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Objectives: Compared with ST-segment elevation myocardial infarction (STEMI) patients, non-STEMI (NSTEMI) patients have more comorbidities and extensive coronary artery disease. Contemporary comparative data on the long-term prognosis of stable post-myocardial infarction subtypes are needed., Design: Long-Term rIsk, clinical manaGement and healthcare Resource utilisation of stable coronary artery dISease (TIGRIS) was a multinational, observational and longitudinal cohort study., Setting: Patients were enrolled from 350 centres, with >95% coming from cardiology practices across 24 countries, from 19 June 2013 to 31 March 2017., Participants: This study enrolled 8277 stable patients 1-3 years after myocardial infarction with ≥1 additional risk factor., Outcome Measures: Over a 2 year follow-up, cardiovascular events and deaths and self-reported health using the EuroQol 5-dimension questionnaire score were recorded. Relative risk of clinical events and health resource utilisation in STEMI and NSTEMI patients were compared using multivariable Poisson regression models, adjusting for prognostically relevant patient factors., Results: Of 7752 patients with known myocardial infarction type, 46% had NSTEMI; NSTEMI patients were older with more comorbidities than STEMI patients. NSTEMI patients had significantly poorer self-reported health and lower prevalence of dual antiplatelet therapy at hospital discharge and at enrolment 1-3 years later. NSTEMI patients had a higher incidence of combined myocardial infarction, stroke and cardiovascular death (5.6% vs 3.9%, p<0.001) and higher all-cause mortality (4.2% vs 2.6%, p<0.001) compared with STEMI patients. Risks were attenuated after adjusting for other patient characteristics. Health resource utilisation was higher in NSTEMI patients, although STEMI patients had more cardiologist visits., Conclusions: Post-NSTEMI chronic coronary syndrome patients had a less favourable risk factor profile, poorer self-reported health and more adverse cardiovascular events during long-term follow-up than individuals post STEMI. Efforts are needed to recognise the risks of stable patients after NSTEMI and optimise secondary prevention and care., Trial Registration Number: NCT01866904., Competing Interests: Competing interests: SP and RO have received research grant support from AstraZeneca. SGG has received speaker/consulting honoraria and/or research grant support from Amgen, Anthos Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol‑Myers Squibb, CSL Behring, Daiichi Sankyo/American Regent, Eli Lilly, Esperion, Ferring Pharmaceuticals, HLS Therapeutics, JAMP Pharma, Merck, Novartis, Novo Nordisk A/C, Pendopharm/Pharmascience, Pfizer, Regeneron, Sanofi, Servier, Valeo Pharma and salary support/honoraria from the Heart and Stroke Foundation of Ontario/University of Toronto (Polo) Chair, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Cleveland Clinic Coordinating Centre for Clinical Research, Duke Clinical Research Institute, New York University Clinical Coordinating Centre, PERFUSE Research Institute, TIMI Study Group (Brigham Health). CBG has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda and The Medicines Company. JCN has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, CSL Behringer, DalCor, Esperion, Janssen, Novartis, Novo Nordisk, Sanofi, Servier and Vifor. TS has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi. DW has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik and Novartis. SY has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi Sankyo, AstraZeneca and Boehringer Ingelheim. DB has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck and Sanofi. MGC has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed and Merit Medical. KA and PRH are employees of AstraZeneca. GB-W was an employee of AstraZeneca at the time of this study. SNK and PK declare no competing interests., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Insights on the differences in clinical outcomes, quality of life (QoL) and health resource utilisation (HRU) with different levels of care available to post-acute myocardial infarction (AMI) populations in rural and urban settings are limited., Methods: The long-Term rIsk, clinical manaGement, and healthcare Resource utilisation of stable coronary artery dISease (TIGRIS), a prospective, observational registry, enrolled 8452 patients aged ≥50 years 1-3 years post-AMI from June 2013 to November 2014 from 24 countries in Asia Pacific/Australia, Europe, North America and South America. Differences in QoL (measured using the EuroQol Research Foundation instrument) and HRU between patients in rural and urban settings were evaluated in this post hoc analysis. The incidence of clinical endpoints (cardiovascular (CV) death, AMI, unstable angina with urgent revascularisation and stroke; bleeding; and all-cause mortality) was analysed. Data were collected at baseline and every 6 months for 24 months., Results: There were fewer hospitalisations and visits to general practitioners (GPs) and cardiologists in the rural versus urban populations (adjusted event rate ratio (ERR)=0.90 (95% CI, 0.82 to 1.00, p=0.04); ERR=0.84 (95% CI, 0.78 to 0.92, p<0.001); ERR=0.86 (95% CI, 0.81 to 0.92, p<0.001), respectively). No statistically significant differences were observed between rural and urban populations in all-cause death, AMI, unstable angina with urgent revascularisation, CV death, stroke, major bleeding events and health-related QoL. The adjusted incidence rate ratio was 0.92 (95% CI, 0.74 to 1.15) for the composite of CV death, AMI and stroke., Conclusions: Living in rural areas was associated with fewer GP/cardiologist visits and hospitalisations; no significant differences in clinical outcomes and QoL were observed., Trial Registration Number: NCT01866904., Competing Interests: Competing interests: JCN has received research grants from Amgen, AstraZeneca, Bayer, Esperion, CLS Behring, Dalcor, Daiichi-Sankyo, Janssen, Novartis, Novo Nordisk, Sanofi, Vifor; honoraria/consultation from Daiichi-Sankyo, Novartis, Sanofi; and a scholarship from the Brazilian National Council for Scientific and Technological Development (CNPq #303448/2021/0). RO has received research grant support from AstraZeneca. RHMF reports research grants and personal fees from AstraZeneca, Bayer, Biomm and Servier, and research grants from Pfizer, EMS, Aché, CytoDin, Brazilian Ministry of Health, University Health Network (received from his institution) and Lemann Foundation Research Fellowship. SG has received research grant support (eg, steering committee or data and safety monitoring committee) and/or speaker/consulting honoraria (eg, advisory boards) from Amgen, Anthos Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi Sankyo/American Regent, Eli Lilly, Esperion, Ferring Pharmaceuticals, HLS Therapeutics, JAMP Pharma, Merck, Novartis, Novo Nordisk A/C, Pendopharm/Pharmascience, Pfizer, Regeneron, Sanofi, Servier and Valeo Pharma, and salary support/honoraria from the Heart and Stroke Foundation of Ontario/University of Toronto (Polo) Chair, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Cleveland Clinic Coordinating Center for Clinical Research, Duke Clinical Research Institute, New York University Clinical Coordinating Centre, PERFUSE Research Institute, and TIMI Study Group (Brigham Health). CBG has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi-Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda and The Medicines Company. MGC has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed and Merit Medical. DW has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik and Novartis. SY has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi-Sankyo, AstraZeneca and Boehringer Ingelheim. TS has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi. KH and PRH are employees of AstraZeneca. DBB has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck and Sanofi. SP has received research grant support from AstraZeneca., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Data on the association of multimorbidity and functional impairment with cardiovascular (CV) and non-CV outcomes among older myocardial infarction (MI) patients are limited., Hypothesis: Multimorbidity and functional impairment among older MI patients are associated with CV and non-CV mortality., Methods: Patients aged ≥65 years, 1-3 years post-MI, and enrolled between June 2013 and Novemeber 2014 from 349 sites in 25 countries in the global TIGRIS registry were categorized by age, number of comorbidities, and presence and degree of functional impairment. Functional impairment was calculated using five-dimension EuroQol based on three domains-mobility, self-care, and usual activities. The association between age, number of comorbid conditions, and degree of functional impairment with 2-year incidence of CV and non-CV death was evaluated using Poisson regression analysis., Results: Older age was associated with higher number of comorbidities and functional impairment; after adjustment, increasing age was significantly associated with non-CV mortality (p = .03) but not CV mortality (p = .38). Greater functional impairment was associated with a higher rate and relatively equal magnitude risk of CV (rate ratios [RR] 1.52, 95% confidence intervals [CI]: 1.29-1.79, per one-step increase) and non-CV mortality (RR 1.42, 95% CI: 1.17-1.73). Multimorbidity was more strongly associated with CV mortality (RR 1.52, 95% CI: 1.38-1.67, per additional comorbidity) versus non-CV mortality (RR 1.29, 95% CI: 1.14-1.47, per additional comorbidity)., Conclusions: Multimorbidity and functional impairment are prevalent among older post-MI patients and are associated with increased CV and non-CV mortality. These findings highlight the importance of considering comorbid conditions and functional impairment as predictors of risk for adverse outcomes and aspects of medical decision making. Clinical Trial Registration: NCT01866904., (© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: Patterns of dual antiplatelet therapy (DAPT) use beyond 1 year post-myocardial infarction (MI) have not been well studied., Methods: TIGRIS (NCT01866904) was a prospective, multi-center (369 centers in 24 countries), observational study of patients 1 to 3 years post-MI. We sought to identify the prevalence and determinants of DAPT use ≥1 year post-MI in patients enrolled in TIGRIS. We used multivariable logistic regression to identify determinants of DAPT use at 396 days post-MI (365 days plus a 31day overrun period to account for intended DAPT discontinuation at 1 year). Patients treated with an oral anticoagulant were excluded., Results: Of 7708 patients (median age 67 years, women 25%, ST-elevation MI 50%), 39% and 16% were on DAPT at 396 days and 5 years post-MI, respectively. DAPT use at 396 days post-MI was more prevalent in patients <65 years of age, treated with percutaneous coronary intervention (versus coronary artery bypass grafting or medical therapy), and with multivessel disease or a history of angina. Additional clinical determinants of ischemic and/or bleeding events following MI (diabetes, second prior MI, hypertension, peripheral artery disease, heart failure, smoking, and renal insufficiency) were not independently associated with DAPT use at 396 days. There were geographic variations in the use of DAPT at 396 days (p<0.001), with the lowest use in Europe and the highest in Asia and Australia., Conclusion: In a contemporary patient cohort, DAPT use beyond 1 year post MI was prevalent and associated with patient and index event characteristics. There were marked geographical variations in DAPT use beyond 1 year post MI., Competing Interests: Declaration of Competing Interest J.J.R. has received consulting honoraria from AstraZeneca. S.J.P. has received research grant support from AstraZeneca. A.T.Y. has received research grant support from AstraZeneca D.B. has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck, and Sanofi. R.O. has received research grant support from AstraZeneca. K.A.S. is an employee of AstraZeneca. C.B.G. has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Hoffmann La Roche, Janssen Pharmaceuticals, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda, and The Medicines Company. M.G.C. has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed, and Merit Medical. S.Y. has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi-Sankyo, AstraZeneca, Boehringer Ingelheim, Bristol-Myers. J.C.N. has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, GSK, Merck, Novartis, Pfizer, and Sanofi. G.B-W. is an employee of AstraZeneca. D.W. has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin Chemie, Biotronik, and Novartis. T.S. has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, and Sanofi. S.G.G. has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, CSL Behring, Daiichi Sankyo, Eli Lilly, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, and Tenax Pharmaceuticals., (Copyright © 2021. Published by Elsevier Ltd.)

Background: The Scoreflex NC scoring angioplasty catheter is designed with a short rapid-exchange tip distal to a non-compliant, high-pressure balloon and an integral wire outside of the balloon, such that the guidewire and the integral wire act as scoring elements during balloon inflation. The external scoring elements enable a focal stress pattern facilitating expansion of resistant lesions at lower pressures using a focused force angioplasty effect., Methods: Patients undergoing elective percutaneous coronary intervention (PCI) were enrolled in a prospective, single-arm study conducted at 12 centers in the United States. The primary endpoint was device procedural success, defined as the composite of successful device delivery to the target lesion with balloon inflation and deflation; absence of vessel perforation, flow-limiting dissection or reduction in TIMI flow from baseline; and achievement of final TIMI 3 flow., Results: Among 200 patients (234 lesions), lesion complexities included: bifurcation disease (37.6%), moderate/severe calcification (36.6%), and total occlusions (5.0%). Successful delivery to the target lesion, inflation and removal of the balloon catheter was achieved in 95.5% of patients (191/200). Procedural success was achieved in 93.5% (187/200) of patients, and final TIMI 3 flow was observed in 99.0% of cases (198/200). No unanticipated device-related events occurred. In-hospital major adverse events were reported in 4.5% of patients (9/200), related to periprocedural myocardial infarction (8/200, 4.0%) and target lesion revascularization (1/200, 0.5%)., Conclusions: Among patients undergoing elective PCI and with varied lesion complexity, these results support the safety and effectiveness of a dilation strategy using the Scoreflex NC scoring catheter., Competing Interests: Declaration of competing interest The following authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Kandzari reports institutional research/grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Inc., OrbusNeich, Medtronic and Ablative Solutions; and personal consulting honoraria from Cardiovascular Systems, Inc., Magenta Medical and Medtronic. Dr. Sanghvi reports institutional research/graft support from Boston Scientific, Cardiovascular system Inc., Recor Medical, Ablative solutions and personal consulting honoraria and royalty payments from Cordis Cardinal Health. Dr. Cohen reports personal consulting honoraria from Medtronic, Merit Medical, Terumo Medical, Astra Zeneca, Zoll, and Abiomed and ownership in Accumed Radial Systems. Dr. Almonacid reports institutional grants from Boston Scientific, Medtronic, Abbott Vascular, COOK, and Terumo. Drs. Hearne, Kumar, Sachdeva, Adams, Blossom, Dahle, Imperi and Riley declare no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Atrial fibrillation (AF) and myocardial infarction (MI) are commonly comorbid and associated with adverse outcomes. Little is known about the impact of AF on quality of life and outcomes post-MI. We compared characteristics, quality of life and clinical outcomes in stable patients post-MI with/without AF., Methods/results: The prospective, international, observational TIGRIS (long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease) registry included 8406 patients aged ≥50 years with ≥1 atherothrombotic risk factor who were 1-3 years post-MI. Patient characteristics were summarised by history of AF. Quality of life was assessed at baseline using EQ-5D. Clinical outcomes over 2 years of follow-up were compared. History of AF was present in 702/8277 (8.5%) registry patients and incident AF was diagnosed in 244/7575 (3.2%) over 2 years. Those with AF were older and had more comorbidities than those without AF. After multivariable adjustment, patients with AF had lower self-reported quality-of-life scores (EQ-5D UK-weighted index, visual analogue scale, usual activities and pain/discomfort) than those without AF. CHA 2 DS 2 -VASc score ≥2 was present in 686/702 (97.7%) patients with AF, although only 348/702 (49.6%) were on oral anticoagulants at enrolment. Patients with AF had higher rates of all-cause hospitalisation (adjusted rate ratio 1.25 [1.06-1.46], p=0.008) over 2 years than those without AF, but similar rates of mortality., Conclusions: In stable patients post-MI, those with AF were commonly undertreated with oral anticoagulants, had poorer quality of life and had increased risk of clinical outcomes than those without AF., Trial Registration Number: ClinicalTrials: NCT01866904., Competing Interests: Competing interests: APC reports grant funding from the National Institutes of Health. RO has received research grant support from AstraZeneca. SJP has received research grant support from AstraZeneca. DBB has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck and Sanofi. SY has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi Sankyo, AstraZeneca, Boehringer Ingelheim and BMS. JCN has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, GSK, Merck, Novartis, Pfizer and Sanofi. SGG has received research grant support (eg, steering committee or data and safety monitoring committee) and/or speaker/consulting honoraria (eg, advisory boards) from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi Sankyo/American Regent, Eli Lilly, Esperion, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Merck, Novartis, Novo Nordisk A/C, Pendopharm, Pfizer, Regeneron, Sanofi, Servier and Valeo Pharma, and salary support/honoraria from the Heart and Stroke Foundation of Ontario/University of Toronto (Polo) Chair, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Cleveland Clinic Coordinating Center for Clinical Research, Duke Clinical Research Institute, New York University Clinical Coordinating Center and PERFUSE Research Institute. MGC has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed and Merit Medical. TS has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi. DW has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik and Novartis. KH and KAS are employees of AstraZeneca. CBG has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda and The Medicines Company., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Over the past few decades, advances in pharmacological, catheter-based, and surgical reperfusion have improved outcomes for patients with acute myocardial infarctions. However, patients with large infarcts or those who do not receive timely revascularization remain at risk for mechanical complications of acute myocardial infarction. The most commonly encountered mechanical complications are acute mitral regurgitation secondary to papillary muscle rupture, ventricular septal defect, pseudoaneurysm, and free wall rupture; each complication is associated with a significant risk of morbidity, mortality, and hospital resource utilization. The care for patients with mechanical complications is complex and requires a multidisciplinary collaboration for prompt recognition, diagnosis, hemodynamic stabilization, and decision support to assist patients and families in the selection of definitive therapies or palliation. However, because of the relatively small number of high-quality studies that exist to guide clinical practice, there is significant variability in care that mainly depends on local expertise and available resources.

Objective: To assess associations of health-related quality of life (HRQoL) with patient profile, resource use, cardiovascular (CV) events and mortality in stable patients post-myocardial infarction (MI)., Methods: The global, prospective, observational TIGRIS Study enrolled 9126 patients 1-3 years post-MI. HRQoL was assessed at enrolment and 6-month intervals using the patient-reported EuroQol-5 dimension (EQ-5D) questionnaire, with scores anchored at 0 (worst possible) and 1 (perfect health). Resource use, CV events and mortality were recorded during 2-years' follow-up. Regression models estimated the associations of index score at enrolment with patient characteristics, resource use, CV events and mortality over 2-years' follow-up., Results: Among 8978 patients who completed the EQ-5D questionnaire, 52% reported 'some' or 'severe' problems on one or more health dimensions. Factors associated with a lower index score were: female sex, older age, obesity, smoking, higher heart rate, less formal education, presence of comorbidity (eg, angina, stroke), emergency room visit in the previous 6 months and non-ST-elevation MI as the index event. Compared with an index score of 1 at enrolment, a lower index score was associated with higher risk of all-cause death, with an adjusted rate ratio of 3.09 (95% CI 2.20 to 4.31), and of a CV event, with a rate ratio of 2.31 (95% CI 1.76 to 3.03). Patients with lower index score at enrolment had almost two times as many hospitalisations over 2-years' follow-up., Conclusions: Clinicians managing patients post-acute coronary syndrome should recognise that a poorer HRQoL is clearly linked to risk of hospitalisations, major CV events and death., Trial Registration Number: ClinicalTrials.gov Registry (NCT01866904) (https://clinicaltrials.gov)., Competing Interests: Competing interests: SP has received research grant support from AstraZeneca. DBB has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck and Sanofi. RO has received research grant support from AstraZeneca. JC has received research grant support from AstraZeneca and consulting honoraria from MicroPort, APT Medical and JW Medical. MGC has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed and Merit Medical. SG has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, CSL Behring, Daiichi Sankyo/American Regent, Eli Lilly, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Servier and Tenax Pharmaceuticals. CBG has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Metronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda and The Medicines Company. JCN has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, GSK, Merck, Novartis, Pfizer and Sanofi. TS has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi. DW has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik and Novartis. SY has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi Sankyo, AstraZeneca, Boehringer Ingelheim and BMS. KH, CM and KAS are employees of AstraZeneca., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Diabetes mellitus (DM) is associated with increased cardiovascular (CV) risk. We compared health-related quality of life (HRQoL), healthcare resource utilization (HRU), and clinical outcomes of stable post-myocardial infarction (MI) patients with and without DM., Hypothesis: In post-MI patients, DM is associated with worse HRQoL, increased HRU, and worse clinical outcomes., Methods: The prospective, observational long-term risk, clinical management, and healthcare Resource utilization of stable coronary artery disease study obtained data from 8968 patients aged ≥50 years 1 to 3 years post-MI (369 centers; 25 countries). Patients with ≥1 of the following risk factors were included: age ≥65 years, history of a second MI >1 year before enrollment, multivessel coronary artery disease, creatinine clearance ≥15 and <60 mL/min, and DM treated with medication. Self-reported health status was assessed at baseline, 1 and 2 years and converted to EQ-5D scores. The main outcome measures were baseline HRQoL and HRU during follow-up., Results: DM at enrollment was 33% (2959 patients, 869 insulin treated). Mean baseline EQ-5D score (0.86 vs 0.82; P < .0001) was higher; mean number of hospitalizations (0.38 vs 0.50, P < .0001) and mean length of stay (LoS; 9.3 vs 11.5; P = .001) were lower in patients without vs with DM. All-cause death and the composite of CV death, MI, and stroke were significantly higher in DM patients, with adjusted 2-year rate ratios of 1.43 (P < .01) and 1.55 (P < .001), respectively., Conclusions: Stable post-MI patients with DM (especially insulin treated) had poorer EQ-5D scores, higher hospitalization rates and LoS, and worse clinical outcomes vs those without DM. Strategies focusing specifically on this high-risk population should be developed to improve outcomes., Trial Registration: ClinicalTrials.gov: NCT01866904 (https://clinicaltrials.gov)., (© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Background: Evidence is lacking on long-term outcomes in unselected patients surviving the first year following myocardial infarction (MI)., Methods and Results: The TIGRIS (long-Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients) prospective registry enrolled 9176 eligible patients aged ≥50 years, 1-3 years post-MI, from 25 countries. All had ≥1 risk factor: age ≥ 65 years, diabetes mellitus, second prior MI, multivessel coronary artery disease, chronic kidney disease (CKD). Primary outcome was a composite of MI, unstable angina with urgent revascularization, stroke, or all-cause death at 2-year follow-up. Bleeding requiring hospitalization was also recorded. 9027 patients (98.4%) provided follow-up data: the primary outcome occurred in 621 (7.0%), all-cause mortality in 295 (3.3%), and bleeding in 109 (1.2%) patients. Events accrued linearly over time. In multivariable analyses, qualifying risk factors were associated with increased risk of primary outcome (incidence rate ratio [RR] per 100 patient-years [95% confidence interval]): CKD 2.06 (1.66, 2.55), second prior MI 1.71 (1.38, 2.10), diabetes mellitus 1.63 (1.39, 1.92), age ≥ 65 years 1.53 (1.28, 1.83), and multivessel disease 1.24 (1.05, 1.48). Risk of bleeding events was greater in older patients (vs <65 years) 65-74 years 2.68 (1.53, 4.70), ≥75 years 4.62 (2.57, 8.28), and those with CKD 1.99 (1.18, 3.35)., Conclusion: In stable patients recruited 1-3 years post-MI, recurrent cardiovascular and bleeding events accrued linearly over 2 years. Factors independently predictive of ischemic and bleeding events were identified, providing a context for deciding on treatment options., Competing Interests: Declaration of competing interest D.B. Speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Merck, Novartis, Sanofi. S.J.P. Statistical consulting honoraria from AstraZeneca. S.B. Speaker/consulting honoraria and/or research grant support from Abbott, Abbott Diagnostics, AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Pfizer, Roche, Siemens, Siemens Diagnostics, Thermo Fisher Scientific. J.-Y.C. Research grant support from AstraZeneca; consulting honoraria from MicroPort, APT Medical and JW Medical. M.G.C. Speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed, Merit Medical. C.B.G. Consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly and Company, Gilead, GlaxoSmithKline, F. Hoffmann-La Roche, Janssen Pharmaceuticals, Metronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda Pharmaceutical Company, The Medicines Company. R.G. None. J.C.N. Speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, CLS Behring, Pfizer, Sanofi. T.S. Speaker/consulting honoraria and/or research grant support from Astellas, Amgen Inc., AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline, Merck, Novartis, Pfizer, Sanofi. D.W. Speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik, Novartis. S.Y. Speaker/consulting honoraria and/or research grant support from Takeda Pharmaceutical Company, Daiichi-Sankyo, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb. J.G. Grants from AstraZeneca during the conduct of the study and outside the submitted work. K.L.R. Employee of OXON Epidemiology Ltd., and paid consultant to AstraZeneca in connection with the conduct, data management and analyses of this study. K.H. Employee of AstraZeneca. K.A.S. Employee of AstraZeneca. S.G.G. Speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CSL Behring, Daiichi Sankyo, Eli Lilly and Company, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, Tenax Pharmaceuticals, HLS Therapeutics, Novo-Nordisk., (Copyright © 2020. Published by Elsevier B.V.)

Background: Risk prediction tools are lacking for patients with stable disease some years after myocardial infarction (MI)., Hypothesis: A practical long-term cardiovascular risk index can be developed., Methods: The long-Term rIsk, Clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients prospective global registry enrolled patients 1 to 3 years post-MI (369 centers; 25 countries), all with ≥1 risk factor (age ≥65 years, diabetes mellitus requiring medication, second prior MI, multivessel coronary artery disease, or chronic non-end-stage kidney disease [CKD]). Self-reported health was assessed with EuroQoL-5 dimensions. Multivariable Poisson regression models were used to determine key predictors of the primary composite outcome (MI, unstable angina with urgent revascularization [UA], stroke, or all-cause death) over 2 years., Results: The primary outcome occurred in 621 (6.9%) of 9027 eligible patients: death 295 (3.3%), MI 195 (2.2%), UA 103 (1.1%), and stroke 58 (0.6%). All events accrued linearly. In a multivariable model, 11 significant predictors of primary outcome (age ≥65 years, diabetes, second prior MI, CKD, history of major bleed, peripheral arterial disease, heart failure, cardiovascular hospitalization (prior 6 months), medical management (index MI), on diuretic, and poor self-reported health) were identified and combined into a user-friendly risk index. Compared with lowest-risk patients, those in the top 16% had a rate ratio of 6.9 for the primary composite, and 18.7 for all-cause death (overall c-statistic; 0.686, and 0.768, respectively). External validation was performed using the Australian Cooperative National Registry of Acute Coronary Care, Guideline Adherence and Clinical Events registry (c-statistic; 0.748, and 0.849, respectively)., Conclusions: In patients >1-year post-MI, recurrent cardiovascular events and deaths accrue linearly. A simple risk index can stratify patients, potentially helping to guide management., (© 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.)

Background: Previous studies comparing outcomes between culprit vessel only percutaneous coronary intervention (CV-PCI) versus multivessel percutaneous coronary intervention (MV-PCI) in patients with cardiogenic shock in the setting of acute myocardial infarction have shown conflicting results. This meta-analysis investigates the optimal approach for management of these patients considering recently published data., Methods: Electronic databases including MEDLINE, ClinicalTrials.gov and the Cochrane Library were searched for all clinical studies published until May 1, 2018, which compared outcomes in patients presenting with acute myocardial infarction and cardiogenic shock. Studies comparing CV-PCI versus MV-PCI in patients with multivessel coronary artery disease were screened for inclusion in final analysis. The primary end point was in-hospital/30 day mortality. Secondary endpoints included long term (>6 months) mortality, renal failure requiring renal replacement therapy, stroke, bleeding, and recurrent myocardial infarction. Odds ratio (OR) with 95% of confidence interval (CI) were computed and p values <0.05 were considered significant., Results: Patient who underwent CV-PCI had significantly lower short-term mortality (in-hospital or 30-day mortality) (OR: 0.73, CI: 0.61-0.87, p = 0.0005), and lower odds of severe renal failure requiring renal replacement therapy (OR: 0.76, CI: 0.59-0.98, p = 0.03). There was no statistically significant difference in long-term mortality, stroke, bleeding, and recurrent myocardial infarction between two groups., Conclusion: This meta-analysis showed lower short-term mortality and decreased odds of renal failure requiring renal replacement therapy with CV-PCI compared to MV-PCI. However, subgroup analysis including studies exclusively assessing STEMI patients revealed no statistically significant difference in outcomes. Further randomized trials are needed to confirm these findings and evaluate long term results., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Rationale: Cell dose and concentration play crucial roles in phenotypic responses to cell-based therapy for heart failure., Objective: To compare the safety and efficacy of 2 doses of allogeneic bone marrow-derived human mesenchymal stem cells identically delivered in patients with ischemic cardiomyopathy., Methods and Results: Thirty patients with ischemic cardiomyopathy received in a blinded manner either 20 million (n=15) or 100 million (n=15) allogeneic human mesenchymal stem cells via transendocardial injection (0.5 cc per injection × 10 injections per patient). Patients were followed for 12 months for safety and efficacy end points. There were no treatment-emergent serious adverse events at 30 days or treatment-related serious adverse events at 12 months. The Major Adverse Cardiac Event rate was 20.0% (95% confidence interval [CI], 6.9% to 50.0%) in 20 million and 13.3% (95% CI, 3.5% to 43.6%) in 100 million ( P =0.58). Worsening heart failure rehospitalization was 20.0% (95% CI, 6.9% to 50.0%) in 20 million and 7.1% (95% CI, 1.0% to 40.9%) in 100 million ( P =0.27). Whereas scar size reduced to a similar degree in both groups: 20 million by -6.4 g (interquartile range, -13.5 to -3.4 g; P =0.001) and 100 million by -6.1 g (interquartile range, -8.1 to -4.6 g; P =0.0002), the ejection fraction improved only with 100 million by 3.7 U (interquartile range, 1.1 to 6.1; P =0.04). New York Heart Association class improved at 12 months in 35.7% (95% CI, 12.7% to 64.9%) in 20 million and 42.9% (95% CI, 17.7% to 71.1%) in 100 million. Importantly, proBNP (pro-brain natriuretic peptide) increased at 12 months in 20 million by 0.32 log pg/mL (95% CI, 0.02 to 0.62; P =0.039), but not in 100 million (-0.07 log pg/mL; 95% CI, -0.36 to 0.23; P =0.65; between group P =0.07)., Conclusions: Although both cell doses reduced scar size, only the 100 million dose increased ejection fraction. This study highlights the crucial role of cell dose in the responses to cell therapy. Determining optimal dose and delivery is essential to advance the field, decipher mechanism(s) of action and enhance planning of pivotal Phase III trials., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02013674., (© 2017 American Heart Association, Inc.)

Objective: To analyze trends in management and outcomes of patients infected with the human immunodeficiency virus (HIV) undergoing percutaneous coronary intervention (PCI) for an acute myocardial infarction (AMI) in the United States., Background: Infection with HIV is an independent risk factor for accelerated atherosclerosis associated with higher rates of AMI. Current trends and outcomes of HIV-infected individuals presenting with AMI in the United States remain unknown., Methods: Using the Healthcare Cost and Utilization Project National Inpatient Sample database we identified HIV-infected individuals who underwent PCI for an AMI from 2002 to 2013. Multivariable logistic regression and propensity-score matching were performed to analyze outcomes., Results: We identified a total of 59 194 patients of which 7841 underwent PCI during index hospitalization (13.3%). Most patients were men (71%), ≥50 years of age (82%), and white (74%). ST-elevation myocardial infarction was present in 21% of cases. Charlson comorbidity index (CCI) was 5.67 ± 0.4. Predictors of post-procedural complications included female sex, black race, higher CCI, and placement of a bare metal stent, whereas predictors of mortality included occurrence of a complication, ST-elevation myocardial infarction, age ≥70 years, and higher CCI. Conversely, placement of a drug-eluting stent was associated with a reduced risk of complications and mortality. After propensity-score matching, HIV-infected individuals were less likely to undergo PCI and receive a drug-eluting stent, while having longer length of stay, higher hospitalization costs, and higher in-hospital mortality when compared to non-infected individuals., Conclusion: Significant disparities continue to affect HIV-infected individuals undergoing PCI for AMI in the United States., (© 2017, Wiley Periodicals, Inc.)

Background: Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. Operator volume patterns and associated outcomes since this change are unknown., Objectives: The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample., Methods: Using data from the National Cardiovascular Data Registry collected between July 1, 2009, and March 31, 2015, we examined operator annual PCI volume. We divided operators into low- (<50 PCIs per year), intermediate- (50 to 100 PCIs per year), and high- (>100 PCIs per year) volume groups, and determined the adjusted association between annual PCI volume and in-hospital outcomes, including mortality., Results: The median annual number of procedures performed per operator was 59; 44% of operators performed <50 PCI procedures per year. Low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. Unadjusted in-hospital mortality was 1.86% for low-volume operators, 1.73% for intermediate-volume operators, and 1.48% for high-volume operators. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio: 1.16 for low versus high; adjusted odds ratio: 1.05 for intermediate vs. high volume) as was the risk for new dialysis post PCI. No volume relationship was observed for post-PCI bleeding., Conclusions: Many PCI operators in the United States are performing fewer than the recommended number of PCI procedures annually. Although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Percutaneous coronary intervention (PCI) is an integral treatment modality for acute coronary syndromes (ACS) as well as chronic stable coronary artery disease (CAD) not responsive to optimal medical therapy. This coupled with studies on the feasibility and safety of performing PCI in centers without on-site surgical backup led to widespread growth of PCI centers. However, this has been accompanied by a recent steep decline in the volume of PCIs at both the operator and hospital level, which raises concerns regarding minimal procedural volumes required to maintain necessary skills and favorable clinical outcomes. The 2011 ACC/AHA/SCAI competency statement required PCI be performed by operators with a minimal procedural volume of >75 PCIs annually at high-volume centers with >400 PCIs per year, a number which was relaxed in the 2013 ACC/AHA/SCAI update to >50 PCIs/operator/year in hospitals with >200 PCIs annually to coincide with reduction in national PCI volume. Recent data suggests that many hospitals do not meet these thresholds. We review data on the importance of volume as a vital quality metric at both an operator and hospital level in determining procedural outcomes following PCI.

Fibrinolytic therapy is still used in patients with ST-segment elevation myocardial infarction (STEMI) when the primary percutaneous coronary intervention cannot be provided in a timely fashion. Management strategies and outcomes in transferred fibrinolytic-treated STEMI patients have not been well assessed in real-world settings. Using the Nationwide Inpatient Sample from 2008 to 2012, we identified 18 814 patients with STEMI who received fibrinolytic therapy and were transferred to a different facility within 24 hours. The primary outcome was in-hospital mortality. Secondary outcomes included gastrointestinal bleeding, bleeding requiring transfusion, intracranial hemorrhage (ICH), length of stay, and cost. The patients were divided into 3 groups: those who received medical therapy alone (n = 853; 4.5%), those who underwent coronary artery angiography without revascularization (n = 2573; 13.7%), and those who underwent coronary artery angiography with revascularization (n = 15 388; 81.8%). Rates of in-hospital mortality among the groups were 20% vs 6.6% vs 2.1%, respectively (P < 0.001); ICH was 8.5% vs 1.1% vs 0.6%, respectively (P < 0.001); and gastrointestinal bleeding was 1.1% vs 0.4% vs 0.4%, respectively (P = 0.011). Multivariate analysis identified increasing age, higher Charlson Comorbidity Index score, cardiogenic shock, cardiac arrest, and ICH as the independent predictors of not performing coronary artery angiography and/or revascularization in patients with STEMI initially treated with fibrinolytic therapy. The majority of STEMI patients transferred after receiving fibrinolytic therapy undergo coronary angiography. However, notable numbers of patients do not receive revascularization, especially patients with cardiogenic shock and following a cardiac arrest., (© 2016 Wiley Periodicals, Inc.)

Background: The Trial of Routine Aspiration Thrombectomy with PCI versus PCI alone in patients with STEMI (TOTAL trial) refuted the salutary effect of routine aspiration thrombectomy (AT) in PPCI for patients with ST-elevation myocardial infarction (STEMI)., Objectives: We performed an updated meta-analysis to assess clinical outcomes with AT prior to PPCI compared with conventional PPCI alone including the additional trial data., Methods and Results: Clinical trials (n = 20) that randomized patients (n = 21,281) with STEMI between Routine AT (n = 10,619) and PPCI (n = 10,662) were pooled. There was no difference in all-cause mortality between the 2 groups (RR: 0.89, 95%CI: 0.78-1.01, P = 0.08). Stratifying by follow up at 1-month (RR: 0.87, 95%CI: 0.69-1.10, P = 0.25), up to 6 months (RR: 0.91, 95%CI: 0.74-1.13, P = 0.39 and beyond 6 months (RR: 0.88, 95%CI: 0.74-1.05, P = 0.16) yielded similar results. There was a statistically significant increase risk of stoke rate in the AT arm (RR: 1.51, 95%CI: 1.01-2.25, P = 0.04). The 2 groups were similar with regards to target vessel revascularization (0.94, 95%CI: 0.83-1.06, P = 0.28) recurrent MI (RR: 0.96, 95%CI: 0.80-1.16, P = 0.68, MACE events (RR: 0.91 95%CI: 0.81-1.02, P = 0.11), early (0.59, 95%CI: 0.23-1.50, P = 0.27) and late (RR: 0.91, 95%CI: 0.69-1.18, P = 0.47) stent thrombosis and net clinical benefit (RR 0.99, 95%CI: 0.91-1.07, P = 0.76)., Conclusion: Routine AT prior to PPCI in STEMI is associated with higher risk of stroke. There is no statistical difference in clinical outcome parameters of mortality, major adverse cardiac events, target vessel revascularization, stent thrombosis, and net clinical benefit between AT and PCI alone., (© 2015, Wiley Periodicals, Inc.)

Aims: We sought to determine the feasibility of conducting percutaneous coronary intervention (PCI) in high-risk acute coronary syndrome (ACS) patients utilising the REG1 system consisting of pegnivacogin, an aptameric factor IXa inhibitor, and its controlling agent anivamersen., Methods and Results: In RADAR, ACS patients were randomised to pegnivacogin 1 mg/kg with 25%, 50%, 75%, or 100% anivamersen reversal or unfractionated heparin. Of the 640 patients randomised, 388 (61%) underwent PCI. Major modified ACUITY 30-day bleeding rates were 18% (25% reversal), 12% (50% reversal), 9% (75% reversal), and 7% (100% reversal), compared with 11% with heparin. The corresponding total bleeding rates were 68%, 39%, 35%, 34%, and 38% (heparin). Ischaemic events were less frequent in those receiving pegnivacogin versus heparin (4.4% vs. 7.3%, p=0.3). Thirty-day urgent TVR (1.1% vs. 0.9%, p=1.0), myocardial infarction (4.0% vs. 6.4%, p=0.3), and angiographic complication (11.2% and 10.8%, p=0.9) rates were similar with pegnivacogin and heparin. There were no incidences of clot formation on guidewires or catheters., Conclusions: High-level factor IXa inhibition in ACS patients undergoing PCI, with at least 50% reversal, has a favourable bleeding profile and appears effective at suppressing ischaemic events and thrombotic complications. Larger phase trials in PCI are warranted., Clinical Trials Registration: ClinicalTrials.gov NCT00932100.

Aims: Establishing factor IX inhibition in patients with acute coronary syndrome/non-ST-elevation myocardial infarction (ACS/NSTEMI), a setting characterized by increased factor IX activity, is critical to investigate the REG1 system in this target population. The REG1 system (Regado Biosciences, Basking Ridge, NJ) consists of pegnivacogin (RB006), an RNA aptamer that directly inhibits factor IXa, and anivamersen (RB007), its complementary control agent., Methods and Results: RADAR is a Phase 2b study investigating the use of pegnivacogin in patients (n = 800) with ACS undergoing planned early cardiac catheterization. To validate dose selection and stability of anticoagulation throughout the time of cardiac catheterization at an early stage of the clinical trial, 33 patients, 22 of whom had not received recent prior heparin, underwent thorough pharmacokinetic and pharmacodynamic assessment. Fold prolongation of activated partial thromboplastin time (aPTT) was used to impute factor IX inhibition. Pegnivacogin 1 mg/kg rapidly achieved a high pegnivacogin plasma concentration (26.1 ± 4.6 µg/mL), prolonged the aPTT (mean aPTT 93.0 ± 9.5 s), and approached near complete factor IX inhibition (mean fold increase from baseline 2.9 ± 0.3). These levels remained stable from the time of drug administration through completion of the catheterization., Conclusion: Pegnivacogin administered at a weight-adjusted dose of 1 mg/kg consistently achieves a high level of factor IX activity inhibition among patients with ACS and provides stable anticoagulation during cardiac catheterization. These findings support the dose of pegnivacogin selected for the RADAR study.

Background: Racial/ethnic differences in cardiovascular care have been well documented. We sought to determine whether racial/ethnic differences in evidence-based acute myocardial infarction care persist among hospitals participating in a national quality improvement program., Methods and Results: We analyzed 142 593 acute myocardial infarction patients (121 528 whites, 10 882 blacks, and 10 183 Hispanics) at 443 hospitals participating in the Get With the Guidelines-Coronary Artery Disease (GWTG-CAD) program between January 2002 and June 2007. We examined individual and overall composite rates of defect-free care, defined as the proportion of patients receiving all eligible performance measures. In addition, we examined temporal trends in use of performance measures according to race/ethnicity by calendar quarter. Overall, individual performance measure use was high, ranging from 78% for use of angiotensin-converting enzyme inhibitors to 96% for use of aspirin at discharge. Use of each of these improved significantly over the 5 years of study. Overall, defect-free care was 80.9% for whites, 79.5% for Hispanics (adjusted odds ratio versus whites 1.00, 95% confidence interval 0.94 to 1.06, P=0.94), and 77.7% for blacks (adjusted odds ratio versus whites 0.93, 95% confidence interval 0.87 to 0.98, P=0.01). A significant gap in defect-free care was observed for blacks mostly during the first half of the study, which was no longer present during the remainder of the study. Overall, progressive improvements in defect-free care were observed regardless of race/ethnic groups., Conclusions: Among hospitals engaged in a national quality monitoring and improvement program, evidence-based care for acute myocardial infarction appeared to improve over time for patients irrespective of race/ethnicity, and differences in care by race/ethnicity care were reduced or eliminated.

Administration of fibrinolytic, antiplatelet, and antithrombotic agents by the intracoronary route may disaggregate clot, but the potential role of the mechanical force of the injection itself in decreasing clot burden has not been studied. Patients with ST-segment elevation myocardial infarction who were pretreated in the emergency room (ER) with unfractionated heparin and aspirin in the TITAN-TIMI 34 study were randomized to treatment with eptifibatide in the ER (n = 131) versus after diagnostic catheterization (n = 150). Quantitative coronary angiography was used to assess change in diameter stenosis from time of first contrast injection to injection before percutaneous coronary intervention (PCI) immediately preceding wire placement down the culprit artery in a matching view. Successful perfusion of the myocardium was assessed after PCI by the presence of Thrombolysis In Myocardial Infarction myocardial perfusion grade of 2 or 3. In patients treated with eptifibatide in the ER, there was a 1.3% absolute improvement in diameter stenosis from the first injection to the injection before PCI (p = 0.02), whereas there was no change in diameter stenosis in patients not treated with eptifibatide in the ER (0.0%, p = NS). Each 1% improvement in percent diameter stenosis during diagnostic injections before PCI was strongly correlated with an open muscle after PCI (adjusted odds ratio 1.09, 95% confidence interval 1.02 to 1.16, p = 0.012). In conclusion, the mechanical force of a contrast injection decreases thrombotic burden in patients with ST-segment elevation myocardial infarction pretreated with eptifibatide but not with placebo. Future trials of intracoronary pharmacotherapies should include a control arm in which saline is injected to account for the potential clot disaggregation that occurs as a result of iodinated contrast injections, particularly if the patient has been pretreated with aggressive pharmacotherapy.

Purpose: An analysis of reginal variation across the United States in the treatment and outcomes of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) has not been previously performed., Subjects and Methods: We assessed contemporary practice and outcomes in 56,466 high-risk patients with NSTE ACS (positive cardiac markers and/or ischemic ST-segment changes) admitted to 310 hospitals across four defined regions in the United States from January 1, 2001, to September 30, 2003. Patient clinical characteristics, acute (<24 hours) and discharge medications, in-hospital procedures, and in-hospital case-fatality rates were evaluated., Results: Statistically significant but clinically small differences in baseline characteristics including age, gender, rates of diabetes, hypertension, and smoking, as well as medical treatment, including a greater than 5% variation in acute use of beta-blockers, clopidogrel, and statins use, were noted across regions. Adjusted rates of revascularization were similar across regions. Overall in-hospital case-fatality rate was 4.1%, with the highest rates in the Midwest (4.6%) and the lowest in the Northeast (3.5%). Adjusted odds ratios (OR) (95% confidence interval [CI] for death were significantly higher in the Midwest (OR 1.42, CI 1.19-1.70), West (OR 1.40 CI 1.05-1.87), and South (OR 1.33, CI 1.08-1.62), compared with the Northeast., Conclusions: Management of high-risk patients with NSTE ACS is relatively uniform across the United States. However, in-hospital case-fatality rates vary significantly by region, and the differences are not explained by adjustment for standard clinical variables.

Background: Black patients with acute myocardial infarction are less likely than whites to receive coronary interventions. It is unknown whether racial disparities exist for other treatments for non-ST-segment elevation acute coronary syndromes (NSTE ACS) and how different treatments affect outcomes., Methods and Results: Using data from 400 US hospitals participating in the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines?) National Quality Improvement Initiative, we identified black and white patients with high-risk NSTE ACS (positive cardiac markers and/or ischemic ST-segment changes). After adjustment for demographics and medical comorbidity, we compared the use of therapies recommended by the American College of Cardiology/American Heart Association guidelines for NSTE ACS and outcomes by race. Our study included 37,813 (87.3%) white and 5504 (12.7%) black patients. Black patients were younger; were more likely to have hypertension, diabetes, heart failure, and renal insufficiency; and were less likely to have insurance coverage or primary cardiology care. Black patients had a similar or higher likelihood than whites of receiving older ACS treatments such as aspirin, beta-blockers, or ACE inhibitors but were significantly less likely to receive newer ACS therapies, including acute glycoprotein IIb/IIIa inhibitors, acute and discharge clopidogrel, and statin therapy at discharge. Blacks were also less likely to receive cardiac catheterization, revascularization procedures, or smoking cessation counseling. Acute risk-adjusted outcomes were similar between black and white patients., Conclusions: Black patients with NSTE ACS were less likely than whites to receive many evidence-based treatments, particularly those that are costly or newer. Longitudinal studies are needed to assess the long-term impact of these treatment disparities on clinical outcomes.

Facilitated percutaneous coronary intervention (PCI) refers to a strategy of immediate PCI following the administration of pharmacological therapies in acute myocardial infarction. It has evolved primarily from the time delays (due to geography or logistics) in getting acute myocardial infarction patients to the catheterization laboratory and the associated irreversible loss of myocardial muscle that occurs as door-to-balloon time increases. Facilitated PCI provides an opportunity to start treating many of these patients before they reach the catheterization laboratory and provides an ability to open the infarct-related artery before PCI, which is associated with better outcomes for AMI patients. Pharmacological strategies before PCI include: thrombolytic therapy, glycoprotein IIb/IIIa inhibitor alone, or a combination of thrombolytic therapy plus glycoprotein IIb/IIIa inhibitor. Initial results of angiographic studies show better patency with the latter strategy but at the expense of higher bleeding event rates. Ongoing trials are evaluating different combinations of thrombolytic and glycoprotein IIb/IIIa inhibitor therapy.

Background: Primary percutaneous coronary intervention (PCI) has become an alternative to thrombolytic therapy as a reperfusion strategy for ST-elevation acute myocardial infarction (AMI)., Methods: The main goal of this study was to determine whether PCI and thrombolytic therapy achieve comparable reperfusion rates, as evidenced by ST-segment resolution. Secondary end points included infarct vessel patency rates before hospital discharge and short- and long-term outcomes. Patients with ischemic chest pain with duration < or =12 hours and no contraindication for thrombolytic therapy were included., Results: Between October 1993 and August 1995, 58 patients were randomly assigned to streptokinase (SK) and 54 patients to primary PCI. Baseline clinical characteristics and infarct location were well balanced in both groups. Median age (interquartile range) was 68 (58, 75) years, 29% were women, and 78% of the patients met at least one criterion for "not low risk" AMI (anterior location, age >70 years old, previous MI, systolic blood pressure <100 mm Hg, and/or heart rate >100 bpm). The median time from symptom onset to random assignment was 217 (139, 335) minutes in the PCI group and 210 (145, 334) minutes in the SK group. Median random assignment to balloon time was 82 (55, 100) minutes, and median random assignment to needle time was 15 (10, 26) minutes (P <.0001). TIMI grade 3 flow after primary PCI was obtained in 85% of patients. The proportion of patients with ST-segment resolution > or =50% at 120 minutes was 80% in the PCI group and 50% in the SK group (P =.001). The predischarge angiogram showed the presence of TIMI 3 flow in 96% of patients who received PCI and 65% of patients who received SK (P <.001). A composite of in-hospital death, reinfarction, severe heart failure, stroke, and major bleeding occurred in 15% of patients who received PCI and 21% of patients who received SK (P =.4). At 3 years, freedom from the composite end point of AMI, postdischarge revascularization, and death was 61% in the PCI group and 40% in the SK group (P =.025)., Conclusions: Our study shows that primary PCI, as compared with SK, is associated with more effective ST-segment resolution, higher patency rates in the infarct vessel at 7 days, and more favorable clinical outcomes at 3 years of follow-up.

In preclinical experiments, the combination of transcutaneous, low-frequency ultrasound and thrombolytic therapy has shown improved patency rates over thrombolytics alone. A total of 25 patients with myocardial infarction were treated with a thrombolytic agent and adjunctive transcutaneous ultrasound. No unanticipated major adverse events were observed.

Primary revascularization (PR) and thrombolytic therapy (TT) reduce infarct size and mortality in patients with ST-segment elevation acute myocardial infarction (AMI). Electrocardiogram methods can determine the extent of myocardial salvage with different AMI therapies by comparing infarct size predicted by initial ST-segment changes and infarct size estimated by later quantitative QRS scores. In a community hospital setting, we used quantitative electrocardiogram methods to estimate infarct size and myocardial salvage associated with TT and PR amongst 50 patients presenting with inferior ST-segment elevation AMI. Baseline and electrocardiogram characteristics did not differ between TT (n = 29) and PR (n = 21) patients. There was no difference in median myocardial salvage (%) between TT vs. PR groups, (38.3% vs. 44.9% respectively, P =.66). Among patients with inferior AMI, myocardial salvage was achieved with both TT and PR therapy and did not differ significantly between reperfusion strategies.

Risk-averse behavior has been reported among physicians and facilities treating cardiogenic shock in states with public reporting. Our objective was to evaluate if public reporting leads to a lower use of mechanical circulatory support in cardiogenic shock. We conducted a retrospective study with the use of the National Inpatient Sample from 2005 to 2011. Hospitalizations of patients ≥18 years old with a diagnosis of cardiogenic shock were included. A regional comparison was performed to identify differences between reporting and nonreporting states. The main outcome of interest was the use of mechanical circulatory support. A total of 13043 hospitalizations for cardiogenic shock were identified of which 9664 occurred in reporting and 3379 in nonreporting states (age 69.9 ± 0.4 years, 56.8% men). Use of mechanical circulatory support was 32.8% in this high-risk population. Odds of receiving mechanical circulatory support were lower (OR 0.50; 95% CI 0.43-0.57; p < 0.01) and in-hospital mortality higher (OR 1.19; 95% CI 1.06-1.34; p < 0.01) in reporting states. Use of mechanical circulatory support was also lower in the subgroup of patients with acute myocardial infarction and cardiogenic shock in reporting states (OR 0.61; 95% CI 0.51-0.72; p < 0.01). In conclusion, patients with cardiogenic shock in reporting states are less likely to receive mechanical circulatory support than patients in nonreporting states. [ABSTRACT FROM AUTHOR]

Aims We sought to determine whether the extent of myocardial ischaemia on the admission electrocardiogram (ECG) has independent predictive value for short-term risk stratification of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS). Although the presence of ischaemic ECG changes on admission has been shown to predict outcome, the relationship between the extent of ECG changes and the risk of cardiac events is still ill defined. [ABSTRACT FROM PUBLISHER]

Keywords: AHA Scientific Statements; percutaneous coronary intervention; angioplasty; coronary artery bypass graft surgery; myocardial infarction; cardiac surgery; stent(s); angiogram; angiography; percutaneous transluminal coronary angioplasty; coronary atherosclerosis; saphenous vein graft; internal mammary artery graft; internal thoracic artery graft; arterial graft; post-bypass; non-ST-segment-elevated myocardial infarction; vein graft lesions; myocardial revascularization; multivessel PCI; left ventricular dysfunction EN AHA Scientific Statements percutaneous coronary intervention angioplasty coronary artery bypass graft surgery myocardial infarction cardiac surgery stent(s) angiogram angiography percutaneous transluminal coronary angioplasty coronary atherosclerosis saphenous vein graft internal mammary artery graft internal thoracic artery graft arterial graft post-bypass non-ST-segment-elevated myocardial infarction vein graft lesions myocardial revascularization multivessel PCI left ventricular dysfunction e18 e114 97 01/21/22 20220118 NES 220118 SP * sp Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry may apply; see Appendix 1 for detailed information. Patients who are most appropriate for complete revascularization at the time of primary PCI include those with uncomplicated PCI of the infarct artery and with low-complexity non-infarct artery disease who have normal left ventricular filling pressures and normal renal function. Recommendation-Specific Supportive Text After controlling for greater baseline comorbidities among patients undergoing revascularization, several observational studies have demonstrated that Black,[28],[52] Hispanic,[24],[50] and Asian [55],[56] patients have outcomes similar to those of White patients. [Extracted from the article]

Aim: The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use.Methods: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline. [ABSTRACT FROM AUTHOR]

Aim: The guideline for coronary artery revascularization replaces the 2011 coronary artery bypass graft surgery and the 2011 and 2015 percutaneous coronary intervention guidelines, providing a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization as well as the supporting documentation to encourage their use.Methods: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered.Structure: Coronary artery disease remains a leading cause of morbidity and mortality globally. Coronary revascularization is an important therapeutic option when managing patients with coronary artery disease. The 2021 coronary artery revascularization guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with coronary artery disease who are being considered for coronary revascularization, with the intent to improve quality of care and align with patients' interests. [ABSTRACT FROM AUTHOR]

Aim: The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use.Methods: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered.Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline. [ABSTRACT FROM AUTHOR]

Background: Although many studies show an inverse association between operator procedural volume and short-term adverse outcomes after percutaneous coronary intervention (PCI), the association between procedural volume and longer-term outcomes is unknown.Methods: Using the National Cardiovascular Data Registry CathPCI registry data linked with Medicare claims data, we examined the association between operator PCI volume and long-term outcomes among patients ≥65 years of age. Operators were stratified by average annual PCI volume (counting PCIs performed in patients of all ages): low- (<50 PCIs), intermediate- (50-100), and high- (>100) volume operators. One-year unadjusted rates of death and major adverse coronary events (MACEs; defined as death, readmission for myocardial infarction, or unplanned coronary revascularization) were calculated with Kaplan-Meier methods. The proportional hazards assumption was not met, and risk-adjusted associations between operator volume and outcomes were calculated separately from the time of PCI to hospital discharge and from hospital discharge to 1-year follow-up.Results: Between July 1, 2009, and December 31, 2014, 723 644 PCI procedures were performed by 8936 operators: 2553 high-, 2878 intermediate-, and 3505 low-volume operators. Compared with high- and intermediate-volume operators, low-volume operators more often performed emergency PCI, and their patients had fewer cardiovascular comorbidities. Over 1-year follow-up, 15.9% of patients treated by low-volume operators had a MACE compared with 16.9% of patients treated by high-volume operators ( P=0.004). After multivariable adjustment, intermediate- and high-volume operators had a significantly lower rate of in-hospital death than low-volume operators (odds ratio, 0.91; 95% CI, 0.86-0.96 for intermediate versus low; odds ratio, 0.79; 95% CI, 0.75-0.83 for high versus low). There were no significant differences in rates of MACEs, death, myocardial infarction, or unplanned revascularization between operator cohorts from hospital discharge to 1-year follow-up (adjusted hazard ratio for MACEs, 0.99; 95% CI, 0.96-1.01 for intermediate versus low; hazard ratio, 1.01; 95% CI, 0.99-1.04 for high versus low).Conclusions: Unadjusted 1-year outcomes after PCI were worse for older adults treated by operators with higher annual volume; however, patients treated by these operators had more cardiovascular comorbidities. After risk adjustment, higher operator volume was associated with lower in-hospital mortality and no difference in postdischarge MACEs. [ABSTRACT FROM AUTHOR]

Cardiogenic shock is a high-acuity, potentially complex, and hemodynamically diverse state of end-organ hypoperfusion that is frequently associated with multisystem organ failure. Despite improving survival in recent years, patient morbidity and mortality remain high, and there are few evidence-based therapeutic interventions known to clearly improve patient outcomes. This scientific statement on cardiogenic shock summarizes the epidemiology, pathophysiology, causes, and outcomes of cardiogenic shock; reviews contemporary best medical, surgical, mechanical circulatory support, and palliative care practices; advocates for the development of regionalized systems of care; and outlines future research priorities. [ABSTRACT FROM AUTHOR]

Background: The outcomes related to chest pain associated with cocaine use and its burden on the healthcare system are not well studied.Methods: Data were collected from the Nationwide Inpatient Sample (2001-2012). Subjects were identified by using the International Classification of Diseases, Ninth Revision, Clinical Modification codes. Primary outcome was a composite of mortality, myocardial infarction, stroke, and cardiac arrest.Results: We identified 363,143 admissions for cocaine-induced chest pain. Mean age was 44.9 (±21.1) years with male predominance. Left heart catheterizations were performed in 6.7%, whereas the frequency of acute myocardial infarction and percutaneous coronary interventions were 0.69% and 0.22%, respectively. The in-hospital mortality was 0.09%, and the primary outcome occurred in 1.19% of patients. Statistically significant predictors of primary outcome included female sex (odds ratio [OR], 1.16; confidence interval [CI], 1.00-1.35; P = .046), age >50 years (OR, 1.24, CI, 1.07-1.43; P = .004), history of heart failure (OR, 1.63, CI, 1.37-1.93; P <.001), supraventricular tachycardia (OR, 2.94, CI, 1.34-6.42; P = .007), endocarditis (OR, 3.5, CI, 1.50-8.18, P = .004), tobacco use (OR, 1.3, CI, 1.13-1.49; P <.001), dyslipidemia (OR, 1.5, CI, 1.29-1.77; P <.001), coronary artery disease (OR, 2.37, CI, 2.03-2.76; P <.001), and renal failure (OR, 1.27, CI, 1.08-1.50; P = .005). The total annual projected economic burden ranged from $155 to $226 million with a cumulative accruement of more than $2 billion over a decade.Conclusion: Hospital admissions due to chest pain and concomitant cocaine use are associated with low rates of adverse outcomes. For the low-risk cohort in whom acute coronary syndrome has been ruled out, hospitalization may not be beneficial and may result in unnecessary cardiac procedures. [ABSTRACT FROM AUTHOR]

Background: REG1 is a novel anticoagulation system consisting of pegnivacogin, an RNA aptamer inhibitor of coagulation factor IXa, and anivamersen, a complementary sequence reversal oligonucleotide. We tested the hypothesis that near complete inhibition of factor IXa with pegnivacogin during percutaneous coronary intervention, followed by partial reversal with anivamersen, would reduce ischaemic events compared with bivalirudin, without increasing bleeding.Methods: We did a randomised, open-label, active-controlled, multicentre, superiority trial to compare REG1 with bivalirudin at 225 hospitals in North America and Europe. We planned to randomly allocate 13,200 patients undergoing percutaneous coronary intervention in a 1:1 ratio to either REG1 (pegnivacogin 1 mg/kg bolus [>99% factor IXa inhibition] followed by 80% reversal with anivamersen after percutaneous coronary intervention) or bivalirudin. Exclusion criteria included ST segment elevation myocardial infarction within 48 h. The primary efficacy endpoint was the composite of all-cause death, myocardial infarction, stroke, and unplanned target lesion revascularisation by day 3 after randomisation. The principal safety endpoint was major bleeding. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, identifier NCT01848106. The trial was terminated early after enrolment of 3232 patients due to severe allergic reactions.Findings: 1616 patients were allocated REG1 and 1616 were assigned bivalirudin, of whom 1605 and 1601 patients, respectively, received the assigned treatment. Severe allergic reactions were reported in ten (1%) of 1605 patients receiving REG1 versus one (<1%) of 1601 patients treated with bivalirudin. The composite primary endpoint did not differ between groups, with 108 (7%) of 1616 patients assigned REG1 and 103 (6%) of 1616 allocated bivalirudin reporting a primary endpoint event (odds ratio [OR] 1·05, 95% CI 0·80-1·39; p=0·72). Major bleeding was similar between treatment groups (seven [<1%] of 1605 receiving REG1 vs two [<1%] of 1601 treated with bivalirudin; OR 3·49, 95% CI 0·73-16·82; p=0·10), but major or minor bleeding was increased with REG1 (104 [6%] vs 65 [4%]; 1·64, 1·19-2·25; p=0·002).Interpretation: The reversible factor IXa inhibitor REG1, as currently formulated, is associated with severe allergic reactions. Although statistical power was limited because of early termination, there was no evidence that REG1 reduced ischaemic events or bleeding compared with bivalirudin.Funding: Regado Biosciences Inc. [ABSTRACT FROM AUTHOR]

Management and outcomes of patients with acute coronary syndromes (ACSs) may vary according to patient race and ethnicity. To assess racial differences in presentation and outcome in high-risk North American patients with non–ST-segment elevation (NSTE) ACS, we analyzed baseline racial/ethnic differences and all-cause death or nonfatal myocardial infarction (MI) in 6,077 white, 586 African-American, and 344 Hispanic patients through 30-day, 6-month, and 1-year follow-up. Frequencies of hypertension were 66% for whites, 83% for African-Americans, and 78% for Hispanics (overall p <0.001). Use of angiography was similar across groups. Use of percutaneous coronary intervention (46% for whites, 41% for African-Americans, and 45% for Hispanics, overall p = 0.046) and coronary artery bypass grafting (20% for whites, 16% for African-Americans, and 22% for Hispanics, overall p = 0.044) differed. African-American patients had significantly fewer diseased vessels compared with white patients (p = 0.0001). Thirty-day death or MI was 14% for whites, 10% for African-Americans, and 14% for Hispanics (overall p = 0.034). After adjustment for baseline variables, African-American patients had lower 30-day death or MI compared with white patients (odds ratio 0.73, 95% confidence interval 0.55 to 0.98). There were no differences in 6-month death or MI across racial/ethnic groups. In conclusion, baseline clinical characteristics differed across North American racial/ethnic groups in the SYNERGY trial. African-American patients had significantly better adjusted 30-day outcomes but similar 6-month outcomes compared with white patients. [Copyright &y& Elsevier]

Background: Ventricular septal defect is a lethal complication after an acute myocardial infarction, which has become infrequent with the advent of reperfusion strategies; however, it remains a major contributor to mortality.Methods: We identified patients using the International Classification of Diseases, 9th Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2001 and 2013. A multivariate hierarchical logistic regression model was used to identify significant predictors of in-hospital mortality.Results: We identified 3,373,206 ST-elevation myocardial infarctions, out of which 10,012 (0.3%) were complicated with ventricular septal defects. Most of the patients (60%) were older than 65 years, male (55%), and white (63%). Inferior (49.7%) and anterior (41.1%) myocardial infarctions were more commonly implicated with the development of ventricular septal defects. The median (interquartile range) hospitalization length was 7 (3.0-13.5) days. Only 7.65% of patients underwent some intervention, with 7% surgical and 0.65% minimally invasive. Mechanical support devices were used in 36.5% of patients, with intra-aortic balloon pump (96%) being the most common. In-hospital mortality remained high at 30.5% (downward trending from 41.6% in 2001 to 23.3% in 2013). Age, cardiogenic shock, and in-hospital cardiac arrest were statistically significant predictors of in-hospital mortality. The utilization of corrective procedures significantly declined. The use of mechanical support devices and performing a corrective procedure were associated with higher mortality, length of stay, and cost.Conclusions: Ventricular septal defects after acute myocardial infarctions remain associated with significantly high mortality rates. Highly specialized regional centers with individual expertise in the management of septal ruptures are required to improve outcomes of these patients. [ABSTRACT FROM AUTHOR]