Provisional Stenting Using the Zilver PTX Drug-Eluting Stent After Drug-Coated Balloon Angioplasty: Initial Experience From the Double Drug Dose “3D” Study

Abstract

Purpose: To explore the provisional use of a drug-eluting stent (DES) after suboptimal drug-coated balloon (DCB) angioplasty in complex, calcified femoropopliteal lesions. Materials and Methods: A prospective, single-center, investigator-initiated pilot study enrolled 15 patients (mean age 71.3 years; 9 men) with symptomatic stenosis (n=6) or occlusion (n=9) of the native superficial femoral and/or proximal popliteal arteries who experienced suboptimal DCB dilation despite postdilation. Lesion characteristics were evaluated with computed tomography angiography and duplex ultrasound confirmed by intravascular ultrasound. Follow-up included clinical and imaging evaluations as well as blood tests to monitor inflammatory markers. Endpoints included systemic inflammation, acute/chronic thrombosis, aneurysm formation, and mortality. Results: Provisional stenting was required for residual stenosis >50% in 4 cases and flow-limiting dissection in 11. Provisional spot stenting was done using the Zilver PTX DES. Clinical improvement was observed in all cases. After 24-month follow-up all patients were alive and in good clinical condition. One- and 2-year primary patency rates were 93.3% and 92.9%, respectively; secondary patency was 100%. Restenosis required reintervention in 2 cases. No local or systemic complications or toxicity were observed due to the use of a double dose of paclitaxel. No significant increase in any inflammation marker was observed in the perioperative period, and no aneurysm formation was seen over 24 months of follow-up. Conclusion: Combined DCB plus DES therapy seems to be safe and correlated with high primary patency following suboptimal angioplasty. Larger studies are required to confirm the safety and efficacy of this approach.

First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study

“…However, there are only a few randomized studies and comparability is difficult, as patients differ according to their risk factors and lesion characteristics. Prior studies describing the results for PAD patients after endovascular therapy have been published ( 8 – 10 ); however, these studies did not enroll Chinese patients which may limit the direct comparison of the results to the current study.…”

Combined use of drug-coated balloon (DCB) and cutting balloon angioplasty (CBA) in the treatment of acute coronary syndrome

“…Research has found that the incidence of ISR after bare metal stent implantation is about 16 -44 %, while that after drug-eluting stent (DES) implantation is about 5 -15 % [4][5][6][7]. Drug-coated balloon (DCB) is a novel strategy for the treatment of ACS [8], and it represents an effective treatment for patients with re-stenosis after stent implantation [9][10][11][12]. Cutting balloon angioplasty (CBA) enables uniform tearing of atherosclerotic plaques, thereby reducing the occurrence of acute vascular occlusion and reducing mortality [13].…”

Impact of Peak Systolic Velocity Ratio after Drug-Coated Balloon for Femoropopliteal Disease: Three-Month Serial Observation Vessel Echo Study

“…Its primary patency estimates at 1 year range between 73.5% and 91.1%. However, provisional stenting after suboptimal DCB treatment is still necessary in 7.3% to 40%, mainly due to flow-limiting dissection or residual stenosis ( 50%) [1][2][3][4][5] . Currently, insurance operator's discretion.…”