title: One-year outcome after percutaneous rotational and aspiration atherectomy in infrainguinal arteries in patient with and without type 2 diabetes mellitus.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Angiology, Heart-Centre Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Hermann
authors.initials: H
authors.lastname: Steinkamp
authors.forename: Andrej
authors.initials: A
authors.lastname: Schmidt
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Erich
authors.initials: E
authors.lastname: Minar
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
authors.forename: Jörn O
authors.initials: JO
authors.lastname: Balzer
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.forename: Christian
authors.initials: C
authors.lastname: Wissgott
authors.forename: Christopher
authors.initials: C
authors.lastname: Nielsen
authors.forename: Uwe
authors.initials: U
authors.lastname: Schwarzwälder
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D055109:Ankle Brachial Index; D017073:Atherectomy / Q000009:adverse effects / Q000379:methods*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D005060:Europe; D005260:Female; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency