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Benefit-risk of colchicine and spironolactone in acute myocardial infarction: a prespecified generalised pairwise comparisons analysis of the CLEAR trial

d'Entremont, Marc-André; Jolly, Sanjit S; Alharthi, Faisal; Shah, Binita; Austin, David; Yi, Quilong; Storey, Robert F; Bossard, Matthias; Cornel, Jan; Jaspers Focks, Jeroen; Kedev, Sasko; Asani, Valon; Stankovic, Goran; Tsang, Michael; Valettas, Nicholas; Tyrwhitt, Jessica; Betz, Jackie; Lee, Shun Fu; Mian, Rajibul; Silvain, Johanne; Beygui, Farzin; Czarnecki, Andrew; Dehghani, Payam; Cantor, Warren; Lavi, Shahar; Spratt, James C; Belley-Côté, Emilie P; Eikelboom, John W
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.
PMID: 40908114
ISSN: 1468-201x
CID: 6009492

Association of Race and Ethnicity With High-Potency P2Y12 Inhibitors Prescription Among Patients With Acute MI Undergoing PCI: An Analysis From the CathPCI Registry

Mansoor, Hend; Young, Rebecca; Kaltenbach, Lisa A; Wojdyla, Daniel M; Shah, Binita; Gilchrist, Ian C; Rymer, Jennifer A; Elgendy, Islam Y
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.
PMID: 41480675
ISSN: 1941-7632
CID: 6001292

Interventional Cardiologists' Perspectives on Percutaneous Coronary Intervention at Ambulatory Surgical Centers

Basala, Thomas R; Alexandrou, Michaella; Strepkos, Dimitrios; Rempakos, Athanasios; Allana, Salman; Azzalini, Lorenzo; Box, Lyndon; Lombardi, William; Rao, Sunil V; Shah, Binita; Seto, Arnold H; Sukul, Devraj; Simsek, Bahadir; Mutlu, Deniz; Carvalho, Pedro E P; Jalli, Sandeep; Ser, Ozgur Selim; Mastrodemos, Olga; Sandoval, Yader; Rangan, Bavana V; Brilakis, Emmanouil S
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.
PMID: 41088884
ISSN: 1522-726x
CID: 5954732

Drug-Coated Balloons for De Novo Non-aorto-ostial and Coronary Bifurcation Lesions: A Systematic Review and Meta-analysis

Mariscal, Enrique Soltero; Slotwiner, Alexander; Karam, Boutros; Bliagos, Dimitrios; Razzouk, Louai; Shah, Binita; Bangalore, Sripal; Rao, Sunil V; Sharma, Atul
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.
PMCID:12766052
PMID: 41498001
ISSN: 2772-9303
CID: 5980912

Characterization and prognostic implication of pulmonary hypertension among patients with myeloproliferative neoplasms

Leiva, Orly; Soo, Steven; Liu, Olivia; Smilowitz, Nathaniel R; Reynolds, Harmony; Shah, Binita; Bernard, Samuel; How, Joan; Lee, Michelle Hyunju; Hobbs, Gabriela
Pulmonary hypertension (PH) is a frequent complication of Philadelphia-negative myeloproliferative neoplasms (MPN), including essential thrombocythemia (ET), polycythemia vera (PV), and myelofibrosis (MF). However, its prognostic significance is understudied, thus we aimed to evaluate the effect of PH identified by echocardiography on risk of progression to secondary MF or acute leukemia in MPN patients. We conducted a multicenter, retrospective cohort study of MPN patients with ≥ 1 echocardiogram from 2010-2023. PH was defined as pulmonary artery systolic pressure (PASP) ≥ 40 mmHg. Outcomes were progression to secondary myelofibrosis or leukemia, major adverse cardiovascular event (MACE) and all-cause death. Multivariable Fine-Gray competing-risk regression was used to estimate subhazard ratio (SHR) of hematologic progression and MACE. 555 patients were included (42.7% PV, 41.1% ET, 16.2% MF) or which 195 (35.1%) had PH. Over a median follow-up period of 51.2 months, PH was associated with increased risk of secondary MF progression (aSHR 2.40, 95% CI 1.25-4.59), leukemia progression (aSHR 3.06, 95% CI 1.13 - 8.25), and MACE (aSHR 1.59, 95% CI 1.01- 2.49) but not all-cause death (aHR 1.48, 95% CI 0.96-2.26). Among patients with PH, absence of left heart disease (LHD) was associated with higher risk of secondary MF progression among patients with ET or PV (aSHR 2.76, 95% CI 1.19 - 6.38) and leukemia progression among patients with MF (aSHR 7.18, 95% CI 1.59-32.46). Prospective studies are needed to assess the role of echocardiography on MPNspecific prognostication.
PMID: 40371905
ISSN: 1592-8721
CID: 5844552

Endothelial Cell and Neutrophil Activation in Untreated Intercritical Patients With Gout [Letter]

Toprover, Michael; Shah, Binita; Drenkova, Kamelia; Leonard, Ana; Pillinger, Michael H; Garshick, Michael
PMCID:12225606
PMID: 40592554
ISSN: 1499-2752
CID: 5887782

Complications of Radial Access

Abu-Much, Arsalan; Restrepo, Valentina Jaramillo; Prasad, Megha; Shah, Binita
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.
PMID: 40962386
ISSN: 2211-7466
CID: 5935312

Colchicine for secondary prevention of vascular events: a meta-analysis of trials

d'Entremont, Marc-André; Poorthuis, Michiel H F; Fiolet, Aernoud T L; Amarenco, Pierre; Boczar, Kevin Emery; Buysschaert, Ian; Chan, Noel C; Cornel, Jan H; Jannink, Jalina; Jansen, Shirley; Kedev, Sasko; Keech, Anthony C; Layland, Jamie; Mewton, Nathan; Montalescot, Gilles; Pascual-Figal, Domingo A; Rodriguez, Alfredo E; Shah, Binita; Teraa, Martin; van Zelm, Aimee; Wang, Yongjun; Mosterd, Arend; Kelly, Peter; Eikelboom, John; Jolly, Sanjit S
BACKGROUND AND AIMS/OBJECTIVE:Randomized trials of colchicine in secondary prevention of atherosclerotic cardiovascular disease have shown mixed results. METHODS:A systematic review and study-level meta-analysis of randomized controlled trials was performed comparing colchicine vs no colchicine in a secondary-prevention atherosclerotic cardiovascular disease population. A fixed-effect inverse variance model was applied using the intention-to-treat population from the included trials. The primary outcome was the composite of cardiovascular death, myocardial infarction, or stroke. RESULTS:Nine trials, including 30 659 patients (colchicine 15 255, no colchicine 15 404) with known coronary artery disease or stroke, were included. Compared with no colchicine, patients randomized to colchicine had a relative risk (RR) of 0.88 [95% confidence interval (CI) 0.81-0.95, P = .002] for the primary composite outcome, including a RR of 0.94 for cardiovascular death (95% CI 0.78-1.13, P = .5), a RR of 0.84 for myocardial infarction (95% CI 0.73-0.97, P = .016), and a RR of 0.90 for stroke (95% CI 0.80-1.02, P = .09). Colchicine was associated with a RR of 1.35 for hospitalization for gastrointestinal events (95% CI 1.10-1.66, P = .004) with no increase in hospitalization for pneumonia, newly diagnosed cancers, or non-cardiovascular death. CONCLUSIONS:In patients with prior coronary disease or stroke, colchicine reduced the composite of cardiovascular death, myocardial infarction, or stroke by 12%.
PMID: 40314334
ISSN: 1522-9645
CID: 5834462

Impact of Echocardiographic Probability of Pulmonary Hypertension on Prognosis and Outcomes Among Patients With Myeloproliferative Neoplasms

Leiva, Orly; Soo, Steven; Smilowitz, Nathaniel R; Reynolds, Harmony; Shah, Binita; Bernard, Samuel; How, Joan; Lee, Michelle Hyunju; Hobbs, Gabriela
BACKGROUND/UNASSIGNED:Myeloproliferative neoplasms (MPN) are a group of chronic leukemias that are associated with pulmonary hypertension (PH), which has been associated with increased risk adverse outcomes. The echocardiographic characterization of PH in MPN has not been reported, and the prognostic significance of PH among patients with MPN remains unclear. METHODS/UNASSIGNED:Multicenter, retrospective cohort study of patients with MPN with ≥1 echocardiogram from 2010 to 2023. The echocardiographic probability of PH was determined according to the guidelines. The outcomes were hematologic progression and major adverse cardiovascular events. Exploratory analysis included outcomes among patients with right heart catheterization after the first echocardiogram, with PH defined as mean pulmonary artery pressure of >20 mm Hg. Multivariable Fine-Gray competing risk regression was used to estimate the subhazard ratio of hematologic progression and major adverse cardiovascular events. RESULTS/UNASSIGNED:=0.048). CONCLUSIONS/UNASSIGNED:Among patients with MPN, echocardiographic probability of PH was associated with an increased risk of hematologic progression. Prospective studies are needed to assess the optimal use of echocardiography on MPN-specific prognostication.
PMID: 40492300
ISSN: 1942-0080
CID: 5869072

Variability in State-Level Regulations Regarding Occupational Radiation Exposure

Vora, Amit N; Hermiller, James B; Gupta, Rahul; Goldsweig, Andrew M; Ephrem, Georges; Al-Azizi, Karim; Shah, Binita; Sutton, Nadia R; Goel, Kashish; Dehghani, Payam; Widmer, Robert J; Szerlip, Molly I; Young, Michael N; Soni, Krishan; Klein, Andrew J; Kaul, Prashant; Salavitabar, Arash; Rao, Sunil V
PMCID:12230476
PMID: 40630239
ISSN: 2772-9303
CID: 5890792