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

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

Definitions. Angiographic success: final post-procedural diameter stenosis of < 10% by visual estimate. Bleeding complications were classified as major (intracranial bleeding or bleeding producing a fall either in hemoglobin of > 5 g/dL or hematocrit > 15%) or minor (spontaneous hematuria or hematemesis, observed hemorrhage producing a fall in hemoglobin > 3 g/dL or a decrease in hemoglobin > 4 g/dL with no identified bleeding site) in accordance with the Thrombolysis in Myocardial Infarction (TIMI) criteria. Vascular complications: occurrence of bleeding or hematoma formation at the puncture site requiring transfusion or vascular repair or prolonged (> 30 minute) external compression. Death: all causes. Myocardial infarction (MI): Q-wave myocardial infarction (occurrence of new pathological Q-waves in conjunction with elevation in creatine kinase levels > 3 times the upper limit of normal); non-Q wave MI (elevation of the cardiac enzymes to greater than three times the normal value without new pathologic Q-wave development). Urgent revascularization: interventions (coronary artery bypass surgery or repeated PTCA) performed during the hospitalization. Target lesion revascularization: non-emergency surgical or percutaneous procedure performed for symptomatic restenosis. Acute or subacute stent thrombosis: stent occlusion or the finding of TIMI I or II flow associated with an intraluminal filling defect occurring following successful stent deployment. Stent restenosis: >= 50% luminal reduction immediately adjacent to (marginal) or within the stent site at follow-up angiogram irrespective of clinical symptoms of the patient.

Statistical analysis. All variables were expressed as means ± standard deviation. All variables in the two treatment arms were compared with the Student’s t-test for all continuous data and with the Chi-square test for all qualitative data. A probability of < 0.05 was considered statistically significant. Fisher’s exact test was also used.

RESULTS



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