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September 7, 2026Työväentutkimus VuosikirjaOpen Access

The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial

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Why the study?

It remains unclear how fractional flow reserve (FFR)-guided PCI affects hard clinical endpoints in STEMI patients with multivessel disease.

Does FFR-guided complete revascularization of non-culprit lesions reduce the combined endpoint of total mortality, non-fatal MI, and unplanned revascularization in STEMI patients with multivessel disease?

Population

1,545 STEMI patients with multivessel disease

Comparison

FFR-guided PCI of non-culprit lesions during index hospitalization vs initial conservative management

Design

Pragmatic, multicenter, international, registry-based randomized clinical trial

Follow-up

Estimated at least 2.75 years (event driven)

Key result

In STEMI patients with multivessel disease, FFR re-classified 20% of angiographically severe (90-99%) and 50% of intermediate (70-89%) non-culprit lesions as non-flow limiting.

Authors

FBFelix BöhmBMBrynjólfur MogensenOÖOllie Östlund

Discussion

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Overview

FFR-guided PCI in STEMI multivessel disease needs prospective validation; registry data leave open effects on hard endpoints.

Key Points

  • To evaluate whether Fractional Flow Reserve (FFR)-guided complete revascularization of non-culprit lesions during index hospitalization reduces major adverse cardiac events in STEMI patients with multivessel disease.
  • Pragmatic, multicenter, international, registry-based randomized clinical trial enrolling N=1,545 patients with STEMI and multivessel disease.
  • Patients were randomized to receive either FFR-guided PCI of non-culprit lesions during index hospitalization or initial conservative management.
  • Event-driven design with an estimated follow-up of at least 2.75 years, powered at 80% (alpha = .05) to detect a primary composite endpoint reduction from 9.9%/year to 7.425%/year (HR = 0.74).
  • FFR reclassified 1 in 5 (20%) angiographically severe non-culprit lesions (90%-99% severity) as non-flow limiting.
  • FFR reclassified half (50%) of intermediate severity non-culprit lesions (70%-89% severity) as non-flow limiting.
  • Primary endpoint assessment of total mortality, non-fatal myocardial infarction, and unplanned revascularization remains ongoing following completion of enrollment in September 2019.

Study Design

Type

RCT (n=1,545)

Randomization

randomized

Multicenter

Yes

Structured PICO

Does FFR-guided complete revascularization of non-culprit lesions reduce the combined endpoint of total mortality, non-fatal MI, and unplanned revascularization in STEMI patients with multivessel disease?

P
Population
1,545 STEMI patients with multivessel disease randomized to FFR-guided PCI or conservative management of non-culprit lesions, with an estimated follow-up of at least 2.75 years.
I
Intervention
FFR-guided percutaneous coronary intervention (PCI) for complete revascularization of non-culprit lesions during the index hospitalization
C
Comparator
Initial conservative management of non-culprit lesions
O
Outcome
Combined primary endpoint of total mortality, non-fatal MI and unplanned revascularizationcomposite

A significant proportion of angiographically severe and intermediate non-culprit lesions in STEMI patients are non-flow limiting by FFR, highlighting the potential value of FFR guidance for complete revascularization.

Cite This Study

Böhm et al. (2021) conducted an RCT in ST elevation myocardial infarction (STEMI) with multivessel disease (n=1,545). FFR-guided PCI of non-culprit lesions vs. initial conservative management of non-culprit lesions was evaluated on total mortality, non-fatal MI and unplanned revascularization. In STEMI patients with multivessel disease, FFR re-classified 20% of angiographically severe (90-99%) and 50% of intermediate (70-89%) non-culprit lesions as non-flow limiting.

synapsesocial.com/papers/6a9e63484decee5062e8abf5https://doi.org/10.1016/j.ahj.2021.07.007
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