Effects of three months of low molecular weight heparin (dalteparin) treatment after bypass surgery for lower limb ischemia--a randomised placebo-controlled double blind multicentre trial.
OBJECTIVE
To test the hypothesis that long-term postoperative dalteparin (Fragmin), Pharmacia Corp) treatment improves primary patency of peripheral arterial bypass grafts (PABG) in lower limb ischemia patients on acetylsalicylic acid (ASA) treatment.


METHODS
Prospective randomised double blind multicenter study.


METHODS
Using a computer algorithm 284 patients with lower limb ischemia, most with pre-operative ischemic ulceration or partial gangrene, from 12 hospitals were randomised, after PABG, to 5000 IU dalteparin or placebo injections once daily for 3 months. All patients received 75 mg of ASA daily for 12 months. Graft patency was assessed at 1, 3 and 12 months.


RESULTS
At 1 year, 42 patients had died or were lost to follow-up. Compliance with the injection schedule was 80%. Primary patency rate, in the dalteparin versus the control group, respectively, was 83 versus 80% (n.s.) at 3 months and 59% for both groups at 12 months. Major complication rates and cardiovascular morbidity were not different between the two groups.


CONCLUSIONS
In patients on ASA treatment, long-term postoperative dalteparin treatment did not improve patency after peripheral artery bypass grafting. Therefore, low molecular weight heparin treatment cannot be recommended for routine use after bypass surgery for critical lower limb ischemia.
Jivegård
L
L
Sahlgrenska Universitetssjukhuset Göteborg, Göteborg, Sweden. lennart.jivegard@vgregion.se
Drott
C
C
Gelin
J
J
Groth
O
O
Hensäter
M
M
Jensen
N
N
Johansson
G
G
Konrad
P
P
Lindberg
B
B
Lindhagen
A
A
Lundqvist
B
B
Oden
A
A
Smith
L
L
Stenberg
B
B
Thornell
E
E
Wingren
U
U
Ortenwall
P
P
D000368:Aged; D017985:Dalteparin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D005528:Foot / Q000473:pathology; D016523:Foot Ulcer / Q000209:etiology / Q000517:prevention & control; D005734:Gangrene / Q000209:etiology / Q000517:prevention & control; D006083:Graft Occlusion, Vascular / Q000150:complications / Q000517:prevention & control*; D006801:Humans; D007279:Injections, Subcutaneous; D007511:Ischemia / Q000601:surgery*; D007866:Leg / Q000098:blood supply* / Q000601:surgery; D008297:Male; D011182:Postoperative Care; D011446:Prospective Studies; D015912:Thrombolytic Therapy; D016896:Treatment Outcome; D014654:Vascular Patency
D005343:Fibrinolytic Agents; D017985:Dalteparin