What is the ISCHEMIA Trial?
- An NHLBI-funded international comparative effectiveness trial to determine the best way to treat chronic coronary disease.
- Patients with moderate or severe ischemia, with or without stress imaging, were eligible for participation.
What is the ISCHEMIA-CKD Trial?
- An international comparative effectiveness trial to determine the best way to manage chronic coronary disease in patients with advanced chronic kidney disease (eGFR <30 or on dialysis).
- Patients with advanced CKD with moderate to severe ischemia on stress testing were randomized to this Trial.
What is ISCHEMIA-EXTEND?
- ISCHEMIA-EXTEND is the long-term follow-up of randomized, surviving participants in the ISCHEMIA and ISCHEMIA-CKD trials.
- ISCHEMIA-EXTEND assesses whether an initial invasive strategy—cardiac catheterization and revascularization when feasible plus optimal medical therapy (OMT)—reduces long-term all-cause mortality as compared with an initial conservative strategy of OMT for chronic coronary disease patients with moderate or severe ischemia over an extended 5 year period of follow-up.
Why is the ISCHEMIA Trial Important?
- Chronic coronary disease is the leading cause of death and disability worldwide and affects an estimated 18,200,000 Americans, resulting in about 541,000 deaths in the United States annually. Globally, 8.9 million deaths are caused by IHD each year. Medical therapy (medication and lifestyle changes) should always be used to treat IHD. The trial showed that heart procedures added to taking medicines and making lifestyle changes did not reduce the overall rate of cardiovascular death and heart attack compared with medicines and lifestyle changes alone. However, for people with chest pain symptoms, heart procedures improved symptoms better than medicines and lifestyle changes alone. The more chest pain to begin with, the more symptoms improved after getting a stent or bypass surgery.
- For ISCHEMIA Trial Results, please click here.
Why is ISCHEMIA-EXTEND Important?
- The ISCHEMIA and ISCHEMIA-CKD trials did not demonstrate a reduction in their primary endpoints with an initial invasive strategy. All-cause mortality was similar over 5 years. There was an early excess of peri-procedural MI and a late reduction in spontaneous MI in both trials. Prior evidence demonstrates that spontaneous MI has a larger impact on subsequent death than most peri-procedural MI’s. Therefore, it is imperative to assess long-term all-cause mortality to provide patients and clinicians with robust evidence regarding survival following the two initial management strategies over the long-term (~10 years).
- Understanding the impact of nonfatal events on subsequent mortality among patients with chronic coronary disease will influence clinical practice and the design of cardiovascular clinical trials for years to come. With the ever-increasing sensitivity of biomarker assays for MI, it is of paramount importance to understand the relationship between MI and subsequent death.
Total Number of Participants in ISCHEMIA-EXTEND:
- Over 5,000 participants worldwide entered ISCHEMIA-EXTEND when this follow-up trial began. Click here to see the participants by country.
Upcoming ISCHEMIA Presentations
- No upcoming presentations at this time.
Recent ISCHEMIA Presentations from ACC.2023
- International Comparisons of Health Status Benefits in Patients Undergoing Initial Invasive Versus Conservative Management for Chronic Coronary Disease: Insights from the ISCH. (Oral presentation by Dr. Nobuhiro Ikemura) Link
For more Presentations, please CLICK HERE.
Recent ISCHEMIA Publications
- Nguyen DD, Spertus JA, Alexander KP, Newman JD, Dodson JA, Jones PG, Stevens SR, O’Brien SM, Gamma R, Perna GP, Garg P, Vitola JV, Chow BJW, Vertes A, White HD, Smanio PEP, Senior R, Held C, Li J, Boden WE, Mark DB, Reynolds HR, Bangalore S, Chan PS, Stone GW, Arnold SV, Maron DJ, Hochman JS. Health status and clinical outcomes in older adults with chronic coronary disease. Journal of the American College of Cardiology. 2023;81:1697–1709. Link
- Sidhu MS, Alexander KP, Huang Z, Mathew RO, Newman JD, O'Brien SM, Pellikka PA, Lyubarova R, Bockeria O, Briguori C, Kretov EL, Mazurek T, Orso F, Roik MF, Sajeev C, Shutov EV, Rockhold FW, Borrego D, Balter S, Stone GW, Chaitman BR, Goodman SG, Fleg JL, Reynolds HR, Maron DJ, Hochman JS, Bangalore S on behalf of the ISCHEMIA-CKD Research Group. Cause-Specific Mortality in Patients with Advanced Chronic Kidney Disease in the ISCHEMIA-CKD Trial. JACC: Cardiovascular Intervantions 2023 Jan 24. Link
- 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, Pracon R, Lopez-Sendon 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 on behalf of the ISCHEMIA-EXTEND Research Group. Survival After Invasive or Conservative Management of Stable Coronary Disease. AHA Journals. 2022 Nov 06. Link
- Mavromatis K, Boden WE, Maron DJ, Mancini GBJ, Wientraub WS, Gosselin G, Berman DS, Shaw LS, Spertus JA, Hochman JS. Comparison of Outcomes of Invasive or Conservative Management of Chronic Coronary Disease in Four Randomized Controlled Trials. The American Journal of Cardiology. 2022 Oct 15. Link
- Anthopolos R, Maron DJ, Bangalore S, Reynolds HR, Xu Y, O'Brien SM, Troxel AB, Mavromichalis S, Chang M, Contreras A, Hochman JS on behalf of ISCHEMIA-EXTEND Research Group. American Heart Journal. 2022 Oct 04. Link
For more Publications, please CLICK HERE.