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Efficacy and safety of drug-coated balloons in the treatment of de novo coronary lesions in very small vessels: a prospective, multicenter, single-arm trial.

ABSTRACT:

Background

Evidence of the use of drug-coated balloons (DCB) in de novo large or small coronary lesions and in-stent restenosis has accumulated over the past years. Due to their anatomical peculiarity, the treatment of very small vessels (VSV) (lumen diameter <2 mm) is still a controversial issue. Studies that examine the use of DCB in VSV are limited. We investigated the efficacy and safety of using DCBs for the de novo coronary lesions in VSV undergoing percutaneous coronary intervention (PCI).

Methods

In this prospective, single-arm study, we enrolled adult patients with coronary artery disease from six centers in China. A total of 29 patients had VSV with a target lesion stenosis ≥70% were included. All patients were treated with DCB. The primary endpoint was late lumen loss (LLL) at 9 months of follow-up. The secondary endpoints were major adverse cardiac events including target lesion revascularization, death, or myocardial infarction at 9 months of follow-up.

Results

Twenty-nine eligible patients with VSV were enrolled between November 2019 to May 2020. Angiographic and clinical follow-up were completed at 9 months in 18 (56.25%) patients (7 patients refused to final angiography; 2 failed to finish DCB angioplasty; 1 patient request; 1 other causes of death). The mean diameter of the reference vessel of the target lesion was 1.71±0.27 mm, the minimum lumen diameter (MLD) of the target lesion before operation was 0.31±0.24 mm, the average LLL of the target lesion was 0.13±0.28 mm, and the MLD of the target vessel immediately after operation was (1.19±0.20 mm) and at the 9-month follow-up (1.06±0.31 mm) were significantly higher than those before operation (P=0.043). One patient (5.56%) underwent revascularization. No myocardial infarction or death occurred during follow-up after treatment with DCBs.

Conclusions

DCB can be a safe and effective alternative in the treatment of de novo coronary lesions in VSV.

SUBMITTER: Zhang M

PROVIDER: S-EPMC9096399 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of drug-coated balloons in the treatment of <i>de novo</i> coronary lesions in very small vessels: a prospective, multicenter, single-arm trial.

Zhang Mingduo M Yong Jingwen J Zhou Yuan Y Zhang Min M Song Xiantao X Qiao Shubin S Wang Lefeng L Tong Qian Q Zhang Li L Shi Bei B

Annals of translational medicine 20220401 8

<h4>Background</h4>Evidence of the use of drug-coated balloons (DCB) in <i>de novo</i> large or small coronary lesions and in-stent restenosis has accumulated over the past years. Due to their anatomical peculiarity, the treatment of very small vessels (VSV) (lumen diameter <2 mm) is still a controversial issue. Studies that examine the use of DCB in VSV are limited. We investigated the efficacy and safety of using DCBs for the <i>de novo</i> coronary lesions in VSV undergoing percutaneous coron ...[more]

PMID: 35571396

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Project description:The role of drug-eluting balloons (DEB) is unclear. Increasing evidence has shown a benefit for the treatment of in-stent restenosis. Its effect on de novo coronary lesions is more controversial. Several smaller randomized trials found conflicting results.This is a systematic review and meta-analysis of randomized controlled trials (RCT) evaluating the effect of local Paclitaxel delivery/drug eluting balloons (DEB) (+/- bare metal stent) compared to current standard therapy (stenting) to treat de novo coronary lesions. Data sources for RCT were identified through a literature search from 2005 through 28 December 2012. The main endpoints of interest were target lesion revascularization (TLR), major adverse cardiac events (MACE), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI), late lumen loss (LLL) and mortality. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals.Eight studies (11 subgroups) and a total of 1,706 patients were included in this analysis. Follow-up duration ranged from 6 to 12 months. Overall, DEB showed similar results to the comparator treatment. The relative risk (RR) for MACE was 0.95 (0.64 to 1.39); P = 0.776, for mortality it was 0.79 (0.30 to 2.11), P = 0.644, for stent thrombosis it was 1.45 (0.42 to 5.01), P = 0.560, for MI it was 1.26 (0.49 to 3.21), P = 0.629, for TLR it was 1.09 (0.71 to 1.68); P = 0.700 and for binary in-stent restenosis it was 0.96 (0.48 to 1.93), P = 0.918. Compared to bare metal stents (BMS), DEB showed a lower LLL (- 0.26 mm (-0.51 to 0.01)) and a trend towards a lower MACE risk (RR 0.66 (0.43 to 1.02)).Overall, drug-eluting balloons (+/- bare metal stent) are not superior to current standard therapies (BMS or drug eluting stent (DES)) in treating de novo coronary lesions. However, the performance of DEB seems to lie in between DES and BMS with a trend towards superiority over BMS alone. Therefore, DEB may be considered in patients with contraindications for DES. The heterogeneity between the included studies is a limitation of this meta-analysis; different drug-eluting balloons have been used.