Background:
There are limited data on the use of DCB in calcified lesions. In particular, evidence regarding the use of cutting balloon before DCB angioplasty is scarce.
Methods:
We retrospectively analyzed our internal registry between May 2017 and May 2023 to retrieve intrastent restenosis angioplasty performed with DCB. We divided our population according to the use of cutting balloon as debulking technique before DCB. The objective of the study was to compare the two population in term of procedural success (primary endpoint defined as absence of flow-limiting dissection or residual stenosis>30% or bail-out to stent strategy) and 6 months target lesion revascularization (secondary endpoint).
Results
Between May 2017 and May 2023 one hundred and six (106) ISR were treated with DCB-angioplasty at our center: twenty-four were prepared with cutting-balloon, mostly because of high calcification burden, while eighty-two only with conventional NC balloon before DCB strategy.
Procedural success was achieved in all patients analyzed (100%). Therefore, there were no differences in procedural success between the two groups.
In the cutting balloon group, mainly for unstable angina, a new angiography was performed for 4 patients: one underwent target vessel revascularization (4.1%) while three target lesion revascularizations (12.5%).
In the second group, seven out of 82 presented stable angina and needed new angiography resulting in target lesion revascularization (9,1%) due to severe ISR (two underwent surgical revascularization, five percutaneous with DCB).
Therefore, cutting balloon was not associated with increased TLR (HR 2.7; 95% CI 0.70-10.52; p 0.147).
Conclusion
Lesion preparation with cutting balloon represent a valid strategy in the setting of in stent restenosis before DCB angioplasty in term of procedural success and 6 months risk for target lesion revascularization. Our monocentric registry presents the limitation of a small number which did not allow for any adjustment and a short follow up period but provides an overview of a real-world experience.
