Directional atherectomy plus drug-coated balloon for femoropopliteal artery disease: real-world evidence from China_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

YAO Yongjie , NI Qihong , WANG Yuli ,  YE Meng

Department of Vascular Surgery, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200127, P. R. China;

Corresponding?author：

YE Meng, Email: 13817145123@163.com

Keywords：

femoropopliteal artery disease; directional atherectomy; drug-coated balloon; vessel preparation; clinical outcomes

DOI：

10.7507/1007-9424.202601051

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Objective To evaluate the clinical efficacy and safety of directional atherectomy (DA) combined with drug-coated balloon (DCB) for the treatment of femoropopliteal artery lesions. Methods A retrospective analysis was performed on data from patients with femoropopliteal artery lesions treated with DA combined with paclitaxel DCB from January 2021 to November 2022 in the TALENT study (NCT04675632). Observational metrics included intraoperative bailout stenting rate, maximum DCB diameter, 12-month freedom from clinically-driven target limb revascularization (CD-TLR), incidence of major adverse events (MAEs), and changes in Rutherford category and vascular-related quality of life score. Results This study enrolled 189 limbs from 184 patients. The age was (71.0±9.4) years, and 69.0% (127/184) were male. Comorbidities were common, including diabetes mellitus [71.2% (131/184)] and coronary artery disease [34.2% ( 63/184)], with 32.6% (60/184) having a history of smoking. The lesions had a length of (181.2±119.6) mm, with chronic total occlusion accounting for 63.0% (119/189). In terms of clinical severity, 47.1% (89/189) were classified as Rutherford category 3, and 52.9% (100/189) presented with chronic limb-threatening ischemia (Rutherford categories 4–6). According to Trans-Atlantic Inter-Society Consensus Ⅱ classification, 52.9% (100/189) were type A+B, and 47.1% (89/189) were type C+D; 18.0%(34/189) of the lesions exhibited severe calcification. The technical success rate of DA combined with DCB treatment was 96.8%(183/189), with a bailout stent implantation rate of 4.2% (8/189). The maximum DCB diameter used was (5.1±0.6) mm. At the 12-month follow-up, the cumulative freedom from CD-TLR rate was 96.1% [95%CI (92.6%, 98.2%)], and the cumulative freedom from MAEs rate was 89.2% [95%CI (84.0%, 92.9%)]. Both the postoperative Rutherford category and quality of life score showed significant improvement compared to baseline [1.81±1.39 versus 3.89±1.22, MD (95%CI)=?2.08 (?2.29, ?1.87), P<0.001; (5.51±1.09) points versus (2.90±1.05) points, MD (95%CI)=2.61 (2.46, 2.76), P<0.001]. Conclusion DA combined with paclitaxel DCB for the treatment of femoropopliteal artery lesions effectively achieves lumen enlargement, reduces the need for intraoperative bailout stenting, and demonstrates favorable 12-month clinical outcomes, representing a feasible vessel preparation strategy.

Citation： YAO Yongjie, NI Qihong, WANG Yuli, YE Meng. Directional atherectomy plus drug-coated balloon for femoropopliteal artery disease: real-world evidence from China. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2026, 33(1): 42-46. doi: 10.7507/1007-9424.202601051 Copy

1.	Korosoglou G, Schmidt A, Lichtenberg M, et al. Global algorithm for the endovascular treatment of chronic femoropopliteal lesions: an interdisciplinary expert opinion statement. JACC Cardiovasc Interv, 2025, 18(5): 545-557.
2.	Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation, 2008, 118(13): 1358-1365.
3.	Jia X, Zhang J, Zhuang B, et al. Acotec drug-coated balloon catheter: randomized, multicenter, controlled clinical study in femoropopliteal arteries: evidence from the AcoArt Ⅰ trial. JACC Cardiovasc Interv, 2016, 9(18): 1941-1949.
4.	Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv, 2012, 5(6): 831-840.
5.	Karthik S, Tuite DJ, Nicholson AA, et al. Cryoplasty for arterial restenosis. Eur J Vasc Endovasc Surg, 2007, 33(1): 40-43.
6.	Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med, 2008, 358(7): 689-699.
7.	Kobayashi N, Hirano K, Yamawaki M, et al. Simple classification and clinical outcomes of angiographic dissection after balloon angioplasty for femoropopliteal disease. J Vasc Surg, 2018, 67(4): 1151-1158.
8.	Ye M, Ni Q, He C, et al. The impact of balloon pre-dilatation techniques on drug-coated balloon therapy for femoropopliteal artery disease: six-month results from the CIVILIAN registry. J Endovasc Ther, 2025, 32(6): 2050-2057.
9.	McKinsey JF, Zeller T, Rocha-Singh KJ, et al. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv, 2014, 7(8): 923-933.
10.	Hu L, Wang H, Pan D, et al. Three-year results of combining debulking devices with drug-coated balloons for the treatment of de novo femoropopliteal arteriosclerosis obliterans. Ann Vasc Surg, 2025, 114: 63-73.
11.	Bhandari M, Pradhan A, Behera S, et al. Coronary drug-coated balloons: current evidence and emerging trends. World J Cardiol, 2025, 17(12): 111468. doi: 10.4330/wjc.v17.i12.111468.
12.	Nakama T, Takahara M, Iwata Y, et al. One-year outcomes of drug-eluting stent versus drug-coated balloon for femoropopliteal artery lesions: BEASTARS study results. J Endovasc Ther, 2024 Aug 26: 15266028241271725. doi: 10.1177/15266028241271725.
13.	Dessì K, Giovannacci L, van den Berg JC. Debulking plus drug-coated balloon combination as revascularization strategy for complex femoropopliteal lesions. J Cardiovasc Surg (Torino), 2018, 59(1): 70-78.
14.	Kitahara H, Okada K, Kimura T, et al. Impact of stent size selection on acute and long-term outcomes after drug-eluting stent implantation in de novo coronary lesions. Circ Cardiovasc Interv, 2017, 10(10): e004795. doi: 10.1161/CIRCINTERVENTIONS.116.004795.
15.	Lin Y, Quan J, Dong J, et al. The midterm outcomes of endovascular therapy for femoropopliteal lesions via drug-coated balloon, directional atherectomy and bare metal stent angioplasty. Rev Cardiovasc Med, 2024, 25(9): 331. doi: 10.31083/j.rcm2509331.
16.	Xue W, Gao J, Lin J, et al. Deformation mechanisms of prototype composite braided stent-grafts in bending fatigue for peripheral artery application. J Mech Behav Biomed Mater, 2018, 78: 74-81.
17.	Mustapha JA, Lansky A, Shishehbor M, et al. A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry. Catheter Cardiovasc Interv, 2018, 91(6): 1144-1148.
18.	Caradu C, Lakhlifi E, Colacchio EC, et al. Systematic review and updated meta-analysis of the use of drug-coated balloon angioplasty versus plain old balloon angioplasty for femoropopliteal arterial disease. J Vasc Surg, 2019, 70(3): 981-995.

1. Korosoglou G, Schmidt A, Lichtenberg M, et al. Global algorithm for the endovascular treatment of chronic femoropopliteal lesions: an interdisciplinary expert opinion statement. JACC Cardiovasc Interv, 2025, 18(5): 545-557.
2. Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation, 2008, 118(13): 1358-1365.
3. Jia X, Zhang J, Zhuang B, et al. Acotec drug-coated balloon catheter: randomized, multicenter, controlled clinical study in femoropopliteal arteries: evidence from the AcoArt Ⅰ trial. JACC Cardiovasc Interv, 2016, 9(18): 1941-1949.
4. Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv, 2012, 5(6): 831-840.
5. Karthik S, Tuite DJ, Nicholson AA, et al. Cryoplasty for arterial restenosis. Eur J Vasc Endovasc Surg, 2007, 33(1): 40-43.
6. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med, 2008, 358(7): 689-699.
7. Kobayashi N, Hirano K, Yamawaki M, et al. Simple classification and clinical outcomes of angiographic dissection after balloon angioplasty for femoropopliteal disease. J Vasc Surg, 2018, 67(4): 1151-1158.
8. Ye M, Ni Q, He C, et al. The impact of balloon pre-dilatation techniques on drug-coated balloon therapy for femoropopliteal artery disease: six-month results from the CIVILIAN registry. J Endovasc Ther, 2025, 32(6): 2050-2057.
9. McKinsey JF, Zeller T, Rocha-Singh KJ, et al. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv, 2014, 7(8): 923-933.
10. Hu L, Wang H, Pan D, et al. Three-year results of combining debulking devices with drug-coated balloons for the treatment of de novo femoropopliteal arteriosclerosis obliterans. Ann Vasc Surg, 2025, 114: 63-73.
11. Bhandari M, Pradhan A, Behera S, et al. Coronary drug-coated balloons: current evidence and emerging trends. World J Cardiol, 2025, 17(12): 111468. doi: 10.4330/wjc.v17.i12.111468.
12. Nakama T, Takahara M, Iwata Y, et al. One-year outcomes of drug-eluting stent versus drug-coated balloon for femoropopliteal artery lesions: BEASTARS study results. J Endovasc Ther, 2024 Aug 26: 15266028241271725. doi: 10.1177/15266028241271725.
13. Dessì K, Giovannacci L, van den Berg JC. Debulking plus drug-coated balloon combination as revascularization strategy for complex femoropopliteal lesions. J Cardiovasc Surg (Torino), 2018, 59(1): 70-78.
14. Kitahara H, Okada K, Kimura T, et al. Impact of stent size selection on acute and long-term outcomes after drug-eluting stent implantation in de novo coronary lesions. Circ Cardiovasc Interv, 2017, 10(10): e004795. doi: 10.1161/CIRCINTERVENTIONS.116.004795.
15. Lin Y, Quan J, Dong J, et al. The midterm outcomes of endovascular therapy for femoropopliteal lesions via drug-coated balloon, directional atherectomy and bare metal stent angioplasty. Rev Cardiovasc Med, 2024, 25(9): 331. doi: 10.31083/j.rcm2509331.
16. Xue W, Gao J, Lin J, et al. Deformation mechanisms of prototype composite braided stent-grafts in bending fatigue for peripheral artery application. J Mech Behav Biomed Mater, 2018, 78: 74-81.
17. Mustapha JA, Lansky A, Shishehbor M, et al. A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry. Catheter Cardiovasc Interv, 2018, 91(6): 1144-1148.
18. Caradu C, Lakhlifi E, Colacchio EC, et al. Systematic review and updated meta-analysis of the use of drug-coated balloon angioplasty versus plain old balloon angioplasty for femoropopliteal arterial disease. J Vasc Surg, 2019, 70(3): 981-995.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Directional atherectomy plus drug-coated balloon for femoropopliteal artery disease: real-world evidence from China

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