Table 2

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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