164 - Treatment of Calcified PAD with Shockwave Peripheral Intravascular Lithotripsy System: One Year Outcomes from the DISRUPT BTK II and FORWARD PAD IDE/Mini-S Study

Purpose: Both balloon-based and non-balloon-based intravascular lithotripsy (IVL) have demonstrated favorable acute results when moderate to severe calcium is present in peripheral lesions, with high rates of procedural success and low angiographic complications. The one-year outcomes from the Disrupt BTK II study (balloon-based IVL) and the FORWARD IDE/Mini-S Feasibility trials (non-balloon-based IVL catheter) are reported here.

Materials and Methods: The Disrupt BTK II study enrolled 250 subjects; 200 patients had chronic limb-threatening ischemia (CLTI, Rutherford Category (RC) 4 or 5). The FORWARD PAD IDE/Feasibility trial enrolled 110 patients (RC 3-5). Twelve-month endpoints for Disrupt BTK II included Kaplan-Meier (KM) estimates of freedom from (FF) clinically driven target lesion revascularization (CD-TLR), FF major target limb amputation, primary patency, and change in Rutherford Category. Twelve-month endpoints for the FORWARD PAD IDE/Feasibility studies included major adverse events (MAE), target limb major amputation, and patency, in both above the knee (ATK) and below the knee (BTK) vessels.

Results: Through 12 months of Disrupt BTK II, there were 30 deaths, 18 withdrawals from the study, and 2 subjects were lost to follow up. At 12 months, there was a 67.1% rate of primary patency with a KM FF CD-TLR of 84.5% and KM FF major amputation of 94.8%. There were no amputations in the RC 3 patients. At baseline, 20%, 23%, and 57% of limbs were classified as RC 3, 4, and 5, respectively. At 12 months, RC was substantially improved as 48% were asymptomatic (RC 0) and 15% reported only mild claudication (RC 1).



In the FORWARD PAD IDE/Feasibility at 12-months, there were 10 deaths, 4 withdrawals from the study, and 3 patients were lost to follow up. The 12-month overall rate of MAE was 18.6% (19/102) with 3.9% (4/102) of subjects experiencing cardiovascular death, 1.0% (1/102) with major amputation, and 14.7% (15/102) having CD-TLR. Primary, primary-assisted, and secondary patency in ATK lesions were 72.7%, 74.5%, and 76.4%, respectively. Primary, primary-assisted, and secondary patency in the BTK lesions were 61.5%, 78.4%, and 88.6%, respectively.

Conclusion: IVL demonstrated continued efficacy in both balloon-based and non-balloon-based IVL with low rates of cardiovascular death and major amputation. IVL continues to offer promising mid-term results in challenging patients with moderate to severe calcium, including CLTI. Continued assessment of when to utilize a balloon-based IVL versus a non-balloon-based IVL catheter is ongoing.