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ISCHEMIA-EXTEND studies: Rationale and design.

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Long-term outcomes of invasive versus conservative strategies for chronic coronary disease are unclear. ISCHEMIA-EXTEND and ISCHEMIA-CKD EXTEND will assess mortality differences, informing clinical practice and policy.

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Area of Science:

  • Cardiology
  • Clinical Trials
  • Nephrology

Background:

  • ISCHEMIA and ISCHEMIA-CKD trials showed no significant difference in primary endpoints between invasive and conservative management for chronic coronary disease with or without CKD.
  • While ISCHEMIA noted lower CV mortality but higher non-CV mortality with invasive strategy, long-term effects on overall mortality remain uncertain.
  • ISCHEMIA-CKD found similar mortality rates between treatment groups during follow-up.

Purpose of the Study:

  • To assess the long-term effects of initial invasive versus conservative management strategies on all-cause, cardiovascular, and non-cardiovascular mortality.
  • To increase precision around treatment effect estimates for mortality risk in patients with chronic coronary disease.
  • To inform clinical practice, guidelines, and health policy regarding invasive vs. conservative management.

Main Methods:

  • ISCHEMIA-EXTEND: Long-term follow-up (median 10 years) of ISCHEMIA trial participants (n=5,179) randomized to invasive or conservative management.
  • ISCHEMIA-CKD EXTEND: Long-term follow-up (median 9 years) of ISCHEMIA-CKD trial participants (n=777) with advanced CKD.
  • Mortality ascertainment via participant contact, medical records, and vital status registries; Bayesian survival modeling will be used.

Main Results:

  • The primary clinical endpoint showed no statistical difference between initial invasive and conservative management in ISCHEMIA and ISCHEMIA-CKD.
  • An invasive strategy in ISCHEMIA was associated with increased peri-procedural MI but decreased spontaneous MI.
  • Long-term mortality differences between invasive and conservative strategies are yet to be determined by the EXTEND studies.

Conclusions:

  • The long-term impact of invasive versus conservative strategies on mortality in chronic coronary disease patients will be evaluated.
  • Findings from ISCHEMIA-EXTEND and ISCHEMIA-CKD EXTEND are expected to guide patient care, clinical decision-making, and health policy.
  • These extended follow-up studies aim to clarify the ultimate benefits and risks of early invasive management.