Increase in BNP in Response to Endothelin-Receptor Antagonist Atrasentan Is Associated With Incident Heart Failure.

BACKGROUND: The endothelin receptor antagonist atrasentan reduced the risk of kidney failure in patients with type 2 diabetes mellitus and chronic kidney disease (CKD) in the SONAR (Study of Diabetic Nephropathy with Atrasentan) trial, although with a numerically higher incidence of heart failure (HF) hospitalization. OBJECTIVES: The purpose of this study was to assess if early changes in B-type natriuretic peptide (BNP) and body weight during atrasentan treatment predict HF risk. METHODS: Participants with type 2 diabetes and CKD entered an open-label enrichment phase to assess response to atrasentan 0.75 mg/day. Participants without substantial fluid retention (>3 kg body weight increase or BNP increase to >300 pg/mL), were randomized to atrasentan 0.75 mg/day or placebo. Cox proportional hazards regression was used to assess the effects of atrasentan vs placebo on the prespecified safety outcome of HF hospitalizations. RESULTS: Among 3,668 patients, 73 (4.0%) participants in the atrasentan and 51 (2.8%) in the placebo group developed HF (HR: 1.39; 95% CI: 0.97-1.99; P = 0.072). In a multivariable analysis, HF risk was associated with higher baseline BNP (HR: 2.32; 95% CI: 1.81-2.97) and percent increase in BNP during response enrichment (HR: 1.46; 95% CI: 1.08-1.98). Body weight change was not associated with HF. Exclusion of patients with at least 25% BNP increase during enrichment attenuated the risk of HF with atrasentan (HR: 1.02; 95% CI: 0.66-1.56) while retaining nephroprotective effects (HR: 0.58; 95% CI: 0.44-0.78). CONCLUSIONS: In patients with type 2 diabetes and CKD, baseline BNP and early changes in BNP in response to atrasentan were associated with HF hospitalization, highlighting the importance of natriuretic peptide monitoring upon initiation of atrasentan treatment. (Study Of Diabetic Nephropathy With Atrasentan [SONAR]; NCT01858532).

Identifying Racial, Ethnic, and Socioeconomic Inequities in the Use of Novel P2Y12 Inhibitors After Percutaneous Coronary Intervention.

BACKGROUND: Novel P2Y12 inhibitors prasugrel and ticagrelor were approved for patients with acute coronary syndrome (ACS) in 2009 and 2011, respectively. We assessed the association of racial, ethnic, and socioeconomic factors with initiation of and adherence to novel P2Y12 inhibitors in a commercially insured population. METHODS: We performed a retrospective cohort analysis of adults undergoing percutaneous coronary intervention with placement of a drug-eluting stent, stratified by ACS status, between January 2008 and December 2016 using Clinformatics Data Mart (OptumInsight). We estimated multivariable logistic regression models to identify factors associated with the initiation of clopidogrel vs novel P2Y12 inhibitors as well as subsequent 6-month medication adherence, assessed via pharmacy records. RESULTS: A total of 55,664 patients were included in the analysis. Hispanic ethnicity was independently associated with the initiation of clopidogrel compared with novel P2Y12 inhibitors among ACS patients (odds ratio [OR], 1.19; 95% confidence interval [CI], 1.04-1.36; P<.01). ACS patients with an annual median household income of over $100,000 were less likely to be started on clopidogrel when compared with those who earned less than $40,000 (OR, 0.67; 95% CI, 0.61-0.75; P<.01). Black race, Hispanic ethnicity, and lower household income were each associated with significantly reduced odds of P2Y12 inhibitor adherence. CONCLUSION: Hispanic ethnicity and lower household income were associated with novel P2Y12 inhibitor initiation, and non-White race and ethnicity were associated with lower P2Y12 inhibitor adherence over 6-month follow-up. These findings highlight continued inequity of care, even in an insured population, and point to a need for new strategies to close these gaps.

Attitudes toward pharmacogenetics in patients undergoing CYP2C19 testing following percutaneous coronary intervention.

Aim: Patient knowledge and attitudes toward pharmacogenetic (PGx) testing may impact adoption of clinical testing. Methods: Questionnaires regarding knowledge, attitudes and ethics of PGx testing were distributed to 504 patients enrolled in the ADAPT study conducted at two urban hospitals in Philadelphia, Pennsylvania, USA. Responses were assessed using multivariable logistic regression. Results: 311 completed the survey (62% response rate). 74% were unaware of PGx testing, but 79% indicated using PGx results to predict medication efficacy was important. In a multivariable model, higher education level (p = 0.031) and greater genetics knowledge (p < 0.001) were associated with more positive attitudes toward PGx testing. Conclusion: Greater patient knowledge of genetics was associated with a more positive attitude toward PGx testing, indicating that educational strategies aimed at increasing genetics knowledge may enhance adoption of PGx testing in the clinic.

Pharmacogenetic (PGx) testing looks for genetic variations that may impact one's ability to respond to certain medications. This has the potential to improve patient care and minimize side effects from medications but is not currently used as standard of care for several reasons including a limited understanding of patient perceptions toward PGx testing. This study aimed to assess patient knowledge, attitudes and ethics of PGx testing. Questionnaires were given to patients enrolled in a clinical trial at two urban hospitals in Philadelphia, Pennsylvania, USA. In the study, patients underwent a nonsurgical procedure to open narrowed blood vessels supplying the heart muscles and were prescribed antiplatelet medications afterward. As part of study participation, some patients had undergone PGx testing to guide antiplatelet therapy following while others received standard of care (no PGx testing). We found that patients were generally not aware of PGx testing but felt it would be important information to have to guide their treatment options. Higher education levels and greater genetics knowledge were factors associated with more positive attitudes toward PGx testing. An understanding of patient perceptions, knowledge and misconceptions of PGx testing can allow healthcare professionals to better address knowledge gaps and increase the use of PGx testing in clinical settings.

Interventional cardiologists' attitudes towards pharmacogenetic testing and impact on antiplatelet prescribing decisions.

Aim: To determine if interventional cardiologists' knowledge and attitudes toward pharmacogenetic (PGx) testing influenced their antiplatelet prescribing decisions in response to CYP2C19 results. Materials & methods: Surveys were administered prior to participating in a randomized trial of CYP2C19 testing. Associations between baseline knowledge/attitudes and agreement with the genotype-guided antiplatelet recommendations were determined using multivariable logistic regression. Results: 50% believed that PGx testing would be valuable to predict medication toxicity or efficacy. 64% felt well informed about PGx testing and its therapeutic application. However, PGx experience, knowledge, nor attitudes were significantly associated with agreement to genotype-guided antiplatelet recommendations. Conclusion: Cardiologists' knowledge and attitudes were not associated with CYP2C19-guided antiplatelet prescribing, but larger studies should be done to confirm this finding.

Lay abstract Our study aimed to determine if interventional cardiologists' knowledge and attitudes toward pharmacogenetic (PGx) testing influenced their medication prescribing decisions in response to variations in patients' genes. Surveys were given to the cardiologist prior to their participation in a PGx study. Associations between initial knowledge/attitudes and agreement with the PGx-guided medication recommendations were determined. 50% believed that PGx testing would be valuable to predict medication toxicity or efficacy. A total of 64% felt well informed about PGx testing and its therapeutic application. However, PGx experience, knowledge, or attitudes did not align with antiplatelet prescribing decisions. Cardiologists' knowledge and attitudes were not associated with PGx-guided medication prescribing, but larger studies should be done to confirm this finding.

Comparison of Patients Undergoing Percutaneous Coronary Intervention in Contemporary U.S. Practice With ISCHEMIA Trial Population.

OBJECTIVES: The study sought to assess the proportion of patients in modern U.S. interventional practice that fulfilled criteria for enrollment in the ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial. BACKGROUND: The ISCHEMIA trial, which enrolled patients with stable ischemic heart disease (SIHD), showed that revascularization improved angina symptoms with little effect on death or myocardial infarction. METHODS: A cross-sectional analysis of the National Cardiovascular Data Registry CathPCI Registry (v5.0), including 1,662 hospitals, was performed. Patients undergoing percutaneous coronary intervention (PCI) for SIHD in routine clinical practice meeting ISCHEMIA trial inclusion criteria and those that did not were evaluated. RESULTS: During the study period, 388,212 patients underwent PCI for SIHD, comprising 41.88% of all patients undergoing PCI during the study period. Of these, 125,302 (32.28%; 13.52% of all patients undergoing PCI) met criteria for enrollment in the ISCHEMIA trial. Among SIHD patients that did not meet criteria, 71,852 (18.51%) had SIHD with high-risk features (35.2% left main disease, 43.7% left ventricular systolic dysfunction, 16.8% end-stage renal disease), 67,159 (17.3%) had SIHD with negative or low-risk functional testing, and 123,899 (31.92%) either had no stress testing or did not have ischemic burden reported. At the median hospital, 32.1% (interquartile range: 23.5%-40.6%) of SIHD patients met criteria for enrollment in the ISCHEMIA trial, with these patients experiencing lower unadjusted in-hospital mortality rate than comparator groups who met exclusion criteria for the trial (0.11%) (P < 0.01 for all comparisons). CONCLUSIONS: Among contemporary U.S. patients undergoing PCI for SIHD, 32.28% clearly met enrollment criteria for the ISCHEMIA trial. There was significant variation among individual centers in the proportion of SIHD patients meeting criteria for the ISCHEMIA trial.

Safety of Intravenous Cangrelor Administration for Antiplatelet Bridging in Hospitalized Patients: A Retrospective Study.

OBJECTIVE: We aimed to characterize outcomes associated with cangrelor administration used in an antiplatelet bridging strategy in real-world clinical scenarios within a large academic medical system. BACKGROUND: Cangrelor has been used for antiplatelet bridging in perioperative settings or for patients unable to take oral medications. Prior studies in these settings have reported bleeding rates from 0%-40%. METHODS: Patients were retrospectively identified via chart review and included if they were over 18 years old, had coronary or peripheral arterial stents, and had received at least 1 hour of cangrelor infusion during inpatient admission. The primary endpoint was Bleeding Academic Research Consortium (BARC) 3-5 bleeding during cangrelor infusion or within 48 hours of discontinuation; secondary endpoints were bleeding events defined by Thrombolysis in Myocardial Infarction (TIMI), Global Use of Strategies to Open Occluded Arteries (GUSTO), and International Society on Thrombosis and Hemostasis (ISTH) criteria, as well as BARC 2 bleeding. RESULTS: Thirty-one patients met the inclusion criteria. Cangrelor indications were bridging to procedure in 22 patients (71.0%) and inability to take oral P2Y12 inhibitors in 9 patients (29.0%). Twenty-three patients (74.2%) were men, 11 patients (35.5%) were in cardiogenic shock, and 4 patients (12.9%) were on extracorporeal membrane oxygenation (ECMO) at the time of administration. No patients received cangrelor for routine percutaneous coronary intervention. Of the 31 patients, 13 (41.9%) had BARC 3-5 bleeding and 7 (22.6%) expired during hospitalization. All 4 patients on ECMO suffered BARC 3-5 bleeding. CONCLUSIONS: We reviewed the use of cangrelor for antiplatelet bridging in real-world clinical scenarios and observed higher rates of clinically significant bleeding than seen in other similar studies. Our study suggests careful consideration when using cangrelor in a sick patient population.

SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021.

The current document commissioned by the Society for Cardiovascular Angiography and Interventions (SCAI) and endorsed by the American College of Cardiology, the American Heart Association, and Heart Rhythm Society represents a comprehensive update to the 2012 and 2016 consensus documents on patient-centered best practices in the cardiac catheterization laboratory. Comprising updates to staffing and credentialing, as well as evidence-based updates to the pre-, intra-, and post-procedural logistics, clinical standards and patient flow, the document also includes an expanded section on CCL governance, administration, and approach to quality metrics. This update also acknowledges the collaboration with various specialties, including discussion of the heart team approach to management, and working with electrophysiology colleagues in particular. It is hoped that this document will be utilized by hospitals, health systems, as well as regulatory bodies involved in assuring and maintaining quality, safety, efficiency, and cost-effectiveness of patient throughput in this high volume area.

Evolution and Outcomes of Premature Coronary Artery Disease.

PURPOSE OF REVIEW: The purpose of this review is to explore the evolution and outcomes of premature coronary artery disease (PCAD) while reviewing strategies for effective screening of those at high risk for developing this disease. RECENT FINDINGS: Premature coronary artery disease (PCAD) affects a population of patients not typically identified as high risk by current risk stratification guidelines or traditional risk calculation tools. Not only does PCAD represent a large proportion of overall cardiovascular disease, it also afflicts a population in which the rate of mortality from cardiovascular disease has plateaued despite an overall declining population-wide cardiovascular mortality rate. There is ample opportunity for behavioral change strategies, screening tools, adapted imaging modalities, and precision pharmacotherapies to be more precisely targeted toward those at highest risk for premature coronary artery disease. Premature coronary artery disease (PCAD) is pervasive and not frequently represented within contemporary risk calculation models. Providers should pursue proactive screening and aggressive risk factor modification and deploy appropriate preventative therapies in caring for younger populations.

Trends in Coded Indications for Percutaneous Coronary Interventions in Medicare and the Veterans Affairs After Implementation of Hospital-Level Reporting of Appropriate Use Criteria.

BACKGROUND: In 2009, the American College of Cardiology and American Heart Association published Appropriate Use Criteria for Coronary Revascularization (AUC) to aid patient selection for percutaneous coronary intervention (PCI). The subsequent decline in inappropriate PCIs was interpreted as a success of AUC. However, there are concerns clinicians reclassify nonacute PCIs to acute indications to fulfill AUC. METHODS: A longitudinal, observational difference-in-differences analysis was performed using administrative claims from US Department of Veterans Affairs (VA) beneficiaries coenrolled in Medicare and from a national random sample of Medicare beneficiaries, undergoing PCI from September 30, 2009, to December 31, 2013. Non-VA hospitals participating in the American College of Cardiology CathPCI registry began receiving AUC reports in 2011, while VA hospitals did not receive reports, serving as quasiexperimental and control cohorts, respectively. We measured the proportion of PCIs coded for acute myocardial infarction, unstable angina, and nonacute coronary syndrome indications by quarter. RESULTS: There were 87 464 and 30 251 PCIs performed in the Medicare and VA cohorts, respectively. In Medicare, proportion of PCIs coded for acute myocardial infarction and unstable angina changed from 31.9% and 12.6% in quarter 4 2009 to 41.0% and 10.5% in quarter 4 2013, an associated 2.00% (95% CI, 1.56%-2.44%; P<0.001) increase per year in PCIs coded for acute coronary syndrome indications. In the VA, proportion of PCIs coded for acute myocardial infarction and unstable angina changed from 26.5% and 15.7% in quarter 4 2009 to 34.3% and 12.3% in quarter 4 2013, an associated 1.20% (95% CI, 0.56%-1.88%; P=0.001) increase per year in PCIs coded for acute coronary syndrome indications. Difference-in-differences modeling found no statistically significant change in PCI coded for acute indications between Medicare and VA, pre- and post-AUC reporting. CONCLUSIONS: After introduction of AUC assessments and reporting, we observed comparable increases in coding for acute myocardial infarction and corresponding decreases in coding for unstable angina and nonacute coronary syndrome indications among national cohorts of Medicare and VA enrollees. The provision of appropriate use reporting did not appear to have a substantial impact on the proportion of PCIs coded for acute indications during this study period.

Patient Characteristics Associated With Telemedicine Access for Primary and Specialty Ambulatory Care During the COVID-19 Pandemic.

Importance: The coronavirus disease 2019 (COVID-19) pandemic has required a shift in health care delivery platforms, necessitating a new reliance on telemedicine. Objective: To evaluate whether inequities are present in telemedicine use and video visit use for telemedicine visits during the COVID-19 pandemic. Design, Setting, and Participants: In this cohort study, a retrospective medical record review was conducted from March 16 to May 11, 2020, of all patients scheduled for telemedicine visits in primary care and specialty ambulatory clinics at a large academic health system. Age, race/ethnicity, sex, language, median household income, and insurance type were all identified from the electronic medical record. Main Outcomes and Measures: A successfully completed telemedicine visit and video (vs telephone) visit for a telemedicine encounter. Multivariable models were used to assess the association between sociodemographic factors, including sex, race/ethnicity, socioeconomic status, and language, and the use of telemedicine visits, as well as video use specifically. Results: A total of 148 402 unique patients (86 055 women [58.0%]; mean [SD] age, 56.5 [17.7] years) had scheduled telemedicine visits during the study period; 80 780 patients (54.4%) completed visits. Of 78 539 patients with completed visits in which visit modality was specified, 35 824 (45.6%) were conducted via video, whereas 24 025 (56.9%) had a telephone visit. In multivariable models, older age (adjusted odds ratio [aOR], 0.85 [95% CI, 0.83-0.88] for those aged 55-64 years; aOR, 0.75 [95% CI, 0.72-0.78] for those aged 65-74 years; aOR, 0.67 [95% CI, 0.64-0.70] for those aged ≥75 years), Asian race (aOR, 0.69 [95% CI, 0.66-0.73]), non-English language as the patient's preferred language (aOR, 0.84 [95% CI, 0.78-0.90]), and Medicaid insurance (aOR, 0.93 [95% CI, 0.89-0.97]) were independently associated with fewer completed telemedicine visits. Older age (aOR, 0.79 [95% CI, 0.76-0.82] for those aged 55-64 years; aOR, 0.78 [95% CI, 0.74-0.83] for those aged 65-74 years; aOR, 0.49 [95% CI, 0.46-0.53] for those aged ≥75 years), female sex (aOR, 0.92 [95% CI, 0.90-0.95]), Black race (aOR, 0.65 [95% CI, 0.62-0.68]), Latinx ethnicity (aOR, 0.90 [95% CI, 0.83-0.97]), and lower household income (aOR, 0.57 [95% CI, 0.54-0.60] for income <$50 000; aOR, 0.89 [95% CI, 0.85-0.92], for $50 000-$100 000) were associated with less video use for telemedicine visits. These results were similar across medical specialties. Conclusions and Relevance: In this cohort study of patients scheduled for primary care and medical specialty ambulatory telemedicine visits at a large academic health system during the early phase of the COVID-19 pandemic, older patients, Asian patients, and non-English-speaking patients had lower rates of telemedicine use, while older patients, female patients, Black, Latinx, and poorer patients had less video use. Inequities in accessing telemedicine care are present, which warrant further attention.

Performance of Hospitals When Assessing Disease-Based Mortality Compared With Procedural Mortality for Patients With Acute Myocardial Infarction.

Importance: Quality of percutaneous coronary intervention (PCI) is commonly assessed by risk-adjusted mortality. However, this metric may result in procedural risk aversion, especially for high-risk patients. Objective: To determine correlation and reclassification between hospital-level disease-specific mortality and PCI procedural mortality among patients with acute myocardial infarction (AMI). Design, Setting, and Participants: This hospital-level observational cross-sectional multicenter analysis included hospitals participating in the Chest Pain-MI Registry, which enrolled consecutive adult patients admitted with a diagnosis of type I non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI), and hospitals in the CathPCI Registry, which enrolled consecutive adult patients treated with PCI with an indication of NSTEMI or STEMI, between April 1, 2011, and December 31, 2017. Exposures: Inclusion into the National Cardiovascular Data Registry Chest Pain-MI and CathPCI registries. Main Outcomes and Measures: For each hospital in each registry, a disease-based excess mortality ratio (EMR-D) for AMI was calculated, which represents a risk-adjusted observed to expected rate of mortality for AMI as a disease using the Chest Pain-MI Registry, and a procedure-based excess mortality ratio (EMR-P) for PCI was calculated using the CathPCI Registry. Results: A subset of 625 sites participated in both registries, with a final count of 776 890 patients from the Chest Pain-MI Registry (509 576 men [65.6%]; 620 981 white [80.0%]; and median age, 64 years [interquartile range, 55-74 years]) and 853 386 patients from the CathPCI Registry (582 701 men [68.3%]; 691 236 white [81.0%]; and median age, 63 years [interquartile range, 54-73 years]). Among the 625 linked hospitals, the Spearman rank correlation coefficient between EMR-D and EMR-P produced a ρ of 0.53 (95% CI, 0.47-0.58), suggesting moderate correlation. Among the highest-performing tertile for disease-based risk-adjusted mortality, 90 of 208 sites (43.3%) were classified into a lower category for procedural risk-adjusted mortality. Among the lowest-performing tertile for disease-based risk-adjusted mortality, 92 of 208 sites (44.2%) were classified into a higher category for procedural risk-adjusted mortality. Bland-Altman plots for the overall linked cohort demonstrate a mean difference between EMR-P and EMR-D of 0.49% (95% CI, -1.61% to 2.58%; P < .001), with procedural mortality higher than disease-based mortality. However, among patients with AMI complicated by cardiogenic shock or cardiac arrest, the mean difference between EMR-P and EMR-D was -0.64% (95% CI, -4.41% to 3.12%; P < .001), with procedural mortality lower than disease-based mortality. Conclusions and Relevance: This study suggests that, for hospitals treating patients with AMI, there is only a moderate correlation between procedural outcomes and disease-based outcomes. Nearly half of hospitals in the highest tertile of performance for PCI performance were reclassified into a lower performance tertile when judged by disease-based metrics. Higher rates of mortality were observed when using disease-based metrics compared with procedural metrics when assessing patients with cardiogenic shock and/or cardiac arrest, signifying what appears to be potential risk avoidance among this highest-risk subset of patients.

SCAI publications committee manual of standard operating procedures.

Evidence-based recommendations for clinical practice are intended to help health care providers and patients make decisions, minimize inappropriate practice variation, promote effective resource use, improve clinical outcomes, and direct future research. The Society for Cardiovascular Angiography and Interventions (SCAI) has been engaged in the creation and dissemination of clinical guidance documents since the 1990s. These documents are a cornerstone of the society's education, advocacy, and quality improvement initiatives. The publications committee is charged with oversight of SCAI's clinical documents program and has created this manual of standard operating procedures to ensure consistency, methodological rigor, and transparency in the development and endorsement of the society's documents. The manual is intended for use by the publications committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program.

Prospective CYP2C19 Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial.

BACKGROUND: CYP2C19 loss-of-function alleles impair clopidogrel effectiveness after percutaneous coronary intervention, but the clinical impact of implementing CYP2C19 genotyping in a real-world setting is unknown. The purpose of the study was to determine whether returning CYP2C19 genotype results along with genotype-guided pharmacotherapy recommendations using a rapid turnaround test would change antiplatelet prescribing following percutaneous coronary intervention.The primary outcome was the rate of prasugrel or ticagrelor prescribing in each arm. Secondary outcomes included agreement to the genotype-guided recommendations. METHODS: At the time of percutaneous coronary intervention, participants were randomly assigned to prospective rapid point-of-care genotyping of CYP2C19 major alleles (*2, *3, *17) via salivary swab (genotyped group) or no genotyping (usual care) to guide antiplatelet drug selection. Interventional cardiologists at 2 cardiac catheterization laboratories within the same health system were provided genotype information along with genotype-guided pharmacotherapy recommendations. RESULTS: A total of 504 participants were randomized, 249 to the genotyped and 255 to the usual care group. The participants were primarily men (73%); age, 63±10 years; and 50% had acute coronary syndromes. In the genotyped group, 28% were carriers of loss-of-function alleles (*2, *3). The use of prasugrel or ticagrelor was significantly higher in the genotyped group compared with the usual care group (30% versus 21%; odds ratio, 1.60 [95% CI, 1.07-2.42]; P=0.03). Within the genotyped group, 53% of loss-of-function allele carriers were started on prasugrel/ticagrelor, while 47% were started on clopidogrel. CONCLUSIONS: In a randomized controlled trial of clinical CYP2C19 genotyping implementation, pharmacogenetic test results significantly influenced antiplatelet drug prescribing; however, almost half of CYP2C19 loss-of-function carriers continued to receive clopidogrel. Interventional cardiologists consider both clinical and genetic factors when selecting antiplatelet therapy following percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT02508116.

Accuracy of Fractional Flow Reserve Derived From Coronary Angiography.

BACKGROUND: Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFRangio) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFRangio Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFRangio. METHODS: Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in ≥2 different projections, on-site operators blinded to FFR then calculated FFRangio using proprietary software. Coprimary end points were the sensitivity and specificity of the dichotomously scored FFRangio for predicting pressure wire-derived FFR using a cutoff value of 0.80. The study was powered to meet prespecified performance goals for sensitivity and specificity. RESULTS: Ten centers in the United States, Europe, and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR≤0.80. The per-vessel sensitivity and specificity were 94% (95% CI, 88% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFRangio was 92% overall and remained high when only considering FFR values between 0.75 to 0.85 (87%). FFRangio values correlated well with FFR measurements ( r=0.80, P<0.001) and the Bland-Altman 95% confidence limits were between -0.14 and 0.12. The device success rate for FFRangio was 99%. CONCLUSIONS: FFRangio measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire-derived FFR. FFRangio has the promise to substantially increase physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262.

A Nurse-Led Limited Risk Factor Modification Program to Address Obesity and Obstructive Sleep Apnea in Atrial Fibrillation Patients.

Background Obesity and obstructive sleep apnea ( OSA ) are associated with atrial fibrillation ( AF ), yet these conditions remain inadequately treated. We report on the feasibility and efficacy of a nurse-led risk factor modification program utilizing a pragmatic approach to address obesity and OSA in AF patients. Methods and Results AF patients with obesity (body mass index ≥30 kg/m2) and/or the need for OSA management (high risk per Berlin Questionnaire or untreated OSA ) were voluntarily enrolled for risk factor modification, which comprised patient education, lifestyle modification, coordination with specialists, and longitudinal management. Weight loss and OSA treatment were monitored by monthly follow-up calls and/or continuous positive airway pressure ( CPAP ) unit downloads. Quality of life and arrhythmia symptoms were assessed with the SF -36 and AF Severity Scale at baseline and at 6 months. From November 1, 2016 to October 31, 2017, 252 patients (age 63±11 years; 71% male; 57% paroxysmal AF ) were enrolled, 189 for obesity and 93 for OSA . Obese patients who enrolled lost significantly greater percent body weight than those who declined (3% versus 0.3%; P<0.05). Among 93 patients enrolled for OSA , 70 completed sleep studies, OSA was confirmed in 50, and the majority (76%) started CPAP therapy. All components of quality of life and arrhythmia symptoms improved significantly from baseline to 6 months among enrolled patients. Conclusions A nurse-led risk factor modification program is a potentially sustainable and generalizable model that can improve weight loss and OSA in AF patients, translating into improved quality of life and arrhythmia symptoms.

Association Between 30-Day Mortality After Percutaneous Coronary Intervention and Education and Certification Variables for New York State Interventional Cardiologists.

BACKGROUND: Patients and other providers have access to few publicly available physician attributes that identify interventional cardiologists with better postprocedural outcomes, particularly in states without public reporting of outcomes. Interventional cardiology board certification, maintenance of certification, graduation from a US medical school, medical school ranking, and length of practice represent such publicly available attributes. Previous studies on these measures have shown mixed results. METHODS AND RESULTS: We included interventional cardiologists practicing in New York State in the years 2011 to 2013. The primary outcome was 30-day risk-standardized mortality rate (RSMR) after percutaneous coronary intervention. Hierarchical regression modeling was used to analyze the physician attributes and was adjusted for provider caseload. A total of 356 providers were studied. The average 30-day RSMR was 1.1 (SD=0.1) deaths per 100 cases for all percutaneous coronary interventions and 0.7 (SD=0.1) deaths per 100 cases for nonemergent procedures. The primary outcome was slightly lower among providers with interventional cardiology board certification compared with noncertified providers (1.06 [SD=0.14] versus 1.14 [SD=0.14] deaths per 100 cases; P<0.001). In multivariable hierarchical regression modeling, after adjusting for provider caseload, none of the physician attributes were associated with the primary outcome. Provider caseload was significantly associated with 30-day RSMR independent of the other attributes. CONCLUSIONS: Interventional cardiology board-certified providers had a modestly lower 30-day RSMR before accounting for caseload. However, after adjusting for provider caseload, none of the examined publicly available physician attributes, including interventional cardiology board certification, were independently associated with 30-day RSMR.

Heart Failure After Ischemic Stroke or Transient Ischemic Attack in Insulin-Resistant Patients Without Diabetes Mellitus Treated With Pioglitazone.

BACKGROUND: The IRIS trial (Insulin Resistance Intervention After Stroke) demonstrated that pioglitazone reduced the risk for both cardiovascular events and diabetes mellitus in insulin-resistant patients. However, concern remains that pioglitazone may increase the risk for heart failure (HF) in susceptible individuals. METHODS: In IRIS, patients with insulin resistance but without diabetes mellitus were randomized to pioglitazone or placebo (1:1) within 180 days of an ischemic stroke or transient ischemic attack and followed for ≤5 years. To identify patients at higher HF risk with pioglitazone, we performed a secondary analysis of IRIS participants without HF history at entry. HF episodes were adjudicated by an external review, and treatment effects were analyzed using time-to-event methods. A baseline HF risk score was constructed from a Cox model estimated using stepwise selection. Baseline patient features (individually and summarized in risk score) and postrandomization events were examined as possible modifiers of the effect of pioglitazone. Net cardiovascular benefit was estimated for the composite of stroke, myocardial infarction, and hospitalized HF. RESULTS: Among 3851 patients, the mean age was 63 years, and 65% were male. The 5-year HF risk did not differ by treatment (4.1% pioglitazone, 4.2% placebo). Risk for hospitalized HF was low and not significantly greater in pioglitazone compared with placebo groups (2.9% versus 2.3%, P=0.36). Older age, atrial fibrillation, hypertension, obesity, edema, high C-reactive protein, and smoking were risk factors for HF. However, the effect of pioglitazone did not differ across levels of baseline HF risk (hazard ratio [95% CI] for pioglitazone versus placebo for patients at low, moderate, and high risk: 1.03 [0.61-1.73], 1.10 [0.56-2.15], and 1.08 [0.58-2.01]; interaction P value=0.98). HF risk was increased in patients with versus those without incident myocardial infarction in both groups (pioglitazone: 31.4% versus 2.7%; placebo: 25.7% versus 2.4%; P<0.0001). Edema, dyspnea, and weight gain in the trial did not predict HF hospitalization but led to more study drug dose reduction with a lower mean dose of pioglitazone versus placebo (29±17 mg versus 33±15 mg, P<0.0001). Pioglitazone reduced the composite outcome of stroke, myocardial infarction, or hospitalized HF (hazard ratio, 0.78; P=0.007). CONCLUSIONS: In IRIS, with surveillance and dose adjustments, pioglitazone did not increase the risk of HF and conferred net cardiovascular benefit in patients with insulin resistance and cerebrovascular disease. The risk of HF with pioglitazone was not modified by baseline HF risk. The IRIS experience may be instructive for maximizing the net benefit of this therapy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00091949.