Drug‐Coated Balloon and Drug‐Eluting Stent Safety in Patients With Femoropopliteal and Severe Chronic Kidney Disease

BACKGROUND: Patients with severe‐stage chronic kidney disease (CKD) were excluded from femoropopliteal disease trials evaluating drug‐coated balloons (DCBs) and drug‐eluting stents (DESs) versus plain balloon angioplasty (POBA) and bare metal stents (BMSs). We examined the interaction between CKD status and device type for the association with 24‐month all‐cause mortality and major amputation risk. METHODS AND RESULTS: We studied patients undergoing femoropopliteal interventions (September 2016–December 2018) from Medicare‐linked VQI (Vascular Quality Initiative) registry data. We compared outcomes for: (1) early‐stage CKD (stages 1–3) receiving DCB/DES, (2) early‐stage CKD receiving POBA/BMS, (3) severe‐stage (4 and 5) CKD receiving DCB/DES, and (4) severe‐stage CKD receiving POBA/BMS. We studied 8799 patients (early‐stage CKD: 94%; severe‐stage: 6%). DCB/DES use was 57% versus 51% in patients with early‐stage versus severe‐stage CKD. Twenty‐four‐month mortality risk for patients with early‐stage CKD receiving DCB/DES (reference) was 21% versus 28% (hazard ratio [HR], 1.47 [95% CI, 1.31–1.65]) for those receiving POBA/BMS; patients with severe‐stage CKD: those receiving DCB/DES had a 49% (HR, 2.61 [95% CI, 2.06–3.31]) mortality risk versus 52% (HR, 3.64 [95% CI, 2.91–4.55]) for those receiving POBA/BMS (interaction P<0.001). Adjusted analyses attenuated these results. For severe‐stage CKD, DCB/DES versus POBA/BMS mortality risk was not significant at 24 months (post hoc comparison P=0.06) but was higher for the POBA/BMS group at 18 months (post hoc P<0.05). Patients with early‐stage CKD receiving DCB/DES had the lowest 24‐month amputation risk (6%), followed by 11% for early‐stage CKD‐POBA/BMS, 15% for severe‐stage CKD‐DCB/DES, and 16% for severe‐stage CKD‐POBA/BMS (interaction P<0.001). DCB/DES versus POBA/BMS amputation rates in patients with severe‐stage CKD did not differ (post hoc P=0.820). CONCLUSIONS: DCB/DES versus POBA/BMS use in patients with severe‐stage CKD was associated with lower mortality and no difference in amputation outcomes.