Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial

Abstract

Background: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. Methods: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. Results: The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone ( P =0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P =0.475), respectively. At 1 year, the TLR rates were 30% (n=10) versus 43% (n=12; P =0.308), the median in Rutherford-Becker class was 2 (0.25–5) versus 5 (0.25–5; P =0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P =0.618) in the DA+DCB group and the DCB group, respectively. Conclusions: Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01763476.

The efficacy and safety of different endovascular modalities for infrapopliteal arteries lesions: A network meta-analysis of randomized controlled trials

“…The results of 12-month TLR rates were also reported in fourteen RCTs ( 6 – 8 , 14 , 15 , 17 , 19 – 21 , 24 – 28 ) involving eight endovascular modalities ( Figure 3D ). No significant inconsistency was found by node-splitting analysis (all p -value > 0.999), and the loop-specific analysis found no loops.…”

“…The results of 6-month primary patency (restenosis <50%) rates were reported in eleven studies ( 6 – 8 , 14 , 18 , 22 , 26 , 27 , 29 – 31 ) involving seven endovascular modalities ( Figure 3A ). No significant inconsistency was found by node-splitting analysis (all p -value > 0.326).…”

“…Fourteen studies ( 6 – 8 , 14 , 15 , 17 – 19 , 21 , 23 – 25 , 27 , 28 ) reported the results of seven endovascular modalities for 12-month major amputations ( Figure 3E ). The node-splitting analysis did not yield significant results (all p -value > 0.999), and the loop-specific analysis found no closed loop.…”

“…Currently, there are four main types of ADs available, including: orbital, rotational, directional, and laser, but only three RCTs involving orbital atherectomy (OA) or directional atherectomy (DA) for IPOD have been published. RCTs of Zeller et al and Rastan et al reported that the efficacy and safety of adjunctive ADs (OA and DA) were similar rather than significantly better than that of DCB alone, and inadequate sample size may be an important reason for limiting the significant advantage of ADs ( 8 , 14 ). However, Zeller et al also found that the 6 and 12-month primary patency of OA + DCB were numerically higher ( p -value = 0.065, 0.076), which showed a trend of statistical difference.…”

Impact of “black rock” on clinical outcomes after endovascular therapy for de novo calcified femoropopliteal lesions

“…In fact, post%DS was signi cantly higher in the BR (+) group. To overcome this, it seems necessary to use devices that can perform lesion modi cation such as JETSTREAM, orbital atherectomy, SilverHawk/TurboHawk, and lithotripsy balloon [12][13][14][15]. Furthermore, it may be effective to use the ARCADIA technique, which involves guidewire passage through the calci ed mass and performing balloon dilatation from the inside [16].…”