Optical coherence tomography-guided drug coated balloon in non-small de novo coronary artery lesions: a prospective clinical research

Abstract

Purpose: The combined use of drug coated balloon (DCB) and optical coherence tomography (OCT) for the treatment of non-small coronary de novo lesion remains to be evaluated. We investigated the safety and efficacy of OCT-guided DCB in non-small coronary de novo lesion patients with predilation of cutting balloon.

Methods: https://clinicaltrials.gov/, ClinicalTrials.gov Identifier: NCT04795144. This study was a prospective, and open-label study. We enrolled patients with non-small de novo lesions treated with OCT-guided DCB. The non-small de novo lesions indicated vessel lesions with a diameter ≥ 2.5 mm. The primary endpoints were the success rate of the procedure and the occurrence of target lesion revascularization. The secondary endpoints were myocardial infarction, cardiac death, and major adverse cardiac events (MACE) within 3 months after the procedure.

Results: At the Second Hospital of Jilin University, we enrolled 54 patients (54 lesions) with non-small de novo lesions who were treated with OCT-guided DCB from October 2018 to June 2019. A total of 52 patients were successfully treated with DCB-only strategy, while 2 patients turned to bailout stenting. A total of 21 patients had undergone angiography 3 months after the procedure with the late lumen loss of 0.24±0.57 mm. There was no statistically significant difference in minimal lumen diameter (MLD) between post-DCB and at 3-month angiographic follow-up (2.25±0.40 mm vs 2.04±0.54 mm; P = 0.110). Only 1 patient developed restenosis with the incidence of MACE rate of only 1.92% (n = 1). There was no significant difference in the stenosis of the lumen diameter of the target lesion vessel between 3 months after operation and immediately after operation.

Conclusions: Our study showed that OCT-guided DCB with cutting balloon under guidance may be a novel approach in non-small de novo coronary artery disease.

Keywords: Drug coated balloon; Non-small Coronary de novo lesion; cutting balloon; optical coherence tomography.

Figure 1

Flow chart.

Figure 2

Asymptomatic survival curve of all 52 patients.

Figure 3

Coronary angiography and OCT findings of the culprit lesion at the time of PCI and follow-up. Note: Pre-PCI CAG detected severe stenosis at the proximal of the LAD [white arrow; (A) a = (2.53±0.06) mm; b = (3.51±0.12) mm]; (B) shows dilation with a DCB (3.5*15 mm) after predilation with a cutting balloon (3.5*10 mm). CAG demonstrated the absence of dissection after PCI (minimal lumen diameter: 2.53 mm; (C)). At the 3-month follow-up, late lumen gain (minimal lumen diameter: 2.68 mm; (D)) was detected by CAG. OCT image after DCB revealed severe dissection after DCB dilation (location a; (E)). OCT image after DCB showed no hematoma at the distal of the lesion (location b; (F)). CAG at follow-up showed the healing of the dissection (location a; (G)). CAG at follow-up revealed the healing of the dissection (location b; (H)).