Assessment of clinical, electrocardiographic, and physiological relevance of diagonal branch in left anterior descending coronary artery bifurcation lesions.

OBJECTIVES: This study sought to investigate the clinical, electrocardiographic, and physiological relevance of main and side branches in coronary bifurcation lesions. BACKGROUND: Discrepancy exists between stenosis severity and clinical outcomes in bifurcation lesions. However, its mechanism has not been fully evaluated yet. METHODS: Sixty-five patients with left anterior descending coronary artery (LAD) bifurcation lesions were prospectively enrolled. Chest pain and 12-lead electrocardiogram were assessed after 1-min occlusion of coronary flow and coronary wedge pressure (Pw) was measured using a pressure wire. RESULTS: ST-segment elevation was more frequent during LAD occlusion (92%) than during diagonal branch occlusion (37%) (p < 0.001). Pain score was also higher with the occlusion of LAD than with the diagonal branch (p < 0.001). However, both Pw and Pw/aortic pressure (Pa) were lower in the LAD than in diagonal branches (Pw: 21.0 ± 6.5 vs. 26.7 ± 9.4, p < 0.0001; Pw/Pa: 0.22 ± 0.07 vs. 0.27 ± 0.08, p = 0.001). The corrected QT interval was prolonged with LAD occlusion (435.0 ± 39.6 ms to 454.0 ± 45.4 ms, p < 0.0001) but not with diagonal branch occlusion. There was no difference in vessel size between the diagonal branches with and without ST-segment elevation during occlusion. Positive and negative predictive values of vessel size (≥2.5 mm) to determine the presence of ST-segment elevation were 48% and 72%, respectively. CONCLUSIONS: Diagonal branch occlusion caused fewer anginas, less electrocardiogram change, less arrhythmogenic potential, and higher Pw than did a LAD occlusion. These differences seem to be the main mechanism explaining why aggressive treatment for side branches has not translated into clinical benefit in coronary bifurcation lesions. (Comparison Between Main Branch and Side Branch Vessels; NCT01046409).

Assessment of the bioequivalence of brand and biogeneric formulations of abciximab for the treatment of acute coronary syndrome: a prospective, open-label, randomized, controlled study in Korean patients.

BACKGROUND: Abciximab has been found to reduce major adverse cardiovascular events in patients with acute coronary syndrome (ACS). A previous study reported on the tolerability of biogeneric abciximab in patients with ACS. This formulation has been approved by the Korea Food and Drug Administration and is currently being marketed. Its ex vivo antiplatelet effect, however, has not been compared with that of branded abciximab. OBJECTIVE: The purpose of the present study was to compare ex vivo antiplatelet activity, angiographic outcome, and bleeding complications between biogeneric and branded abciximab. METHODS: This prospective, open-label, randomized, controlled study was conducted in Korea. Patients with ACS who underwent percutaneous coronary intervention (PCI) were randomized to receive biogeneric abciximab or branded abciximab. All patients received intracoronary unfractionated heparin 70 IU/kg and either biogeneric or branded abciximab 0.25 mg/kg IV bolus approximately 10 minutes before undergoing PCI, followed by a 0.125 microg/kg/min 12-hour infusion of the same formulation. The antiplatelet effect of both drugs was assessed at 3 time points (at baseline, and 10 minutes and 24 hours after the end of the bolus infusion) using a validated rapid platelet-function assay. RESULTS: In total, 37 patients (30 men and 7 women; 19 receiving biogeneric abciximab and 18 receiving branded abciximab) were included. Patient demographics did not differ significantly between the 2 groups (16 men [84.2%] and 3 women [15.8%] in the biogeneric group vs 14 men [77.8%] and 4 women [22.2%] in the branded group; mean [SD] age, 65 [11] vs 60 [10] years; weight, 64.6 [8.7] vs 67.9 [10.1] kg, respectively). The bolus and the continuous infusion of the biogeneric and branded formulations achieved similar levels of platelet inhibition, with a mean (SD) inhibition of platelet aggregation >90% at 10 minutes after the end of the bolus infusion (94.7% [8.2%] vs 92.6% [16.9%], respectively; P = NS) and >65% at 24 hours (68.1% [9.8%] vs 70.9% [9.7%]; P = NS) compared with baseline. One thrombolysis in myocardial infarction major bleeding complication (retro-peritoneal hemorrhage) was reported in a patient who received biogeneric abciximab. CONCLUSION: There were no statistically significant differences in the antiplatelet effects of these 2 formulations in this small, selected population of Korean patients with ACS.