Evaluation of Prasugrel Compared With Clopidogrel in Patients With Acute Coronary Syndromes and Planned Percutaneous Coronary Intervention: The TRITON–TIMI 38 Study

s The Reperfusion of Acute MI in Carolina Emergency Departments (RACE) Systems Improvement Program: Primary Results Christopher B Granger, Duke Univ Med Cntr, Durham, NC; Joseph D Babb, East Carolina Univ, Greenville, NC; David J Bohle, Forsyth Med Ctr, Winston Salem, NC; Sidney M Fletcher, Presbyterian Hosp, Charlotte, NC; J. L Garvey, Carolinas Med Ctr, Charlotte, NC; William R Hathaway, Mission Memorial Hosp, Asheville, NC; James W Hoekstra, Wake Forest Univ, Winston Salem, NC; Mayme L Roettig, Duke Univ Med Cntr, Durham, NC; B. H Wilson, Carolinas Med Ctr, Charlotte, NC; James G Jollis; Duke Univ Med Cntr, Durham, NC Despite 25 years of data indicating survival benefit from timely coronary reperfusion, registries continue to demonstrate that patients are treated too slowly or not at all. We developed a statewide approach to develop systems for ACC/AHA guideline-based coronary reperfusion involving 5 regions, 10 PCI hospitals, 58 non PCI hospitals, and their associated EMS services. Protocols were established for each hospital and EMS system. Results: Times to treatment were measured over 3 month periods prior to and 1 year after initiation of the system, representing 1440 patient observations [age 75, 21%; women, 31%; Killip class 3 , 6%; arrived by EMS, 44%]. In non-PCI centers, in the post intervention phase, 46% received lytics, 39% primary PCI, and 15% no reperfusion. Door-to-needle within 30 minutes improved from 35 to 52% (p 0.001). PCI center door to dilation median times pre and post intervention are shown, contrasted with contemporaneous NRMI data that represent selected (high quality) US hospitals. Conclusion: Using a state-wide, multidisciplinary program to improve reperfusion according to guidelines, we substantially reduced reperfusion times, particularly time to primary PCI in transfer patients. Thus, this is the first and largest statewide intervention program across the spectrum of urban and rural emergency medical systems for STEMI reperfusion and resulted in substantial improvements in public health. RACE provides important experience to support similar national programs such as the AHA Mission: Lifeline. First Door to Balloon Times (median) Pre Post Change p value Transfer National NRMI 156 143 -13 RACE (n 237) 160 128 -32 0.001 Non-transfer National NRMI 89 81 -8 RACE (n 515) 85 74 -11 0.001 Long-Term Clinical Outcomes Following Drug-Eluting and Bare Metal Stenting in Massachusetts Laura Mauri, Brigham and Women’s Hosp, Boston, MA; Treacy Silverstein, Ann Lovett, Harvard Med Sch, Boston, MA; Frederic S Resnic, Brigham and Women’s Hosp, Boston, MA; Sharon-Lise Normand; Harvard Med Sch, Boston, MA Background: Observational studies of drug eluting stents (DES) have yielded conflicting results regarding late mortality relative to bare metal stents (BMS). We report on the largest consecutive series of patients followed after DES and BMS from a regional contemporary US practice with mandatory reporting. Methods: All adults undergoing percutaneous coronary intervention (PCI) with stenting between April 1, 2003, and September 30, 2004, at all acute care non-US governmental hospitals in Massachusetts (MA) were identified from a state database that monitors the quality of cardiac care. According to the stent types used from the index admission, patients were classified as DES-treated if all stents were drug-eluting and BMS-treated if all stents were bare metal. Crude mortality risk differences (DES BMS) were determined from vital statistics records of those patients with 2 year follow-up, and risk-adjusted mortality differences were estimated using matched pairs constructed from propensity scores that included prospectively collected demographic, clinical, and procedural information. Results: The analysis cohort consisted of 11517 DES and 6210 BMS patients. LAD location (p 0.0001), multi-vessel treatment (p 0.0001), and diabetes (p 0.04) were associated with increased DES use. Age 65 (p 0.0001), STEMI (p 0.0001), saphenous vein graft location (p 0.0001), history of malignancy (p 0.0001) or GI bleed (p 0.0001) were associated with increased BMS use. The unadjusted cumulative incidence of mortality at 2 years was 6.7% for DES and 12.4% for BMS (-5.7% difference, 95% confidence interval [-6.6%, -4.8%], p 0.0001). The propensity score model included 63 variables, matched exactly within Canadian Cardiovascular Society angina score and yielded 5441 matched pairs. After matching, the 2-year risk-adjusted mortality rates were 9.5% and 11.9% (-2.4% difference, [-3.6%, -1.3%] (p 0.001). Conclusion: In this contemporary US practice, treatment with DES was not associated with a higher rate of adjusted 2-year mortality than treatment with BMS. 2-year risk-adjusted rates of MI and revascularization will be available at presentation. Impact of Patient Self-Management Skills Training on Death and Hospitalization in Patients With Heart Failure: Results From the Heart Failure Adherence and Retention Trial Lynda H Powell, Rush Univ Med Ctr, Chicago, IL; James E Calvin, Rush Univ Med Cntr, Chicago, IL; Carlos F Mendes de Leon, Rush Univ Med Cntr, Chicago, IL; DeJuran Richardson, Lake Forest College, Lake Forest, IL; Kathleen L GradyNorthwestern Memorial Hosp, Chicago, IL, Northwestern Univ, Chicago, IL; Cheryl S Rucker-Whitaker, Rush Univ Med Cntr, Chicago, IL; Imke Janssen, Rush Univ Med Cntr, Chicago, IL; Kristin J Flynn-Peters, Rush Univ Med Cntr, Chicago, IL; Glenda Kravitz, Rush Univ Med Cntr, Chicago, IL; Claudia Eaton; Rush Univ Med Cntr, Chicago, IL Heart failure (HF) is one of the few cardiovascular conditions that is increasing in prevalence. Drug therapies and lifestyle changes can slow progression, but only if patients adhere to them. HART was a randomized behavioral clinical trial aimed at reducing death and repeat hospitalizations by offering patients one year of small group counseling to improve adherence through training in self-management skills. Treatment was compared to an educational control delivered over one year by mail and phone. The HART cohort was recruited from the Chicago metropolitan area and followed for an average of 34 months. It consisted of 902 patients with NYHA HF Class II (68%) or Class III (32%). The baseline age was 63.6 years and 23% had diastolic dysfunction, 47% were women, and 40% were ethnic minorities. This diversity makes it generalizable to current clinical practice. Description of the cohort at baseline revealed challenges to adherence and areas in need of intervention. Patients had an average of 3.2 co-morbidities, including hypertension (79%), diabetes (40%), previous MI (43%), and depression (30%), translating into an average of 6.8 medications per patient. Using data from electronic pill caps, 37% of the patients were not taking medications as prescribed and the average daily intake of sodium was 3338 mg/day, 67% higher than the recommended intake of 2000 mg/day. Average relative weight was in the obese range (BMI 31.2) and 32.5% watched TV more than 4 hours/day. Ethnic minorities, relative to Caucasians, were more non-adherent to medications (48.9% vs 29.3%), had higher salt intake (3530 mg/day vs 3184 mg/day), and had higher BMI (32.8 vs 30.1), all comparisons p 0.001. These data suggest that better adherence to evidence-based medical advice is a critical need in HF, particularly in the ethnic minorities. The HART investigators will become unblinded to outcome data during the summer. This presentation will determine whether treatment improved adherence and, if so, benefited the clinical outcomes of death, HF hospitalization, all-cause hospitalization, and the composite of death or HF hospitalization. Implications bear on the value of patient skills training, as an adjunct to standard health education, in clinical practice for HF patients. The Simplified Treatment Intervention to Control Hypertension (STITCH) Trial: A Cluster Randomized Controlled Trial of a Step-Care Algorithm Using Initial Fixed Dose Combination Therapy for the Management of Hypertension Ross D Feldman, Robarts Rsch Institute, London, Canada; Guangyong Zou, Brian G Feagan, Cindy J Wong, Margaret K Vandervoort; ROBARTS Rsch INSTITUTE, London, Canada Context: Notwithstanding the availability of antihypertensive drugs and practice guidelines, blood pressure control rates remain suboptimal. The complexity of current treatment guidelines may contribute to this problem. Objective: To determine if a simplified treatment algorithm featuring low dose angiotensin converting enzyme inhibitor (ACE-I)/diuretic or angiotensin receptor blocker (ARB)/diuretic combinations is more effective than guideline-based management. Design and Setting: Cluster randomization trial conducted at 45 family practices in Southwestern Ontario, Canada. Within each practice, up to 50 patients with uncontrolled hypertension were evaluated. Interventions: Practices randomized to GUIDELINE-care were provided with the implementation materials from the Canadian Hypertension Education Program. Practices assigned to STITCH-care were treated according to the following algorithm: (1) initiation of therapy with a low-dose ACE-I/diuretic or ARB/diuretic combination, (2) up-titration combination therapy to the highest dose, (3) addition of a calcium channel blocker and up-titration, (4) addition of a non-first line antihypertensive agent. Main Outcome Measure: The proportion of patients treated to target blood pressure (systolic blood pressure [SBP] less than 140 mmHg and diastolic blood pressure [DBP] less than 90 mmHg for patients without diabetes or SBP less than 130 mmHg and DBP less than 80 mmHg for patients with diabetes) at 6 months analyzed at the level of the practice. Results: The proportion of patients achieving target blood pressure was significantly higher in the STITCH-care group compared with the GUIDELINE-care group (64.7% vs 52.7%, Absolute difference 12.0%, 95% CI 1.5% to 22.4%; P 0.026). Multivariate analysis of patient-level data showed that assignment to the intervention arm increased the possibility of reaching the blood pressure prevention target by 2007 Late-Breaking Clinical Trial Abstracts 2629 by gest on N ovem er 6, 2017 http://ciajournals.org/ D ow nladed from 20% (P 0.028), when adjusted for other covariates. Conclusion: A simplified antihypertensive algorithm utilizing initial low-dose fixed dose combination therapy is superior to guideline-based practice for the management of hypertension. Late-Breaking Clinical Trials II