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

W. Douglas Weaver, Mark A. Reisman, John J. Griffin, Christopher E. Buller, Pierre P. Leimgruber, Timothy Henry, Christopher D'Haem, Vivian L. Clark, Jenny S. Martin, David J. Cohen, Nancy Neil, Nathan R. Every

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99 Scopus citations

Abstract

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 g-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.

Original languageEnglish (US)
Pages (from-to)2199-2203
Number of pages5
JournalLancet
Volume355
Issue number9222
DOIs
StatePublished - Jun 24 2000

Bibliographical note

Funding Information:
Supported in part by unrestricted grants from the Johnson and Johnson Interventional Systems, Warren, NJ; Guidant Corporation, San Jose, CA; the MITI Research Foundation, Seattle, WA; and the Department of Veterans Affairs Health Services Research and Development.

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