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

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).

Coronary artery disease: novel insights in a long-standing disease

“…An interim analysis of 12-month follow-up showed a good performance of this device, along with an adequate safety profile 33 . The Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study) included patients treated with paclitaxel DCBs (Pantera Lux, Biotronik) 34 . Even the results of this study confirmed the efficacy and safety of DCBs treatment, showing excellent performances up to 5 years after the procedure.…”

“…Even the results of this study confirmed the efficacy and safety of DCBs treatment, showing excellent performances up to 5 years after the procedure. Drug-coated balloons have several advantages as compared with DES such as avoiding multiple strut layers, shorter dual antiplatelet therapy and subsequently fewer bleeding complications, and are theoretically repeatable several times 34 …”

“…Drugcoated balloons have several advantages as compared with DES such as avoiding multiple strut layers, shorter dual antiplatelet therapy and subsequently fewer bleeding complications, and are theoretically repeatable several times. 34 Dual antiplatelet therapy is essential to prevent thrombotic events after PCI. In a single-arm crossover platelet reactivity study, platelet function was assessed by impedance aggregometry after 30-90 days of therapy with acetylsalicylic acid and ticagrelor and over 15 days after switching to prasugrel.…”

Intravascular ultrasound-guided ‘OrbiTripsy’ for a severely calcified neo-atherosclerotic coronary in-stent restenosis

“…Refractory ISR represents a major problem in CCS patients and its optimal management is still a matter of debate. Drug-coated balloons are safe and effective 1,2 ; however, in the setting of calcified neo-atherosclerosis, plaque-modifying tools (such as IVL and rotational atherectomy) can be needed. Sometimes, therapeutic combinations are required 3 .…”