Elsevier

The Lancet

Volume 352, Issue 9122, 11 July 1998, Pages 87-92
The Lancet

Articles
Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade

https://doi.org/10.1016/S0140-6736(98)85010-1Get rights and content

Summary

Background

Coronary stenting with use of heparin, aspirin, and ticlopidine for thromboprophylaxis is performed in more than 500 000 patients per year worldwide. We did a randomised controlled trial to assess the role of platelet glycoprotein-IIb/IIIa blockade for use in elective stenting.

Methods

At 63 hospitals in the USA and Canada, 2399 patients with ischaemic heart disease and suitable coronary-artery lesions were randomly assigned stenting plus placebo (n=809), stenting plus abciximab, a IIb/IIIa inhibitor (n=794), or balloon angioplasty plus abciximab (n=796). The primary endpoint was a combination of death, myocardial infarction, or need for urgent revascularisation in the first 30 days. All patients received heparin, aspirin, and standard pharmacological therapy.

Findings

The primary endpoint occurred in 87 (10·8%) of 809 patients in the stent plus placebo group, 42 (5·3%) of 794 in the stent plus abciximab group (hazard ratio 0·48 [95% CI 0·33–0.69] p<0·001), and 55 (6·9%) of 796 in the balloon plus abciximab group (0·63 [0·45–0.88] p=0·007). The main outcomes that occurred less with abciximab were death and large myocardial infarction—7·8% in the placebo group, 3·0% for stent plus abciximab (p<0·001), and 4·7% for balloon angioplasty plus abciximab (p=0·01). Major bleeding complications occurred in 2·2% of patients assigned stent plus placebo, 1·5% assigned stent plus abciximab, and 1·4% assigned balloon angioplasty plus abciximab (p=0·38).

Interpretation

Platelet glycoprotein-IIb/IIIa blockade with abciximab substantially improves the safety of coronary-stenting procedures. Balloon angioplasty with abciximab is safer than stenting without abciximab.

Introduction

Clinical trials have shown that stenting with a metal scaffolding device is superior to balloon angioplasty in terms of the need for repeat revascularisation.1, 2 Coronary stenting has been adopted as the main approach for percutaneous coronary revascularisation worldwide.3 More than 500 000 coronary-stent procedures will be performed across the world in 1998.4 Standard pharmacological prevention of stent thrombosis involves administration of heparin, aspirin, and ticlopidine during the procedure.5, 6, 7

Inhibition of the platelet glycoprotein-IIb/IIIa receptor has been shown to improve outcomes of balloon angioplasty.8, 9, 10, 11, 12, 13, 14, 15 Whether this therapy should be combined with stenting remains unclear. Therefore, we did a randomised controlled trial with the hypothesis that stenting or balloon angioplasty plus IIb/IIIa inhibition would be superior to stenting plus placebo. The primary outcome measure was rates of death, myocardial infarction, or urgent revascularisation within 30 days of intervention.

Section snippets

Patients

In 63 centres in the USA and Canada, patients scheduled to undergo elective or urgent percutaneous coronary revascularisation were eligible for inclusion if: target lesions had caused stenosis of at least 60% amenable to balloon angioplasty or stenting; the target vessel was not an unprotected left-mainstem stenosis; and the patient did not have a bleeding diathesis, intracranial neoplasm, a history of stroke in the previous 2 years, uncontrolled hypertension (systolic blood pressure >180

Results

From July 22, 1996, to Sept 25, 1997, we enrolled 2399 patients and none were excluded. Baseline demographic and key angiographic features are shown in table 1. More than 98·5% of patients in each group received the study drugs, and therapy was discontinued before 12 h in only 8·5% of patients, with no differences between the three groups. Interventions were attempted in 99% of all patients (figure 1).

Abrupt closure and side-branch occlusion were seen among fewer patients on abciximab than

Discussion

We found a significantly lower the rate of death and myocardial infarction after stenting and balloon angioplasty with the use of platelet glycoprotein-IIb/IIIa blockade.

Six randomised placebo-controlled studies of platelet-IIb/IIIa inhibitors have been done previously on balloon angioplasty and atherectomy.8, 9, 10, 11, 12, 13 In all of these trials, patients in all groups received aspirin, and all trials showed decreases in myocardial infarction. Three of the trials tested abciximab,8, 10, 12

References (30)

  • Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty

    N Engl J Med

    (1994)
  • Randomized placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention

    Lancet

    (1997)
  • Effect of the platelet glycoprotein IIb/IIIa receptor inhibitor abciximab with lower heparin dosages on ischemic complications of percutaneous coronary revascularization

    N Engl J Med

    (1997)
  • Effects of platelet glycoprotein IIb/IIIa blockade with tirofiban on adverse cardiac events in patients with unstable angina or acute myocardial infarction undergoing coronary angioplasty

    Circulation

    (1997)
  • Randomised placebo-controlled trial of abxicimab before and during intervention in refractory unstable angina: the CAPTURE study

    Lancet

    (1997)
  • Cited by (0)

    Investigators, study organisation, and writing committee in the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting (EPISTENT) trial listed at end of paper

    View full text