The Optimal Intravascular Ultrasound Guided Complex Percutaneous Coronary Intervention (OPTIVUS-Complex PCI) study was a prospective multicenter single-arm trial that enrolled patients undergoing PCI for LMCA or multivessel disease including a target lesion in left anterior descending coronary artery (LAD). The design of this study was previously reported in detail. The participating centers were encouraged to enroll consecutive patients who were planned to undergo IVUS-guided PCI for LMCA or multivessel disease including LAD target. The PCI operators were mandated to perform optimal IVUS-guided PCI with a target for the prespecified OPTIVUS criteria for optimal stent implantation. The exclusion criteria were those patients with ST-segment-elevation myocardial infarction, cardiogenic shock, and previous history of CABG. The study protocol was approved by the central review board, Kyoto University Certified Review Board, based on the enforcement of the Clinical Trials Act in Japan. Written informed consent was provided from all enrolled patients. One-year clinical outcomes in the OPTIVUS-Complex PCI multivessel cohort was previously reported. This trial was not registered at the trial registration sites because this study was cohort study to assess the feasibility prespecified IVUS criteria and did not investigate any intervention.

In this report, we investigated 1-year clinical outcomes in the LMCA cohort. Between March 2019 and February 2023, 912 patients were screened and planned to undergo PCI for LMCA disease. The current study population consisted of 902 patients who actually underwent IVUS-guided PCI with stenting for LMCA disease in 90 Japanese facilities ( Supplemental Figure 1 ).

Enrolled patients underwent PCI using platinum-chromium everolimus-eluting stents (Synergy; Boston Scientific, Marlborough, MA, USA). IVUS-guided PCI was mandatory to optimize stent expansion and apposition according to the OPTIVUS criteria. The prespecified OPTIVUS criteria for LMCA disease were defined as follows; minimal stent area (MSA) ≥5.0 mm ² for the left circumflex artery (LCX) ostium (assessed only when LCX was stented), ≥6 mm ² for the LAD ostium, ≥7 mm ² for the polygon of confluence (POC), and ≥8.0 mm ² for the proximal LMCA (5–6–7–8 rule) according to the previous report. All of the OPTIVUS criteria were described in the Supplemental materials. Preintervention IVUS assessment was also recommended to help choosing the appropriate sizes of balloons and/or stents and the modalities for lesion preparation. Quantitative and qualitative coronary angiographic analysis was performed in all target lesions, and IVUS analysis was performed in all target lesions with stenting by an independent core laboratory (Cardiocore, Tokyo, Japan). Among 902 patients in the LMCA cohort, coronary angiograms and IVUS images were available in 900 patients (99.8%), and 895 patients (99.2%), respectively, and were deemed suitable for evaluation by the core laboratory in 896 patients (99.3%), and 883 patients (97.9%), respectively. In the analysis for meeting or not meeting the OPTIVUS criteria, we excluded 38 patients (4.2%) in whom MSAs for LMCA, POC, LAD, and LCX could not be evaluated.

In addition to the IVUS-related recommendations, there were other recommendations to adopt contemporary clinical, procedural, and pharmacological practices. Target lesions were to be selected based on a stress imaging or physiological assessment (fractional flow reserve [FFR] or instantaneous wave-free ratio [iFR]). Radial access was recommended as the standard approach. PCI for chronic total occlusion (CTO) was to be performed by dedicated CTO operators. The use of an atherectomy device was recommended in severely calcified lesions. A proximal optimization technique was recommended in bifurcation lesions. Kissing balloon inflation was recommended if bifurcation lesions were treated with 2-sent strategies. Scheduled follow-up coronary angiography after PCI was discouraged in asymptomatic patients. Recommended pharmacologic management included the use of high-intensity statins therapy with the maximum approved dose of strong statins in Japan, and short duration (3 to 6 months) of dual antiplatelet therapy (DAPT) after PCI.

The primary endpoint was a major adverse cardiac and cerebrovascular event (MACCE) defined as a composite of death from any cause, myocardial infarction, stroke, or any coronary revascularization. Myocardial infarction was adjudicated according to the academic research consortium (ARC) definition. Stroke was defined as ischemic or hemorrhagic stroke with neurological symptoms lasting >24 hours. The definitions of secondary endpoints were described in the Supplemental materials. All endpoints were assessed at 1 year (between 335 and 394 days), with censoring on day 366. All clinical events comprising the primary endpoint were adjudicated based on the source documents by an independent clinical event committee.

The event rate for the primary endpoint in this single-arm trial was compared against the predefined performance goals. To define the performance goals in this study, we used data from the Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) PCI/CABG registry cohort-2 who fulfilled the inclusion criteria for the LMCA cohort in the OPTIVUS-Complex PCI study. IVUS was used in 59.0% of patients during the PCI procedure in the CREDO-Kyoto registry cohort-2. The rate of MACCE in the registry was 32.0% in the PCI group and 13.9% in the CABG group at 1 year, which were regarded as the performance goals in the present study. The sample size of the LMCA cohort was calculated based on the performance goal at 1 year derived from the PCI patients. Assuming a 15% relative risk reduction in this cohort compared to the PCI patients in CREDO-Kyoto PCI/CABG registry cohort-2, a sample size of 957 patients would provide a power of 90% with one-sided alpha of 2.5% to conduct superiority analysis against the performance goal of 32.0% at 1 year. We decided to enroll 1,000 patients considering the possible dropouts. In the present 1-year analysis of this paper, we performed only a superiority analysis for the PCI performance goal at 1 year with a numerical comparison with the CABG performance goal at 1 year.

Categorical variables were presented as number and percentage and were compared with the chi-square test. Continuous variables were expressed as mean ± standard deviation or median with interquartile range and were compared using the Student t test or Wilcoxon rank-sum test depending on their distributions. The cumulative incidence was estimated with the Kaplan-Meier method. We used one-sample binominal test to compare the 1-year incidence of the primary endpoint in this study with the performance goal of 32.0% derived from the PCI patients. The cumulative 1-year incidences of the primary and secondary endpoints were compared between patients meeting and not meeting the OPTIVUS criteria in the LMCA lesion. In addition, the cumulative 1-year incidence of the primary endpoint was compared between patients with and without true bifurcation LMCA lesion (medica classification 1,1,1/1,0,1/0,1,1).

All p values were 2-sided and p value <0.05 were considered statistically significant except for the assessment to fulfill the performance goal where one-sided p values <0.025 were considered statistically significant. All analyses were conducted by a physician (R.N. and K.Y.) and a statistician (T.M.) using JMP version 16.1.0 software (SAS Institute Inc., Cary, NC) and R version 4.1.2 (R Foundation for Statistical Computing).

The mean age of the current study population was 73.2 years, 83.9% of the patients were men, and 12.5% of the patients presented as acute coronary syndrome ( Table 1 ). The prevalence of diabetes and high bleeding risk (HBR) by ARC were 51.4% and 60.9%, respectively. Regarding the lesion and procedural characteristics, the prevalence of radial approach was 72.4%. The prevalence of patients who had isolated LMCA, LMCA with 1 vessel disease (VD), LMCA with 2VD, and LMCA with 3VD were 9.3%, 36.0%, 30.6%, and 24.1%, respectively. The mean SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) score was 22.3 with 54.5% of patients <23, 34.0% of patients 23 to 32, and 11.5% of patients ≥33. The prevalence of true bifurcation LMCA lesion (medina classification 1,1,1/1,0,1/0,1,1) and 2-stent strategy for LMCA bifurcation was 18.4%, and 5.7%, respectively. Majority of LMCA lesions (759 of 883 lesions with angiographic evaluation in the core angiographic laboratory, 86.0%) were treated with the single stent crossover from LMCA to LAD. The prevalence of pre-dilatation was 90.0%. Kissing balloon inflation after stent implantation was performed in 58.2% of patients. In terms of medications at discharge, the prescription rates of statins and high-intensity statins were 92.1% and 35.1%, respectively ( Supplemental Table 1 ).

The angiographic findings were shown in Table 2 . PCI strategies were changed in 47.1% of LMCA lesions based on the preintervention IVUS findings ( Supplemental Table 2 ), while PCI strategies were changed in 46.9% of LMCA lesions based on the postintervention IVUS findings ( Supplemental Table 3 ). Among the 759 patients who underwent stenting from LMCA to LAD, we excluded 3 patients with POC and 5 patients with LAD from OPTIVUS criteria assessment due to difficulties in analysis. Similarly, among the 50 patients who underwent 2 stenting, we excluded 1 patient with LAD and 20 patients with LCX for the same reason. Postprocedure mean MSA was 10.3 mm ² at LMCA, 9.0 mm ² at POC, 7.9 mm ² at LAD, and 5.4 mm ² at LCX. The rate of meeting the OPTIVUS criteria was 73.7% overall, 75.4% with 1-stent strategy, while it was 36.1% with 2-stent strategy in which the criteria was met only in 60.0% of lesions at the LCX ostium. Postprocedure MSA was 11.0 mm ² at LMCA, 9.7 mm ² at POC, 8.6 mm ² at LAD, and 6.6 mm ² at LCX in lesions that met the OPTIVUS criteria, while it was 8.1 mm ² at LMCA, 7.1 mm ² at POC, 6.1 mm ² at LAD, and 4.3 mm ² at LCX in lesions that did not meet the OPTIVUS criteria ( Table 2 and Figure 1 ).

Table 2

Angiographic and IVUS characteristics of LMCA lesions (per lesion basis)

Angiographic and procedural characteristics	N = 896
Preprocedure
LMCA to LAD
Lesion length (mm)	22.0 ± 14.3 (N = 882)
Reference vessel diameter (mm)	3.1 ± 0.8 (N = 892)
Minimum lumen diameter (mm)	1.1 ± 0.4 (N = 892)
Percent diameter stenosis (%)	64.6 ± 10.4 (N = 892)
Total occlusion	9/892 (1.0)
In-stent restenosis	35/892 (3.9)
Moderate or severe calcification	544/892 (61.0)
LCX
Lesion length (mm)	3.0 (3.0) (N = 881)
Reference vessel diameter (mm)	2.6 ± 0.7 (N = 885)
Minimum lumen diameter (mm)	2.0 ± 0.7 (N = 885)
Percent diameter stenosis (%)	15.2 (7.4 to 33.9) (N = 885)
Postprocedure
LMCA to LAD
Minimum lumen diameter (mm)
In-stent	3.0 ± 0.6
In-segment	2.5 ± 0.7 (N = 833)
Percent diameter stenosis (%)
In-stent	16.4 ± 7.6
In-segment	21.3 ± 8.7 (N = 833)
Acute gain (mm)
In-stent	1.9 ± 0.6 (N = 892)
In-segment	1.4 ± 0.7 (N = 829)
LCX in the 1-stent strategy
Minimum lumen diameter (mm)
In-segment	2.1 ± 0.7 (N = 830)
Percent diameter stenosis (%)
In-segment	17.4 ± 15.4 (N = 830)
Acute gain (mm)
In-segment	0.1 ± 0.5 (N = 819)
LCX in the 2-stent strategy
Minimum lumen diameter (mm)
In-stent	2.5 ± 0.4 (N = 49)
In-segment	2.2 ± 0.5 (N = 49)
Percent diameter stenosis (%)
In-stent	16.4 ± 8.6 (N = 49)
In-segment	20.5 ± 10.8 (N = 49)
Acute gain (mm)
In-stent	1.5 ± 0.6 (N = 49)
In-segment	1.2 ± 0.6 (N = 49)
IVUS analysis postprocedure
Number of lesions with IVUS evaluation in the core IVUS laboratory	883
OPTIVUS criteria in LMCA lesion
Meeting	637/864 (73.7)
Not meeting	227/864 (26.3)
Stenting strategies
1-stent for LMCA only	72 (8.2)
1-stent for LMCA to LAD	759 (86.0)
1-stent for LMCA to LCX	2 (0.2)
2-stent	50 (5.7)
MSA
LMCA proximal to the POC, mm 2	10.3 ± 2.5
MSA ≥8.0 mm 2	740 (83.8)
POC, mm 2	9.0 ± 2.1 (N = 808)
MSA ≥7.0 mm 2	696 (86.1) (N = 808)
LAD, mm 2	7.9 ± 2.1 (N = 803)
MSA ≥6.0 mm 2	699 (87.0) (N = 803)
LCX (2-stent strategy only), mm 2	5.4 ± 1.6 (N = 32)
MSA ≥5.0 mm 2	20 (62.5) (N = 32)
Incomplete stent apposition	500 (56.6%)
Dissection	32 (3.6%)
Stent fracture	3 (0.3%)

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