International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD): Rationale and design

Sripal Bangalore; David J. Maron; Jerome L. Fleg; Sean M. O'Brien; Charles A. Herzog; Gregg W. Stone; Daniel B. Mark; John A. Spertus; Karen P. Alexander; Mandeep S. Sidhu; Glenn M. Chertow; William E. Boden; Judith S. Hochman; The ISCHEMIA-CKD Research Group; Joseph B Selvanayagam; Magid Fahim; Jonathan M Gleadle; Majo X. Joseph; Sau Lee

doi:10.1016/j.ahj.2018.07.023

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD): Rationale and design

Sripal Bangalore, David J. Maron, Jerome L. Fleg, Sean M. O'Brien, Charles A. Herzog, Gregg W. Stone, Daniel B. Mark, John A. Spertus, Karen P. Alexander, Mandeep S. Sidhu, Glenn M. Chertow, William E. Boden, Judith S. Hochman, The ISCHEMIA-CKD Research Group, Joseph B Selvanayagam, Magid Fahim, Jonathan M Gleadle, Majo X. Joseph, Sau Lee

College of Medicine and Public Health

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

27 Citations (Scopus)

Abstract

Background: Patients with chronic kidney disease (CKD) and stable ischemic heart disease are at markedly increased risk of cardiovascular events. Prior trials comparing a strategy of optimal medical therapy (OMT) with or without revascularization have largely excluded patients with advanced CKD. Whether a routine invasive approach when compared with a conservative strategy is beneficial in such patients is unknown. Methods: ISCHEMIA-CKD is a National Heart, Lung, and Blood Institute–funded randomized trial designed to determine the comparative effectiveness of an initial invasive strategy (cardiac catheterization and optimal revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] plus OMT) versus a conservative strategy (OMT alone, with cardiac catheterization and revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] reserved for failure of OMT) on long-term clinical outcomes in 777 patients with advanced CKD (defined as those with estimated glomerular filtration rate <30 mL/min/1.73m² or on dialysis) and moderate or severe ischemia on stress testing. Participants were randomized in a 1:1 fashion to the invasive or a conservative strategy. The primary end point is a composite of death or nonfatal myocardial infarction. Major secondary endpoints are a composite of death, nonfatal myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest; angina control; and disease-specific quality of life. Safety outcomes such as initiation of maintenance dialysis and a composite of initiation of maintenance dialysis or death will be reported. The trial is projected to have 80% power to detect a 22% to 24% reduction in the primary composite end point with the invasive strategy when compared with the conservative strategy. Conclusions: ISCHEMIA-CKD will determine whether an initial invasive management strategy improves clinical outcomes when added to OMT in patients with advanced CKD and stable ischemic heart disease.

Original language	English
Pages (from-to)	42-52
Number of pages	11
Journal	American Heart Journal
Volume	205
DOIs	https://doi.org/10.1016/j.ahj.2018.07.023
Publication status	Published - Nov 2018

Keywords

stable ischemic heart disease
cardiovascular events
optimal medical therapy (OMT)

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Bangalore, S., Maron, D. J., Fleg, J. L., O'Brien, S. M., Herzog, C. A., Stone, G. W., Mark, D. B., Spertus, J. A., Alexander, K. P., Sidhu, M. S., Chertow, G. M., Boden, W. E., Hochman, J. S., The ISCHEMIA-CKD Research Group, Selvanayagam, J. B., Fahim, M., Gleadle, J. M., Joseph, M. X., & Lee, S. (2018). International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD): Rationale and design. American Heart Journal, 205, 42-52. https://doi.org/10.1016/j.ahj.2018.07.023

Bangalore, Sripal ; Maron, David J. ; Fleg, Jerome L. ; O'Brien, Sean M. ; Herzog, Charles A. ; Stone, Gregg W. ; Mark, Daniel B. ; Spertus, John A. ; Alexander, Karen P. ; Sidhu, Mandeep S. ; Chertow, Glenn M. ; Boden, William E. ; Hochman, Judith S. ; The ISCHEMIA-CKD Research Group ; Selvanayagam, Joseph B ; Fahim, Magid ; Gleadle, Jonathan M ; Joseph, Majo X. ; Lee, Sau. / International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD) : Rationale and design. In: American Heart Journal. 2018 ; Vol. 205. pp. 42-52.

@article{67d69e95194d49c0b9e98026cdde32da,

title = "International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD): Rationale and design",

abstract = "Background: Patients with chronic kidney disease (CKD) and stable ischemic heart disease are at markedly increased risk of cardiovascular events. Prior trials comparing a strategy of optimal medical therapy (OMT) with or without revascularization have largely excluded patients with advanced CKD. Whether a routine invasive approach when compared with a conservative strategy is beneficial in such patients is unknown. Methods: ISCHEMIA-CKD is a National Heart, Lung, and Blood Institute–funded randomized trial designed to determine the comparative effectiveness of an initial invasive strategy (cardiac catheterization and optimal revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] plus OMT) versus a conservative strategy (OMT alone, with cardiac catheterization and revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] reserved for failure of OMT) on long-term clinical outcomes in 777 patients with advanced CKD (defined as those with estimated glomerular filtration rate <30 mL/min/1.73m2 or on dialysis) and moderate or severe ischemia on stress testing. Participants were randomized in a 1:1 fashion to the invasive or a conservative strategy. The primary end point is a composite of death or nonfatal myocardial infarction. Major secondary endpoints are a composite of death, nonfatal myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest; angina control; and disease-specific quality of life. Safety outcomes such as initiation of maintenance dialysis and a composite of initiation of maintenance dialysis or death will be reported. The trial is projected to have 80% power to detect a 22% to 24% reduction in the primary composite end point with the invasive strategy when compared with the conservative strategy. Conclusions: ISCHEMIA-CKD will determine whether an initial invasive management strategy improves clinical outcomes when added to OMT in patients with advanced CKD and stable ischemic heart disease.",

keywords = "stable ischemic heart disease, cardiovascular events, optimal medical therapy (OMT)",

author = "Sripal Bangalore and Maron, {David J.} and Fleg, {Jerome L.} and O'Brien, {Sean M.} and Herzog, {Charles A.} and Stone, {Gregg W.} and Mark, {Daniel B.} and Spertus, {John A.} and Alexander, {Karen P.} and Sidhu, {Mandeep S.} and Chertow, {Glenn M.} and Boden, {William E.} and Hochman, {Judith S.} and {The ISCHEMIA-CKD Research Group} and Roy Mathew and Krishnan, {Mavil S.} and Milliken, {Jeffrey C.} and Patel, {Pranev M.} and Seto, {Arnold H.} and Harley, {Kevin T.} and Gibson, {Michael A.} and Allen, {Byron J.} and Lau, {Wei Ling} and Shirin Heydari and Edgar Karanjah and Marfori, {Wanda C.} and Eduardo Hernandez_Rangel and Pam Singh and Patricia Pellikka and Hickson, {LaTonya J.} and Gaylin Petty and Milbrandt, {Susan K.} and Shelstad, {Dawn D.} and Reynolds, {Harmony R.} and Newman, {Jonathan D.} and Phillips, {Lawrence M.} and Muhamed Saric and Olga Zhdanova and Cobos, {Stanley E.} and Quiles, {Kirsten J.} and Dwyer, {Raven R.} and Dalisa Espinosa and Kreton Mavromatis and Jason Linesfsky and Harold Franch and John Doan and Raven Lee and Risha Patel and Anjali Acharya and Seth Sokol and Jay Meisner and Amit Kakkar and Tarek Rashid and Hatem Elabd and Jeanne Russo and Cidney Schultz and Mengistu Simegn and Shari Mackedanz and Barbara Wicklund and Costa, {Salvatore P.} and Terrance Welch and Michael Chobanian and Stokes, {Henry C.} and Subhash Banerjee and Preeti Kamath and Ishita Tejani and Abedayo Adeboye and Amy Flowers and Kathryn Mason and Anjana Rishmawi and Hegde, {Sudhanva S.} and Gruber, {Carolyn J.} and Durfee, {Noelle M.} and Khaled Abdul-Nour and Lalathaksha Kumbar and Jerry Yee and Heather Golden and Ogletree, {Naima L.} and Schawana Thaxton and Alec Moorman and Bilal Malik and Fatima Ranjbaran and Bryn Smith and Radmilar Lyubarova and Mohammad El-Hajjar and Fein, {Steven A.} and Torosoff, {Mikhail T.} and Sulagna Mookherjee and Krzysztof Drzymalski and Rafia Chaudhry and Khrisnakumar Hongalgi and Arif Asif and Loay Salman and Stewart, {Wendy L.} and Salmi, {Kristin M.} and Nguyen, {Patricia K.} and Yiming Lit and Davis Vo and James Hirsch and Sedis, {Stephen P.} and Donnino, {Robert M.} and Jeffrey Lorin and David Goldfarb and Maranan, {Leandro C.} and {Der Mesropian}, Paul and Joseph Sacco and Naveed Akhtar and Maris Orgera and Elvira Gosmanova and Jennifer Thomson and Fadi Hage and Dana Rizk and Davies, {James E.} and Massoud Leesar and Jaekyeong Heo and Amy Iskandrian and {Al Solaiman}, Firas and Satinder Singh and Badhma Valalyapathi and Stone, {Peter H.} and Charytan, {David M.} and Hermine Osseni and Charlene Wiyarand and Peter Douglass and Hayley Pomeroy and Alexandra Craft and Bethany Harvey and Kevin Marzo and Juan Gaztanaga and Shayan Shirazian and Wendy Drewes and Dipti Patel and Lekshmi Dharmarajan and Jose, {Jenne M.} and Janani Rangaswami and Christian Witzke and Gregg Pressman and Rachel Murphy and Kinnari Murphy and Kostis, {John B.} and Moreyra, {Abel E.} and Jonathan Lebowitz and Cosgrove, {Nora M.} and Lader, {Ellis W.} and Beth Stefanchik and Martha Meyer and Sampoornima Setty and Balaji Srinivasan and Halverson, {Kimberly E.} and Christine Roraff and Jonean Thorsen and Rita Coram and Webb, {Anne Marie} and Ellie Fridell and Heidi Wilson and David Booth and John Kotter and Ahmed Abdel-Latif and Sadiq Ahmed and Yvonne Taul and Caroline Rodgers and Jennifer Isaacs and Viktoria Bulkley and Laura True and Alexandra Hunter and Michelle Ratliff and Karen Servilla and Robyn Elliott and Jennifer Hogan and Jang, {James J.} and Gennie Yee and Deepa Ramaswamy and Olivia Anaya and Khouri, {Michel Georges} and John Middleton and Kristine Arges and Melissa LeFevre and Jennifer Tomfohr and Call, {Jason T.} and David Sisson and Lane, {Stephanie, M.} and Stanford, {Jennifer L.} and Prakash Deedwania and Kiran Reddy and Mei Hwang and Antonia Vega and Steven Weitz and Page Salanger and Steven Giovannone and Lori Pritchard and Ray Wyman and Joy Burkhardt and Suellen Hosino and Khaled Dajani and Holly Mattix-Kramer and Verghese Mathew and Kartje, {Carol M.} and Shapiro, {Michael D.} and Jose Rueda and Aynun Naher and David Schlichting and Omar Almousalli and John Lehman and Norbert Urbanski and Elizabeth Capasso-Gulve and Loehr, {Alaine Melanie} and Marlowe Mosley and Olga Bockeria and Evgeny Shutov and Chernyavskiy, {Alexander M.} and Kretov, {Evgeniy I.} and Grazhdankin, {Igor O.} and Borisov, {Alexander Sergeevich} and Naryshkin, {Ivan A.} and Bockeria, {Leo A.} and Karen Petrosyan and Zalina Kudzoeva and Bershtein, {Leonid L.} and Sayganov, {Sergey A.} and Kuzmina-Krutetskaya, {Anastasia M.} and Zbyshevskaya, {Elizaveta V.} and Katamadze, {Nana O.} and Vladimir Ryasniansky and Irina Subbotina and Victoria Gumerova and Radoslaw Pracon and Marcin Demkow and Robert Malecki and Tomasz Mazurek and Karolina Wojtera and Anna Fojt and Ewa Szczerba and Jakub Maksym and Piotr Pruszczyk and Marek Roik and Andrzej {\L}abyk and Agnieszka Szramowska and Olga Zdo{\'n}czyk and Cezary Kepka and Anna Teresinska and Karolina Kryczka and Jan Henzel and Mateusz Solecki and Edyta Kaczmarska and Olga Walesiak and Katarzyna Malinowska and Jaroslaw Drozdz and Marta Swiderek and Selvanayagam, {Joseph B} and Magid Fahim and Gleadle, {Jonathan M} and Joseph, {Majo X.} and Sau Lee",

year = "2018",

month = nov,

doi = "10.1016/j.ahj.2018.07.023",

language = "English",

volume = "205",

pages = "42--52",

journal = "American Heart Journal",

issn = "0002-8703",

}

Bangalore, S, Maron, DJ, Fleg, JL, O'Brien, SM, Herzog, CA, Stone, GW, Mark, DB, Spertus, JA, Alexander, KP, Sidhu, MS, Chertow, GM, Boden, WE, Hochman, JS, The ISCHEMIA-CKD Research Group, Selvanayagam, JB, Fahim, M, Gleadle, JM, Joseph, MX & Lee, S 2018, 'International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD): Rationale and design', American Heart Journal, vol. 205, pp. 42-52. https://doi.org/10.1016/j.ahj.2018.07.023

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD) : Rationale and design. / Bangalore, Sripal; Maron, David J.; Fleg, Jerome L.; O'Brien, Sean M.; Herzog, Charles A.; Stone, Gregg W.; Mark, Daniel B.; Spertus, John A.; Alexander, Karen P.; Sidhu, Mandeep S.; Chertow, Glenn M.; Boden, William E.; Hochman, Judith S.; The ISCHEMIA-CKD Research Group ; Selvanayagam, Joseph B; Fahim, Magid; Gleadle, Jonathan M; Joseph, Majo X.; Lee, Sau.

In: American Heart Journal, Vol. 205, 11.2018, p. 42-52.

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

TY - JOUR

T1 - International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD)

T2 - Rationale and design

AU - Bangalore, Sripal

AU - Maron, David J.

AU - Fleg, Jerome L.

AU - O'Brien, Sean M.

AU - Herzog, Charles A.

AU - Stone, Gregg W.

AU - Mark, Daniel B.

AU - Spertus, John A.

AU - Alexander, Karen P.

AU - Sidhu, Mandeep S.

AU - Chertow, Glenn M.

AU - Boden, William E.

AU - Hochman, Judith S.

AU - The ISCHEMIA-CKD Research Group

AU - Mathew, Roy

AU - Krishnan, Mavil S.

AU - Milliken, Jeffrey C.

AU - Patel, Pranev M.

AU - Seto, Arnold H.

AU - Harley, Kevin T.

AU - Gibson, Michael A.

AU - Allen, Byron J.

AU - Lau, Wei Ling

AU - Heydari, Shirin

AU - Karanjah, Edgar

AU - Marfori, Wanda C.

AU - Hernandez_Rangel, Eduardo

AU - Singh, Pam

AU - Pellikka, Patricia

AU - Hickson, LaTonya J.

AU - Petty, Gaylin

AU - Milbrandt, Susan K.

AU - Shelstad, Dawn D.

AU - Reynolds, Harmony R.

AU - Newman, Jonathan D.

AU - Phillips, Lawrence M.

AU - Saric, Muhamed

AU - Zhdanova, Olga

AU - Cobos, Stanley E.

AU - Quiles, Kirsten J.

AU - Dwyer, Raven R.

AU - Espinosa, Dalisa

AU - Mavromatis, Kreton

AU - Linesfsky, Jason

AU - Franch, Harold

AU - Doan, John

AU - Lee, Raven

AU - Patel, Risha

AU - Acharya, Anjali

AU - Sokol, Seth

AU - Meisner, Jay

AU - Kakkar, Amit

AU - Rashid, Tarek

AU - Elabd, Hatem

AU - Russo, Jeanne

AU - Schultz, Cidney

AU - Simegn, Mengistu

AU - Mackedanz, Shari

AU - Wicklund, Barbara

AU - Costa, Salvatore P.

AU - Welch, Terrance

AU - Chobanian, Michael

AU - Stokes, Henry C.

AU - Banerjee, Subhash

AU - Kamath, Preeti

AU - Tejani, Ishita

AU - Adeboye, Abedayo

AU - Flowers, Amy

AU - Mason, Kathryn

AU - Rishmawi, Anjana

AU - Hegde, Sudhanva S.

AU - Gruber, Carolyn J.

AU - Durfee, Noelle M.

AU - Abdul-Nour, Khaled

AU - Kumbar, Lalathaksha

AU - Yee, Jerry

AU - Golden, Heather

AU - Ogletree, Naima L.

AU - Thaxton, Schawana

AU - Moorman, Alec

AU - Malik, Bilal

AU - Ranjbaran, Fatima

AU - Smith, Bryn

AU - Lyubarova, Radmilar

AU - El-Hajjar, Mohammad

AU - Fein, Steven A.

AU - Torosoff, Mikhail T.

AU - Mookherjee, Sulagna

AU - Drzymalski, Krzysztof

AU - Chaudhry, Rafia

AU - Hongalgi, Khrisnakumar

AU - Asif, Arif

AU - Salman, Loay

AU - Stewart, Wendy L.

AU - Salmi, Kristin M.

AU - Nguyen, Patricia K.

AU - Lit, Yiming

AU - Vo, Davis

AU - Hirsch, James

AU - Sedis, Stephen P.

AU - Donnino, Robert M.

AU - Lorin, Jeffrey

AU - Goldfarb, David

AU - Maranan, Leandro C.

AU - Der Mesropian, Paul

AU - Sacco, Joseph

AU - Akhtar, Naveed

AU - Orgera, Maris

AU - Gosmanova, Elvira

AU - Thomson, Jennifer

AU - Hage, Fadi

AU - Rizk, Dana

AU - Davies, James E.

AU - Leesar, Massoud

AU - Heo, Jaekyeong

AU - Iskandrian, Amy

AU - Al Solaiman, Firas

AU - Singh, Satinder

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AU - Charytan, David M.

AU - Osseni, Hermine

AU - Wiyarand, Charlene

AU - Douglass, Peter

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AU - Craft, Alexandra

AU - Harvey, Bethany

AU - Marzo, Kevin

AU - Gaztanaga, Juan

AU - Shirazian, Shayan

AU - Drewes, Wendy

AU - Patel, Dipti

AU - Dharmarajan, Lekshmi

AU - Jose, Jenne M.

AU - Rangaswami, Janani

AU - Witzke, Christian

AU - Pressman, Gregg

AU - Murphy, Rachel

AU - Murphy, Kinnari

AU - Kostis, John B.

AU - Moreyra, Abel E.

AU - Lebowitz, Jonathan

AU - Cosgrove, Nora M.

AU - Lader, Ellis W.

AU - Stefanchik, Beth

AU - Meyer, Martha

AU - Setty, Sampoornima

AU - Srinivasan, Balaji

AU - Halverson, Kimberly E.

AU - Roraff, Christine

AU - Thorsen, Jonean

AU - Coram, Rita

AU - Webb, Anne Marie

AU - Fridell, Ellie

AU - Wilson, Heidi

AU - Booth, David

AU - Kotter, John

AU - Abdel-Latif, Ahmed

AU - Ahmed, Sadiq

AU - Taul, Yvonne

AU - Rodgers, Caroline

AU - Isaacs, Jennifer

AU - Bulkley, Viktoria

AU - True, Laura

AU - Hunter, Alexandra

AU - Ratliff, Michelle

AU - Servilla, Karen

AU - Elliott, Robyn

AU - Hogan, Jennifer

AU - Jang, James J.

AU - Yee, Gennie

AU - Ramaswamy, Deepa

AU - Anaya, Olivia

AU - Khouri, Michel Georges

AU - Middleton, John

AU - Arges, Kristine

AU - LeFevre, Melissa

AU - Tomfohr, Jennifer

AU - Call, Jason T.

AU - Sisson, David

AU - Lane, Stephanie, M.

AU - Stanford, Jennifer L.

AU - Deedwania, Prakash

AU - Reddy, Kiran

AU - Hwang, Mei

AU - Vega, Antonia

AU - Weitz, Steven

AU - Salanger, Page

AU - Giovannone, Steven

AU - Pritchard, Lori

AU - Wyman, Ray

AU - Burkhardt, Joy

AU - Hosino, Suellen

AU - Dajani, Khaled

AU - Mattix-Kramer, Holly

AU - Mathew, Verghese

AU - Kartje, Carol M.

AU - Shapiro, Michael D.

AU - Rueda, Jose

AU - Naher, Aynun

AU - Schlichting, David

AU - Almousalli, Omar

AU - Lehman, John

AU - Urbanski, Norbert

AU - Capasso-Gulve, Elizabeth

AU - Loehr, Alaine Melanie

AU - Mosley, Marlowe

AU - Bockeria, Olga

AU - Shutov, Evgeny

AU - Chernyavskiy, Alexander M.

AU - Kretov, Evgeniy I.

AU - Grazhdankin, Igor O.

AU - Borisov, Alexander Sergeevich

AU - Naryshkin, Ivan A.

AU - Bockeria, Leo A.

AU - Petrosyan, Karen

AU - Kudzoeva, Zalina

AU - Bershtein, Leonid L.

AU - Sayganov, Sergey A.

AU - Kuzmina-Krutetskaya, Anastasia M.

AU - Zbyshevskaya, Elizaveta V.

AU - Katamadze, Nana O.

AU - Ryasniansky, Vladimir

AU - Subbotina, Irina

AU - Gumerova, Victoria

AU - Pracon, Radoslaw

AU - Demkow, Marcin

AU - Malecki, Robert

AU - Mazurek, Tomasz

AU - Wojtera, Karolina

AU - Fojt, Anna

AU - Szczerba, Ewa

AU - Maksym, Jakub

AU - Pruszczyk, Piotr

AU - Roik, Marek

AU - Łabyk, Andrzej

AU - Szramowska, Agnieszka

AU - Zdończyk, Olga

AU - Kepka, Cezary

AU - Teresinska, Anna

AU - Kryczka, Karolina

AU - Henzel, Jan

AU - Solecki, Mateusz

AU - Kaczmarska, Edyta

AU - Walesiak, Olga

AU - Malinowska, Katarzyna

AU - Drozdz, Jaroslaw

AU - Swiderek, Marta

AU - Selvanayagam, Joseph B

AU - Fahim, Magid

AU - Gleadle, Jonathan M

AU - Joseph, Majo X.

AU - Lee, Sau

PY - 2018/11

Y1 - 2018/11

N2 - Background: Patients with chronic kidney disease (CKD) and stable ischemic heart disease are at markedly increased risk of cardiovascular events. Prior trials comparing a strategy of optimal medical therapy (OMT) with or without revascularization have largely excluded patients with advanced CKD. Whether a routine invasive approach when compared with a conservative strategy is beneficial in such patients is unknown. Methods: ISCHEMIA-CKD is a National Heart, Lung, and Blood Institute–funded randomized trial designed to determine the comparative effectiveness of an initial invasive strategy (cardiac catheterization and optimal revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] plus OMT) versus a conservative strategy (OMT alone, with cardiac catheterization and revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] reserved for failure of OMT) on long-term clinical outcomes in 777 patients with advanced CKD (defined as those with estimated glomerular filtration rate <30 mL/min/1.73m2 or on dialysis) and moderate or severe ischemia on stress testing. Participants were randomized in a 1:1 fashion to the invasive or a conservative strategy. The primary end point is a composite of death or nonfatal myocardial infarction. Major secondary endpoints are a composite of death, nonfatal myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest; angina control; and disease-specific quality of life. Safety outcomes such as initiation of maintenance dialysis and a composite of initiation of maintenance dialysis or death will be reported. The trial is projected to have 80% power to detect a 22% to 24% reduction in the primary composite end point with the invasive strategy when compared with the conservative strategy. Conclusions: ISCHEMIA-CKD will determine whether an initial invasive management strategy improves clinical outcomes when added to OMT in patients with advanced CKD and stable ischemic heart disease.

AB - Background: Patients with chronic kidney disease (CKD) and stable ischemic heart disease are at markedly increased risk of cardiovascular events. Prior trials comparing a strategy of optimal medical therapy (OMT) with or without revascularization have largely excluded patients with advanced CKD. Whether a routine invasive approach when compared with a conservative strategy is beneficial in such patients is unknown. Methods: ISCHEMIA-CKD is a National Heart, Lung, and Blood Institute–funded randomized trial designed to determine the comparative effectiveness of an initial invasive strategy (cardiac catheterization and optimal revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] plus OMT) versus a conservative strategy (OMT alone, with cardiac catheterization and revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] reserved for failure of OMT) on long-term clinical outcomes in 777 patients with advanced CKD (defined as those with estimated glomerular filtration rate <30 mL/min/1.73m2 or on dialysis) and moderate or severe ischemia on stress testing. Participants were randomized in a 1:1 fashion to the invasive or a conservative strategy. The primary end point is a composite of death or nonfatal myocardial infarction. Major secondary endpoints are a composite of death, nonfatal myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest; angina control; and disease-specific quality of life. Safety outcomes such as initiation of maintenance dialysis and a composite of initiation of maintenance dialysis or death will be reported. The trial is projected to have 80% power to detect a 22% to 24% reduction in the primary composite end point with the invasive strategy when compared with the conservative strategy. Conclusions: ISCHEMIA-CKD will determine whether an initial invasive management strategy improves clinical outcomes when added to OMT in patients with advanced CKD and stable ischemic heart disease.

KW - stable ischemic heart disease

KW - cardiovascular events

KW - optimal medical therapy (OMT)

UR - http://www.scopus.com/inward/record.url?scp=85052473569&partnerID=8YFLogxK

UR - https://www.nejm.org/doi/suppl/10.1056/NEJMoa1915925/suppl_file/nejmoa1915925_appendix.pdf

U2 - 10.1016/j.ahj.2018.07.023

DO - 10.1016/j.ahj.2018.07.023

M3 - Article

C2 - 30172098

AN - SCOPUS:85052473569

VL - 205

SP - 42

EP - 52

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD): Rationale and design

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