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Randomized controlled trial for de-novo
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)
- Secondary endpoints @ 12 months: TLR, ST, Death, Target Vessel MI, MACE
Results
Primary endpoints:
- 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.