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Randomized controlled trials for ISR
First in Man Trials in Malaysia, Germany & Switzerland
Scheller B et al. Circ Cardiovasc Interv. 2022 Sep;15(9):e012305.
Design: Randomized | Prospective | Multicenter | Non-inferiority
Indication: DES-ISR
Control: SeQuent® Please NEO
Primary endpoints: LLL @ 6-month follow-up
Secondary endpoints:
101 patients (DES-ISR) | ||
51 patients | 50 patients | |
Follow-up: | ||
1 month | 6 months | 12 months |
Quantitative coronary angiography revealed no differences in baseline parameters.
After 6 months, in-segment late lumen loss was:
Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24).
Non-inferiority at a predefined margin of 0.35 was shown.
Angiographic patency: cumulative frequency distribution of in-segment late lumen loss determined by quantitative coronary angiography. Paclitaxel-coated balloon (PCB) versus sirolimus-coated balloon (SCB).
Clinical follow-up at 1 year
| SCB Total | PCB Total | P value SCB vs. PCB | |
| Number of patients (n [%]) | 50 (100) | 51 (100) | |
| TLR (n [%]) | 8 (16) | 5 (10) | 0.389 |
| Stent thrombosis (n [%]) | 0 | 1 (2) | 1.000 |
| Death (n [%]) | 1 (2) | 1 (2) | 1.000 |
| MI (n [%]) | 0 | 1 (2) | 1.000 |
| MACE (n [%]) | 9 (18) | 7 (14) | 0.596 |
Clinical events up to 12 months did not differ between the groups.
This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB.