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 - ISCHEMIA-EXTEND Research Group
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 - Guzman, 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 - 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
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 -