Sanne W de Boer1, Daniel A F van den Heuvel1, Debbie A B de Vries-Werson2, Jan Albert Vos1, Bram Fioole3, Damnis Vroegindeweij4, Otto E Elgersma5, Rudolph P Tutein Nolthenius6, Jan M M Heyligers7, Gerlof P T Bosma8, Bernart de Leeuw9, Lee H Bouwman10, Dittmar Böckler11, Dmitriy I Dovzhanskiy11, Floris W F Vos12, Ted W F Vink13, Pieter G A Hooijboer14, Rutger J Hissink15, Jean-Paul P M de Vries2. 1. 1 Department of Interventional Radiology, St Antonius Hospital, Nieuwegein, the Netherlands. 2. 2 Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands. 3. 3 Department of Vascular Surgery, Maasstad Hospital, Rotterdam, the Netherlands. 4. 4 Department of Interventional Radiology, Maasstad Hospital, Rotterdam, the Netherlands. 5. 5 Department of Interventional Radiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands. 6. 6 Department of Vascular Surgery, Albert Schweitzer Hospital, Dordrecht, the Netherlands. 7. 7 Department of Vascular Surgery, Elisabeth Tweesteden Hospital, Tilburg, the Netherlands. 8. 8 Department of Interventional Radiology, Elisabeth Tweesteden Hospital, Tilburg, the Netherlands. 9. 9 Department of Interventional Radiology, Zuyderland Medical Centre, Heerlen, the Netherlands. 10. 10 Department of Vascular Surgery, Zuyderland Medical Centre, Heerlen, the Netherlands. 11. 11 Clinic for Vascular and Endovascular Surgery, University Hospital Heidelberg, Germany. 12. 12 Department of Vascular Surgery, Medical Centre Leeuwarden, the Netherlands. 13. 13 Department of Interventional Radiology, Medical Centre Leeuwarden, the Netherlands. 14. 14 Department of Interventional Radiology, Scheper Hospital, Emmen, the Netherlands. 15. 15 Department of Vascular Surgery, Scheper Hospital, Emmen, the Netherlands.
Abstract
PURPOSE: To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions. METHODS: The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography. RESULTS: Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively. CONCLUSION: The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.
RCT Entities:
PURPOSE: To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions. METHODS: The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography. RESULTS: Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively. CONCLUSION: The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.
Authors: Paweł Latacz; Marian Simka; Paweł Brzegowy; Marek Piwowarczyk; Tadeusz Popiela Journal: Wideochir Inne Tech Maloinwazyjne Date: 2018-11-29 Impact factor: 1.195
Authors: Josef Tacke; Stephan Müller-Hülsbeck; Henrik Schröder; Johannes Lammer; Karl Schürmann; Walter Gross-Fengels; Roman Fischbach; Jochen Textor; Lothar Boguth; Christian Loewe; Hannes Häuser; Manfred Gschwendtner; Gunnar Tepe; Rembert Pogge von Strandmann; Stefanie Stahnke; Johannes Dambach; Klaus Hausegger Journal: Cardiovasc Intervent Radiol Date: 2019-08-20 Impact factor: 2.740