Shockwave Medical announced today that long-term data from the Disrupt PAD III trial found that superior vessel preparation with intravascular lithotripsy (IVL) led to excellent long-term outcomes out to two years with preservation of future treatment options compared to percutaneous transluminal angioplasty (PTA) in the treatment of calcified peripheral arterial disease (PAD).
The final outcomes of what Shockwave claims to be the largest randomised trial of severely calcified peripheral lesions were presented by investigators today in a featured clinical research session at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions (19–22 May, Atlanta, USA) and published simultaneously in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI).
As previously published, IVL at 30 days demonstrated superiority over PTA in the primary endpoint analysis, defined as procedural success with a residual stenosis less than or equal to 30% without flow-limiting dissection, prior to drug-coated balloon (DCB) or stent, with a rate of 65.8% vs. 50.4% (p=0.0065) as determined by an independent angiographic core lab. Additionally, PAD III showed that IVL achieved a reduction in frequency and severity of flow-limiting major dissections (1.4% vs. 6.8%, p=0.03), a reduction in stent implantation rate (4.6% vs. 18.3%, p<0.001) and no distal embolisation or perforation events.
These new long-term results found that the powered secondary endpoint of primary patency (defined as freedom from clinically-driven target lesion revascularisation [CD-TLR], restenosis determined by duplex ultrasound and provisional stenting) favoured IVL over PTA at one year (80.5% vs. 68.0%, p=0.017) and remained favourable through two years (Kaplan-Meier estimate: 74.4% vs. 57.7%, p=0.005), respectively.
“Prior to the PAD III study, there were limited long-term data available to provide treatment guidance for this challenging population since patients with severe calcification have historically been excluded from endovascular trials,” said William Gray (Main Line Health, Wynnewood, USA), co-principal investigator of PAD III who presented the long-term results. “The primary endpoint at 30 days showed IVL to be a superior vessel preparation strategy by demonstrating stenosis resolution with significantly fewer complications including severe dissections and the subsequent need for bailout stent implantation. Avoiding unplanned stent implantations allows interventionalists to preserve all their future treatment options should reintervention be necessary. These new long-term data show that vessel preparation with IVL followed by DCB result in excellent efficacy and durable patency out to two years, and taken together the acute and long-term results reinforce IVL as a preferred vessel preparation strategy for calcified femoropopliteal disease.”
Disrupt PAD III was a prospective, multicentre, randomised study designed to demonstrate the safety and effectiveness of IVL as a vessel preparation procedure in moderate to severely calcified superficial femoral and popliteal lesions, followed by a DCB or stent. The study enrolled 306 patients randomised between IVL and PTA at 45 sites in the USA, Germany, Austria, and New Zealand. In the IVL arm, 82.9% of patients were classified by the angiographic core lab as having severe calcification, with an average calcified lesion length of 129.4mm. Joining Gray as co-principal investigator of the study was Gunnar Tepe (RoMed Clinic Rosenheim, Rosenheim, Germany).