Hans Krankenberg1, Thilo Tübler2, Maja Ingwersen2, Michael Schlüter2, Dierk Scheinert2, Erwin Blessing2, Sebastian Sixt2, Arne Kieback2, Ulrich Beschorner2, Thomas Zeller2. 1. From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.). h.krankenberg@hgz-bb.de. 2. From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
Abstract
BACKGROUND:Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain. METHODS AND RESULTS: One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6%) lesions were totally occluded; 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4% (8 of 52) in the DCBA and 44.7% (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4% versus 81.0% (P=0.0117) at 6 months and 90.8% versus 52.6% (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8%) and 23 of 44 POBA patients (52.3%; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related. CONCLUSIONS:DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01305070.
RCT Entities:
BACKGROUND:Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain. METHODS AND RESULTS: One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6%) lesions were totally occluded; 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4% (8 of 52) in the DCBA and 44.7% (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4% versus 81.0% (P=0.0117) at 6 months and 90.8% versus 52.6% (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBApatients (77.8%) and 23 of 44 POBApatients (52.3%; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related. CONCLUSIONS:DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01305070.