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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

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]
Chart for the conclusion on evidence for ISR

THINK ABOUT…

Clinical evidence on drug coated balloons and learn more about the “Best investigated DCB”. [7]

Find out more

[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)