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Background: There is a dearth of research on immunophenotyping in peripheral artery disease (PAD). This study aimed to describe the baseline characteristics, immunophenotypic profile, and quality of life (QoL) of participants with PAD in the Project Baseline Health Study (PBHS)., Methods: The PBHS study is a prospective, multicenter, longitudinal cohort study that collected clinical, molecular, and biometric data from participants recruited between 2017 and 2018. In this analysis, baseline demographic, clinical, mobility, QoL, and flow cytometry data were stratified by the presence of PAD (ankle brachial index [ABI] ≤0.90)., Results: Of 2,209 participants, 58 (2.6%) had lower-extremity PAD, and only 2 (3.4%) had pre-existing PAD diagnosed prior to enrollment. Comorbid smoking (29.3% vs 14%, P < .001), hypertension (54% vs 30%, P < .001), diabetes (25% vs 14%, P = .031), and at least moderate coronary calcifications (Agatston score >100: 32% vs 17%, P = .01) were significantly higher in participants with PAD than in those with normal ABIs, as were high-sensitivity C-reactive protein levels (5.86 vs 2.83, P < .001). After adjusting for demographic and risk factors, participants with PAD had significantly fewer circulating CD56-high natural killer cells, IgM+ memory B cells, and CD10/CD27 double-positive B cells (P < .05 for all)., Conclusions: This study reinforces existing evidence that a large proportion of PAD without claudication may be underdiagnosed, particularly in female and Black or African American participants. We describe a novel immunophenotypic profile of participants with PAD that could represent a potential future screening or diagnostic tool to facilitate earlier diagnosis of PAD., Gov Identifier: NCT03154346, https://clinicaltrials.gov/ct2/show/NCT03154346., Competing Interests: Conflict of interest JAG reports research funding from the Department of Veterans Affairs. NL reports grants from the NIH and AHA. He is a director of Bitterroot Bio and receives consulting fees unrelated to this study. FR reports consulting relationships with Healthpals, Amgen, NovoNordisk (CEC), and Novartis outside the submitted work. AH reports grants from Verily; grants and personal fees from AstraZeneca, Amgen, Bayer, Merck, and Novartis; and personal fees from Boston Scientific outside the submitted work. KM reports grants from Verily, Afferent, the American Heart Association (AHA), Cardiva Medical Inc, Gilead, Luitpold, Medtronic, Merck, Eidos, Ferring, Apple Inc, Sanifit, and St. Jude; grants and personal fees from Amgen, AstraZeneca, Bayer, CSL Behring, Johnson & Johnson, Novartis, and Sanofi; and personal fees from Anthos, Applied Therapeutics, Elsevier, Inova, Intermountain Health, Medscape, Mount Sinai, Mundi Pharma, Myokardia, Novo Nordisk, Otsuka, Portola, SmartMedics, and Theravance outside the submitted work. RVS reports advisory board fees from Philips; research support from ACIST Medical. The other authors have no conflicts of interest to disclose., (Published by Elsevier Inc.)

Background: Accumulating evidence from clinical trials suggests that a lower (restrictive) hemoglobin threshold (<8 g/dL) for red blood cell (RBC) transfusion, compared with a higher (liberal) threshold (≥10 g/dL) is safe. However, in anemic patients with acute myocardial infarction (MI), maintaining a higher hemoglobin level may increase oxygen delivery to vulnerable myocardium resulting in improved clinical outcomes. Conversely, RBC transfusion may result in increased blood viscosity, vascular inflammation, and reduction in available nitric oxide resulting in worse clinical outcomes. We hypothesize that a liberal transfusion strategy would improve clinical outcomes as compared to a more restrictive strategy., Methods: We will enroll 3500 patients with acute MI (type 1, 2, 4b or 4c) as defined by the Third Universal Definition of MI and a hemoglobin <10 g/dL at 144 centers in the United States, Canada, France, Brazil, New Zealand, and Australia. We randomly assign trial participants to a liberal or restrictive transfusion strategy. Participants assigned to the liberal strategy receive transfusion of RBCs sufficient to raise their hemoglobin to at least 10 g/dL. Participants assigned to the restrictive strategy are permitted to receive transfusion of RBCs if the hemoglobin falls below 8 g/dL or for persistent angina despite medical therapy. We will contact each participant at 30 days to assess clinical outcomes and at 180 days to ascertain vital status. The primary end point is a composite of all-cause death or recurrent MI through 30 days following randomization. Secondary end points include all-cause mortality at 30 days, recurrent adjudicated MI, and the composite outcome of all-cause mortality, nonfatal recurrent MI, ischemia driven unscheduled coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), or readmission to the hospital for ischemic cardiac diagnosis within 30 days. The trial will assess multiple tertiary end points., Conclusions: The MINT trial will inform RBC transfusion practice in patients with acute MI., Competing Interests: Disclosures JLC: DSMB member for Cerus Corporation project. MMB: DSMB member for Cerus Corporation project. JDA: Research funding MicroPort, Boston Scientific. Advisory Boards Philips, Medtronic. Consulting Abbott, Shockwave, Penumbra, Recor. SGG: 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, Tolmar Pharmaceuticals, 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). AMG: None. MHB: None. Philippe Gabriel Steg: has received research grants from Bayer, Merck, Sanofi, Servier; has been a speaker or consultant for Amarin, Amgen, AstraZeneca, Bayer, Bristol-Myers-Squibb, Janssen, Lexicon, Merck, Novartis, Novo-Nordisk, PhaseBio, Pfizer, Regeneron, Sanofi, Servier. He is a Senior Associate Editor for Circulation. APD: Consultant Velakor Biotherapeutics Inc. RDL: Grants from Bristol-Myers Squibb, GlaxoSmithKline plc., Medtronic, Pfizer, Bayer, Sanofi; consulting fees from Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Novo Nordisk, GlaxoSmithKline plc., Medtronic, Merck, Pfizer, Portola, Sanofi; and honoraria for lectures from Bristol-Myers Squibb, Pfizer, Daiichi Sankyo, Novo Nordisk, and Bayer. PCH: DSMB member of Cerus Corporation project., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Appropriate use criteria (AUC) have been developed to promote the rational use of percutaneous coronary intervention (PCI) among clinicians and to provide benchmarking feedback to hospitals. The original AUC were published in 2012 and subsequently updated in 2017 to reflect emerging, contemporary evidence however the degree to which the updated guidance re-classifies PCI appropriateness is unknown., Methods: Elective PCI cases from March 1, 2018 until June 30, 2021 were identified from within the NCDR CathPCI database. PCI cases were classified as 'appropriate,' 'uncertain' or 'inappropriate' under 2012 AUC and 'appropriate,' 'may be appropriate' or 'rarely appropriate' under 2017 AUC; those with missing data elements were termed 'not mappable.' Groups that 'remained appropriate' (appropriate in both 2012 and 2017), 'became non-appropriate' ('appropriate' in 2012 but became either 'may be appropriate' or 'rarely appropriate in 2017) and 'became appropriate' ('appropriate' in 2017 but were 'uncertain' or 'inappropriate' in 2012) were descriptively compared. Concordance was assessed by calculation of Cohen's Kappa., Results: A total of 245,196 patients underwent elective PCI across 1669 centers. By 2012 AUC, 44% were classified 'appropriate,' 28% were 'uncertain' and 16% were 'inappropriate' compared with 2017 AUC which considered 34% 'appropriate', 56% may be 'appropriate' and 4% 'rarely appropriate'. Overall fair agreement was observed with a Kappa statistic of 0.40 (95%CI 0.396-0.403). Compared with PCI that 'remained appropriate' under the 2017 AUC, PCI that 'became non-appropriate' in 2017 were more likely to be asymptomatic, less likely to be on anti-anginals and less likely to have complex lesions. Compared with PCI that 'became non-appropriate', PCI that 'became appropriate' had a higher proportion of atypical and non-anginal symptoms and were less likely to have had positive functional tests. Procedural related outcomes were similar across all groups. A total of 29 429 PCI (12.0%) were not mappable by 2012 AUC while 16 077 (6.6%) were not mappable by 2017 AUC., Conclusions: In this contemporary analysis of patients undergoing PCI in the United States, only fair agreement between the 2012 and updated 2017 AUC was observed. While some of this reflects the intention of the updated guidance, the large proportion that were considered 'maybe appropriate' or who 'became non-appropriate' reflect the difficulties of documenting and implementing contemporary AUC guidance., Competing Interests: Conflict of interest The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents. AJN, Consulting honoraria from Boehringer Ingelheim, AstraZeneca and Amgen. TI: Nil. SVR: Nil. LAK: Nil. DW: Nil. TYW: research grants provided to the Duke Clinical Research Institute from Amgen, AstraZeneca, Bristol Meyers Squibb, Cyrolife, Novartis, Pfizer, Portola, and Regeneron. She has also received consulting honoraria from Grifols and Gilead., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Introduction: The decision to shorten the duration of DAPT following PCI in patients with ACS remains controversial because of the concern for increased ischemic events., Methods: We performed a comprehensive literature search in seven databases to explore the efficacy of 1 to 3 months of DAPT in patients who underwent PCI for ACS. Randomized controlled trials that compared 1 to 3 months with 6 to 12 months of DAPT after PCI for ACS were identified. Integrated hazard ratio (HR) and 95% confidence interval (CI) were calculated by random effects model for each prespecified outcome of interest. Meta-regression analyses were performed to examine the association of outcomes with select patient characteristics., Results: A total of 9 randomized controlled trials consisting of 25,907 patients were included. There was no difference in the hazard of NACE (HR 0.92, 95% CI 0.79-1.07) and MACE (HR 0.96, 95% CI 0.78-1.17) between 1 and 3 months of DAPT and 6 to 12 months of DAPT. However, implementing 1 to 3 months of DAPT was associated with lower hazard of both any bleeding (HR 0.55, 95% CI 0.46-0.66) and major bleeding (HR 0.47, 95% CI 0.36-0.62). Meta-regression revealed a nonsignificant but increasing trend of both NACE and MACE with greater proportion of left main and left anterior descending coronary artery lesions and greater proportion of STEMI included in the trials., Conclusion: Our findings suggest that 1 to 3 months of DAPT has similar efficacy for preventing ischemic events with reduced bleeding risk compared with 6 to 12 months of DAPT., Competing Interests: Conflicts of Interest Ohman M: Research Chiesi USA, Abiomed; Consulting: Cara Therapeutics, Cytokinetics, Milestone, Neurocrine, Otsuka, Pfizer, XyloCor Therapeutics. Dr. Rao reports institutional research funding from Bayer AG for role on steering committee. Dr. Nanna reports funding from the American College of Cardiology Foundation supported by the George F. and Ann Harris Bellows Foundation and from the National Institute on Aging/National Institutes of Health from R03AG074067 (GEMSSTAR award)., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Optimal dual antiplatelet therapy (DAPT) duration in patients at high bleeding risk (HBR) is not fully defined. We aimed to compare the safety and effectiveness of short-term DAPT (S-DAPT) with longer duration DAPT (L-DAPT) after percutaneous coronary intervention (PCI) with drug eluting stents (DES) in patients at HBR., Methods: We searched for studies comparing S-DAPT (≤3 months) followed by aspirin or P2Y 12 inhibitor monotherapy against L-DAPT (6-12 months) after PCI in HBR patients. Primary end points of interest were major bleeding and myocardial infarction (MI). Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs., Results: Six randomized trials and 3 propensity-matched studies (n = 16,848) were included in the primary analysis. Compared with L-DAPT (n = 8,422), major bleeding was lower with S-DAPT (n = 8,426) [OR 0.68; 95% CI 0.51-0.89] whereas MI did not differ significantly between the 2 groups [1.16; 0.94-1.44]. There were no significant differences in risks of death, stroke or stent thrombosis (ST) between S-DAPT and L-DAPT groups. These findings were consistent when propensity-matched studies were analysed separately. Finally, there was a numerically higher, albeit statistically non-significant, ST in the S-DAPT arm of patients without an indication for OAC [1.98; 0.86-4.58]., Conclusions: Among HBR patients undergoing current generation DES implantation, S-DAPT reduces bleeding without an increased risk of death or MI compared with L-DAPT. More research is needed to (1) evaluate risks of late ST after 1 to 3 months DAPT among patients with high ischemic and bleeding risks, (2) defining the SAPT of choice after 1 to 3 months DAPT., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Importance: The benefit of an electronic support system for the prescription and adherence to oral anticoagulation therapy among patients with atrial fibrillation (AF) and atrial flutter at heightened risk for of stroke and systemic thromboembolism is unclear., Objective: To evaluate the effect of a combined alert intervention and shared decision-making tool to improve prescription rates of oral anticoagulation therapy and adherence., Design, Setting, and Participants: A prospective single arm study of 939 consecutive patients treated at a large tertiary healthcare system., Exposures: An electronic support system comprising 1) an electronic alert to identify patients with AF or atrial flutter, a CHA 2 DS 2 -VASc score ≥ 2, and not on oral anticoagulation and 2) electronic shared decision-making tool to promote discussions between providers and patients regarding therapy., Main Outcomes and Measures: The primary endpoint was prescription rate of anticoagulation therapy. The secondary endpoint was adherence to anticoagulation therapy defined as medication possession ratio ≥ 80% during the 12 months of follow-up., Results: Between June 13, 2018 and August 31, 2018, the automated intervention identified and triggered a unique alert for 939 consecutive patients with AF or atrial flutter, a CHA 2 DS 2 -VASc score ≥2 who were not on oral anticoagulation. The median CHA 2 DS 2 -VASc score among all patients identified by the alert was 2 and the median untreated duration prior to the alert was 495 days (interquartile range 123 - 1,831 days). Of the patients identified by the alert, 345 (36.7%) initiated anticoagulation therapy and 594 (63.3%) did not: 68.7% were treated with a non-Vitamin K antagonist oral anticoagulant (NOAC), 22.0% with warfarin, and 9.3 % combination of NOAC and warfarin. Compared with historical anticoagulation rates, the electronic alert was associated with a 23.6% increase in anticoagulation prescriptions. The overall 1-year rate of adherence to anticoagulant therapy was 75.4% (260/345)., Conclusion and Relevance: An electronic automated alert can successfully identify patients with AF and atrial flutter at high risk for stroke, increase oral anticoagulation prescription, and support high rates of adherence., (Published by Elsevier Inc.)

Background: Bleeding is a common and costly complication of percutaneous coronary intervention (PCI). Bleeding avoidance strategies (BAS) are used paradoxically less in patients at high-risk of bleeding: "bleeding risk-treatment paradox" (RTP). We determined whether hospitals and physicians, who do not align BAS to PCI patients' bleeding risk (ie, exhibit a RTP) have higher bleeding rates., Methods: We examined 28,005 PCIs from the National Cardiovascular Data Registry CathPCI Registry for 7 hospitals comprising BJC HealthCare. BAS included transradial intervention, bivalirudin, and vascular closure devices. Patients' predicted bleeding risk was based on National Cardiovascular Data Registry CathPCI bleeding model and categorized as low (<2.0%), moderate (2.0%-6.4%), or high (≥6.5%) risk tertiles. BAS use was considered risk-concordant if: at least 1 BAS was used for moderate risk; 2 BAS were used for high risk and bivalirudin or vascular closure devices were not used for low risk. Absence of risk-concordant BAS use was defined as RTP. We analyzed inter-hospital and inter-physician variation in RTP, and the association of RTP with post-PCI bleeding., Results: Amongst 28,005 patients undergoing PCI by 103 physicians at 7 hospitals, RTP was observed in 12,035 (43%) patients. RTP was independently associated with a higher likelihood of bleeding even after adjusting for predicted bleeding risk, mortality risk and potential sources of variation (OR 1.66, 95% CI 1.44-1.92, P < .001). A higher prevalence of RTP strongly and independently correlated with worse bleeding rates, both at the physician-level (Wilk's Lambda 0.9502, F-value 17.21, P < .0001) and the hospital-level (Wilk's Lambda 0.9899, F-value 35.68, P < .0001). All the results were similar in a subset of PCIs conducted since 2015 - a period more reflective of the contemporary practice., Conclusions: Bleeding RTP is a strong, independent predictor of bleeding. It exists at the level of physicians and hospitals: those with a higher rate of RTP had worse bleeding rates. These findings not only underscore the importance of recognizing bleeding risk upfront and using BAS in a risk-aligned manner, but also inform and motivate national efforts to reduce PCI-related bleeding., (Copyright © 2021. Published by Elsevier Inc.)

Background: Interventional cardiologists receive feedback on their clinical care from a variety of sources including registry-based quality measures, case conferences, and informal peer interactions. However, the impact of this feedback on clinical care is unclear., Methods: We interviewed interventional cardiologists regarding the use of feedback to improve their care of percutaneous coronary intervention (PCI) patients. Interviews were assessed with template analysis using deductive and inductive techniques., Results: Among 20 interventional cardiologists from private, academic, and Department of Veterans Affairs practice, 85% were male, 75% performed at least 100 PCIs annually, and 55% were in practice for 5 years or more. All reported receiving feedback on their practice, including formal quality measures and peer learning activities. Many respondents were critical of quality measure reporting, citing lack of trust in outcomes measures and poor applicability to clinical care. Some respondents reported the use of process measures such as contrast volume and fluoroscopy time for benchmarking their performance. Case conferences and informal peer feedback were perceived as timelier and more impactful on clinical care. Respondents identified facilitators of successful feedback interventions including transparent processes, respectful and reciprocal peer relationships, and integration of feedback into collective goals. Hierarchy and competitive environments inhibited useful feedback., Conclusions: Despite substantial resources dedicated to performance measurement and feedback for PCI, interventional cardiologists perceive existing quality measures to be of only modest value for improving clinical care. Catherization laboratories should seek to integrate quality measures into a holistic quality program that emphasizes peer learning, collective goals and mutual respect., (Published by Elsevier Inc.)

Background: Revascularization of ischemic cardiomyopathy by coronary artery bypass grafting has been shown to improve survival among patients with left ventricular ejection fraction (LVEF) ≤35%, but the role of percutaneous coronary intervention (PCI) in this context is incompletely described. This study sought to evaluate the effect of PCI on mortality and hospitalization among patients with stable coronary artery disease and reduced left ventricular ejection fraction., Methods: We performed a retrospective analysis comparing PCI with medical therapy among patients with ischemic cardiomyopathy in the Veterans Affairs Health Administration. Patients with angiographic evidence of 1 or more epicardial stenoses amenable to PCI and LVEF ≤35% were included in the analysis. Outcome data were determined by VA and non-VA data sources on mortality and hospital admission., Results: From 2008 through 2015, a study sample of 4,628 patients was identified, of which 1,322 patients underwent ad hoc PCI. Patients were followed to a maximum of 3 years. Propensity score weighted landmark analysis was used to evaluate the primary and secondary outcomes. The primary outcome of all-cause mortality was significantly lower in the PCI cohort compared with medical therapy (21.6% vs 30.0%, P <.001). The secondary outcome of all-cause rehospitalization or death was also lower in the PCI cohort (76.5% vs 83.8%, P <.001)., Conclusions: In this retrospective analysis of patients with ischemic cardiomyopathy with coronary artery disease amenable to PCI and LVEF ≤35%, revascularization by PCI was associated with decreased all-cause mortality and decreased all-cause death or rehospitalization., (Published by Elsevier Inc.)

Competing Interests: Conflicts of interest Alexander G. Truesdell is a consultant and member of the Speakers Bureau of Abiomed Inc. David A. Morrow reports no conflicts relevant to this work and reports grants from Anthos Therapeutics, grants and personal fees from AstraZeneca, personal fees from Bayer Pharma, grants from Daiichi Sankyo, grants from Eisai,grants from GlaxoSmithKline, personal fees from InCarda, grants from Medicines Company, grants and personal fees from Merck & Co, grants and personal fees from Novartis, grants from Pfizer, grants from Quark, grants from Regeneron, grants and personal fees from Roche Diagnostics, grants from Siemens, grants from Takeda, and grants from Zora Biosciences outside the submitted work; Dr. Morrow is also a member of the TIMI Study Group which has received institutional research grant support through Brigham and Women's Hospital from Abbott; Amgen; Aralez; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; BRAHMS, Daiichi-Sankyo; Eisai; GlaxoSmithKline; Intarcia; Janssen; MedImmune; Merck; Novartis; Pfizer; Poxel; Quark Pharmaceuticals; Regeneron; Roche; Siemens; Takeda; The Medicines Company; and Zora Biosciences. E. Magnus Ohman mentions Chiesi (USA), Jansen Pharmaceutical, Xylocor, Cardinal Health, Milestone Pharmaceutical, Abiomed, and Cara Therapeutics. Ian C. Gilchrist reports no conflicts relevant to this work and is a consultant for Terumo Medical, Inc. Judith S. Hochman reports no conflicts relevant to this work; Dr. Hochman is PI for the ISCHEMIA trial for which, in addition to support by National Heart, Lung, and Blood Institute grant, there were in-kind donations for participating sites from Abbott Vascular; Medtronic, Inc.; St. Jude Medical, Inc.; Volcano Corporation; Arbor Pharmaceuticals, LLC; AstraZeneca Pharmaceuticals, LP; Merck Sharp & Dohme Corp.; Omron Healthcare, Inc.; and Amgen Inc.; and financial donations from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP. Navin K. Kapur is a consultant/receives speaker honoraria from Abbott, Abiomed, Boston Scientific, Medtronic, LivaNova, Getinge, MD Start, and Precardia as well as institutional research grants from Abiomed, Boston Scientific, and MD Start. Ron Waksman is an advisory board/board member and consultant for Abbott Vascular, Amgen, Pi-Cardia LTD, Cardioset, Medtronic, Philips (Volcano), and Boston Scientific Corp; consultant for Biosensors, Biotronik; received grant support from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Chiesi, and Boston Scientific Corp; is on the Speaker Bureau of AstraZeneca and Chiesi; and is an investor in MedAlliance. Eric Chen is an employee of Abbott. Adam DeVore reports research funding through his institution from the American Heart Association; Amgen; AstraZeneca; Bayer; Intra-Cellular Therapies; American Regent, Inc; the NHLBI; Novartis; and PCORI. He also provides consulting services for Amgen, AstraZeneca, Bayer, CareDx, InnaMed, LivaNova, Mardil Medical, Novartis, Procyrion, scPharmaceuticals, Story Health and Zoll and has also received non-financial support from Abbott for educational activities. William O’Neill is a consultant for Abiomed and Abbott and receives consulting fees for his services. Charles A. Simonton is an employee of Abiomed. Behram N. Tehrani is a consultant for Medtronic. Alastair G. Proudfoot, Andrew D. Althouse, Fernando Aguel, Fred Senatore, Holger Thiele , Ileana Pina, John Sapirstein, Marc Samsky, Mitchell Krucoff, Sunil Rao, Timothy D. Henry, Valarie Morrow, William T. Abraham, Joaquin E. Cigarroa, Jonathan Seltzer, and Meir Shinnar all report no conflicts relevant to this work.

Background: Randomized controlled trials (RCTs) have yielded conflicting results about the impact of transradial access (TRA) versus transfemoral access (TFA) in patients with ST-segment elevation myocardial infarction (STEMI)., Methods: We performed a trial sequential analysis (TSA) of RCTs comparing TRA and TFA in patients with STEMI. The outcomes of interest were 30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications., Results: A total of 17 studies with 11,992 patients were included in the current TSA. The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001). There was no difference in MI and stroke between the 2groups. Applying TSA boundaries, the z-curve for 30-day mortality, major bleeding, MACE and access site complications crossed the conventional and the TSA boundaries, indicating firm evidence for better outcomes in the TRA group. For MI and stroke, the z-curve failed to cross the conventional and the TSA boundaries for both outcomes, indicating lack of signals of benefit or harm., Conclusions: In the current TSA, the available data from RCTs support improved 30-day mortality, major bleeding, MACE and access site complication rates in STEMI patients treated by PCI through the radial access., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The evolution and clinical impact of cardiac remodeling after large ST-elevation myocardial infarction (STEMI) is not well delineated in the current therapeutic era., Methods: The PRESERVATION I trial longitudinally assessed cardiac structure and function in STEMI patients receiving primary percutaneous coronary intervention (PCI). Echocardiograms were performed immediately post-PCI and at 1, 3, 6 and 12 months after STEMI. The extent of cardiac remodeling was assessed in patients with ejection fraction (EF) ≤ 40% after PCI. Patients were stratified by the presence or absence of reverse remodeling, defined as an increase in end-diastolic volume (EDV) of ≤10 mL or decrease in EDV at 1 month, and evaluated for an association with adverse events at 1 year., Results: Of the 303 patients with large STEMI enrolled in PRESERVATION I, 225 (74%) had at least moderately reduced systolic function (mean EF 32 ± 5%) immediately after primary PCI. In the following year, there were significant increases in EF and LV volumes, with the greatest magnitude of change occurring in the first month. At 1 month, 104 patients (46%) demonstrated reverse remodeling, which was associated with a significantly lower rate of death, recurrent myocardial infarction and repeat cardiovascular hospitalization at 1 year (HR 0.44; 95% CI: 0.19-0.99)., Conclusion: Reduced EF after large STEMI and primary PCI is common in the current therapeutic era. The first month following primary reperfusion is a critical period during which the greatest degree of cardiac remodeling occurs. Patients demonstrating early reverse remodeling have a significantly lower rate of adverse events in the year after STEMI., Competing Interests: Disclosures Duke Clinical Research Institute was the recipient of research funding from Bellerophon Therapeutics Inc. Dr Zeymer has received honoraria for participation at steering committee meetings of PRESERVATION I. Dr Kasprzak has received investigator fees from Bellerophon Therapeutics Inc. Drs Rao, Krucoff and Douglas have received research grant support from Bellerophon Therapeutics Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes., Methods: We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection., Results: Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest., Conclusions: Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Available data suggest that same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is safe in select patients. Yet, little is known about contemporary adoption rates, safety, and costs in a universal health care system like the Veterans Affairs Health System., Methods: Using data from the Veterans Affairs Clinical Assessment Reporting and Tracking Program linked with Health Economics Resource Center data, patients undergoing elective PCI for stable angina between October 1, 2007 and Sepetember 30, 2016, were stratified by SDD versus overnight stay. We examined trends of SDD, and using 2:1 propensity matching, we assessed 30-day rates of readmission, mortality, and total costs at 30 days., Results: Of 21,261 PCIs from 67 sites, 728 were SDDs (3.9% of overall cohort). The rate of SDD increased from 1.6% in 2008 to 9.7% in 2016 (P < .001). SDD patients had lower rates of atrial fibrillation, peripheral arterial disease, and prior coronary artery bypass grafting and were treated at higher-volume centers. Thirty-day readmission and mortality did not differ significantly between the groups (readmission: 6.7% SDD vs 5.6% for overnight stay, P = .24; mortality: 0% vs. 0.07%, P = .99). The mean (SD) 30-day cost accrued by patients undergoing SDD was $23,656 ($15,480) versus $25,878 ($17,480) for an overnight stay. The accumulated median cost savings for SDD was $1503 (95% CI $738-$2,250)., Conclusions: Veterans Affairs Health System has increasingly adopted SDD for elective PCI procedures, and this is associated with cost savings without an increase in readmission or mortality. Greater adoption has the potential to reduce costs without increasing adverse outcomes., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, seniors presenting with STEMI remain an understudied population despite contributing to 140,000 hospital admissions annually. The SAFE-STEMI for Seniors study is a prospective, multicenter, unblinded, randomized clinical trial designed to examine the efficacy and safety of instantaneous wave-free ratio-guided complete revascularization in multivessel disease, while also investigating other components of STEMI care for patients ≥60 years including the efficacy and safety of zotarolimus-eluting stents for primary PCI and transradial PCI with the Glidesheath Slender and TR band. The SAFE-STEMI trial represents North America's first and only prospective randomized investigational device exemption study to use a Coordinated Registry Network infrastructure with collaborative partnering across industry manufacturers, promoting both efficiency and reduced cost of evidence development for regulatory decisions related to both diagnostic and therapeutic technologies in a single study design. The study has been powered to evaluate 2 independent co-primary end points in a population of older patients with STEMI: (1) third-generation drug-eluting stents for primary PCI and (2) instantaneous wave-free ratio-guided complete revascularization versus infarct-related artery-only revascularization., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Percutaneous coronary intervention (PCI) may be performed in the same procedure as diagnostic coronary angiography (ad hoc PCI). This study aimed to evaluate current rates of ad hoc PCI use and associated risks of adverse outcomes in patients with stable coronary artery disease (CAD)., Methods: We identified 550,742 patients with stable CAD who underwent PCI in the National Cardiovascular Data Registry CathPCI Registry from 2009 to 2017. We compared in-hospital bleeding, acute kidney injury (AKI), and mortality between patients receiving ad hoc versus non-ad hoc PCI using logistic regression with inverse probability weighted propensity adjustment., Results: Between 2009 and 2017, 82.9% of patients underwent ad hoc PCI. Patients who did not undergo ad hoc PCI had higher prevalence of peripheral vascular disease, heart failure, chronic kidney disease, and coronary artery bypass graft. Ad hoc PCI was associated with lower bleeding risk (adjusted odds ratio [aOR] 0.83, 95% CI 0.79-0.87) but no differences in risks of AKI (aOR 0.95, 95% CI 0.90-1.00) or mortality (aOR 1.09, 95% CI 0.97-1.23) compared with non-ad hoc PCI. Ad hoc PCI was associated with AKI risk in patients with glomerular filtration rate <30 mL/min (interaction P < .001), mortality risk in multivessel PCI (interaction P = .031), and risks of AKI and mortality in PCI of chronic total occlusions (interaction P = .045 and .002, respectively)., Conclusions: Ad hoc PCI is extremely common among US patients with stable CAD and is associated with lower bleeding risk but no differences in risks of AKI or mortality compared with non-ad hoc PCI., (Copyright © 2019 Elsevier Inc. All rights reserved.)

We sought to determine the risk of obstructive coronary artery disease (oCAD) associated with noncoronary atherosclerosis (cerebrovascular disease [CVD] or peripheral arterial disease [PAD]) and major adverse cardiac events following percutaneous coronary intervention (PCI)., Methods: Rates of the angiographic end point of oCAD were compared among patients with and without noncoronary atherosclerosis undergoing coronary angiography within the Veterans Health Administration between October 2007 and August 2015. The primary angiographic end point of oCAD was defined as left main stenosis ≥50% or any stenosis ≥70% in 1, 2, or 3 vessels. In patients who proceeded to PCI, the rate of the composite clinical end point of death, myocardial infarction, or stroke was compared among those with concomitant noncoronary atherosclerosis (CVD, PAD, or CVD + PAD) versus isolated CAD., Results: Among 233,353 patients undergoing angiography, 9.6% had CVD, 12.4% had PAD, and 6.1% had CVD + PAD. Rates of oCAD were 57.9% for neither CVD nor PAD, 66.4% for CVD, 73.6% for PAD, and 80.9% for CVD + PAD. Compared with patients without noncoronary atherosclerosis, the adjusted risk of oCAD with CVD, PAD, or CVD + PAD was 1.03 (95% CI 1.02-1.04), 1.10 (95% CI 1.09-1.11), and 1.12 (95% CI 1.11-1.13), respectively. In patients who underwent PCI, the adjusted hazard for death, myocardial infarction, or stroke among those with CVD, PAD, or CVD + PAD was 1.36 (95% CI 1.26-1.45), 1.53 (95% CI 1.45-1.62), and 1.72 (95% CI 1.59-1.86), respectively., Conclusions: In patients undergoing coronary angiography, noncoronary atherosclerosis was associated with increased burden of oCAD and adverse events post-PCI., (Published by Elsevier Inc.)

Background: The radial artery (RA) is routinely used for both hemodynamic monitoring and for cardiac catheterization. Although cannulation of the RA is usually undertaken through manual palpation, ultrasound (US)-guided access has been advocated as a mean to increase cannulation success rates and to lower RA complications; however, the published data are mixed. We sought to evaluate the impact of US-guided RA access compared with palpation alone on first-pass success to access RA., Methods and Results: Meta-analysis of 12 randomized controlled trials comparing US-guided with palpation-guided radial access in 2,432 adult participants was done. Hemodynamic monitoring was the most common reason for RA catheterization. Only 2 randomized controlled trials evaluated patients undergoing cardiac catheterization. Ultrasound-guided radial access was associated with increased first-attempt success rate (risk ratio [RR] 1.35, 95% CI 1.16-1.57]) and decreased failure rate (RR 0.52, 95% CI 0.32-0.87). There were no significant differences in the risk of hematoma (RR 0.43, 95% CI 0.27-1.06), the mean time to first successful attempt (mean difference 25.13 seconds, 95% CI -1.06 to 51.34) or to any successful attempt (mean difference -4.74 seconds; 95% CI -22.67 to 13.18) between both groups., Conclusions: Ultrasound-guided technique for RA access has higher first-attempt success and lower failure rate compared with palpation alone, with no significant differences in access site hematoma or time to a successful attempt. These findings support the routine use of US guidance for RA access., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Several new trials evaluating transfusion strategies in patients with cardiovascular disease have recently been published, increasing the number of enrolled patients by over 30%. The objective was to evaluate transfusion thresholds in patients with cardiovascular disease., Methods: We conducted an updated systematic review of randomized trials that compared patients assigned to maintain a lower (restrictive transfusion strategy) or higher (liberal transfusion strategy) hemoglobin concentration. We focused on new trial data in patients with cardiovascular disease. The primary outcome was 30-day mortality. Specific subgroups were patients undergoing cardiac surgery and with acute myocardial infarction., Results: A total of 37 trials that enrolled 19,049 patients were appraised. In cardiac surgery, mortality at 30days was comparable between groups (risk ratio 0.99; 95% confidence interval 0.74-1.33). In 2 small trials (n=154) in patients with myocardial infarction, the point estimate for the mortality risk ratio was 3.88 (95% CI, 0.83-18.13) favoring the liberal strategy. Overall, from 26 trials enrolling 15,681 patients, 30-day mortality was not different between restrictive and liberal transfusion strategies (risk ratio 1.0, 95% CI, 0.86-1.16). Overall and in the cardiovascular disease subgroup, there were no significant differences observed across a range of secondary outcomes., Conclusions: New trials in patients undergoing cardiac surgery establish that a restrictive transfusion strategy of 7 to 8g/dL is safe and decreased red cell use by 24%. Further research is needed to define the optimal transfusion threshold in patients with acute myocardial infarction., (Copyright © 2018. Published by Elsevier Inc.)

Background and Objectives: We sought to determine the frequency of use and association between prasugrel and outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) in clinical practice., Methods: PROMETHEUS was a multicenter observational registry of acute coronary syndrome patients undergoing PCI from 8 centers in the United States that maintained a prospective PCI registry for patient outcomes. The primary end points were major adverse cardiovascular events at 90days, a composite of all-cause death, nonfatal myocardial infarction, stroke, or unplanned revascularization. Major bleeding was defined as any bleeding requiring hospitalization or blood transfusion. Hazard ratios (HRs) were generated using multivariable Cox regression and stratified by the propensity to treat with prasugrel., Results: Of 19,914 patients (mean age 64.4years, 32% female), 4,058 received prasugrel (20%) and 15,856 received clopidogrel (80%). Prasugrel-treated patients were younger with fewer comorbid risk factors compared with their counterparts receiving clopidogrel. At 90days, there was a significant association between prasugrel use and lower major adverse cardiovascular event (5.7% vs 9.6%, HR 0.58, 95% CI 0.50-0.67, P<.0001) and bleeding (1.9% vs 2.9%, HR 0.65, 95% CI 0.51-0.83, P<.001). After propensity stratification, associations were attenuated and no longer significant for either outcome. Results remained consistent using different approaches to adjusting for potential confounders., Conclusions: In contemporary clinical practice, patients receiving prasugrel tend to have a lower-risk profile compared with those receiving clopidogrel. The lower ischemic and bleeding events associated with prasugrel use were no longer evident after accounting for these baseline differences., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Older adults presenting with acute myocardial infarction (MI) often have multivessel coronary artery disease amenable to percutaneous coronary intervention (PCI), yet the risks of multivessel intervention may outweigh potential benefits in these patients. We sought to determine if nonculprit intervention during the index PCI is associated with better outcomes among older patients with acute MI and multivessel disease., Methods: We examined 19,271 ST-segment elevation MI (STEMI) and 31,361 non-STEMI (NSTEMI) patients 65years or older with multivessel disease in a linked CathPCI Registry-Medicare database, excluding patients with prior coronary artery bypass grafting, left main disease, or cardiogenic shock. Using inverse probability-weighted propensity adjustment, we compared mortality between patients receiving culprit-only vs multivessel intervention during the index PCI procedure., Results: Most older MI patients (91% STEMI and 74% NSTEMI) received culprit-only intervention during the index PCI. Among STEMI patients, multivessel intervention during the index PCI was associated with higher 30-day mortality (8.3% vs 6.3%, adjusted hazard ratio [HR] 1.36, 95% CI 1.14-1.62) than culprit-only intervention, and this trend persisted at 1year (13.8% vs 12.2%, adjusted HR 1.14, 95% CI 0.99-1.31). No significant mortality differences were observed among NSTEMI patients at 30days (3.4% vs 4.1%, adjusted HR 1.01, 95% CI 0.88-1.15) or at 1year (10.1% vs 10.8%, adjusted HR 0.99, 95% CI 0.91-1.08)., Conclusions: Nonculprit intervention during the index PCI was associated with worse outcomes among STEMI patients, but not NSTEMI patients., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Despite several randomized controlled trials and meta-analyses, the ideal anticoagulant for patients undergoing primary percutaneous coronary intervention (PCI) remains controversial. We performed an updated meta-analysis including recently reported randomized clinical trials that compare bivalirudin and heparin with or without provisional administration of a glycoprotein IIb/IIIa inhibitor (GPI) for primary PCI., Methods and Results: Scientific databases and Web sites were searched for randomized clinical trials. Data from 6 trials involving 14,095 patients were included. The pooled risk ratios (RRs) were calculated using random-effects models. Moderator analyses examined the impact of routine use of GPI, radial access, and P2Y12 inhibitors on safety outcomes. At 30 days, patients receiving bivalirudin had rates of major adverse cardiac events similar to those receiving heparin with or without provisional GPI (RR 1.02, 95% CI 0.87-1.19, P = .800), myocardial infarction (RR 1.41, 95% CI 0.94-2.11, P = .089), target vessel revascularization (RR 1.37, 95% CI 0.91-2.04, P = .122), and net adverse clinical events (RR 0.81, 95% CI 0.64-1.01, P = .069). However, bivalirudin use decreased the risk of all-cause mortality (RR 0.81, 95% CI 0.67-0.99, P = .041) and cardiac mortality (RR 0.68, 95% CI 0.51-0.91, P = .009) at 30 days, There were higher rates of acute stent thrombosis (RR 3.31, 95% CI 1.79-6.10, P < .001) in patients receiving bivalirudin. Bivalirudin use also decreased the risk of major bleeding at 30 days by 37% (RR 0.63, 95% CI 0.44-0.90, P = .012), but bleeding risk varied depending on routine GPI use with heparin (RR 0.44, 95% CI 0.23-0.81, P = .009) vs bailout (RR 0.73, 95% CI 0.42-1.25, P = .252), predominantly radial access (RR 0.54, 95% CI 0.25-1.15, P = .114) vs non-radial access (RR 0.60, 95% CI 0.36-0.99, P = .049), and second-generation P2Y12 inhibitor use with bivalirudin (RR 0.70, 95% CI 0.40-1.24, P = .226) vs clopidogrel use (RR 0.39, 95% CI 0.18-0.85, P = .018)., Conclusions: In primary PCI, relative to heparin, bivalirudin reduces the risk for all-cause mortality, cardiac mortality, and major bleeding but yields similar rates of major adverse cardiac event and net adverse clinical event at 30 days. However, the benefit of a reduction in bleeding with bivalirudin appears to be modulated by the concurrent administration of second-generation P2Y12 inhibitors with bivalirudin, using radial access, and avoiding routine GPI use with heparin., (Published by Elsevier Inc.)

Introduction: Public reporting (PR) is a policy mechanism that may improve clinical outcomes for percutaneous coronary intervention (PCI). However, prior studies have shown that PR may have an adverse impact on patient selection. It is unclear whether alternatives to PR, such as collaborative quality improvement (CQI), may drive improvements in quality of care and outcomes for patients receiving PCI without the unintended consequences seen with PR., Methods: Using National Cardiovascular Data Registry CathPCI Registry data from January 2011 through September 2012, we evaluated patients who underwent PCI in New York (NY), a state with PR (N = 51,983), to Michigan, a state with CQI (N = 53,528). We compared patient characteristics, the quality of care delivered, and clinical outcomes., Results: Patients undergoing PCI in NY had a lower-risk profile, with a lower proportion of patients with ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or cardiogenic shock, compared with Michigan. Quality of care was broadly similar in the 2 states; however, outcomes were better in NY. In a propensity-matched analysis, patients in NY were less likely to be referred for emergent, urgent, or salvage coronary artery bypass surgery (odds ratio [OR] 0.67, 95% CI 0.51-0.88, P < .0001) and to receive blood transfusion (OR 0.7, 95% CI 0.61-0.82, P < .0001), and had lower in-hospital mortality (OR 0.72, 95% CI 0.63-0.83, P < .0001)., Conclusions: Public reporting of PCI data is associated with fewer high-risk patients undergoing PCI compared with CQI. However, in comparable samples of patients, PR is also associated with a lower risk of mortality and adverse events. The optimal quality improvement method may involve combining these 2 strategies to protect access to care while still driving improvements in patient outcomes., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Postinfarction left ventricular (LV) remodeling can result in chronic heart failure and functional impairment. Although pharmacological strategies for established heart failure can be beneficial, preventing remodeling remains a challenge. Injectable bioabsorbable alginate or "bioabsorbable cardiac matrix" (BCM), composed of an aqueous mixture of sodium alginate and calcium gluconate, is a sterile colorless liquid that is a polysaccharide polymer produced from brown seaweed. When exposed to excess ionized calcium present in infarcted myocardium, BCM assembles to form a flexible gel, structurally resembling extracellular matrix, which provides temporary structural support to the infarct zone through and beyond the time needed for mature fibrotic tissue to develop. The PRESERVATION I trial is an early phase randomized, double-blind, placebo-controlled trial comparing intracoronary application of 4 mL of BCM with saline control in patients who develop large infarctions after successful reperfusion of large ST-segment elevation myocardial infarction (MI). Subjects will be randomized 2:1 to either BCM or saline control and will have the study device deployed through an intracoronary microcatheter in the infarct-related artery 2 to 5 days after index ST-segment elevation MI treated with successful primary or rescue percutaneous coronary intervention. The primary effectiveness end point is the absolute change in LV diastolic volume index as measured by 3-dimensional echocardiography from baseline to 6 months after BCM deployment. Secondary effectiveness end points include clinical outcomes, patient-reported quality of life, additional echocardiographic measures, and functional status measures. In summary, the PRESERVATION I trial is a randomized double-blind trial evaluating the effectiveness and safety of the novel device BCM in preventing LV remodeling patients who have large MIs despite undergoing successful primary or rescue percutaneous coronary intervention., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The benefit of transradial access (TRA) in patients with cardiogenic shock (CS) is uncertain. We sought to determine the benefits of TRA in patients with CS undergoing coronary angiography/intervention., Methods: MEDLINE, Embase, Cochrane Central, and electronic databases were searched for studies that assessed the following: (1) patients with CS who underwent percutaneous coronary intervention (PCI) and (2) the association between choice of arterial access, 30-day all-cause mortality, and 30-day major adverse cardiac and cerebral events (MACCEs) using random-effects model., Results: From 3,652 retrieved citations, 8 studies involving 8,131 patients with CS undergoing PCI (via TRA: 2,321 patients, via TFA: 5,810 patients) were included. Transradial access was associated with significantly reduced risk for all-cause mortality (unadjusted: risk ratio [RR] 0.60, 95% CI 0.52-0.71, P < .001, I(2) = 29%, 8 included studies; adjusted: RR 0.55, 95% CI 0.46-0.65, P < .001, I(2) = 0%, 6 included studies) and MACCE (unadjusted: RR 0.68, 95% CI 0.63-0.73, P < .001, I(2) = 0%, 6 included studies; adjusted: RR 0.63, 95% CI 0.52-0.75, P < .001, I(2) = 0%, 4 included studies) at 30 days when compared with TFA., Conclusions: Transradial access is associated with reduced mortality and MACCE at 30 days in patients with CS undergoing PCI. Considering the possible influence of selection bias on the effect estimate in our analysis, randomized controlled trials are needed to better assess this association., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: In the SAFE-PCI for Women trial, patient preference for radial access for future procedures was greater than for femoral access. We sought to assess whether radial or femoral access impacts formal measures of quality-of-life (QOL) among women undergoing cardiac catheterization., Methods: We assessed QOL using European quality of life-5 dimensions (EQ-5D) and EQ visual analog scale (EQ-VAS) scores among 304 women randomized to radial or femoral arteriotomy in the SAFE-PCI for Women trial at sites with QOL substudy approval. Patient surveys were administered at baseline, hospital discharge, and 30 days (for percutaneous coronary intervention patients)., Results: Women randomized to both treatments had similar EQ-5D index and EQ-VAS scores at baseline, hospital discharge, and 30-day follow-up. After adjustment for baseline scores, there was no effect of assigned treatment on EQ-5D (discharge 0.004; 95% CI -0.03 to 0.04; 30 days -0.03; 95% CI -0.09 to 0.02) or EQ-VAS (discharge -1.31; 95% CI -4.74 to 2.12; 30 days -2.10; 95% CI -8.92 to 4.71) scores. At discharge, 60.5% versus 63.5% (P = .60) of patients in radial and femoral groups were free from access site pain; at 30 days, rates were 85.7% versus 77.6% (P = .30), respectively. Patient preference for the same access strategy for repeat procedures was greater in the radial versus femoral group (77.2% vs 26.8%; P < .0001)., Conclusions: Using established QOL instruments, we did not measure any difference in QOL or functional status according to access site strategy in women undergoing cardiac catheterization, yet patient preference for the radial approach was significantly greater. Other factors influencing patient choice for radial access should be investigated., (Published by Elsevier Inc.)

The prevention of major bleeding during percutaneous coronary intervention is one of the most widely discussed and often controversial topics within interventional cardiology. The choice of arterial access should be considered a mechanism for bleeding avoidance, and various strategies have been proposed to prevent or lower major bleeding and vascular complications with varying levels of strength. Herein, we review the current literature on arterial access as a bleeding avoidance strategy during percutaneous coronary intervention and its impact on outcome and provide a consensus opinion based on the strength of the evidence supporting various techniques., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: In the setting of ST-segment elevation myocardial infarction, timely restoration of normal blood flow is associated with improved myocardial salvage and survival. Despite improvements in door-to-needle and door-to-balloon times, there remains an unmet need with respect to improved symptom-to-door times. A prior report of an implanted device to monitor ST-segment deviation demonstrated very short times to reperfusion among patients with an acute coronary syndrome (ACS) with documented thrombotic occlusion. The goal of the ANALYZE ST study is to evaluate the safety and effectiveness of a novel ST-segment monitoring feature using an existing implantable cardioverter-defibrillator (ICD) among patients with known coronary artery disease., Methods: The ANALYZE ST study is a prospective, nonrandomized, multicenter, pivotal Investigational Device Exemption study enrolling 5,228 patients with newly implanted ICD systems for standard clinical indications who also have a documented history of coronary artery disease. Patients will be monitored for 48 months, during which effectiveness of the device for the purpose of early detection of cardiac injury will be evaluated by analyzing the sensitivity of the ST monitoring feature to identify clinical ACS events. In addition, the safety of the ST monitoring feature will be evaluated through the assessment of the percentage of patients for which monitoring produces a false-positive event over the course of 12 months., Conclusions: The ANALYZE ST trial is testing the hypothesis that the ST monitoring feature in the Fortify ST ICD system (St. Jude Medical, Inc., St. Paul, MN) (or other ICD systems with the ST monitoring feature) will accurately identify patients with clinical ACS events., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Background: Erythropoiesis-stimulating agents (ESAs) have been investigated in small studies in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Erythropoiesis-stimulating agents did not show a clear effect on left ventricular function or clinical outcome, but some studies suggested an increased risk of thromboembolic events., Methods: A systematic literature search in MEDLINE was performed, until December 2012. We included randomized clinical trials investigating the effect of ESAs in STEMI patients undergoing primary PCI, with ≥30 days of follow-up. The primary end point was a composite of all-cause mortality, myocardial infarction, and stent thrombosis after PCI. Secondary end point was all-cause mortality., Results: Individual patient data were obtained from 10 of 11 trials, including 97.3% (1,242/1,277) of all patients randomized to control (n = 600) or to ESAs (n = 642). Baseline characteristics were well balanced between the treatment allocations. Mean follow-up time was 248 (±131) days. The primary end point occurred in 3.5% (20/577) in the control group and in 2.1% (13/610) in the ESA group (hazard ratio for ESAs, 0.63; 95% CI [0.31-1.27]; P = .20). Mortality occurred in 13 (2.3%) in the control group and 5 (0.8%) in the ESA group (hazard ratio for ESAs, 0.38; 95% CI [0.13-1.06]; P = .06)., Conclusions: Erythropoiesis-stimulating agent administration does not result in an increased risk of adverse cardiac events in STEMI patients undergoing primary PCI. Results of ongoing studies may provide further insight to the potential beneficial clinical effects of ESAs in STEMI patients., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Background: Hybrid coronary revascularization (HCR) represents a minimally invasive revascularization strategy in which the durability of the internal mammary artery to left anterior descending artery graft is combined with percutaneous coronary intervention to treat remaining lesions. We performed a systematic review and meta-analysis to compare clinical outcomes after HCR with conventional coronary artery bypass graft (CABG) surgery., Methods: A comprehensive EMBASE and PUBMED search was performed for comparative studies evaluating in-hospital and 1-year death, myocardial infarction (MI), stroke, and repeat revascularization., Results: Six observational studies (1 case control, 5 propensity adjusted) comprising 1,190 patients were included; 366 (30.8%) patients underwent HCR (185 staged and 181 concurrent), and 824 (69.2%) were treated with CABG (786 off-pump, 38 on-pump). Drug-eluting stents were used in 328 (89.6%) patients undergoing HCR. Hybrid coronary revascularization was associated with lower in-hospital need for blood transfusions, shorter length of stay, and faster return to work. No significant differences were found for the composite of death, MI, stroke, or repeat revascularization during hospitalization (odds ratio 0.63, 95% CI 0.25-1.58, P = .33) and at 1-year follow-up (odds ratio 0.49, 95% CI 0.20-1.24, P = .13). Comparisons of individual components showed no difference in all-cause mortality, MI, or stroke, but higher repeat revascularization among patients treated with HCR., Conclusions: Hybrid coronary revascularization is associated with lower morbidity and similar in-hospital and 1-year major adverse cerebrovascular or cardiac events rates, but greater requirement for repeat revascularization compared with CABG. Further exploration of this strategy with adequately powered randomized trials is warranted., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Background: The contemporary need for repeat revascularization in older patients after percutaneous coronary intervention (PCI) has not been well studied. Understanding repeat revascularization risk in this population may inform treatment decisions., Methods: We analyzed patients ≥65 years old undergoing native-vessel PCI of de novo lesions from 2005 to 2009 discharged alive using linked CathPCI Registry and Medicare data. Repeat PCIs within 1 year of index procedure were identified by claims data and linked back to CathPCI Registry to identify target vessel revascularization (TVR). Surgical revascularization and PCIs not back linked to CathPCI Registry were excluded from main analyses but included in sensitivity analyses. Independent predictors of TVR after drug-eluting stent (DES) or bare-metal stent (BMS) implantation were identified by multivariable logistic regression., Results: Among 343,173 PCI procedures, DES was used in 76.5% (n = 262,496). One-year TVR ranged from 3.3% (overall) to 7.1% (sensitivity analysis). Precatheterization and additional procedure-related TVR risk models were developed in BMS (c-indices 0.54, 0.60) and DES (c-indices 0.57, 0.60) populations. Models were well calibrated and performed similarly in important patient subgroups (female, diabetic, and older [≥75 years]). The use of DES reduced predicted TVR rates in high-risk older patients by 35.5% relative to BMS (from 6.2% to 4.0%). Among low-risk patients, the number needed to treat with DES to prevent 1 TVR was 63-112; among high-risk patients, this dropped to 28-46., Conclusions: In contemporary clinical practice, native-vessel TVR among older patients occurs infrequently. Our prediction model identifies patients at low versus high TVR risk and may inform clinical decision making., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Background: A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy., Objective: The objective of this study is to evaluate the efficacy of routine upfront manual aspiration thrombectomy during PPCI compared with percutaneous coronary intervention alone in patients with STEMI., Design: This is a multicenter, prospective, open, international, randomized trial with blinded assessment of outcomes. Patients with STEMI undergoing PPCI are randomized to upfront routine manual aspiration thrombectomy with the Export catheter (Medtronic CardioVascular, Santa Rosa, CA) or to percutaneous coronary intervention alone. The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure up to 180 days. The trial uses an event-driven design and will recruit 10,700 patients., Summary: The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes., (Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.)

Background: The role of intraaortic balloon pump (IABP) during percutaneous coronary intervention (PCI) in high-risk acute patients remains debated. Device-related complications and the more complex patient management could explain such lack of clinical benefit. We aimed to assess the impact of transradial versus transfemoral access for PCI requiring IABP support on vascular complications and clinical outcome., Methods: We retrospectively analyzed 321 consecutive patients receiving IABP support during transfemoral (n = 209) or transradial (n = 112) PCI. Thirty-day net adverse clinical events (NACEs) (composite of postprocedural bleeding, cardiac death, myocardial infarction, target lesion revascularization, and stroke) were the primary end point, with access-related bleeding and hospital stay as secondary end points., Results: Cardiogenic shock and hemodynamic instability were the most common indications for IABP support. Cumulative 30-day NACE rate was 50.2%, whereas an access site-related bleeding occurred in 14.3%. Patients undergoing transfemoral PCI had a higher unadjusted rate of NACEs when compared with the transradial group (57.4% vs 36.6%, P < .01), mainly due more access-related bleedings (18.7% vs 6.3%, P < .01). Such increased risk of NACEs was confirmed after propensity score adjustment (hazard ratio 0.57 [0.4-0.9], P = .007), whereas hospital stay appeared comparable in the 2 groups., Conclusions: In this observational registry, high-risk patients undergoing PCI and requiring IABP support appeared to have fewer NACEs if transradial access was used instead of transfemoral, mainly due to fewer access-related bleedings. Given the inherent limitations of this retrospective work, including the inability to adjust for unknown confounders, further controlled studies are warranted to confirm or refute these findings., (© 2013.)

Women are at higher risk than men for bleeding and vascular complications after percutaneous coronary intervention (PCI). Compared with femoral access, radial access reduces these complications but may be more challenging in women because of higher rates of radial artery spasm, tortuosity, and occlusion as well as lower rates of procedure success. Whether the safety advantages of radial versus femoral access in women undergoing PCI are outweighed by reduced effectiveness has not been studied. The Study of Access site For Enhancement of PCI for Women is a prospective, randomized clinical trial comparing radial with femoral arterial access in women undergoing PCI. In conjunction with the US Food and Drug Administration's Critical Path Cardiac Safety Research Consortium, this study embeds the randomized clinical trial into the existing infrastructure of the National Cardiovascular Data Registry CathPCI Registry through the National Institute of Health's National Cardiovascular Research Infrastructure. The primary efficacy end point is a composite of bleeding (Bleeding Academic Research Consortium types 2, 3, or 5) or vascular complication requiring intervention occurring at 72 hours after PCI or by hospital discharge. The primary feasibility end point is procedure success. Secondary end points include procedure duration, contrast volume, radiation dose, quality of life, and a composite of 30-day death, vascular complication, or unplanned revascularization., (© 2013.)

Background: New percutaneous coronary intervention (PCI) device technologies are often rapidly adopted into clinical practice, yet few studies have examined the overall impact of these new technologies on patient outcomes in community practice., Methods: In hopes of determining temporal trends in PCI outcomes, we used data from the Centers for Medicare & Medicaid Service's Chronic Condition Warehouse (n = 3,250,836) by comparing patient characteristics and rates of 3-year major adverse cardiac events (MACE) across the balloon angioplasty (POBA) era (01/1991-09/1995), the bare metal stent (BMS) era (02/1998-04/2003), and the drug-eluting stent (DES) era (05/2004-10/2006). The adjusted association between era and outcomes was determined with Cox proportional hazards modeling (POBA era as reference)., Results: Compared with the POBA era, patients undergoing PCI were significantly older and had more medical comorbidities, and the risk for 3-year MACE was significantly lower during the BMS and DES eras (BMS vs. POBA adjusted HR [95% CI]: 0.930 [0.926-0.935]; DES vs. BMS: 0.831 [0.827-0.835]). Compared with males, the adjusted risk for 3-year MACE among females was lower during the POBA era, but slightly higher during the BMS and DES eras. Across all three eras, patients ≥75 years of age had higher adjusted risk for MACE compared with younger patients, and the risk for revascularization was lower for both females and older patients., Conclusions: Despite its application in older and sicker Medicare beneficiaries, there has been a significant decrease in post-PCI MACE over time. The risk for death or myocardial infarction is higher among females and older patients compared with males and younger patients; therefore, future studies should focus on improving clinical outcomes in these high-risk subgroups., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Background: Prior trials suggest it is safe to defer transfusion at hemoglobin levels above 7 to 8 g/dL in most patients. Patients with acute coronary syndrome may benefit from higher hemoglobin levels., Methods: We performed a pilot trial in 110 patients with acute coronary syndrome or stable angina undergoing cardiac catheterization and a hemoglobin <10 g/dL. Patients in the liberal transfusion strategy received one or more units of blood to raise the hemoglobin level ≥10 g/dL. Patients in the restrictive transfusion strategy were permitted to receive blood for symptoms from anemia or for a hemoglobin <8 g/dL. The predefined primary outcome was the composite of death, myocardial infarction, or unscheduled revascularization 30 days post randomization., Results: Baseline characteristics were similar between groups except age (liberal, 67.3; restrictive, 74.3). The mean number of units transfused was 1.6 in the liberal group and 0.6 in the restrictive group. The primary outcome occurred in 6 patients (10.9%) in the liberal group and 14 (25.5%) in the restrictive group (risk difference = 15.0%; 95% confidence interval of difference 0.7% to 29.3%; P = .054 and adjusted for age P = .076). Death at 30 days was less frequent in liberal group (n = 1, 1.8%) compared to restrictive group (n = 7, 13.0%; P = .032)., Conclusions: The liberal transfusion strategy was associated with a trend for fewer major cardiac events and deaths than a more restrictive strategy. These results support the feasibility of and the need for a definitive trial., (Copyright © 2013 Mosby, Inc. All rights reserved.)

With the large number of antithrombotic therapies available and under investigation for the treatment of non-ST-segment elevation acute coronary syndromes (NSTE ACS), practice guidelines now stress the importance of selecting an antithrombotic strategy according to the efficacy and safety profiles of the chosen agent. Contemporary trials have incorporated bleeding along with ischemic end points into a composite end point commonly referred to as net clinical benefit, which allows for simultaneous evaluation of the differences between benefit and harm for an investigational antithrombotic therapy. However, incorporating major bleeding into a composite end point that includes ischemic events is not warranted and is associated with many pitfalls. In this article, we discuss the validity of combining efficacy and safety end points to form a net clinical benefit composite end point with the traditional time-to-event analysis for trials evaluating antithrombotic therapies for NSTE ACS. We describe alternative statistical approaches for concurrent assessment of the safety and efficacy of antithrombotic therapies used to treat patients with NSTE ACS., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Background: Bleeding is a major limitation of antithrombotic therapy among invasively managed non-ST-segment elevation acute coronary syndromes (NSTE-ACS) patients; therefore, we examined the use of radial access and its association with outcomes among NSTE-ACS patients., Methods: Clinical characteristics and geographic variation in radial access were examined, as well as its association with bleeding, red blood cell transfusion and ischemic outcomes (96-hour death/myocardial infarction/recurrent ischemic/thrombotic bailout; 30-day death/myocardial infarction; 1-year death) in the EARLY versus delayed, provisional eptifibatide in acute coronary syndromes trial., Results: Of 9126 patients, 13.5% underwent radial-access catheterization. Female sex, age, weight, and prior revascularization were inversely associated with radial access, and its use varied widely by country (2%-97%). There were fewer GUSTO severe/moderate bleeds and red blood cell transfusions in the radial access group; however, it was attenuated after adjustment (odds ratio 0.73, 95% confidence intervals [CI] [0.50-1.06], P = .094 and 1.00 [0.71-1.40] P = .991). Ischemic outcomes did not differ by access site., Conclusions: In this post hoc analysis of a large clinical trial, there was significant international variation in use of radial access for NSTE-ACS patients undergoing invasive management, and it was preferentially used in those at lower risk for bleeding. Radial approach was not associated with a significant reduction in either bleeding or ischemic outcomes. Further study is needed to determine whether wider application of radial approach to acute coronary syndrome patients at high risk for bleeding improves overall outcomes., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Background: Despite lower risks of access site-related complications with transradial approach (TRA), its clinical benefit for percutaneous coronary intervention (PCI) is uncertain. We conducted a systematic review and meta-analysis of clinical studies comparing TRA and transfemoral approach (TFA) for PCI., Methods: Randomized trials and observational studies (1993-2011) comparing TRA with TFA for PCI with reports of ischemic and bleeding outcomes were included. Crude and adjusted (for age and sex) odds ratios (OR) were estimated by a hierarchical Bayesian random-effects model with prespecified stratification for observational and randomized designs. The primary outcomes were rates of death, combined incidence of death or myocardial infarction, bleeding, and transfusions, early (≤ 30 days) and late after PCI., Results: We collected data from 76 studies (15 randomized, 61 observational) involving a total of 761,919 patients. Compared with TFA, TRA was associated with a 78% reduction in bleeding (OR 0.22, 95% credible interval [CrI] 0.16-0.29) and 80% in transfusions (OR 0.20, 95% CrI 0.11-0.32). These findings were consistent in both randomized and observational studies. Early after PCI, there was a 44% reduction of mortality with TRA (OR 0.56, 95% CrI 0.45-0.67), although the effect was mainly due to observational studies (OR 0.52, 95% CrI 0.40-0.63, adjusted OR 0.49 [95% CrI 0.37-0.60]), with an OR of 0.80 (95% CrI 0.49-1.23) in randomized trials., Conclusion: Our results combining observational and randomized studies show that PCI performed by TRA is associated with substantially less risks of bleeding and transfusions compared with TFA. Benefit on the incidence of death or combined death or myocardial infarction is found in observational studies but remains inconclusive in randomized trials., (Copyright © 2012 Mosby, Inc. All rights reserved.)