We are pleased to announce that the ISCHEMIA Trials have been recognized by the New England Journal of Medicine and by the Clinical Research Forum!
The ISCHEMIA main results publication was selected by NEJM editors as one of the most notable studies published in 2020. It was one of 14 studies designated by the editors as being the most meaningful in changing medical practice and impacting patient care in 2020.
Concurrently, NEJM Journal Watch Cardiology selected ISCHEMIA and ISCHEMIA-CKD as their 2020 Top Stories. https://www.jwatch.org/na52906/2020/12/30/nejm-journal-watch-cardiology-2020-top-stories An excerpt from their announcement:
“Our top story is the same as last year's, the ISCHEMIA trial. Last year, we felt compelled to choose it, even as we awaited publication of the study. With its publication this year, we are again ranking it at the top. This trial is indeed game-changing, even as some people debate it around the edges. Its main finding was that an invasive strategy for patients with stable ischemic heart disease did not improve survival or reduce the risk for myocardial infarction (MI). We also have selected the substudy focusing on patients with chronic kidney disease, in whom the invasive strategy did not confer a benefit in clinical outcomes or health status.”
The original Journal Watch story from March 2020 can be found here: https://www.jwatch.org/na51208/2020/03/30/medical-therapy-vs-invasive-strategy-stable-ischemic-heart. It provides an excellent synopsis of the main trial clinical and quality of life outcomes.
Finally, ISCHEMIA has been selected to receive a Clinical Research Forum 2021 Top 10 Clinical Research Achievement Award. The Top 10 Awards honor outstanding accomplishments in clinical research. The winning projects identify major advances resulting from the nation’s investment in research to benefit the health and welfare of its citizens. These projects represent innovation, creativity and scientific advancement; contribute to the understanding of human disease, and demonstrate impact on the prevention, diagnosis and treatment or increased understanding of the disease state.
The ISCHEMIA Trials represent the best of team science. All ISCHEMIA and ISCHEMIA-CKD research teams around the world should be proud of the recognition the trials have received.
What is the ISCHEMIA Study?
- An NHLBI-funded international comparative effectiveness study 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 Study?
- An international comparative effectiveness study 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 Study.
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 Study 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 Study 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 study began. Click here to see the participants by country.
Upcoming ISCHEMIA Presentations
Stay tuned for announcements regarding upcoming ISCHEMIA presentations!
Recent ISCHEMIA Presentations from ACC.21
- Impact of Completeness of Revascularization on Clinical Outcomes in Patients With Stable Ischemic Heart Disease Treated With an Invasive Versus Conservative Strategy. (Presented by Dr. Gregg W. Stone) (LBCT) Link
For more Presentations, please CLICK HERE.
Recent ISCHEMIA Publications
- Lopes RD, Alexander KP, Hochman JS, Maron DJ. Response by Lopes et al to Letter Regarding Article, "Initial Invasive Versus Conservative Management of Stable Ischemic Heart Disease Patients with a History of Heart Failure or Left Ventricular Dysfunction: Insights From the ISCHEMIA Trial." Circulation. 2021;143:e961–e962. Link
- Herzog CA, Simegn MA, Xu Y, Costa SR, Mathew RO, El-Hajjar MC, Gulati S, Maldonado RA, Daugas E, Madero M, Fleg JL, Anthopolos R, Stone GW, Sidhu MS, Maron DJ, Hochman JS, Bangalore S. Kidney Transplant List Status and Outcomes in the ISCHEMIA-CKD Trial. J AM Coll Cardiol. May 11, 2021. Epublished DOI: 10.1016/j.jacc.2021.05.001 Link
- White HD, O’Brien SM, Alexander KP, Boden WE, Bangalore S, Li J, Manjunath CN, Lopez-Sendon JL, Peteiro J, Gosselin G, Berger JS, Maggioni AP, Reynolds HR, Hochman JS, Maron DJ. Comparison of Days Alive Out of Hospital With Initial Invasive vs Conservative Management: A Prespecified Analysis of the ISCHEMIA Trial. JAMA Cardiology. May 03 2021 Link
- Ali ZA, Horst J, Gaba P, Shaw LJ, Bangalore S, Hochman JS, Maron DJ, Moses JW, Alfonso MA, Madhavan MV, Dressler O, Reynolds HR, Stone GW. Standardizing the Definition and Analysis Methodology for Complete Coronary Artery Revascularization. J Am Heart Assoc. 2021;10:e020110. DOI: 10.1161/JAHA.120.020110 Link
- Chaitman BR, Alexander KP, Cyr DD, Berger JS, Reynolds HR, Bangalore S, Boden WE, Lopes RD, Demkow M, Piero Perna G, Riezebos RK, McFalls EO, Banerjee S, Bagai A, Gosselin G, O'Brien SM, Rockhold FW, Waters DD, Thygesen KA, Stone GW, White HD, Maron DJ, Hochman JS and Group IR. Myocardial Infarction in the ISCHEMIA Trial: Impact of Different Definitions on Incidence, Prognosis, and Treatment Comparisons. Circulation. 2021;143:790-804. Link
- Mancini GBJ, Leipsic J, Budoff MJ, Hague CJ, Min JK, Stevens SR, Reynolds HR, O'Brien SM, Shaw LJ, Manjunath CN, Mavromatis K, Demkow M, Lopez-Sendon JL, Chernavskiy AM, Gosselin G, Schuchlenz H, Devlin GP, Chauhan A, Bangalore S, Hochman JS, Maron DJ. Coronary CT Angiography Followed by Invasive Angiography in Patients With Moderate or Severe Ischemia-Insights From the ISCHEMIA Trial. JACC Cardiovasc Imaging. Jan 07 2021:S1936-878X(20)31019-6. doi: 10.1016/j.jcmg.2020.11.012. Epub ahead of print. PMID: 33454249. Link
For more Publications, please CLICK HERE.