Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial

Judith S. Hochman; Harmony R. Reynolds; Sripal Bangalore; Sean M. O'Brien; Karen P. Alexander; Roxy Senior; William E. Boden; Gregg W. Stone; Shaun G. Goodman; Renato D. Lopes; Jose Lopez-Sendon; Harvey D. White; Aldo P. Maggioni; Leslee J. Shaw; James K. Min; Michael H. Picard; Daniel S. Berman; Bernard R. Chaitman; Daniel B. Mark; John A. Spertus; Derek D. Cyr; Balram Bhargava; Witold Ruzyllo; Gurpreet S. Wander; Alexander M. Chernyavskiy; Yves D. Rosenberg; David J. Maron; The ISCHEMIA Research Group; Joseph B. Selvanayagam

doi:10.1001/jamacardio.2019.0014

Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial

Judith S. Hochman, Harmony R. Reynolds, Sripal Bangalore, Sean M. O'Brien, Karen P. Alexander, Roxy Senior, William E. Boden, Gregg W. Stone, Shaun G. Goodman, Renato D. Lopes, Jose Lopez-Sendon, Harvey D. White, Aldo P. Maggioni, Leslee J. Shaw, James K. Min, Michael H. Picard, Daniel S. Berman, Bernard R. Chaitman, Daniel B. Mark, John A. SpertusDerek D. Cyr, Balram Bhargava, Witold Ruzyllo, Gurpreet S. Wander, Alexander M. Chernyavskiy, Yves D. Rosenberg, David J. Maron, The ISCHEMIA Research Group, Joseph B. Selvanayagam

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

114 Citations (Scopus)

Abstract

Importance: It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia. Objective: To describe baseline characteristics of participants enrolled and randomized in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate whether qualification by stress imaging or nonimaging exercise tolerance test (ETT) influenced risk profiles. Design, Setting, and Participants: The ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing. Blinded coronary computed tomography angiography was performed in most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (<50% for imaging stress test and <70% for ETT). The study included 341 enrolling sites (320 randomizing) in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing. Data presented were extracted on December 17, 2018. Main Outcomes and Measures: Enrolled, excluded, and randomized participants' baseline characteristics. No clinical outcomes are reported. Results: A total of 8518 patients were enrolled, and 5179 were randomized. Common reasons for exclusion were core laboratory determination of insufficient ischemia, unprotected left main stenosis of at least 50%, or no stenosis that met study obstructive CAD criteria on study coronary computed tomography angiography. Randomized participants had a median age of 64 years, with 1168 women (22.6%), 1726 nonwhite participants (33.7%), 748 Hispanic participants (15.5%), 2122 with diabetes (41.0%), and 4643 with a history of angina (89.7%). Among the 3909 participants randomized after stress imaging, core laboratory assessment of ischemia severity (in 3901 participants) was severe in 1748 (44.8%), moderate in 1600 (41.0%), mild in 317 (8.1%) and none or uninterpretable in 236 (6.0%), Among the 1270 participants who were randomized after nonimaging ETT, core laboratory determination of ischemia severity (in 1266 participants) was severe (an eligibility criterion) in 1051 (83.0%), moderate in 101 (8.0%), mild in 34 (2.7%) and none or uninterpretable in 80 (6.3%). Among the 3912 of 5179 randomized participants who underwent coronary computed tomography angiography, 79.0% had multivessel CAD (n = 2679 of 3390) and 86.8% had left anterior descending (LAD) stenosis (n = 3190 of 3677) (proximal in 46.8% [n = 1749 of 3739]). Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging. Conclusions and Relevance: The ISCHEMIA trial randomized an SIHD population with moderate or severe ischemia on stress testing, of whom most had multivessel CAD.

Original language	English
Pages (from-to)	273-286
Number of pages	14
Journal	JAMA Cardiology
Volume	4
Issue number	3
DOIs	https://doi.org/10.1001/jamacardio.2019.0014
Publication status	Published - 27 Feb 2019
Externally published	Yes

Keywords

Risk Profiles
ISCHEMIA
Randomized Clinical Trial
SIHD
Moderate to severe ischemia

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1001/jamacardio.2019.0014Licence: In Copyright

Cite this

Hochman, J. S., Reynolds, H. R., Bangalore, S., O'Brien, S. M., Alexander, K. P., Senior, R., Boden, W. E., Stone, G. W., Goodman, S. G., Lopes, R. D., Lopez-Sendon, J., White, H. D., Maggioni, A. P., Shaw, L. J., Min, J. K., Picard, M. H., Berman, D. S., Chaitman, B. R., Mark, D. B., ... Selvanayagam, J. B. (2019). Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial. JAMA Cardiology, 4(3), 273-286. https://doi.org/10.1001/jamacardio.2019.0014

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title = "Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial",

abstract = "Importance: It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia. Objective: To describe baseline characteristics of participants enrolled and randomized in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate whether qualification by stress imaging or nonimaging exercise tolerance test (ETT) influenced risk profiles. Design, Setting, and Participants: The ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing. Blinded coronary computed tomography angiography was performed in most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (<50% for imaging stress test and <70% for ETT). The study included 341 enrolling sites (320 randomizing) in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing. Data presented were extracted on December 17, 2018. Main Outcomes and Measures: Enrolled, excluded, and randomized participants' baseline characteristics. No clinical outcomes are reported. Results: A total of 8518 patients were enrolled, and 5179 were randomized. Common reasons for exclusion were core laboratory determination of insufficient ischemia, unprotected left main stenosis of at least 50%, or no stenosis that met study obstructive CAD criteria on study coronary computed tomography angiography. Randomized participants had a median age of 64 years, with 1168 women (22.6%), 1726 nonwhite participants (33.7%), 748 Hispanic participants (15.5%), 2122 with diabetes (41.0%), and 4643 with a history of angina (89.7%). Among the 3909 participants randomized after stress imaging, core laboratory assessment of ischemia severity (in 3901 participants) was severe in 1748 (44.8%), moderate in 1600 (41.0%), mild in 317 (8.1%) and none or uninterpretable in 236 (6.0%), Among the 1270 participants who were randomized after nonimaging ETT, core laboratory determination of ischemia severity (in 1266 participants) was severe (an eligibility criterion) in 1051 (83.0%), moderate in 101 (8.0%), mild in 34 (2.7%) and none or uninterpretable in 80 (6.3%). Among the 3912 of 5179 randomized participants who underwent coronary computed tomography angiography, 79.0% had multivessel CAD (n = 2679 of 3390) and 86.8% had left anterior descending (LAD) stenosis (n = 3190 of 3677) (proximal in 46.8% [n = 1749 of 3739]). Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging. Conclusions and Relevance: The ISCHEMIA trial randomized an SIHD population with moderate or severe ischemia on stress testing, of whom most had multivessel CAD.",

keywords = "Risk Profiles, ISCHEMIA, Randomized Clinical Trial, SIHD, Moderate to severe ischemia",

author = "Hochman, {Judith S.} and Reynolds, {Harmony R.} and Sripal Bangalore and O'Brien, {Sean M.} and Alexander, {Karen P.} and Roxy Senior and Boden, {William E.} and Stone, {Gregg W.} and Goodman, {Shaun G.} and Lopes, {Renato D.} and Jose Lopez-Sendon and White, {Harvey D.} and Maggioni, {Aldo P.} and Shaw, {Leslee J.} and Min, {James K.} and Picard, {Michael H.} and Berman, {Daniel S.} and Chaitman, {Bernard R.} and Mark, {Daniel B.} and Spertus, {John A.} and Cyr, {Derek D.} and Balram Bhargava and Witold Ruzyllo and Wander, {Gurpreet S.} and Chernyavskiy, {Alexander M.} and Rosenberg, {Yves D.} and Maron, {David J.} and {The ISCHEMIA Research Group} and Kreton Mavromatis and Todd Miller and Subhash Banerjee and Harmony Reynolds and Khaled Abdul-Nour and Stone, {Peter H.} and Jang, {James J.} and Steven Weitz and Suzanne Arnold and Shapiro, {Michael D.} and Mohammad El-Hajjar and McFalls, {Edward O.} and Khouri, {Michael Georges} and Goldberg, {Jonathan L.} and Richard Goldweit and Cohen, {Ronny A.} and Winchester, {David E.} and Marvin Kronenberg and Heitner, {John F.} and Dauber, {Ira M.} and Charles Cannan and Sriram Sudarshan and Mehta, {Puja R.} and Hedgepeth, {Chester M.} and Zakir Sahul and David Booth and Sampoornima Setty and Barua, {Rajat S.} and Fadi Hage and Khaled Dajani and Mohammad El-Hajjar and Imran Arif and Trejo, {Jorge F.} and Anthony Gemignani and Meadows, {Judith L.} and Call, {Jason T.} and Joseph Hannan and Martin, {Edward T.} and Gabriel Vorobiof and Alec Moorman and Scott Kinlay and Glenn Rayos and Ashraf Seedhom and Gregory Kumkumian and Sedlis, {Steven P.} and Tamis-Holland, {Jacqueline E.} and Souheil Saba and Umesh Badami and Kevin Marzo and Robbins, {Inga H.} and Hamroff, {Glenn S.} and Little, {Raymond W.} and Lui, {Charles Y.} and David Booth and Bob Hu and Labovitz, {Arthur J.} and Maron, {David J.} and Fatima Rodriguez and Prakash Deedwania and Joseph Sweeny and Christopher Spizzieri and Hochberg, {Claudia P} and Salerno, {William D.} and Ray Wyman and Amer Zarka and Thomas Haldis and Kohn, {Jeffrey A.} and Saket Girotra and Omar Almousalli and Krishnam, {Mayil S.} and Rita Coram and Sabu Thomas and Shahawy, {Mahfouz El} and James Stafford and Abernethy, {William B.} and Andrew Zurick and Meyer, {Thomas M.} and Bruce Rutkin and Sabahat Bokhari and Sokol, {Seth I.} and Ihab Hamzeh and Turner, {Michael C.} and Good, {Arnold P.} and Shammas, {Nicolas W.} and Robert Chilton and Nguyen, {Patricia K.} and Matthew Jezior and Gordon, {Paul C.} and Robert Stenberg and Pedalino, {Ronald P.} and Joseph Wiesel and Juang, {George J.} and Mohammed Al-Amoodi and David Wohns and Lader, {Ellis W.} and Michael Mumma and Lekshmi Dharmarajan and {McGarvey Jr}, {Joseph F.X.} and Downes, {Thomas R.} and Benjamin Cheong and Srinivasa Potluri and Mastouri, {Ronald A.} and Dayuan Li and Kenneth Giedd and Wayne Old and Francis Burt and Kozhaya Sokhon and Deepika Gopal and Valeti, {Uma S.} and Jon Kobashigawa and Govindan, {Sajeev Chakanalil} and Manjunath, {Cholenahally Nanjappa} and Neeraj Pandit and S.K. Dwivedi and Wander, {Gurpreet S.} and Balram Bhargava and Anoop Mathew and Gadkari, {Milind Avdhoot} and Santhosh Satheesh and Atul Mathur and Johann Christopher and Abraham Oomman and Sudhir Naik and Purvez Grant and Ranjan Kachru and Ajit Kumar and Upendra Kaul and Roxy Senior and Gamma, {Reto Andreas} and {de Belder}, {Mark A} and Thuraia Nageh and Lindsay, {Steven J.} and Angela Hoye and Patrick Donnelly and Anoop Chauhan and Craig Barr and Khaled Alfakih and Peter Henriksen and Peter OKane and {de Silva}, Ramesh and Conway, {Dwayne S.G.} and Sirker, {Alexander A} and Hoole, {Stephen P} and Witherow, {Fraser N.} and Nicola Johnston and Matthew Luckie and Jolanta Sobolewska and Paramjit Jeetley and Christopher Travill and Denise Braganza and Robert Henderson and Colin Berry and Moriarty, {Andrew J} and Glover, {Jason D.} and Ghada Mikhail and Gilbert Gosselin and Ariel Diaz and Phaneuf, {Denis Carl} and Pallav Garg and Chow, {Benjamin J.W.} and Bainey, {Kevin R.} and Cheema, {Asim N.} and Cheema, {Asim Nazir} and Cha James and Howarth, {Andrew G.} and Graham Wong and Amar Uxa and Paul Galiwango and Andy Lam and Shamir Mehta and Jacob Udell and Philippe Genereux and Adnan Hameed and Ledjalem Daba and Whady Hueb and Smanio, {Paola Emanuela Poggio} and {de Quadros}, {Alexandre Schaan} and Vitola, {Joav V} and Marin-Neto, {Jose Antonio} and Polanczyk, {Carisi A.} and Carvalho, {Antonio Carlos} and {Alves Junior}, {Alvaro Rabelo} and Dracoulakis, {Marianna D.A.} and Estevao Figueiredo and Caramori, {Paulo Ricardo} and Rogerio Tumelero and Frederico Dall'Orto and Mesquita, {Claudio T.} and {da Silva}, {Expedito Eust{\'a}quio Ribeiro} and Saraiva, {Jose Francisco} and Costantino Costantini and Marcin Demkow and Tomasz Mazurek and Jaroslaw Drozdz and Hanna Szwed and Adam Witkowski and Grzegorz Gajos and Piotr Pruszczyk and Krystyna Loboz-Grudzien and Maciej Lesiak and Reczuch, {Krzysztof W.} and Zbigniew Kalarus and Musial, {Wlodzimierz J.} and Leo Bockeria and Chernyavskiy, {Alexander M.} and Bershtein, {Leonid L.} and Demchenko, {Elena A.} and Lopez-Sendon, {Jose Luis} and Jes{\'u}s Peteiro and Juanatey, {Jose Ramon Gonzalez} and Alessandro Sionis and Vincent Miro and Ortu{\~n}o, {F. Marin} and Blancas, {Montserrat Gracida} and Luena, {Jose Enrique Castillo} and Francisco Fernandez-Aviles and Jiyan Chen and Yongjian Wu and Yitong Ma and Zheng Ji and Xinchun Yang and Wenhua Lin and Hesong Zeng and Xin Fu and Bin Yang and Songtao Wang and Gong Cheng and Yulan Zhao and Xuehua Fang and Qiutang Zeng and Xi Su and Qingxian Li and Shao-ping Nie and Qin Yu and Jian'an Wang and Shuyang Zhang and Perna, {Gian Piero} and Stefano Provasoli and Lorenzo Monti and Chiara, {Antonio Di} and Andrea Mortara and Marcello Galvani and Marco Sicuro and Paolo Calabro and Giuseppe Tarantini and Emanuela Racca and Carlo Briguori and Roberto Amati and Aldo Russo and Kian-Keong Poh and David Foo and Terrance Chua and Rolf Doerr and Udo Sechtem and Schulze, {P. Christian} and Georg Nickenig and Herwig Schuchlenz and Lang, {Irene Marthe} and Kurt Huber and Andras Vertes and Albert Varga and Geza Fontos and Bela Merkely and Gabor Kerecsen and Sasa Hinic and Beleslin, {Branko D.} and Nada Cemerlic-Adjic and Goran Davidovi{\'c} and Dekleva, {Milica Nikola} and Goran Stankovic and Svetlana Apostolovic and Jorge Escobedo and Rosas, {Erick Alex{\'a}nderson} and Selvanayagam, {Joseph B.} and Thambar, {Suku T.} and Beltrame, {John F.} and Hillis, {Graham S.} and Christophe Thuaire and Philippe-Gabriel Steg and Slama, {Michel S.} and Mahmoud, {Rami El} and Eric Nicollet and Gilles Baron-Rochette and Alain Furber and Aleksandras Laucevicius and Elvin Kedhi and Riezebos, {Robert K.} and Harry Suryapranata and Ruben Ramos and Pinto, {Fausto J.} and Nuno Ferreira and Luis Guzman and Figal, {Julio C{\'e}sar} and Carlos Alvarez and Javier Courtis and Lilia Schiavi and Mariano Rubio and Devlin, {Gerard Patrick} and Stewart, {Ralph Alan Huston} and Sasko Kedev and Claes Held and Johannes Aspberg and Tali Sharir and Arthur Kerner and Keiichi Fukuda and Satoshi Yasuda and Shigeyuki Nishimura and Kaatje Goetschalckx and Chung-Lieh Hung and Mpiko Ntsekhe and Tiziano Moccetti and Magdy Abdelhamid and Calin Pop and Popescu, {Bogdan A.} and Al-Mallah, {Mouaz H.} and Ramos, {Walter Enrique Mogrovejo} and Srun Kuanprasert and Sukit Yamwong and Ahmad Khairuddin",

year = "2019",

month = feb,

day = "27",

doi = "10.1001/jamacardio.2019.0014",

language = "English",

volume = "4",

pages = "273--286",

journal = "JAMA Cardiology",

issn = "2380-6583",

publisher = "The JAMA Network",

number = "3",

}

Hochman, JS, Reynolds, HR, Bangalore, S, O'Brien, SM, Alexander, KP, Senior, R, Boden, WE, Stone, GW, Goodman, SG, Lopes, RD, Lopez-Sendon, J, White, HD, Maggioni, AP, Shaw, LJ, Min, JK, Picard, MH, Berman, DS, Chaitman, BR, Mark, DB, Spertus, JA, Cyr, DD, Bhargava, B, Ruzyllo, W, Wander, GS, Chernyavskiy, AM, Rosenberg, YD, Maron, DJ, The ISCHEMIA Research Group & Selvanayagam, JB 2019, 'Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial', JAMA Cardiology, vol. 4, no. 3, pp. 273-286. https://doi.org/10.1001/jamacardio.2019.0014

TY - JOUR

T1 - Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial

AU - Hochman, Judith S.

AU - Reynolds, Harmony R.

AU - Bangalore, Sripal

AU - O'Brien, Sean M.

AU - Alexander, Karen P.

AU - Senior, Roxy

AU - Boden, William E.

AU - Stone, Gregg W.

AU - Goodman, Shaun G.

AU - Lopes, Renato D.

AU - Lopez-Sendon, Jose

AU - White, Harvey D.

AU - Maggioni, Aldo P.

AU - Shaw, Leslee J.

AU - Min, James K.

AU - Picard, Michael H.

AU - Berman, Daniel S.

AU - Chaitman, Bernard R.

AU - Mark, Daniel B.

AU - Spertus, John A.

AU - Cyr, Derek D.

AU - Bhargava, Balram

AU - Ruzyllo, Witold

AU - Wander, Gurpreet S.

AU - Chernyavskiy, Alexander M.

AU - Rosenberg, Yves D.

AU - Maron, David J.

AU - The ISCHEMIA Research Group

AU - Mavromatis, Kreton

AU - Miller, Todd

AU - Banerjee, Subhash

AU - Reynolds, Harmony

AU - Abdul-Nour, Khaled

AU - Stone, Peter H.

AU - Jang, James J.

AU - Weitz, Steven

AU - Arnold, Suzanne

AU - Shapiro, Michael D.

AU - El-Hajjar, Mohammad

AU - McFalls, Edward O.

AU - Khouri, Michael Georges

AU - Goldberg, Jonathan L.

AU - Goldweit, Richard

AU - Cohen, Ronny A.

AU - Winchester, David E.

AU - Kronenberg, Marvin

AU - Heitner, John F.

AU - Dauber, Ira M.

AU - Cannan, Charles

AU - Sudarshan, Sriram

AU - Mehta, Puja R.

AU - Hedgepeth, Chester M.

AU - Sahul, Zakir

AU - Booth, David

AU - Setty, Sampoornima

AU - Barua, Rajat S.

AU - Hage, Fadi

AU - Dajani, Khaled

AU - El-Hajjar, Mohammad

AU - Arif, Imran

AU - Trejo, Jorge F.

AU - Gemignani, Anthony

AU - Meadows, Judith L.

AU - Call, Jason T.

AU - Hannan, Joseph

AU - Martin, Edward T.

AU - Vorobiof, Gabriel

AU - Moorman, Alec

AU - Kinlay, Scott

AU - Rayos, Glenn

AU - Seedhom, Ashraf

AU - Kumkumian, Gregory

AU - Sedlis, Steven P.

AU - Tamis-Holland, Jacqueline E.

AU - Saba, Souheil

AU - Badami, Umesh

AU - Marzo, Kevin

AU - Robbins, Inga H.

AU - Hamroff, Glenn S.

AU - Little, Raymond W.

AU - Lui, Charles Y.

AU - Booth, David

AU - Hu, Bob

AU - Labovitz, Arthur J.

AU - Maron, David J.

AU - Rodriguez, Fatima

AU - Deedwania, Prakash

AU - Sweeny, Joseph

AU - Spizzieri, Christopher

AU - Hochberg, Claudia P

AU - Salerno, William D.

AU - Wyman, Ray

AU - Zarka, Amer

AU - Haldis, Thomas

AU - Kohn, Jeffrey A.

AU - Girotra, Saket

AU - Almousalli, Omar

AU - Krishnam, Mayil S.

AU - Coram, Rita

AU - Thomas, Sabu

AU - Shahawy, Mahfouz El

AU - Stafford, James

AU - Abernethy, William B.

AU - Zurick, Andrew

AU - Meyer, Thomas M.

AU - Rutkin, Bruce

AU - Bokhari, Sabahat

AU - Sokol, Seth I.

AU - Hamzeh, Ihab

AU - Turner, Michael C.

AU - Good, Arnold P.

AU - Shammas, Nicolas W.

AU - Chilton, Robert

AU - Nguyen, Patricia K.

AU - Jezior, Matthew

AU - Gordon, Paul C.

AU - Stenberg, Robert

AU - Pedalino, Ronald P.

AU - Wiesel, Joseph

AU - Juang, George J.

AU - Al-Amoodi, Mohammed

AU - Wohns, David

AU - Lader, Ellis W.

AU - Mumma, Michael

AU - Dharmarajan, Lekshmi

AU - McGarvey Jr, Joseph F.X.

AU - Downes, Thomas R.

AU - Cheong, Benjamin

AU - Potluri, Srinivasa

AU - Mastouri, Ronald A.

AU - Li, Dayuan

AU - Giedd, Kenneth

AU - Old, Wayne

AU - Burt, Francis

AU - Sokhon, Kozhaya

AU - Gopal, Deepika

AU - Valeti, Uma S.

AU - Kobashigawa, Jon

AU - Govindan, Sajeev Chakanalil

AU - Manjunath, Cholenahally Nanjappa

AU - Pandit, Neeraj

AU - Dwivedi, S.K.

AU - Wander, Gurpreet S.

AU - Bhargava, Balram

AU - Mathew, Anoop

AU - Gadkari, Milind Avdhoot

AU - Satheesh, Santhosh

AU - Mathur, Atul

AU - Christopher, Johann

AU - Oomman, Abraham

AU - Naik, Sudhir

AU - Grant, Purvez

AU - Kachru, Ranjan

AU - Kumar, Ajit

AU - Kaul, Upendra

AU - Senior, Roxy

AU - Gamma, Reto Andreas

AU - de Belder, Mark A

AU - Nageh, Thuraia

AU - Lindsay, Steven J.

AU - Hoye, Angela

AU - Donnelly, Patrick

AU - Chauhan, Anoop

AU - Barr, Craig

AU - Alfakih, Khaled

AU - Henriksen, Peter

AU - OKane, Peter

AU - de Silva, Ramesh

AU - Conway, Dwayne S.G.

AU - Sirker, Alexander A

AU - Hoole, Stephen P

AU - Witherow, Fraser N.

AU - Johnston, Nicola

AU - Luckie, Matthew

AU - Sobolewska, Jolanta

AU - Jeetley, Paramjit

AU - Travill, Christopher

AU - Braganza, Denise

AU - Henderson, Robert

AU - Berry, Colin

AU - Moriarty, Andrew J

AU - Glover, Jason D.

AU - Mikhail, Ghada

AU - Gosselin, Gilbert

AU - Diaz, Ariel

AU - Phaneuf, Denis Carl

AU - Garg, Pallav

AU - Chow, Benjamin J.W.

AU - Bainey, Kevin R.

AU - Cheema, Asim N.

AU - Cheema, Asim Nazir

AU - James, Cha

AU - Howarth, Andrew G.

AU - Wong, Graham

AU - Uxa, Amar

AU - Galiwango, Paul

AU - Lam, Andy

AU - Mehta, Shamir

AU - Udell, Jacob

AU - Genereux, Philippe

AU - Hameed, Adnan

AU - Daba, Ledjalem

AU - Hueb, Whady

AU - Smanio, Paola Emanuela Poggio

AU - de Quadros, Alexandre Schaan

AU - Vitola, Joav V

AU - Marin-Neto, Jose Antonio

AU - Polanczyk, Carisi A.

AU - Carvalho, Antonio Carlos

AU - Alves Junior, Alvaro Rabelo

AU - Dracoulakis, Marianna D.A.

AU - Figueiredo, Estevao

AU - Caramori, Paulo Ricardo

AU - Tumelero, Rogerio

AU - Dall'Orto, Frederico

AU - Mesquita, Claudio T.

AU - da Silva, Expedito Eustáquio Ribeiro

AU - Saraiva, Jose Francisco

AU - Costantini, Costantino

AU - Demkow, Marcin

AU - Mazurek, Tomasz

AU - Drozdz, Jaroslaw

AU - Szwed, Hanna

AU - Witkowski, Adam

AU - Gajos, Grzegorz

AU - Pruszczyk, Piotr

AU - Loboz-Grudzien, Krystyna

AU - Lesiak, Maciej

AU - Reczuch, Krzysztof W.

AU - Kalarus, Zbigniew

AU - Musial, Wlodzimierz J.

AU - Bockeria, Leo

AU - Chernyavskiy, Alexander M.

AU - Bershtein, Leonid L.

AU - Demchenko, Elena A.

AU - Lopez-Sendon, Jose Luis

AU - Peteiro, Jesús

AU - Juanatey, Jose Ramon Gonzalez

AU - Sionis, Alessandro

AU - Miro, Vincent

AU - Ortuño, F. Marin

AU - Blancas, Montserrat Gracida

AU - Luena, Jose Enrique Castillo

AU - Fernandez-Aviles, Francisco

AU - Chen, Jiyan

AU - Wu, Yongjian

AU - Ma, Yitong

AU - Ji, Zheng

AU - Yang, Xinchun

AU - Lin, Wenhua

AU - Zeng, Hesong

AU - Fu, Xin

AU - Yang, Bin

AU - Wang, Songtao

AU - Cheng, Gong

AU - Zhao, Yulan

AU - Fang, Xuehua

AU - Zeng, Qiutang

AU - Su, Xi

AU - Li, Qingxian

AU - Nie, Shao-ping

AU - Yu, Qin

AU - Wang, Jian'an

AU - Zhang, Shuyang

AU - Perna, Gian Piero

AU - Provasoli, Stefano

AU - Monti, Lorenzo

AU - Chiara, Antonio Di

AU - Mortara, Andrea

AU - Galvani, Marcello

AU - Sicuro, Marco

AU - Calabro, Paolo

AU - Tarantini, Giuseppe

AU - Racca, Emanuela

AU - Briguori, Carlo

AU - Amati, Roberto

AU - Russo, Aldo

AU - Poh, Kian-Keong

AU - Foo, David

AU - Chua, Terrance

AU - Doerr, Rolf

AU - Sechtem, Udo

AU - Schulze, P. Christian

AU - Nickenig, Georg

AU - Schuchlenz, Herwig

AU - Lang, Irene Marthe

AU - Huber, Kurt

AU - Vertes, Andras

AU - Varga, Albert

AU - Fontos, Geza

AU - Merkely, Bela

AU - Kerecsen, Gabor

AU - Hinic, Sasa

AU - Beleslin, Branko D.

AU - Cemerlic-Adjic, Nada

AU - Davidović, Goran

AU - Dekleva, Milica Nikola

AU - Stankovic, Goran

AU - Apostolovic, Svetlana

AU - Escobedo, Jorge

AU - Rosas, Erick Alexánderson

AU - Selvanayagam, Joseph B.

AU - Thambar, Suku T.

AU - Beltrame, John F.

AU - Hillis, Graham S.

AU - Thuaire, Christophe

AU - Steg, Philippe-Gabriel

AU - Slama, Michel S.

AU - Mahmoud, Rami El

AU - Nicollet, Eric

AU - Baron-Rochette, Gilles

AU - Furber, Alain

AU - Laucevicius, Aleksandras

AU - Kedhi, Elvin

AU - Riezebos, Robert K.

AU - Suryapranata, Harry

AU - Ramos, Ruben

AU - Pinto, Fausto J.

AU - Ferreira, Nuno

AU - Guzman, Luis

AU - Figal, Julio César

AU - Alvarez, Carlos

AU - Courtis, Javier

AU - Schiavi, Lilia

AU - Rubio, Mariano

AU - Devlin, Gerard Patrick

AU - Stewart, Ralph Alan Huston

AU - Kedev, Sasko

AU - Held, Claes

AU - Aspberg, Johannes

AU - Sharir, Tali

AU - Kerner, Arthur

AU - Fukuda, Keiichi

AU - Yasuda, Satoshi

AU - Nishimura, Shigeyuki

AU - Goetschalckx, Kaatje

AU - Hung, Chung-Lieh

AU - Ntsekhe, Mpiko

AU - Moccetti, Tiziano

AU - Abdelhamid, Magdy

AU - Pop, Calin

AU - Popescu, Bogdan A.

AU - Al-Mallah, Mouaz H.

AU - Ramos, Walter Enrique Mogrovejo

AU - Kuanprasert, Srun

AU - Yamwong, Sukit

AU - Khairuddin, Ahmad

PY - 2019/2/27

Y1 - 2019/2/27

N2 - Importance: It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia. Objective: To describe baseline characteristics of participants enrolled and randomized in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate whether qualification by stress imaging or nonimaging exercise tolerance test (ETT) influenced risk profiles. Design, Setting, and Participants: The ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing. Blinded coronary computed tomography angiography was performed in most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (<50% for imaging stress test and <70% for ETT). The study included 341 enrolling sites (320 randomizing) in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing. Data presented were extracted on December 17, 2018. Main Outcomes and Measures: Enrolled, excluded, and randomized participants' baseline characteristics. No clinical outcomes are reported. Results: A total of 8518 patients were enrolled, and 5179 were randomized. Common reasons for exclusion were core laboratory determination of insufficient ischemia, unprotected left main stenosis of at least 50%, or no stenosis that met study obstructive CAD criteria on study coronary computed tomography angiography. Randomized participants had a median age of 64 years, with 1168 women (22.6%), 1726 nonwhite participants (33.7%), 748 Hispanic participants (15.5%), 2122 with diabetes (41.0%), and 4643 with a history of angina (89.7%). Among the 3909 participants randomized after stress imaging, core laboratory assessment of ischemia severity (in 3901 participants) was severe in 1748 (44.8%), moderate in 1600 (41.0%), mild in 317 (8.1%) and none or uninterpretable in 236 (6.0%), Among the 1270 participants who were randomized after nonimaging ETT, core laboratory determination of ischemia severity (in 1266 participants) was severe (an eligibility criterion) in 1051 (83.0%), moderate in 101 (8.0%), mild in 34 (2.7%) and none or uninterpretable in 80 (6.3%). Among the 3912 of 5179 randomized participants who underwent coronary computed tomography angiography, 79.0% had multivessel CAD (n = 2679 of 3390) and 86.8% had left anterior descending (LAD) stenosis (n = 3190 of 3677) (proximal in 46.8% [n = 1749 of 3739]). Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging. Conclusions and Relevance: The ISCHEMIA trial randomized an SIHD population with moderate or severe ischemia on stress testing, of whom most had multivessel CAD.

AB - Importance: It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia. Objective: To describe baseline characteristics of participants enrolled and randomized in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate whether qualification by stress imaging or nonimaging exercise tolerance test (ETT) influenced risk profiles. Design, Setting, and Participants: The ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing. Blinded coronary computed tomography angiography was performed in most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (<50% for imaging stress test and <70% for ETT). The study included 341 enrolling sites (320 randomizing) in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing. Data presented were extracted on December 17, 2018. Main Outcomes and Measures: Enrolled, excluded, and randomized participants' baseline characteristics. No clinical outcomes are reported. Results: A total of 8518 patients were enrolled, and 5179 were randomized. Common reasons for exclusion were core laboratory determination of insufficient ischemia, unprotected left main stenosis of at least 50%, or no stenosis that met study obstructive CAD criteria on study coronary computed tomography angiography. Randomized participants had a median age of 64 years, with 1168 women (22.6%), 1726 nonwhite participants (33.7%), 748 Hispanic participants (15.5%), 2122 with diabetes (41.0%), and 4643 with a history of angina (89.7%). Among the 3909 participants randomized after stress imaging, core laboratory assessment of ischemia severity (in 3901 participants) was severe in 1748 (44.8%), moderate in 1600 (41.0%), mild in 317 (8.1%) and none or uninterpretable in 236 (6.0%), Among the 1270 participants who were randomized after nonimaging ETT, core laboratory determination of ischemia severity (in 1266 participants) was severe (an eligibility criterion) in 1051 (83.0%), moderate in 101 (8.0%), mild in 34 (2.7%) and none or uninterpretable in 80 (6.3%). Among the 3912 of 5179 randomized participants who underwent coronary computed tomography angiography, 79.0% had multivessel CAD (n = 2679 of 3390) and 86.8% had left anterior descending (LAD) stenosis (n = 3190 of 3677) (proximal in 46.8% [n = 1749 of 3739]). Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging. Conclusions and Relevance: The ISCHEMIA trial randomized an SIHD population with moderate or severe ischemia on stress testing, of whom most had multivessel CAD.

KW - Risk Profiles

KW - ISCHEMIA

KW - Randomized Clinical Trial

KW - SIHD

KW - Moderate to severe ischemia

UR - http://www.scopus.com/inward/record.url?scp=85062373702&partnerID=8YFLogxK

U2 - 10.1001/jamacardio.2019.0014

DO - 10.1001/jamacardio.2019.0014

M3 - Article

C2 - 30810700

AN - SCOPUS:85062373702

SN - 2380-6583

VL - 4

SP - 273

EP - 286

JO - JAMA Cardiology

JF - JAMA Cardiology

IS - 3

ER -

Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial

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