Changes in non-culprit coronary lesions with PCSK9 inhibitors: the randomised, placebo-controlled FITTER trial
Authors' conclusion
In patients with ACS and relevant non-culprit coronary artery lesions, the addition of evolocumab to HIST for 12 weeks, compared to placebo, did not result in improvement of FFR or maxLCBI4mm. (ClinicalTrials.gov: NCT04141579).
Study context
- Population
- Patients with an acute coronary syndrome (ACS) and relevant multivessel disease, with relevant non-culprit coronary artery lesionsrandomised, 143 underwent follow-up coronary angiography
- Participants
- 150 patients
- Comparison
- Evolocumab or placebo for 12 weeks in addition to high-intensity statin therapy (HIST)
- Evolocumabn = 74
- Placebon = 76
- Primary endpoint
- Change in FFR and change in maxLCBI4mm
- Follow-up
- 12 weeks
Primary result
As reported in the abstract
Evolocumab
- Fractional flow reserve (FFR)
- 0.00 (95% CI: −0.02 to 0.02)
- maxLCBI4mm
- −27.8 (95% CI: −72.2 to 16.6)
Placebo
- FFR
- 0.01 (95% CI: −0.01 to 0.03)
- maxLCBI4mm
- −35.6 (95% CI: −82.5 to 11.4)
Fractional flow reserve (FFR)
Evolocumab0.00 (95% CI: −0.02 to 0.02)
Placebo0.01 (95% CI: −0.01 to 0.03)
maxLCBI4mm
Evolocumab−27.8 (95% CI: −72.2 to 16.6)
Placebo−35.6 (95% CI: −82.5 to 11.4)
evolocumab vs placeboAdjusted mean difference (95% CI)P value
Change in FFR
−0.01(−0.03 to 0.01)
P = 0.6Change in maxLCBI4mm
7.8(−40.9 to 56.4)
P = 0.8Secondary outcomes
Intravascular ultrasound (IVUS)-derived atheroma volume parameters (secondary)
- No between-group differences in any IVUS-derived parameter
Original publication
Changes in non-culprit coronary lesions with PCSK9 inhibitors: the randomised, placebo-controlled FITTER trial. EuroIntervention. Published 18 August 2025. doi:10.
Summarised from the published abstract; every number is checked against it