In a randomized trial, optical coherence tomography–guided PCI resulted in a larger minimum stent area than angiography-guided PCI, but there was no between-group difference in target-vessel failure ...at 2 years.
Objective
The LightLab Clinical Initiative was designed to examine adoption of optical coherence tomography (OCT) imaging during routine percutaneous coronary intervention (PCI) practice, and enable ...identification and reduction of barriers to broader adoption of intracoronary imaging in real‐world practice.
Background
Intracoronary imaging guidance during PCI has been shown to improve clinical outcomes and features as a recommendation in societal guidelines, yet widespread routine adoption remains low. Perceived barriers to utilization include familiarity with, and ability to interpret imaging, concerns over added procedure time and contrast load, alongside a lack of actionable outcome data.
Methods and Results
LightLab was a multicenter prospective observational data‐gathering project, conducted between January 2019, and June 2021, with 17 participating hospitals and physicians. Data were gathered in real‐time, where OCT guidance was employed during PCI using a standardized OCT‐guided workflow algorithm, MLD MAX (where MLD stands for plaque Morphology, lesion Length, vessel Diameter and MAX for Medial dissection, stent Apposition, stent eXpansion) which was developed to simplify and integrate information from OCT throughout the PCI procedure. Integration of this workflow/algorithm was implemented through a series of phases, focusing on physician decision‐making, efficiency, and safety improvements during the procedure.
Conclusions
Through real‐time, prospective procedural data acquisition in the cardiac catheterization laboratory setting, the LightLab Clinical Initiative demonstrates the impact of a standardized OCT‐guided workflow on procedural metrics, including time, contrast use, radiation exposure, as well as financial efficiencies such as device utilization. These results can potentially mitigate underlying concerns over the utility of adoption of intracoronary imaging guidance during PCI.
ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical ...characteristics and/or complex angiographic lesions.
The authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup.
From the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction MI, or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization.
The postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm2 vs 5.26 ± 1.81 mm2; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20).
In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777)
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ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical ...characteristics and/or complex angiographic lesions.BACKGROUNDILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions.The authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup.OBJECTIVESThe authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup.From the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction MI, or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization.METHODSFrom the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction MI, or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization.The postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm2 vs 5.26 ± 1.81 mm2; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20).RESULTSThe postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm2 vs 5.26 ± 1.81 mm2; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20).In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777).CONCLUSIONSIn complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777).
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