Although use of drug-coated balloons (DCB) is a promising technique, little is known about the clinical efficacy of the Dissolve DCB in drug-eluting stent (DES) in-stent restenosis (ISR).
Objectives
This study sought to evaluate the efficacy and safety of the Dissolve DCB in patients with DES ISR.
Methods
This was a prospective, multicenter, randomized, noninferiority trial comparing Dissolve DCB with SeQuent Please DCB in patients with DES ISR. Angiographic and clinical follow-up was planned at 9 months in all patients. The primary endpoint was 9-month in-segment late loss.
Results
A total of 260 patients with ISR from 10 Chinese sites were included (Dissolve DCB, n = 128; SeQuent Please DCB, n = 132). Nine-month in-segment late loss was 0.50 ± 0.06 mm with Dissolve DCB vs 0.47 ± 0.07 mm with SeQuent Please DCB; the 1-sided 97.5% upper confidence limit of the difference was 0.18 mm (P for noninferiority = 0.03). Rates of target lesion failure and binary restenosis were numerical higher in the Dissolve DCB cohort compared with the SeQuent Please DCB cohort at 9 months (17.5% vs 10.7%; P = 0.12; 23.4% vs 16.4%; P = 0.19, respectively). At 9 months, major adverse cardiac and cerebrovascular events occurred in 36 patients (28.3%) vs 30 patients (22.9%) in the Dissolve DCB and SeQuent Please DCB groups, respectively.
Conclusions
In this head-to-head randomized trial, the Dissolve DCB was noninferior to the SeQuent Please DCB for 9-month in-segment late loss. However, Dissolve DCB with its numerical increase in target lesion failure and binary restenosis warrants assessment in larger clinical trials (A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-Stent Restenosis; NCT03373695)
Central Illustration
Key Words
drug-coated balloons
in-stent restenosis
noninferiority trial
Abbreviations and Acronyms
DCB
drug-coated balloon(s)
DES
drug-eluting stent(s)
ISR
in-stent restenosis
ITT
intention-to-treat
LLL
late lumen loss
MACCE
major adverse cardiovascular and cerebrovascular event(s)
MI
myocardial infarction
MLD
minimal lumen diameter
PCI
percutaneous coronary intervention
TLF
target lesion failure
TLR
target lesion revascularization
TVR
target vessel revascularization
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