Article Impact Level: HIGH Data Quality: STRONG Summary of JACC: Cardiovascular Interventions, 16(23), 2884–2896. https://doi.org/10.1016/j.jcin.2023.09.026 Dr. Kai Ninomiya et al.
Points
- A comparative study between sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs) for the treatment of de novo small vessel disease (SVD) was conducted.
- The study involved 121 patients with 129 SVD lesions, and the primary endpoint was noninferiority for the 6-month angiographic net lumen gain.
- Results showed that SCBs, specifically the SCB MagicTouch, failed to demonstrate noninferiority for angiographic net lumen gain at six months compared to the PCB SeQuent Please Neo.
- The angiographic net gains with SCBs were lower than those with PCBs, and SCBs had a smaller late loss and more frequent late lumen enlargement but a higher binary restenosis rate.
- The findings highlight the need for further investigation and consideration of alternative treatment strategies for de novo SVD.
Summary
The study aimed to compare the quantitative coronary angiographic outcomes at six months following the treatment of de novo small vessel disease (SVD) using sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs). In a prospective, multicenter, noninferiority trial, 121 patients (129 SVD lesions) were randomized to receive treatment with either an SCB or PCB, with balloon sizing determined using optical coherence tomography. The primary endpoint was noninferiority for the 6-month angiographic net lumen gain.
The results revealed that the SCB MagicTouch did not meet the criterion for noninferiority, as the angiographic net gains with SCBs were lower than those with PCBs. Specifically, the study reported a mean angiographic net gain of 0.25 ± 0.40 mm with SCBs compared to 0.48 ± 0.37 mm with PCBs. Additionally, the analysis showed a smaller late loss, more frequent late lumen enlargement with PCBs, and a higher binary restenosis rate following treatment with SCBs. The angiography-derived fractional flow ratio also favored PCBs, with a statistically significant difference observed between the two groups.
In conclusion, the study’s findings indicated that the SCB MagicTouch did not demonstrate noninferiority for angiographic net lumen gain at six months compared to the PCB SeQuent Please Neo. These results provide valuable insights into the comparative efficacy of SCBs and PCBs in the treatment of de novo SVD, highlighting the need for further investigation and consideration of alternative treatment strategies.
Link to the article: https://www.sciencedirect.com/science/article/abs/pii/S1936879823013213
References Ninomiya, K., Serruys, P. W., Colombo, A., Reimers, B., Basavarajaiah, S., Sharif, F., Testa, L., Di Mario, C., Nerla, R., Ding, D., Huang, J., Kotoku, N., Kageyama, S., Kageyama, M., Sevestre, E., Fezzi, S., Dijkstra, J., O’Leary, N., Morel, M. A., … Onuma, Y. (2023). A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With Paclitaxel-Coated Balloon in De Novo Small Vessels. JACC: Cardiovascular Interventions, 16(23), 2884–2896. https://doi.org/10.1016/j.jcin.2023.09.026
