Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency

Abstract

Background—Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB.Methods and Results—DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency—A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB (P=0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%; P=0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB (P=0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB (P=0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB (P=0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB (P=0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB (P=0.86).Conclusions—DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted.Clinical Trial Registration—http://www.clinicaltrials.gov. Unique Identifier: NCT01366482.

Novel laser‐based catheter for peripheral atherectomy: 6‐month results from the Eximo Medical B‐Laser™ IDE study

“…Also, no differences in CD‐TLR were noted in patients with calcific atherosclerosis with unusual, very low CD‐TLR across all patient and lesion cohorts. Calcium burden has been demonstrated to impact clinical results with DCB, and vessel preparation to ablate this calcium may improve results particularly in longer lesions . Our current data supports further investigation with debulking of calcific lesions with the B‐Laser™ technology prior to arterial drug delivery.…”

“…Predefined secondary endpoints included ≤30% final residual diameter stenosis (including any adjunctive therapy), with no flow limiting dissection; Freedom from perioperative and up to 30 days device related complications in the target vessel (defined as perforation, dissection, distal embolization, in‐situ thrombus or pseudo‐aneurysm); as well as clinical outcome at 30 days and 6 months compared to baseline, as assessed by WIQ, ABI, Rutherford and duplex ultrasound patency (PSVR < 2.5). All angiographic cines and duplex films were evaluated by the respective core laboratories for the respective endpoints and all endpoints adverse events were adjudicated by CEC.…”

Effect of Paclitaxel+Hirudin on the TLR4-MyD88 Signaling Pathway During Inflammatory Activation of Human Coronary Artery Smooth Muscle Cells and Mechanistic Analysis

“…Compared with conventional paclitaxel-coated stents, paclitaxel elution balloons show major advantages. High liposolubility indicates that paclitaxel is more suitable than other drugs for balloon coating: the paclitaxel on the surface of a balloon can be rapidly taken up by local vascular cells for drug transfer at the time of balloon expansion, which continuously inhibits the proliferation and migration of vascular smooth muscle cells [46,47]. Among various paclitaxel elution balloon products, the most representative are Braun SeQuent®Please balloons (Germany); the anti-restenosis effect of these products has been proven by a series of studies [48,49].…”

SCAI consensus guidelines for device selection in femoral‐popliteal arterial interventions

“…Recently, the DEFINITIVE AR trial (Determination of EFfectiveness of the SilverHawk_ PerIpheral Plaque ExcisioN System (SIlver‐HawkDevice) for the Treatment of Infrainguinal VEssels Antirestenosis) evaluated the use of DA + DCB (Bayer Healthcare's Paccocath®) or DCB alone in 100 patients with lesions between 7 and 15 cm. The trial showed no difference between the two groups with respect to 1‐year CD‐TLR (7.3% for DA + DCB vs. 8.0% for DCB alone) and patency as assessed by DUS (84.6% for DA + DCB vs. 81.3% for DCB alone) .…”