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144


Colchicine in Acute Myocardial Infarction

Jolly, Sanjit S; d'Entremont, Marc-André; Lee, Shun Fu; Mian, Rajibul; Tyrwhitt, Jessica; Kedev, Sasko; Montalescot, Gilles; Cornel, Jan H; Stanković, Goran; Moreno, Raul; Storey, Robert F; Henry, Timothy D; Mehta, Shamir R; Bossard, Matthias; Kala, Petr; Layland, Jamie; Zafirovska, Biljana; Devereaux, P J; Eikelboom, John; Cairns, John A; Shah, Binita; Sheth, Tej; Sharma, Sanjib K; Tarhuni, Wadea; Conen, David; Tawadros, Sarah; Lavi, Shahar; Yusuf, Salim; ,
BACKGROUND:Inflammation is associated with adverse cardiovascular events. Data from recent trials suggest that colchicine reduces the risk of cardiovascular events. METHODS:In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients who had myocardial infarction to receive either colchicine or placebo and either spironolactone or placebo. The results of the colchicine trial are reported here. The primary efficacy outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization, evaluated in a time-to-event analysis. C-reactive protein was measured at 3 months in a subgroup of patients, and safety was also assessed. RESULTS:A total of 7062 patients at 104 centers in 14 countries underwent randomization; at the time of analysis, the vital status was unknown for 45 patients (0.6%), and this information was most likely missing at random. A primary-outcome event occurred in 322 of 3528 patients (9.1%) in the colchicine group and 327 of 3534 patients (9.3%) in the placebo group over a median follow-up period of 3 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.16; P = 0.93). The incidence of individual components of the primary outcome appeared to be similar in the two groups. The least-squares mean difference in C-reactive protein levels between the colchicine group and the placebo group at 3 months, adjusted according to the baseline values, was -1.28 mg per liter (95% CI, -1.81 to -0.75). Diarrhea occurred in a higher percentage of patients with colchicine than with placebo (10.2% vs. 6.6%; P<0.001), but the incidence of serious infections did not differ between groups. CONCLUSIONS:Among patients who had myocardial infarction, treatment with colchicine, when started soon after myocardial infarction and continued for a median of 3 years, did not reduce the incidence of the composite primary outcome (death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization). (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.).
PMID: 39555823
ISSN: 1533-4406
CID: 5758132

Perceptions of interventional cardiologists on diversity and discrimination

Rempakos, Athanasios; Alexandrou, Michaella; Simsek, Bahadir; Kostantinis, Spyridon; Karacsonyi, Judit; Mutlu, Deniz; Hall, Allison; Seto, Arnold H; Danek, Barbara; Shah, Binita; Baechler, Courtney; Thomas, Delaine; Choi, James W; Rier, Jeremy; Kearney, Kathleen E; Park, Ki; Bennett, Mosi; Garcia, Santiago; Duong, Thao; Kerrigan, Jimmy; Al-Ogaili, Ahmed; Rangan, Bavana V; Mastrodemos, Olga C; Allana, Salman S; Sandoval, Yader; Burke, M Nicholas; Brilakis, Emmanouil S
BACKGROUND:There are limited data on diversity and discrimination against interventional cardiologists (ICs). METHODS:We performed an online, anonymous, international survey of interventional cardiologists on their perceptions of diversity and discrimination in their field. RESULTS:A total of 445 ICs participated in the survey. The median age of participants was 46 to 50 years and most (60%) practice in the United States. Among the respondents, 13% identified as women, while 31% identified as Asian, 10% as Latino, and 3.2% as Black/African American. Women ICs were less likely to be married (62% vs 92%; P < .001) or have children (48% vs 87%; P < .001). Women, non-native English speakers, and non-white individuals had a higher likelihood of reporting discrimination from patients/families, peers, supervisors, support staff, and nursing staff, compared with men, native English speakers, and non-Hispanic white individuals, respectively. Women were less satisfied with the level of gender diversity in their workplace (25% vs 45%; P = .015) and were more likely to believe that women physicians have fewer opportunities in the field of IC compared with men (69% vs 35%; P < .001). Non-white individuals were more likely to believe that their race/ethnicity may impede the progress of their career (54% vs 15%; P < .001), that their race/ethnicity negatively impacted their fellowship prospects/acceptance (35% vs 11%; P < .001), and that their religion negatively impacted their fellowship prospects/acceptance (17% vs 4%; P = .003). Several participants (41%) expressed concerns that diversity, equity, and inclusion initiatives might result in unintended consequences. CONCLUSIONS:Our survey suggests that ICs perceive high rates of discrimination in their field.
PMID: 39008356
ISSN: 1557-2501
CID: 5731812

Colchicine for secondary prevention of ischaemic stroke and atherosclerotic events: a meta-analysis of randomised trials

Fiolet, Aernoud T L; Poorthuis, Michiel H F; Opstal, Tjerk S J; Amarenco, Pierre; Boczar, Kevin Emery; Buysschaert, Ian; Budgeon, Charley; Chan, Noel C; Cornel, Jan H; Jolly, Sanjit S; Layland, Jamie; Lemmens, Robin; Mewton, Nathan; Nidorf, Stefan M; Pascual-Figal, Domingo A; Price, Christopher; Shah, Binita; Tardif, Jean-Claude; Thompson, Peter L; Tijssen, Jan G P; Tsivgoulis, Georgios; Walsh, Cathal; Wang, Yongjun; Weimar, Christian; Eikelboom, John W; Mosterd, Arend; Kelly, Peter J; ,
BACKGROUND/UNASSIGNED:Guidelines recommend low-dose colchicine for secondary prevention in cardiovascular disease, but uncertainty remains concerning its efficacy for stroke, efficacy in key subgroups and about uncommon but serious safety outcomes. METHODS/UNASSIGNED:In this trial-level meta-analysis, we searched bibliographic databases and trial registries form inception to May 16, 2024. We included randomised trials of colchicine for secondary prevention of ischaemic stroke and major adverse cardiovascular events (MACE: ischaemic stroke, myocardial infarction, coronary revascularisation, or cardiovascular death). Secondary outcomes were serious safety outcomes and mortality. A fixed-effect inverse-variance model was used to generate a pooled estimate of relative risk (RR) with 95% confidence intervals (CI). This study is registered with PROSPERO, CRD42024540320. FINDINGS/UNASSIGNED:Six trials involving 14,934 patients with prior stroke or coronary disease were included. In all patients, colchicine compared with placebo or no colchicine reduced the risk for ischaemic stroke by 27% (132 [1.8%] events versus 186 [2.5%] events, RR 0.73 [95% CI 0.58-0.90]) and MACE by 27% (505 [6.8%] events versus 693 [9.4%] events, with RR 0.73 [0.65-0.81]). Efficacy was consistent in key subgroups (females versus males, age below versus above 70, with versus without diabetes, statin versus non-statin users). Colchicine was not associated with an increase in serious safety outcomes: hospitalisation for pneumonia (109 [1.5%] versus 106 [1.5%], RR 0.99 [0.76-1.30]), cancer (247 [3.5%] versus 255 [3.6%], RR 0.97 [0.82-1.15]), and gastro-intestinal events (153 [2.1%] versus 135 [1.9%]), RR 1.15 [0.91-1.44]. There was no difference in all-cause death (201 [2.7%] versus 181 [2.4%], RR 1.09 [0.89-1.33]), cardiovascular death (70 [0.9%] versus 80 [1.1%], RR 0.89 [0.65-1.23]), or non-cardiovascular death (131 [1.8%] versus 101 [1.4%], RR 1.26 [0.98-1.64]). INTERPRETATION/UNASSIGNED:In patients with prior stroke or coronary disease, colchicine reduced ischaemic stroke and MACE, with consistent treatment effect in key subgroups, and did not increase serious safety events or death. FUNDING/UNASSIGNED:There was no funding source for this study.
PMCID:11490869
PMID: 39431112
ISSN: 2589-5370
CID: 5739532

Neutrophil Activation and Adhesiveness in Coronary Artery Disease: Results From the COLCHICINE-PCI Biomarker Substudy

Talmor, Nina; Pillinger, Michael H; Xia, Yuhe; Leonard, Ana; Curovic, Fatmira; Shah, Binita
Registration URL: https://clinicaltrials.gov. Unique identifier: NCT02594111.
PMID: 39344637
ISSN: 2047-9980
CID: 5714172

Case Volumes and Outcomes Among Early-Career Interventional Cardiologists in the United States

Rymer, Jennifer A; Narcisse, Dennis I; Chen, Angel; Wojdyla, Daniel; Ashley, Sarah; Damluji, Abdulla A; Shah, Binita; Nanna, Michael G; Swaminathan, Rajesh; Gutierrez, J Antonio; Uzendu, Anezi; Nelson, Adam J; Bethel, Garrett; Kearney, Katherine; Jones, W Schuyler; Rao, Sunil V; Doll, Jacob A
BACKGROUND:Little is known about the procedural characteristics, case volumes, and mortality rates for early- vs non-early-career interventional cardiologists in the United States. OBJECTIVES/OBJECTIVE:This study examined operator-level data for patients who underwent percutaneous coronary intervention (PCI) between April 2018 and June 2022. METHODS:Data were collected from the National Cardiovascular Data Registry CathPCI Registry, American Board of Internal Medicine certification database, and National Plan and Provider Enumeration System database. Early-career operators were within 5 years of the end of training. Annual case volume, expected mortality and bleeding risk, and observed/predicted mortality and bleeding outcomes were evaluated. RESULTS:A total of 1,451 operators were early career; 1,011 changed their career status during the study; and 6,251 were non-early career. Overall, 514,540 patients were treated by early-career and 2,296,576 patients by non-early-career operators. The median annual case volume per operator was 59 (Q1-Q3: 31-97) for early-career and 57 (Q1-Q3: 28-100) for non-early-career operators. Early-career operators were more likely to treat patients presenting with ST-segment elevation myocardial infarction and urgent indications for PCI (both P < 0.001). The median predicted mortality risk was 2.0% (Q1-Q3: 1.5%-2.7%) for early-career and 1.8% (Q1-Q3: 1.2%-2.4%) for non-early-career operators. The median predicted bleeding risk was 4.9% (Q1-Q3: 4.2%-5.7%) for early-career and 4.4% (Q1-Q3: 3.7%-5.3%) for non-early-career operators. After adjustment, an increased risk of mortality (OR: 1.08; 95% CI: 1.05-1.17; P < 0.0001) and bleeding (OR: 1.08; 95% CI: 1.05-1.12; P < 0.0001) were associated with early-career status. CONCLUSIONS:Early-career operators are caring for patients with more acute presentations and higher predicted risk of mortality and bleeding compared with more experienced colleagues, with modestly worse outcomes. These data should inform institutional practices to support the development of early-career proceduralists.
PMID: 38749617
ISSN: 1558-3597
CID: 5656192

Update on the Role of Colchicine in Cardiovascular Disease

Banco, Darcy; Mustehsan, Mohammad; Shah, Binita
PURPOSE OF REVIEW/OBJECTIVE:This review focuses on the use of colchicine to target inflammation to prevent cardiovascular events among those at-risk for or with established coronary artery disease. RECENT FINDINGS/RESULTS:Colchicine is an anti-inflammatory drug that reduces cardiovascular events through its effect on the IL-1β/IL-6/CRP pathway, which promotes the progression and rupture of atherosclerotic plaques. Clinical trials have demonstrated that colchicine reduces cardiovascular events by 31% among those with chronic coronary disease, and by 23% among those with recent myocardial infarction. Its ability to dampen inflammation during an acute injury may broaden its scope of use in patients at risk for cardiovascular events after major non-cardiac surgery. Colchicine is an effective anti-inflammatory therapy in the prevention of acute coronary syndrome. Ongoing studies aim to assess when, and in whom, colchicine is most effective to prevent cardiovascular events in patients at-risk for or with established coronary artery disease.
PMID: 38340273
ISSN: 1534-3170
CID: 5632192

SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions

Riley, Robert F; Patel, Mitul P; Abbott, J Dawn; Bangalore, Sripal; Brilakis, Emanouil S; Croce, Kevin J; Doshi, Darshan; Kaul, Prashant; Kearney, Kathleen E; Kerrigan, Jimmy L; McEntegart, Margaret; Maehara, Akiko; Rymer, Jennifer A; Sutton, Nadia R; Shah, Binita
The prevalence of calcification in obstructive coronary artery disease is on the rise. Percutaneous coronary intervention of these calcified lesions is associated with increased short-term and long-term risks. To optimize percutaneous coronary intervention results, there is an expanding array of treatment modalities geared toward calcium modification prior to stent implantation. The Society for Cardiovascular Angiography and Interventions, herein, puts forth an expert consensus document regarding methods to identify types of calcified coronary lesions, a central algorithm to help guide use of the various calcium modification strategies, tips for when using each treatment modality, and a look at future studies and trials for treating this challenging lesion subset.
PMCID:11307856
PMID: 39132214
ISSN: 2772-9303
CID: 5726702

Confronting Treatment Disparities in Chronic Limb-Threatening Ischemia [Editorial]

Butala, Neel M; Shah, Binita
PMID: 38152882
ISSN: 1941-7632
CID: 5623262

Echocardiographic and Clinical Outcomes in Symptomatic Patients With Less Than Severe Aortic Stenosis After Supra-Annular Self-Expanding Transcatheter Aortic Valve Replacement

Sharma, Ravi K; Laham, Roger J; Sorajja, Paul; Shah, Binita; Garcia, Santiago; Jain, Renuka; Fender, Erin A; Philip, Femi; Eisenberg, Ruth; Popma, Jeffrey J; Chetcuti, Stanley
Optimal timing for aortic valve replacement in symptomatic patients with less than severe aortic stenosis (AS) is not well defined. There is limited information on the benefit of valve replacement in these patients. Symptomatic patients with less than severe AS, defined as a mean aortic gradient ≥20 and <40 mm Hg, peak aortic velocity >3 and <4 m/s, and aortic valve area >1.0 and <1.5 cm2, enrolled in the Society for Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry and who underwent attempted supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) were reviewed. Site-reported valve hemodynamics, clinical events, and quality of life metrics were analyzed at 30 days and 1 year after the procedure. A total of 1,067 patients with attempted TAVR (mean age 78.4 ± 8.4 years; Society for Thoracic Surgery score 4.7 ± 3.4%) were found to have symptoms but less than severe AS. From baseline to postprocedure, mean gradient decreased (29.9 ± 4.9 vs 8.4 ± 4.8 mm Hg, p <0.001), and aortic valve area increased (1.2 ± 0.1 vs 2.2 ± 0.7 cm2, p <0.001). Clinical events included 30-day and 1-year all-cause mortality (1.5% and 9.6%), stroke (2.2% and 3.3%), and new pacemaker implantation (18.1% and 20.9%). There were statistically significant improvements in the New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire at 30 days and 1 year. In conclusion, patients with symptomatic but less than severe AS who underwent supra-annular, self-expanding TAVR experienced improved valve hemodynamics and quality of life measures 1 year after the procedure. Randomized studies of TAVR versus a control arm in symptomatic patients with less than severe AS are ongoing.
PMID: 37812864
ISSN: 1879-1913
CID: 5604762

Psychosocial Factors of Women Presenting With Myocardial Infarction With or Without Obstructive Coronary Arteries

Hausvater, Anaïs; Spruill, Tanya M; Xia, Yuhe; Smilowitz, Nathaniel R; Arabadjian, Milla; Shah, Binita; Park, Ki; Giesler, Caitlin; Marzo, Kevin; Thomas, Dwithiya; Wei, Janet; Trost, Jeffrey; Mehta, Puja K; Har, Bryan; Bainey, Kevin R; Zhong, Hua; Hochman, Judith S; Reynolds, Harmony R
BACKGROUND:Women with myocardial infarction (MI) are more likely to have elevated stress levels and depression than men with MI. OBJECTIVES:We investigated psychosocial factors in women with myocardial infarction with nonobstructive coronary arteries (MINOCA) and those with MI and obstructive coronary artery disease (CAD). METHODS:Women with MI enrolled in a multicenter study and completed measures of perceived stress (Perceived Stress Scale-4) and depressive symptoms (Patient Health Questionnaire-2) at the time of MI (baseline) and 2 months later. Stress, depression, and changes over time were compared between MI subtypes. RESULTS:We included 172 MINOCA and 314 MI-CAD patients. Women with MINOCA were younger (age 59.4 years vs 64.2 years; P < 0.001) and more diverse than those with MI-CAD. Women with MINOCA were less likely to have high stress (Perceived Stress Scale-4 ≥6) at the time of MI (51.0% vs 63.0%; P = 0.021) and at 2 months post-MI (32.5% vs 46.3%; P = 0.019) than women with MI-CAD. There was no difference in elevated depressive symptoms (Patient Health Questionnaire-2 ≥2) at the time of MI (36% vs 43%; P = 0.229) or at 2 months post-MI (39% vs 40%; P = 0.999). No differences in the rate of 2-month decline in stress and depression scores were observed between groups. CONCLUSIONS:Stress and depression are common among women at the time of and 2 months after MI. MINOCA patients were less likely to report high stress compared with MI-CAD patients, but the frequency of elevated depressive symptoms did not differ between the 2 groups. Stress and depressive symptoms decreased in both MI-CAD and MINOCA patients over time.
PMID: 37852694
ISSN: 1558-3597
CID: 5684972