Purpose: To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions. Methods: The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69 +/- 9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8 +/- 28.1 mm, and diameter stenosis was 86.3%+/- 16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio 2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months. Results: All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73 +/- 0.22 at baseline to 1.02 +/- 0.20 at 12 months. Conclusion: MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months.
机构:
Huntington Hosp, Huntington, WV USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Dearing, David D.
Patel, Kaushal R.
论文数: 0引用数: 0
h-index: 0
机构:
Univ So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Patel, Kaushal R.
Compoginis, John M.
论文数: 0引用数: 0
h-index: 0
机构:
Huntington Hosp, Huntington, WV USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Compoginis, John M.
Kamel, Mary A.
论文数: 0引用数: 0
h-index: 0
机构:
Huntington Hosp, Huntington, WV USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Kamel, Mary A.
Weaver, Fred A.
论文数: 0引用数: 0
h-index: 0
机构:
Univ So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Weaver, Fred A.
Katz, Steven G.
论文数: 0引用数: 0
h-index: 0
机构:
Univ So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Huntington Hosp, Huntington, WV USA
Abbott Labs, Abbott Pk, IL 60064 USA
Cordis Corp, Miami Lakes, FL USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
机构:
Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, AustriaMed Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Dick, Petra
Wallner, Hubert
论文数: 0引用数: 0
h-index: 0
机构:
Kardinal Schwarzenberg Hosp Schwarzach, Dept Internal Med, Salzburg, AustriaMed Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Wallner, Hubert
Sabeti, Schila
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Sabeti, Schila
Loewe, Christian
论文数: 0引用数: 0
h-index: 0
机构:
Med Univ Vienna, Dept Angiog & Intervent Radiol, A-1090 Vienna, AustriaMed Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Loewe, Christian
Mlekusch, Wolfgang
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Mlekusch, Wolfgang
Lammer, Johannes
论文数: 0引用数: 0
h-index: 0
机构:
Med Univ Vienna, Dept Angiog & Intervent Radiol, A-1090 Vienna, AustriaMed Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Lammer, Johannes
Koppensteiner, Renate
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Koppensteiner, Renate
Minar, Erich
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Minar, Erich
Schillinger, Martin
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
机构:
Huntington Hosp, Huntington, WV USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Dearing, David D.
Patel, Kaushal R.
论文数: 0引用数: 0
h-index: 0
机构:
Univ So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Patel, Kaushal R.
Compoginis, John M.
论文数: 0引用数: 0
h-index: 0
机构:
Huntington Hosp, Huntington, WV USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Compoginis, John M.
Kamel, Mary A.
论文数: 0引用数: 0
h-index: 0
机构:
Huntington Hosp, Huntington, WV USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Kamel, Mary A.
Weaver, Fred A.
论文数: 0引用数: 0
h-index: 0
机构:
Univ So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Weaver, Fred A.
Katz, Steven G.
论文数: 0引用数: 0
h-index: 0
机构:
Univ So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
Huntington Hosp, Huntington, WV USA
Abbott Labs, Abbott Pk, IL 60064 USA
Cordis Corp, Miami Lakes, FL USAUniv So Calif, Keck Sch Med, Cardiovasc Thorac Inst, Los Angeles, CA 90033 USA
机构:
Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, AustriaMed Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Dick, Petra
Wallner, Hubert
论文数: 0引用数: 0
h-index: 0
机构:
Kardinal Schwarzenberg Hosp Schwarzach, Dept Internal Med, Salzburg, AustriaMed Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Wallner, Hubert
Sabeti, Schila
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Sabeti, Schila
Loewe, Christian
论文数: 0引用数: 0
h-index: 0
机构:
Med Univ Vienna, Dept Angiog & Intervent Radiol, A-1090 Vienna, AustriaMed Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Loewe, Christian
Mlekusch, Wolfgang
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Mlekusch, Wolfgang
Lammer, Johannes
论文数: 0引用数: 0
h-index: 0
机构:
Med Univ Vienna, Dept Angiog & Intervent Radiol, A-1090 Vienna, AustriaMed Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Lammer, Johannes
Koppensteiner, Renate
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Koppensteiner, Renate
Minar, Erich
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria
Minar, Erich
Schillinger, Martin
论文数: 0引用数: 0
h-index: 0
机构:Med Univ Vienna, Div Angiol, Vienna Gen Hosp, Dept Internal Med 2, A-1090 Vienna, Austria