Two-Year CONSEQUENT Trial Outcomes Published for B. Braun's SeQuent Please DCB

March 28, 2018—The 2-year results from the CONSEQUENT study were published by Professor Thomas Albrecht, MD, et al in CardioVascular and Interventional Radiology. CONSEQUENT assessed the safety and efficacy of the SeQuent Please over-the-wire (OTW) paclitaxel-resveratrol–coated balloon catheter (B. Braun Interventional Systems, Inc.) to treat steno-occlusive lesions in the femoropopliteal artery. The investigators also reported on the results of a cost-benefit analysis for Germany.

Prof. Albrecht presented the 2-year safety and efficacy data at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany. In 2017, 6- and 12-month angiographic and clinical outcomes from the CONSEQUENT trial were published by Gunnar Tepe, MD, et al in CardioVascular and Interventional Radiology.

In the CONSEQUENT study, patients with symptomatic peripheral artery occlusive disease in femoropopliteal lesions were randomized either to the SeQuent Please drug-coated balloon (DCB;n = 78) or plain old balloon angioplasty (POBA; n = 75). As secondary endpoints, the 2-year clinical results consisting of target lesion revascularization (TLR), patency, and increase in walking distance were recorded. Based on the Kaplan-Meier analyses for TLR and other adverse events, a cost-benefit analysis was conducted for the German DRG system.

The investigators reported that there were no additional TLRs in both groups between 14 and 24 months so that the corresponding rates remained significantly different between the DCB and POBA treatment groups (19.1 vs 40.6%; P = .007). At 2 years, the patency rate was significantly higher in the DCB group (72.3% vs 48.4%; P = .006). The walking distance increase was also significantly higher after DCB angioplasty (172 ± 103 m vs 52 ± 136 m; P = .001).

Additionally, the investigators estimated 2-year cost savings of €1,111.97 per patient treated with DCB instead of POBA.

The use of paclitaxel-resveratrol matrix–coated peripheral balloons compared to POBA was associated with a significantly reduced TLR rate, superior patency, and substantial cost savings at 2 years, concluded the CONSEQUENT investigators in CardioVascular and Interventional Radiology.