Slow-flow phenomena following lower limb paclitaxel- and sirolimus-coated balloon angioplasty in the setting of chronic limb threatening ischaemia—a case series

Tang, Tjun Yip; Sulaiman, Muhammad Syadad Bin; Soon, Shereen Xue Yun; Yap, Chun Wei; Patel, Ankur; Chong, Tze Tec

doi:10.21037/qims-21-633

Cited by 11 publications

(8 citation statements)

References 20 publications

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“…Although a strong in vitro adherence of the coating is not inevitably associated with increased in vivo drug transfer into the vessel wall, drug loss might result in both unreliable clinical efficacy and increased risk of distal particulate embolization of amorphous- or crystalline-like material. Downstream loss of paclitaxel is held accountable for fibroid necrosis and inflammation in small arteries [ 17 ] that might be associated with slow flow [ 18 ]. However, in the EffPac trial, no treatment interaction of previously identified risk factors of slow flow, such as chronic total occlusion or poor distal runoff [ 19 ] became clinically evident.…”

Section: Discussionmentioning

confidence: 99%

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

Teichgräber

Ingwersen

Aschenbach

et al. 2022

Cardiovasc Intervent Radiol

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Purpose This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB). Materials and Methods The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants. Results Kaplan–Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34). Conclusions Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).

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Section: Discussionmentioning

confidence: 99%

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

Teichgräber

Ingwersen

Aschenbach

et al. 2022

Cardiovasc Intervent Radiol

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“…Furthermore, our results showed no difference in lesion characteristics and clinical outcomes including restenosis, thrombosis, target lesion revascularization, or death rates in patients with or without the slow-flow phenomenon. 4 This result may be due to the limitations of this study, such as selection bias due to its retrospective nature, the small number of patients in a single hospital, and the limited follow-up period. Further studies are required to validate our results.…”

Section: Discussionmentioning

confidence: 90%

“…The slow-flow phenomenon has been associated with worse clinical outcomes if encountered during DCB angioplasty, and its pathophysiology is thought to be related to particulate embolization into the microvasculature of the foot, causing vasospasm or blockage. 4 During DCB application, more than 50% of the drug is lost downstream; a phenomenon termed particulate embolization. 5 This is thought to account for the slow-flow phenomenon encountered after DCB use with paclitaxel.…”

Section: Discussionmentioning

confidence: 99%

Slow-flow phenomenon after drug-coated balloon angioplasty for lower-extremity arteries is associated with lack of prescribing of calcium channel blockers

Arita¹,

Fukui²,

Ogasawara³

2023

Indian Heart Journal

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“…In addition, particulate embolization due to downstream showers of drug particle and less found in the sirolimus coated balloon when compare with paclitaxel coated balloons. Comparing with paclitaxel coated balloon, the slow flow or no-flow phenomenon induced CD-TLR and MALE are less present in sirolimus coated balloon in patients with CLTI patients [80] . Thus, the sirolimus coated balloon may have a benefit to prevent restenosis of the target artery without significant MACE and MALE in ET in CLTI patients who candidate for revascularization.…”

Section: Pharmacologic Effect and Pathophysiology Of Drug-delivering ...mentioning

confidence: 83%

Cardiovascular Complications Related to Lower Limb Revascularization and Drug-Delivering Technology in Peripheral Arterial Disease

Orrapin¹

2023

Novel Pathogenesis and Treatments for Cardiovascular Disease

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The cardiovascular complication related to lower limb revascularization is the common cause of mortality in patients with peripheral arterial disease (PAD). The coexisting multisite atherosclerotic vascular disease is increasing risk of major adverse cardiovascular events (MACE). The minimally invasive approach for revascularization, namely, endovascular-first strategy for decreasing risk of intervention is the modern approach. The novel technology of the drug delivering device by paclitaxel, sirolimus, and other antiproliferative drug coated balloon (DCB) and drug eluting stent (DES) to increase the patency of the target artery are trending to use in patients with CLTI. However, the long-term result and safety of a drug delivering device are still controversial. The paclitaxel related to MACE and major adverse limb events (MALE) need to be investigated. The new drug coating balloon, sirolimus demonstrated the excellent short-term result. However, there are some limitations of previous randomized studies and meta-analyses to conclude the best strategy and device to perform the best result for revascularization without increasing risk of MACE and MALE in CLTI patients who candidate for revascularization. This article is summarized the pathophysiology of MACE and MALE in the patients with PAD during revascularization, paclitaxel related cardiovascular complications and sirolimus coated balloon.

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Slow-flow phenomena following lower limb paclitaxel- and sirolimus-coated balloon angioplasty in the setting of chronic limb threatening ischaemia—a case series

Cited by 11 publications

References 20 publications

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

Slow-flow phenomenon after drug-coated balloon angioplasty for lower-extremity arteries is associated with lack of prescribing of calcium channel blockers

Cardiovascular Complications Related to Lower Limb Revascularization and Drug-Delivering Technology in Peripheral Arterial Disease

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