Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention - RENOVATE-COMPLEX-PCI

May 24, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC; Kim A. Eagle, MD, MACC
Trial Sponsor:
Abbott Vascular and Boston Scientific
Date Presented:
03/05/2023
Date Published:
04/03/2024
Date Updated:
05/24/2024
Original Posted Date:
03/05/2023
References

Contribution To Literature:

Highlighted text has been updated as of May 24, 2024.

The RENOVATE-COMPLEX-PCI trial showed that intravascular imaging-guided PCI improves outcomes by reducing target vessel failure.

Description:

The goal of the trial was to evaluate intravascular imaging-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI among patients with complex coronary artery disease.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients with complex coronary artery disease undergoing PCI were randomized to intravascular imaging-guided PCI (n = 1,092) vs. angiography-guided PCI (n = 547). In the intravascular imaging-guided PCI group, choice of intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was left to operator discretion.

  • Total number of enrollees: 1,639
  • Duration of follow-up: Median 2.1 years
  • Mean patient age: 66 years
  • Percentage female: 21%
  • Percentage with diabetes: 38%

Inclusion criteria:

  • At least 19 years of age
  • Complex coronary artery disease defined as:
  1. Bifurcation lesion
  2. Chronic total occlusion
  3. Unprotected left main disease
  4. Implanted stent length ≥38 mm
  5. Multivessel (≥2) or multi-stent (≥3) PCI
  6. In-stent restenosis
  7. Severely calcified lesion
  8. Ostial lesion

Exclusion criteria:

  • PCI not feasible
  • Cardiogenic shock
  • Intolerance to aspirin, P2Y12 inhibitor, heparin, or everolimus
  • Anaphylaxis to contrast dye
  • Pregnancy
  • Limited life expectancy

Other salient features/characteristics:

  • Stable ischemic heart disease: 49%
  • Acute coronary syndrome: 51%
  • In the intravascular imaging group, IVUS was used 75% of the time, while OCT was used 25% of the time.

Principal Findings:

The primary outcome, target vessel failure (cardiac death, target vessel myocardial infarction [MI], or clinically driven target vessel revascularization) was 7.7% in the intravascular imaging-guided PCI group vs. 12.3% in the angiography-guided PCI group (p = 0.008).

Secondary outcomes:

  • Cardiac death: 1.7% in the intravascular imaging-guided PCI group vs. 3.8% in the angiography-guided PCI group
  • Target vessel MI: 3.7% in the intravascular imaging-guided PCI group vs. 5.6% in the angiography-guided PCI group
  • Repeat revascularization: 6.3% in the intravascular imaging-guided PCI group vs. 7.1% in the angiography-guided PCI group

Outcomes according to sex:

  • Primary outcome among women: 5.2% in the intravascular imaging-guided PCI group vs. 14.5% in the angiography-guided PCI group
  • Primary outcome among men: 8.3% in the intravascular imaging-guided PCI group vs. 11.7% in the angiography-guided PCI group (p for interaction = 0.86)

Interpretation:

Among patients with complex coronary artery disease, intravascular imaging-guided PCI improves outcomes compared with angiography-guided PCI. The treatment benefit from imaging-guided PCI vs. angiography-guided PCI was similar among women and men. Intravascular imaging was performed with IVUS (75% of the time) and OCT in the remainder. Individual components of the primary outcome—cardiac death, target vessel MI, and clinically driven target vessel revascularization—all appeared to be reduced with intravascular imaging.

This trial is directionally in line with other trials that have all suggested benefit from intravascular imaging-guided PCI. Among patients with complex coronary artery disease undergoing PCI, intravascular imaging should be considered.

References:

Cha JH, Lee JM, Choi KH, et al., on behalf of the RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging–Guided Optimization of Complex Percutaneous Coronary Intervention by Sex: A Subgroup Analysis of the RENOVATE-COMPLEX-PCI Trial. JAMA Cardiol 2024;9:466-74.

Lee JM, Choi KH, Song YB, et al., on behalf of the RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging–Guided or Angiography-Guided Complex PCI. N Engl J Med 2023;388:1668-79.

Editorial: Williams DO. When Images Speak, Listen. N Engl J Med 2023;388:1714-6.

Presented by Dr. Joo Yong Hahn at the American College of Cardiology Annual Scientific Session (ACC.23/WCC), New Orleans, LA, March 5, 2023.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Angiography, Echocardiography/Ultrasound, Nuclear Imaging

Keywords: ACC23, ACC Annual Scientific Session, Coronary Angiography, Percutaneous Coronary Intervention, Tomography, Optical Coherence, Ultrasonography


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