Aim-To compare the immediate and late outcomes of patients treated by a pol
icy of routine stent implantation with routine balloon angioplasty and the
use of stents only when an ideal result has not been obtained.
Methods-A nine centre, multinational, randomised study of 300 patients with
coronary artery disease thought suitable for treatment of a single lesion
by balloon angioplasty or stent implantation. Only new lesions in patients
who had not undergone previous bypass surgery were included, and totally oc
cluded vessels were excluded.
Results-The initial procedure was considered successful in 96% of patients.
There was more complete angiographic restoration of luminal diameter in pa
tients treated by elective stent (minimum lumen diameter (MLD) 2.68 mm for
stent v 2.27 mm for balloon; p < 0.007), but analysis of the subgroup of ba
lloon angioplasty patients who crossed over to stenting showed that they ac
hieved similar results to the elective stent group. Late luminal loss was g
reater in stented patients than in those undergoing balloon angioplasty onl
y, and by six months the angiographic benefit of stenting had disappeared (
MLD 1.90 mm for stent group v 2.00 mm for balloon angioplasty). Angiographi
c and clinical results in the balloon angioplasty group were assisted by th
e high crossover rate (30.1%). Both groups had similar symptom relief, with
58.9% of patients improving by two or more angina grades. The need for fur
ther revascularisation was also similar in the two groups at one year (18.2
% in the stented group v 17.1% in the balloon angioplasty group). Haemorrha
gic complications at the local arterial entry site were more common than ex
pected and were distributed equally between the patients receiving full ant
icoagulation and those receiving antiplatelet treatment only. The results o
f both Wiktor stent placement and balloon angioplasty were similar to the f
indings in the stent group in previous randomised studies (Benestent II, ST
RESS).
Conclusions-Provisional stenting appears to offer the same longer term outc
ome as elective stenting in this selected group of patients. Improvement in
the results of conventional balloon angioplasty in the past 10 years means
that a policy of obtaining an ideal result without the use of stents appea
rs to be practicable in many of these patients, with consequent cost saving
s.