Optimum percutaneous transluminal coronary angioplasty compared with routine stent strategy trial (OPUS-1): a randomised trial

Lancet. 2000 Jun 24;355(9222):2199-203. doi: 10.1016/s0140-6736(00)02403-x.


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.

Interpretation: 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary* / economics
  • Cardiac Surgical Procedures
  • Chi-Square Distribution
  • Coronary Disease / therapy*
  • Female
  • Follow-Up Studies
  • Health Care Costs
  • Hospital Costs
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Proportional Hazards Models
  • Quality of Life
  • Retreatment
  • Stents* / economics
  • Survival Rate
  • Treatment Outcome