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SeQuent® Please vs. POBA (SeQuent® NEO) in small vessel de novo lesions

A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients with small vessel disease

Funatsu A et al. Clin. Res. Cardiol. 2017; 106(10): 824-32

Key findings

TVF was low for treatment of SVD with DCB. In addition, LLL was observed significantly more frequent in the DCB group in comparison to the POBA group.


Design: Randomized | Open-label | Prospective | Multicenter | Superiority (test for difference)

Indication: De novoMain patient inclusion criterion: Reference vessel diameter ≤ 2.75 mm, ≥ 2 mm

Primary endpoint: TVF @ 6-month follow-up. Components of TVF:

  • Cardiac death: Death due to target vessel
  • MI: Creatine phosphokinase (CPK) elevation C3 times the normal value in addition to continuous chest symptoms and electrocardiogram changes due to target vessel
  • Composite events: Revascularization of target vessel (PCI or CABG)

Secondary endpoints:

  • TLR @ 6-month follow-up: Ischemia-driven if the lesion revealed restenosis (DS ≥ 50) associated with symptom or presence of ischemia, or if lesion diameter stenosis > 70% (by core laboratory QCA), even in the absence of clinical or functional ischemia
  • LLL @ 6-month follow-up

DAPT: 6 months


Patients: In total, 135 patients were enrolled and randomized into a DCB group and POBA group with a ratio of 2:1. Some patients were excluded from the trial due to unsuccessful treatment, consent withdrawal and protocol violation. Follow-up was performed in 88 patients from the DCB group and in 39 patients from the POBA group.

Baseline characteristics: The two treatment groups were well balanced. Apart from a higher proportion of diabetes mellitus in the DCB group, there were no statistically significant differences between the two treatment groups.

Primary endpoints: TVF was low in the DCB group

n = 88
n = 39
TVF3.4 %10.3 %0.20
Cardiac death0 %0 %-
MI0 %0 %-
TLR2.3 %10.3 %0.07

Secondary endpoints:

Clinical follow-up
No. of patients8839-
TLR2.3 %10.3 %0.07
Angiographic follow-up
No. of lesions10343-
LLL0.01 ± 0.31 mm0.32 ± 0.34 mm< 0.01