Heparin infusion prior to stenting (HIPS) trial: final results of a prospective, randomized, controlled trial evaluating the effects of local vascular delivery on intimal hyperplasia.
BACKGROUND
Local delivery of pharmacologic agents or genes at the site of angioplasty is a promising approach to reduce restenosis. However, there are unresolved questions concerning the safety and feasibility of local vascular delivery in clinical practice as well as the efficacy of delivered drug. To this end, the safety, feasibility, and efficacy of local delivery of heparin were evaluated in the Heparin Infusion Prior to Stenting (HIPS) trial.


RESULTS
A total of 179 patients were enrolled in this multicenter, randomized, prospective, core laboratory-evaluated trial. Patients were randomly assigned to 5000 U heparin either administered to the coronary artery lumen or infused into the arterial wall immediately after angioplasty and before stent placement. End points included procedural events and clinical, angiographic, and intravascular ultrasound events at 6 months. Patient groups were evenly matched. There was no difference in the incidence of arterial injury, defined as an increase in arterial dissection, acute closure, or decrease in Thrombolysis In Myocardial Infarction grade blood flow in the group receiving local delivery. At follow-up there was no difference in the major adverse event rate between intraluminal (22.7%) and local groups (24.7%). There was no difference between intraluminal and local therapy in the angiographic in-stent restenosis rate (12.5%, 12.7%) or the in-stent volumetric analysis by intravascular ultrasound (IVUS) (37.19 +/- 20. 86 mm(3) vs 43.79 +/- 25.52 mm(3)).


CONCLUSIONS
Local delivery of 5000 U heparin into the arterial wall before stent implantation is safe and feasible. There was not a favorable effect of locally delivered heparin on clinical, angiographic, or IVUS end points of restenosis. The use of IVUS to measure volume of intimal hyperplasia in a multicenter, core laboratory-controlled trial is feasible.
Wilensky
R L
RL
University of Pennsylvania Medical Center, Philadelphia 19104, USA. ewilensk@mail.med.upenn.edu
Tanguay
J F
JF
Ito
S
S
Bartorelli
A L
AL
Moses
J
J
Williams
D O
DO
Bailey
S R
SR
Martin
J
J
Bucher
T A
TA
Gallant
P
P
Greenberg
A
A
Popma
J J
JJ
Weissman
N J
NJ
Mintz
G S
GS
Kaplan
A V
AV
Leon
M B
MB
D001783:Blood Flow Velocity / Q000187:drug effects; D019917:Blood Vessel Prosthesis Implantation; D017023:Coronary Angiography; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology; D004341:Drug Evaluation; D019160:Endosonography; D005240:Feasibility Studies; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D006965:Hyperplasia / Q000517:prevention & control; D007261:Infusions, Intra-Arterial; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011300:Preoperative Care; D011446:Prospective Studies; D012449:Safety; D055502:Secondary Prevention; D015607:Stents; D015912:Thrombolytic Therapy; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology*
D005343:Fibrinolytic Agents; D006493:Heparin