Comparative efficacy of two paclitaxel-coated balloons with different excipient coatings in patients with coronary in-stent restenosis

Colleran, Roisin; Joner, Michael; Kufner, Sebastian; Altevogt, Felix; Neumann, Franz‐Josef; Abdel‐Wahab, Mohamed; Bohner, Janika; Valina, Christian; Richardt, Gert; Zrenner, Bernhard; Cassese, Salvatore; Ibrahim, Tareq; Laugwitz, Karl‐Ludwig; Schunkert, Heribert; Kastrati, Adnan; Byrne, Robert A.

doi:10.1016/j.ijcard.2017.11.076

Cited by 17 publications

(3 citation statements)

References 25 publications

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“…This device has been proven to be noninferior to new generation DESs in terms of 6-month MLD and also showed no significant differences in clinical end points, including target vessel revascularization, up to 12 months 8 . However, BTHC-based Pantera Lux DCB is a valid alternative, commonly used in Europe: Colleran et al 16 showed no significant difference in angiographic and clinical follow-up at 1 year between iopromide and BTHC-DCB; Assadi-Schmidt et al 17 reported lower rates of adverse events at 3-year follow-up in patients with ISR treated with the BTHC-DCB compared with iopromide-DCB, which was mainly driven by a lower rate of TLR.…”

Section: Discussionmentioning

confidence: 99%

“…With regard to lesion preparation, as it is mandatory in the DCB approach, in this study it was strongly recommended (obtaining 93% of lesion preparation with the standard/cutting balloon). Although the DCB approach, over time, will avoid additional layers of stent, 16 on the other hand, as indicated in the international guideline, in patients with recurrent episodes of diffuse ISR, CABG should be considered before a new PCI attempt. In our study, this choice was left to the investigator after evaluation of the lesion complexity and patient diseases.…”

Section: Discussionmentioning

confidence: 99%

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

Galli

Troiano

Tespili

et al. 2021

Journal of Cardiovascular Medicine

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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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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

Galli

Troiano

Tespili

et al. 2021

Journal of Cardiovascular Medicine

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“…There are a number of alternative DEB devices that are available for DES-ISR. Colleran et al [ 41 ] compared two different kinds of paclitaxel-coated balloons for DES-ISR; the results demonstrated that the clinical outcomes including TLR ( P =0.91), ACD ( P =0.73), MI ( P =0.73), ST ( P =0.34), and MACEs ( P =0.91) at 1 year were similar between the BTHC-based PEB group and iopromide-based PEB group. In a multicenter randomized trial enrolling 50 patients with DES-ISR, the incidence of TLR, ACD, ST, and MACES up to 12 months did not differ between the sirolimus-coated balloon group and paclitaxel-coated balloon group [ 42 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes of Drug-Eluting versus Bare-Metal In-Stent Restenosis after the Treatment of Drug-Eluting Stent or Drug-Eluting Balloon: A Systematic Review and Meta-Analysis

Yang

Liu

et al. 2020

Journal of Interventional Cardiology

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Background. Although drug-eluting stents (DES) have reduced the rates of in-stent restenosis (ISR) compared with bare-metal stents (BMS), DES related ISR (DES-ISR) still occurs and outcomes of DES-ISR remain unclear. The objective of this meta-analysis was to investigate the long-term clinical outcomes of patients with DES-ISR compared with patients with BMS related ISR (BMS-ISR) after the treatment of DES or drug-eluting balloon (DEB). Methods and results. We searched the literature in the main electronic databases including PUBMED, EMBASE, Cochrane Library, and Web of Science. The primary endpoints were target lesion revascularization (TLR) and target vessel revascularization (TVR). The secondary endpoints included all cause death (ACD), cardiac death (CD), myocardial infarction (MI), stent thrombosis or re-in-stent restenosis (ST/RE-ISR), and major adverse cardiovascular events (MACEs). A total of 19 studies with 6256 participants were finally included in this meta-analysis. Results showed that the rates of TLR (P<0.00001), TVR (P<0.00001), CD (P=0.02), ST/RE-ISR (P<0.00001), and MACEs (P<0.00001) were significantly higher in the DES-ISR group than in the BMS-ISR group. No significant differences were found between the two groups in the rates of MI (P=0.05) and ACD (P=0.21). Conclusions. Our study demonstrated that patients with DES-ISR had worse clinical outcomes at the long-term follow-up than patients with BMS-ISR after the treatment of DES or DEB, suggesting that DES and DEB may be more effective for BMS-ISR than that for DES-ISR. Positive prevention of DES-ISR is indispensable and further studies concentrating on detecting the predictors of outcomes of DES-ISR are required.

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A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB)

Sun

et al. 2021

Cathet Cardio Intervent

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Objectives: This study sought to compare the efficacy and clinical safety of the LONGTY drug-coated balloon (DCB) with those of SeQuent Please DCB in patients with in-stent restenosis (ISR).Background: Although DCB technologies have evolved, little is known about the clinical efficacy of the new-generation LONGTY DCB.Methods: This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow-up.Results: A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow-up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority <.001). The target lesion revascularization rates at 1 year

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Comparative efficacy of two paclitaxel-coated balloons with different excipient coatings in patients with coronary in-stent restenosis

Cited by 17 publications

References 25 publications

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

Clinical Outcomes of Drug-Eluting versus Bare-Metal In-Stent Restenosis after the Treatment of Drug-Eluting Stent or Drug-Eluting Balloon: A Systematic Review and Meta-Analysis

A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs. SeQuent Please DCB)

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