IVL maintains superiority over PTA at 1 year for peripheral artery calcification
In the Disrupt PAD III trial, superior primary patency (PP) was achieved at 1 year with intravascular lithotripsy (IVL) plus a drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) + DCB, confirming the consistent safety and efficacy of IVL to facilitate a durable approach for individuals with heavily calcified femoropopliteal arteries largely without stent requirement.
“This trial offers important new insights because patients with severe peripheral artery disease (PAD) are often excluded from trials, resulting in a very limited amount of randomized data to guide treatment,” said study lead author Dr William Gray from the Lankenau Heart Institute/Main Line Health, Wynnewood, Pennsylvania, US, at SCAI 2022.
A total of 306 participants (mean age 72 years, 73 percent male) with moderate-to-severe (86 percent severe) calcium de novo femoropopliteal arteries were prospectively evaluated. All participants received DCB and were randomized 1:1 to undergo either IVL or PTA.
At 1 year, PP was significantly greater with IVL vs PTA (80 percent vs 68 percent; p=0.017). PP was the powered secondary efficacy endpoint, which was defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and re-stenosis. [SCAI 2022, abstract A-38]
Overall, most participants did not require provisional stenting at index procedure, but the rate was significantly higher in the IVL vs the PTA arm (95 percent vs 82 percent; p<0.0001). Similar rates of freedom from CD-TLR (96 percent vs 98 percent; p=0.94) and binary re-stenosis (90 percent vs 89 percent; p=0.48) were noted between the IVL and the PTA arms.
The superiority of IVL over PTA in terms of PP was sustained at 2 years (74 percent vs 58 percent; p=0.005).
No major adverse events were tied to IVL at 1 year, while two were reported with PTA.
Heavily calcified PAD presents a challenge for endovascular treatment (EVT), as it can lead to poor balloon expansion, acute procedural failure, and dissections. “[It may also] impair effectiveness of DCBs by limiting durability of EVT, [and] stents to address PTA failure may subsequently fracture and complicate future revascularization,” said Gray.
The study has achieved the primary endpoint of procedural success (defined as residual stenosis ≤30 percent without flow-limiting dissection after initial balloon therapy and prior to DCB with or without stenting) and has been previously reported. [JACC Cardiovasc Interv 2021;14:1352-1361]
“[The current findings] demonstrated the utility of IVL, rendering these challenging procedures safe and predictable. This offers patients future treatment pathways without the potential long-term risk of adverse clinical events such as stent fracture and re-stenosis,” he added.
The efficacy and safety of IVL for the treatment of calcified PAD in the real-world setting shall be evaluated in the Disrupt PAD III Observational Study.