(Circulation. 1999;100:918-923.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Influence of Balloon Pressure During Stent Placement in Native Coronary Arteries on Early and Late Angiographic and Clinical Outcome
A Randomized Evaluation of High-Pressure Inflation
From the 1. Medizinische Klinik rechts der Isar der Technischen Universität (J.D., H.S., J.P., E.A.); the Deutsches Herzzentrum (A.K., F.J.N., S.E., J.M., R.B., A.S.); and the 1. Medizinische Klinik, Klinikum Großhadern der Ludwig-Maximilians-Universität (P.B., G.S.), Munich, Germany.
Correspondence to Dr Josef Dirschinger, 1. Medizinische Klinik rechts der Isar der TU, Ismaningerstraße 22, 81675 München, Germany.
Background—High-pressure dilatation is considered a better stent placement strategy, but this has not yet been proved by appropriately designed studies. The objective of this randomized trial was to assess the role of high-pressure dilatation in the early and late outcome of patients undergoing coronary stent placement.
Methods and Results—Consecutive patients with coronary
stent placement were randomly assigned to high- (15 to 20 atm, 468
patients) or low- (8 to 13 atm, 466 patients) balloon-pressure
dilatation. The primary end point of the study was the event-free
survival at 1 year. Secondary end points were the incidence of stent
thrombosis at 30 days and angiographic restenosis (
50%
diameter stenosis) at 6 months. The incidence of stent
thrombosis was 1.7% in the high-pressure and 1.9% in the low-pressure
group (relative risk 0.89; 95% CI 0.30 to 2.56). During the first 30
days, although there was no significant difference in the incidence of
Q-wave myocardial infarction, the incidence of non–Q-wave infarction
was 6.4% in the high-pressure and 3.4% in the low-pressure group
(relative risk 1.87; 95% CI 1.02 to 3.42). The restenosis rate
was 30.4% in the high-pressure and 31.4% in the low-pressure group
(relative risk 0.97; 95% CI 0.75 to 1.26). Event-free survival at 1
year was not significantly different between the groups, with 78.8% in
high-pressure patients and 75.5% in patients assigned to low-pressure
dilatation (hazard ratio 0.85; 95% CI 0.65 to 1.11).
Conclusions—The systematic use of high-balloon-pressure inflation (15 to 20 atm) during coronary stent placement is not associated with any significant influence on the 1-year outcome of patients undergoing this intervention.
Key Words: stents • balloon • thrombosis • restenosis • trials
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