한빛사논문
- 조회74
Prof Sung-Jin Hong MD a*, Seung-Jun Lee MD a*, Sang-Hyup Lee MD a, Prof Jong-Young Lee MD b, Prof Deok-Kyu Cho MD c, Prof Jin Won Kim MD d, Prof Sang Min Kim MD e, Prof Seung-Ho Hur MD f, Prof Jung Ho Heo MD g, Prof Ji-Yong Jang MD h, Prof Jin Sin Koh MD i, Prof Hoyoun Won MD j, Prof Jun-Won Lee MD k, Prof Soon Jun Hong MD l, Prof Dong-Kie Kim MD m, Prof Jeong Cheon Choe MD n, Prof Jin Bae Lee MD o, Prof Soo-Joong Kim MD p, Prof Tae-Hyun Yang MD q, Prof Jung-Hee Lee MD k, Prof Young Joon Hong MD r, Prof Jong-Hwa Ahn MD s, Yong-Joon Lee MD a, Prof Chul-Min Ahn MD a, Prof Jung-Sun Kim MD a, Prof Young-Guk Ko MD a, Prof Donghoon Choi MD a, Prof Myeong-Ki Hong MD a, Prof Yangsoo Jang MD t, Prof Byeong-Keuk Kim MD a for the OCCUPI investigators †
aDivision of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea
bDivision of Cardiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea
cDivision of Cardiology, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, South Korea
dDivision of Cardiology, Korea University Guro Hospital, Seoul, South Korea
eDivision of Cardiology, Chungbuk National University Hospital, Cheongju, South Korea
fDivision of Cardiology, Keimyung University Dongsan Hospital, Daegu, South Korea
gDivision of Cardiology, Kosin University Gospel Hospital, Busan, South Korea
hDivision of Cardiology, National Health Insurance Service Ilsan Hospital, Goyang, South Korea
iDivision of Cardiology, Gyeongsang National University Jinju Hospital, Jinju, South Korea
jDivision of Cardiology, Chung-Ang University Hospital, Seoul, South Korea
kDivision of Cardiology, Wonju Severance Christian Hospital, Wonju, South Korea
lDivision of Cardiology, Korea University Anam Hospital, Seoul, South Korea
mDivision of Cardiology, Inje University Haeundae Paik Hospital, Busan, South Korea
nDivision of Cardiology, Pusan National University Hospital, Busan, South Korea
oDivision of Cardiology, Daegu Catholic University Medical Center, Daegu, South Korea
pDivision of Cardiology, Kyung Hee University Hospital, Seoul, South Korea
qDivision of Cardiology, Inje University Busan Paik Hospital, Busan, South Korea
rDivision of Cardiology, Chonnam National University Hospital, Gwangju, South Korea
sDivision of Cardiology, Gyeongsang National University Changwon Hospital, Changwon, South Korea
tDivision of Cardiology, CHA Gangnam Medical Center, CHA University College of Medicine, Seoul, South Korea
*Contributed equally
Correspondence to: Prof Byeong-Keuk Kim, Prof Yangsoo Jang, MD
†OCCUPI investigators are listed in appendix 2 (p 3)
Abstract
Background
Despite the detailed imaging information provided by optical coherence tomography (OCT) during percutaneous coronary intervention (PCI), clinical benefits of this imaging technique in this setting remain uncertain. The aim of the OCCUPI trial was to compare the clinical benefits of OCT-guided versus angiography-guided PCI for complex lesions, assessed as the rate of major adverse cardiac events at 1 year.
Methods
This investigator-initiated, multicentre, randomised, open-label, superiority trial conducted at 20 hospitals in South Korea enrolled patients aged 19–85 years for whom PCI with drug-eluting stents was clinically indicated. After diagnostic angiography, clinical and angiographic findings were assessed to identify patients who met the criterion of having one or more complex lesions. Patients were randomly assigned 1:1 to receive PCI with OCT guidance (OCT-guidance group) or angiography guidance without OCT (angiography-guidance group). Web-response permuted-block randomisation (mixed blocks of four or six) was used at each participating site to allocate patients. The allocation sequence was computer-generated by an external programmer who was not involved in the rest of the trial. Outcome assessors were masked to group assignment. Patients, follow-up health-care providers, and data analysers were not masked. PCI was done according to conventional standard methods with everolimus-eluting stents. The primary endpoint was major adverse cardiac events (a composite of cardiac death, myocardial infarction, stent thrombosis, or ischaemia-driven target-vessel revascularisation), 1 year after PCI. The primary analysis was done in the intention-to-treat population. The margin used to establish superiority was 1·0 as a hazard ratio. This trial is registered with ClinicalTrials.gov(NCT03625908) and is completed.
Findings
Between Jan 9, 2019, and Sept 22, 2022, 1604 patients requiring PCI with drug-eluting stents for complex lesions were randomly assigned to receive either OCT-guided PCI (n=803) or angiography-guided PCI (n=801). 1290 (80%) of 1604 patients were male and 314 (20%) were female. The median age of patients at randomisation was 64 years (IQR 57–70). 1588 (99%) patients completed 1-year follow-up. The primary endpoint occurred in 37 (5%) of 803 patients in the OCT-guided PCI group and 59 (7%) of 801 patients in the angiography-guided PCI group (absolute difference –2·8% [95% CI –5·1 to –0·4]; hazard ratio 0·62 [95% CI 0·41 to 0·93]; p=0·023). Rates of stroke, bleeding events, and contrast-induced nephropathy were not significantly different across the two groups.
Interpretation
Among patients who required drug-eluting stent implantation for complex lesions, OCT guidance resulted in a lower incidence of major adverse cardiac events at 1 year compared with angiography guidance. These findings indicate the existence of a therapeutic benefit of OCT as an intravascular imaging technique for PCI guidance in patients with complex coronary lesions.
논문정보
- Research article
- 2024년 09월 (BRIC 등록일 2024-09-06)
- 국내 연구진
- 의약학 > 응용의학
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