Original title: Paclitaxel – coated balloon catheter compared with drug- eluting stent for drug-eluting stent restenosis in routine clinical practice. Reference: SeijiHabara et al.EuroIntervention 2015; 10-online publish-ahead-of-printFebruary 2015.
The paclitaxel coated balloon catheter (PCB) is not inferior to DES for the treatment of instent restenosis (IRS). The aim of this study is to compare the efficacy of the paclitaxel-coated balloon (PCB) vs. repeat DES for the treatment of DES instent restenosis.
The study is analytical, retrospective and unicenter. 685 patients with ISR were included. 260 patients with 306 lesions were treated with PCB and 425 patients with 471 lesions received DES. Angiographic follow up was performed between 6 and 8 months and later at 12 months.
The primary end point was the presence of binary restenosis. Secondary end points included: new revascularization, cardiac death, myocardial infarction, instent thrombosis, and late lumen loss.
There were no significant differences with respect to instent restenosis between both groups (23.5 % vs 25.9%, p=0.48). Revascularization incidence by lesion and by patient did not show significant differences (by lesion: 15.7% in the PCB group and 20.3% in the DES group, p =0.13; by patients: 16.7% in the PCB group and 19.4% in the DES group DES, p=0.41). There was a significant difference in late lumen loss (0.34 +/- 0.57 mm in the PCB group vs. 0.68 +/- 0.76 mm in the DES group (p<0.001). There were no significant differences in clinical end points.
In patients with non-focal ISR and in bifurcation patients, late lumen loss ,new IRS and new revascularization saw a significant difference in favor of PCB (0.38 +/-0.56 mm vs 0.89+/-0.88 mm p<0.001 ; 25.4% vs 40.9% p<0.002 ; 17.5% vs 31.2% p=0.003 respectively).
Conclusion
There were no significant clinical or angiographic differences in the treatment of ISR with the use of PCB vs. DES. The use of PCB could be beneficial for diffuse and bifurcation IRS.
Editorial Discussion
We consider several aspects of the present study to be worth noting:
- It includes real patients from a “real world” and uses PCB or any DES to treat any DES, and this fact did not produce different outcomes.
- It reinforces the use of PCB for the treatment of IRS, in accordance with the 2014 European Revascularization Guidelines that states this treatment as IA.
- It contributes to the evidence in favor of the use of PCB for the treatment of ISR in complex situations.
Courtesy of Drs. Juan Pablo Bachini and Pedro Trujillo.
Montevideo. Uruguay.
Dres. Juan Pablo Bachini y Pedro Trujillo