This observational, single-center study included consecutive patients who underwent DCA/DCB without stenting at New Tokyo Hospital between January 2019 and March 2024. The selection of the DCA/DCB approach without stenting was at the discretion of the physician based on the plaque burden and calcification on coronary computed tomography angiography, intravascular ultrasound (IVUS), or OCT. The inclusion criteria were: (1) de novo atherosclerotic lesion with significant angiographic stenosis; (2) OCT imaging before, after PCI and at the 3 months, 6 months, and 18 months post-PCI; and (3) IVUS before and after PCI. The exclusion criteria were: (1) bypass graft; (2) severe calcification on angiogram or superficial calcification on IVUS or OCT; and (3) diffuse lesion ≥20 mm. All patients provided informed consent for study participation. The study protocol was approved by the ethics committees of New Tokyo Hospital and Massachusetts General Hospital.

DCA was performed by 2 experienced physicians using an ATHEROCUT catheter (Nipro Corporation, Osaka, Japan) and an 8Fr guiding catheter via the transfemoral approach. Heparin (7,000–10,000 IU) was administered immediately before the procedure. The DCA procedure was performed with IVUS guidance. The target endpoint of the DCA procedure was a maximum residual plaque area (PA) of <40% measured by IVUS. When a deep cut, reaching to the adventitia, was made or the physician deemed it unsafe to continue the procedure, DCA was terminated even if the residual PA was ≥40%. DCBs of an appropriate size, as determined by IVUS, were chosen after IVUS confirmed that the target plaque volume reduction was achieved without major medial dissection. The DCBs used in this study were paclitaxel-coated balloons, SeQuent Please (B Braun, Germany) or Agent (Boston Scientific, Germany). The DCB size and dilatation pressure were decided based on the target lumen diameter and length, as determined by IVUS. A stent was used when IVUS exhibited major dissection or inadequate lumen gain after DCA, and the cases with stent were excluded. The procedural success of the DCA/DCB strategy was defined as a final residual stenosis of <50% by visual estimate of the angiogram, absence of stenting and medial dissection on IVUS or OCT.

Dual-antithrombotic therapy (DATT) was used according to the guidelines of the Japanese Circulation Society after DCB, with DAPT initially given for 1 to 3 months, followed by a single antiplatelet therapy. 100 mg aspirin and 75 mg clopidogrel or 3.25 mg prasugrel was administered as the maintenance, 200 mg aspirin and 300 mg clopidogrel or 20 mg prasugrel as the loading dose of DAPT were administered. For patients with atrial fibrillation, triple-antithrombotic therapy was administered for 2 weeks after PCI, followed by DATT with aspirin or P2Y12 inhibitor on direct oral anticoagulant (DOAC) treatment for 6 months. After 6 months, DOAC monotherapy was continued without antiplatelet agents.

Statins and ezetimibe were used according to the guidelines of the Japan Atherosclerosis Society and the Japanese Circulation Society. The moderate intensities of rosuvastatin, atorvastatin, and pitavastatin were achieved at doses of 5, 10, and 2 mg, respectively. Higher than moderate intensity was considered high intensities.

OCT, IVUS, and quantitative coronary angiography (QCA) were performed before and after the PCI procedure. OCT was repeated at 3, 6, and 18 months, whereas IVUS was repeated only at 18 months of follow-up (F/U).

OCT was performed using a Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter (Abbott, Santa Clara, CA). The OCT images were analyzed at the Core Laboratory by 2 experienced investigators who were blinded to the patient data using an offline review workstation (Abbott, Santa Clara, CA). A layer progression was defined as the development of a new layer at the target lesion or thickening of the previous layer >0.1 mm by OCT. A layer formation is defined as layer progression or unchanged layer. The minimum lumen area (MLA) and reference lumen area (RLA) were measured. The percent area stenosis (%AS) was defined as MLA/RLA × 100. The other definitions and analysis of the OCT images are described in the Supplemental Methods .

IVUS was performed using AltaView (Terumo, Tokyo, Japan). The IVUS images were assessed at New Tokyo Hospital by 2 experienced investigators using the VISICUBE IVUS (Terumo, Tokyo, Japan). The MLA, vessel area, and PA on the frame corresponding to the initial MLA site were measured.

The QCA images were assessed at New Tokyo Hospital by a single experienced investigator using the CAAS II research system (Pie Medical Imaging, Maastricht, the Netherlands), and the lesion length, reference vessel diameter, minimum luminal diameter, and diameter stenosis (DS) were measured. Angiographic restenosis was defined as a DS of >50%.

Continuous variables with a normal distribution are expressed as mean ± standard deviation, whereas the variables that were not normally distributed are expressed as median (interquartile range [IQR]). Normally distributed variables were compared using the Student’s t-test, whereas non-normally distributed variables were compared using the Mann–Whitney U test. Categorical data were expressed as absolute frequencies and percentages, and compared using the Fisher’s exact test. All probability values were 2-sided and p values of <0.05 were considered statistically significant. Statistical analyses were performed using SPSS (version 30 for Windows; SPSS, Inc, Chicago, IL).

Among 80 patients, 22 required a bailout stent procedure. Altogether, 40 patients underwent the 3-month F/U study, 33 both 3-month and 6-month F/Us, and 23 all 3 F/Us ( Figure 1 ). The median periods from PCI to the 3-month, 6-month, and 18-month F/Us were 99 (IQR 91–105), 203 (IQR 185–218), and 581 (IQR 549–633) days, respectively. One patient at the 3-month F/U and 3 patients at the 6-month F/U who had angiographic restenosis with positive fractional flow reserve underwent target lesion revascularization (TLR) and were thus excluded.

Study flowchart.

CVA = cerebrovascular accident; DCA = directional coronary atherectomy; DCB = drug-coated balloon; F/U = follow-up; OCT = optical coherence tomography; PCI = percutaneous coronary intervention; TLR = target lesion revascularization.

The baseline and procedural characteristics are summarized in Table 1 . The patients’ age was 62.0 ± 12.6 years, and 33 patients (82.5%) were male. Nine patients (22.5%) presented with acute coronary syndrome. Large DCA was used in 22 patients (55.0%), and the average number of DCA cuts was 34.2 ± 17.4 with a maximum pressure of 3.3 (2.5–5.0) atm. The average diameter and length of DCB were 3.5 (3.5–4.0) and 20.0 (15.0–20.0) mm, respectively.

Lipid-rich plaques were present in 36 patients (94.7%), and calcifications were present in 18 (47.4%) Ypatients ( Supplementary Table 1 ). The %AS decreased from 73.1% ± 17.8% to 22% ± 10.1% by OCT, and the plaque burden decreased from 82.9% ± 9.0% to 38.1% ± 8.5% after PCI assessed by IVUS ( Supplementary Table 2 ).

At 3-month F/U, DATT was continued in 29 patients (72.5%) and reduced from DATT to single-antithrombotic therapy (SATT) in 10 patients (25.0%). In 1 case, antithrombic therapy (ATT) was discontinued during the initial 3 months. At 19-month F/U, 60.9% of the cases were on SATT and 7 patients (30.4%) discontinued ATT. Moderate- or high-intensity statins were used in >80% of the patients at each F/U ( Supplementary Table 3 ).

The changes in OCT findings between adjacent F/U periods are summarized in Table 2 . Among the 40 cases, 36 (90.0%) showed a new layer at the 3-month F/U. New layer was most frequently observed at the 3-month F/U and became less frequent at the 6-month and 18-month F/Us (15.1% and 8.7%, respectively). Layer thickening was frequent at the 6-month F/U and became rare at 18-month F/U (48.5% and 8.7%, respectively). Layer progression defined as composite of new layer and layer thickening, was most frequent at 3-month F/U, then gradually decreased at 6- and 18-month F/U (90.0%, 63.6% and 17.4%, respectively). The layer remained unchanged without a new layer or layer thickening in the majority (78.3%) of the cases between the 6- and 18-month F/Us ( Figure 2 ). MLA decreased and %AS increased from post-PCI to the 3-month F/U and from the 3- to the 6-month F/U, but these did not change between the 6- and 18-month F/U ( Figure 3 ). Representative OCT images of new layer formation and layer thickening are shown in Figure 4 .

Table 2

Optical coherence tomography findings

	Post PCI–3-month F/U ( n = 40)			3–6-month F/U ( n = 33)			6–18-month F/U ( n = 23)
	Post PCI	3-month F/U	p value	3-month F/U	6-month F/U	p value	6-month F/U	18-month F/U	p value
Layer formation *		36 (90.0)		31 (93.9)	32 (97.0)	1.000	22 (95.7)	22 (95.7)	1.000
Layer progression †		36 (90.0)		31 (93.9)	21 (63.6)	0.005	13 (56.5)	4 (17.4)	0.013
New layer		36 (90.0)		31 (93.9)	5 (15.1)	<0.001	3 (13.0)	2 (8.7)	1.000
Layer thickening		N/A		N/A	16 (48.5)		10 (43.5)	2 (8.7)	0.017
Unchanged layer		N/A		N/A	11 (33.3)		9 (39.1)	18 (78.3)	0.016
Intimal thickening without layer		4 (10.0)		2 (6.1)	1 (3.0)	1.000	1 (4.4)	1 (4.4)	1.000
MLA, mm 2	6.9 ± 2.0	6.2 ± 2.3	0.020	6.1 ± 2.3	5.0 ± 2.4	<0.001	5.6 ± 2.4	5.1 ± 1.9	0.093
% AS	22.1 ± 10.1	28.1 ± 16.5	0.006	26.6 ± 15.7	38.2 ± 19.4	<0.001	34.3 ± 13.5	35.9 ± 16.6	0.549

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