Is Paclitaxel Causing Mortality During Lower‐Extremity Revascularization?

Swaminathan, Rajesh V.; Jones, W. Schuyler; Patel, Manesh R.

doi:10.1161/jaha.119.012523

Cited by 12 publications

(7 citation statements)

References 21 publications

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“…The most recent 2019 Global Vascular Guidelines for treating chronic limb-threatening ischemia contain an apparent statement on the uncertain risk and efficacy of these devices, weighing the need to exercise appropriate caution until data from controlled prospective studies are available 20 . Moreover, ongoing trials, such as BASIL-3 (Balloon Versus Stenting in Severe Ischemia of the Leg-3) or SWEDEPAD (Swedish Drug Elution Trial in Peripheral Arterial Disease), have been temporarily paused until this critical issue is resolved 21 .…”

Section: Discussionmentioning

confidence: 99%

Mortality is not associated with paclitaxel-coated devices usage in peripheral arterial disease of lower extremities

Bae

Choi

et al. 2021

Sci Rep

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A recent meta-analysis addressed increased risk of death following revascularization with paclitaxel-coated devices in femopopliteal artery. We evaluated differences in all-cause mortality and amputation free survival between peripheral arterial disease (PAD) patients who were treated with paclitaxel-coated devices and non-paclitaxel-coated devices. This was retrospective population-based cohort study from the National Health Insurance Service claims in South Korea from 2015 to 2019. Multivariate Cox regression analyses after propensity score matching were applied to identify all-cause mortality and amputation-free survival. After propensity score matching, there were 6090 patients per group. The median follow-up days was 580 days (interquartile range [IQR] 240–991 days) and 433 days (IQR 175–757 days) for the non-paclitaxel-coated device group and paclitaxel-coated device group, respectively. Multivariate analysis adjusted for age, sex, diabetes, hypertension, warfarin, and new oral anticoagulants showed that the mortality rate associated with paclitaxel-coated devices was not significantly higher than non-paclitaxel-coated devices (hazard ratio [HR] 0.992; 95% CI 0.91–1.08). The rate of amputation events was higher in patients with paclitaxel-coated devices than those with non-paclitaxel-coated devices (HR 1.614; 95% CI 1.46–1.78). In this analysis, the mortality rate in patients with PAD was not associated with the use of paclitaxel-coated devices, despite a higher amputation rate.

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Section: Discussionmentioning

confidence: 99%

Mortality is not associated with paclitaxel-coated devices usage in peripheral arterial disease of lower extremities

Bae

Choi

et al. 2021

Sci Rep

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“…Although the mechanism by which paclitaxel causes death is not clear, likewise, no evidence of obvious drug-related side effects has been found. Moreover, it is known that the peak systemic blood levels of paclitaxel are insignificantly minimal [ 28 ]. Thus, considering the abovementioned data, DCB can currently be considered safe for at least 2 years.…”

Section: Discussionmentioning

confidence: 99%

Multiple drug-coated balloons can be used effectively for peripheral arterial disease including long femoropopliteal lesions

et al. 2021

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Purpose Drug-coated balloons have shown successful results in treating peripheral arterial occlusive disease. However, using multiple balloons for long femoropopliteal lesions (>15 cm) remains challenging; their safety and efficacy need to be explored. Therefore, we aimed to evaluate the outcomes of multiple drug-coated balloons for long femoropopliteal lesions in terms of the primary patency, freedom from clinically-driven target lesion revascularization, and mortality. Methods Between April 2015 and September 2018, 96 patients (117 limbs) who underwent balloon angioplasty using at least 2 drug-coated balloons for femoropopliteal lesions were retrospectively reviewed. Lesions were classified as Trans-Atlantic Inter-Society Consensus (TASC) classification C or D. The outcomes were analyzed using Kaplan-Meyer analysis. Results The mean age of 96 enrolled patients was 70.8 ± 9.8 years, and 83 patients were males (86.5%). Critical limb-threatening ischemia was found in 29 cases (24.8%). The mean lesion and drug-coated balloon lengths per limb were 292.3 ± 77.8 mm and 325.0 ± 70.2 mm, respectively. The technical success rate was 99.2%. A total of 82.1% were followed-up for more than 6 months. The primary patency rates at 12 and 24 months were 71.4% and 41.7%, respectively; freedom from clinically-driven target lesion revascularization rates were 96.4% and 71.0% at 12 and 24 months, respectively. The Kaplan-Meier estimate of the 2-year overall cumulative mortality rate was 20.8%. All identified mortalities appeared to be less associated with paclitaxel. Conclusion Drug-coated balloons can be effectively used without drug-related mortality, even for long lesions, such as TASC classification C or D femoropopliteal lesions.

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“…The drug dose, the drug formulation, the excipient, and the exposure time are still in debate. [30][31][32] Patient characteristics must also be taken into account. Manufacturers and others have performed independent patient data meta-analyses, 33 examined large populations, 34 and published pooled analyses.…”

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

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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.

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Is Paclitaxel Causing Mortality During Lower‐Extremity Revascularization?

Cited by 12 publications

References 21 publications

Mortality is not associated with paclitaxel-coated devices usage in peripheral arterial disease of lower extremities

Mortality is not associated with paclitaxel-coated devices usage in peripheral arterial disease of lower extremities

Multiple drug-coated balloons can be used effectively for peripheral arterial disease including long femoropopliteal lesions

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

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