RENOVATE-COMPLEX-PCI
Trial question
What is the role of intravascular imaging-guided PCI in patients with complex coronary artery lesions?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 1639
1639 patients (339 female, 1300 male).
Inclusion criteria: adult patients undergoing PCI for complex coronary artery lesions.
Key exclusion criteria: coronary lesions not appropriate for PCI; cardiogenic shock at presentation; pregnancy; known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor.
Interventions
N=1092 intravascular imaging (intravascular imaging-guided PCI with either intravascular ultrasonography or optical coherence tomography).
N=547 angiography (angiography-guided PCI).
Primary outcome
Composite of death from cardiac causes, target-vessel-related MI or revascularization
7.7%
12.3%
12.3 %
9.2 %
6.2 %
3.1 %
0.0 %
Intravascular
imaging
Angiography
Significant
decrease ▼
NNT = 21
Significant decrease in death from cardiac causes, target-vessel-related MI or revascularization (7.7% vs. 12.3%; HR 0.64, 95% CI 0.45 to 0.89).
Secondary outcomes
Significant decrease in target-vessel failure without procedure-related MI (5.1% vs. 8.7%; HR 0.59, 95% CI 0.39 to 0.9).
Significant decrease in target-vessel-related MI and death from cardiac causes (5.3% vs. 8.5%; HR 0.63, 95% CI 0.42 to 0.93).
No significant difference in death from any cause (5.3% vs. 6.4%; HR 0.71, 95% CI 0.44 to 1.15).
Safety outcomes
No significant difference in procedure-related complications.
Conclusion
In adult patients undergoing PCI for complex coronary artery lesions, intravascular imaging was superior to angiography with respect to the composite of death from cardiac causes, target-vessel-related MI or revascularization.
Reference
Joo Myung Lee, Ki Hong Choi, Young Bin Song et al. Intravascular Imaging-Guided or Angiography-Guided Complex PCI. N Engl J Med. 2023 May 4;388(18):1668-1679.
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