Clinical outcomes following percutaneous coronary intervention (PCI) in patients with complex coronary artery lesions are worse than in patients with non-complex lesions. Specifically, chronic total occlusion, left main disease, true bifurcation lesion, long lesion, multi-vessel PCI, multiple overlapping stents, or severely calcified lesions have poor clinical outcomes.
The RENOVATE-COMPLEX-PCI trial (NCT03381872) compared outcomes between intravascular imaging-guided PCI and angiography-guided PCI in complex lesions. The choice of specific intravascular imaging method (intravenous ultrasound or optical coherence tomography) was left to imaging operators.
Investigators randomized 1639 patients in a 2:1 fashion to undergo PCI guided by either intravascular imaging (n=1092) or angiography (n=547). The primary endpoint was target vessel failure within one year after final patient enrollment. This endpoint was a composite of death from cardiac causes, target-vessel-related myocardial infarction (MI), or clinically driven target-vessel revascularization.
Fewer endpoints with intravascular imaging-guided PCI
Interestingly, at median follow-up of 2.1 years, a primary endpoint event occurred in 76 patients (cumulative incidence, 7.7%) and 60 patients (cumulative incidence, 12.3%) in the intravascular imaging and angiography groups, respectively (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.89; P=0.008).
Death from cardiac causes occurred in 16 (cumulative incidence, 1.7%) and 17 patients (cumulative incidence, 3.8%) in the intravascular imaging and angiography groups, respectively. Target-vessel–related MI occurred in 38 patients in the intravascular imaging guided group (cumulative incidence, 3.7%) and 30 patients in the angiography-guided group (cumulative incidence, 5.6%). Finally, 32 patients in the intravascular imaging guided group (cumulative incidence, 3.4%), and 25 in the angiography-guided group (cumulative incidence, 5.5%) had to undergo clinically driven target-vessel revascularization. The incidence of procedure-related safety events did not differ between the groups.
Investigators concluded that among patients with complex coronary-artery lesions, intravascular imaging–guided PCI led to a lower risk of a composite of death from cardiac causes, target-vessel–related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI.
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Author: Kelly Schoonderwoerd
Original Article: Lee JM et al. NEJM March 2023. DOI: 10.1056/NEJMoa2216607
