German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization
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German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization. / Krankenberg, Hans; Tübler, Thilo; Sixt, Sebastian; Fischer, Matthias; Schmiedel, Rainer; Schulte, Karl-Ludwig; Balzer, Jörn O; Kieback, Arne; Fiehn, Eduard; Wittenberg, Günther; Ali, Tammam; Tiefenbacher, Christiane; Jahnke, Thomas; Steinkamp, Hermann J; Wegscheider, Karl; Treszl, András; Ingwersen, Maja; Zeller, Thomas.
in: J ENDOVASC THER, Jahrgang 21, Nr. 4, 01.08.2014, S. 463-471.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization
AU - Krankenberg, Hans
AU - Tübler, Thilo
AU - Sixt, Sebastian
AU - Fischer, Matthias
AU - Schmiedel, Rainer
AU - Schulte, Karl-Ludwig
AU - Balzer, Jörn O
AU - Kieback, Arne
AU - Fiehn, Eduard
AU - Wittenberg, Günther
AU - Ali, Tammam
AU - Tiefenbacher, Christiane
AU - Jahnke, Thomas
AU - Steinkamp, Hermann J
AU - Wegscheider, Karl
AU - Treszl, András
AU - Ingwersen, Maja
AU - Zeller, Thomas
PY - 2014/8/1
Y1 - 2014/8/1
N2 - PURPOSE: To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants.METHODS: Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months.RESULTS: Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047).CONCLUSION: Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.
AB - PURPOSE: To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants.METHODS: Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months.RESULTS: Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047).CONCLUSION: Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.
U2 - 10.1583/13-4625R.1
DO - 10.1583/13-4625R.1
M3 - SCORING: Journal article
C2 - 25101571
VL - 21
SP - 463
EP - 471
JO - J ENDOVASC THER
JF - J ENDOVASC THER
SN - 1526-6028
IS - 4
ER -