Drug Coated Balloons: Link between Femoropopliteal Lesion Calcification Grade and Clinical Outcomes

At present, the use of drug coated balloons (DCB) in femoropopliteal territory is more and more frequent. However, when it comes to treating moderate to severe calcification, the evidence is still limited.

Balones cubiertos de fármacos: relación entre grado de calcificación en lesiones femoropopliteas y sus resultados clínicos

Using a peripheral artery calcification scoring system (PACSS) has been associated to clinical outcomes after DCB angioplasty for femoropopliteal lesions.

The system categorizes lesions into 5 grades (Grade 0: no visible calcification of the target lesion; Grade 1: unilateral wall calcification < 5 cm; Grade 2: unilateral calcification ≥ 5 cm; Grade 3 bilateral wall calcification < 5 cm; Grade 4 bilateral calcification ≥ 5 cm).

The aim of this retrospective study was to assess the link between PACSS score severity and clinical outcomes after DCB in femoropopliteal territory.

Primary end point was primary patency at one year.

The study looked at 626 patients with intermittent claudication undergoing DCB angioplasty in de novo femoropopliteal lesions between 2017 and 2021 in Japan. Mean age was 74 and patients were mostly men. The most frequent clinical presentation across all grades was Rutherford 3.

Distribution according to PACSS was: grade 0 in 38%, grade 1 in 17%, grade 2 in 7%, grade 3 in 16%, and grade 4 in 23% of cases. 1-year primary patency rates were 88%, 89%, 71%, 96%, and 82%, respectively (p < 0.001). PACSS grade 4 was significantly associated with increased risk of restenosis (HR: 1.82, 95% CI 1.15-2.87, p = 0.010).

Conclusion

PACSS grade 4, bilateral calcification > 5 cm, was significantly associated to worse clinical outcomes after angioplasty with DCB in femoropopliteal lesions.