Prevention & lipids

Intensive vs More Intensive Lipid-Lowering Therapy and Plaque Regression in Statin-Naive Patients: Prespecified Analyses From the FLOWPROMOTE Randomized Clinical Trial

JAMA CardiolPublished multicenter randomized clinical trial

Authors' conclusion

This secondary analysis of the FLOWPROMOTE randomized clinical trial demonstrated that in statin-naive patients with CAD, more intensive lipid-lowering therapy was associated with significantly greater regression of total and noncalcified coronary plaque burden compared with intensive therapy. The extent of plaque regression was related to achieved LDL-C levels, supporting the potential for partial reversal of coronary atherosclerosis with intensive lipid reduction.

Study context

Population
Statin-naive patients with newly diagnosed stable coronary artery disease (CAD), defined by a coronary computed tomography angiography (CTA) stenosis greater than 50% and fractional flow reserve CT less than or equal to 0.80included in this analysis
Participants
104 patients
Comparison
More intensive vs intensive
  • More intensiven = 52
  • Intensiven = 52
Methodological detailssecondary analysis, prespecified secondary imaging end points
  • Secondary analysis
  • Prespecified secondary imaging end points

Primary result

As reported in the abstract

LDL-C levels

Intensive

from 119.7 to 69.5 mg/dL

change −38%

More intensive

from 127.4 to 42.5 mg/dL

change −65%

Secondary outcomes

mm³

OutcomeMore intensiveIntensiveBetween-group difference (mm³) (95% CI)P value
Change in total plaque volume (TPV) · 18 monthsGreater regression with more intensive therapy−69.8 (−21.1%)−39.0 (−13.6%)−30.9 (−57.2 to −4.5)P = 0.02
Change in noncalcified plaque volume (NCPV) · 18 monthsGreater regression with more intensive therapy−82.3 (−28.2%)−53.5 (−20.0%)−28.9 (−53.2 to −4.6)P = 0.02

Regression of TPV (patients)

Regression of NCPV (patients)

  • Regression of total plaque volume (TPV) (patients): P = .05
  • Regression of TPV (patients): text also prints 76% for intensive therapy
  • Regression of noncalcified plaque volume (NCPV) (patients): P =.001

Change in calcified plaque volume (CPV)

CPV increased similarly in both groups

Achieved low-density lipoprotein cholesterol (LDL-C) and plaque regression

Lower achieved LDL-C levels were linearly associated with greater regression of TPV and NCPV

Original publication

Intensive vs More Intensive Lipid-Lowering Therapy and Plaque Regression in Statin-Naive Patients: Prespecified Analyses From the FLOWPROMOTE Randomized Clinical Trial. JAMA Cardiol. Published 30 October 2026. doi:10.1001/jamacardio.2026.4788

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