Optimum percutaneous transluminal coronary angioplasty compared with routine stent strategy trial (OPUS-1): a randomised trial.
BACKGROUND
Whether routine implantation of coronary stents is the best strategy to treat flow-limiting coronary stenoses is unclear. An alternative approach is to do balloon angioplasty and provisionally use stents only to treat suboptimum results. We did a multicentre trial to compare the outcomes of patients treated with these strategies.


METHODS
We randomly assigned 479 patients undergoing single-vessel coronary angioplasty routine stent implantation or initial balloon angioplasty and provisional stenting. We followed up patients for 6 months to determine the composite rate of death, myocardial infarction, cardiac surgery, and target-vessel revascularisation.


RESULTS
Stents were implanted in 227 (98.7%) of the patients assigned routine stenting. 93 (37%) patients assigned balloon angioplasty had at least one stent placed because of suboptimum angioplasty results. At 6 months the composite endpoint was significantly lower in the routine stent strategy (14 events, 6.1%) than with the strategy of balloon angioplasty with provisional stenting (37 events, 14.9%, p=0.003). The cost of the initial revascularisation procedure was higher than when a routine stent strategy was used (US$389 vs $339, p<0.001) but at 6 months, average per-patient hospital costs did not differ ($10,206 vs $10,490). Bootstrap replication of 6-month cost data showed continued economic benefit of the routine stent strategy.


CONCLUSIONS
Routine stent implantation leads to better acute and long-term clinical outcomes at a cost similar to that of initial balloon angioplasty with provisional stenting.
Weaver
W D
WD
Henry Ford Health System Heart and Vascular Institute, Detroit, MI 48202, USA. wweaver1@hfhs.org
Reisman
M A
MA
Griffin
J J
JJ
Buller
C E
CE
Leimgruber
P P
PP
Henry
T
T
D'Haem
C
C
Clark
V L
VL
Martin
J S
JS
Cohen
D J
DJ
Neil
N
N
Every
N R
NR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000191:economics; D006348:Cardiac Surgical Procedures; D016009:Chi-Square Distribution; D003327:Coronary Disease / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D017048:Health Care Costs; D017721:Hospital Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D016016:Proportional Hazards Models; D011788:Quality of Life; D019233:Retreatment; D015607:Stents / Q000191:economics; D015996:Survival Rate; D016896:Treatment Outcome