Abstract

To compare the effects of paclitaxal-coated balloon (PCB) versus conventional balloon (CB) on side branch (SB) lesion and cardiovascular outcomes in patients with de novo true bifurcation lesions. In total, 219 patients with de novo true bifurcation lesions were enrolled and divided into PCB group (102 cases) and CB group (117 cases) according to angioplasty strategy in SB. Drug-eluting stent (DES) was implanted in main vessel (MV) for each subject. All subjects underwent a 12-month follow-up for late lumen loss (LLL), restenosis, and major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). MACEs included cardiac death, nonfatal myocardial infarction, and unstable angina requiring admission. There were no differences in diameter, minimum lumen diameter (MLD), and stenosis for bifurcation lesions between the two groups before and immediately after PCI (P > 0.05). After 12-month follow-up, no differences occurred in MV-MLD and MV-LLL between the two groups (P > 0.05); SB-MLD in PCB group was higher than that in CB group (1.97 ± 0.36mm vs. 1.80 ± 0.43mm, P = 0.007); SB-LLL in PCB group was lower than that in CB group (0.11 ± 0.18mm vs. 0.19 ± 0.25mm, P = 0.024). Multivariate COX analyses indicated that PCB group had lower MACE risk than CB group (HR = 0.480, 95%CI 0.244-0.941, P = 0.033). PCB could decrease SB-LLL and MACE risk in patients with de novo true coronary bifurcation lesion 12months after single-DES intervention.

Highlights

  • Interventional therapy for coronary bifurcation diseases accounts for about 15%-20% of percutaneous coronary intervention (PCI) [1]

  • There were no differences in diameter, minimum lumen diameter (MLD) and stenosis for bifurcation lesions between the two groups before and immediately after PCI (P > 0.05)

  • After 12-month follow-up, no differences occurred in main vessel (MV)-MLD and MV-late lumen loss (LLL) between the two groups (P > 0.05); side branch (SB)-MLD in paclitaxel-coated balloons (PCB) group was higher than that in conventional balloon (CB) group (1.97 ± 0.36 mm vs. 1.80 ± 0.43 mm, P = 0.007); SB-LLL in PCB group was lower than that in CB group (0.11 ± 0.18 mm vs. 0.19 ± 0.25 mm, P = 0.024)

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Summary

Introduction

Interventional therapy for coronary bifurcation diseases accounts for about 15%-20% of percutaneous coronary intervention (PCI) [1]. In the era of stentless PCI, DCB could be considered as an interventional option for small-vessel lesion, in-stent restenosis (ISR), and bifurcation lesion [7]. Few studies have been reported in de novo bifurcation lesion, especially lack of evidence for SB intervention based on the patients with true bifurcation lesions. Previous evidences showed that paclitaxel-coated balloons (PCB) significantly reduced ISR risk [8, 9]. We hypothesize that PCB angioplasty may decrease SB-LLL and the incidence of adverse cardiovascular events in the singlestent intervention strategy for bifurcation lesions. This study aims to compare the effects of PCB versus conventional balloon (CB) on SB lesion and cardiovascular outcomes in patients with de novo true bifurcation lesions

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