Koen Deloose1, Marc Bosiers2, Joren Callaert2, Jürgen Verbist3, Frank Vermassen4, Dierk Scheinert5, Giovanni Torsello6, Patrick Peeters3. 1. Department of Vascular Surgery, AZ Sint‑Blasius, Dendermonde, Belgium - office@fmrp.be. 2. Department of Vascular Surgery, AZ Sint‑Blasius, Dendermonde, Belgium. 3. Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium. 4. Department of Thoracic and Vascular Surgery, University Hospital Gent, Gent, Belgium. 5. Department of Angiology, Leipzig Heart Center, Leipzig, Germany. 6. Department of Vascular Surgery, St. Franziskus Hospital and University Hospital of Münster, Münster, Germany.
Abstract
BACKGROUND: The MISAGO ILIAC Study is a prospective, non-randomized, multicenter, bi-national, monitored trial, conducted in 3 hospitals in Belgium and 2 hospitals in Germany. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study was primary patency, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, peak systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR), within 12 months. METHODS: Between September 2011 and April 2012, 120 patients with TASC II Class A or TASC II Class B aortoiliac lesions were included. The cumulative lesion length in the overall population was 45.49 mm with a maximum stenosis pre-treatment of 83.76%. The demographic data were compatible for the TASC II class A and TASC II class B cohort. One patient with a TASC II class C was included as a protocol deviation. RESULTS: The primary patency rate for the total patient population was 97.4%. The primary patency rates at 12 months for the TASC II class A and TASC II class B(C) lesions were respectively 98.3% and 96.6%. No statistical significant difference was shown when comparing these 2 groups (P=0.6407). CONCLUSIONS: Our findings confirm that nowadays primary stenting with modern generation stents replaced the more invasive surgery as the golden standard treatment for patients with TASC II class A and B aortoiliac lesions.
BACKGROUND: The MISAGO ILIAC Study is a prospective, non-randomized, multicenter, bi-national, monitored trial, conducted in 3 hospitals in Belgium and 2 hospitals in Germany. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study was primary patency, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, peak systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR), within 12 months. METHODS: Between September 2011 and April 2012, 120 patients with TASC II Class A or TASC II Class B aortoiliac lesions were included. The cumulative lesion length in the overall population was 45.49 mm with a maximum stenosis pre-treatment of 83.76%. The demographic data were compatible for the TASC II class A and TASC II class B cohort. One patient with a TASC II class C was included as a protocol deviation. RESULTS: The primary patency rate for the total patient population was 97.4%. The primary patency rates at 12 months for the TASC II class A and TASC II class B(C) lesions were respectively 98.3% and 96.6%. No statistical significant difference was shown when comparing these 2 groups (P=0.6407). CONCLUSIONS: Our findings confirm that nowadays primary stenting with modern generation stents replaced the more invasive surgery as the golden standard treatment for patients with TASC II class A and B aortoiliac lesions.