A pilot study of coronary angioplasty in outpatients.

BACKGROUND--Is it safe to discharge patients from hospital on the same day as percutaneous transluminal coronary angioplasty (PTCA)? The hypothesis tested was that careful pre and post angioplasty selection of patients can identify a group that is at very low risk of postprocedural complications and that these patients may be discharged on the day of the procedure. METHODS--63 patients undergoing limited risk coronary angioplasty of 72 lesions were studied. So that patients would be able to walk soon after PTCA miniature equipment (6 French catheters and balloon-on-a-wire devices) was passed percutaneously through the right brachial artery. After coronary angioplasty patients with angiographic evidence of dissection and/or thrombus and with complications were assigned to an inpatient group and those in whom PTCA had achieved a good angiographic result were assigned to an outpatient group. RESULTS--Two patients were excluded because the brachial approach failed, leaving 61 patients (70 lesions). After PTCA 50 patients (82%) with 57 lesions (81%) attempted were assigned to the outpatient group. No cardiac complication occurred in this subset (0%; 95% confidence interval 0 to 7%). Eleven patients (18%), in whom 13 lesions (19%) were attempted, were assigned to the inpatient group. Three of these patients (27%; 95% confidence interval 6 to 61%) had cardiac complications. Two patients needed local surgical repair after catheterisation of the brachial artery; one had a haematoma and one had a false aneurysm. CONCLUSIONS--Coronary angioplasty with miniature equipment passed through the brachial artery was a safe procedure with a high initial success rate. The results of this pilot trial suggest that with careful selection of patients before and after angioplasty PTCA can be performed safely in outpatients

Pharmacodynamics and safety of lefradafiban, an oral platelet glycoprotein IIb/IIIa receptor antagonist, in patients with stable coronary artery disease undergoing elective angioplasty

OBJECTIVE—Lefradafiban is the orally active prodrug of fradafiban, a glycoprotein IIb/IIIa receptor antagonist. The present phase II study aimed to determine the dose of lefradafiban that provides 80% blockade of the glycoprotein IIb/IIIa receptors by fradafiban, and to study the pharmacodynamics and safety of different doses in patients with stable angina undergoing angioplasty.
DESIGN—A double blind, placebo controlled, dose finding study.
SETTING—Four academic and community hospitals in the Netherlands.
PATIENTS—64 patients with stable coronary artery disease undergoing elective percutaneous transluminal coronary angioplasty.
INTERVENTIONS—30 mg, 45 mg, and 60 mg of lefradafiban three times daily or placebo was given for 48( )hours.
MAIN OUTCOME MEASURES—The primary safety end point was the occurrence of bleeding, classified as major, minor, or insignificant according to the thrombolysis in myocardial infarction (TIMI) criteria. Efficacy indices included per cent fibrinogen receptor occupancy (FRO), ex vivo platelet aggregation, and plasma concentrations of fradafiban.
RESULTS—Administration of lefradafiban 30, 45, and 60 mg three times daily resulted in a dose dependent increase in median FRO levels of 71%, 85%, and 88%, respectively. Inhibition of platelet aggregation was closely related to FRO. There were no major bleeding events. The 60 mg lefradafiban group had a high (71%) incidence of minor and insignificant bleeding. The incidence of bleeding was 44% in the 30 mg and 45 mg groups, compared with 9% in placebo patients. Puncture site bleeding was the most common event. The odds of bleeding increased by 3% for every 1% increase in FRO.
CONCLUSIONS—Lefradafiban is an effective oral glycoprotein IIb/IIIa receptor blocker. The clinical effectiveness of doses up to 45 mg three times daily should be investigated.


Keywords: platelet aggregation inhibitors; glycoprotein IIb/IIIa blockers; lefradafiban; angioplast