Soon-Jun Hong

Comparison of Antiplatelet Effect and Tolerability of Clopidogrel Resinate With Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD-Equivalent Risks: A Phase IV, Prospective, Double-Dummy, Parallel-Group, 4-Week Noninferiority Trial

BACKGROUND Clopidogrel resinate is a resinate complex of (+)-clopidogrel optical isomer, wherein the (+)-clopidogrel isomer binds to a water-soluble cation exchange resin via sulfonic acid groups. It was approved by the Korean Food and Drug Administration on the basis of a Phase I study that demonstrated the bioequivalence of clopidogrel resinate and clopidogrel bisulfate. However, there are no available data regarding efficacy and tolerability in patients with vascular disease. OBJECTIVE The goal of this study was to investigate the antiplatelet efficacy and tolerability of clopidogrel resinate in patients with coronary heart disease (CHD) or CHD-equivalent risks. METHODS This study was a Phase IV, randomized, double-blind, double-dummy, parallel-group, noninferiority trial. We prospectively recruited patients in 10 centers between March 2008 and July 2008. Patients who had documented CHD or CHD-equivalent risks were randomly assigned to 1 of 3 groups: group A, aspirin (100 mg) + clopidogrel bisulfate placebo + clopidogrel resinate placebo; group B, aspirin (100 mg) + clopidogrel bisulfate placebo + clopidogrel resinate (75 mg); or group C, aspirin (100 mg) + clopidogrel bisulfate (75 mg) + clopidogrel resinate placebo. The primary outcome was the percent P2Y(12) inhibition after medication, assessed by using a point-of-care assay. If the 1-sided 90% upper confidence limit for the difference was less than the prespecified delta value (-5.7), clopidogrel resinate would be considered noninferior to clopidogrel bisulfate. The secondary outcome, the prevalence of adverse events (AEs) associated with study medications, was assessed at each visit by direct interview. RESULTS A total of 314 patients (mean [SD] age, 62.2 [9.0] years; male 63.7%; weight, 67.3 [13.6] kg [range, 45-102 kg]; all Asian) were enrolled, and 287 patients finished the study (group A, n = 97; group B, n = 90; and group C, n = 100). Eight patients took no study medications and were excluded from the tolerability and efficacy analyses. Nineteen patients discontinued the study because of protocol violation (n = 15), adverse events (n = 3), or voluntary withdrawal (n = 1) and were excluded from the efficacy analysis. There were no significant differences in baseline clinical characteristics among the groups except for the frequency of a history of CHD (group A, 85.4%; group B, 73.0%; and group C, 88.3%; P = 0.01). Patients treated with either type of clopidogrel showed significant inhibition (mean [SD]) of P2Y(12) (group A, -5.9% [15.1%]; group B, 23.4% [21.9%]; and group C, 19.5% [23.8%]; P < 0.001). Differences between clopidogrel resinate and clopidogrel bisulfate in the inhibition of P2Y(12) did not exceed the predetermined value for inferiority (P for noninferiority, 0.02; 90% CI, -0.9 to 10.3). In the tolerability analysis, there was no mortality during the study period and no significant differences between groups in the frequency of AEs and serious AEs (AEs: group A, 33.0%; group B, 26.0%; and group C, 23.3% [P = 0.27]; serious AEs: group A, 1.0%; group B, 3.0%; and group C, 1.0% [P = 0.42]). One patient in group B underwent coronary stent implantation for treatment of stable angina. CONCLUSIONS In this small, selected Asian patient population, differences in the platelet inhibition efficacies of clopidogrel resinate and clopidogrel bisulfate did not exceed the predetermined limits for noninferiority. The differences in tolerability between the 2 drugs did not reach statistical significance.

TCT-108 Comparison of Ticagrelor versus Prasugrel on Inflammation, Vascular Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients with Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting: Prospective, Randomized, Cross-Over Design

Although both ticagrelor and prasugrel have shown potent anti-platelet effects, only ticagrelor inhibits cellular uptake of adenosine. We therefore compared adenosine associated pleiotropic effects such as systemic inflammation, vascular function, and circulating endothelial progenitor cells between

TCT-559 Optical coherence tomography (OCT) guided percutaneous coronary intervention : clinical impact of acute abnormal findings after drug-eluting stent implantation detected only by OCT.

TCT-559 Optical coherence tomography (OCT) guided percutaneous coronary intervention : clinical impact of acute abnormal findings after drug-eluting stent implantation detected only by OCT Seung Hun Lee, Jae Young Cho, Hyung Joon Joo, Jae Hyoung Park, Soonjun Hong, Cheol Woong Yu, Do Sun Lim Anam Hospital, Korea University Medical Center., Seoul, Korea, Republic of; Korea University Cardiovascular center, Seoul, Korea, Republic of; Korea University Anam Hospital, Seoul, Korea, Republic of; Korea University Anam Hospital, Seoul, Korea, Republic of; Korea University College fo Medicine, Seoul, Korea, Republic of; Korean University Anam Hospital, Seoul, Korea, Republic of; Korea University Anam Hospital, Seoul, Korea, Republic of

TCT-620 A comparison of clinical outcomes between triple antithrombotic therapy versus dual antiplatelet with left atrial appendage occlusion in patients with atrial fibrillation undergoing drug-eluting stent implantation

RESULTS Over a lifetime, LAAC provided an additional 0.35 life years (LY) and 0.52 QALYs relative to warfarin and an additional 0.17 LYs and 0.23 QALYs relative to NOACs. LAAC was dominant (more effective and less costly) relative to warfarin and NOACs. NOACs were cost effective but not cost saving relative to warfarin. In sensitivity analyses, LAAC was cost effective in 97% and 90% of simulations relative to warfarin and NOACs, respectively.

Lbps 02–43 Angiotensin Ii Receptor Blocker Combined With Calcium Channel Blocker Is More Effective in Reduction of Blood Pressure Variability Than Combined With Diuretics:

Objective: Hypertensive patients with greater blood pressure variability (BPV) are associated with a higher rate of cardiovascular events. We compared the efficacy of angiotensin II receptor blocker (ARB)/calcium-channel blocker combination with ARB/diuretic combination in reduction of 24-hour BPV. Design and Method: In a prospective, randomized, double-blind trial, hypertensive patients were assigned to Losartan/Amlodipine (L/A, dose of 50 mg/5 mg or 100 mg/5 mg) group or Losartan/Hydrochlorothiazide (L/H, dose of 50 mg/12.5 mg or 100 mg/25 mg) group. 24-hour ambulatory BP was measured at baseline and after 20 weeks treatment. BPV was calculated from weighted standard deviation and compared between two groups. Results: Total 220 patients [mean age = 59.6 ± 12.3 years, men = 154 (70%)] were enrolled. After 20 weeks treatment, systolic and diastolic weighted standard deviations were significantly lower in L/A group than L/H group. (Table) In multivariate regression analysis, significant difference of diastolic weighted standard deviation after 20 weeks treatment was independent of 24-hour SBP and DBP between two groups. Conclusions: ARB/calcium-channel blocker combination is more favorable in reduction of 24-hour BPV than ARB/diuretic combination independent of 24-hour BP differences. Figure. No caption available.

MPS 15-08 BLOOD PRESSURE REDUCTION EFFICACY OF ANGIOTENSIN II RECEPTOR BLOCKER COMBINED WITH CALCIUM CHANNEL BLOCKER IS MORE SYNERGISTIC THAN WITH DIURETICS: 24-HOUR AMBULATORY BLOOD PRESSURE MONITORING

Background: The optimal combination drug therapy for hypertension is not yet established. The aim of this study was to compare the effects between fixed dose calcium channel blocker and double dose diuretics when used in combination with angiotensin II receptor blocker (ARB) on 24-hour ambulatory blood pressure (BP). Methods: In a prospective, randomized, double-blind trial, hypertensive patients were assigned to Losartan/Amlodipine (L/A, dose of 50 mg/5 mg) group or Losartan/Hydrochlorothiazide (L/H, dose of 50 mg/12.5 mg) group. The patients who failed to achieved BP goal after 4 weeks treatment were increased dose to 100 mg/5 mg (L/A group) and 100 mg/25 mg (L/H group) respectively. 24-hour ambulatory BP was measured at baseline and after 20 weeks treatment. Results: Total 220 patients [mean age = 59.6 ± 12.3 years, men = 154 (70%)] were enrolled. After 4 weeks initial treatment, the averaged office systolic and diastolic BP showed no significant differences between groups and 38 (34.9%) subjects in L/A group and 51 (45.9%) in L/H group needed increase in drug dose (p < 0.001). After 20 weeks treatment, the office diastolic BP and 24-hour mean ambulatory systolic BP were significantly lower in L/A group. Also the reductions of office diastolic BP and 24-hour ambulatory systolic BP were significantly apparent in L/A group compared with L/H group. (Table) Conclusion: Losartan combined with amlodipine showed favorable office and 24-hour ambulatory BP lowering efficacy even with fixed dose amlodipine compared with double dose hydrochlorothiazide. These findings suggest that calcium channel blocker is more synergistic than diuretics when used with ARB on office BP and 24-hour BP reduction. Figure. No caption available.

LBOS 01-05 24-HOUR CENTRAL BLOOD PRESSURE REDUCTION EFFICACY OF CALCIUM CHANNEL BLOCKER COMBINATION IS SUPERIOR TO DIURETICS COMBINATION WITH ANGIOTENSIN II RECEPTOR BLOCKER ESPECIALLY IN MALE HYPERTENSIVE PATIENTS.

Background: The aim of this study was to compare 24-hour central blood pressure (24 hr c-BP) reduction efficacy between angiotensin II receptor blocker (ARB) combined with calcium channel blocker and with diuretics. Methods: We conducted a prospective, randomized, double-blind trial in 220 hypertensive patients [mean age = 59.6 ± 12.3 years, men = 154(70%)]. Patients received losartan 50 mg monotherapy for 4 weeks, followed by additional use of amlodipine 5 mg (L/A group) or hydrochlorothiazide 12.5 mg (L/H group) for 20 weeks. The patients without achievement of BP goal after 4 weeks randomization were increased dose to 100 mg/5 mg (L/A group) and 100 mg/25 mg (L/H group) respectively. 24 hr ambulatory c-BP was measured at baseline and after 20 weeks treatment. Results: The 24 hr mean systolic c-Systolic BP was significantly lower in L/A group than L/H group especially in male hypertensive patients. The office BP showed no significant differences between two groups in male hypertensives. However, the 24 hr mean systolic c-BP of female hypertensives showed no significant differences even with significant greater office BP reduction in L/A groups. (Table) Conclusion: These data showed that the combination of losartan and amlodipine had a more beneficial effect on 24 hr c-Systolic BP than the combination of losartan and hydrochlorothiazide in men hypertensives regardless of office BP reduction efficacy. This gender specific 24 hr c-Systolic BP reduction efficacy needs to be evaluated. Figure. No caption available.