Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque - PREVENT

Apr 08, 2024
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
CardioVascular Research Foundation, Abbott, Yuhan Corp, CAH-Cordis, Philips, Infraredx
Date Presented:
04/08/2024
Date Published:
04/08/2024
Original Posted Date:
04/08/2024
References

Contribution To Literature:

The PREVENT trial showed that preventive PCI of focal non-FFR-positive plaques that are angiographically >50% and have evidence of vulnerability on intravascular imaging along with OMT is superior to OMT for clinical outcomes at 2 years.

Description:

The goal of the trial was to compare the safety and efficacy of medical therapy along with focal preventive percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaque compared with medical therapy alone.

Study Design

Patients were randomized in a 1:1 open-label fashion to either preventive PCI + optimal medical therapy (OMT) (n = 803) or OMT alone (n = 803).

  • Total randomized participants: 1,606
  • Median duration of follow-up: 7 years
  • Median patient age: 64.5 years
  • Percentage female: 27%
  • Percentage with diabetes: 31%

Inclusion criteria:

  • Age ≥18 years
  • Undergoing coronary angiography for stable ischemic heart disease (SIHD) or acute coronary syndrome
  • Coronary stenosis (>50%) with negative fractional flow reserve (FFR) (≥0.80) and meeting two of the following (imaging-defined vulnerable plaque):
    • Minimal lumen area (MLA) ≤4.0 mm2
    • Plaque burden >70%
    • Thin-cap fibroatheroma by optical coherence tomography (OCT) or radiofrequency intravascular ultrasound (IVUS)
    • Lipid-rich plaque by near-infrared spectroscopy (maxLCBI4mm >315)

Exclusion criteria:

  • Previous coronary artery bypass grafting
  • Target lesion previously stented
  • ≥3 target lesions in same patient, or ≥2 target lesions in same vessel
  • Heavily calcified or angulated lesions
  • Bifurcation lesion requiring 2-stent technique

Other salient features/characteristics:

  • History of cardiovascular disease: 6%
  • History of peripheral artery disease: 3%
  • Presentation: SIHD: 84%, unstable angina: 12%, non-ST-segment elevation myocardial infarction: 3%
  • Left ventricular ejection fraction: 63%
  • Baseline low-density lipoprotein cholesterol: 91 mg/dL
  • The most common criteria met by patients were MLA <4 by OCT/IVUS or plaque burden >70% by IVUS (97%)
  • Median FFR of target lesions: 0.87
  • Any PCI of target lesion was pursued in 91% of patients in the PCI arm (67% drug-eluting stent, 33% bioabsorbable scaffold implantation)

Principal Findings:

The primary endpoint of target vessel failure at 2 years (composite of death from cardiac causes, target vessel myocardial infarction [TV-MI], ischemia-driven target-vessel revascularization [ID-TLR], or hospitalization for unstable or progressive angina) for PCI + OMT vs. OMT alone, was: 0.4% vs. 3.4% (hazard ratio [HR] 0.11, 95% confidence interval [CI] 0.03-0.36, p = 0.0003).

Target vessel failure at 7 years: 6.5% vs. 9.4% (HR 0.54, 95% CI 0.33-0.87, p = 0.0097)

Key secondary outcomes for PCI + OMT vs. OMT:

  • All-cause mortality at 2 years: 0.5% vs. 1.3%, p > 0.05
  • All-cause mortality at 7 years: 5.2% vs. 7.4%, p > 0.05
  • All MI at 2 years: 1.1% vs. 1.7%, p > 0.05
  • All MI at 7 years: 2.4% vs. 3.5%, p > 0.05
  • ID-TLR at 2 years: 0.1% vs. 2.4%, p < 0.05
  • ID-TLR at 7 years: 4.9% vs. 8.0%, p < 0.05
  • All-cause mortality or TV-MI at 2 years: 0.6% vs. 1.9%, p < 0.05
  • All-cause mortality or TV-MI at 7 years: 6.2% vs. 8.6%, p > 0.05

Interpretation:

The results of this trial suggest that PCI of focal non-FFR-positive plaques that are angiographically >50% and have evidence of vulnerability on intravascular imaging (preventive PCI) along with OMT is superior to OMT for clinical outcomes at 2 years among patients with predominantly SIHD. The majority of this benefit was driven by a reduction in subsequent revascularization including ID-TLR. These benefits were sustained at 7 years of follow-up.

These are important and interesting findings that are likely to stimulate significant discussion. A few considerations: This trial poses questions regarding anatomy vs. physiology for management of coronary artery disease. Historically, physiology-based indices such as FFR have been used to define lesions that merit revascularization. This trial included lesions that were specifically FFR negative but met imaging-based definitions for vulnerable plaque. A clear definition of what constitutes vulnerable plaque and the best modality to assess this will be important going forward. Also, the main benefit was in need for revascularization procedures downstream, which could be influenced by the open-label design of the study. Event rates were significantly lower than expected, possibly because this was primarily an SIHD cohort. Finally, systemic therapies such as antiplatelets and lipid-lowering therapy are felt to be beneficial for atherosclerotic cardiovascular disease given its diffuse nature. Indeed, the event rate at 7 years is very low in the OMT only arm. This confirms the success of OMT but the trial opens the door to an additional small benefit of PCI based on carefully selected criteria.

References:

Park SJ, Ahn JM, Kang DY, et al., on behalf of the PREVENT Investigators. Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicenter, open-label, randomized controlled trial. Lancet 2024;Apr 8:[Epub ahead of print].

Presented by Dr. Seung-Jung Park at the American College of Cardiology Annual Scientific Session (ACC.24), Atlanta, GA, April 8, 2024.

Clinical Topics: Atherosclerotic Disease (CAD/PAD)

Keywords: ACC24, ACC Annual Scientific Session, Atherosclerosis, Coronary Artery Disease


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