TY - JOUR
T1 - Optical Coherence Tomography-Guided versus Angiography-Guided PCI
AU - Ali A, Ziad
AU - Landmesser, Ulf
AU - Maehara, Akiko
AU - Matsumura, Mitsuaki
AU - Shlofmitz, Richard A
AU - Guagliumi, Giulio
AU - Price, Matthew J
AU - Hill, Jonathan M
AU - Akasaka, Takashi
AU - Prati, Francesco
AU - Bezerra, Hiram G
AU - Wijns, William
AU - Leistner, David
AU - Canova, Paolo
AU - Alfonso, Fernando
AU - Fabbiocchi, Franco
AU - Dogan, Ozgen
AU - Mcgreevy, Robert J
AU - Mcnutt, Robert W
AU - Nie, Hong
AU - Buccola, Jana
AU - West, Nick E J
AU - Stone, Gregg W
AU - Trani, Carlo
AU - Investigators:, ILUMIEN IV
PY - 2023
Y1 - 2023
N2 - BACKGROUND Data regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited.METHODS In this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and targetvessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed.RESULTS The trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72 +/- 2.04 mm(2) in the OCT group and 5.36 +/- 1.87 mm(2) in the angiography group (mean difference, 0.36 mm(2); 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group.CONCLUSIONS Among patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.)
AB - BACKGROUND Data regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited.METHODS In this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and targetvessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed.RESULTS The trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72 +/- 2.04 mm(2) in the OCT group and 5.36 +/- 1.87 mm(2) in the angiography group (mean difference, 0.36 mm(2); 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group.CONCLUSIONS Among patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.)
KW - PCI
KW - angiography
KW - cardiovascular disease
KW - oct
KW - PCI
KW - angiography
KW - cardiovascular disease
KW - oct
UR - http://hdl.handle.net/10807/256774
U2 - 10.1056/NEJMoa2305861
DO - 10.1056/NEJMoa2305861
M3 - Article
SN - 0028-4793
VL - 389
SP - 1466
EP - 1476
JO - THE NEW ENGLAND JOURNAL OF MEDICINE
JF - THE NEW ENGLAND JOURNAL OF MEDICINE
ER -
