Final 24-Month CONSEQUENT Data Presented for B. Braun's SeQuent Please OTW DCB

February 7, 2018—Final angiographic and clinical 24-month results of the CONSEQUENT trial were presented by Professor Thomas Albrecht, MD, at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.

Prof. Albrecht stated that the objective of CONSEQUENT is to assess the safety and efficacy of the SeQuent Please over-the-wire (OTW) paclitaxel-coated balloon catheter (B. Braun Melsungen AG) to treat steno-occlusive lesions in the femoropopliteal artery. 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 (2017;40:135–144).

The study's inclusion criteria were de novo or restenotic lesions after plain old balloon angioplasty (POBA) in the superficial femoral or popliteal arteries, Rutherford class 2­–4 status, reference vessel diameters of 4 to 7 mm, lesion lengths of 4 to 27 cm, preprocedural diameter stenosis ≥ 70%, and adequate runoff with one or more vessels to the foot. Exclusion criteria were restenosis after stent or drug-coated balloon (DCB) treatment, more than two lesions in the target vessel, and chronic total occlusions > 10 cm.

The primary endpoint of the study is late lumen loss at 6 months. Secondary endpoints included binary restenosis rates > 50% at 6 months, as well as clinically driven target lesion revascularization (TLR), ankle-brachial index, walking distance, and Rutherford class assessments at 6, 12, and 24 months.

Study investigators randomized (1:1) 153 patients (68% male; median age, 68.1 ± 8.7 years; diabetes mellitus, 36.6%; Rutherford class 3, 94.8%) to treatment with the SeQuent Please DCB (n = 78) or treatment with POBA (n = 75). The investigators highlighted that 17% of lesions were TASC C and 6.5% were TASC D, with a mean length of 13.2 ± 10.4 cm.

Angiographic follow-up was conducted at 6 months. Clinical follow-up included walking test, ankle-brachial index assessment, and duplex ultrasound at 6, 12, and 24 months.

The investigators reported that predilatation was performed in 55.6% of cases (DCB, 52.6% vs POBA, 58.7%; P = .448). Bailout stenting was performed in 16.3% of cases (14.1% vs 18.7%; P = .445). The procedural success rate was 100% for both groups.

The CONSEQUENT investigators reported that at 6-month follow-up, the primary endpoint of late lumen loss was significantly lower in the DCB group versus the POBA group (0.35 mm vs 0.72 mm; P = .006).

At 24 months, the DCB-treated patients demonstrated lower clinically driven all-cause TLR rates (19.1% vs 40.6%; P = .007) with no additional TLRs between 14 and 24 months, significantly higher patency (72.3% vs 48.3%; P = .006), and longer increase of walking distance (172 m vs 52 m; P = .001).

In the trial, which included longer lesions than in any other previously published DCB study in a Caucasian patient population, the SeQuent Please OTW device delivered sustained clinical outcomes in patients with long lesions up to 24 months, concluded Prof. Albrecht for the CONSEQUENT investigators at LINC 2018.