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A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With Paclitaxel-Coated Balloon in De Novo Small
Kai Ninomiya1, Patrick W Serruys1, Antonio Colombo2
1Department of Cardiology, University of Galway, Galway, Ireland.
Background:
There are no data comparing sirolimus-coated balloons (SCBs [MagicTouch, Concept Medical]) to paclitaxel-coated balloons (PCBs [SeQuent Please Neo, B. Braun]) for the treatment of de novo small vessel disease (SVD).
Objectives:
This study sought to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo SVD with a PCB or SCB.
Methods:
This prospective, multicenter, noninferiority trial randomized 121 patients (129 SVD lesions) to treatment with 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.
Results:
Angiographic follow-up was completed in 109 (90.1%) patients in the per-protocol analysis. The mean ± SD angiographic net gains were 0.25 ± 0.40 mm with SCBs vs 0.48 ± 0.37 mm with PCBs, resulting in SCBs failing to meet the 0.30 mm criterion for noninferiority (Pnoninferiority = 0.173), with an absolute difference of -0.23 mm (95% CI: -0.37 to -0.09) secondary to a smaller late loss (0.00 ± 0.32 mm vs 0.32 ± 0.47 mm; P < 0.001) and more frequent late lumen enlargement (53.7% vs 30.0%; OR: 2.60; 95% CI: 1.22-5.67; P = 0.014) with PCBs. Binary restenosis rates were 32.8% and 12.5% following treatment with SCBs and PCBs, respectively (OR: 3.41; 95% CI: 1.36-9.44; P = 0.012). The mean angiography-derived fractional flow ratio at follow-up was 0.86 ± 0.15 following treatment with SCBs and 0.91 ± 0.09 following PCBs (P = 0.026); a fractional flow ratio ≤0.80 occurred in 13 and 5 vessels after treatment with SCBs and PCBs, respectively.
Conclusions:
The SCB MagicTouch failed to demonstrate noninferiority for angiographic net lumen gain at 6 months compared to the PCB SeQuent Please Neo.
Insights
Sirolimus-coated balloons (SCBs) did not meet noninferiority criteria compared to paclitaxel-coated balloons (PCBs) for small vessel disease treatment. PCBs showed significantly better angiographic outcomes and lower restenosis rates at six months.
Area of Science:
- Interventional Cardiology
- Vascular Medicine
- Biomedical Engineering
Background:
- Limited comparative data exists for sirolimus-coated balloons (SCBs) versus paclitaxel-coated balloons (PCBs) in treating de novo small vessel disease (SVD).
- This study addresses the need for direct comparison of these two treatment modalities.
Purpose of the Study:
- To compare the 6-month quantitative coronary angiographic outcomes of SCBs and PCBs in patients with de novo SVD.
- To evaluate the noninferiority of SCBs compared to PCBs based on net lumen gain.
Main Methods:
- A prospective, multicenter, noninferiority trial randomized 121 patients (129 SVD lesions) to SCB or PCB treatment.
- Balloon sizing was guided by optical coherence tomography.
- The primary endpoint was the 6-month angiographic net lumen gain.
Main Results:
- SCBs failed to demonstrate noninferiority, with a mean net lumen gain of 0.25 mm versus 0.48 mm for PCBs (P=0.173).
- PCBs exhibited significantly less late lumen loss and higher rates of late lumen enlargement.
- Binary restenosis rates were higher with SCBs (32.8%) compared to PCBs (12.5%).
- Mean fractional flow reserve at follow-up was lower in the SCB group (0.86) versus the PCB group (0.91).
Conclusions:
- The sirolimus-coated balloon (MagicTouch) did not achieve noninferiority compared to the paclitaxel-coated balloon (SeQuent Please Neo) for de novo SVD treatment.
- Paclitaxel-coated balloons demonstrated superior angiographic outcomes at 6 months.
