One-Year Clinical Outcome and Risk Factor Analysis of Directional Atherectomy Followed With Drug-Coated Balloon for Femoropopliteal Artery Disease

Abstract

Purpose: This study investigated the 1-year clinical outcomes of directional atherectomy combined with drug-coated balloon (DA + DCB) in femoropopliteal artery disease (FPAD) from real-world experience. Materials and Methods: A retrospective study was conducted of patients treated between July 2016 and June 2019 using DA + DCB for FPAD. Patients’ demographics, comorbidities, clinical characteristics and outcomes, and angiography and duplex ultrasound findings were analyzed. The 6-month and 1-year primary patency, primary assisted patency, secondary patency, and freedom from clinically-driven target lesion revascularization (CD-TLR) were evaluated. Univariate and multivariate analyses were performed to identify risk factors of primary patency loss or CD-TLR. Results: Seventy-nine consecutive patients (83 lesions, mean age 70.9 years, 52 men) were included. Twenty-seven limbs had lifestyle-limiting claudication and 56 limbs had critical limb ischemia. There were 73 and 10 limbs with de novo lesion and in-stent restenosis, respectively. The mean lesion length of all the patients was 22.1 cm. The mean length of chronic total occlusions (CTOs) was 8.3 cm. Severe calcification was found in 32.5% cases. The 1-year primary patency rate was 80.8% and freedom from CD-TLR was 92.2%. The bailout stenting rate was 2.4%. Patients with CTO >10 cm had significantly lower 1-year primary patency rate and freedom from CD-TLR than did patients with CTO ≤10 cm. Total length of CTO (stratified as ≤5 cm, 5–10 cm, >10 cm) was identified as an independent risk factor of 1-year primary patency loss and CD-TLR. Conclusion: DA + DCB appears to be a safe and effective endovascular therapy to treat FPAD in real-world clinical practice, with a promising 1-year patency rate with a low rate of bailout stenting.

Twelve‐month safety and effectiveness of TCD‐17187 drug‐coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery

“…Although these anatomical features have a major impact on loss of primary patency after EVT, 11–15 the 12‐month primary patency in this trial was comparable to that of approved DCBs, demonstrating that the novel technical design and characteristics of the TCD‐17187 DCB ensured a good balance between drug retention during balloon delivery to the lesion and effective drug transit to the vessel wall to optimize drug uptake, achieving durable results without any increased risk of adverse events including the downstream effect adjudicated by core laboratory. Univariate analysis of variables for loss of primary patency revealed that presence of CTO was the sole anatomical factor for loss of patency with an HR of 2.39, which was consistent with the results obtained in other DCB studies, 16,17 while other clinical and lesion factors including vessel diameter, lesion length, and severity of vessel calcification were not statistically significant. These results potentially represent an insight into the specific features of the TCD‐17187 DCB, but the sample size of this trial was limited and these findings need to be confirmed in real‐world practice.…”

The Diagnostic Value of Circulating Biomarkers and Role of Drug-Coated Balloons for In-Stent Restenosis in Patients with Peripheral Arterial Disease

“…There is a focus on more complex and combined techniques for the treatment of ISRs which are producing more encouraging results such as DES, again with major limitations such as a stent length which excludes treating long stenosis. DCB shows superior results compared to traditional re-PTA with a stent and is becoming the technique of choice for ISRs [ 12 , 13 , 14 , 15 , 62 ]. Combined techniques such as laser atherectomy and DCB are also being developed and appear to be candidates to become the reference technique, but adequate studies are warranted [ 1 , 11 , 18 , 19 ].…”

“…In addition to all the data collected on the efficacy of the specific drug, the anatomy of the stenosis should also be carefully considered. Feng et al [ 14 ] specifically evaluated the length of the stenosis by dividing the patients into two main categories. CTO (chronic total occlusion) >10 cm, in the reported analysis.…”

“…Another problem for which we are turning to combined procedures, as described above, is the degree of stenosis or calcification that does not allow for the passage of devices. For this reason, many stenoses or ISRs must be pretreated with traditional balloons to fragment the stenosing plaque, bringing the vessel back to an adequate caliber and allowing the absorption of drugs in situ [ 12 , 13 , 14 , 15 ].…”

“…Angiographic and clinical data highlight the superiority of this technique, and the European clinical practice guidelines endorsed its use in the treatment of ISR (class I, Evidence A) [ 11 , 12 , 13 ]. The DCB is a traditional drug-coated balloon, mainly with Paclitaxel, which significantly improves the short- and medium-term patency of angioplasty by minimizing neo-intimal hyperplasia [ 14 , 15 , 16 , 17 ]. Paclitaxel, with a nominal dose between 2 and 3.5 μg/mm 2 , has lipophilic and hydrophobic properties and, together with a hydrophilic agent, allows the drug to be released to the surface of the artery ( Figure 1 ).…”