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 stra tegy to treat flow-limiting coronary stenoses is unclear. An alternative ap proach is to do balloon angioplasty and provisionally use stents only to tr eat 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 targe t-vessel revascularisation. Results Stents were implanted in 227 (98.7%) of the patients assigned routi ne stenting. 93 (37%) patients assigned balloon angioplasty had at least on e stent placed because of suboptimum angioplasty results. At 6 months the c omposite endpoint was significantly lower in the routine stent strategy (14 events, 6.1%) than with the strategy of balloon angioplasty with provision al stenting (37 events, 14.9%, p=0.003). The cost of the initial revascular isation procedure was higher than when a routine stent strategy was used (U S$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-te rm clinical outcomes at a cost similar to that of initial balloon angioplas ty with provisional stenting.