Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries

• Published in: Journal of vascular surgery Vol. 58; no. 3; pp. 682 - 686
• Main Authors: Sixt, Sebastian, MD, Carpio Cancino, Oscar Gerardo, MD, Treszl, András, MD, Beschorner, Ulrich, MD, Macharzina, Roland, MD, Rastan, Aljoscha, MD, Krankenberg, Hans, MD, Neumann, Franz-Josef, MD, Zeller, Thomas, MD
• Format: Journal Article
• Language: English
• Published: United States Mosby, Inc 01.09.2013
• Subjects: Aged; Aged, 80 and over; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Angioplasty, Balloon - mortality; Atherectomy - adverse effects; Atherectomy - methods; Atherectomy - mortality; Coated Materials, Biocompatible; Combined Modality Therapy; Constriction, Pathologic; Disease-Free Survival; Drug Carriers; Equipment Design; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease - mortality; Peripheral Arterial Disease - therapy; Popliteal Artery; Proportional Hazards Models; Recurrence; Retrospective Studies; Risk Factors; Surgery; Time Factors; Treatment Outcome; Vascular Access Devices
• ISSN: 0741-5214; 1097-6809
• DOI: 10.1016/j.jvs.2013.02.019

Background Restenosis remains an unresolved problem despite different treatment modalities and new stent technology in femoropopliteal arteries. No standard therapy has proven to provide acceptable outcome data for this entity. Directional atherectomy alone did not result in satisfactory long-term patency rates. The outcome might be improved in conjunction with drug-coated balloon angioplasty. Methods In this retrospective study, restenotic lesions of the femoropopliteal arteries were treated with directed atherectomy in 89 lesions of consecutive patients (58% male; mean age, 69 ± 11 years). All patients received adjunctive treatment with conventional balloon percutaneous angioplasty (PTA; n = 60) or drug-coated balloon angioplasty (DCB; n = 29). Results Lesion location was in the stent (DCB [n = 27] vs PTA [n = 36]) and in native restenotic vessels (DCB [n = 2] vs PTA [n = 25]). The 1-year Kaplan-Meier freedom from restenosis estimates (95% confidence intervals) in the DCB and PTA groups were 84.7% (70.9%-98.5%) and 43.8% (30.5%-57.1%), respectively. In a multivariable Cox model for restenosis, DCB treatment had a hazard ratio (95% confidence interval) of 0.28 (0.12-0.66; P  = .0036) compared with the PTA group. In the multivariable model for procedural success, the effect of treatment did not differ between PTA and DCB ( P  = .134). Conclusions The combination of directed atherectomy with adjunctive DCB is associated with a better event-free survival at 12 months of follow-up compared with PTA after directed atherectomy.