Atherectomy to Angioplasty for Femoropopliteal Disease
Atherectomy to Angioplasty for Femoropopliteal Disease
Objective. This study compares treatment results of orbital atherectomy (OA) vs balloon angioplasty (BA) for calcified femoropopliteal (FP) disease. BA for calcified FP disease is associated with increased dissection rates and suboptimal results. OA is hypothesized to decrease these acute complications via lesion compliance change.
Methods. Fifty patients (65 lesions) with calcified FP disease were randomized to OA plus BA vs BA alone and followed for 12 months. The primary endpoint was freedom from target lesion revascularization (TLR), including adjunctive stenting, or restenosis as evidenced by duplex ultrasound at 6 months.
Results. Mean maximum balloon pressure was 4.0 atm in the OA arm vs 9.1 atm in the BA arm (P<.001). In subjects with residual stenosis >30%, the operator chose to stent 2/38 lesions (5.3%) in the OA arm vs 21/27 lesions (77.8%) in the BA arm (P<.001). Freedom from TLR (including adjunctive stenting) or restenosis was achieved in 77.1% of lesions in the OA group vs 11.5% in the BA group (P<.001) at 6 months, and 81.2% vs 78.3% at 12 months, excluding adjunctive stenting (P>.99).
Conclusions. Compared to BA alone, OA plus BA yields better luminal gain by improving lesion compliance and decreases adjunctive stenting in the treatment of calcified FP disease. At 12 months, the occurrence of TLR or restenosis was similar in both groups despite the large disparity in stent usage at the time of initial treatment.
The adductor canal portion of the superficial femoral artery (SFA) and the popliteal artery are mechanically dynamic vascular segments. Stents placed in this region are subjected to a number of unfavorable forces that increase the risk of stent fracture and restenosis. While newer iterations of vascular stents have led to a decrease in the incidence of these complications, none of the randomized stent trials have included the popliteal artery beyond its proximal third, and restenosis remains a problem and accrues over time. Furthermore, the superiority of stenting to balloon angioplasty (BA) has been demonstrated in 15 cm SFA lesions; however, stenting for short SFA lesions may offer no benefit over PTA alone. In addition, the lack of an effective therapy for in-stent restenosis has led many practitioners to pursue a treatment strategy of provisional stenting for femoropopliteal (FP) disease and therefore BA and atherectomy continue to be used in practice.
The presence of lesion calcification plagues all methods of endovascular revascularization, especially BA. Fitzgerald et al demonstrated through intravascular ultrasound (IVUS) investigation that three-quarters of lesions in both peripheral and coronary arteries that dissect after BA contain calcium. Heavy calcification can also lead to stent underexpansion. Interventional tools that can modify lesion calcification while minimizing vessel injury and the need for stent placement (in a provisional stent strategy)would be beneficial.
The Diamondback 360° Peripheral Orbital Atherectomy System (Cardiovascular Systems, Inc) has been previously well described. The chief mechanism of action involves differential sanding with preferential removal of the relatively non-compliant elements of the plaque, particularly calcium, and a lesser effect on the more elastic components, most notably the normal vessel wall. The orbital nature of the device lends itself to the larger diameter of the FP vascular segment. The investigators hypothesize that vessel preparation utilizing orbital atherectomy (OA) decreases the acute complications associated with BA in calcium-containing FP lesions, reducing the need for adjunctive stenting.
Abstract and Introduction
Abstract
Objective. This study compares treatment results of orbital atherectomy (OA) vs balloon angioplasty (BA) for calcified femoropopliteal (FP) disease. BA for calcified FP disease is associated with increased dissection rates and suboptimal results. OA is hypothesized to decrease these acute complications via lesion compliance change.
Methods. Fifty patients (65 lesions) with calcified FP disease were randomized to OA plus BA vs BA alone and followed for 12 months. The primary endpoint was freedom from target lesion revascularization (TLR), including adjunctive stenting, or restenosis as evidenced by duplex ultrasound at 6 months.
Results. Mean maximum balloon pressure was 4.0 atm in the OA arm vs 9.1 atm in the BA arm (P<.001). In subjects with residual stenosis >30%, the operator chose to stent 2/38 lesions (5.3%) in the OA arm vs 21/27 lesions (77.8%) in the BA arm (P<.001). Freedom from TLR (including adjunctive stenting) or restenosis was achieved in 77.1% of lesions in the OA group vs 11.5% in the BA group (P<.001) at 6 months, and 81.2% vs 78.3% at 12 months, excluding adjunctive stenting (P>.99).
Conclusions. Compared to BA alone, OA plus BA yields better luminal gain by improving lesion compliance and decreases adjunctive stenting in the treatment of calcified FP disease. At 12 months, the occurrence of TLR or restenosis was similar in both groups despite the large disparity in stent usage at the time of initial treatment.
Introduction
The adductor canal portion of the superficial femoral artery (SFA) and the popliteal artery are mechanically dynamic vascular segments. Stents placed in this region are subjected to a number of unfavorable forces that increase the risk of stent fracture and restenosis. While newer iterations of vascular stents have led to a decrease in the incidence of these complications, none of the randomized stent trials have included the popliteal artery beyond its proximal third, and restenosis remains a problem and accrues over time. Furthermore, the superiority of stenting to balloon angioplasty (BA) has been demonstrated in 15 cm SFA lesions; however, stenting for short SFA lesions may offer no benefit over PTA alone. In addition, the lack of an effective therapy for in-stent restenosis has led many practitioners to pursue a treatment strategy of provisional stenting for femoropopliteal (FP) disease and therefore BA and atherectomy continue to be used in practice.
The presence of lesion calcification plagues all methods of endovascular revascularization, especially BA. Fitzgerald et al demonstrated through intravascular ultrasound (IVUS) investigation that three-quarters of lesions in both peripheral and coronary arteries that dissect after BA contain calcium. Heavy calcification can also lead to stent underexpansion. Interventional tools that can modify lesion calcification while minimizing vessel injury and the need for stent placement (in a provisional stent strategy)would be beneficial.
The Diamondback 360° Peripheral Orbital Atherectomy System (Cardiovascular Systems, Inc) has been previously well described. The chief mechanism of action involves differential sanding with preferential removal of the relatively non-compliant elements of the plaque, particularly calcium, and a lesser effect on the more elastic components, most notably the normal vessel wall. The orbital nature of the device lends itself to the larger diameter of the FP vascular segment. The investigators hypothesize that vessel preparation utilizing orbital atherectomy (OA) decreases the acute complications associated with BA in calcium-containing FP lesions, reducing the need for adjunctive stenting.
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