Treatment of coronary de novo lesions by a sirolimus- or paclitaxel-coated balloon
First in Man Trials in Malaysia Ahmad WAW et al. Cardiovascular Interventions 15.7 (2022): 770-779.
Overview
First in Man RCT in de-novo lesions in 70 patients (35 in PCB, 35 in SCB)
1:1 Randomization of SeQuent® Please NEO vs. SeQuent® SCB
Major inclusion criteria: 70% diameter of stenosis or more or intermediate between 50% to 70% diameter stenosis with positive functional test or symptom of ischemia
Major exclusion criteria: Myocardial infarction within the past 72 hours, reference vessel diameter (RVD) <2.5 mm
Primary endpoint @ 6 months: In segment late lumen loss (LLL)
SCB is non-inferior to PCB in terms of LLL after 6 months
LLL was 0.01 +/- 0.33 mm in the PCB group versus 0.10 +/- 0.32 mm in the SCB group (p=0.08)
Secondary endpoints:
PCB (n=35)
SCB (n=35)
P value
TLR
0
0
1.000
Stent thrombosis
0
0
1.000
Death
2 (6)
0
0.493
TV MI
0
0
1.000
Unscheduled angiography
2 (6)
3 (9)
1.000
MACE
2 (6)
0
0.493
No difference in clinical endpoints after 12 months.
Not any event of TLR, Stent thrombosis, TV-MI.
Conclusion
This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment.
