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Implementation of a Multidimensional Strategy to Reduce Post-PCI Bleeding Risk

Price, Andrea L; Amin, Amit P; Rogers, Susan; Messenger, John C; Moussa, Issam D; Miller, Julie M; Jennings, Jonathan; Masoudi, Frederick A; Abbott, J Dawn; Young, Rebecca; Wojdyla, Daniel M; Rao, Sunil V
BACKGROUND/UNASSIGNED:The American College of Cardiology Reduce the Risk: PCI Bleed Campaign was a hospital-based quality improvement campaign designed to reduce post-percutaneous coronary intervention (PCI) bleeding events. The aim of the campaign was to provide actionable evidence-based tools for participants to review, adapt, and adopt, depending upon hospital resources and engagement. METHODS/UNASSIGNED:We used data from 8 757 737 procedures in the National Cardiovascular Data Registry between 2015 and 2021 to compare patient and hospital characteristics and bleeding outcomes among campaign participants (n=195 hospitals) and noncampaign participants (n=1384). Post-PCI bleeding risk was compared before and after campaign participation. Multivariable hierarchical logistic regression was used to determine the adjusted association between campaign participation and post-PCI bleeding events. Prespecified subgroups were examined. RESULTS/UNASSIGNED:Campaign hospitals were more often higher volume teaching facilities located in urban or suburban locations. After adjustment, campaign participation was associated with a significant reduction in the rate of bleeding (bleeding: adjusted odds ratio, 0.61 [95% CI, 0.53-0.71]). Campaign hospitals had a greater decrease in bleeding events than noncampaign hospitals. In a subgroup analysis, the reduction in bleeding was noted in non-ST-segment-elevation acute coronary syndrome and ST-segment-elevation myocardial infarction patients, but no significant reduction was seen in patients without acute coronary syndrome. CONCLUSIONS/UNASSIGNED:Participation in the American College of Cardiology Reduce the Risk: PCI Bleed Campaign was associated with a significant reduction in post-PCI bleeding. Our results underscore that national quality improvement efforts can be associated with a significant impact on PCI outcomes.
PMCID:10942247
PMID: 38410946
ISSN: 1941-7632
CID: 5639762

Bleeding Outcomes in Patients Treated With Asundexian in Phase II Trials

Eikelboom, John W; Mundl, Hardi; Alexander, John H; Caso, Valeria; Connolly, Stuart J; Coppolecchia, Rosa; Gebel, Martin; Hart, Robert G; Holberg, Gerlind; Keller, Lars; Patel, Manesh R; Piccini, Jonathan P; Rao, Sunil V; Shoamanesh, Ashkan; Tamm, Miriam; Viethen, Thomas; Yassen, Ashraf; Bonaca, Marc P
BACKGROUND:Phase II trials of asundexian were underpowered to detect important differences in bleeding. OBJECTIVES/OBJECTIVE:The goal of this study was to obtain best estimates of effects of asundexian vs active control/placebo on major and clinically relevant nonmajor (CRNM) and all bleeding, describe most common sites of bleeding, and explore association between asundexian exposure and bleeding. METHODS:We performed a pooled analysis of 3 phase II trials of asundexian in patients with atrial fibrillation (AF), recent acute myocardial infarction (AMI), or stroke. Bleeding was defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria. RESULTS:In patients with AF (n = 755), both asundexian 20 mg and 50 mg once daily vs apixaban had fewer major/CRNM events (3 of 249; incidence rate [IR] per 100 patient-years 5.47 vs 1 of 254 [IR: not calculable] vs 6 of 250 [IR: 11.10]) and all bleeding (12 of 249 [IR: 22.26] vs 10 of 254 [IR: 18.21] vs 26 of 250 [IR: 50.56]). In patients with recent AMI or stroke (n = 3,409), asundexian 10 mg, 20 mg, and 50 mg once daily compared with placebo had similar rates of major/CRNM events (44 of 840 [IR: 7.55] vs 42 of 843 [IR: 7.04] vs 56 of 845 [IR: 9.63] vs 41 of 851 [IR: 6.99]) and all bleeding (107 of 840 [IR: 19.57] vs 123 of 843 [IR: 22.45] vs 130 of 845 [IR: 24.19] vs 129 of 851 [IR: 23.84]). Most common sites of major/CRNM bleeding with asundexian were gastrointestinal, respiratory, urogenital, and skin. There was no significant association between asundexian exposure and major/CRNM bleeding. CONCLUSIONS:Analyses of phase II trials involving >500 bleeds highlight the potential for improved safety of asundexian compared with apixaban and similar safety compared with placebo. Further evidence on the efficacy of asundexian awaits the results of ongoing phase III trials.
PMID: 38325992
ISSN: 1558-3597
CID: 5632262

Use of Calcium Modification During Percutaneous Coronary Intervention After Introduction of Coronary Intravascular Lithotripsy

Butala, Neel M; Waldo, Stephen W; Secemsky, Eric A; Kennedy, Kevin F; Spertus, John A; Rymer, Jennifer A; Rao, Sunil V; Messenger, John C; Yeh, Robert W
BACKGROUND/UNASSIGNED:Calcified coronary lesions are a challenge for percutaneous coronary interventions (PCIs). Coronary intravascular lithotripsy (IVL) is a novel calcium modification technology approved for commercial use in February 2021, but little is known about its uptake in US clinical practice. METHODS/UNASSIGNED:We described trends in use of calcium modification strategies, variation in use across hospitals, and predictors of calcium modification and IVL use in PCI. We included National Cardiovascular Data Registry CathPCI Registry patients who underwent PCI between April 1, 2018, and December 31, 2022. We examined trends and hospital variation in calcium modification and IVL use. We used multivariate hierarchical logistic regression to identify predictors of calcium modification and IVL use at hospitals in 2022. RESULTS/UNASSIGNED:Of 2,733,494 PCIs across 1676 hospitals over 4.75 years, 11.4% were performed with calcium modification. Coronary IVL use increased rapidly from 0% of PCIs in Q4 2020 to 7.8% of PCIs in Q4 2022, which was accompanied by an overall increase in use of all calcium modification strategies (11.1%-16.0%) during this period with a slight corresponding decrease in coronary atherectomy use (5.4%-4.4%). In 2022, there was wide variation in IVL use across hospitals (median, 3.86%; IQR, 0%-8.19%), with IVL being the most common calcium modification strategy in 48% of hospitals. The treating hospital was the strongest predictor of calcium modification (median odds ratio [OR], 2.49; 95% CI, 2.40-2.57) and IVL use (median OR, 2.89; 95% CI, 2.74-3.04). CONCLUSIONS/UNASSIGNED:IVL has rapidly changed the landscape of calcium modification use for PCI, although there remains wide variation across hospitals.
PMCID:11308754
PMID: 39132220
ISSN: 2772-9303
CID: 5726712

Sex differences in the well-being of interventional cardiologists

Alexandrou, Michaella; Simsek, Bahadir; Rempakos, Athanasios; Kostantinis, Spyridon; Karacsonyi, Judit; Rangan, Bavana V; Mastrodemos, Olga C; Kirtane, Ajay J; Bortnick, Anna E; Jneid, Hani; Azzalini, Lorenzo; Milkas, Anastasios; Alaswad, Khaldoon; Linzer, Mark; Egred, Mohaned; Rao, Sunil V; Allana, Salman S; Sandoval, Yader; Brilakis, Emmanouil S
Several studies suggest differences in burnout and coping mechanisms between female and male physicians. We conducted an international, online survey exploring sex-based differences in the well-being of interventional cardiologists. Of 1251 participants, 121 (9.7%) were women. Compared with men, women were more likely to be single and under 50 years old, and they asked more often for development opportunities and better communication with administration. Overall burnout was similar between women and men, but women interventional cardiology attendings were more likely to think that they were achieving less than they should. Improved communication with administration and access to career development opportunities may help prevent or mitigate burnout in women interventional cardiologists.
PMID: 38335507
ISSN: 1557-2501
CID: 5632042

Effects of complete revascularization according to age in patients with ST-segment elevation myocardial infarction and multivessel disease (COMPLETE-AGE)

Bainey, Kevin R; Wood, David A; Bossard, Matthias; Campo, Gianluca; Cantor, Warren J; Lavi, Shahar; Madan, Mina; Mehran, Roxana; Pinilla-Echeverri, Natalia; Rao, Sunil; Sarma, Jaydeep; Sheth, Tej; Stankovic, Goran; Steg, Phillipe Gabriel; Storey, Robert F; Tanguay, Jean-Francois; Velianou, James L; Welsh, Robert C; Mani, Thenmozhi; Cairns, John A; Mehta, Shamir R; ,
BACKGROUND:In ST-segment elevation myocardial infarction (STEMI), complete revascularization with percutaneous coronary intervention (PCI) reduces major cardiovascular events compared with culprit-lesion-only PCI. Whether age influences these results remains unknown. METHODS:COMPLETE was a multinational, randomized trial evaluating a strategy of staged complete revascularization, consisting of angiography-guided PCI of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only PCI. In this prespecified subgroup analysis, treatment effect according to age (≥65 years vs <65 years) was determined for the first coprimary outcome of cardiovascular (CV) death or new myocardial infarction (MI) and the second coprimary outcome of CV death, new MI, or ischemia-driven revascularization (IDR). Median follow-up was 35.8 months (interquartile range [IQR]: 27.6-44.3 months). RESULTS:Of 4,041 patients randomized in COMPLETE, 1,613 were aged ≥ 65 years (39.9%). Higher event rates were observed for both coprimary outcomes in patients aged ≥ 65 years comparted with those aged < 65 years (11.2% vs 7.9%, HR 1.49, 95% CI 1.22-1.83; 14.4% vs 11.8%, HR 1.28, 95% CI 1.07-1.52, respectively). Complete revascularization reduced the first coprimary outcome in patients ≥ 65 years (9.7% vs 12.5%, HR 0.77; 95% CI, 0.58-1.04) and < 65 years (6.7% vs 9.1%, HR 0.72; 95% CI, 0.54-0.96)(interaction P = .74). The second coprimary outcome was reduced in those ≥ 65 years (HR 0.56, 95% CI, 0.43-0.74) and < 65 years (HR 0.48, 95% CI, 0.37-0.61 (interaction P = .37). A sensitivity analysis was performed with consistent results demonstrated using a 75-year threshold (albeit attenuated). CONCLUSIONS:In patients with STEMI and multivessel CAD, complete revascularization compared with culprit-lesion-only PCI reduced major cardiovascular events regardless of patient age and could be considered as a revascularization strategy in older adults.
PMID: 37871781
ISSN: 1097-6744
CID: 5590932

Clinical outcomes with intravascular ultrasound guidance of percutaneous coronary interventions: a targeted literature review of randomized controlled trials [Review]

Flattery, Erin; Razzouk, Louai; Rao, Sunil, V
ISI:001399202500001
CID: 5928652

Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia

Carson, Jeffrey L; Brooks, Maria Mori; Hébert, Paul C; Goodman, Shaun G; Bertolet, Marnie; Glynn, Simone A; Chaitman, Bernard R; Simon, Tabassome; Lopes, Renato D; Goldsweig, Andrew M; DeFilippis, Andrew P; Abbott, J Dawn; Potter, Brian J; Carrier, Francois Martin; Rao, Sunil V; Cooper, Howard A; Ghafghazi, Shahab; Fergusson, Dean A; Kostis, William J; Noveck, Helaine; Kim, Sarang; Tessalee, Meechai; Ducrocq, Gregory; Gabriel Melo de Barros E Silva, Pedro; Triulzi, Darrell J; Alsweiler, Caroline; Menegus, Mark A; Neary, John D; Uhl, Lynn; Strom, Jordan B; Fordyce, Christopher B; Ferrari, Emile; Silvain, Johanne; Wood, Frances O; Daneault, Benoit; Polonsky, Tamar S; Senaratne, Manohara; Puymirat, Etienne; Bouleti, Claire; Lattuca, Benoit; White, Harvey D; Kelsey, Sheryl F; Steg, P Gabriel; Alexander, John H; ,
BACKGROUND:A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS:In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS:A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS:In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).
PMID: 37952133
ISSN: 1533-4406
CID: 5610762

Management of Adults With Anomalous Aortic Origin of the Coronary Arteries: State-of-the-Art Review

Gaudino, Mario; Di Franco, Antonino; Arbustini, Eloisa; Bacha, Emile; Bates, Eric R; Cameron, Duke E; Cao, Davide; David, Tirone E; De Paulis, Ruggero; El-Hamamsy, Ismail; Farooqi, Kanwal M; Girardi, Leonard N; Gräni, Christoph; Kochav, Jonathan D; Molossi, Silvana; Puskas, John D; Rao, Sunil V; Sandner, Sigrid; Tatoulis, James; Truong, Quynh A; Weinsaft, Jonathan W; Zimpfer, Daniel; Mery, Carlos M
As a result of increasing adoption of imaging screening, the number of adult patients with a diagnosis of anomalous aortic origin of the coronary arteries (AAOCA) has grown in recent years. Existing guidelines provide a framework for management and treatment, but patients with AAOCA present with a wide range of anomalies and symptoms that make general recommendations of limited applicability. In particular, a large spectrum of interventions can be used for treatment, and there is no consensus on the optimal approach to be used. In this paper, a multidisciplinary group of clinical and interventional cardiologists and cardiac surgeons performed a systematic review and critical evaluation of the available evidence on the interventional treatment of AAOCA in adult patients. Using a structured Delphi process, the group agreed on expert recommendations that are intended to complement existing clinical practice guidelines.
PMID: 37855783
ISSN: 1552-6259
CID: 5611552

Management of Adults With Anomalous Aortic Origin of the Coronary Arteries: State-of-the-Art Review

Gaudino, Mario; Di Franco, Antonino; Arbustini, Eloisa; Bacha, Emile; Bates, Eric R; Cameron, Duke E; Cao, Davide; David, Tirone E; De Paulis, Ruggero; El-Hamamsy, Ismail; Farooqi, Kanwal M; Girardi, Leonard N; Gräni, Christoph; Kochav, Jonathan D; Molossi, Silvana; Puskas, John D; Rao, Sunil V; Sandner, Sigrid; Tatoulis, James; Truong, Quynh A; Weinsaft, Jonathan W; Zimpfer, Daniel; Mery, Carlos M
As a result of increasing adoption of imaging screening, the number of adult patients with a diagnosis of anomalous aortic origin of the coronary arteries (AAOCA) has grown in recent years. Existing guidelines provide a framework for management and treatment, but patients with AAOCA present with a wide range of anomalies and symptoms that make general recommendations of limited applicability. In particular, a large spectrum of interventions can be used for treatment, and there is no consensus on the optimal approach to be used. In this paper, a multidisciplinary group of clinical and interventional cardiologists and cardiac surgeons performed a systematic review and critical evaluation of the available evidence on the interventional treatment of AAOCA in adult patients. Using a structured Delphi process, the group agreed on expert recommendations that are intended to complement existing clinical practice guidelines.
PMID: 37855757
ISSN: 1558-3597
CID: 5635432

Novel approach to stenting the left anterior descending coronary artery through a retrograde approach via the left internal mammary artery graft in a patient with occlusion of the coronary ostium from a prior aortic valve replacement [Case Report]

Soud, Mohamad; Feit, Frederick; Rao, Sunil; Bangalore, Sripal
Total occlusion of both coronary ostia is a rare and potentially life-threatening complication following surgical aortic valve replacement. This report presents a case of a patient with known total occlusion of both coronary artery ostia following combined coronary artery bypass graft surgery and aortic valve replacement who underwent successful percutaneous coronary intervention through a retrograde approach.
PMID: 37731297
ISSN: 1522-726x
CID: 5609512