Drug Coated Balloon PEPCAD Japan SVD

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PEPCAD Japan SVD

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.

Description

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

Indication: De novo

Main 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

Results

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

  DCB
n = 88
POBA
n = 39
p-value
TVF 3.4 % 10.3 % 0.20
Cardiac death 0 % 0 % -
MI 0 % 0 % -
TLR 2.3 % 10.3 % 0.07

Secondary endpoints:

  DCB POBA p-value
Clinical follow-up 
No. of patients 88 39 -
TLR 2.3 % 10.3 % 0.07
Angiographic follow-up
No. of lesions 103 43 -
LLL 0.01 ± 0.31 mm 0.32 ± 0.34 mm < 0.01
B. Braun Melsungen AG
Sieversufer 8
12359 Berlin
Germany