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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

Periprocedural Myocardial Injury Using CKMB Following Elective PCI: Incidence and Associations With Long-Term Mortality

Talmor, Nina; Graves, Claire; Kozloff, Sam; Major, Vincent J; Xia, Yuhe; Shah, Binita; Babaev, Anvar; Razzouk, Louai; Rao, Sunil V; Attubato, Michael; Feit, Frederick; Slater, James; Smilowitz, Nathaniel R
BACKGROUND/UNASSIGNED:Myocardial injury detected after percutaneous coronary intervention (PCI) is associated with increased mortality. Predictors of post-PCI myocardial injury are not well established. The long-term prognostic relevance of post-PCI myocardial injury remains uncertain. METHODS/UNASSIGNED:Consecutive adults aged ≥18 years with stable ischemic heart disease who underwent elective PCI at NYU Langone Health between 2011 and 2020 were included in a retrospective, observational study. Patients with acute myocardial infarction or creatinine kinase myocardial band (CKMB) or troponin concentrations >99% of the upper reference limit before PCI were excluded. All patients had routine measurement of CKMB concentrations at 1 and 3 hours post-PCI. Post-PCI myocardial injury was defined as a peak CKMB concentration >99% upper reference limit. Linear regression models were used to identify clinical factors associated with post-PCI myocardial injury. Cox proportional hazard models were generated to evaluate relationships between post-PCI myocardial injury and all-cause mortality at long-term follow-up. RESULTS/UNASSIGNED:<0.001). After adjustment for demographics and clinical covariates, post-PCI myocardial injury was associated with an excess hazard for long-term mortality (hazard ratio, 1.46 [95% CI, 1.20-1.78]). CONCLUSIONS/UNASSIGNED:Myocardial injury defined by elevated CKMB early after PCI is common and associated with all-cause, long-term mortality. More complex coronary anatomy is predictive of post-PCI myocardial injury.
PMID: 40160098
ISSN: 1941-7632
CID: 5818652

Outcomes After Noncardiac Surgery Performed Within 2 Years of Percutaneous Coronary Intervention

Butala, Neel M; Hebbe, Annika; Shah, Binita; Smilowitz, Nathaniel R; Aijaz, Bilal; Uzendu, Anezi; Boulos, Peter; Waldo, Stephen W
BACKGROUND:Limited data exist on noncardiac surgery patients with prior percutaneous coronary intervention (PCI) in the contemporary era. The objective was to examine rate, characteristics, and outcomes of patients who underwent noncardiac surgery within 2 years of PCI and develop a risk model of factors that predict long-term postoperative outcomes among patients with recent PCI. METHODS AND RESULTS/RESULTS:Patients in the Veterans Affairs Surgical Quality Improvement Program database who underwent noncardiac surgery between October 1, 2017 and September 30, 2021 were included. Patients with versus without PCI within 2 years were propensity matched to examine major adverse cardiovascular events (MACE), defined as a 1-year composite of mortality, revascularization, and rehospitalization for myocardial infarction or stroke. Among patients with recent PCI, multivariable logistic regression was used to develop a risk model to predict 1-year postoperative MACE. Among 334 828 patients undergoing surgery, 2297 (0.68%) had PCI within 2 years. Among 9160 propensity-matched veterans, there was no difference in MACE between patients with and without preceding PCI (hazard ratio [HR], 1.04 [95% CI, 0.96-1.17]). Patients with versus without preceding PCI within 2 years had lower risk of all-cause death (HR, 0.83 [95% CI, 0.72-0.96]) but higher risk of revascularization (HR, 1.88 [95% CI, 1.50-2.36]) at 1 year. A 13-component MACE prediction model among patients with recent PCI had moderate discrimination (area under the receiver operating characteristic curve 0.73 derivation, 0.72 validation). CONCLUSIONS:Among patients who underwent surgery, risk of MACE did not differ, but the risk of revascularization was higher and all-cause death was lower in patients with versus without recent PCI. A risk model can be used to stratify risk of surgery among patients with preceding PCI.
PMID: 40079295
ISSN: 2047-9980
CID: 5808672

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

Intravascular Coronary Imaging

Rymer, Jennifer; Abbott, J Dawn; Ali, Ziad A; Basir, Mir B; Busman, Denise; Dangas, George D; Kolansky, Daniel M; Naidu, Srihari S; Riley, Robert F; Seto, Arnold H; Shah, Binita; Shlofmitz, Evan; ,; Baumgard, Connie S; Cavalcante, Rafa; Culbertson, Casey; Gaalswyk, Crista; Miltner, Rob J; Moretz, Jeremy; Niebuhr, Jeannie; Ollivier, Ann; Ramakrishnan, Krish; Serwer, Bradley; West, Nick E J; Zizzo, Steve
PMCID:11725079
PMID: 39807236
ISSN: 2772-9303
CID: 5776502

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

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

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

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