J.P. Bae

Factors associated with clopidogrel use, adherence, and persistence in patients with acute coronary syndromes undergoing percutaneous coronary intervention

Abstract Objective: Recent guidelines recommend use of aspirin and either clopidogrel or prasugrel for at least 12 months following use of drug-eluting or bare metal stents in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI). This study evaluated factors associated with clopidogrel use and adherence in ACS patients following PCI. Research design and methods: The US employer-based MarketScan commercial claims database was used to examine factors associated with clopidogrel use and adherence. Adherence was defined as a medication possession ratio of 80% or higher. Multivariate logistic regression analyses were conducted to identify factors associated with clopidogrel use and adherence and included patient demographics, comorbidities, and prior beta-blocker, statin, and angiotensin converting enzyme inhibitor (BSI) use as factors. Results: A total of 10,465 patients aged 18–65 years who met inclusion criteria were hospitalized for ACS and underwent PCI between 01/01/2005 and 12/31/2006. Overall, the rate of clopidogrel use was 92.8% for ACS-PCI patients and 66.8% of the clopidogrel users were adherent. Receiving PCI without stenting (Odds Ratio [OR] = 3.28), comorbid hypertension (OR = 1.50), diabetes (OR = 1.49), and atrial fibrillation (OR = 1.91) were associated with decreased filled prescriptions for clopidogrel. Younger age (OR = 0.83) and prior use of clopidogrel (OR = 0.54) or other BSI medications (OR = 0.44) were associated with increased use of clopidogrel (all p values < 0.05). Factors significantly associated with non-adherence of clopidogrel were prior use of clopidogrel (OR = 1.40), prior hospitalization (OR = 1.34), chronic pulmonary disease (OR = 1.31), PCI without stenting (OR = 1.32), diabetes (OR = 1.17), and younger age (OR = 1.29). Prior use of BSI medications (OR = 0.82) increased adherence to clopidogrel. Conclusions: Prior use of clopidogrel, comorbid conditions such as diabetes and chronic pulmonary disease, prior hospitalization, PCI without stenting, and younger age had a negative impact on clopidogrel adherence. These findings may assist programs to improve thienopyridine compliance through a better understanding of patients’ disease profiles and concomitant medication use.

Real-world observations with prasugrel compared to clopidogrel in acute coronary syndrome patients treated with percutaneous coronary intervention in the United States.

Abstract Objectives: To compare 30 and 90 day real-world acute myocardial infarction (AMI) and bleeding related rehospitalization rates in acute coronary syndrome (ACS) patients receiving percutaneous coronary intervention (PCI; ACS-PCI) treated with clopidogrel or prasugrel. Research design and methods: Using the Premier hospital database, ACS-PCI patients receiving a drug-eluting (DES) or bare-metal (BMS) stent and clopidogrel or prasugrel from July 2009 to June 2011 were analyzed. Patients were included based on the prasugrel US prescribing information (USPI), excluding patients with a history of transient ischemic attack/stroke and patients ≥75 years without diabetes or prior MI. The primary endpoint was 30 day adjusted AMI rehospitalization rate. Secondary endpoints included 90 day AMI and 30 and 90 day bleeding-related rehospitalization rates. Treatment comparisons were adjusted using propensity score stratification. Results: At the index event, prasugrel patients (N = 9404) differed from clopidogrel patients (N = 74,163) by having a lower risk of comorbid conditions associated with bleeding, being more likely younger and male, having ST-elevation MI and receiving a DES. For clopidogrel and prasugrel, respectively, the observed AMI-related rehospitalization rates were 4.7% and 3.9% at 30 days (p < 0.0001) and 6.3% and 5.1% at 90 days (p < 0.0001). After adjustment, prasugrel was associated with ∼10% lower odds of AMI-related rehospitalization (30 days: OR = 0.892 [95% CI: 0.798, 0.998]; 90 days, OR = 0.901 [95% CI: 0.817, 0.994]). Adjusted bleeding-related rehospitalization rates were similar to each other (OR = 1.035 at 30 days [95% CI: 0.765, 1.399]; OR = 0.922 at 90 days [95% CI: 0.725, 1.172]). Study limitations: Treatment adherence was not assessed. Bleeding events not resulting in a hospitalization (e.g. office, outpatient, or emergency room visits), deaths outside the hospital, or readmissions to a hospital outside of the Premier alliance were not captured in the database. Conclusions: The different patient characteristics between prasugrel- and clopidogrel-treated patients suggest physicians are more selective in choosing patients for prasugrel than recommended in the prasugrel USPI. However, after adjustment for these differences, 30 and 90 day AMI rehospitalization rates were lower for prasugrel-treated patients compared to clopidogrel-treated patients, with no difference in adjusted bleeding-related rehospitalization rates.

Potential unrecognised costs of clopidogrel pretreatment in acute coronary syndrome

Abstract Objective: To examine adherence in clinical practice to the American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations of observing a 5-day waiting period after clopidogrel administration before undergoing coronary artery bypass graft (CABG) surgery and to examine the costs of waiting. Methods: This retrospective study used a nationwide inpatient database (Solucient ACTracker) to identify patients who were admitted for acute coronary syndrome (ACS), and who had same-stay CABG. Cost of additional days of stay was estimated using regression analysis. Results: The recommended 5-day waiting was adhered to in 16.9% (n=3,809) of patients. The percentage of patients with ACS undergoing CABG surgery on day 0 was 14.6%. Adherence to the waiting was higher for teaching and rural hospitals; and in female and elderly patients and urgent admissions. Conclusions: The recommended 5-day waiting for CABG surgery after clopidogrel treatment is poorly adhered to in clinical practice. This study was unable to determine specific reasons for the low adherence; however, there may be a compromise between the clinically urgent need for revascularisation and increased risk of bleeding, as well as economic costs associated with waiting. The cost of an additional hospital day in this group of patients was approximately £1,400 per day or £7,000 for 5 days. Thus, a full 5-day wait would have a significant economic impact on hospital costs.

Comparative resource utilization and costs for patients with acute coronary syndrome managed with percutaneous coronary intervention and treated with clopidogrel or prasugrel.

PURPOSE Results of a study of bleeding events and other inhospital outcomes with the use of clopidogrel versus prasugrel in patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) are reported. METHODS Demographic and clinical data on adults hospitalized for ACS, managed with PCI, and treated with clopidogrel or prasugrel during a two-year period were extracted from a large hospital claims database. Bleeding rates, hospital length of stay (LOS), and total hospital costs during the index hospitalization were evaluated. RESULTS The study sample consisted of 75,297 patients who received clopidogrel and 9,477 who received prasugrel. The unadjusted bleeding rates were 5.7% with clopidogrel use and 3.2% with prasugrel use (p < 0.0001). After propensity score stratification to adjust for selection bias, rates of bleeding events were not significantly different between clopidogrel- and prasugrel-treated patients (odds ratio, 0.90; 95% confidence interval [CI], 0.80-1.02; p = 0.0949). The adjusted mean ± S.D. hospital LOS was 0.22 day lower (95% CI, 0.15-0.28; p < 0.001) with the use of prasugrel versus clopidogrel, and adjusted total mean hospital costs were

PCV118 CHARACTERIZATION OF COMMERCIALLY INSURED PATIENTS WITH ACUTE CORONARY SYNDROME (ACS) RECEIVING PERCUTANEOUS CORONARY INTERVENTION (PCI)

375 less for prasugrel-treated patients (p = 0.003). CONCLUSION After adjustments for demographic and clinical characteristics, rates of inhospital bleeding in patients who received prasugrel and those who received clopidogrel were not significantly different. The adjusted analyses showed that the mean hospital LOS was shorter and total mean hospital costs were lower for patients treated with prasugrel.

PCV126 REDUCTION IN REHOSPITALIZATIONS AND ASSOCIATED COSTS WITHIN 30 DAYS AFTER DISCHARGE FROM HOSPITALIZATION FOR ACUTE CORONARY SYNDROMES AND PLANNED PCI WITH PRASUGREL VS. CLOPIDOGREL: RESULTS FROM THE TRITON-TIMI 38 TRIAL FOR PATIENTS WITH NO HISTORY OF STROKE OR TIA

PCV117 QUALITY OF LIFE OF PATIENTS WITH HYPERTENSION USING THE 2007 NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY (NHANES) OF KOREA Kim J University of Utah, Salt Lake City, UT, USA OBJECTIVES: This study was to compare health-related quality of life of patients with hypertension to people without hypertension. METHODS: Using the 2007 NHANES of Korea, EuroQol (EQ-5D) was used to estimate a relation between quality of life and hypertension. In the analysis, adults (age ≥19 years old) at the time of the survey were included. EQ-5D as well as each 5 category such as mobility, self-care, usual activity, pain/discomfort and anxiety/depression were considered for the analysis. For the estimation in EQ-5D, a generalized linear model with a logit link and the binomial family was used because EQ-5D was a proportion variable and had high negative skewness. In each specific category, there were 3 categories indicating good (1) to worse (3). Thus, ordered logit regressions were used for the analyses. In all analyses, age, gender, types of insurance, income, years of education and comorbid conditions were included. Survey weights were incorporated in the analyses to consider the survey design. RESULTS: A total of 2767 subjects was available. Among those, 518 (18.7%) subjects had a hypertension based on self-report on whether they had hypertension or not. Mean (SD) in quality-of-life of patients with hypertension was 0.84 (0.19), while mean (SD) of patients without hypertension was 0.93 (0.12). Among patients with hypertension, 51.7% were elderly (age >= 65 years) and 59.5% were female. Among patients without hypertension, 16.6% were elderly and 57.1% were female. Patients with hypertension as compare to people without hypertension were lower in quality of life by −0.20 (p-value: 0.038) after controlling other factors. Patients with hypertension were worsen in mobility and usual activity, but self-care, pain/discomfort and anxiety/depression had no difference from people without hypertension. CONCLUSIONS: Patients with hypertension as compared to people without hypertension were lower in quality of life mostly due to difficulties in mobility and usual activity.

PCV35 PRASUGREL AND CLOPIDOGREL PERSISTENCE AND DISCONTINUATION AMONG LOWER BLEEDING RISK PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION FOR ACUTE CORONARY SYNDROMES

angiography (DSA) when used to diagnose peripheral arterial occlusive disease (PAOD) from a German Hospital’s perspective. METHODS: In this study we considered the direct cost attributable to the radiological department in a hospital, including proportionate investigation costs such as personnel and machine usage. The costs for contrast agents and consumer goods were considered in a second step as they vary strongly from hospital to hospital. A total of eleven examinations, each of MRA and DSA type, were documented and analyzed. RESULTS: The investigation costs for a MRA examination excluding consumer goods was found to be a142.38 and about 20% (a34.25) lower than that of a DSA-examination (a176.63), owing to the shorter occupation time of the operating room with MRA (average: 32 minutes) than with DSA (average: 58 minutes) and resulting in a lower proportional investigation costs for machine, room, and personnel per examination assuming routine operating hours of 12 hours per day at seven days a week. When the list prices for consumer goods were also regarded, there was still an advantage for MRA of a11.22 ( 7%) per examination. CONCLUSIONS: For patients with suspected PAOD angiography with contrast-enhanced MRA was found to be less costly than DSA. Our results align with cost-effectiveness analyses conducted in the UK and the USA that included in addition the outcomes of diagnosis-based therapeutic decisions. Increased use of contrastenhanced MRA for diagnostic purposes and optimization of cost drivers might promote cost reductions in radiological departments in German hospitals.

PCV157 MEDICATION ADHERENCE AND PERSISTENCE OF CLOPIDOGREL IN ACUTE CORONARY SYNDROME PATIENTS WITH AND WITHOUT DIABETES MELLITUS

PCV33 ADHERENCE AND PERSISTENCE WITH STATIN THERAPY: PHARMACOUTILIZATION ANALYSIS FROM ADMINISTRATIVE DATABASES OF 5 ITALIAN LOCAL HEALTH UNITS (LHU) Santoni L, Spampinato A, Dall’Asta G, Didoni G, Moschetta V, Bottacchi E, Corso G, Bossone E, Raiola V, Orsini A, Ruffini D, Cillo M Pfizer Italy, Rome, RM, Italy, ASL Bari, Bari, BA, Italy, AUSL Valle d’Aosta, Aosta, AO, Italy, ASL Salerno 1, Nocera Inferiore, SA, Italy, ASL Teramo, Teramo, TE, Italy, ASL Salerno 3, Vallo della Lucania, SA, Italy OBJECTIVES: To describe the statins prescriptive patterns in primary or secondary prevention patients, to quantify treatment adherence and persistence and to produce data useful to administrators for better health care planning. METHODS: Five phar macoutilization observational retrospective studies were conducted in five italian Local Healthare Units, using the same methodology and statistical plan. Two databases (Pharmacy Claims and Hospital Discharges) were queried to select subjects with at least one statin prescription during the study period or an hospitalization for ischemic cerebro-cardiovascular causes. Record linkage was carried on using personal tax code as primary key (replaced with an anonymous code to ensure compliance with privacy rules). Subjects were classified in primary or secondary prevention (absence or presence of cerebro-cardiovascular events and/or at least two antidiabetics prescriptions) and in occasional or not-occasional users (time between the first and last prescription was 28 days or 28 days). A statin tablet was assumed as treatment unit. Adherence was quantified as MPR (Medication Possetion Ratio): ratio of tablets dispensed during the follow-up and the follow-up duration. Persistence was estimated using “Life Table” and Kaplan-Meier methods. A multiple linear regression model was built to describe adherence predictors. RESULTS: Demographic characteristics of the 5 samples are essentially superimposable. Occasional users vary from 24% to 75%, mainly in younger classes, females and primary prevention. MPR ranges from 39% to 59% and seems better in males and secondary prevention. After 6 months of treatment likelihood to stop therapy varies from 50% to 70% and it is lower in males and secondary prevention. Sex, age, type of cardiovascular prevention, follow-up duration and statin switch absence seem the major adherence predictors. CONCLUSIONS: Adherence and persistence levels with statin therapy are far from optimal values, resulting in failure to maximize therapy effectiveness and health care resources investment.

Longitudinal patterns of antidiabetes medication prescription among privately insured medicare patients

PCV157 MEDICATION ADHERENCE AND PERSISTENCE OF CLOPIDOGREL IN ACUTE CORONARY SYNDROME PATIENTS WITH AND WITHOUT DIABETES MELLITUS Zhu B, Zhao Z, Bayt T, Bae JP, McCollam PL, Anderson J, LeNarz L Lilly USA, LLC, Indianapolis, IN, USA, Eli Lilly and Company, Indianapolis, IN, USA OBJECTIVES: The recent ACC/AHA guidelines recommend the use of clopidogrel for at least 1 year in ACS-PCI patients who are not at high risk of bleeding. However, use of clopidogrel may not meet this guidance due to compliance issues. In this study, 1-year compliance of clopidogrel by ACS patients with or without diabetes mellitus (DM) was studied. METHODS: A total of N 12,502 ACS patients, aged 18–64 years and hospitalized with a primary diagnosis of ACS between January 1, 2005 and December 31, 2006 were identified with complete 1-year follow-up eligibility and drug use information in the MarketScan claims database. Patients were categorized into two cohorts: DM (N 3040) and non-DM (N 9462). Adherence was measured by the medication possession ratio (MPR). Persistence was reported using the time from index hospitalization to the first gap of 30 days between exhausting the supplied medication and filling the next prescription. Adherence and persistence between cohorts was compared using propensity score-adjusted bootstrapping method. RESULTS: A total of 72.1% (2193/3040) DM patients and 76.1% (7197/9462, p 0.01) non-DM patients had at least 1 outpatient fill for clopidogrel in the 1-year after the index hospitalization. Among the clopidogrel users (64.9% PCI, 30.8% medical management, 4.3% CABG), the average MPR was 0.78 for DM patients and 0.80 for non-DM patients (p 0.189). Significantly lower persistence was observed for DM patients vs. non-DM patients (257.6 vs. 274.7 days, p 0.012). ACS patients undergoing PCI had significantly higher persistence compared to medical management patients (280.7 vs. 231.4 days, p 0.001 for DM; 285.7 vs. 254.6 days, p 0.001 for nonDM). CONCLUSIONS: Approximately three-fourths of patients in this study had used clopidogrel after being hospitalized for ACS. ACS patients with prior diabetic history were less likely to be persistent with medication than non-diabetic ACS patients. This finding might have clinical consequences since DM patients typically have higher risk of cardiac events.