LMWH and Percutaneous Coronary Intervention

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Two complementary registry studies evaluating the safety and usefulness of two specific dose regimens of enoxaparin with, and without, concomitant abciximab during percutaneous coronary intervention (PCI) have been reported by Kereiakes et al. (60). Patients undergoing PCI were enrolled in separate conducted by the National Investigators Collaborating on Enoxaparin (NICE) study groups (NICE 1 and NICE 4 studies). NICE 1 patients were treated with 1.0 mg/kg intravenous enoxaparin without abciximab, while NICE 4 patients received a reduced dose (0.75 mg/kg) intravenous enoxaparin combined with standard dose abciximab. The studies indicated that enoxaparin with or without abciximab provided safe and effective anticoagulation during PCI. A combina-

Abciximab Induced Thrombocytopenia

Fig. 3. Event rates for enoxaparin with or without glycoprotein Ilb/IIIa antagonists in the NICE trials. NICE 1 patients received enoxaparin alone, NICE 4 patients received enoxaparin plus abciximab, while NICE 3 patients received enoxaparin plus either tirofiban, eptifibatide, or abciximab. Adapted from Kereiakes DJ, et al. J Invas Cardiol 2001;13:272-278.

Fig. 3. Event rates for enoxaparin with or without glycoprotein Ilb/IIIa antagonists in the NICE trials. NICE 1 patients received enoxaparin alone, NICE 4 patients received enoxaparin plus abciximab, while NICE 3 patients received enoxaparin plus either tirofiban, eptifibatide, or abciximab. Adapted from Kereiakes DJ, et al. J Invas Cardiol 2001;13:272-278.

tion of abciximab and reduced dose enoxaparin was associated with a low incidence of bleeding or ischemic events. Major and minor bleeding occurred in 1.1 and 6.2% of NICE 1 patients and 0.4 and 7.0% of NICE 4 patients, respectively, at 30 d post-PCI. There was a low incidence of thrombocytopenia with only 0.9 and 2.1% of NICE 1 and NICE 4 patients having a platelet count less than 100,000 at 30 d. The composite end point of death, MI, and urgent revascularization in-hospital (Fig. 3) and at 30 d post-PCI was 6.2 and 7.7% in NICE 1 patients and 6.5 and 6.8% in NICE 4 patients, respectively. Anticoagulant activity measured at 5 and 15 min post-enoxaparin bolus reflected values expected for 1.0 and 0.75 mg/kg enoxaparin treatment, while no differences occurred at 4 and 8 h. The conclusion from these studies is that enoxaparin (1.0 mg/kg) without abciximab, as well as enoxaparin (0.75 mg/kg) in combination with abciximab, provides safe and efficacious anticoagulation during PCI. Subsequently, the NICE-3 study was performed to assess the safety of subcutaneous enoxaparin in combination with eptifi-batide, tirofiban, or abciximab, in patients who subsequently underwent PCI (56). The study confirms the low risk of major bleeding (4.5%) found in the NICE 1 and 4 trials, and also demonstrated a low rate of clinical end points (death, MI, and urgent revascu-larization) of 4.5% for any glycoprotein IIb/IIIa inhibitor in combination with enoxaparin (Fig. 3). The Can Routine Ultrasound Influence Stent Expansion (CRUISE) study was also recently initiated to evaluate the safety and efficacy of either 0.75 mg/kg intravenous enoxaparin or 60 IU/kg intravenous UFH in combination with eptifibatide in patients undergoing nonemergency PCI with planned stent implantation. Bhatt et al. (61) recently presented results that showed that the risk of minor or major bleeding events was not significantly different between patients treated with a combination of eptifibatide and either enoxaparin (129 patients) or UFH (132 patients). They also reported that the efficacy of these combined therapies were not significantly different.

Although evidence has shown that UFH can be safely and effectively replaced in patients with UA or NQWMI by subcutaneous injections of LMWH, the optimal coagulation strategy for such patients when they require cardiac catheterization is not clear.

To address this issue, Collet et al. (62) conducted a study with the aim of evaluating a new anticoagulation strategy in these patients. A total of 451 patients with UA/NQWMI were treated for at least 48 h with twice-daily 1.0 mg/kg subcutaneous enoxaparin, cycled at 6 am and 6 pm. From this group, 65% underwent coronary angiography within 8 h of the morning enoxaparin injection, followed by immediate PCI in 28% of patients. PCI was performed without any further UFH/LMWH treatment. Anti-Xa activity was 0.98 ± 0.03 IU/mL at the time of catheterization, >0.5 IU/mL in 97.6% of patients and did not relate to LMWH-to-catheterization time. At 30 d, the death and/or MI rate was 3.0% in the PCI group, 6.2% in the total population, and 10.8% in patients not undergoing catheterization. The bleeding rate at 30 d was 0.8% in the PCI group, which was comparable to that of patients not undergoing catheterization. They concluded that PCI conducted within 8 h of subcutaneous enoxaparin injection was both safe and efficacious. The early complications of PCI (abrupt closure and urgent revascularization) were prevented, and a low event rate at 1-mo follow-up was evident.

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