surgical risk and post-operative complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear., Methods: In the PARTNER 2A (Placement of Aortic Transcatheter Valve) trial, 2,032 patients with severe aortic stenosis at intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. Adverse clinical outcomes at 30 days and 2 years were compared using Kaplan-Meier event rates and multivariate Cox proportional hazards regression models. The primary endpoint of the PARTNER 2 trial was all-cause death and disabling stroke., Results: Five hundred nine patients (25.1%) had PCS, mostly (98.2%) coronary artery bypass grafting. There were no significant differences between TAVR and SAVR in patients with or without PCS in the rates of the primary endpoint at 30 days or 2 years. Nevertheless, an interaction was observed between PCS and treatment arm; whereas no-PCS patients treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted hazard ratio: 2.66; 95% confidence interval: 1.68 to 4.22), the opposite was true for patients with PCS (adjusted hazard ratio: 0.27; 95% confidence interval: 0.11 to 0.66) (p interaction  <0.0001). A similar interaction was observed for life-threatening or disabling bleeding., Conclusions: In the PARTNER 2A trial of intermediate-risk patients with severe aortic stenosis undergoing SAVR versus TAVR, the relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors sought to investigate the association between P2Y 12 reaction units (PRU) and the risk of ischemic stroke (IS) after successful coronary drug-eluting stents (DES) implantation., Background: The association between platelet reactivity on clopidogrel and the risk for ischemic cerebrovascular events remains unclear., Methods: Incidence, predictors, and prognostic impact of IS were evaluated among patients enrolled in the multicenter, prospective ADAPT-DES (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents) study. By protocol, patients were maintained on aspirin for 2 years and clopidogrel for at least 1 year. Baseline platelet reactivity on clopidogrel and aspirin were assessed by means of VerifyNow point-of-care assay after successful DES implantation., Results: Among 8,582 patients enrolled, 68 (0.8%) had an IS during 2-year follow-up. Across the spectrum of PRU, rates of IS were progressively greater as patients transitioned from the lowest quintile of PRU (more P2Y 12  receptor inhibition; 2-year rate of 0.51%) to the highest quintile of PRU (less P2Y 12 receptor inhibition; 2-year rate of 1.34%; adjusted p = 0.04). PRU >208 was independently associated with higher risk of IS at 2 years (adjusted hazard ratio 1.81; 95% confidence interval 1.08 to 3.04; p = 0.03). The association between higher PRU and risk for IS was also consistent in patients with versus without high CHA 2 DS 2 -VASc score (p interaction  = 0.30) and in those on or off oral anticoagulation at discharge (p interaction  = 0.99). Occurrence of IS was strongly associated with increased risk of all-cause mortality at 2 years (adjusted HR: 4.16; 95% CI: 1.95 to 8.87; p < 0.0001)., Conclusions: Higher PRU was associated with increased risk of IS after coronary DES implantation. Ensuring adequate platelet P2Y 12 receptor inhibition may reduce the risk of IS in this patient population. (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents [ADAPT-DES]; NCT00638794)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In-hospital bleeding after percutaneous coronary intervention is associated with increased mortality. We studied the impact of bleeding severity, defined as magnitude of Hgb (hemoglobin) reduction from baseline (ΔHgb), on the risk of death and other adverse events., Methods and Results: We studied the association between ΔHgb, baseline characteristics, and outcomes among 7608 patients in the ADAPT-DES registry (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) who had information on Hgb values before and after they underwent successful percutaneous coronary intervention. Post-percutaneous coronary intervention, 5985 (78.7%) patients had a drop in Hgb, with 2684 patients (35.3%) having a ΔHgb <1.0 g/dL, 2338 (30.7%) ≥1.0 to <2.0 g/dL, 745 (9.8%) ≥2.0 to <3.0 g/dL, 145 (1.9%) ≥3.0 to <4.0 g/dL, and 73 (1.0%) ≥4.0 g/dL. The risk of dying within 2 years was 3.3% with <1.0 g/dL ΔHgb, 3.4% with ΔHgb ≥1.0 to <2.0 g/dL, 3.7% with ΔHgb ≥2.0 to <3.0 g/dL, 4.1% with ΔHgb ≥3.0 to <4.0 g/dL, and 9.8% with ΔHgb ≥4.0 g/dL ( P =0.03). The risk of major adverse cardiac events (defined as cardiac death, myocardial infarction, or stent thrombosis) was higher for patients with ΔHgb ≥4.0 g/dL (adjusted hazard ratio, 3.39; 95% confidence interval, 1.97-5.83; P <0.001) and for patients with ΔHgb ≥3.0 to <4.0 g/dL (adjusted hazard ratio, 2.17; 95% confidence interval, 1.34-3.53; P =0.002)., Conclusions: Among patients who undergo successful percutaneous coronary intervention, bleeding events that result in ΔHgb ≥4.0 g/dL are associated with a considerably increased risk of dying., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00638794., (© 2018 American Heart Association, Inc.)

Objectives: This study sought to determine how many patients with atrial fibrillation (AF) are not treated with oral anticoagulants (OAC) due to a high risk of bleeding and to characterize their risk of ischemic stroke in a real-world setting., Background: AF is associated with a 5-fold increased risk of ischemic stroke. OAC reduce the risk of stroke in patients with AF who do not have an increased bleeding risk, but no comparably effective treatment exists for patients with contraindications to OAC., Methods: We analyzed administrative claims data from individuals with commercial and Medicare supplemental health insurance in the United States. We selected patients with AF and a documented contraindication to OAC who were not treated with OAC. The primary endpoint was the occurrence of ischemic stroke, as calculated per patient year., Results: We identified 1,300,643 patients with AF claims, of which 43,248 had a contraindication event and remained OAC naive for at least 1 year or died in hospital. More than 80% of the patients had a CHA 2 DS 2 -VASc score of >1. The incidence of ischemic stroke was 4.1% in the overall OAC naive cohort and was more common with increasing CHA 2 DS 2 /CHA 2 DS 2 -VASc score. Hemorrhagic stroke occurred in 3.6%. For patients with previous intracranial bleeding, the incidences of ischemic and hemorrhagic stroke were 12.2% and 20.3%, respectively., Conclusions: Patients with AF who are not treated with OAC due to increased bleeding risk are common. These patients are at considerable risk of both ischemic and hemorrhagic events. A novel approach to stroke prophylaxis in this population is needed., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Importance: Bleeding complications after percutaneous transcatheter interventions that used large-bore catheters are frequent and associated with high mortality and morbidity., Objective: To describe the incidence of bleeding complications among patients undergoing contemporary endovascular interventions involving large-bore catheters and its association with in-hospital mortality, length of stay, and health care cost., Design, Setting, and Participants: This retrospective cohort study analyzed all 17 672 patients from the Healthcare Cost and Utilization Project's National Inpatient Sample database who were recorded as having undergone a transcatheter aortic valve replacement (n = 3223), an endovascular aneurysm repair (n = 12 633), or a percutaneous left ventricular assist device implant (n = 1816) between January 1, 2012, and December 31, 2013. Bleeding complication was defined as any transfusion, any hemorrhage or hematoma, or the need for percutaneous or surgical intervention to control the bleeding event. Health care costs were determined by multiplying the total charge for each visit by the cost to charge ratios reported for each hospital code in the database. Data were collected from the database on April 29, 2016., Main Outcomes and Measures: Adjusted association between bleeding complications and mortality was determined by multivariable logistic regression. Length of stay and total health care costs were compared using multivariable linear regression between patients who did and patients who did not have bleeding complications., Results: Bleeding complications occurred in 3128 patients (17.7%) (1984 men and 1144 women, with a mean [SD] age of 75.6 [11.9] years). Bleeding was associated with higher mortality (adjusted odds ratio, 2.70; 95% CI, 2.27-3.22; P < .001) and longer hospital stay (adjusted multiplicative difference, 2.14; 95% CI, 2.06-2.16; P < .001). Median (interquartile range) total health care costs were $48 663 ($32 620-$71 547) for patients with bleeding complications compared with $29 968 ($21 924-$43 287) for patients without a bleeding complication (adjusted multiplicative difference, 1.55; 95% CI, 1.52-1.59; P < .001)., Conclusions and Relevance: Periprocedural bleeding was common among patients who underwent transcatheter intervention using large-bore catheters and was associated with a statistically significant increase in mortality, length of stay, and cost.