Survival after Invasive or Conservative Management of Stable Coronary Disease

Judith S. Hochman; Rebecca Anthopolos; Harmony R. Reynolds; Sripal Bangalore; Yifan Xu; Sean M. O'Brien; Stavroula Mavromichalis; Michelle Chang; Aira Contreras; Yves Rosenberg; Ruth Kirby; Balram Bhargava; Roxy Senior; Ann Banfield; Shaun G. Goodman; Renato D. Lopes; Radosław Pracoń; José López-Sendón; Aldo Pietro Maggioni; Jonathan D. Newman; Jeffrey S. Berger; Mandeep S. Sidhu; Harvey D. White; Andrea B. Troxel; Robert A. Harrington; William E. Boden; Gregg W. Stone; Daniel B. Mark; John A. Spertus; David J. Maron; Judith S. Hochman; David J. Maron; Harmony R. Reynolds; Sripal Bangalore; Stavroula Mavromichalis; Michelle Chang; Aira Contreras; Shari Esquenazi-Karonika; Margaret Gilsenan; Ewelina Gwiszcz; Patenne Mathews; Samaa Mohamed; Anna Naumova; Arline Roberts; Kerrie Vanloo; Rebecca Anthopolos; Yifan Xu; Andrea B. Troxel; Ying Lu; Zhen Huang; Samuel Broderick; Luis Guzmán; Joseph Selvanayagam; Renato D. Lopes; Shaun G. Goodman; Gabriel Steg; Jean Michel Juliard; Rolf Doerr; Matyas Keltai; Balram Bhargava; Boban Thomas; Tali Sharir; Eugenia Nikolsky; Aldo P. Maggioni; Shun Kohsaka; Jorge Escobedo; Harvey D. White; Radosław Pracoń; Olga Bockeria; José López-Sendón; Claes Held; Roxy Senior; Ann Banfield; Leslee J. Shaw; Lawrence Phillips; Daniel Berman; Raymond Y. Kwong; Michael H. Picard; Bernard R. Chaitman; Ziad Ali; James Min; G. B.John Mancini; Jonathon Leipsic; Luis Guzman; Graham Hillis; Suku Thambar; Majo Joseph; Joseph Selvnayagam; John Beltrame; Irene Lang; Herwig Schuchlenz; Kurt Huber; Kaatje Goetschalckx; Whady Hueb; Paulo Ricardo Caramori; Alexandre De Quadros; Paola Smanio; Claudio Mesquita; Renato D. Lopas; João Vitola; José Marin-Neto; Expedito Ribeiro Da Silva; Rogério Tumelero; Marianna Andrade; Alvaro Rabelo Alves; Frederico Dall'Orto; Carisi Polanczyk; Estevão Figueiredo; Andrew Howarth; Gilbert Gosselin; Asim Cheema; Kevin Bainey; Denis Phaneuf; Ariel Diaz; Pallav Garg; Shamir Mehta; Graham Wong; Andy Lam; James Cha; Paul Galiwango; Amar Uxa; Benjamin Chow; Adnan Hameed; Jacob Udell; Asim Chema; Magdy Hamid; Marie Hauguel-Moreau; Alain Furber; Pascal Goube; Philippe Gabriel Steg; Gilles Barone-Rochette; Christophe Thuaire; Michel Slama; Rolf Doer; Georg Nickenig; Raffi Bekeredjian; P. Christian Schulze; Bela Merkely; Geza Fontos; András Vértes; Albert Varga; Balram Bhargva; Ajit Kumar; Rajesh G. Nair; Purvez Grant; Cholenahally Manjunath; Nagaraja Moorthy; Santhosh Satheesh; Ranjit Kumar Nath; Gurpreet Wander; Johann Christopher; Sudhanshu Dwivedi; Abraham Oomman; Atul Mathur; Milind Gadkari; Sudhir Naik; Eapen Punnoose; Ranjan Kachru; Johann Christophar; Upendra Kaul; Tali Sharer; Arthur Kerner; Giuseppe Tarantini; Gian Piero Perna; Emanuela Racca; Andrea Mortara; Lorenzo Monti; Carlo Briguori; Gianpiero Leone; Roberto Amati; Mauro Salvatori; Antonio Di Chiara; Paolo Calabro; Marcello Galvani; Stefano Provasoli; Keiichi Fukuda; Shun Koshaka; Shintaro Nakano; Aleksandras Laucevicius; Sasko Kedev; Ahmad Khairuddin; Jorge Escobdo; Robert Riezebos; Jorik Timmer; Spencer Heald; Ralph Stewart; Walter Mogrovejo Ramos; Marcin Demkow; Tomasz Mazurek; Jarozlaw Drozdz; Hanna Szwed; Adam Witkowski; Nuno Ferreira; Fausto Pinto; Ruben Ramos; Bogdan Popescu; Calin Pop; Leo Bockeria; Olga Bockerya; Elena Demchenko; Alexander Romanov; Leonid Bershtein; Ahmed Jizeeri; Goran Stankovic; Svetlana Apostolovic; Nada Cemerlic Adjic; Marija Zdravkovic; Branko Beleslin; Milica Dekleva; Goran Davidovic; Terrance Chua; David Foo; Kian Keong Poh; Mpiko Ntsekhe; Alessandro Sionis; Francisco Marin; Vicente Miró; José López-Sendon; Montserrat Gracida Blancas; José González-Juanatey; Francisco Fernández-Avilés; Jesús Peteiro; Jose Enrique Castillo Luena; Cleas Held; Johannes Aspberg; Mariagrazia Rossi; Srun Kuanprasert; Sukit Yamwong; Nicola Johnston; Patrick Donnelly; Andrew Moriarty; R. Roxy; Ahmed Elghamaz; Sothinathan Gurunathan; Nikolaos Karogiannis; Benoy N. Shah; Richard H.J. Trimlett; Michael B. Rubens; Edward D. Nicol; Tarun K. Mittal; Reinette Hampson; Reto Gamma; Mark De Belder; Thuraia Nageh; Steven Lindsay; Kreton Mavromatis; Todd Miller; Subhash Banerjee; Harmony Reynolds; Khaled Nour; Peter Stone

doi:10.1161/CIRCULATIONAHA.122.062714

Survival after Invasive or Conservative Management of Stable Coronary Disease

Judith S. Hochman, Rebecca Anthopolos, Harmony R. Reynolds, Sripal Bangalore, Yifan Xu, Sean M. O'Brien, Stavroula Mavromichalis, Michelle Chang, Aira Contreras, Yves Rosenberg, Ruth Kirby, Balram Bhargava, Roxy Senior, Ann Banfield, Shaun G. Goodman, Renato D. Lopes, Radosław Pracoń, José López-Sendón, Aldo Pietro Maggioni, Jonathan D. NewmanJeffrey S. Berger, Mandeep S. Sidhu, Harvey D. White, Andrea B. Troxel, Robert A. Harrington, William E. Boden, Gregg W. Stone, Daniel B. Mark, John A. Spertus, David J. Maron, Judith S. Hochman, David J. Maron, Harmony R. Reynolds, Sripal Bangalore, Stavroula Mavromichalis, Michelle Chang, Aira Contreras, Shari Esquenazi-Karonika, Margaret Gilsenan, Ewelina Gwiszcz, Patenne Mathews, Samaa Mohamed, Anna Naumova, Arline Roberts, Kerrie Vanloo, Rebecca Anthopolos, Yifan Xu, Andrea B. Troxel, Ying Lu, Zhen Huang, Samuel Broderick, Luis Guzmán, Joseph Selvanayagam, Renato D. Lopes, Shaun G. Goodman, Gabriel Steg, Jean Michel Juliard, Rolf Doerr, Matyas Keltai, Balram Bhargava, Boban Thomas, Tali Sharir, Eugenia Nikolsky, Aldo P. Maggioni, Shun Kohsaka, Jorge Escobedo, Harvey D. White, Radosław Pracoń, Olga Bockeria, José López-Sendón, Claes Held, Roxy Senior, Ann Banfield, Leslee J. Shaw, Lawrence Phillips, Daniel Berman, Raymond Y. Kwong, Michael H. Picard, Bernard R. Chaitman, Ziad Ali, James Min, G. B.John Mancini, Jonathon Leipsic, Luis Guzman, Graham Hillis, Suku Thambar, Majo Joseph, Joseph Selvnayagam, John Beltrame, Irene Lang, Herwig Schuchlenz, Kurt Huber, Kaatje Goetschalckx, Whady Hueb, Paulo Ricardo Caramori, Alexandre De Quadros, Paola Smanio, Claudio Mesquita, Renato D. Lopas, João Vitola, José Marin-Neto, Expedito Ribeiro Da Silva, Rogério Tumelero, Marianna Andrade, Alvaro Rabelo Alves, Frederico Dall'Orto, Carisi Polanczyk, Estevão Figueiredo, Andrew Howarth, Gilbert Gosselin, Asim Cheema, Kevin Bainey, Denis Phaneuf, Ariel Diaz, Pallav Garg, Shamir Mehta, Graham Wong, Andy Lam, James Cha, Paul Galiwango, Amar Uxa, Benjamin Chow, Adnan Hameed, Jacob Udell, Asim Chema, Magdy Hamid, Marie Hauguel-Moreau, Alain Furber, Pascal Goube, Philippe Gabriel Steg, Gilles Barone-Rochette, Christophe Thuaire, Michel Slama, Rolf Doer, Georg Nickenig, Raffi Bekeredjian, P. Christian Schulze, Bela Merkely, Geza Fontos, András Vértes, Albert Varga, Balram Bhargva, Ajit Kumar, Rajesh G. Nair, Purvez Grant, Cholenahally Manjunath, Nagaraja Moorthy, Santhosh Satheesh, Ranjit Kumar Nath, Gurpreet Wander, Johann Christopher, Sudhanshu Dwivedi, Abraham Oomman, Atul Mathur, Milind Gadkari, Sudhir Naik, Eapen Punnoose, Ranjan Kachru, Johann Christophar, Upendra Kaul, Tali Sharer, Arthur Kerner, Giuseppe Tarantini, Gian Piero Perna, Emanuela Racca, Andrea Mortara, Lorenzo Monti, Carlo Briguori, Gianpiero Leone, Roberto Amati, Mauro Salvatori, Antonio Di Chiara, Paolo Calabro, Marcello Galvani, Stefano Provasoli, Keiichi Fukuda, Shun Koshaka, Shintaro Nakano, Aleksandras Laucevicius, Sasko Kedev, Ahmad Khairuddin, Jorge Escobdo, Robert Riezebos, Jorik Timmer, Spencer Heald, Ralph Stewart, Walter Mogrovejo Ramos, Marcin Demkow, Tomasz Mazurek, Jarozlaw Drozdz, Hanna Szwed, Adam Witkowski, Nuno Ferreira, Fausto Pinto, Ruben Ramos, Bogdan Popescu, Calin Pop, Leo Bockeria, Olga Bockerya, Elena Demchenko, Alexander Romanov, Leonid Bershtein, Ahmed Jizeeri, Goran Stankovic, Svetlana Apostolovic, Nada Cemerlic Adjic, Marija Zdravkovic, Branko Beleslin, Milica Dekleva, Goran Davidovic, Terrance Chua, David Foo, Kian Keong Poh, Mpiko Ntsekhe, Alessandro Sionis, Francisco Marin, Vicente Miró, José López-Sendon, Montserrat Gracida Blancas, José González-Juanatey, Francisco Fernández-Avilés, Jesús Peteiro, Jose Enrique Castillo Luena, Cleas Held, Johannes Aspberg, Mariagrazia Rossi, Srun Kuanprasert, Sukit Yamwong, Nicola Johnston, Patrick Donnelly, Andrew Moriarty, R. Roxy, Ahmed Elghamaz, Sothinathan Gurunathan, Nikolaos Karogiannis, Benoy N. Shah, Richard H.J. Trimlett, Michael B. Rubens, Edward D. Nicol, Tarun K. Mittal, Reinette Hampson, Reto Gamma, Mark De Belder, Thuraia Nageh, Steven Lindsay, Kreton Mavromatis, Todd Miller, Subhash Banerjee, Harmony Reynolds, Khaled Nour, Peter Stone

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

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: https://www.clinicaltrials.gov; Unique identifier: NCT04894877.

Original language	English
Pages (from-to)	8-19
Number of pages	12
Journal	Circulation
Volume	147
Issue number	1
DOIs	https://doi.org/10.1161/CIRCULATIONAHA.122.062714
State	Published - 3 Jan 2023

Keywords

catheterization
coronary artery bypass
medication therapy management
myocardial ischemia
percutaneous coronary intervention

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10.1161/CIRCULATIONAHA.122.062714

Cite this

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., ... Stone, P. (2023). Survival after Invasive or Conservative Management of Stable Coronary Disease. Circulation, 147(1), 8-19. https://doi.org/10.1161/CIRCULATIONAHA.122.062714

@article{df75f0e9abef4708a3092f2a176cabe7,

title = "Survival after Invasive or Conservative Management of Stable Coronary Disease",

abstract = "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: https://www.clinicaltrials.gov; Unique identifier: NCT04894877.",

keywords = "catheterization, coronary artery bypass, medication therapy management, myocardial ischemia, percutaneous coronary intervention",

author = "Hochman, {Judith S.} and Rebecca Anthopolos and Reynolds, {Harmony R.} and Sripal Bangalore and Yifan Xu and O'Brien, {Sean M.} and Stavroula Mavromichalis and Michelle Chang and Aira Contreras and Yves Rosenberg and Ruth Kirby and Balram Bhargava and Roxy Senior and Ann Banfield and Goodman, {Shaun G.} and Lopes, {Renato D.} and Rados{\l}aw Praco{\'n} and Jos{\'e} L{\'o}pez-Send{\'o}n and Maggioni, {Aldo Pietro} and Newman, {Jonathan D.} and Berger, {Jeffrey S.} and Sidhu, {Mandeep S.} and White, {Harvey D.} and Troxel, {Andrea B.} and Harrington, {Robert A.} and Boden, {William E.} and Stone, {Gregg W.} and Mark, {Daniel B.} and Spertus, {John A.} and Maron, {David J.} and Hochman, {Judith S.} and Maron, {David J.} and Reynolds, {Harmony R.} and Sripal Bangalore and Stavroula Mavromichalis and Michelle Chang and Aira Contreras and Shari Esquenazi-Karonika and Margaret Gilsenan and Ewelina Gwiszcz and Patenne Mathews and Samaa Mohamed and Anna Naumova and Arline Roberts and Kerrie Vanloo and Rebecca Anthopolos and Yifan Xu and Troxel, {Andrea B.} and Ying Lu and Zhen Huang and Samuel Broderick and Luis Guzm{\'a}n and Joseph Selvanayagam and Lopes, {Renato D.} and Goodman, {Shaun G.} and Gabriel Steg and Juliard, {Jean Michel} and Rolf Doerr and Matyas Keltai and Balram Bhargava and Boban Thomas and Tali Sharir and Eugenia Nikolsky and Maggioni, {Aldo P.} and Shun Kohsaka and Jorge Escobedo and White, {Harvey D.} and Rados{\l}aw Praco{\'n} and Olga Bockeria and Jos{\'e} L{\'o}pez-Send{\'o}n and Claes Held and Roxy Senior and Ann Banfield and Shaw, {Leslee J.} and Lawrence Phillips and Daniel Berman and Kwong, {Raymond Y.} and Picard, {Michael H.} and Chaitman, {Bernard R.} and Ziad Ali and James Min and Mancini, {G. B.John} and Jonathon Leipsic and Luis Guzman and Graham Hillis and Suku Thambar and Majo Joseph and Joseph Selvnayagam and John Beltrame and Irene Lang and Herwig Schuchlenz and Kurt Huber and Kaatje Goetschalckx and Whady Hueb and Caramori, {Paulo Ricardo} and {De Quadros}, Alexandre and Paola Smanio and Claudio Mesquita and Lopas, {Renato D.} and Jo{\~a}o Vitola and Jos{\'e} Marin-Neto and {Da Silva}, {Expedito Ribeiro} and Rog{\'e}rio Tumelero and Marianna Andrade and Alves, {Alvaro Rabelo} and Frederico Dall'Orto and Carisi Polanczyk and Estev{\~a}o Figueiredo and Andrew Howarth and Gilbert Gosselin and Asim Cheema and Kevin Bainey and Denis Phaneuf and Ariel Diaz and Pallav Garg and Shamir Mehta and Graham Wong and Andy Lam and James Cha and Paul Galiwango and Amar Uxa and Benjamin Chow and Adnan Hameed and Jacob Udell and Asim Chema and Magdy Hamid and Marie Hauguel-Moreau and Alain Furber and Pascal Goube and Steg, {Philippe Gabriel} and Gilles Barone-Rochette and Christophe Thuaire and Michel Slama and Rolf Doer and Georg Nickenig and Raffi Bekeredjian and Schulze, {P. Christian} and Bela Merkely and Geza Fontos and Andr{\'a}s V{\'e}rtes and Albert Varga and Balram Bhargva and Ajit Kumar and Nair, {Rajesh G.} and Purvez Grant and Cholenahally Manjunath and Nagaraja Moorthy and Santhosh Satheesh and Nath, {Ranjit Kumar} and Gurpreet Wander and Johann Christopher and Sudhanshu Dwivedi and Abraham Oomman and Atul Mathur and Milind Gadkari and Sudhir Naik and Eapen Punnoose and Ranjan Kachru and Johann Christophar and Upendra Kaul and Tali Sharer and Arthur Kerner and Giuseppe Tarantini and Perna, {Gian Piero} and Emanuela Racca and Andrea Mortara and Lorenzo Monti and Carlo Briguori and Gianpiero Leone and Roberto Amati and Mauro Salvatori and {Di Chiara}, Antonio and Paolo Calabro and Marcello Galvani and Stefano Provasoli and Keiichi Fukuda and Shun Koshaka and Shintaro Nakano and Aleksandras Laucevicius and Sasko Kedev and Ahmad Khairuddin and Jorge Escobdo and Robert Riezebos and Jorik Timmer and Spencer Heald and Ralph Stewart and Ramos, {Walter Mogrovejo} and Marcin Demkow and Tomasz Mazurek and Jarozlaw Drozdz and Hanna Szwed and Adam Witkowski and Nuno Ferreira and Fausto Pinto and Ruben Ramos and Bogdan Popescu and Calin Pop and Leo Bockeria and Olga Bockerya and Elena Demchenko and Alexander Romanov and Leonid Bershtein and Ahmed Jizeeri and Goran Stankovic and Svetlana Apostolovic and Adjic, {Nada Cemerlic} and Marija Zdravkovic and Branko Beleslin and Milica Dekleva and Goran Davidovic and Terrance Chua and David Foo and Poh, {Kian Keong} and Mpiko Ntsekhe and Alessandro Sionis and Francisco Marin and Vicente Mir{\'o} and Jos{\'e} L{\'o}pez-Sendon and Blancas, {Montserrat Gracida} and Jos{\'e} Gonz{\'a}lez-Juanatey and Francisco Fern{\'a}ndez-Avil{\'e}s and Jes{\'u}s Peteiro and Luena, {Jose Enrique Castillo} and Cleas Held and Johannes Aspberg and Mariagrazia Rossi and Srun Kuanprasert and Sukit Yamwong and Nicola Johnston and Patrick Donnelly and Andrew Moriarty and R. Roxy and Ahmed Elghamaz and Sothinathan Gurunathan and Nikolaos Karogiannis and Shah, {Benoy N.} and Trimlett, {Richard H.J.} and Rubens, {Michael B.} and Nicol, {Edward D.} and Mittal, {Tarun K.} and Reinette Hampson and Reto Gamma and {De Belder}, Mark and Thuraia Nageh and Steven Lindsay and Kreton Mavromatis and Todd Miller and Subhash Banerjee and Harmony Reynolds and Khaled Nour and Peter Stone",

note = "Funding Information: The project was funded by National Institutes of Health grant R01HL149888. This project was supported in part by Clinical Translational Science Award No. 11UL1 TR001445 from the National Center for Advancing Translational Sciences. Publisher Copyright: {\textcopyright} 2023 Lippincott Williams and Wilkins. All rights reserved.",

year = "2023",

month = jan,

day = "3",

doi = "10.1161/CIRCULATIONAHA.122.062714",

language = "English",

volume = "147",

pages = "8--19",

journal = "Circulation",

issn = "0009-7322",

publisher = "Lippincott Williams and Wilkins Ltd.",

number = "1",

}

Hochman, JS, Anthopolos, R, Reynolds, HR, Bangalore, S, Xu, Y, O'Brien, SM, Mavromichalis, S, Chang, M, Contreras, A, Rosenberg, Y, Kirby, R, Bhargava, B, Senior, R, Banfield, A, Goodman, SG, Lopes, RD, Pracoń, R, López-Sendón, J, Maggioni, AP, Newman, JD, Berger, JS, Sidhu, MS, White, HD, Troxel, AB, Harrington, RA, Boden, WE, Stone, GW, Mark, DB, Spertus, JA, Maron, DJ, Hochman, JS, Maron, DJ, Reynolds, HR, Bangalore, S, Mavromichalis, S, Chang, M, Contreras, A, Esquenazi-Karonika, S, Gilsenan, M, Gwiszcz, E, Mathews, P, Mohamed, S, Naumova, A, Roberts, A, Vanloo, K, Anthopolos, R, Xu, Y, Troxel, AB, Lu, Y, Huang, Z, Broderick, S, Guzmán, L, Selvanayagam, J, Lopes, RD, Goodman, SG, Steg, G, Juliard, JM, Doerr, R, Keltai, M, Bhargava, B, Thomas, B, Sharir, T, Nikolsky, E, Maggioni, AP, Kohsaka, S, Escobedo, J, White, HD, Pracoń, R, Bockeria, O, López-Sendón, J, Held, C, Senior, R, Banfield, A, Shaw, LJ, Phillips, L, Berman, D, Kwong, RY, Picard, MH, Chaitman, BR, Ali, Z, Min, J, Mancini, GBJ, 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, PR, De Quadros, A, Smanio, P, Mesquita, C, Lopas, RD, Vitola, J, Marin-Neto, J, Da Silva, ER, Tumelero, R, Andrade, M, Alves, AR, 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, PG, Barone-Rochette, G, Thuaire, C, Slama, M, Doer, R, Nickenig, G, Bekeredjian, R, Schulze, PC, Merkely, B, Fontos, G, Vértes, A, Varga, A, Bhargva, B, Kumar, A, Nair, RG, Grant, P, Manjunath, C, Moorthy, N, Satheesh, S, Nath, RK, 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, GP, 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, WM, 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, NC, Zdravkovic, M, Beleslin, B, Dekleva, M, Davidovic, G, Chua, T, Foo, D, Poh, KK, Ntsekhe, M, Sionis, A, Marin, F, Miró, V, López-Sendon, J, Blancas, MG, González-Juanatey, J, Fernández-Avilés, F, Peteiro, J, Luena, JEC, 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, BN, Trimlett, RHJ, Rubens, MB, Nicol, ED, Mittal, TK, Hampson, R, Gamma, R, De Belder, M, Nageh, T, Lindsay, S, Mavromatis, K, Miller, T, Banerjee, S, Reynolds, H, Nour, K & Stone, P 2023, 'Survival after Invasive or Conservative Management of Stable Coronary Disease', Circulation, vol. 147, no. 1, pp. 8-19. https://doi.org/10.1161/CIRCULATIONAHA.122.062714

TY - JOUR

T1 - Survival after Invasive or Conservative Management of Stable Coronary Disease

AU - Hochman, Judith S.

AU - Anthopolos, Rebecca

AU - Reynolds, Harmony R.

AU - Bangalore, Sripal

AU - Xu, Yifan

AU - O'Brien, Sean M.

AU - Mavromichalis, Stavroula

AU - Chang, Michelle

AU - Contreras, Aira

AU - Rosenberg, Yves

AU - Kirby, Ruth

AU - Bhargava, Balram

AU - Senior, Roxy

AU - Banfield, Ann

AU - Goodman, Shaun G.

AU - Lopes, Renato D.

AU - Pracoń, Radosław

AU - López-Sendón, José

AU - Maggioni, Aldo Pietro

AU - Newman, Jonathan D.

AU - Berger, Jeffrey S.

AU - Sidhu, Mandeep S.

AU - White, Harvey D.

AU - Troxel, Andrea B.

AU - Harrington, Robert A.

AU - Boden, William E.

AU - Stone, Gregg W.

AU - Mark, Daniel B.

AU - Spertus, John A.

AU - Maron, David J.

AU - Hochman, Judith S.

AU - Maron, David J.

AU - Reynolds, Harmony R.

AU - Bangalore, Sripal

AU - Mavromichalis, Stavroula

AU - Chang, Michelle

AU - Contreras, Aira

AU - Esquenazi-Karonika, Shari

AU - Gilsenan, Margaret

AU - Gwiszcz, Ewelina

AU - Mathews, Patenne

AU - Mohamed, Samaa

AU - Naumova, Anna

AU - Roberts, Arline

AU - Vanloo, Kerrie

AU - Anthopolos, Rebecca

AU - Xu, Yifan

AU - Troxel, Andrea B.

AU - Lu, Ying

AU - Huang, Zhen

AU - Broderick, Samuel

AU - Guzmán, Luis

AU - Selvanayagam, Joseph

AU - Lopes, Renato D.

AU - Goodman, Shaun G.

AU - Steg, Gabriel

AU - Juliard, Jean Michel

AU - Doerr, Rolf

AU - Keltai, Matyas

AU - Bhargava, Balram

AU - Thomas, Boban

AU - Sharir, Tali

AU - Nikolsky, Eugenia

AU - Maggioni, Aldo P.

AU - Kohsaka, Shun

AU - Escobedo, Jorge

AU - White, Harvey D.

AU - Pracoń, Radosław

AU - Bockeria, Olga

AU - López-Sendón, José

AU - Held, Claes

AU - Senior, Roxy

AU - Banfield, Ann

AU - Shaw, Leslee J.

AU - Phillips, Lawrence

AU - Berman, Daniel

AU - Kwong, Raymond Y.

AU - Picard, Michael H.

AU - Chaitman, Bernard R.

AU - Ali, Ziad

AU - Min, James

AU - Mancini, G. B.John

AU - Leipsic, Jonathon

AU - Guzman, Luis

AU - Hillis, Graham

AU - Thambar, Suku

AU - Joseph, Majo

AU - Selvnayagam, Joseph

AU - Beltrame, John

AU - Lang, Irene

AU - Schuchlenz, Herwig

AU - Huber, Kurt

AU - Goetschalckx, Kaatje

AU - Hueb, Whady

AU - Caramori, Paulo Ricardo

AU - De Quadros, Alexandre

AU - Smanio, Paola

AU - Mesquita, Claudio

AU - Lopas, Renato D.

AU - Vitola, João

AU - Marin-Neto, José

AU - Da Silva, Expedito Ribeiro

AU - Tumelero, Rogério

AU - Andrade, Marianna

AU - Alves, Alvaro Rabelo

AU - Dall'Orto, Frederico

AU - Polanczyk, Carisi

AU - Figueiredo, Estevão

AU - Howarth, Andrew

AU - Gosselin, Gilbert

AU - Cheema, Asim

AU - Bainey, Kevin

AU - Phaneuf, Denis

AU - Diaz, Ariel

AU - Garg, Pallav

AU - Mehta, Shamir

AU - Wong, Graham

AU - Lam, Andy

AU - Cha, James

AU - Galiwango, Paul

AU - Uxa, Amar

AU - Chow, Benjamin

AU - Hameed, Adnan

AU - Udell, Jacob

AU - Chema, Asim

AU - Hamid, Magdy

AU - Hauguel-Moreau, Marie

AU - Furber, Alain

AU - Goube, Pascal

AU - Steg, Philippe Gabriel

AU - Barone-Rochette, Gilles

AU - Thuaire, Christophe

AU - Slama, Michel

AU - Doer, Rolf

AU - Nickenig, Georg

AU - Bekeredjian, Raffi

AU - Schulze, P. Christian

AU - Merkely, Bela

AU - Fontos, Geza

AU - Vértes, András

AU - Varga, Albert

AU - Bhargva, Balram

AU - Kumar, Ajit

AU - Nair, Rajesh G.

AU - Grant, Purvez

AU - Manjunath, Cholenahally

AU - Moorthy, Nagaraja

AU - Satheesh, Santhosh

AU - Nath, Ranjit Kumar

AU - Wander, Gurpreet

AU - Christopher, Johann

AU - Dwivedi, Sudhanshu

AU - Oomman, Abraham

AU - Mathur, Atul

AU - Gadkari, Milind

AU - Naik, Sudhir

AU - Punnoose, Eapen

AU - Kachru, Ranjan

AU - Christophar, Johann

AU - Kaul, Upendra

AU - Sharer, Tali

AU - Kerner, Arthur

AU - Tarantini, Giuseppe

AU - Perna, Gian Piero

AU - Racca, Emanuela

AU - Mortara, Andrea

AU - Monti, Lorenzo

AU - Briguori, Carlo

AU - Leone, Gianpiero

AU - Amati, Roberto

AU - Salvatori, Mauro

AU - Di Chiara, Antonio

AU - Calabro, Paolo

AU - Galvani, Marcello

AU - Provasoli, Stefano

AU - Fukuda, Keiichi

AU - Koshaka, Shun

AU - Nakano, Shintaro

AU - Laucevicius, Aleksandras

AU - Kedev, Sasko

AU - Khairuddin, Ahmad

AU - Escobdo, Jorge

AU - Riezebos, Robert

AU - Timmer, Jorik

AU - Heald, Spencer

AU - Stewart, Ralph

AU - Ramos, Walter Mogrovejo

AU - Demkow, Marcin

AU - Mazurek, Tomasz

AU - Drozdz, Jarozlaw

AU - Szwed, Hanna

AU - Witkowski, Adam

AU - Ferreira, Nuno

AU - Pinto, Fausto

AU - Ramos, Ruben

AU - Popescu, Bogdan

AU - Pop, Calin

AU - Bockeria, Leo

AU - Bockerya, Olga

AU - Demchenko, Elena

AU - Romanov, Alexander

AU - Bershtein, Leonid

AU - Jizeeri, Ahmed

AU - Stankovic, Goran

AU - Apostolovic, Svetlana

AU - Adjic, Nada Cemerlic

AU - Zdravkovic, Marija

AU - Beleslin, Branko

AU - Dekleva, Milica

AU - Davidovic, Goran

AU - Chua, Terrance

AU - Foo, David

AU - Poh, Kian Keong

AU - Ntsekhe, Mpiko

AU - Sionis, Alessandro

AU - Marin, Francisco

AU - Miró, Vicente

AU - López-Sendon, José

AU - Blancas, Montserrat Gracida

AU - González-Juanatey, José

AU - Fernández-Avilés, Francisco

AU - Peteiro, Jesús

AU - Luena, Jose Enrique Castillo

AU - Held, Cleas

AU - Aspberg, Johannes

AU - Rossi, Mariagrazia

AU - Kuanprasert, Srun

AU - Yamwong, Sukit

AU - Johnston, Nicola

AU - Donnelly, Patrick

AU - Moriarty, Andrew

AU - Roxy, R.

AU - Elghamaz, Ahmed

AU - Gurunathan, Sothinathan

AU - Karogiannis, Nikolaos

AU - Shah, Benoy N.

AU - Trimlett, Richard H.J.

AU - Rubens, Michael B.

AU - Nicol, Edward D.

AU - Mittal, Tarun K.

AU - Hampson, Reinette

AU - Gamma, Reto

AU - De Belder, Mark

AU - Nageh, Thuraia

AU - Lindsay, Steven

AU - Mavromatis, Kreton

AU - Miller, Todd

AU - Banerjee, Subhash

AU - Reynolds, Harmony

AU - Nour, Khaled

AU - Stone, Peter

N1 - Funding Information: The project was funded by National Institutes of Health grant R01HL149888. This project was supported in part by Clinical Translational Science Award No. 11UL1 TR001445 from the National Center for Advancing Translational Sciences. Publisher Copyright: © 2023 Lippincott Williams and Wilkins. All rights reserved.

PY - 2023/1/3

Y1 - 2023/1/3

N2 - 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: https://www.clinicaltrials.gov; Unique identifier: NCT04894877.

AB - 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: https://www.clinicaltrials.gov; Unique identifier: NCT04894877.

KW - catheterization

KW - coronary artery bypass

KW - medication therapy management

KW - myocardial ischemia

KW - percutaneous coronary intervention

UR - http://www.scopus.com/inward/record.url?scp=85144800377&partnerID=8YFLogxK

U2 - 10.1161/CIRCULATIONAHA.122.062714

DO - 10.1161/CIRCULATIONAHA.122.062714

M3 - Article

C2 - 36335918

AN - SCOPUS:85144800377

SN - 0009-7322

VL - 147

SP - 8

EP - 19

JO - Circulation

JF - Circulation

IS - 1

ER -

Survival after Invasive or Conservative Management of Stable Coronary Disease

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