Continued benefit of coronary stenting versus balloon angioplasty: one-year clinical follow-up of Benestent trial. Benestent Study Group.
OBJECTIVE
This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial.


BACKGROUND
The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations.


METHODS
To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion.


RESULTS
After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up.


CONCLUSIONS
These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.
Macaya
C
C
Catheterization Laboratory, Thorax Center, Erasmus University, Rotterdam, The Netherlands.
Serruys
P W
PW
Ruygrok
P
P
Suryapranata
H
H
Mast
G
G
Klugmann
S
S
Urban
P
P
den Heijer
P
P
Koch
K
K
Simon
R
R
Morice
M C
MC
Crean
P
P
Bonnier
H
H
Wijns
W
W
Danchin
N
N
Bourdonnec
C
C
Morel
M A
MA
D000787:Angina Pectoris / Q000453:epidemiology / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass / Q000706:statistics & numerical data; D003327:Coronary Disease / Q000453:epidemiology / Q000628:therapy; D003331:Coronary Vessels; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome