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Hochman, J. S.; Anthopolos, R.; Reynolds, H. R.; Bangalore, S.; Xu, Y.; O'Brien, S. M.; Mavromichalis, S.; Chang, M.; Contreras, A.; Rosenberg, Y.; Kirby, R.; Bhargava, B.; Senior, R.; Banfield, A.; Goodman, S. G.; Lopes, R. D.; Pracoń, R.; López-Sendón, J.; Maggioni, A. P.; Newman, J. D.; Berger, J. S.; Sidhu, M. S.; White, H. D.; Troxel, A. B.; Harrington, R. A.; Boden, W. E.; Stone, G. W.; Mark, D. B.; Spertus, J. A.; Maron, D. J.; Hochman, J. S.; Maron, D. J.; Reynolds, H. R.; Bangalore, S.; Chang, M.; Contreras, A.; Esquenazi-Karonika, S.; Gilsenan, M.; Gwiszcz, E.; Mathews, P.; Mohamed, S.; Naumova, A.; Roberts, A.; Vanloo, K.; Xu, Y.; Troxel, A. B.; Lu, Y.; Huang, Z.; Broderick, S.; Guzmán, L.; Selvanayagam, J.; Lopes, R. D.; Goodman, S. G.; Steg, G.; Juliard, J. M.; Doerr, R.; Keltai, M.; Bhargava, B.; Thomas, B.; Sharir, T.; Nikolsky, E.; Maggioni, A. P.; Kohsaka, S.; Escobedo, J.; White, H. D.; Bockeria, O.; López-Sendón, J.; Held, C.; Senior, R.; Shaw, L. J.; Phillips, L.; Berman, D.; Kwong, R. Y.; Picard, M. H.; Chaitman, B. R.; Ali, Z.; Min, J.; Mancini, G. B. J.; Leipsic, J.; Guzman, L.; Hillis, G.; Thambar, S.; Joseph, M.; Selvnayagam, J.; Beltrame, J.; Lang, I.; Schuchlenz, H.; Huber, K.; Goetschalckx, K.; Hueb, W.; Caramori, P. R.; De Quadros, A.; Smanio, P.; Mesquita, C.; Lopas, R. D.; Vitola, J.; Marin-Neto, J.; Da Silva, E. R.; Tumelero, R.; Andrade, M.; Alves, A. R.; Dall'Orto, F.; Polanczyk, C.; Figueiredo, E.; Howarth, A.; Gosselin, G.; Cheema, A.; Bainey, K.; Phaneuf, D.; Diaz, A.; Garg, P.; Mehta, S.; Wong, G.; Lam, A.; Cha, J.; Galiwango, P.; Uxa, A.; Chow, B.; Hameed, A.; Udell, J.; Chema, A.; Hamid, M.; Hauguel-Moreau, M.; Furber, A.; Goube, P.; Steg, P. G.; Barone-Rochette, G.; Thuaire, C.; Slama, M.; Doer, R.; Nickenig, G.; Bekeredjian, R.; Schulze, P. C.; Merkely, B.; Fontos, G.; Vértes, A.; Varga, A.; Bhargva, B.; Kumar, A.; Nair, R. G.; Grant, P.; Manjunath, C.; Moorthy, N.; Satheesh, S.; Nath, R. K.; Wander, G.; Christopher, J.; Dwivedi, S.; Oomman, A.; Mathur, A.; Gadkari, M.; Naik, S.; Punnoose, E.; Kachru, R.; Christophar, J.; Kaul, U.; Sharer, T.; Kerner, A.; Tarantini, G.; Perna, G. P.; Racca, E.; Mortara, A.; Monti, L.; Briguori, C.; Leone, G.; Amati, R.; Salvatori, M.; Di Chiara, A.; Calabro, P.; Galvani, M.; Provasoli, S.; Fukuda, K.; Koshaka, S.; Nakano, S.; Laucevicius, A.; Kedev, S.; Khairuddin, A.; Escobdo, J.; Riezebos, R.; Timmer, J.; Heald, S.; Stewart, R.; Ramos, W. M.; Demkow, M.; Mazurek, T.; Drozdz, J.; Szwed, H.; Witkowski, A.; Ferreira, N.; Pinto, F.; Ramos, R.; Popescu, B.; Pop, C.; Bockeria, L.; Bockerya, O.; Demchenko, E.; Romanov, A.; Bershtein, L.; Jizeeri, A.; Stankovic, G.; Apostolovic, S.; Adjic, N. C.; Zdravkovic, M.; Beleslin, B.; Dekleva, M.; Davidovic, G.; Chua, T.; Foo, D.; Poh, K. K.; Ntsekhe, M.; Sionis, A.; Marin, F.; Miró, V.; López-Sendon, J.; Blancas, M. G.; González-Juanatey, J.; Fernández-Avilés, F.; Peteiro, J.; Luena, J. E. C.; Held, C.; Aspberg, J.; Rossi, M.; Kuanprasert, S.; Yamwong, S.; Johnston, N.; Donnelly, P.; Moriarty, A.; Roxy, R.; Elghamaz, A.; Gurunathan, S.; Karogiannis, N.; Shah, B. N.; Trimlett, R. H. J.; Rubens, M. B.; Nicol, E. D.; Mittal, T. K.; Hampson, R.; Gamma, R.; De Belder, M.; Nageh, T.; Lindsay, S.; Mavromatis, K.; Miller, T.; Banerjee, S.; Reynolds, H.; Nour, K.; Stone, P..
Circulation ; 147(1):43678.0, 2023.
Article in English | Scopus | ID: covidwho-2241476


Background: The ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) compared an initial invasive versus an initial conservative management strategy for patients with chronic coronary disease and moderate or severe ischemia, with no major difference in most outcomes during a median of 3.2 years. Extended follow-up for mortality is ongoing. Methods: ISCHEMIA participants were randomized to an initial invasive strategy added to guideline-directed medical therapy or a conservative strategy. Patients with moderate or severe ischemia, ejection fraction ≥35%, and no recent acute coronary syndromes were included. Those with an unacceptable level of angina were excluded. Extended follow-up for vital status is being conducted by sites or through central death index search. Data obtained through December 2021 are included in this interim report. We analyzed all-cause, cardiovascular, and noncardiovascular mortality by randomized strategy, using nonparametric cumulative incidence estimators, Cox regression models, and Bayesian methods. Undetermined deaths were classified as cardiovascular as prespecified in the trial protocol. Results: Baseline characteristics for 5179 original ISCHEMIA trial participants included median age 65 years, 23% women, 16% Hispanic, 4% Black, 42% with diabetes, and median ejection fraction 0.60. A total of 557 deaths accrued during a median follow-up of 5.7 years, with 268 of these added in the extended follow-up phase. This included a total of 343 cardiovascular deaths, 192 noncardiovascular deaths, and 22 unclassified deaths. All-cause mortality was not different between randomized treatment groups (7-year rate, 12.7% in invasive strategy, 13.4% in conservative strategy;adjusted hazard ratio, 1.00 [95% CI, 0.85-1.18]). There was a lower 7-year rate cardiovascular mortality (6.4% versus 8.6%;adjusted hazard ratio, 0.78 [95% CI, 0.63-0.96]) with an initial invasive strategy but a higher 7-year rate of noncardiovascular mortality (5.6% versus 4.4%;adjusted hazard ratio, 1.44 [95% CI, 1.08-1.91]) compared with the conservative strategy. No heterogeneity of treatment effect was evident in prespecified subgroups, including multivessel coronary disease. Conclusions: There was no difference in all-cause mortality with an initial invasive strategy compared with an initial conservative strategy, but there was lower risk of cardiovascular mortality and higher risk of noncardiovascular mortality with an initial invasive strategy during a median follow-up of 5.7 years. Registration: URL:;Unique identifier: NCT04894877. © 2023 Lippincott Williams and Wilkins. All rights reserved.

Heart and Lung ; 58:45047.0, 2023.
Article in English | Scopus | ID: covidwho-2243548


Background: Male sex, elevated troponin levels, and elevated D-dimer levels are associated with more complicated COVID-19 illness and greater mortality;however, while there are known sex differences in the prognostic value of troponin and D-dimer in other disease states, it is unknown whether they exist in the setting of COVID-19. Objective: We assessed whether sex modified the relationship between troponin, D-dimer, and severe COVID-19 illness (defined as mechanical ventilation, ICU admission or transfer, discharge to hospice, or death). Methods: We conducted a retrospective cohort study of patients hospitalized with COVID-19 at a large, academic health system. We used multivariable regression to assess associations between sex, troponin, D-dimer, and severe COVID-19 illness, adjusting for demographic, clinical, and laboratory covariates. To test whether sex modified the relationship between severe COVID-19 illness and troponin or D-dimer, models with interaction terms were utilized. Results: Among 4,574 patients hospitalized with COVID-19, male sex was associated with higher levels of troponin and greater odds of severe COVID-19 illness, but lower levels of initial D-dimer when compared with female sex. While sex did not modify the relationship between troponin level and severe COVID-19 illness, peak D-dimer level was more strongly associated with severe COVID-19 illness in male patients compared to female patients (males: OR=2.91, 95%CI=2.63-2.34, p<0.001;females: OR=2.31, 95%CI=2.04-2.63, p<0.001;p-interaction=0.005). Conclusion: Sex did not modify the association between troponin level and severe COVID-19 illness, but did modify the association between peak D-dimer and severe COVID-19 illness, suggesting greater prognostic value for D-dimer in males with COVID-19. © 2022 Elsevier Inc.