Document Detail


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.
MedLine Citation:
PMID:  10827388     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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. METHODS AND 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.
Authors:
R L Wilensky; J F Tanguay; S Ito; A L Bartorelli; J Moses; D O Williams; S R Bailey; J Martin; T A Bucher; P Gallant; A Greenberg; J J Popma; N J Weissman; G S Mintz; A V Kaplan; M B Leon
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  American heart journal     Volume:  139     ISSN:  0002-8703     ISO Abbreviation:  Am. Heart J.     Publication Date:  2000 Jun 
Date Detail:
Created Date:  2000-07-13     Completed Date:  2000-07-13     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1061-70     Citation Subset:  AIM; IM    
Affiliation:
University of Pennsylvania Medical Center, Philadelphia 19104, USA. ewilensk@mail.med.upenn.edu
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MeSH Terms
Descriptor/Qualifier:
Blood Flow Velocity / drug effects
Blood Vessel Prosthesis Implantation*
Coronary Angiography
Coronary Vessels / drug effects,  pathology,  ultrasonography
Drug Evaluation
Endosonography
Feasibility Studies
Female
Fibrinolytic Agents / administration & dosage*
Heparin / administration & dosage*
Humans
Hyperplasia / prevention & control
Infusions, Intra-Arterial
Male
Middle Aged
Myocardial Infarction / diagnosis,  physiopathology,  therapy*
Preoperative Care
Prospective Studies
Recurrence / prevention & control
Safety
Stents*
Thrombolytic Therapy
Treatment Outcome
Tunica Intima / drug effects,  pathology*,  ultrasonography
Chemical
Reg. No./Substance:
0/Fibrinolytic Agents; 9005-49-6/Heparin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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