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Background Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes. Methods We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection. Results Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest. Conclusions Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.

Background There is a paucity of data on the distribution of cardiovascular risk factors in patients with familial hypercholesterolemia (FH) as compared to the general population. The aim of the study was to compare cardiovascular risk factors in a cohort of FH patients to the representative sample of adults in Poland who represent a high–cardiovascular risk European region. Methods We compared the distribution of risk factors in 1,382 individuals with FH phenotype referred for genetic testing between 2006 and 2014 to the National Centre of Familial Hypercholesterolemia in Gdansk, Poland. The cohort was comprised of 637 positive FH(+) and 745 negative FH(−) patients who were compared to a nationally representative sample of 2,413 adults age 18-79, standardized by age and sex, from the NATPOL 2011 study (NATPOL). We analyzed patients' distribution of history of atherosclerotic cardiovascular disease (ASCVD) and standard risk factors including total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, triglycerides, systolic and diastolic blood pressure (SBP, DBP), body mass index, smoking, and diabetes. Results FH(+) patients (mean age 45.6 years) had the highest LDL-C of 241.7 mg/dL (95% CI 234.8-248.5) compared to 206.1 mg/dL (200.5-211.7) in FH(−) patients (mean age 48.2) and 126.2 mg/dL (124.8-127.6) in NATPOL. Mean SBP was the lowest in FH(+) patients at 128.7 mm Hg (126.7-130.7) compared to 133.4 mm Hg (132.6-134.3) in NATPOL and 134.4 mm Hg (132.3-136.5) in FH(−). No differences were found in the prevalence of diabetes and body mass index. Smoking was less common in FH(+) at 12.4% (9.4-15.4) compared to both FH(−) and NATPOL: 20.4% (16.6-24.1) and 28.4% (26.6-30.2), respectively. The prevalence of individuals with a history of ASCVD in both FH(+) and FH(−) was nearly 3-fold higher compared to NATPOL: 26% (21.8-30.1) and 26.6% (22.2-30.9) versus 9.5% (8.3-10.7), respectively. Conclusions The FH(+) patients had significantly higher mean LDL-C, but the levels of nonlipid factors were lower or similar compared to the other groups. Both FH(+) and FH(−) were characterized by a heavy burden of ASCVD. This suggests that cholesterol, and no other risk factors, is a key contributor to cardiovascular risk in patients with FH, especially those with genetic mutation.

Background Guidelines recommend exercise training as a component of heart failure (HF) management. There are large disparities in access to rehabilitation and introducing hybrid comprehensive telerehabilitation (TR) consisting of remote monitoring of training in patients' homes might be an optimal solution in Poland. Purpose The primary objective of the TELEREH-HF trial is to determine whether introducing TR will significantly increase days alive and out of hospital compared with usual care. The secondary objectives including assessment the effects of TR compared to usual care on all-cause and cardiovascular mortality and all-cause, cardiovascular and HF hospitalization. The tertiary analyses include: evaluation of the safety, effectiveness, quality of life, depression, anxiety, patients' acceptance of and adherence to TR. Methods The TELEREH-HF study is a randomized, multi-center, prospective, open-label, parallel group controlled trial in 850 HF patients after a hospitalization incident in NYHA I-III and LVEF≤40%. Patients were randomized to TR + usual care (TR group) or to usual care only (control group) and are followed for a maximum of 24 months. The TR group patients underwent a 9-week TR program consisting of an initial stage (1 week) conducted at hospital and a basic stage (8-week) home-based TR five times weekly. Results All patients were randomized and completed initial intervention in the TR group. The follow up of both groups is in progress. Conclusion The TELEREH-HF trial will provide novel data on the effects of telerhabilitation on hospitalization and mortality in HF patients, and on safety, qaulity of life, depression, anxiety and acceptance of and adherence to this intervention.

IMPORTANCE: The extent to which levels of high-sensitivity C-reactive protein (hs-CRP), a known marker of increased cardiovascular risk, are elevated and are associated with standard cardiovascular risk factors in patients with a history of myocardial infarction (MI) is unknown. OBJECTIVES: To determine the pattern and determinants of the distribution of hs-CRP in those with a prior MI in the United States using a nationally representative sample. DESIGN AND PARTICIPANTS: Adults with hs-CRP data in the National Health and Nutrition Examination Surveys from 1999–2010. RESULTS: Among 1296 individuals in our cohort, the median age was 65 years and the median hs-CRP level was 2.69 mg/L, measured an average of 7.1 years after the MI. Among these patients, 22% had hs-CRP levels of

BACKGROUND: Current cholesterol guidelines recommend using 10-year risk of atherosclerotic cardiovascular disease (ASCVD) to guide informed decisions regarding statin therapy, yet patients may have difficulty conceptualizing absolute risk estimates. Peer comparisons may provide an improved tool for patient risk comprehension. METHODS: Using data from the 2009–2014 National Health and Nutrition Examination Survey (NHANES), we estimated standardized cardiovascular risk percentiles for various age-, sex-, and race-specific subgroups based on their 10-year ASCVD risks using the Pooled Cohort Equations. RESULTS: We examined 9,160 adults in NHANES who were free of cardiovascular disease and had complete clinical data. Among specific age, sex, and race groups, we estimated the distribution of 10-year risk, calculating the 10-year risk corresponding to each percentile in order to generate standardized cardiovascular risk percentiles. Estimated 10-year ASCVD absolute risk varied markedly by age, sex, and race subgroups. A 10-year risk of 7.0% would put a 55 year-old black male in the 20(th) percentile relative to his peers (i.e., at lower risk than 80% of his peers), whereas a 10-year risk of 7.0% would put a 55 year-old white female in the 95(th) percentile (i.e., only 5% of her peers would have higher risk). Standardized cardiovascular risk percentiles by age, race, and sex are available online at populationrelativerisk.dcri.org. CONCLUSION: Cardiovascular risk varies substantially by age, sex, and race. These data allow for 10-year absolute risks of ASCVD to be translated into a standardized cardiovascular risk percentile, providing patients with information that is easy to understanding regarding how their personal risk of cardiovascular disease compares with their age-, sex-, and race-matched peers.

Left ventricle (LV) remodeling after anterior wall myocardial infarction leads to increased LV volumes, myocardial stress, and, ultimately, heart failure (HF). Patients have high morbidity and mortality risk, and treatment remains limited. Percutaneous ventricular restoration (PVR) therapy using the Parachute device, a fluoropolymer membrane stretched over a nitinol conical frame, is a novel approach to partition off the damaged myocardium. In the European and United States PARACHUTE feasibility trials, the observed rates of death or rehospitalization for HF were17% at 12 months. These data compare favorably with historical data and support the need of a randomized trial to determine the clinical efficacy of PVR on outcomes for patients with ischemic HF.To determine the safety and efficacy of PVR utilizing a LV partitioning device, Parachute, in a randomized clinical trial compared with optimal medical therapy.This US pivotal trial is approved by the Food and Drug Administration (ClinicalTrials.gov Identifier: NCT01286116) and will randomly assign (1:1) 478 patients with New York Heart Association class III-IV ischemic HF, akinetic or dyskinetic LV wall abnormality, and ejection fraction between 15% and 35% to optimal medical therapy (control) versus Parachute device implantation in approximately 65 hospitals. The primary endpoint is death or rehospitalization for worsening HF. Sample size calculation assumes constant hazards and follow-up ≥12 months using an event-driven trial design.We reported the rational and design of the first multicenter randomized trial to test the efficacy of PVR using the Parachute device to treat patients with ischemic HF and dilated LV.

Seasonal variation with winter preponderance of myocardial infarction incidence has been described decades ago, but only a few small studies have classified myocardial infarction based on ST-segment elevation. It is unclear whether seasonal and circadian variations are equally present in warmer and colder regions. We investigated whether seasonal and circadian variations in acute myocardial infarction (AMI) are more prominent in colder northern states compared with warmer southern states. We also investigated the peak time of admission to better understand the circadian rhythm.Data from the GWTG-CAD database were used. We analyzed 82,971 consecutive acute myocardial infarction (AMI) patients treated at 276 US centers from 2003 to 2008. The country was geographically divided into warmer southern and colder northern states using latitude 35 degrees for this purpose.Overall, acute myocardial infarction (AMI) admissions varied across seasons (P.01), and were higher in winter (winter vs. spring n = 21,483 vs. 20,291, respectively). When stratified based on type of AMI, non-ST-segment elevation myocardial infarction (NSTEMI) admissions varied across seasons (P.01) and were highest in winter and lowest in spring. Seasonal variation was not significant in STEMI admissions (P = .30). Seasonal variation with winter predominance was noted in AMI patients in warmer southern states (P.01), but not in colder states. The distributions of length of stay for AMI patients and door to balloon times for STEMI patients were minimally different across all four seasons (P.01) with longest occurring in winter. Most patients with AMI presented during daytime with a peak close to 11 am and a nadir at approximately 4 am.Seasonal variation with winter predominance exists in AMI admissions and was significant in NSTEMI admissions but not in STEMI admissions. Seasonal variation was only significant in warmer southern states.

Background Emergency surgery has become an increasingly rare event after percutaneous coronary intervention (PCI). There have been no randomized trials evaluating whether cardiac surgery services on-site are essential for patient safety and optimal outcomes during and after PCI. Study Design The MASS COMM trial (ClinicalTrials.gov no. NCT01116882 ) is a randomized trial comparing the safety and effectiveness of nonemergency PCI at hospitals without surgery on-site (SOS) (non-SOS hospitals) and hospitals with SOS (SOS hospitals). A total of 3,690 subjects will be randomized in a 3:1 fashion to undergo PCI at non-SOS and SOS hospitals, with follow-up at hospital discharge, 30 days, and 12 months after PCI. The rate of major adverse cardiac events (all-cause mortality, myocardial infarction, repeat revascularization, and stroke) will serve as the primary safety end point at 30 days and the primary effectiveness end point at 12 months. The design is a 1-way randomized trial with a statistical hypothesis of noninferiority of nonemergency PCI at non-SOS hospitals for both safety and effectiveness end points. Conclusions This multicenter, randomized trial will compare the relative safety and effectiveness of nonemergency PCI at sites with and without cardiac SOS.

The aim of the study was to describe the incidence and consequences of minor surgery after drug-eluting stent (DES) implantation.The Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) Registry prospectively enrolled unselected patients undergoing percutaneous coronary intervention at 47 US centers between July 2004 and December 2007. We examined 8,323 patients who received a DES in EVENT to determine the frequencies of minor surgery and postoperative adverse events.Minor surgery (defined as procedures not requiring a major surgical incision) was performed in 164 (2.0%) of 8,323 patients1 year after stenting, as follows: pacemaker/defibrillator implantation (46%), eye surgery (17%), orthopedic (9%), dermatologic (8%), endovascular (6%), and gastrointestinal procedures (5%). Compared with patients who did not undergo minor surgery, those who did were older, had more comorbidities, had more extensive coronary disease, and were more likely to have received warfarin after stenting. Only 1 (0.6%, 95% CI 0.0%-3.4%) of 164 patients had an event (stent thrombosis causing myocardial infarction) during the first week after minor surgery; this rate was slightly higher than the background rate of ischemic events in the study population (exact mid P = .01). Clopidogrel use at 12 months was similar between patients who did and those who did not undergo minor surgery (65.2% vs 65.5%, P = .95).In the EVENT Registry, minor surgery was performed in 2% of patients in the first year after DES implantation. The risk of stent thrombosis during the first week after surgery was increased slightly compared with background rates, but the absolute event rate was low (0.6%).

Aortic valve replacement (AVR) therapy is an obvious choice for symptomatic severe aortic stenosis (AS) patients as it improves symptoms, left ventricular function, and survival. The treatment decisions and indication for AVR in asymptomatic patients with severe AS and normal left ventricular ejection fraction are less well established and the subject of ongoing debate. Many efforts have been made to define the best treatment option in asymptomatic AS patients with normal left ventricular ejection fraction. Retrospective and observational data imply that elective AVR for asymptomatic severe AS may lead to improvement in outcomes in comparison to surgery performed after onset of symptoms. The AVATAR trial will aim to assess outcomes among asymptomatic AS patients randomized to either elective early AVR or medical management with vigilant follow-up. In the latter group, AVR would be delayed until either the onset of symptoms or changes in predefined echocardiographic parameters. To the best of the authors' knowledge, it will be the first large prospective, randomized, controlled, multicenter clinical trial that will evaluate the safety and efficacy of elective AVR in this specific group of patients.

There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity.

Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1,360 confirmed primary composite cardiovascular end points, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, have occurred. The primary efficacy hypothesis is that exenatide once-weekly is superior to usual care with respect to the primary composite cardiovascular end point. EXSCEL is powered to detect a 15% relative risk reduction in the exenatide once-weekly group, with 85% power and a 2-sided 5% alpha. The primary safety hypothesis is that exenatide once-weekly is noninferior to usual care with respect to the primary cardiovascular composite end point. Noninferiority will be concluded if the upper limit of the CI is

Background The applicability to different race/ethnic groups and effects on cardiovascular disease (CVD) outcomes of the 2013 American College of Cardiology and American Heart Association (ACC/AHA) guidelines for cholesterol management remain to be determined. We estimated the proportion of Korean adults who would be affected by the 2013 cholesterol guidelines and to determine the related effects on cardiovascular events. Methods Using data from the Korean National Health and Nutrition Examination Survey of 2008 to 2012 (n = 18,573), we compared the estimated number of statin candidates under the 2013 ACC/AHA and the Third Adult Treatment Panel (ATP-III) guidelines and extrapolated the results to 19.0 million Koreans between the ages of 40 and 75 years. Using an external cohort (n = 63,329) from the 2003 National Health Examination with 7years of prospective follow-up, we determined the potential effects of recent recommendations changes on atherosclerotic CVD events (composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Results Compared with the ATP-III guidelines, the ACC/AHA guidelines would increase the number of statin candidates from 3.5 million (18.6%) to 6.7 million (35.1%). The increase of statin candidates would be larger among older adults (60-75 years; from 29.8% to 74.9%) as compared with younger adults (40-59 years; from 15.6% to 19.8%) and among men (from 25.7% to 45.4%) compared with women (from 14.6% to 26.8%). In the external cohort, compared with adults who were recommended by neither of the 2 guidelines, those who were recommended by both and those who were recommended by ACC/AHA but not ATP-III guidelines had significantly higher risks of atherosclerotic CVD events (hazard ratios [HRs] 3.65 [95% CI, 3.33-4.02] and 3.98 [95% CI 3.64-4.35], respectively). However, adults who were recommended by ATP-III but not ACC/AHA guidelines did not have an increased risk (HR 0.90, 95% CI 0.64-1.28). Conclusions In the Korean population, the 2013 ACC/AHA cholesterol guidelines would substantially increase the number of adults who are potentially eligible for statin therapy and would recommend statin therapy for more adults at higher cardiovascular risk. However, the clinician-patient discussion of the potential benefits, possible harms, and other factors before the initiation of statin therapy must be considered.

Background Stroke is common and costly, annually depriving the lives and well-being of 800,000 Americans. Despite demonstrated efficacy in clinical trials, questions remain about the safety and clinical effectiveness of various treatment options given patient characteristics, conditions, preferences, and their desired outcomes. Methods and results The Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) is a Patient-Centered Outcomes Research Institute–sponsored project designed to help patients, physicians, and other stakeholders make informed decisions regarding stroke care and improve outcomes through patient-centered comparative effectiveness research. The primary outcomes identified and prioritized by stroke patients are "home time" (time spent alive and outside a hospital) and major adverse cardiovascular events. With inputs from stroke patients themselves, a series of comparative safety and effectiveness analyses will be performed across 3 prioritized therapeutic areas identified as important by stroke survivors: oral anticoagulants, statin therapy, and antidepressants. We obtained data from Get With the Guidelines-Stroke linked with Medicare claims and follow-up telephone interviews. Our combined retrospective and prospective research strategy allows the evaluation of the safety and effectiveness of various treatment options and patient-centered longitudinal outcomes. To ensure the rapid translation of findings into clinical practice, results will be disseminated to stroke survivors, caregivers, and health care providers through traditional and social media, including an online decision aid tool. Conclusions PROSPER is a patient-centered outcome research study guided by patients, caregivers, and the broader health care community. By addressing knowledge gaps in treatment uncertainties through comparative effectiveness research, PROSPER has the potential to improve decision making in stroke care and patient outcomes reflecting individual patient preferences, needs, and values.

In randomized clinical trials, procedural myocardial infarction (MI) or spontaneous MI is often weighted equally as a component of a composite clinical end point. An underlying assumption of this approach is that procedural and spontaneous MIs have similar prognostic impact. Our aim was to evaluate the prognostic impact of procedural vs spontaneous MI in patients undergoing percutaneous coronary intervention (PCI).We used data from the EVENT registry to examine the relative prognostic impact of procedural vs spontaneous MI. For the purposes of this study, patients undergoing initial PCI were stratified into 3 groups-no MI, procedural MI, or spontaneous MI-based on standard definitions applied at the time of the index procedure and followed for 1 year for outcomes of all-cause mortality and cardiovascular mortality. Multiple propensity score adjustment analysis was used to adjust for differences in baseline covariates among the 3 groups.Among 7,380 patients included in this analysis, 4,568 (62%) patients had no MI, 580 (8%) patients had procedural MI at the time of their index procedure, and 2,232 (30%) patients presented with a spontaneous MI before PCI. In unadjusted analyses, there was a graded increase in risk of 1-year mortality (1.9% vs 3.1% vs 3.9%; P.0001) and cardiovascular death (0.5% vs 1.0% vs 1.7%; P.0001) across the 3 groups. After adjusting for propensity scores, spontaneous MI (adjusted hazard ratio [HR] 1.62, 95% CI 1.11-2.37, P = .01) but not procedural MI (adjusted HR 1.51, 95% CI 0.89-2.54, P = .12) was independently associated with death at 12 months when compared with the no-MI group. Findings were similar when the analysis was limited to cardiovascular death (adjusted HRs 3.14 [95% CI 1.68-5.90, P.001] and 1.74 [95% CI 0.69-4.40, P = .24], respectively).Among patients undergoing PCI, spontaneous but not procedural MI was independently associated with death and cardiovascular death at 1 year. These finding suggest that the prognostic impact of procedural MI may be less than that of spontaneous MI and should be considered in designing end points for future studies of coronary revascularization.

Background Atrial fibrillation (AF) is associated with increased morbidity. P-wave indices (PWIs) measure atrial electrical function and are associated with AF. Study of PWI has been limited to single-cohort investigations, and their contributions to risk enhancement are unknown. Methods We examined PWI from the FHS and ARIC study. We calculated 10-year AF risk using adjusted Cox models. We conducted cross-cohort meta-analyses for the PWI estimates and assessed their contributions to risk discrimination (c statistic), net reclassification index, and integrated discrimination improvement. Results After exclusions, the analysis included 3,110 FHS (62.6 ± 9.8 years, 56.9% women) and 8,254 ARIC participants (62.3 ± 5.6 years, 57.3% women, 20.3% black race). Over 10 years, 217 FHS and 458 ARIC participants developed AF. In meta-analysis, P-wave duration >120 milliseconds was significantly associated with AF (hazard ratio 1.55, 95% CI 1.29-1.85) compared with ≤120 milliseconds. P-wave area was marginally but not significantly related to AF (hazard ratio 1.31, 95% CI 0.95-1.80). P-wave terminal force was strongly associated with AF in ARIC but not FHS. P-wave indices had a limited contribution toward predictive risk beyond traditional risk factors and markers. Conclusions P-wave indices are intermediate phenotypes for AF. They are associated with AF in cross-cohort meta-analyses but contribute minimally toward enhancing risk prediction.

Background Dual antiplatelet therapy with aspirin and thienopyridines (clopidogrel or prasugrel) is required after placement of coronary stents to prevent thrombotic complications. Although current clinical practice guidelines recommend 12-month treatment after drug-eluting stent placement, even longer durations may prevent thrombotic events. Study Design The Dual Antiplatelet Therapy (DAPT) Study is comparing the benefits and risks of 12 versus 30 months of dual antiplatelet therapy in preventing stent thrombosis or major adverse cardiovascular and cerebrovascular events in subjects undergoing percutaneous coronary intervention (PCI) for the treatment of coronary artery obstructive lesions. The DAPT Study is a multicenter, international, randomized, double-blind, placebo-controlled trial that will enroll 15,245 subjects treated with drug-eluting stent (DES) and 5,400 subjects treated with bare-metal stents (BMS). All subjects will receive 12 months of open-label thienopyridine treatment in addition to aspirin. After 12 months, subjects who are free from death, myocardial infarction, or stroke (MACCE), repeat revascularization, and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events will be randomized to receive either 18 additional months of thienopyridine (clopidogrel or prasugrel) (30 month DAPT arm) or placebo (12 month DAPT arm) plus aspirin. Coprimary end points are MACCE and stent thrombosis. The primary safety end point is GUSTO moderate or severe bleeding. Conclusions This randomized trial is designed to define the relative safety and effectiveness of 12 versus 30 months of dual antiplatelet therapy across the broad spectrum of patients receiving coronary stents.

We sought to evaluate the early drug-eluting stent (DES) era, characterized by widespread device use.Contemporary clinical practice incorporating more selective DES use can only be assessed by understanding the early DES era.All patients receiving DES during the first 3 waves of the Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) Registry (2004-2006) were evaluated. The primary end point was a composite of death, myocardial infarction (MI), and urgent revascularization at discharge and death, MI, or target lesion revascularization (TLR) at 1 year. The composite end point at each time point was compared across waves. Multivariable logistic regression was used for in-hospital outcomes and multivariable Cox regression was used for 1-year end points.Ninety-two percent of EVENT patients received at least one DES. One third of patients were treated for Acute Coronary Syndromes (ACS) (33.8%), and later waves included lower lesion complexity. Across waves there was more frequent clopidogrel loading, a decrease in heparin and an increase in bivalirudin use (all P.01). The primary composite end point of in-hospital death, MI or urgent revascularization occurred in 7.2% of patients, and did not differ across waves. Despite remarkably high levels of routine DES usage, the composite end point of death, MI, or TLR at 1 year averaged 13.5% and did not differ across waves. After adjustment, no statistically significant effect of wave on composite bleeding (P = .068) as well as in-hospital TLR (P = .053) was noted. At 1 year, wave was associated with a lower likelihood of TLR in the adjusted model (HR 0.81, P = .03).The high-adoption DES era was associated with favorable outcomes, decreasing bleeding rates and changes in antithrombotic approach.