Prophylactic Abciximab in Elective Coronary Stenting: Results of a Randomized Trial

Volume 14 - Issue 2 - February, 2002
Posted on: 8/1/08
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Author(s):

Corrado Tamburino, MD, Giovanni Russo, MD, Antonino Nicosia, MD,
Alfredo R. Galassi, MD, Rosario Foti, MD, V. Scriffignano, DSc, *Dean J. Kereiakes, MD, Giuseppe Giuffrida, MD

Stent implantation procedure. Procedures were performed via the femoral artery using 8 French (Fr) guiding catheters as previously described.21 Briefly, different types of slotted tubular and coil stents were used according to the characteristics of the lesions and availability in the catheterization laboratory. All stents were implanted after predilation of the lesion. Post-deployment high-pressure balloon inflations (> 16 atm) using non-compliant balloons were then performed to achieve a final angiographic result of < 10% residual diameter stenosis by visual estimate.

Angiographic analysis. Coronary angiograms before stenting, immediately after stenting and at follow-up were analyzed by two experienced angiographers not involved in the procedure and blinded to the study medication treatment. Patients received intracoronary nitroglycerin (2 mg) before baseline and final angiograms to achieve maximal coronary vasodilation. Stenoses were measured on manual calipers in end-diastolic frames on two orthogonal views. The guiding catheter was used as the reference object for measurement of vessel length and diameter. The following parameters were calculated from the angiographic analysis: acute gain [minimal luminal diameter (MLD) post-stenting minus MLD pre-stenting], late loss (MLD after stenting minus MLD at follow-up) and net gain (MLD at follow-up minus MLD pre-stenting). Lesion severity at the baseline angiogram was characterized according to the modified American College of Cardiology/American Heart Association classification.22

Objectives. The primary objective of the study was to assess the safety (bleeding and vascular complications) of prophylactic abciximab and its efficacy in reducing major in-hospital adverse cardiac events related to the procedure (death, myocardial infarction and urgent revascularization) during elective implantation of long or multiple overlapping coronary stents. The secondary objective was to evaluate the efficacy of abciximab in reducing death, myocardial infarction, or target lesion revascularization (TLR) and angiographic binary restenosis in such a complex setting to 6 months of follow-up.