Response by Schneider et al to Letter Regarding Article, “Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial”

Abstract

E ndovascular intervention has become the primary mode of revascularization for patients with symptomatic femoropopliteal peripheral artery disease. Multiple modalities of treatment exist; however, the mainstay is percutaneous transluminal angioplasty (PTA) and implantation of a bare metal stent (BMS). 1 Angioplasty, though effective in luminal gain, has been associated with restenosis rate of up to 60% at 12 months. 2,3 Although implantation of a BMS has been shown to reduce this restenosis rate by nearly half, 2-7 BMSs are associated with inherent problems, including in-stent restenosis, thrombosis, and stent fracture. 8-10 See Editorial by Sethi and Parikh To overcome the limitations of standard interventions such as PTA or BMSs, drug-coated balloons (DCBs) were developed in hopes of improved patency over the long term,

Drug‐coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta‐analysis of randomized controlled trials

“…The nonsignificant RR of mortality was 1.33 with a CI that crossed null ( P = 0.08) and the trend became less apparent with omission of data from the THUNDER study which carried the greatest relative strength. Our findings are consistent with findings from the IN PACT SFA trial which found no association between paclitaxel‐coated balloon use and mortality. Interestingly a recent meta‐analysis published by Katsanos et al compared paclitaxel devices (both stents and balloons) in FPD to nondrug‐coated treatment device and reported higher mortality both at 2‐year and 5‐year follow‐up.…”

“…Primary patency rates (freedom from TLR) at 1 follow‐up were significantly higher in patients with Lutonix DCB when compared to POBA (65.2% vs. 52.6%, P = 0.02). IN PACT Admiral SFA (Medtronic, Minneapolis, MN) prospective single blind RCT trial compared paclitaxel‐coated DCB versus POBA for treatment of FPD . Primary patency rates (82.2% vs. 52.4%; P < 0.001) were higher and clinically driven TLR (2.4% vs. 20.6%; P < 0.001) was significantly lower in patients with DCB when compared to POBA at 12 months.…”

“…Treatment options for femoropopliteal disease (FPD) include medical therapy and surgical or endovascular revascularization. Plain balloon angioplasty (POBA) remains the initial endovascular therapy for symptomatic patients with FPD but given primary patency rates of only 55%, it is rarely adequate as a stand‐alone treatment . Provisional stenting has improved this patency rate to almost 80% at 12 months but the risk of stent fracture and in‐stent restenosis (ISR) limit long‐term patency and make repeat interventions more challenging.…”

“…Drug‐coated balloons (DCBs) were then introduced to overcome the limitations of stents, while maintaining the ability to deliver anti‐proliferative therapies to limit restenosis. Revascularization of FPD with DCB has been shown to improve primary patency and reduces target lesion revascularization (TLR) . However, a recent study suggested that there may be increased all‐cause mortality in patients with FPD who are treated with paclitaxel devices (DCB and drug eluting stents) .…”

Is the S.M.A.R.T® stent the smart option to treat femoropopliteal disease?

“…However, whether stents should be first‐line treatment for PVD is questionable. The recently published IN.PACT SFA trial showed for the treatment of femoropopliteal disease, the paclitaxel‐coated DEB had significantly higher patency and a lower rate of repeat interventions compared to balloon angioplasty. The average lesion treated in the DEB group was 89.4 mm; at 3 years, the target vessel patency was 69.5%, and freedom from clinically driven TLR was 84.5% in the DEB group.…”