Use of Paclitaxel-Eluting Technologies in the Femoropopliteal Segment Under Scrutiny Over Possible Link to Late All-Cause Mortality: Time to Panic or an Opportunity to Resurge?

Fanelli, Fabrizio; Cortese, Bernardo; Zeller, Thomas

doi:10.1177/1526602818824682

Cited by 11 publications

(7 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Remarkably, Katsanos considered death from all causes as primary safety measure ignoring the relationship between the procedure and the event. 21 These results are in line with other reports. More notably, and importantly for greater use of the therapy, our 1-year patency rates were greater than those reported in most earlier studies.…”

Section: Discussionsupporting

confidence: 93%

Drug-coated balloon angioplasty in failing haemodialysis arteriovenous shunts: 12-month outcomes in 200 patients from the Aperto Italian registry

et al. 2019

View full text Add to dashboard Cite

Background: We evaluated the safety and technical and clinical outcomes of angioplasty with a drug-coated balloon for the management of venous stenosis in arteriovenous grafts and arteriovenous fistulas in patients undergoing haemodialysis. Methods: Data were obtained from an ongoing prospective, non-randomised registry conducted at three Italian centres. Patients were treated with a drug-coated balloon according to standard procedures in each participating centre. Evaluation was by colour Doppler imaging every 3 months. The primary end-point was primary assisted patency. The secondary end-point was the rate of assisted patency of the vascular access. Results: A total of 311 angioplasty procedures in 200 patients, (60.4% male), were analysed. The procedural success rate was 100%. A total of 192 treatments of restenosis were necessary in 81 patients during average 21 ± 8 months follow-up. Kaplan–Meier estimates indicated that 88.0%, 64.2% and 40.6% of treated lesions were free from restenosis at 6, 12 and 24 months, respectively. Including multiple angioplasty, circuit patency rates were 99.2%, 92.5% and 84.8% at 6, 12 and 24 months, respectively. Primary patency rates were highest in shunts treated de novo with drug-coated balloons. Risk of restenosis was associated with circuit age (p = 0.017), history of treatment with conventional angioplasty (p < 0.001) and the kind of balloon used during pre-dilation (p = 0.001). Conclusion: The results suggest that favourable long-term patency rates can be achieved with the drug-coated balloon in a varied population of patients with failing haemodialysis arteriovenous shunts treated under conditions of actual care.

show abstract

Section: Discussionsupporting

confidence: 93%

Drug-coated balloon angioplasty in failing haemodialysis arteriovenous shunts: 12-month outcomes in 200 patients from the Aperto Italian registry

et al. 2019

View full text Add to dashboard Cite

show abstract

“…However, further studies are of course required to better understand the potential risks of these devices. 29 Discussion among specialists and key opinion leaders is still open to fully understand if there is any direct correlation between mortality and the application of intra-arterial paclitaxel in the periphery. The drug dose, the drug formulation, the excipient, and the exposure time are still in debate.…”

Section: Discussionmentioning

confidence: 99%

“…However, further studies are of course required to better understand the potential risks of these devices. 29…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2019

Self Cite

View full text Add to dashboard Cite

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.

show abstract

“…There are numerous arguments put forth [8][9][10][11][12][13][14] to counter the Katsanos meta-analysis 1 for those who simply do not believe or refuse to accept the results, for example, lack of standardization between trial endpoints preventing meaningful data comparison, lack of patient-level outcome, merging of DCB and DES device outcomes, lack of correlation between paclitaxel dose and mortality, and a paucity of longterm follow-up data for most of the included trials (100% at 12 months, 43% at 2 years, and only 10% at 4-5 years). Clearly these RCTs were never designed or powered to look at mortality outcomes in the first instance.…”

mentioning

confidence: 99%

What Now for the Endovascular Community After the Paclitaxel Mortality Meta-Analysis: Can Sirolimus Replace Paclitaxel in the Peripheral Vasculature?

et al. 2019

View full text Add to dashboard Cite

Use of Paclitaxel-Eluting Technologies in the Femoropopliteal Segment Under Scrutiny Over Possible Link to Late All-Cause Mortality: Time to Panic or an Opportunity to Resurge?

Cited by 11 publications

References 30 publications

Drug-coated balloon angioplasty in failing haemodialysis arteriovenous shunts: 12-month outcomes in 200 patients from the Aperto Italian registry

Drug-coated balloon angioplasty in failing haemodialysis arteriovenous shunts: 12-month outcomes in 200 patients from the Aperto Italian registry

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

What Now for the Endovascular Community After the Paclitaxel Mortality Meta-Analysis: Can Sirolimus Replace Paclitaxel in the Peripheral Vasculature?

Contact Info

Product

Resources

About