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Randomized Controlled Trial
. 2022 Aug;36(4):655-664.
doi: 10.1007/s10557-021-07172-4. Epub 2021 Mar 13.

A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Xue Yu  1 , Xinyue Wang  1 , Fusui Ji  2 , Wenduo Zhang  1 , Chenguang Yang  1 , Feng Xu  1 , Fang Wang  1
Affiliations
Randomized Controlled Trial

A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Xue Yu et al. Cardiovasc Drugs Ther. 2022 Aug.

Erratum in

Abstract

Background: Drug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including reference vessel diameter more than 3.0mm) compared with new-generation drug-eluting stent (DES) are lacking. We hypothesized that a DCB-only strategy for coronary de novo lesions would be non-inferior to DES treatment on angiographic outcomes.

Methods: In this randomized controlled trial, we compared the effect of DCB with DES on late lumen loss (LLL) at 9-month angiographic follow-up and 12-month major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR).

Results: From July 2017 to July 2018, 288 consecutive patients with reference vessel diameter (RVD) between 2.25 and 4.0mm were screened. After proper pre-dilation, 170 patients were enrolled and randomized to the DCB and the DES groups at 1:1 ratio. Seven patients withdrew the consent forms during hospital stay (1 in DCB group, 6 in DES group). Two patients in DCB group underwent bailout stenting due to severe dissection after DCB release. The primary endpoint of 9-month LLL was -0.19±0.49mm with the DCB versus 0.03±0.64mm with the DES. The one-sided 97.5% upper confidence limit of the difference was -0.04mm, achieving non-inferiority of the DCB compared with the DES (P=0.019). The 12-month cumulative MACE rate was similar in the DCB and DES groups (2.44% vs. 6.33%, P=0.226).

Conclusions: In this prospective study, the DCB only strategy for de novo lesion was non-inferior to the new-generation DES in terms of 9-month late lumen loss.

Keywords: Angioplasty; Coronary artery disease; De novo lesion; Drug-coated balloon; Drug-eluting stent.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Study flow chart. DCB, drug-coated balloon; DES, drug-eluting stent
Fig. 2
Fig. 2
a Frequency distribution of MLD at the 9-month angiographic follow-up. b Frequency distribution of DS% at the 9-month angiographic follow-up. DCB, drug-coated balloon; DES, drug-eluting stent; MLD, minimal lumen diameter; DS% percentage of diameter stenosis
See this image and copyright information in PMC

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