Anatomical and Physiological Changes after Paclitaxel-Coated Balloon for Atherosclerotic De Novo Coronary Lesions: Serial IVUS-VH and FFR Study

Abstract

Aims: To assess the serial changes of de novo coronary lesions treated with paclitaxel-coated balloon (PCB) using intravascular ultrasound virtual histology (IVUS-VH) and fractional flow reserve (FFR).

Method and results: This prospective observational study enrolled 27 patients with coronary artery disease treated with PCB who underwent coronary angiography, IVUS-VH and FFR before, immediately after intervention and at 9 months. 28 de novo lesions were successfully treated with PCB. Angiographic late luminal loss was 0.02 ± 0.27 mm. Mean vessel and lumen areas showed increase at 9 months (12.0 ± 3.5 mm(2) to 13.2 ± 3.9 mm(2), p <0.001; and 5.4 ± 1.2 mm(2) to 6.5 ± 1.8 mm(2), p <0.001, respectively). Although mean plaque area was unchanged (6.6 ± 2.6 mm2 to 6.6 ± 2.4 mm(2), p = 0.269), percent atheroma volume decreased significantly (53.4 ± 7.9% to 49.5 ± 6.4%, p = 0.002). The proportion of plaque compositions including fibrous, fibrofatty, dense calcium and necrotic core by IVUS-VH was unchanged at 9 months. The FFR of the treated lesion was 0.71 ± 0.13 pre-procedure, 0.87 ± 0.06 post-procedure and 0.84 ± 0.06 at follow-up.

Conclusions: De novo coronary lesions treated with PCB showed persistent anatomical and physiological patency with plaque redistribution and vessel remodeling without chronic elastic recoil or plaque compositional change during follow-up.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Serial changes in mean vessel, lumen and plaque area.

Fig 2. Serial changes in percent atheroma volume and minimal lumen areas.

Fig 3. Serial changes in plaque composition.

Fig 4. Serial changes of plaque phenotypes.

TCFA = thin-cap fibroatheroma, ThCFA = thick-cap fibroatheroma, PIT = pathologic intima thickening.

Fig 5. A representative case of paclitaxel-coated balloon treatment in a de novo lesion.

A 67-year-old woman who had unstable angina with near total occlusion of the left anterior descending coronary artery (A) underwent paclitaxel-coated balloon (PCB) treatment after plain balloon angioplasty (POBA). After POBA, the lesion showed minimal residual stenosis including a non-flow-limiting type A dissection (B). The patient experienced no procedural-related complications and was discharged without symptoms after the procedure. She took dual antiplatelet therapy for 6 weeks followed by aspirin alone. Serial intravascular ultrasound virtual histology was performed right after POBA and at 2 months and 9 months follow-up. After POBA, the lesion was well expanded with dissection of plaque seen on IVUS (F). At 2 months, IVUS demonstrated an enlarged lumen accompanied by a slightly enlarged vessel (G). At 9 months, the lumen and vessel were both well preserved (H). The plaque phenotype, fibroatheroma remain unchanged and the plaque burden (PB) decreased over time (I; 66%, J; 50%, K; 47%, L: 40%). Plaque burden (%) was defined as P&M area divided by EEM area x 100. Asterisks and arrows indicate a small septal branch and a dissected flap, respectively. Bar = 1 mm.