The safety and efficacy of a paclitaxel-eluting wrap for preventing peripheral bypass graft stenosis: a 2-year controlled randomized prospective clinical study.
OBJECTIVE
To compare the safety and efficacy of a bioresorbable paclitaxel-eluting wrap implanted with a synthetic vascular graft (treatment) versus the graft implanted alone (control).


METHODS
Prospective, randomized, controlled, multicentre, 2-year clinical study conducted in adults scheduled to undergo femoropopliteal peripheral bypass surgery with a polytetrafluoroethylene (PTFE) graft.


METHODS
Hundred and nine subjects were randomized 2:1 to treatment or control. All subjects were implanted with a 6mm expanded PTFE vascular graft; in addition, treated subjects had a 2.5 cm x 4 cm paclitaxel-eluting wrap (1.6 microg/mm(2)) placed around the distal graft anastomosis.


RESULTS
The overall incidence of adverse events was similar in both groups. Treated subjects required fewer limb amputations than controls (15.5% vs 18.4%) and time to amputation for those that required amputation was twice as long (153 days vs 76 days). Among diabetics, this effect was pronounced with 13.8% of treated subjects requiring limb amputations compared with 23.5% of controls. Over the course of study, the diameter at the distal graft anastomosis was greater in treated subjects than in controls (difference of 2.1mm at 2 yr, p=0.03).


CONCLUSIONS
The paclitaxel-eluting wrap maintained graft patency at the distal anastomosis and was safe to use in patients who had received a peripheral bypass PTFE graft.
Mátyás
L
L
University Teaching County Hospital, Miskolc, Hungary.
Berry
M
M
Menyhei
G
G
Tamás
L
L
Acsády
G
G
Cuypers
P
P
Halmos
F
F
de Vries
A C
AC
Forgacs
V
V
Ingenito
G
G
Avelar
R
R
D000671:Amputation, Surgical; D000714:Anastomosis, Surgical; D001458:Bandages; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009427:Netherlands Antilles; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D016491:Peripheral Vascular Diseases / Q000503:physiopathology / Q000601:surgery*; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D012086:Reoperation; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
D002317:Cardiovascular Agents; D011138:Polytetrafluoroethylene; D017239:Paclitaxel