Elsevier

The Lancet

Volume 355, Issue 9222, 24 June 2000, Pages 2199-2203
The Lancet

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

https://doi.org/10.1016/S0140-6736(00)02403-XGet rights and content

Summary

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.

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.

Section snippets

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

References (29)

  • T Kimura et al.

    Serial angiographic follow-up after Palmaz-Schatz stent implantation: comparison with conventional balloon angioplasty

    J Am Coll Cardiol

    (1993)
  • D Fischman et al.

    A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease

    N Engl J Med

    (1994)
  • P Serruys et al.

    A comparison of balloon-expandable stent implantation with ballon angioplasty in patients with coronary disease

    N Engl J Med

    (1994)
  • F Versaci et al.

    A comparison of coronary-artery stenting with angioplasty for isolated stenosis of the proximal left anterior descending coronary artery

    N Engl J Med

    (1997)
  • Cited by (102)

    • Direct drug-eluting stenting to reduce stent restenosis: A randomized comparison of direct stent implantation to conventional stenting with pre-dilation or provisional stenting in elective PCI patients

      2014, JACC: Cardiovascular Interventions
      Citation Excerpt :

      The study design was not changed. It was still thought to be interesting to compare differences between stenting groups and a provisional group, although previous studies have shown balloon angioplasty to be inferior to a stenting approach for restenosis (16). This most likely explains the high rate of DES implantation in the PS group.

    • The Pathophysiology and Burden of Restenosis

      2007, American Journal of Cardiology
      Citation Excerpt :

      However, restenosis was also associated with a significantly higher rate of MI (p = 0.0001), CABG (p <0.0001), and repeat angioplasty (p = 0.0001).28 Although these data suggest that the presence of restenosis does not confer an increase in mortality, the impact of restenosis on patient quality of life has been confirmed in prospective and retrospective clinical trials.29,30 In the Optimum Percutaneous Transluminal Coronary Angioplasty Compared with Routine Stent Strategy (OPUS-1) trial, patients without restenosis experienced fewer physical limitations and an improved quality of life compared with patients with restenosis.29

    View all citing articles on Scopus
    View full text