Glycoprotein (GP) IIb/IIIa inhibitors, such as abciximab, are used as adjunctive therapy for percutaneous coronary intervention (PCI) in high-risk non-ST-elevation myocardial infarction (NSTEMI) and in ST-elevation myocardial infarction (STEMI), although their effects when used for STEMI are less clear. As the use of GP IIb/IIIa inhibitors becomes more widespread, determining the risks associated with them becomes more important. The major risks associated with the use of GP IIb/IIIa inhibitors are the potential for major bleeding and thrombocytopenia. This is the first reported case in Korea of hemorrhagic pericarditis resulting in cardiac tamponade associated with the use of abciximab, a commonly used GP Ilb/IIa inhibitor, following PCI.
Aged ; Angioplasty, Transluminal, Percutaneous Coronary/*adverse effects ; Antibodies, Monoclonal/*adverse effects ; Anticoagulants/*adverse effects ; Cardiac Tamponade/*etiology/therapy ; Emergency Medical Services ; Hemorrhage/*etiology/therapy ; Humans ; Immunoglobulin Fab Fragments/*adverse effects ; Korea ; Male ; Pericardiocentesis ; Pericarditis/*etiology/therapy ; Platelet Aggregation Inhibitors/*adverse effects ; Risk Factors

PURPOSE: This study was designed as a multicenter, randomized, open-label study to evaluate the efficacy and tolerability of Clotinab(TM). We expected to obtain same results as with ReoPro(R) in improving ischemic cardiac complications in high-risk patients who were about to undergo percutaneous coronary intervention (PCI). PATIENTS AND METHODS: Patients of 19-80 years of age with acute coronary syndrome (ACS) who were about to undergo PCI were enrolled. After screening and confirmation of eligibility, patients were randomly assigned to different groups. Clotinab(TM) was given to 84 patients (58.7+/-10.6 years, M:F=68:16)and ReoPro(R)(59.0+/-10.5 years, M:F=30:10) was given to 40 patients before PCI. The primary efficacy endpoint was the onset of major adverse cardiac event (MACE) within 30 days from day 1. The tolerability endpoints were assessed based on bleeding, thrombocytopenia, change in Hb/Hct, human antichimetric antibody development, and adverse events. RESULTS: The number of Clotinab(TM) patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact CI was [0.00-4.74%]. A major bleeding event developed in 3 patients in the ReoPro(R) group. The probability of MACE onset in Clotinab(TM) was estimated to be less than 5%. There was no clinically significant result in tolerability variables. CONCLUSION: Clotinab(TM) is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.
Acute Coronary Syndrome/surgery ; Adult ; Aged ; Aged, 80 and over ; *Angioplasty, Transluminal, Percutaneous Coronary ; Antibodies, Monoclonal/adverse effects/*therapeutic use ; Drugs, Investigational/adverse effects/therapeutic use ; Female ; Humans ; Immunoglobulin Fab Fragments/adverse effects/*therapeutic use ; Male ; Middle Aged ; Myocardial Ischemia/prevention & control ; Platelet Aggregation Inhibitors/adverse effects/*therapeutic use ; Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors ; Prospective Studies ; Risk Factors ; Treatment Outcome