PMID- 8688309
OWN - NLM
STAT- MEDLINE
DCOM- 19960829
LR  - 20191101
IS  - 0890-5096 (Print)
IS  - 0890-5096 (Linking)
VI  - 9 Suppl
DP  - 1995
TI  - Low-molecular-weight heparin vs. unfractionated heparin in femorodistal 
      reconstructive surgery: a multicenter open randomized study. Enoxart Study Group.
PG  - S45-53
AB  - Several clinical trials have been conducted to study the role of 
      low-molecular-weight heparin (LMWH) in the prevention and treatment of venous 
      thrombosis. In contrast, there have been few studies investigating LMWH in the 
      prophylaxis in arterial thrombosis. After informed consent and institutional 
      approval were obtained, 201 consecutive patients scheduled for femorodistal 
      reconstructive surgery under general anesthesia were enrolled in an open 
      randomized multicenter (n = 14) study (from November 1990 to November 1992). 
      Immediately before arterial cross-clamping, patients were given an intravenous 
      bolus of either enoxaparin (ENX), 75 anti-Xa IU/kg (n = 100), or unfractionated 
      heparin (UFH), 50 IU kg (n = 101). Meanwhile the saphenous vein or a prosthetic 
      graft was flushed with ENX (25,000 anti-Xa IU) or UFH (25,000 IU) in 250 ml of 
      saline solution. Subsequent treatment consisted of subcutaneous administration of 
      ENX, 75 anti-Xa IU/kg, or UFH, 150 IU kg, beginning 8 hours after the intravenous 
      injection and then every 12 hours thereafter for 10 days. The primary end point 
      was graft patency on day 10 +/- 2 after surgery as assessed clinically and/or by 
      arteriography on day 10 +/- 2 and/or during reintervention or autopsy. Analysis 
      of patients on an intention-to-treat basis (patients who received at least on 
      injection of ENX or UFH and who had at least one end-point evaluation) showed 
      that graft thrombosis occurred in 30 of 199 cases: eight (8%) in the ENX group 
      and 22 (22%) in the UFH group (p = 0.009). Among the 131 patients who were 
      evaluated by arteriography before day 12, twelve (9.1%) had graft thrombosis: 
      four (6%) in the ENX group and eight (12.5%) in the UFH group (NS). There were no 
      significant differences between the two groups in terms of safety--that is, there 
      were 12 major hemorrhages in each group, and during the follow-up period five 
      patients in the ENX group died compared to nine in the UFH group (NS). These 
      results indicate that ENX is as safe as but more effective than UFH when used for 
      the prevention of early graft thrombosis in patients undergoing femorodistal 
      reconstructive surgery.
FAU - Samama, C M
AU  - Samama CM
AD  - Departement d'Anesthesie-Reanimation, Groupe Hospitalier, Pitie-Salpetriere, 
      Paris, France.
FAU - Gigou, F
AU  - Gigou F
FAU - Ill, P
AU  - Ill P
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Netherlands
TA  - Ann Vasc Surg
JT  - Annals of vascular surgery
JID - 8703941
RN  - 0 (Anticoagulants)
RN  - 0 (Enoxaparin)
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/*therapeutic use
MH  - *Blood Vessel Prosthesis
MH  - Enoxaparin/*therapeutic use
MH  - Female
MH  - Heparin/*therapeutic use
MH  - Humans
MH  - Leg/*blood supply
MH  - Male
MH  - Middle Aged
MH  - Postoperative Complications/*prevention & control
MH  - Risk Factors
MH  - Thrombosis/*prevention & control
MH  - Treatment Outcome
MH  - Vascular Patency
EDAT- 1995/01/01 00:00
MHDA- 1995/01/01 00:01
CRDT- 1995/01/01 00:00
PHST- 1995/01/01 00:00 [pubmed]
PHST- 1995/01/01 00:01 [medline]
PHST- 1995/01/01 00:00 [entrez]
AID - S0890-5096(06)60451-2 [pii]
AID - 10.1016/s0890-5096(06)60451-2 [doi]
PST - ppublish
SO  - Ann Vasc Surg. 1995;9 Suppl:S45-53. doi: 10.1016/s0890-5096(06)60451-2.