Author + information
- Seiji Habara, MD⁎ (, )
- Kazushige Kadota, MD and
- Kazuaki Mitsudo, MD
- ↵⁎Kurashiki Central Hospital, Department of Cardiology, 1-1-1 Miwa, Kurashiki-shi, Okayama 710-8602, Japan
We thank Dr. Alfonso and colleagues for their concern and suggestions based on our recent publication (1). We appreciate their suggestions and have performed the following analysis.
Focal restenosis occurs frequently at stent edges after drug-eluting stent (DES) implantation (2). In the paclitaxel-eluting balloon (PEB) group of our study, stent edge restenosis affected 3 of the 13 focal restenotic lesions. No recurrent restenosis occurred in this group. We cannot conclude that PEB was effective for stent edge restenosis, because of the small sample size in this study. We believe stent edge restenosis should be handled carefully to not cause coronary dissection.
Stent underexpansion is considered the cause of recurrent restenosis (3). We did not have adequate intravascular ultrasound data that could assess DES restenosis at the time of PEB use. In our study, pre-dilation was performed with a noncompliant balloon in all lesions. Pre-dilation pressure was higher in the conventional balloon angioplasty group than in the PEB group (21.4 ± 3.7 atm vs. 19.2 ± 6.4 atm; p = 0.001). Balloon artery ratio was similar (1.08 ± 0.07 vs. 1.10 ± 0.08; p = 0.3) between the groups. In the PEB group, inflation pressure for the SeQuent Please balloon catheter (B. Braun Melsungen AG, Vascular Systems, Berlin, Germany) was 13.0 ± 2.4 atm. We believe that obtaining a high acute gain and avoiding stent underexpansion by high-pressure pre-dilation are essential for minimizing the risk of recurrent restenosis and target lesion revascularization in patients with in-stent restenosis lesions. We used PEB with relatively high pressure, because we believed that it might be more effective for drug delivery into the vascular wall. In our study, we had no major dissection after PEB use.
Late loss is used as an important endpoint to compare interventional therapy. In our study, late loss had a normal distribution between the PEB and balloon angioplasty groups (p = 0.31 and p = 0.22, respectively). Thus, late loss might be a reliable marker of the true efficacy of PEB.
Our study was a single-center randomized trial with a relatively small sample size. Further studies with a larger sample size are required for studying the management of DES restenosis.
- American College of Cardiology Foundation
- Habara S.,
- Mitsudo K.,
- Kadota K.,
- et al.
- Corbett S.J.,
- Cosgrave J.,
- Melzi G.,
- et al.