Did the ischemia trial include patients who underwent coronary physiology studies, such as fractional flow reserve (FFR) measurements?

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ISCHEMIA Trial and Coronary Physiology Studies

Yes, the ISCHEMIA trial explicitly incorporated fractional flow reserve (FFR) measurements as part of its contemporary revascularization strategy to achieve complete ischemic revascularization. 1

FFR Integration in ISCHEMIA Trial Design

The ISCHEMIA trial was specifically designed to address limitations of previous strategy trials by using physiologically guided decision-making with FFR to achieve complete ischemic (rather than anatomic) revascularization. 1 This represented a key methodological advancement over earlier trials that relied solely on angiographic assessment.

Key Design Features

  • FFR was used to guide revascularization decisions in patients randomized to the invasive strategy, ensuring that only functionally significant lesions (those causing ischemia) were treated rather than all anatomically visible stenoses. 1

  • The trial employed contemporary drug-eluting stents combined with FFR-guided physiologic assessment as part of the optimal revascularization approach, distinguishing it from older trials that used bare-metal stents and angiography-alone strategies. 1

  • This physiologic guidance approach was implemented to minimize unnecessary revascularization procedures and focus treatment on lesions truly responsible for myocardial ischemia. 1

Rationale for FFR Use in ISCHEMIA

The incorporation of FFR into ISCHEMIA's design was based on strong evidence from the FAME trial, which demonstrated that:

  • FFR-guided PCI resulted in significantly lower composite event rates (13.2%) compared to angiography-guided PCI (18.3%, P=0.02) at 1 year. 1

  • FFR assessment led to fewer stents being placed (1.9±1.3 vs 2.7±1.2, P<0.001) by identifying that 37% of angiographically significant lesions had FFR >0.80 and were not functionally significant. 1

  • Systematic FFR assessment in multivessel disease improved clinical outcomes compared to angiographic assessment alone, establishing FFR as a superior strategy for determining which lesions require intervention. 1

Clinical Context

  • The ISCHEMIA trial used FFR with a threshold of ≤0.80 to define functionally significant stenoses requiring revascularization, consistent with contemporary guidelines and the established ischemic threshold. 1, 2

  • This approach aligns with Class I and Class IIa guideline recommendations for FFR-guided management in stable coronary artery disease. 1

  • The trial's design recognized that visual angiographic assessment correlates poorly with physiological significance, making FFR essential for optimal decision-making in patients with moderate-to-severe stenoses. 1

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

2
Guideline

Fractional Flow Reserve (FFR) in Angioplasty

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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