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

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Title: Optimum percutaneous transluminal coronary angioplasty compared with routine stent strategy trial (OPUS-1): a randomised trial.
Authors: Weaver WD (AUTHOR), Reisman MA (AUTHOR), Griffin JJ (AUTHOR), Buller CE (AUTHOR), Leimgruber PP (AUTHOR), Henry T (AUTHOR), D'Haem C (AUTHOR), Clark VL (AUTHOR), Martin JS (AUTHOR), Cohen DJ (AUTHOR), Neil N (AUTHOR), Every NR (AUTHOR), Weaver, W D (AUTHOR), Reisman, M A (AUTHOR), Griffin, J J (AUTHOR), Buller, C E (AUTHOR), Leimgruber, P P (AUTHOR), Henry, T (AUTHOR), D'Haem, C (AUTHOR), Clark, V L (AUTHOR)
Source: Lancet. 6/24/2000, Vol. 355 Issue 9222, p2199-2203. 5p.
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 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. [ABSTRACT FROM AUTHOR]
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Database: Psychology and Behavioral Sciences Collection
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Abstract:<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Interpretation: </bold>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. [ABSTRACT FROM AUTHOR]
ISSN:01406736
DOI:10.1016/s0140-6736(00)02403-x