This article was originally published here
J Endovasc Ther. 2022 Feb 7: 15266028221075563. doi: 10.1177/15266028221075563. Online ahead of print.
INTRODUCTION: The combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, 12-month performance data for this treatment option are lacking. This study reports the results of IVL and DCB angioplasty for calcified femoropopliteal disease.
Methods: Patients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included in this study. The primary endpoint of this analysis was primary patency. Secondary patency, absence of target lesion revascularization (TLR), and overall mortality were also analyzed.
RESULTS: Fifty-five (not = 55) patients and 71 lesions were analyzed. Most patients had long-term limb-threatening ischemia (not = 31.56%), 47% (not = 26) were diabetic and 66% (not = 36) had long-term kidney disease. The median length of the lesions was 77 mm (interquartile range: 45-136) and 20% (not = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (not = 16) and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (not = 55) of treated lesions. Technical success after IVL was 87% (not = 62) and 97% procedural success (not = 69). Flow-limiting dissection was observed in 2 cases (3%). The target lesion perforation and distal embolization rates were 1% (not = 1). A rescue scaffold was deployed in 5 lesions (7%). At 12 months, the Kaplan-Meier estimate of primary patency was 81%, absence of TLR was 92%, and secondary patency was 98%. Overall survival was 89%, while freedom from major amputation was 98%. The presence of eccentric, CTO, or PACSS class 4 disease did not increase the risk of loss of patency or TLR.
CONCLUSIONS: In this difficult cohort of patients, the use of VILI and DCB for calcified femoropopliteal lesions was associated with promising results over 12 months and an excellent safety profile.