ArticlesOptimum percutaneous transluminal coronary angioplasty compared with routine stent strategy trial (OPUS-1): a randomised trial
Introduction
Intracoronary stent implantation is now the predominant method of percutaneous coronary artery revascularisation because of its relative ease of use and lower frequency of clinical and angiographic restenosis compared with balloon angioplasty.1, 2, 3 Wohl4 estimated that more than half of all percutaneous coronary interventions in the USA use stents. Randomised trials comparing balloon angioplasty and coronary-stent placement in patients with favourable lesion characteristics (eg, discrete de-novo lesions in large vessels) have shown that stenting results in a larger luminal diameter and higher restenosis rate than does balloon angioplasty.1, 2 In addition, the BENESTENT trial2 reported fewer adverse clinical events at 7 months among patients in the stent group, mainly a reduction in the need for target-vessel revascularisation. These data also suggested that larger luminal diameter produces a better response independent of the device used to achieve it.
However, there is reason to question whether the current strategy of treating a large proportion of patients with routine stenting5 is preferable to a strategy of ballooon angioplasty with provisional stenting. Several studies have suggested that generalisation from the STRESS and BENESTENT trials6, 7 is limited, since fewer than 20% of patients currently treated would have qualified for a stent under the restrictive criteria used in these trials. Furthermore, despite their benefits, coronary stents also create complications such as greater neointimal proliferation2 and the possibility of in-stent restenosis, which, when it occurs, has a high recurrence rate and is difficult to treat.8, 12
As stent technology has improved, so too has balloon angioplasty. The availability of stents allows an operator to attempt to achieve near perfect results with balloons, knowing that a stent can be used if balloon angioplasty fails. Nairns and colleagues13 suggested that only 20–40% of patients need remedial stenting.
We undertook a randomised trial to compare the clinical effectiveness, health status, and economic implications of the two strategies to test whether routine stenting offers an advantage over optimum angioplasty and provisional stenting in a typical North American population.
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Participating centres and investigators
Investigators at 44 hospitals in the USA and Canada were chosen to participate in the trial based on their experience with implantation of coronary stents and coronary angioplasty, and their familiarity with investigation in interventional cardiology. The trial protocol was reviewed and approved by each site's institutional review board.
Enrolment criteria
Patients between age 21 years and 81 years with stable or unstable angina, a positive functional test for ischaemia, or who were undergoing angioplasty after a
Patient characteristics
The treatment groups were balanced for demographics and cardiovascular risk factors (table 1). Most patients underwent the index procedure because of unstable angina or recent acute myocardial infarction. Only 19 (4%) patients enrolled had undergone previous angioplasty. The left-ventricular ejection fraction averaged 59% (13%) in the routine stent group and 61% (11%) in the optimum PTCA group.
Procedural and in-hospital outcomes
Table 2 shows the principle angiographic and clinical data. Most patients had single-vessel coronary
Discussion
Implantation of intracoronary stents represents perhaps the greatest technological breakthrough in percutaneous coronary revascularisation. Stents have reduced restenosis, the incidence of acute complications, and the need for emergency surgery.18, 19, 20, 21, 22, 23, 24, 25, 26, 27 However, when stent restenosis occurs, it is more resistant to treatment and has a high rate of recurrence.9, 10, 11, 12 Finally, the long-term efficacy of stents, particularly in patients requiring multiple
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