Antithrombotic regimens for percutaneous coronary intervention of the left main coronary artery: The EXCEL trial.

OBJECTIVES: We compared the effect of bivalirudin or heparin and use or nonuse of glycoprotein IIb/IIIa inhibitors (GPI) on the outcome of left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the randomized EXCEL trial. BACKGROUND: The optimal antithrombotic regimen to support PCI of the LMCA remains controversial because of low representation of this subset in clinical trials. METHODS: The PCI cohort (n = 928) in EXCEL was divided according to bivalirudin versus heparin antithrombin treatment and compared for the primary composite endpoint of death, myocardial infarction (MI), or stroke at 30 days and 5 years. RESULTS: Bivalirudin was used in 319 patients (34.4%). The composite endpoint at 30 days occurred in 7.2% versus 3.8% bivalirudin and heparin patients, respectively, p = .02; at 5 years, the composite endpoint occurred in 26.3% versus 19.9% bivalirudin and heparin patients, respectively, p = .02. Major bleeding was more frequent in bivalirudin patients (4.1% versus 1.3%, p = .008). There were no differences in stent thrombosis between the groups. Bivalirudin use was an independent predictor of the 30-day composite endpoint (OR 2.88, 95% CI 1.28-6.48, p = .01) but not of the 5-year composite endpoint (OR 1.30, 95% CI 0.84-2.02, p = .23). GPI use was infrequent (n = 67, 7.2%) and was not associated with adverse outcomes. CONCLUSION: Among patients undergoing LMCA PCI in the EXCEL trial, procedural use of bivalirudin was associated with greater rates of periprocedural MI and the 30-day composite endpoint without reducing bleeding complications. Five-year outcomes were similar. GPIs were used infrequently and were not associated with clinical outcomes.

High-throughput targeted proteomics discovery approach and spontaneous reperfusion in ST-segment elevation myocardial infarction.

BACKGROUND: Although spontaneous reperfusion (SR) prior to primary percutaneous coronary intervention (pPCI) is associated with improved outcomes, its pathophysiology remains unclear. The objective of the study was to explore associations between SR in ST-segment elevation myocardial infarction (STEMI) using a multimarker cardiovascular proteins strategy METHODS: We evaluated STEMI patients from the Assessment of Pexelizumab in Acute Myocardial Infarction trial treated with pPCI within 6 hours from symptom onset. SR was core laboratory-defined as pre-PCI Thrombolysis in Myocardial Infarction flow 2 or 3. Ninety-one cardiovascular disease-related serum biomarkers drawn prior to PCI were analyzed using a high-throughput "targeted discovery" panel. Expression levels for individual biomarkers were compared between patients with/without SR. A hierarchical clustering method of biomarkers identified clusters of biomarkers that differentiated the 2 groups. Associations between individual biomarkers and clusters with SR were further evaluated by multivariable logistic regression. RESULTS: Of 683 patients studied, 290 had spontaneous reperfusion; those with compared to without SR were more likely noninferior STEMI and had lower clinical acuity and lower baseline levels of troponin and creatine kinase. SR was associated with a lower occurrence of 90-day composite of death, heart failure, or cardiogenic shock. Fifty-two of 91 individual biomarkers were significantly univariably associated with SR. Forty-five remained significant with adjustment for false discovery rate. Using cluster analysis, 26 biomarkers clusters were identified, explaining 72% of total covariance, and 13 biomarker clusters were significantly associated with SR after multivariable adjustment. SR was associated with higher mean expression levels of proteins in all 13 clusters. The cluster most strongly associated with SR consisted of novel proteins across various distinct, yet interlinked, pathobiological processes (kallikrein-6, matrix extracellular phosphoglycoprotein, matrix mettaloproteinaise-3, and elafin). CONCLUSIONS: Spontaneous reperfusion prior to pPCI in STEMI was associated with a lower risk of adverse clinical events. These exploratory data from a targeted discovery proteomics platform identifies novel proteins across diverse, yet complementary, pathobiological axes that show promise in providing mechanistic insights into spontaneous reperfusion in STEMI. CONDENSED ABSTRACT: Spontaneous reperfusion has been established with improved STEMI outcomes, yet its pathobiology is unclear and appears to involve diverse physiological processes. Using a 91-biomarker high-throughput proteomics platform, we studied 683 STEMI patients in the APEX AMI trial (290 had core laboratory-adjudicated pre-PCI TIMI 2/3 flow) and identified 52 proteins that univariably associate with spontaneous reperfusion. Cluster analysis identified 26 biomarker clusters (explaining 72% of total variance), 13 of which, after multivariable adjustment, were significantly associated with spontaneous reperfusion. Four proteins (kallikrein-6, matrix extracellular phosphoglycoprotein, matrix mettaloproteinaise-3, and elafin) across diverse, yet complementary, pathways appear to be associated most strongly with spontaneous reperfusion.

The impact of pre-existing peripheral artery disease on transcatheter aortic valve implantation outcomes: A systematic review and meta-analysis.

BACKGROUND: Peripheral arterial disease (PAD) plays a decisive role in the preinterventional selection process of the optimal vascular access site in patients undergoing transcatheter aortic valve implantation (TAVI). However, the impact of PAD on mortality and vascular complications (VCs) in TAVI-treated patients remains unclear. Accordingly, we aimed to assess the outcomes of patients with and without PAD undergoing TAVI, by performing a meta-regression analysis. METHODS: Studies published between January 2002 and March 2018 and reporting outcomes according to the presence of PAD in TAVI patients were identified. Outcome measures analyzed were short-, mid- and long-term mortality, and peri-procedural VC. The interaction between sheath size and PAD on outcomes was also assessed. RESULTS: A total of 26 studies (68,581 TAVI patients, of whom 17,326 with preprocedural PAD) were included in the analysis. Patients with PAD had higher risk of mortality at short- (HR 1.36, 95% confidence interval [CI] 1.13-1.63, p = .0009), mid- (HR 1.18, 95% CI 1.08-1.30, p = .0005), and long-term (HR 1.36, 95% CI 1.24-1.48, p < .0001) follow-up, and higher risk of VC (RR 1.55, 95% CI 1.27; 1.89, p < .0001). Moreover, the adoption of smaller sheaths during TAVI procedures was associated with fewer VC both in PAD and non-PAD patients, but the latter group had a more pronounced benefit. CONCLUSIONS: Patients with pre-existent PAD are at increased risk of all-cause mortality and VC after TAVI. The adoption of smaller sheaths during the procedure seems to be associated with fewer peri-procedural VC both in PAD and non-PAD patients.

Time course of the survival advantage of transcatheter over surgical aortic valve replacement: Interplay between sex and patient risk profile.

OBJECTIVES: The aim of this study was to explore the time course of survival advantage of TAVR over SAVR as function of the patients' risk and sex. BACKGROUND: Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available. METHODS: A systematic review of studies reporting clinical outcomes of men and women undergoing TAVR or SAVR was performed. Studies were divided into two groups according to average patient's risk score and the interplay of surgical risk and sex on outcomes were analyzed. RESULTS: Eight studies involving 6,596 women and 7,204 men patients were extracted. Unlike mens, women patients had survival advantage from TAVR over SAVR that became substantial at 1 year from index procedure and persisted at 2-year of follow-up. Moreover, this sex-based TAVR survival advantage was mainly observed in higher surgical risk patients. Men showed a significantly lower rate of residual paravalvular leak after SAVR. CONCLUSIONS: Women patients had a selective mortality benefit from TAVR compared to SAVR. This sex-based TAVR benefit was mainly observed in high surgical risk patients beyond 1 year from procedure.

Efficacy and safety of potent platelet P2Y12 receptor inhibitors in elderly versus nonelderly patients with acute coronary syndrome: A systematic review and meta-analysis.

BACKGROUND: The use of the potent oral P2Y12 inhibitors prasugrel and ticagrelor in patients with acute coronary syndromes (ACS) has a favorable net clinical effect compared with clopidogrel and is recommended as first-line therapy. However, the impact of these agents on ischemic and bleeding events in elderly ACS patients is not well defined. METHODS: We performed a systematic review of articles comparing potent P2Y12 inhibitors to clopidogrel in elderly and nonelderly patients (defined according to each study) with ACS in terms of efficacy (composite of cardiovascular death, myocardial infarction, or stroke) and safety (major bleeding) end points. RESULTS: A total of 7,860 elderly and 37,857 nonelderly patients from 7 studies (5 randomized control trials and 2 observational studies) were included. Potent P2Y12 inhibitors significantly reduced efficacy end point in nonelderly patients (relative risk [RR] 0.85, 95% CI 0.79-0.93) and less so in elderly patients (RR 0.95, 95% CI 0.86-1.05). No significant differences were found between potent P2Y12 inhibitors and clopidogrel in terms of safety end point in both elderly (RR 1.19, 95% CI 0.95-1.49) and nonelderly patients (RR 1.16, 95% CI 0.95-1.41). There were no significant interactions between age and treatment effect in both analyses (efficacy Pint=.16; safety Pint=.83). CONCLUSIONS: The effect of more potent P2Y12 inhibitors compared with clopidogrel on efficacy and safety end points is consistent in elderly and younger patients. These data imply that potent P2Y12 inhibitors should not be withheld from eligible patients solely because of advanced age.

Angiographic predictors of 2-year stent thrombosis in patients receiving drug-eluting stents: Insights from the ADAPT-DES study.

OBJECTIVES: We sought to identify angiographic predictors of 2-year stent thrombosis (ST) in the ADAPT-DES study. BACKGROUND: A strong relationship between platelet reactivity and ST after implantation of drug-eluting stents (DES) was recently confirmed in the prospective, multicenter ADAPT-DES study. METHODS: In a pre-specified analysis of patients enrolled in ADAPT-DES, an independent angiographic core laboratory performed detailed angiographic analyses for all cases of ST. Patients with Academic Research Consortium definite/probable target-lesion ST were matched with controls in a 1:2 ratio, and multivariable Cox regression models identified angiographic predictors of 2-year ST. RESULTS: Among 8,582 patients who had successful percutaneous coronary intervention (PCI) and were included in the ADAPT-DES study, 92 (1.1%) patients had ST at 2-year follow-up. Target lesion-related ST was identified in 77 patients (82 lesions) who were clinically matched with 153 patients (196 lesions) without ST. Patients with ST were more likely to have longer target lesions, thrombus, moderate/severe calcification, American College of Cardiology/American Heart Association (ACC/AHA) type C lesions, and saphenous vein grafts. After adjustment for clinical covariates the angiographic variables that predicted ST were lesion complexity (ACC/AHA type C lesion, adjusted HR: 1.97, 95% CI: 1.19 to 3.26, P = 0.01) and presence of thrombus on index PCI (HR: 2.25, 95% CI: 1.40 to 3.59, P < 0.01). CONCLUSIONS: Anatomically complex lesions and the presence of thrombus are strong predictors of 2-year ST in the DES era. © 2016 Wiley Periodicals, Inc.

Fogarty Maneuver to Restore Coronary Flow in ST-Segment Elevation Myocardial Infarction: Desperate Times Call for Desperate Measures.

Nonatherosclerotic embolism is a rare cause (4%-7%) of coronary occlusion in ST-segment elevation myocardial infarction (STEMI) patients, approximately half of which occur in inadequately anticoagulated patients with prosthetic valves. We report a rare case of a patient with severe rheumatic heart disease and 3 mechanical valves presenting with STEMI that was successfully managed by Fogarty maneuver thrombus extraction after failed thrombus aspiration and balloon angioplasty. A 56-year-old woman presented with an acute anterior STEMI and Killip class III heart failure. She had severe rheumatic heart disease with mechanical tricuspid, mitral and aortic valve prostheses, and atrial fibrillation on warfarin anticoagulation. The international normalized ratio on admission was 1.1. Emergency coronary angiography revealed normal right and circumflex coronary arteries and a total occlusion in the mid left anterior descending artery with a meniscus appearance. Multiple attempts at thrombus aspiration and balloon angioplasty failed to restore flow in the left anterior descending artery. Ultimately, a Fogarty maneuver using a compliant balloon inflated at a low pressure was performed successfully, removing the thrombus into the guiding catheter. There was Thrombolysis in Myocardial Infarction flow grade 3 and near-normal myocardial blush at the end of the procedure. Signs and symptoms of heart failure resolved quickly.

Efficacy and Safety of Prasugrel Compared With Clopidogrel for Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

Dual antiplatelet therapy comprising aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor) is essential to prevent thrombotic complications after percutaneous coronary intervention (PCI). The comparative efficacy between clopidogrel at a higher loading dose (600 mg) and prasugrel is uncertain. The aim of this study was to compare efficacy and safety of clopidogrel (higher loading dose) with prasugrel (loading dose of 60 mg) along with their respective maintenance doses in patients with acute coronary syndrome (ACS) undergoing PCI at 1 year. This is a retrospective, observational, pilot study. Patients with ACS who underwent PCI and received clopidogrel 600 mg or prasugrel 60 mg loading dose followed by maintenance doses of 75 mg and 10 mg, respectively, daily between July 1, 2009 and June 30, 2011 were enrolled. For patients who have died during the study period, investigators attempted to identify the cause of deaths through medical records or death certificates. Two hundred twenty-one patients were enrolled in the study. Primary efficacy end point, composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke occurring through 1 year were not significantly different between the 2 treatment groups. Bleeding events were also not significant between the clopidogrel (N = 136) and prasugrel (N = 85) groups: 9.6% versus 8.2%, P = 0.85. Prasugrel is at least as effective and safe as clopidogrel in patients with ACS undergoing early invasive management.

Cardiac Amyloidosis Presenting With Cardiogenic Shock.

Cardiac amyloidosis is an infiltrative disorder of the myocardium. It is the result of one of 4 types of amyloidosis: primary systemic (immunoglobulin light chain), secondary, familial (hereditary), or senile. Cardiac amyloidosis ultimately causes congestive heart failure due to irreversible restrictive cardiomyopathy. Because of the rapid progression of the disease, early recognition and determination of underlying etiology are important for tailored therapy. Current interventions range from conservative heart failure management to autologous stem cell and heart transplantation. We present a case of cardiac amyloidosis accompanying undiagnosed multiple myeloma to illustrate the rapid progression of the disease and the complexities of diagnosing and treating this disorder.

Predictors and impact of target vessel revascularization after stent implantation for acute ST-segment elevation myocardial infarction: lessons from HORIZONS-AMI.

BACKGROUND: Target vessel revascularization (TVR) may compromise the benefits of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction (STEMI) We set out to identify the predictors and examine the impact of TVR after STEMI in patients receiving a coronary stent. METHODS: In HORIZONS-AMI, 3,602 patients with STEMI were randomized to bivalirudin versus heparin and a glycoprotein IIb/IIIa inhibitor. Stents were implanted in 3,202 patients (2,982 were randomized to bare-metal stents versus paclitaxel-eluting stents, and 220 received nonrandomized stents). RESULTS: Target vessel revascularization occurred in 219 patients (6.9%) at 1 year and in 437 patients (14.4%) at 3 years. Target vessel revascularization was ischemia-driven in 418 cases (95.7%). Target vessel revascularization was due to restenosis in 219 patients (50.1%), definite stent thrombosis in 124 (28.4%), and disease progression in 94 (21.5%). Independent predictors of TVR were more extensive coronary artery disease, smaller vessel size, longer lesion length and the number of stents implanted, post-percutaneous coronary intervention diameter stenosis, symptom onset to balloon time, treatment with bare-metal stents rather than paclitaxel-eluting stents, and scheduled angiographic follow-up. Target vessel revascularization was an independent predictor of subsequent myocardial infarction (hazard ratio [HR] 5.25, P < .0001), ST (HR 5.98, P < .0001), and major bleeding (HR 5.25, P < .0001) but not mortality (HR 0.88, P = .61). CONCLUSIONS: In HORIZONS-AMI, TVR within 3 years after stent implantation was performed in ~1 of every 7 patients and was associated with more extensive coronary disease, more complex procedures, and bare metal stents. Target vessel revascularization was often due to stent thrombosis and disease progression as well as restenosis and was strongly associated with adverse outcomes but not mortality.

Sex, adverse cardiac events, and infarct size in anterior myocardial infarction: an analysis of intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction (INFUSE-AMI).

BACKGROUND: Women are more likely than men to experience adverse cardiac events after ST-elevation myocardial (STEMI). Whether differences in infarct size or reperfusion contribute to sex differences in outcomes is unknown. METHODS: We compared baseline and procedural characteristics, angiographic and electrocardiographic indices of reperfusion, microvascular obstruction, infarct size, and clinical outcomes in 118 women and 334 men with anterior STEMI enrolled in the INFUSE-AMI randomized trial of intralesion abciximab and aspiration thrombectomy (NCT00976521). Infarct size was assessed by cardiac magnetic resonance imaging at 30 days, and clinical end points were adjudicated by an independent committee. RESULTS: Women were older, were more commonly affected by hypertension and renal impairment, and had a 50.5-minute longer delay to reperfusion. There were no differences in infarct size, microvascular obstruction, or reperfusion success. At 30 days, major adverse cardiac events (MACE), defined as death, reinfarction, new-onset severe heart failure, or rehospitalization for heart failure, were more common in women (11.1% vs 5.4%, hazard ratio 2.09, 95% CI 1.03-4.27, P = .04). After multivariable adjustment, age, but not sex or time to reperfusion, was an independent predictor of MACE. CONCLUSIONS: In the INFUSE-AMI randomized trial, women with anterior STEMI experienced a higher rate of MACE, attributable to older age. Despite longer delay from symptom onset to reperfusion therapy, there was no difference between women and men in infarct size or reperfusion success.

The Evolution of Coronary Revascularization Appropriateness Use Criteria: From Mandatory to Forgotten.

The appropriateness use criteria (AUC) for coronary revascularization have been formulated through the joint efforts of several professional societies. The goals of AUC were to aid in physician decision making and to objectively define the need and context for revascularization. These criteria, developed using a standardized approach, were widely promoted and adopted in many practices. Rigorous use in daily practice and public reporting of adherence to these criteria has exposed some of their deficiencies. Revisions to the original version were made to accommodate public and physician sentiments. Not surprisingly, the recent percutaneous coronary intervention performance measures developed by the same professional societies that have proposed AUC, have suggested that AUC should be used for internal quality improvement only at this time. Therefore, the present role and future application of AUC to cardiology practice is uncertain. The goals of this review are to describe methodology and development of the coronary revascularization AUC, to focus on the strengths and limitations of AUC, and to identify challenges related to application of these criteria in daily practice.

Cost implications of intraprocedural thrombotic events during PCI.

OBJECTIVES: We sought to estimate the direct costs (in-hospital and 30-day) associated with an intraprocedural thrombotic event (IPTE) among patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing percutaneous coronary intervention (PCI). BACKGROUND: Patients with IPTE have higher rates of in-hospital and 30-day major adverse cardiac events than patients without IPTE. The extent to which IPTE also add to medical costs is unknown. METHODS: Hospital costs for patients in the ACUITY Trial were compared between patients with and without IPTE. Adjusted comparisons were performed using generalized linear models (GLMs). All costs are reported in 2012 US dollars. RESULTS: A total of 1,307 patients with both core laboratory-based angiographic assessment and detailed economic data were included in the final study population. IPTE occurred in 52 patients (4.0%). Median in-hospital costs were higher in patients with IPTE than in those without IPTE ($23,719 vs. $18,419, P = 0.01). Thirty-day median costs were also higher for IPTE patients ($23,719 vs. $19,556, P = 0.05). After adjusting for baseline differences, IPTE was associated with 19.5% (95% CI: [2.8-38.8%], P = 0.02) and 18.9% (95% CI: [1.2-39.7%], P = 0.04) increases in in-hospital and 30-day costs, respectively. These relative differences represent median increases of $3,592 in initial hospital costs and $3,696 in 30-day costs. CONCLUSIONS: The occurrence of IPTE during the index PCI in patients with NSTEACS is associated with substantial increases in-hospital and 30-day costs. These findings suggest that strategies to prevent IPTE may be associated with important cost offsets as well as improved clinical outcomes.

SYNTAX score and the risk of stent thrombosis after percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: an ACUITY trial substudy.

OBJECTIVE: We sought to investigate the relationship between the SYNTAX score (SS) and stent thrombosis (ST) in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI). BACKGROUND: The relationship between the SS and ST is undetermined. METHODS: We stratified 2,627 patients undergoing PCI in the ACUITY trial by SS tertile according to the current population (true tertiles, SS <7, SS = 7-12, and SS >12) and by the SYNTAX trial (original SYNTAX tertiles, SS <23, SS = 23-32, and SS >32). Thirty-day and 1-year rates of definite/probable ST were determined for each tertile. RESULTS: A total 30 (1.1%) and 41 (1.6%) definite/probable ST events occurred by 30 days and 1 year, respectively. When stratified by true tertiles, 30-day and 1-year rates of definite/probable ST were significantly greater in the highest tertile (SS >12; 2.0% and 2.8%) compared with the intermediate (SS = 7-12; 0.7% and 1.1%) and lowest tertiles (SS <7; 0.6% and 0.7%), P = 0.007 and P = 0.0009, respectively. When stratified by original SYNTAX tertiles, 30-day and 1-year rates of definite/probable ST were significantly greater in the highest (SS >32; 6.3% and 8.8%) and intermediate tertiles (SS = 23-32; 2.8% and 3.7%) compared with the lowest tertile (SS < 22; 0.8% and 1.2%), P <0.0001 for both. By multivariable analysis, the SS was an independent predictor for both 30-day and 1-year definite/probable ST. CONCLUSIONS: In patients with NSTE-ACS undergoing PCI, the extent and severity of CAD, as assessed by the SS before revascularization, was strongly associated with the occurrence of ST both at 30 days and 1 year. © 2014 Wiley Periodicals, Inc.

Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI: results from the HORIZONS-AMI trial.

OBJECTIVE: To assess the relationship of femoral vascular closure device (VCD) use to bleeding and ischemic events in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via different anticoagulation strategies. BACKGROUND: It is unknown whether femoral VCD reduce major bleeding after primary PCI for STEMI using bivalirudin anticoagulation. METHODS: We compared VCD-treated patients with propensity-matched controls in the HORIZONS-AMI trial with respect to net adverse clinical events (NACE), defined as the composite of major bleeding unrelated to coronary artery bypass graft surgery (CABG) and major adverse cardiac events (comprised of death, reinfarction, ischemia-driven target vessel revascularization, and stroke), at 30 days and 1 year. RESULTS: Among 3,602 patients enrolled in HORIZONS-AMI, 2,948 underwent primary PCI via femoral arterial access and 896 (30%) received VCDs, of whom 642 were included in our model along with 642 propensity-matched controls. At 30 days, VCD-treated patients had significantly less NACE (6.7% vs. 10.8%, HR: 0.61, 95% CI: 0.42-0.89, P = 0.009), driven by a lower rate of non-CABG related major bleeding (5.0% vs. 8.1%, HR: 0.61, 95% CI: 0.39-0.94, P = 0.02). Bleeding reduction was maintained at one year and consistent in magnitude regardless of randomization to bivalirudin or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (P for interaction = 0.84). CONCLUSION: In patients undergoing transfemoral primary PCI for STEMI, VCD use was associated with significantly lower non-CABG major bleeding irrespective of anticoagulation strategy.

Contrast-induced acute kidney injury after primary percutaneous coronary intervention: results from the HORIZONS-AMI substudy.

AIM: We sought to examine the short- and long-term outcomes of patients who developed contrast-induced acute kidney injury (CI-AKI; defined as an increase in serum creatinine of ≥0.5 mg/dL or a 25% relative rise within 48 h after contrast exposure) from the large-scale HORIZONS-AMI trial. METHODS AND RESULTS: Multivariable analyses were used to identify predictors of CI-AKI, as well predictors of the primary and secondary endpoints. The incidence of CI-AKI in this cohort of ST-segment elevation myocardial infarction (STEMI) patients was 16.1% (479/2968). Predictors of CI-AKI were contrast volume, white blood cell count, left anterior descending infarct-related artery, age, anaemia, creatinine clearance <60 mL/min, and history of congestive heart failure. Patients with CI-AKI had higher rates of net adverse clinical events [NACE; a combination of major bleeding or composite major adverse cardiac events (MACE; consisting of death, reinfarction, target vessel revascularization for ischaemia, or stroke)] at 30 days (22.0 vs. 9.3%; P < 0.0001) and 3 years (40.3 vs. 24.6%; P < 0.0001). They also had higher rates of mortality at 30 days (8.0 vs. 0.9%; P < 0.0001) and 3 years (16.2 vs. 4.5%; P < 0.0001). Multivariable analysis confirmed CI-AKI as an independent predictor of NACE [hazard ratio ([HR), 1.53; 95% confidence interval (CI), 1.23-1.90; P = 0.0001], MACE (HR, 1.56; 95% CI, 1.23-1.98; P = 0.0002), non-coronary artery bypass grafting major bleeding (HR, 2.07; 95% CI, 1.57-2.73; P < 0.0001), and mortality (HR, 1.80; 95% CI, 1.19-2.73; P = 0.005) at 3-year follow-up. CONCLUSION: Contrast-induced acute kidney injury is associated with poor short- and long-term outcomes after primary percutaneous coronary intervention in STEMI.

Impact of baseline hemorrhagic risk on the benefit of bivalirudin versus unfractionated heparin in patients treated with coronary angioplasty: a meta-regression analysis of randomized trials.

BACKGROUND: Bivalirudin significantly reduces 30-day major and minor bleeding compared with unfractionated heparin (UFH), while resulting in similar or lower rates of ischemic events in both patients with stable and unstable coronary disease undergoing percutaneous coronary intervention. We performed a meta-analysis of randomized trials to evaluate the impact of bivalirudin compared with UFH, with or without glycoprotein IIb/IIIa receptor inhibitors (GPI), on the rates of mortality, myocardial infarction (MI), and major bleeding. METHODS: We searched electronic databases for randomized controlled trials with >100 patients comparing bivalirudin (±provisional GPI) with UFH with either routine or provisional GPI in patients undergoing percutaneous coronary intervention. The principal efficacy end points were mortality and MI within 30 day, whereas major bleeding was the principal safety end point. We assessed the benefit of bivalirudin for each efficacy end point relative to the baseline bleeding risk, using the control (UFH) major bleeding rate as proxy for that risk. RESULTS: A total of 12 randomized trials that enrolled 33,261 patients were included. Overall, there was no significant difference in mortality and MI between bivalirudin monotherapy and UFH (±GPI), whereas major bleeding was significantly lower with bivalirudin. Bivalirudin reduced major and minor bleeding across the entire bleeding risk spectrum. CONCLUSIONS: Bivalirudin significantly reduces major and minor bleeding regardless of the estimated baseline hemorrhagic risk.

Utilization of trained volunteers decreases 30-day readmissions for heart failure.

Background: This study evaluated the effectiveness of using trained volunteer staff in reducing 30-day readmissions of congestive heart failure (CHF) patients.Methods: From June 2010 to December 2010, 137 patients (mean age 73 years) hospitalized for CHF were randomly assigned to either: an interventional arm (arm A) receiving dietary and pharmacologic education by a trained volunteer, follow-up telephone calls within 48 hours, and a month of weekly calls; ora control arm (arm B) receiving standard care. Primary outcomes were 30-day readmission rates for CHF and worsening New York Heart Association (NYHA) functional classification; composite and all-cause mortality were secondary outcomes.Results: Arm A patients had decreased 30-day readmissions (7% vs 19%; P ! .05) with a relative risk reduction (RRR) of 63% and an absolute risk reduction (ARR) of 12%. The composite outcome of 30-day readmission, worsening NYHA functional class, and death was decreased in the arm A (24% vs 49%;P ! .05; RRR 51%, ARR 25%). Standard-care treatment and hypertension, age $65 years and hypertension,and cigarette smoking were predictors of increased risk for readmissions, worsening NYHA functional class, and all-cause mortality, respectively, in the multivariable analysis.Conclusions: Utilizing trained volunteer staff to improve patient education and engagement might be an efficient and low-cost intervention to reduce CHF readmissions.

Outcomes in diabetic patients undergoing primary percutaneous coronary intervention for acute anterior myocardial infarction: results from the INFUSE-AMI study.

OBJECTIVES: To evaluate the clinical, angiographic, and cardiac magnetic resonance imaging (cMRI) results in patients with and without diabetes mellitus (DM) undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). BACKGROUND: DM has been associated with increased mortality in patients with STEMI, yet the mechanisms underpinning this association have not been completely elucidated. METHODS: Overall, 451 patients (51 diabetics) from the INFUSE-AMI trial were studied. They presented with an anterior STEMI due to an occluded left anterior descending artery (LAD) and underwent bivalirudin-supported primary PCI with or without intralesion abciximab and with or without thrombus aspiration. Angiographic baseline and post-procedure parameters, cMRI at 30 days, and clinical follow-up at 30 days and at 1 year were compared between diabetic and nondiabetic patients. RESULTS: Patients with DM had significantly more comorbidities and more extensive LAD disease than nondiabetics. Primary PCI was equally effective in restoring coronary flow in both groups and the infarct size at 30 days was similar (14.3% [7.1, 24.5] vs. 17.3% [8.1, 23.6], respectively, P = 0.55). Diabetic patients had more major cardiovascular and cerebrovascular events at 1 year (16.5% vs. 8.0%, P = 0.04). Stent thrombosis within 30 days after primary PCI was higher in diabetic than in nondiabetic subjects (4.3% vs. 0.8%, P = 0.03). CONCLUSIONS: Patients with DM presenting with STEMI had a higher baseline risk profile than those without DM. Although reperfusion success and infarct size were similar, diabetic patients experienced more death, reinfarction, stent thrombosis, and revascularization than nondiabetics.

Neutrophil-to-lymphocyte ratio and prognosis in patients undergoing percutaneous coronary intervention for acute coronary syndrome.

OBJECTIVE: The purpose of this study was to characterize Acute Coronary Syndrome (ACS)-associated inflammation by investigating correlates of the neutrophil-to-lymphocyte ratio (NLR), a surrogate marker of inflammation, and its relation to 1-year mortality in a cohort of patients undergoing percutaneous coronary intervention (PCI) for ACS at a single institution. METHODS: We performed a single-institution, retrospective, observational study of all-comer ACS patients who underwent PCI and were discharged home before the COVID-19 pandemic between September 23, 2011 and July 31, 2017 for who outcomes data were available. RESULTS: NLRhigh group tended to be older, white patients, less likely to smoke, more likely to have a history of heart failure and cardiac arrest, higher creatinine values, lower LVEF, and higher CK-MB (a surrogate for infarct size). Linear regression model demonstrated a strong correlation between increasing NLR and white race (B = 1.103, p = 0.001, hemoglobin (B = -0.30, p < 0.001), peak CK-MB (B = 0.004, p = 0.02), LVEF (B = -0.048, p < 0.001), and serum creatinine (B = 0.47, p = 0.03). There were a total of 87 deaths at one year. NLR > 3.4 was associated with worse one-year survival post-PCI (91.4 % vs. 95.4 %, log-rank p < 0.004), which was confirmed on multivariate analysis. CONCLUSION: Our data confirm the independent prognostic significance of inflammation to mortality after ACS and may provide some insight into the putative benefits of inflammation modulation.