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Randomized Controlled Trial
. 2025 Oct;40(4):827-839.
doi: 10.1007/s12928-025-01177-8. Epub 2025 Jul 23.

Comparison of the incidence of slow flow following rotational atherectomy to severely calcified coronary artery lesions between short single session and long single session strategies: the randomized ROTASOLO trial

Kenichi Sakakura  1 , Hiroyuki Jinnouchi  2 , Yousuke Taniguchi  2 , Kei Yamamoto  2 , Yoshimasa Tsurumaki  3 , Takunori Tsukui  2 , Yusuke Watanabe  2 , Takaaki Mase  4 , Masaru Seguchi  2 , Taku Kasahara  2 , Masashi Hatori  2 , Shun Ishibashi  2 , Hiroshi Wada  2 , Yusuke Tamanaha  4 , Kenshiro Arao  4 , Norifumi Kubo  3 , Hideo Fujita  2
Affiliations
Randomized Controlled Trial

Comparison of the incidence of slow flow following rotational atherectomy to severely calcified coronary artery lesions between short single session and long single session strategies: the randomized ROTASOLO trial

Kenichi Sakakura et al. Cardiovasc Interv Ther. 2025 Oct.

Abstract

Slow flow is the most common complication of rotational atherectomy (RA). Compared with long single sessions, short single sessions may reduce the incidence of slow flow just after RA. This study aimed to compare the incidence of slow flow just after RA between short single session and long single session strategies. This multicenter, 1:1 randomized clinical trial was conducted at 3 hospitals in Japan. The short single session strategy was defined as repeating short single sessions (up to 15 s) of RA, whereas the long single session strategy was defined as repeating long single sessions (20-30 s) until the burr crossed the target lesion. The primary outcome was slow flow just after RA, which was defined as [(initial TIMI-frame count before RA) × 1.1 minus (TIMI-frame count just after RA)] less than 0. During the study period, 266 patients were included in the final study population and were randomly assigned to the Short single session group (n = 132) or the long single session group (n = 134). The protocol adherence rate was equally high in both groups (Short single session: 98.5% versus long single session 94.8%, p = 0.172). The incidence of slow flow just after RA was similar between the 2 groups (short single session:14.4% versus long single session: 14.9%, p > 0.999). In conclusion, this randomized trial did not show a benefit of the short single session strategy compared with the long single session strategy in RA with respect to the prevention of slow flow (Unique identifier: UMIN000047231).

Keywords: Complications; Percutaneous coronary intervention; Randomized control study; Rotational atherectomy; Slow flow.

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Conflict of interest statement

Declarations. Conflict of interest: Dr. Sakakura has received speaking honoraria from Boston Scientific; he has served as a proctor for Rotablator for Boston Scientific; and he has served as a consultant for Boston Scientific. Dr. Jinnouchi and Dr. Taniguchi have received speaking honoraria from Boston Scientific. Dr. Yamamoto has received speaking honoraria from Boston Scientific, and has served as a consultant for Boston Scientific.

Figures

Fig. 1
Fig. 1
Patient flow diagram. CT computed tomography, PCI percutaneous coronary intervention, RA rotational atherectomy, IVUS intravascular ultrasound, OCT optical coherence tomography
Fig. 2
Fig. 2
Incidence of slow flow just after rotational atherectomy between the short single session and long single session groups. Fischer’s exact test
See this image and copyright information in PMC

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