Table 2 |
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|
Registries of patients treated with rotational and orbital atherectomy |
||||
|
Pathway System |
Diamondback 360° OAS (CSI) |
|||
|
|
||||
|
Study |
Pilot study |
Multicenter, prospective registry |
OASIS trial |
PAD II |
|
|
||||
|
Patients/lesions |
15/15 |
172/210 |
124/201 |
66/86 |
|
|
||||
|
Lesion location |
47% SFA |
64% SFA |
94% popliteal and tibial |
Reference vessel diameter of 1.5–4 mm |
|
|
||||
|
Mean lesion length |
61 mm |
35 mm |
30 mm |
35 mm |
|
|
||||
|
Calcified |
---- |
---- |
55% |
---- |
|
|
||||
|
Chronic total occlusion |
---- |
---- |
12% |
---- |
|
|
||||
|
Stand-alone treatment |
6 (40%) |
33% |
58.2% |
39.5% |
|
|
||||
|
Adjunctive balloon angioplasty |
7 (47%) |
59% |
39.3% |
60.5% |
|
|
||||
|
Adjunctive stenting |
2 (13%) |
7% |
2.50% |
---- |
|
|
||||
|
Primary patency (by duplex) at 6 months |
73% |
---- |
---- |
---- |
|
|
||||
|
TLR at 6 months |
0% |
13% |
2.4% |
13.6% |
|
|
||||
|
TLR at 12 months |
---- |
26% |
---- |
---- |
|
|
||||
|
Preprocedure ABI |
0.54 ± 0.3 |
0.59 ± 0.2 |
0.68 ± 0.2 |
---- |
|
|
||||
|
ABI at 6 months |
0.81 ± 0.2 |
0.77 ± 0.3 |
0.82 ± 0.1 |
---- |
|
|
||||
|
ABI at 12 months |
---- |
0.82 ± 0.3 |
---- |
---- |
|
|
||||
|
MAEsa at 1 month |
---- |
---- |
4 (3.2%) |
---- |
|
|
||||
|
MAEsa at 6 months |
15% |
13 (10.4%) |
37.9% |
|
|
|
||||
|
Device-related SAEs |
2.9% |
6% |
||
|
|
||||
|
aDeath, myocardial infarction, amputation, or repeat revascularization. |
||||
|
Franzone et al. BMC Surgery 2012 12(Suppl 1):S13 doi:10.1186/1471-2482-12-S1-S13 |
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