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Observational Study
. 2021 Jun 1;22(6):469-477.
doi: 10.2459/JCM.0000000000001127.

Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study

Stefano Galli  1 , Sarah Troiano  1 , Maurizio Tespili  2 , Alfonso Ielasi  2 , Giampaolo Niccoli  3 , Luigi Sommariva  4 , Francesco Amico  5 , Giampaolo Pasquetto  6 , Roberto Ceravolo  7 , Daniele Forlani  8 , Marco Contarini  9 , Martina Del Maestro  10 , Piero Montorsi  1
Affiliations
Observational Study

Results of paclitaxel-drug-coated balloons (Pantera Lux) for coronary in-stent restenosis: Italian experience from REGistry of Paclitaxel Eluting Balloon in ISR study

Stefano Galli et al. J Cardiovasc Med (Hagerstown). .

Abstract

Aims: Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment.

Methods: One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year.

Results: A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE.

Conclusion: Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).

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References

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