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