Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries

Schneider, Peter A.; Laird, John R.; Tepe, Gunnar; Brodmann, Marianne; Zeller, Thomas; Scheinert, Dierk; Metzger, Christopher; Micari, Antonio; Sachar, Ravish; Jaff, Michael R.; Wang, Hong; Hasenbank, Melissa S.; Ramanathan, Krishnan

doi:10.1161/circinterventions.117.005891

Cited by 183 publications

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“…Rates of 3‐ and 5‐year freedom from TLR of 83.6 and 83.1%, respectively. Similarly, long‐term outcomes after treatment with the In.Pact Admiral drug‐coated balloon have now been presented at 3‐ and 4‐years . DUS patency (PSVR < 2.5) assessed through 3 years was 69.5% .…”

Section: Discussionmentioning

confidence: 99%

“…Similarly, long‐term outcomes after treatment with the In.Pact Admiral drug‐coated balloon have now been presented at 3‐ and 4‐years . DUS patency (PSVR < 2.5) assessed through 3 years was 69.5% . Rates of freedom from TLR with the technology were 84.5 and 76.8%, respectively, although treated lesions were of lower complexity (25.8% chronic occlusions, 8.1% with severe calcification).…”

Section: Discussionmentioning

confidence: 99%

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Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

Bunte

Cohen

Jaff

et al. 2018

Cathet Cardio Intervent

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

Bunte

Cohen

Jaff

et al. 2018

Cathet Cardio Intervent

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“…Currently, DCBs used in the peripheral space use paclitaxel to prevent restenosis following treatment. Randomized and controlled trials have shown that DCBs are safe and effective to treat patients with femoropopliteal artery disease, and show improved outcomes compared to PTA . However, these trials are composed almost entirely of Caucasian patients.…”

Section: Introductionmentioning

confidence: 99%

Drug‐coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2‐year results of the MDT‐2113 SFA Japan randomized trial

Iida

Soga

Urasawa

et al. 2019

Cathet Cardio Intervent

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Objectives To assess the longer‐term safety and efficacy of the IN.PACT Admiral (MDT‐2113) drug‐coated balloon (DCB) for the treatment of de novo and non‐stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort. Background Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non‐Caucasian populations. Methods IN.PACT SFA Japan is an independently‐adjudicated, prospective, multicenter, randomized, single‐blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device‐ and procedure‐related death through 30 days, freedom from target limb major amputation and freedom from clinically‐driven target vessel revascularization at 24 months. Results One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well‐matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm ( P = 0.838), respectively. Patients treated with DCB exhibited superior 24‐month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001). The 24‐month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA ( P = 0.177). There were no device‐ or procedure‐related deaths, major amputations, or thromboses in either group. Conclusions Two‐year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD‐TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials.

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“…In this issue of Circulation: Cardiovascular Interventions, the investigators report the 3-year results of the study. 9 Primary patency adjudicated by duplex Doppler ultrasound was superior in the DCB group (69.5%) compared with the PTA group (45.1%). It is notable that there has been a loss of primary patency from 1 (82%) to 2 years (78%) and now to 3 years.…”

Section: See Article By Schneider Et Almentioning

confidence: 84%

“…It is notable that there has been a loss of primary patency from 1 (82%) to 2 years (78%) and now to 3 years. [7][8][9] Over 3 years, primary patency rates after PTA hovered around 50% suggesting that after the first year, PTA patients that remained patent had a similar trajectory when compared with the DCB group. Similarly, 85% of patients in the DCB group remained free from clinically driven target lesion revascularization (TLR) at 3 years compared with 69% in the PTA group.…”

Section: See Article By Schneider Et Almentioning

confidence: 99%

Leave No Stent Behind

Sethi

Parikh

2018

Circ: Cardiovascular Interventions

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E ndovascular revascularization is recommended for patients who fail medical and exercise therapy for lifestyle-limiting claudication secondary to peripheral arterial disease. 1 The cornerstone of endovascular intervention has been percutaneous transluminal angioplasty (PTA) since the advent of the procedure over 50 years ago.2 However, restenosis rates for PTA in the femoropopliteal circulation remain up to 50% at 2 years, resulting in the development of alternate techniques to improve postintervention patency.3,4 Stenting with nitinol self-expanding stents and drug-eluting nitinol self-expanding stents has reduced restenosis in the femoropopliteal artery compared with PTA; however, long-term patency even with stents remains suboptimal. [3][4][5] In theory, stents may not maintain long-term patency because of the mechanical strain exerted from torsion, flexion, and extension of the femoropopliteal artery. Consequently, enormous resources have been devoted to the development of drug-coated balloons (DCBs) which deliver an antiproliferative drug to mitigate neointimal hyperplasia after PTA while also avoiding the continuous hazard of a chronic indwelling metallic endoprosthesis. See Article by Schneider et alDCBs which deliver paclitaxel have now been studied for over a decade as one potential option of facilitating antirestenotic drug delivery while avoiding the implantation of a stent. 6 To date, long-term data on patency after DCB angioplasty have been lacking. The patient demographics were consistent with other studies with an average age of 68 years, 65% men and 45% with diabetes mellitus. The average lesion length was just under 9 cm with almost 60% of the lesions calcified. The study sponsor and subjects remained blinded for 1 year, whereas the clinical events committee and the core laboratories remained blinded for 3 years. In this issue of Circulation: Cardiovascular Interventions, the investigators report the 3-year results of the study.9 Primary patency adjudicated by duplex Doppler ultrasound was superior in the DCB group (69.5%) compared with the PTA group (45.1%). It is notable that there has been a loss of primary patency from 1 (82%) to 2 years (78%) and now to 3 years. 7-9 Over 3 years, primary patency rates after PTA hovered around 50% suggesting that after the first year, PTA patients that remained patent had a similar trajectory when compared with the DCB group. Similarly, 85% of patients in the DCB group remained free from clinically driven target lesion revascularization (TLR) at 3 years compared with 69% in the PTA group. Again, this difference seems to occur in the first 6 months to 1 year and remains sustained out to 3 years. There is no late catch-up effect. Observations from preclinical models indicate that paclitaxel remains resident in the artery for up to 180 days after the index procedure, providing a plausible mechanistic explanation for why the peak biological benefits of DCBs occur in the first 6 months. 10Despite the clear sustained improvement in primary patency and a decrease ...

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Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries

Abstract: Supplemental Digital Content is available in the text.

Cited by 183 publications

References 28 publications

Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

Long‐term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3‐year results from the STROLL study

Drug‐coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2‐year results of the MDT‐2113 SFA Japan randomized trial

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