- 作者：Sebastian Sixt ; Dierk Scheinert ; Aljoscha Rastan ; Hans Krankenberg ; Hermann Steinkamp ; Andrej Schmidt ; Horst Sievert ; Erich Minar ; Marc Bosiers ; Patrick Peeters ; Jö ; rn O. Balzer ; Thilo Tü ; bler ; Christian Wissgott ; Christopher Nielsen ; Uwe Schwarzwä ; lder ; Thomas Zeller
- 刊名：Annals of Vascular Surgery
- 出版年：2011
- 出版时间：May 2011
- 年：2011
- 卷：25
- 期：4
- 页码：520-529
- 全文大小：248 K
Background
To compare the safety and efficacy of a rotational aspiration atherectomy system (Jetstream) for the treatment of infrainguinal arteries in diabetic versus nondiabetic patients.Methods
A total of 172 patients with Rutherford stage 1-5 lower limb ischemia were treated with rotational aspiration atherectomy between February 2006 and February 2007. Of these, 80 patients with type 2 diabetes mellitus (DM: 46.5 % ) were compared with 92 nonDM (53.5 % ) patients. Overall, 210 target lesions (99 DM; 111 nonDM) were treated, located in the superficial femoral (67 % DM; 61 % nonDM), popliteal (25 % DM; 30 % nonDM), and tibial (8 % DM; 9 % nonDM) arteries. Lesion characteristics were comparable in both groups, mean lesion length was 28.5 mm (DM) and 26.2 mm (nonDM); total occlusions were present in 29 % (DM) and 32 % (nonDM), and 15 % (DM) and 14 % (nonDM) were restenotic.
Results
In the entire cohort, device success was 99 % (all but two lesions). The major adverse event (MAE) rate (death, index limb amputation, myocardial infarction, target lesion revascularization [TLR] and target vessel revascularization) in DM at 30 days was 2.5 % (n = 2 planned amputations) and 0 % in nonDM. At 6 and 12 months, MAE in DM was seen in 13.8 % (11/80) and 25 % (20/80) compared with 21.7 % (20/92) and 31.5 % (29/92) in nonDM, respectively. TLR rate through 12 months was 20 % (16/80) in DM and 28 % in nonDM (26/92). Overall, 1 year restenosis rate was 38.2 % based on duplex. The ankle–brachial index, mean Rutherford categories, and walking impairment questionnaire did not differ between groups at baseline and were increased significantly in both study cohorts at 12 months.
Conclusion
Jetstream-assisted atherectomy in infrainguinal arteries is safe and effective in DM compared with nonDM patients. In this short-lesion cohort, vessel patency in diabetics was as good as for non-DM at 1 year. TLR and MAE were higher by trend in nonDM, although planned amputations were seen only in DM. The clinical benefit was similar in both groups.