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Drug Coated Balloon

The Class 1A ESC recommendation for DCB in ISR

Based on studies which were mainly performed with SeQuent® Please/NEO coating technology (PACCOCATH®)

European Society of Cardiology

The European Society of Cardiology (ESC) recommends the usage of drug coated balloons (DCB) to treat coronary in-stent restenosis (within BMS or DES) with its highest possible evidence class: 1A. [1]

In its recommendation, the ESC considers studies which were performed in its majority with the SeQuent® Please product family. As there are different DCB technologies on the market, the ESC indicated that a class effect for all DCBs cannot be assumed. [1]

Chart for the Class 1A ESC recommendation for drug coated balloons in ISR

Therefore, it might be concluded that the ESC recommendation is based on the SeQuent® Please coating technology.

Extract from studies used in the ESC recommendations [1] referring to the coating (PACCOCATH®-Technology) of SeQuent® Please product family for the usage in in-stent restenosis (ISR) treatment:

PACCOCATH ISR I [2] and II [3]

Randomised Controlled Trial in a total of 108 patients shows

  • Superiority for DCB vs. POBA in BMS-ISR after 6 months [2]  and 5 years [3]
  • In-Segment LLL @ 6-month: 0.11 ± 0.44 mm [2]
  • Binary Restenosis Rate In-Segment @ 6-month: 3 / 54 (6%) [2]
  • MACE @ 5-year: 27.8% [3]
  • TLR @ 5-year: 9.3% [3] 

PEPCAD II [4] 

Randomised Controlled Trial in a total of 130 patients shows

  • As least as efficient than DES usage in BMS-ISR [4]
  • In-Segment LLL @ 6-month 0.17 ± 0.42 mm [4]
  • Binary Restenosis Rate In-Segment: 4 / 57 (7%) [4]
  • MACE @ 12-month: 9% [4]
  • TLR @ 12-month: 6% [4]

PEPCAD-DES [5]

Randomised Controlled Trial in a total of 110 patients demonstrates

  • Superiority for DCB vs. POBA in DES-ISR
  • In-Segment LLL @ 6-month 0.43 ± 0.61 mm [5]
  • Binary Restenosis Rate In-Segment: 17.2% [5]
  • Significant lower MACE for DCB [5]

Kurashiki [6]

Randomised Controlled Trial in a total of 74 patients shows

  • Superiority for DCB vs. POBA in DES-ISR [6]
  • In-Segment LLL @ 6-month 0.18 ± 0.45 mm [6]
  • Binary Restenosis Rate In-Segment: 2 / 23 (8.7%) [6]
  • TLR @ 6-month: 4.3% [6]
Chart for the conclusion on evidence for ISR

Follow-up data after treatment with SeQuent® Please BMS-ISR and DES-ISR are available from 6 months [3], [4], [5], [6] up to 5 years. [3]

THINK ABOUT…

Clinical evidence on drug coated balloons and learn more about the “Best investigated DCB”. [7]
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[1] Neumann FJ et al. ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. 

[2] Scheller B et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med 2006;355:2113–2124.

[3] Scheller B et al. Long-term follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. JACC Cardiovasc Interv. 2012;5:323-30.

[4] Unverdorben et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. EuroIntervention. 2015;11:926-934.

[5] Rittger H et al. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis. JACC. 2012;59:1377-82.

[6] Habara S, Mitsudo K, Kadota K, et al. Effectiveness of paclitaxel-eluting balloon catheter in patients with sirolimus-eluting stent restenosis. JACC Cardiovasc Interv. 2011;4:149-54.

[7] All numbers referring to clinical coronary trials on PCBs, patients enrolled therein and countries in which these trials were conducted, are based on a PubMed literature search conducted with due diligence in February/March 2022. (Data on file at B. Braun)