Faculty Bibliography

BACKGROUND:Decisions involving the purchase of procedural equipment at the health system level require balancing efficacy, safety, physician preference, and cost. The application of efficient and low-cost pragmatic study designs has the potential to rapidly generate data to inform health system operations. METHODS:The aim of the pragmatic RAISE-EMR study is to determine physician preference between two commercially available radial artery introducer sheaths, one of which has a higher acquisition cost, to guide inventory selection in the hospital system's catheterization laboratories. Patients undergoing coronary angiography using 6-French radial artery access were prospectively identified and randomized through the health system's electronic medical record (EMR). Among 1696 eligible unique patients, 554 patients (32.7%) were randomized over 37 days across three hospitals. Randomization took place through the EMR after the attending interventional cardiologist signed a mandated pre-procedure note. The study was deemed non-human subject research and approved by the NYU Langone Health Quality Improvement Oversight Committee. The primary endpoint, a physician satisfaction score, will be ascertained by a mandated semi-quantitative survey within the electronic procedure note. All data, including co-variables and clinical outcomes, will be ascertained using structured data within the EMR. CONCLUSIONS:The RAISE-EMR study is designed to determine physician preference of two commercially available radial artery introducer sheaths and potentially reduce supply costs using an entirely EMR-based randomized study design. Pragmatic study designs leveraging structured data within an EMR can be used to rapidly provide data to inform operational decision-making and have implications for the future of evidence generation.

BACKGROUND:inhibitors, newer generation drug-eluting stents, and intracoronary imaging. OBJECTIVES/OBJECTIVE:The aim of this study was to examine the trends, characteristics, and outcomes of patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) for ST in the United States. METHODS:Patients undergoing PCI for AMI between April 2018 and June 2023 were identified from the National Cardiovascular Data Registry CathPCI registry. The rates of PCI for ST were evaluated over time using linear regression. In-hospital outcomes of PCI for ST vs no ST were compared using multivariable logistic regression. RESULTS:Among 2,023,032 patients undergoing PCI for AMI, 57,268 (2.8%) procedures were for ST. The timing of ST was early (18,189 of 55,351 [31.8%]), late (8,825 of 55,351 [15.4%]), very late (28,337 of 55,351 [49.5%]), or unknown (1,917 of 55,351 [3.4%]). There was no temporal change in the frequency of PCI for ST during the study period. PCI for ST was associated with a higher incidence of major adverse cardiac events (adjusted OR [aOR]: 1.24; 95% CI: 1.19-1.29), all-cause mortality (aOR: 1.17; 95% CI: 1.12-1.22), recurrent myocardial infarction (aOR: 1.80; 95% CI: 1.63-1.98), and major bleeding (aOR: 1.18; 95% CI: 1.15-1.22) compared with PCI for non-ST. CONCLUSIONS:In this contemporary, nationwide, real-world analysis, there was no temporal change in the frequency of PCI for ST. Most STs were early or very late. PCI for ST was associated with a higher rate of in-hospital adverse outcomes.

BACKGROUND:Composite outcomes in cardiovascular trials often group events of unequal clinical importance, and conventional analyses may obscure treatment trade-offs. Generalised pairwise comparisons (GPC), expressed as a win ratio (WR), allow for hierarchical ranking of events and incorporation of recurrent outcomes, providing a potentially more intuitive assessment of benefit-risk. METHODS:In a prespecified exploratory analysis of the 2×2 factorial, randomised CLEAR (Colchicine and Spironolactone in Patients with Myocardial Infarction) trial (7062 patients within 72 hours of acute myocardial infarction (MI) and percutaneous coronary intervention), we applied both time-to-first and recurrent-event GPC to reassess low-dose colchicine (0.5 mg daily) and spironolactone (25 mg daily) versus placebo. For the colchicine comparison, the hierarchical benefit-risk outcome included all-cause death, stroke, recurrent MI, unplanned ischaemia-driven revascularisation, serious infection or diarrhoea. For the spironolactone comparison, the outcome included all-cause death, stroke, MI, new or worsening heart failure, significant ventricular arrhythmia, hyperkalaemia or gynaecomastia/gynaecodynia. GPC results were compared with Cox, logistic and Andersen-Gill models. RESULTS:For colchicine, the time-to-first event GPC showed a 12% lower proportional win rate compared with placebo (WR 0.88, 95% CI 0.79 to 0.98; win difference -2.10%, 95% CI -3.84 to -0.37), driven largely by excess diarrhoea. For spironolactone, patients experienced a 14% lower win rate (WR 0.86, 95% CI 0.75 to 0.99; win difference -1.46%, 95% CI -2.84% to -0.08%), largely attributable to gynaecomastia and hyperkalaemia. Conventional statistical approaches yielded concordant results. Across both interventions, higher-order efficacy outcomes (death, MI, stroke, heart failure) showed no benefit. CONCLUSIONS:In patients with post-MI, both low-dose colchicine and spironolactone demonstrated disadvantageous benefit-risk profiles, reinforcing that neither agent should be used routinely. This prespecified application of GPC provided results consistent with traditional methods but offered a clinically intuitive framework for interpreting composite outcomes.

BACKGROUND/UNASSIGNED:Racial and ethnic disparities exist in postacute myocardial infarction (AMI) care. High-potency P2Y12 inhibitors use among patients with AMI who undergo percutaneous coronary intervention (PCI) carries a class I indication in the guidelines. This study aims to examine racial and ethnic differences in high-potency P2Y12 inhibitor prescription on discharge among patients with AMI undergoing PCI. METHODS/UNASSIGNED:Using data from the NCDR Cath PCI registry, we identified consecutive patients with AMI who underwent PCI from April 2018 to June 2023. Likelihood of high-potency P2Y12 inhibitor prescription on discharge was assessed using logistic regression models adjusted for social deprivation index and other patient- and procedure-related variables. RESULTS/UNASSIGNED:Among 1 662 387 patients hospitalized with AMI and who underwent PCI, 165 579 (9.9%) were Black, 58 595 (3.5%) were Asian, and 1 302 576 (78.3%) were of White race, while 135 637 (8.1%) were of Hispanic ethnicity. At discharge 876 078 (52.7%) were prescribed a high-potency P2Y12 inhibitor. Compared with White patients, Black patients were less likely (adjusted odds ratio, 0.93 [95% CI, 0.92-0.94]), while Asians were more likely (adjusted odds ratio, 1.08 [1.07-1.10]) to have a high-potency P2Y12 inhibitor discharge prescription. Compared with non-Hispanics, Hispanic patients were less likely to have a high-potency P2Y12 inhibitor discharge prescription (adjusted odds ratio, 0.95 [95% CI, 0.93-0.96). CONCLUSIONS/UNASSIGNED:In a contemporary national registry of hospitalized patients with AMI who underwent PCI, Black and Hispanic patients were less likely to be discharged on a high-potency P2Y12 inhibitor irrespective of socioeconomic status. These findings highlight an opportunity to achieve equity in guideline-directed AMI pharmacotherapies to improve outcomes.

BACKGROUND/UNASSIGNED:Stenting of bifurcation and non-aorto-ostial coronary lesions presents significant challenges due to geographic miss and restenosis. Drug-coated balloons (DCBs) offer an attractive alternative to drug-eluting stents in the treatment of these lesions. METHODS/UNASSIGNED:We conducted a systematic review of studies published from 2001 to 2024 comparing DCBs with plain old balloon angioplasty and/or drug-eluting stents (DES) in de novo coronary bifurcation lesions and non-aorto-ostial (NAO) lesions. A meta-analysis was performed with target lesion failure (TLF) as the selected outcome, defined as a composite of target lesion revascularization, target vessel myocardial infarction, or cardiovascular death. RESULTS/UNASSIGNED:= .0015), respectively. CONCLUSIONS/UNASSIGNED:In our meta-analysis, DCBs were associated with a lower rate of TLF compared with plain old balloon angioplasty and DES. These findings suggest that DCBs could be preferred for the treatment of bifurcation and NAO lesions.

BACKGROUND:The volume of percutaneous coronary intervention (PCI) at ambulatory surgical centers (ASC) is expected to increase. METHODS:We surveyed US interventional cardiologists with a 58-question, anonymous online survey to evaluate their knowledge of and perspectives on ASC PCI. RESULTS:A total of 114 interventional cardiologists (9 fellows) responded. Participants were most commonly between 45 and 54 years old (33%). Most participants identified as male (95%), white (58%), non-Hispanic (95%), and with an academic affiliation (61%); 13 participants (11%) were PCI operators at an ASC. Most participants (59%) were in support of ASC PCI, 63% were very confident in their ability to decide if a patient is well-suited for ASC PCI, and 43% were not familiar with national and state-level laws/regulations of ASC PCI. Perceived benefits of ASC PCI included positive patient experience (69%), greater efficiency (79%), and lower costs for patients (50%) and institutions (53%). Participants reported a high level of concern about private equity involvement in ASC PCI (58%), occurrence of adverse events away from the hospital (47%), lower quality of care (39%), inappropriate patient selection (40%), inadequate regulatory standards (35%), and institutional pressures (47%). Supporters of ASC PCI reported a better self-assessed knowledge of it and perceived more benefits with fewer concerns. CONCLUSIONS:Most survey participants expressed support for ASC PCI, citing benefits such as improved patient experience, greater efficiency, and reduced costs. However, participants expressed concern for private equity involvement and the risk of adverse events occurring away from the hospital setting.

Radial artery access is a widely used approach due to its reduced bleeding risk. However, complications associated with radial access may occur, including dissection, perforation, occlusion, and bleeding with hematoma formation, which may lead to compartment syndrome. Equipment entrapment can occur due to the small caliber of the artery combined with spasm, and granuloma formation may arise from retained sheath material. Careful assessment of radial artery diameter and patency using ultrasound is highly recommended to minimize these risks. Employing proper access techniques, including adequate local anesthesia, ultrasound guidance, and vasodilator administration, can mitigate risk of complications and improve patient outcomes.

[This corrects the article DOI: 10.1016/j.jscai.2024.102399.].