Document Detail


A randomized comparison of the effects of gradual prolonged versus standard primary balloon inflation on early and late outcome. Results of a multicenter clinical trial. Perfusion Balloon Catheter Study Group.
MedLine Citation:
PMID:  8124798     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Observational studies have suggested that prolonged balloon inflation during coronary angioplasty is associated with a high clinical success rate. This randomized clinical trial sought to evaluate the impact of primary gradual and prolonged inflations versus standard short dilatations in patients undergoing elective angioplasty. METHODS AND RESULTS: In phase 1 of the study, patients were randomized to receive two to four standard (1 minute) dilatations or one or two prolonged (15 minutes) dilatations after a perfusion balloon had been placed across a single target lesion. Patients with unsuccessful angiographic appearance after phase 1 dilatations had further dilatations in phase 2. Patients were followed for 6 to 12 months after the procedure. Of 478 patients, 242 received a median of one prolonged dilatation of 15 minutes' duration, and 236 received three dilatations for a median of 1 minute. Patients assigned to prolonged dilatations had a higher success rate (< or = 50% residual visual stenosis) (95% versus 89%; P = .016), less severe residual stenosis by quantitative angiography (median [25th and 75th percentiles], 35% [26%, 42%] versus 38% [30%, 46%]; P = .001), and a lower rate of major dissections (3% versus 9%; P = .003) at the end of phase 1. A total of 114 patients had further dilatations in phase 2-43 in the prolonged arm and 71 in the standard arm. The final procedural success rate was 98% with both primary dilatation strategies, which included additional maneuvers such as prolonged dilatations in the patients randomized to the primary standard dilatation. Overall, 320 of 416 patients (77%) who were discharged after a successful procedure without any in-hospital event (death, myocardial infarction, coronary artery bypass graft surgery, abrupt closure, or repeat angioplasty in target vessel) returned for follow-up angiography. The restenosis rate (> 50% residual visual stenosis) was 44% (95% confidence interval, 37% to 52%) in the prolonged dilatation group and 44% (36% to 52%) in the standard dilatation group. The primary angiographic end point of failure at the end of phase 1, abrupt closure, or restenosis throughout the study period was similar in both groups (prolonged, 51%; standard, 49%; P = .62). The secondary end point of absence of clinical events (death, nonfatal myocardial infarction, coronary artery bypass graft surgery, or repeat angioplasty in target vessel) also was similar (prolonged, 66%; standard, 74%; P = .15). CONCLUSIONS: Primary gradual and prolonged dilatations caused less arterial trauma with a modestly larger arterial lumen compared with standard dilatations. This initial improvement in angiographic appearance did not lead to a significant reduction in restenosis or clinical adverse events during follow-up.
Authors:
E M Ohman; J F Marquis; D R Ricci; R I Brown; M L Knudtson; D J Kereiakes; J K Samaha; J R Margolis; A L Niederman; L S Dean
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Circulation     Volume:  89     ISSN:  0009-7322     ISO Abbreviation:  Circulation     Publication Date:  1994 Mar 
Date Detail:
Created Date:  1994-04-13     Completed Date:  1994-04-13     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1118-25     Citation Subset:  AIM; IM    
Affiliation:
Duke University Medical Center, Durham, NC 27710.
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MeSH Terms
Descriptor/Qualifier:
Angioplasty, Transluminal, Percutaneous Coronary / methods*
Coronary Angiography
Coronary Disease / epidemiology,  radiography,  therapy*
Female
Follow-Up Studies
Humans
Male
Middle Aged
Recurrence
Time Factors
Treatment Outcome

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


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