Circulation, Vol 89, 1118-1125, Copyright © 1994 by American Heart Association
EM Ohman, JF Marquis, DR Ricci, RI Brown, ML Knudtson, DJ Kereiakes, JK Samaha, JR Margolis, AL Niederman and LS Dean
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.
ARTICLES
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
Duke University Medical Center, Durham, NC 27710.
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