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Background: Professional guidelines have reduced the recommended minimum number to an average of 50 percutaneous coronary intervention (PCI) procedures performed annually by each operator. Operator volume patterns and associated outcomes since this change are unknown., Objectives: The authors describe herein PCI operator procedure volumes; characteristics of low-, intermediate-, and high-volume operators; and the relationship between operator volume and clinical outcomes in a large, contemporary, nationwide sample., Methods: Using data from the National Cardiovascular Data Registry collected between July 1, 2009, and March 31, 2015, we examined operator annual PCI volume. We divided operators into low- (<50 PCIs per year), intermediate- (50 to 100 PCIs per year), and high- (>100 PCIs per year) volume groups, and determined the adjusted association between annual PCI volume and in-hospital outcomes, including mortality., Results: The median annual number of procedures performed per operator was 59; 44% of operators performed <50 PCI procedures per year. Low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. Unadjusted in-hospital mortality was 1.86% for low-volume operators, 1.73% for intermediate-volume operators, and 1.48% for high-volume operators. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio: 1.16 for low versus high; adjusted odds ratio: 1.05 for intermediate vs. high volume) as was the risk for new dialysis post PCI. No volume relationship was observed for post-PCI bleeding., Conclusions: Many PCI operators in the United States are performing fewer than the recommended number of PCI procedures annually. Although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: Public reporting (PR) is a policy mechanism that may improve clinical outcomes for percutaneous coronary intervention (PCI). However, prior studies have shown that PR may have an adverse impact on patient selection. It is unclear whether alternatives to PR, such as collaborative quality improvement (CQI), may drive improvements in quality of care and outcomes for patients receiving PCI without the unintended consequences seen with PR., Methods: Using National Cardiovascular Data Registry CathPCI Registry data from January 2011 through September 2012, we evaluated patients who underwent PCI in New York (NY), a state with PR (N = 51,983), to Michigan, a state with CQI (N = 53,528). We compared patient characteristics, the quality of care delivered, and clinical outcomes., Results: Patients undergoing PCI in NY had a lower-risk profile, with a lower proportion of patients with ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or cardiogenic shock, compared with Michigan. Quality of care was broadly similar in the 2 states; however, outcomes were better in NY. In a propensity-matched analysis, patients in NY were less likely to be referred for emergent, urgent, or salvage coronary artery bypass surgery (odds ratio [OR] 0.67, 95% CI 0.51-0.88, P < .0001) and to receive blood transfusion (OR 0.7, 95% CI 0.61-0.82, P < .0001), and had lower in-hospital mortality (OR 0.72, 95% CI 0.63-0.83, P < .0001)., Conclusions: Public reporting of PCI data is associated with fewer high-risk patients undergoing PCI compared with CQI. However, in comparable samples of patients, PR is also associated with a lower risk of mortality and adverse events. The optimal quality improvement method may involve combining these 2 strategies to protect access to care while still driving improvements in patient outcomes., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The duration of ischemic time is directly related to permanent myocardial damage and mortality in the setting of ST-elevation myocardial infarction (STEMI). Rapidly restoring myocardial blood flow to limit the total ischemic time is a priority. The time duration between a patient entering the medical system and being treated with percutaneous coronary intervention to open the occluded culprit vessel is termed door-to-balloon (DTB) time, which is publicly reported and used to judge hospital quality of care. While longer DTB time is associated with increased mortality in the setting of STEMI, efforts to lower DTB time have not translated into decreased mortality. Here we review the literature on DTB time, explore the factors thought to influence the interpretation of the association between DTB time and mortality, and make suggestions on goals for future efforts related to DTB time., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Rates of referral to cardiac rehabilitation after percutaneous coronary intervention (PCI) have been historically low despite the evidence that rehabilitation is associated with lower mortality in PCI patients., Objectives: This study sought to determine the prevalence of and factors associated with referral to cardiac rehabilitation in a national PCI cohort, and to assess the association between insurance status and referral patterns., Methods: Consecutive patients who underwent PCI and survived to hospital discharge in the National Cardiovascular Data Registry between July 1, 2009 and March 31, 2012 were analyzed. Cardiac rehabilitation referral rates, and patient and institutional factors associated with referral were evaluated for the total study population and for a subset of Medicare patients presenting with acute myocardial infarction., Results: Patients who underwent PCI (n = 1,432,399) at 1,310 participating hospitals were assessed. Cardiac rehabilitation referral rates were 59.2% and 66.0% for the overall population and the AMI/Medicare subgroup, respectively. In multivariable analyses, presentation with ST-segment elevation myocardial infarction (odds ratio 2.99; 95% confidence interval: 2.92 to 3.06) and non-ST-segment elevation myocardial infarction (odds ratio: 1.99; 95% confidence interval: 1.94 to 2.03) were associated with increased odds of referral to cardiac rehabilitation. Models adjusted for insurance status showed significant site-specific variability in referral rates, with more than one-quarter of all hospitals referring <20% of patients., Conclusions: Approximately 60% of patients undergoing PCI in the United States are referred for cardiac rehabilitation. Site-specific variation in referral rates is significant and is unexplained by insurance coverage. These findings highlight the potential need for hospital-level interventions to improve cardiac rehabilitation referral rates after PCI., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The purpose of this study was to evaluate the frequency and temporal trends in use of transradial access (TRA) for percutaneous coronary intervention (PCI) in ST-segment-elevation myocardial infarction (STEMI). The use of TRA has been associated with less bleeding and improved clinical outcomes in patients undergoing PCI for STEMI., Methods and Results: The frequency of TRA compared with transfemoral access for patients undergoing PCI for STEMI or other indications (non-ST-segment-elevation myocardial infarction, unstable angina, and non-acute coronary syndrome) in The Blue Cross Blue Shield of Michigan Cardiovascular Consortium database between 2010 and 2013 was evaluated. Propensity matching was used to assess the relationship of TRA with in-hospital clinical end points of major bleeding, transfusion, and death. The TRA cohort of patients was stratified into deciles based on their predicted bleeding risk and compared with PCI indication. Of 122,728 PCI procedures, 17,912 (14.6%) were via TRA. Among patients with STEMI cases, 8.3% of the PCI cases were performed via TRA. The use of TRA increased over the study period although the growth was slower for STEMI than for other indications, P<0.001. The use of TRA for PCI in STEMI was associated with a lower rate of bleeding (11.7% versus 20.0%; P<0.001) and vascular complications (0.7% versus 2.6%; P=0.001), but no mortality difference (1.25% versus 2.33%; P=0.175). There was a strong negative association between the predicted risk of bleeding and the use of TRA (P<0.001)., Conclusions: The use of radial access for PCI in STEMI is increasing but at a slower pace than for patients with other indications. TRA was associated with a reduction in bleeding and transfusion, but there is a strong negative correlation between the predicted risk of bleeding and actual use of TRA in STEMI., (© 2015 American Heart Association, Inc.)

Background: Although randomized clinical trials have compared clopidogrel with higher potency ADP receptor inhibitors (ADPris) among patients with myocardial infarction, little is known about the frequency and factors associated with switching between ADPris in clinical practice., Methods and Results: We studied 47 040 patients with myocardial infarction treated with percutaneous coronary intervention, who received either clopidogrel or prasugrel within 24 hours of admission at 361 US hospitals from July 2009 to June 2011 using the merged Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines and CathPCI Registry database. Hierarchical logistic regression modeling was used to determine factors independently associated with in-hospital ADPri switching. Among 40 531 patients treated initially in-hospital with clopidogrel, 2125 (5.2%) were discharged on prasugrel; this frequency steadily increased from 0% to 7% during the study period. Among 6509 patients treated initially in-hospital with prasugrel, 751 (11.5%) were discharged on clopidogrel. The frequency of this switch increased from 6% to 18% during the first 2 quarters of the study period and decreased to 9% by the end. Switching clopidogrel to prasugrel was associated with high-risk angiographic characteristics (thrombotic, long, and bifurcating lesions), reinfarction in-hospital, and private health insurance coverage. Older age, previous cerebrovascular event, in-hospital coronary artery bypass grafting, in-hospital bleeding, and warfarin use at discharge were associated with switching prasugrel to clopidogrel., Conclusions: Clopidogrel and prasugrel are not uncommonly switched in-hospital in patients with myocardial infarction undergoing percutaneous coronary intervention. In contemporary US practice, in addition to risk for bleeding and recurrent ischemic events, medical drug coverage is a major determinant of ADPri selection., (© 2014 American Heart Association, Inc.)

Background: Whether increasing use of radial access has improved percutaneous coronary intervention outcomes remains unknown. We sought to determine the relationship between increasing facility-level use of transradial percutaneous coronary intervention (TRI) and periprocedural outcomes., Methods and Results: Within the National Cardiovascular Data Registry CathPCI Registry, we estimated the risk-adjusted association between hospital category of change in TRI use (during the 3-year period from 2009 to 2012) and trends in access site and overall bleeding, fluoroscopy time, and contrast use among 818 facilities with low baseline TRI use. There were 4 categories of hospital change in TRI use: very low (baseline, 0.2% increasing to 1.8% at the end of 3 years), low (0.9% increasing to 8.9%), moderate (1.6% increasing to 27.2%), and high (1.0% increasing to 45.1%). Risk-adjusted access site bleeding decreased over time for all hospital categories; however, the rate of decline varied across hospital categories (P for interaction, <0.001). The decrease in access site bleeding was significantly greater for hospitals with moderate or high increases in TRI use (relative risk, 0.45, 95% confidence interval, 0.36-0.56) when compared with that of very low or low hospitals (relative risk, 0.65; 95% confidence interval, 0.58-0.74; P for comparison, 0.002). Similar findings were observed for overall bleeding. An increase in fluoroscopy time (≈1.3 minutes) was noted at hospitals with moderate and high use of TRI (P=0.01). Trends in contrast use were similar across hospital categories., Conclusions: In a national sample of hospitals performing percutaneous coronary intervention, bleeding rates decreased over time for all hospital categories of change in TRI use. The decline in bleeding outcomes was larger at hospitals with increased adoption of TRI when compared with hospitals with minimal or no change in TRI use., Competing Interests: Dr Rao has received consulting fees from Terumo Medical and Medtronic. Dr Curtis receives salary support under contract with the National Cardiovascular Data Registry (NCDR) to provide analytic services and with the Centers for Medicare and Medicaid Services to support development of quality measures in addition to equity interest in Medtronic. The other authors report no conflicts., (© 2014 American Heart Association, Inc.)

Background: Current guidelines for the treatment of ST-segment elevation myocardial infarction recommend a door-to-balloon time of 90 minutes or less for patients undergoing primary percutaneous coronary intervention (PCI). Door-to-balloon time has become a performance measure and is the focus of regional and national quality-improvement initiatives. However, it is not known whether national improvements in door-to-balloon times have been accompanied by a decline in mortality., Methods: We analyzed annual trends in door-to-balloon times and in-hospital mortality using data from 96,738 admissions for patients undergoing primary PCI for ST-segment elevation myocardial infarction from July 2005 through June 2009 at 515 hospitals participating in the CathPCI Registry. In a subgroup analysis using a linked Medicare data set, we assessed 30-day mortality., Results: Median door-to-balloon times declined significantly, from 83 minutes in the 12 months from July 2005 through June 2006 to 67 minutes in the 12 months from July 2008 through June 2009 (P<0.001). Similarly, the percentage of patients for whom the door-to-balloon time was 90 minutes or less increased from 59.7% in the first year to 83.1% in the last year (P<0.001). Despite improvements in door-to-balloon times, there was no significant overall change in unadjusted in-hospital mortality (4.8% in 2005-2006 and 4.7% in 2008-2009, P=0.43 for trend) or in risk-adjusted in-hospital mortality (5.0% in 2005-2006 and 4.7% in 2008-2009, P=0.34), nor was a significant difference observed in unadjusted 30-day mortality (P=0.64)., Conclusions: Although national door-to-balloon times have improved significantly for patients undergoing primary PCI for ST-segment elevation myocardial infarction, in-hospital mortality has remained virtually unchanged. These data suggest that additional strategies are needed to reduce in-hospital mortality in this population. (Funded by the National Cardiovascular Data Registry of the American College of Cardiology Foundation.).

Objectives: We sought to evaluate trends in door-to-balloon (D2B) times and false activation rates for the cardiac catheterization laboratory (CCL) in patients presenting to the emergency department (ED) with acute ST-elevation myocardial infarction (STEMI). In patients with STEMI, national efforts have focused on reducing D2B times for primary percutaneous coronary intervention (P-PCI). This emphasis on time-to-treatment may increase the rate of false CCL activations and unnecessary healthcare utilization., Study Design: Retrospective quality improvement chart review., Methods: We examined all emergent CCL activations for P-PCI between 2007 and 2011 at the University of Michigan Hospital. False activation was defined as emergent CCL activation when the patient did not require CCL care or emergent cardiology evaluation in the ED. Pre-hospital or ED false activation rates and mean D2B time were retrospectively determined by chart review., Results: The CCL was activated 717 times for suspected STEMI. The number of CCL activations increased from 96 in 2007 to 190 in 2011. False CCL activations accounted for 28% of all prehospital and 29% of all ED activations. The false activation rate increased from 15% of all cases in 2007 to 40% of all cases in 2011. The median D2B time decreased from 67 minutes in 2007 to 55 minutes in 2011., Conclusions: Over a 5-year period with a strong emphasis on reducing D2B times, there has been an increased CCL false activation rate for P-PCI.

Early use of β blockers (BBs) in acute myocardial infarction remains controversial, with some studies demonstrating benefit and others harm. The aim of this study was to assess the association between pre-percutaneous coronary intervention (PCI) BB use and in-hospital outcomes in patients who underwent primary PCI for ST-segment elevation myocardial infarction between 2007 and 2009 at institutions participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC-2). Inverse propensity score weighting was used to account for the nonrandomized use of pre-PCI BBs. The cohort comprised 7,667 patients, with 4,769 (62%) receiving pre-PCI BBs. These patients were older, with higher rates of diabetes mellitus, hypertension, and previous myocardial infarction, PCI, or coronary artery bypass grafting. In adjusted models, pre-PCI BB use was associated with lower rates of intraprocedural ventricular tachycardia or ventricular fibrillation (odds ratio [OR] 0.58, p <0.01) and lower in-hospital mortality (OR 0.65, p = 0.022), with increases in rates of emergent coronary artery bypass grafting (OR 1.56, p <0.01) and repeat PCI (OR 1.93, p <0.01). There were no significant increases in rates of cardiogenic shock and congestive heart failure. In conclusion, pre-PCI BB use in this population was associated with decreased arrhythmia and mortality, without increasing rates of cardiogenic shock and heart failure but with higher rates of repeat PCI and emergent coronary artery bypass grafting, suggesting that there may yet remain a role for early BB use in pre-PCI patients with ST-segment elevation myocardial infarctions., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: There is a paucity of data on the outcome of contemporary percutaneous coronary intervention (PCI) in the elderly. Accordingly, we assessed the impact of age on outcome of a large cohort of patients undergoing PCI in a regional collaborative registry., Hypothesis: Increasing age is associated with a higher incidence of procedural-related complications., Methods: We evaluated the outcome of 152,373 patients who underwent PCI from 2003 to 2008 in the 31 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. The procedural outcomes of the cohort were compared by dividing patients into < 70 years of age, 70 to 79 years, 80 to 84 years, 85 to 89 years, and ≥ 90 years., Results: Of the cohort, 64.64% were <70 years of age, 23.83% were 70 to 79 years, 7.85% were 80 to 84 years, 3.09% were 85 to 89 years, and 0.58% were 90 years or older. Increasing age was associated with an increase in all-cause in-hospital mortality, contrast-induced nephropathy, transfusion, stroke/transient ischemic attack, and vascular complications. The overall in-hospital mortality rate was 1.09% and increased from 0.67% in those younger than 70 years up to 5.44% in those 90 years old or greater. The mortality rate in patients over 80 years approached 12% to 15% for those with ST-segment myocardial infarction and 39% in cardiogenic shock patients., Conclusions: The proportion of elderly patients referred for PCI is increasing. Procedural complications increase with age, and patients presenting with unstable symptoms are at the highest risk., (© 2011 Wiley Periodicals, Inc.)

Little is known about non-ST-segment elevation myocardial infarction (MI) in patients with an initial negative troponin finding. The aim of this study was to determine in post hoc analysis of a large regional medical center presenting clinical characteristics, treatment differences, and in-hospital and 6-month outcomes of first troponin-negative MI (FTNMI). In this study, 659 of 1,855 consecutive patients with non-ST-segment elevation MI (35.5%) were classified as having FTNMI. In-hospital cardiac catheterization rates were similar between the 2 groups (70.1% vs 71.5%, p = 0.53) In hospital, patients with FTNMI were less likely to receive statins (48.9% vs 59.9%, p <0.001). On discharge, patients with FTNMI were less likely to be on clopidogrel (53.1% vs 59.0%, p = 0.019) and statins (67.7% vs 75.2%, p <0.001). At 6-month follow-up, patients with FTNMI were less likely to be on clopidogrel (43.5% vs 55.2%, p = 0.01) In-hospital recurrent ischemia was 2 times as common in FTNMI (20.1% vs 11.5%, p <0.001). There were no differences, however, in congestive heart failure, cardiogenic shock, cardiac arrest, stroke, or death in hospital. At 6 months, patients with FTNMI were 2 times as likely to have had recurrent MI (12.0% vs 6.6%, p <0.001). Combined end points of death at 6 months, MI, stroke, and rehospitalization were higher for FTNMI (47.7% vs 40.9%, p = 0.017); however, this was due to higher rates of recurrent MI. In conclusion, patients with FTNMI received less aggressive pharmacotherapy and were 2 times as likely to have recurrent MI at 6 months. FTNMI is common and represents a clinical entity that should be treated more aggressively., (Published by Elsevier Inc.)

Background: historically, women with ST elevation myocardial infarction (STEMI) have had a higher mortality compared with men. It is unclear if these differences persist among patients undergoing contemporary primary percutaneous coronary intervention (PCI) with focus on early reperfusion., Methods: we assessed the impact of sex on the outcome of 8,771 patients with acute STEMI who underwent primary PCI from 2003 to 2008 at 32 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry. A propensity-matched analysis was performed to adjust for differences in baseline characteristics and comorbidities between men and women., Results: twenty-nine percent of the cohort was female. Compared with men, women were older and had more comorbidity. Female sex was associated with a higher unadjusted in-hospital mortality (6.02% vs 3.45%, odds ratio [OR] 1.79, 95% CI 1.45-2.22, P < .0001) and higher risk of contrast-induced nephropathy (OR 1.75, P < .0001), vascular complications (OR 2.13, P < .0001), and postprocedure transfusion (OR 2.84, P < .0001). The gap in sex-specific mortality narrowed over time. In a propensity-matched analysis, female sex was associated with a higher rate of transfusion (OR 1.88, 95% CI 1.57-2.24, P < .0001) and vascular complications (OR 1.65, 95% CI 1.26-2.14, P < .0002); but there was no difference in mortality (OR 1.30, 95% CI 0.98-1.72, P = .07)., Conclusions: women make up approximately one third of patients undergoing primary PCI for STEMI. Female sex is associated with an apparent hazard of increased mortality among patients undergoing primary PCI for STEMI, but this difference is likely explained by older age and worse baseline comorbidities among women.

Background: In patients with acute ST-elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention, current guidelines for reperfusion therapy recommend a door-to-balloon (DTB) time of less than 90 minutes. Considerable effort has focused on reducing DTB time with the assumption that a reduction in DTB time translates into a significant reduction in mortality; however, the clinical impact of this effort has not been evaluated. Therefore, our objective was to determine whether a decline in DTB time in patients with STEMI was associated with an improvement in clinical outcomes., Methods: We assessed the yearly trend in DTB time for 8771 patients with STEMI who were undergoing primary percutaneous coronary intervention from 2003 to 2008 as part of the Blue Cross Blue Shield of Michigan Cardiovascular Consortium and correlated it with trends in in-hospital mortality. Patients were stratified according to risk of death using a mortality model to evaluate whether patient risk factors affect the relationship between DTB time and mortality., Results: Median DTB time decreased each year from 113 minutes in 2003 to 76 minutes in 2008 (P < .001), and the percentage of patients who were revascularized with a DTB time of less than 90 minutes increased from 28.5% in 2003 to 67.2% in 2008 (P < .001). In-hospital mortality remained unchanged at 4.10% in 2003, 4.02% in 2004, 4.40% in 2005, 4.42% in 2006, 4.73% in 2007, and 3.62% in 2008 (P = .69). After the differences in baseline characteristics were adjusted for, there was no difference in the standardized mortality ratios (SMRs) across the study period (SMR, 1.00; 95% confidence interval [CI], 0.74-1.26 in 2003 compared with SMR, 0.95; 95% CI, 0.77-1.13 in 2008)., Conclusions: There has been a dramatic reduction in median DTB time and increased compliance with the related national guideline. Despite these improvements, in-hospital mortality was unchanged over the study period. Our results suggest that a successful implementation of efforts to reduce DTB time has not resulted in the expected survival benefit.

Objective: To study the association of the fragmented QRS complex versus the Q wave with myocardial scar and viability., Background: A prior study has suggested that the fragmented QRS complex on an electrocardiogram (ECG) is a highly sensitive and specific marker of myocardial scar as detected by regional perfusion abnormalities on a nuclear stress test. There is no external validation of this data., Methods: We correlated the ECG and nuclear perfusion images of 460 consecutive patients with known or suspected coronary artery disease. The presence of fragmented QRS or Q waves in two contiguous ECG leads was correlated with major coronary artery distributions on nuclear perfusion imaging., Results: For the 1842 evaluated territories, the fragmented QRS complex was not superior to the Q wave in detecting fixed or mixed myocardial defects. The fragmented QRS complex was associated with worse sensitivity (1.7%) in comparison to the Q wave (31.7%) for identifying myocardial scar. The fragmented QRS complex carried a higher false positive rate in patients with normal perfusion scans (15.8%, 221 segments), in comparison to Q waves (1.4%, 17 segments)., Conclusion: In our study population, both the fragmented QRS and Q wave had poor sensitivity and specificity in detecting fixed or mixed myocardial scar. Larger studies are needed to evaluate fragmented QRS as a surrogate of myocardial scar before it can be incorporated into clinical practice., (©2010, Wiley Periodicals, Inc.)

Background: Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI) in patients with acute ST elevation myocardial infarction (STEMI) have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI., Methods: Seventeen randomized trials (n = 3,909 patients) of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG), thrombolysis in myocardial infarction (TIMI) grade flow, and post procedural ST segment resolution (STR) using random-effects and fixed-effects models., Results: There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42) among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007), MBG 3 (730/1526 vs. 486/1513, OR 2.42, P < 0.001), STR (923/1500 vs. 715/1494, OR 2.30, P < 0.001), and with a higher risk of stroke (14/1403 vs. 3/1413, OR 2.88, 95% CI 1.06-7.85, P = 0.04). Outcomes differed significantly between different device classes with a trend towards lower mortality with manual aspiration thrombectomy (MAT) (21/949 vs.36/953, OR 0.59, 95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards higher mortality (20/416 vs.10/418, OR 2.07, 95% CI 0.95-4.48, P = 0.07)., Conclusions: Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices.

Background: Current guidelines recommend abciximab as the preferred agent for patients undergoing primary percutaneous coronary intervention, yet small-molecule glycoprotein IIb/IIIa inhibitors are more commonly used in clinical practice. The objective of our meta-analysis was to evaluate for differences in clinical outcome between small-molecule glycoprotein IIb/IIIa inhibitors and abciximab in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention., Methods and Results: Five randomized trials (n=2138 patients) comparing tirofiban or eptifibatide with abciximab as an adjunctive therapy to primary percutaneous coronary intervention were included in this meta-analysis. Summary odds ratios (ORs) for 30-day death, reinfarction, and major bleeding were calculated using random- and fixed-effect models. There were no differences in 30-day mortality (1.9% for small molecule versus 2.3% for abciximab; OR, 0.84; 95% CI, 0.46 to 1.55; P=0.58), reinfarction (1.3% versus 1.2%; OR, 1.22; 95% CI, 0.51 to 2.91; P=0.69), or major bleeding (1.7% versus 1.3%; OR, 1.21; 95% CI, 0.58 to 2.49; P=0.61) between the 2 adjunctive strategies. Similarly, there was no significant difference in the incidence of death (3.9% versus 5%; OR, 0.77; 95% CI, 0.41 to 1.46; P=0.43) or reinfarction on follow-up at 8 months between small-molecule glycoprotein IIb/IIIa inhibitors and abciximab., Conclusions: In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction, no difference in outcome could be identified in patients treated with small-molecule glycoprotein IIb/IIIa inhibitor or abciximab.

Objectives: We sought to examine the short- and long-term outcomes of blood transfusion in patients presenting with ST-segment elevation myocardial infarction (STEMI)., Background: The short- and long-term consequences of blood transfusion in anemic patients with recent STEMI remain controversial., Methods: We evaluated 30-day, 6-month, and 1-year all-cause mortality among 4,131 STEMI patients enrolled in the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) IIb trial. Patients were categorized according to whether they received a blood transfusion during hospitalization. Cox proportional hazards survival models with transfusion as a time-dependent covariate were conducted for the whole and for the propensity-matched groups. Additionally, a series of sensitivity analyses assessed the magnitude of hidden bias that would need to be present to explain the associations actually observed., Results: Death at 30 days (13.7% vs. 5.5%), 6 months (19.7% vs. 6.9%), and 1 year (21.8% vs. 8.7%) was significantly higher for transfused patients than for nontransfused patients, respectively. After adjusting for over 25 baseline characteristics, nadir hemoglobin, and propensity score for transfusion, and using transfusion as a time-dependent covariate, transfusion remained significantly associated with increased risk of mortality at 30 days (hazard ratio [HR]: 3.89, 95% confidence interval [CI]: 2.66 to 5.68, p < 0.001), 6 months (HR: 3.63, 95% CI: 2.67 to 4.95, p < 0.001), and 1 year (HR: 3.03, 95% CI: 2.25 to 4.08, p < 0.001). Similar results were observed in the propensity-matched patients., Conclusions: Blood transfusion is associated with increased short- and long-term mortality in the setting of STEMI.

Animal experimental data have shown that lipid-lowering agents reduce myocardial infarct size. This association has not been well studied in humans. We compared infarct size in 10,548 patients in the GUSTO IIb and PURSUIT trials who were (n = 1,028) or were not (n = 9,520) on lipid-lowering therapy before an enrolling myocardial infarction (MI). Patients using lipid-lowering agents before their index MI had smaller infarcts than those who were not using these agents (median peak creatine kinase [CK]-MB 4.2 vs 5.2 times the upper limit of normal [ULN]; p <0.0001). Similarly, in an unadjusted model, patients on previous lipid-lowering therapy were less likely to have a peak CK-MB >3 times the ULN (620 of 1,028 [60.3%] vs 6,486 of 9,520 patients [68.1%]; p <0.001; relative risk 0.88, 95% confidence interval 0.84 to 0.93, p <0.0001). In a covariate- and propensity-adjusted multivariable model, the association between pretreatment with lipid-lowering agents and smaller infarct size persisted (relative risk for CK-MB >3 times the ULN 0.94, 95% confidence interval 0.88 to 0.99, p = 0.04). In conclusion, patients on lipid-lowering agents before an MI had significantly smaller infarcts. These findings suggest that lipid-lowering therapy may exert additional salutary effects in the setting of acute coronary syndromes.

Primary percutaneous coronary intervention (PCI) with adjunctive glycoprotein (GP) IIb/IIIa receptor inhibitor therapy administered in the cardiac catheterization laboratory is the optimal reperfusion strategy for patients with ST-elevation myocardial infarction. Most available data regarding these agents are from trials comparing abciximab to placebo alone. Noninferiority trials comparing small-molecule GP IIb/IIIa receptor inhibitors, such as tirofiban and eptifibatide with abciximab, have used markers for myocardial reperfusion as primary end points but are underpowered to detect significant differences in hard clinical outcomes. Such a trial would need to enroll a very large number of patients and thus make it practically impossible to perform. Registry data reveal that most patients undergoing primary PCI are treated with small-molecule GP IIb/IIIa receptor inhibitors in clinical practice, and no observed difference is observed in safety and efficacy when compared with patients treated with abciximab therapy.

Objectives: This study sought to assess whether the use of eptifibatide instead of abciximab is associated with a difference in outcomes of patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI)., Background: Pooled data from randomized controlled trials suggest that the use of abciximab may be associated with a survival advantage in patients undergoing primary PCI for acute STEMI. However, a large proportion of patients in the community are treated with eptifibatide, an agent that shares some but not all pharmacological properties with abciximab., Methods: We evaluated the outcomes of 3,541 patients who underwent primary PCI for STEMI from October 2002 to July 2006 in a large regional consortium and who were treated with abciximab (n = 729) or with eptifibatide (n = 2,812)., Results: There was no difference in the incidence of in-hospital death (4.1% with abciximab vs. 3.5% with eptifibatide, p = 0.39), recurrent myocardial infarction (0.8% vs. 1.2%, p = 0.42), or stroke/transient ischemic attack (0.7% vs. 0.6%, p = 0.80). There was no difference in the need for blood transfusion (12.4% vs. 11.7%, p = 0.61), whereas there was a greater incidence of gastrointestinal bleeding with abciximab (4.8% vs. 2.8%, p = 0.01). In parsimonious risk-adjusted models, no significant difference between abciximab and eptifibatide was observed with respect to any of the outcomes measures., Conclusions: Currently, eptifibatide is used as the adjunct antiplatelet agent in the majority of patients undergoing primary PCI. There is no apparent difference in early outcomes of patients treated with eptifibatide compared with patients treated with abciximab.

Introduction: Primary percutaneous coronary intervention (PCI) is the treatment of choice for patients with ST-segment elevation myocardial infarction (STEMI), but given logistics, many patients are still managed with thrombolytics. Unfractionated heparin (UFH) is recommended for routine use in STEMI patients treated with thrombolytics. However, other anticoagulants have been evaluated for use in STEMI patients treated with thrombolysis, including the low-molecular-weight heparins (LMWHs, enoxaparin, dalteparin, and reviparin), fondaparinux and bivalirudin., Methods and Results: A review of the available randomized controlled study data shows that most evidence, in terms of number of trials and number of patients treated with anticoagulants in STEMI has accumulated for LMWHs. The use of enoxaparin and reviparin improves hard clinical efficacy endpoints although there is an excess of bleeding events. Trials with dalteparin have failed to demonstrate improvement in hard clinical efficacy endpoints compared with UFH., Summary: Enoxaparin is currently the only LMWH with FDA approval for use in STEMI patients and should be considered as a preferable alternative to UFH in STEMI patients treated with fibrinolysis.

Background: Aspirin resistance is a well-documented laboratory finding, but the effects of clinical aspirin (ASA) failure on patients with acute coronary syndrome (ACS) have been debated. Likewise, there is recognition of clopidogrel resistance, but the clinical effects of clopidogrel failure are not well understood. We sought to determine the 6-month outcomes of patients who developed an ACS while on ASA or dual antiplatelet agents., Methods: Of all patients admitted to the University of Michigan, Ann Arbor, between 1999 and 2005 with a diagnosis of ACS, 6-month follow-up data were available for 3126. The cohort was divided into 3 groups based on medication history: no prior antiplatelet agent, ASA only, and ASA with clopidogrel (or ticlopidine). Primary end point was the rate of death, myocardial infarction, and stroke, or composite major adverse cardiac events (MACEs) at 6 months., Results: Aside from a lower rate of myocardial infarction in patients without any prior antiplatelet agent use, there were no significant differences in 6-month stroke, death, or MACE between the 3 medication cohorts. In the propensity-adjusted model, whereas dual antiplatelet status was not an independent predictor of 6-month mortality or MACE, there was a trend toward lower 6-month death rates for patients with prior ASA use (odds ratio 0.72, 95% CI 0.51-1.04, P = .08)., Conclusions: Patients who "fail" antiplatelet therapy do not have overall worse prognosis. Our data do not support ASA or dual antiplatelet agent failure as a distinct clinical entity.

Background: Recent clinical trials found that high-dose statin therapy, compared with conventional-dose statin therapy, reduces the risk of cardiovascular events in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). However, the actual benefit and cost-effectiveness of high-dose statin therapy are unknown., Methods and Results: We designed a Markov model to compare daily high-dose with conventional-dose statin therapy for hypothetical 60-year-old cohorts with ACS and stable CAD over patient lifetime. Pooled estimates for major clinical end points (all-cause mortality, myocardial infarction, stroke, rehospitalization, and revascularization) from relevant clinical trials were incorporated. Incremental benefit was quantified as quality-adjusted life-years (QALYs). Threshold analyses determined at what price difference high-dose statins would yield incremental cost-effective ratios below $50,000, $100,000, and $150,000 per QALY gained. In ACS patients, a high-dose versus conventional-dose statin strategy resulted in a gain of 0.35 QALYs. In threshold analyses, a high-dose statin strategy consistently yielded incremental cost-effective ratios below $30,000 per QALY even under conservative model assumptions. In stable CAD patients, a high-dose statin strategy yielded a gain of only 0.10 QALYs and was sensitive to model assumptions about statin efficacy. The daily cost difference between a high- and conventional-dose statin would need to be <$1.70, $2.65, and $3.55 to yield incremental cost-effective ratios below $50,000, $100,000, and $150,000 per QALY., Conclusions: High-dose statin therapy is potentially highly effective and cost-effective in patients with ACS. In patients with stable CAD, however, the cost-effectiveness of high-dose statin therapy is highly sensitive to model assumptions about statin efficacy and cost. Use of high-dose statins can be supported on health economic grounds in patients with ACS, but the case is less clear for patients with stable CAD.

Medical advances may be shifting patients with coronary artery disease away from the hospital setting despite an aging United States population. We explored this possibility using national inpatient data to estimate the number and population-based rates of hospitalization for acute myocardial infarction (AMI) and coronary revascularization from 2002 to 2005. Our primary data source was the Acute Care Tracker database, a proprietary administrative database that contains data on approximately 6 million discharges per year from 458 hospitals across the United States. Using the Acute Care Tracker database, we estimated the annual number and population-based rates of hospitalization for AMI (transmural, subendocardial) and coronary revascularization (percutaneous coronary intervention [PCI] and coronary artery bypass grafting [CABG]). Hospitalizations for AMI steadily decreased from 661,000 to 591,000 per year between 2002 and 2005, primarily due to decreases in transmural AMI. Hospitalizations for coronary revascularizations during this period varied between 794,000 and 815,000 per year, with the number of PCIs increasing and the number of CABGs decreasing. In addition, rates of hospitalization for AMI decreased from 309 to 266 per 100,000 persons between 2002 and 2005, with rates of transmural AMI decreasing substantially from 118 to 87 per 100,000 persons. Rates of hospitalization for coronary revascularization also decreased from 382 to 358 per 100,000 during this period, primarily due to decreases in CABG. In conclusion, the number and rates of hospitalization for AMI and coronary revascularization in the United States are decreasing.

Objective: To evaluate the impact of diabetic status on outcome of patients undergoing carotid artery stenting (CAS)., Background: Diabetes has been demonstrated to be a strong predictor of adverse outcome in patients undergoing coronary revascularization. Its significance in predicting outcome of patients undergoing carotid interventions has not been ascertained., Methods: We evaluated the short-term outcomes of 833 patients who underwent CAS at our institution. The primary outcome of this analysis was 30 day incidence of stroke, myocardial infarction, and death., Results: Diabetes was present in 311 patients. Baseline characteristics were comparable between diabetics and nondiabetics except for the diabetics having a lower left ventricular ejection fraction, lower hemoglobin, and a higher body mass index at baseline. Further, they were more likely to have congestive heart failure and coronary artery disease. There was no difference in the incidence of stroke (1.9% versus 2.7%,), myocardial infarction (MI) (2.6% versus 1.9%), death (3.9% versus 2.5%), or the composite of death stroke or MI (6.8% versus 5.9%) at 30 days between diabetics and nondiabetics. Similar results were seen when the analysis was restricted to patients treated with an emboli protection device. Diabetes was not a risk factor for adverse outcome after CAS after multivariate adjustment., Conclusion: Diabetics undergoing CAS are more likely to have associated co-morbidities. However despite this handicap, their short term outcome after CAS is similar to that of nondiabetics., ((c) 2007 Wiley-Liss, Inc.)

Background: The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GPIIb/IIIa) inhibition is not inferior to heparin plus GPIIb/IIIa inhibition in patients undergoing percutaneous coronary intervention. The extent to which this applies to patients with acute coronary syndromes (ACS) is unclear. Therefore, we sought to determine if bivalirudin has similar efficacy in ACS patients as compared with "stable" patients in the REPLACE-2 trial., Methods: We analyzed the outcomes of ACS patients compared with stable patients and the outcomes of ACS patients according to whether or not they had received bivalirudin, including the economic costs. The trial enrolled 1351 ACS patients (myocardial infarction within 7 days or unstable angina within 48 hours, but not on ongoing GPIIb/IIIa or heparin therapy) and 4554 stable patients., Results: Patients with ACS had a similar rate of death or myocardial infarction at 30 days compared to stable patients (7.2% vs 6.7%, P = .51) and death at 1 year (1.6% vs 2.2%, P = .169), but a higher rate of urgent coronary artery bypass graft at 30 days (1.0% vs 0.3%, P = .002). Patients with ACS treated with bivalirudin had a similar rate of 30-day death, myocardial infarction, or urgent revascularization compared with ACS patients treated with heparin and GPIIb/IIIa inhibitors (8.7% vs 8.0%, P = .616) and death at 1 year (1.5% vs 1.8%, P = .701), but a higher rate of revascularization at 6 months (12% vs 8.4%, P = .04). Patients with ACS treated with bivalirudin had less major bleeding than ACS patients treated with heparin and GPIIb/IIIa inhibitors, although this was not statistically significant (2.7% vs 4.5%, P = .07). Mean 30-day costs for patients with ACS were dollar 12415 for those treated with bivalirudin and dollar 12806 for those treated with heparin plus GPIIb/IIIa inhibitors (P = .022)., Conclusion: Bivalirudin with provisional GPIIb/IIIa inhibitor use in low-risk ACS patients (not receiving preprocedural GPIIb/IIIa blockade) appears to provide similar protection against death and myocardial infarction as the combination of heparin and GPIIb/IIIa inhibitors, although we observed a higher rate of revascularization at 6 months.

Background: Although practice guidelines do not recommend routine exercise testing of patients after coronary stenting, several small studies have suggested that stress myocardial perfusion imaging can provide prognostic information about future adverse cardiac events. We sought to determine if exercise nuclear testing provides independent prognostic information in patients after coronary stenting., Methods: We analyzed the outcomes of 370 patients who underwent dual isotope exercise nuclear scintigraphy at least 1 month after coronary stenting and had testing between April 1996 and May 2002. Patients were classified according to presence or absence of any ischemia. The primary endpoint was all-cause mortality or myocardial infarction (MI) during a median of 30 months (range 6-59) of follow-up., Results: There were 86 patients (23%) who had ischemia. Major events--death or MI--occurred in 62 patients including 22 deaths. Among patients with no ischemia, the 30-month event rate was 9.1%, whereas among patients with ischemia, the event rate was 17.0% (P = .001). After adjusting for age, sex, standard cardiac risk factors, cardiac history, left ventricular ejection fraction, angiographic findings, procedural variables, exercise capacity, and heart-rate dynamics, the presence of scintigraphic evidence of ischemia predicted death or MI (adjusted hazard ratio 2.08, 95% CI 1.21-3.56, P = .008). The presence of ischemia similarly predicted events in asymptomatic patients (adjusted hazard ratio 2.19, 95% CI 1.17-4.11, P = .015)., Conclusions: In patients with recent coronary stent placement, reversible nuclear perfusion defects independently predicted risk of death or MI.

Anemia and renal insufficiency impart an increased risk of mortality in patients with congestive heart failure. There is a paucity of data on the mortality hazard associated with anemia and renal insufficiency in patients undergoing percutaneous coronary intervention in the setting of contemporary practice. We analyzed the short- and long-term outcomes among patients enrolled in EPIC, EPILOG and EPISTENT trials according to degree of kidney dysfunction (glomerular filtration rate [GFR] <60, 60 to 75, and >75 ml/min/1.73 m2) and by hematocrit (<35, 35 to 39 and 40). GFR was calculated as GFR = 186 x (serum creatinine-1.154) x (age-0.203) x 1.212 (if black) or x 0.742 (if female). There were 20 deaths (3.2%) among 638 patients with a hematocrit of <35, 41 deaths among 2,066 patients (2.0%) with a hematocrit of 35 to 39, and 43 deaths in 3,618 patients (1.2%) with a hematocrit >40 at 6 months (p <0.001). Similarly, a significant increase in mortality was seen with lower GFR [33 of 1,168 (2.9%) at GFR <60, 33 of 1,766 (1.9%) at GFR 60 to 75 and 37 of 3,317 (1.1%) at GFR >75, p <0.001)]. Further, GFR and anemia independently and in combination predicted mortality at 3 years. Thus, renal insufficiency and anemia are significant independent and additive predictors of short- and long-term complications in patients undergoing percutaneous coronary intervention.

Objectives: We studied the outcome of diabetics enrolled in the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) V trial to assess whether the combination of half-dose reteplase and abciximab provides any propitious benefits over standard fibrinolytic therapy in diabetic patients., Background: Diabetics with acute ST-segment elevation myocardial infarction (MI) have a worse outcome compared with nondiabetics. Higher-risk patients are usually more likely to benefit from advances in medical therapy., Methods: We analyzed diabetic patients enrolled in the GUSTO V trial to assess the outcome of those randomized to the combination of half-dose reteplase and abciximab versus those randomized to reteplase. We also evaluated whether any differences existed in presentation and outcome of MI among the diabetics versus the nondiabetics enrolled in the study., Results: The trial enrolled 13782 nondiabetics and 2633 diabetics. Compared to nondiabetics, diabetics had a significantly higher mortality at 30 days (8.5% vs. 5.1%, p < 0.001) and at 1 year (12.7% vs. 7.5%, p < 0.001). Among the diabetic subset, no significant difference existed in the incidence of 30-day (8.8% vs. 8.2%, p = 0.52) or 1-year mortality (13.0% vs. 12.4%, p = 0.62) among patients randomized to reteplase compared to those receiving combination of abciximab and reteplase. The incidence of reinfarction (2.5% vs. 4.3%, p = 0.013), recurrent ischemia (11.8% vs. 14.9%, p = 0.017), and urgent revascularization (10.9% vs. 13.3%, p = 0.055) at seven days was lower in diabetics treated with the combination therapy., Conclusions: Compared to nondiabetics, diabetics continue to have a worse outcome with MI. Although combination therapy did not provide a survival benefit, nonfatal ischemic outcomes, including reinfarction, recurrent ischemia, and urgent revascularization, were substantially reduced.

Background: Mortality related to percutaneous coronary intervention (PCI) has gradually declined during the last decade. However, the causes and circumstances of death remain largely undescribed in contemporary practice.Methods: We retrospectively evaluated all patients undergoing PCI at our institution from July 2013 to March 2021. Three cardiologists independently determined the causes and circumstances of death, and evaluated the preventability of death using validated methods.Results: During study period, 4334 patients underwent 5506 PCIs, of whom 166 patients suffered in-hospital death (3.0%). Ninety-three percent of deceased patients initially presented with acute coronary syndrome, and 45% with cardiogenic shock. Left ventricular failure was the most common cause of death (39.7%), followed by neurologic compromise after cardiac arrest (16.8%) and infections (13.8%). The circumstance of death was most commonly acute cardiac (51.8%), followed by non-cardiac (19.2%) and non-procedural complications (17.4%). Death was attributed to a procedural complication in only 12% of cases. Reviewers determined that 90% of cases as being unpreventable or slightly preventable. Inter-reviewer agreement was substantial (the three reviewers agreed in >80% of cases for cause and preventability of death).Conclusion: Mortality after PCI is uncommon, largely unpreventable, and most often related to pre-existing, acute cardiovascular conditions. Procedural complications account for a minority of cases of death, and future effort should focus on the treatment of acute cardiovascular conditions, in particular cardiogenic shock, to decrease acute mortality after PCI. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the association between reported marijuana use and post–percutaneous coronary intervention (PCI) in-hospital outcomes. Marijuana use is increasing as more states in the United States legalize its use for recreational and medicinal purposes. Little is known about the frequency of use and relative safety of marijuana among patients presenting for PCI. The authors analyzed Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry data between January 1, 2013, and September 30, 2016. One-to-one propensity matching and multivariable logistic regression were used to adjust for differences between patients with or without reported marijuana use, and rates of post-PCI complications were compared. Among 113,477 patients, 3,970 reported marijuana use. Compared with those without reported marijuana use, patients with reported marijuana use were likely to be younger (53.9 years vs 65.8 years), to use tobacco (73.0% vs 26.8%), to present with ST-segment elevation myocardial infarction (27.3% vs 15.9%), and to have fewer cardiovascular comorbidities. After matching, compared with patients without reported marijuana use, those with reported marijuana use experienced significantly higher risks for bleeding (adjusted odds ratio [aOR]: 1.54; 95% confidence interval [CI]: 1.20-1.97; P < 0.001) and cerebrovascular accident (aOR: 11.01; 95% CI: 1.32-91.67; P = 0.026) and a lower risk for acute kidney injury (aOR: 0.61; 95% CI: 0.42-0.87; P = 0.007). There were no significant differences in risks for transfusion and death. A modest fraction of patients undergoing PCI used marijuana. Reported marijuana use was associated with higher risks for cerebrovascular accident and bleeding and a lower risk for acute kidney injury after PCI. Clinicians and patients should be aware of the higher risk for post-PCI complications in these patients. [Display omitted] [ABSTRACT FROM AUTHOR]

Objectives: We sought to evaluate the patterns of use and outcomes associated with eptifibatide and abciximab administration among dialysis patients who underwent percutaneous coronary intervention (PCI).Background: Contraindicated medications are frequently administered to dialysis patients undergoing PCI often resulting in adverse outcomes. Eptifibatide is a glycoprotein IIb/IIIa inhibitor that is often used during PCI and is contraindicated in dialysis.Methods: We included dialysis patients who underwent PCI from January 2010 to September 2015 at 47 hospitals in Michigan. We compared outcomes between patients who received eptifibatide compared with abciximab. Both groups required concurrent treatment with unfractionated heparin only. In-hospital outcomes included repeat PCI, bleeding, major bleeding, need for transfusion, and death. Optimal full matching was used to adjust for non-random drug administration.Results: Of 177 963 patients who underwent PCI, 4303 (2.4%) were on dialysis. Among those, 384 (8.9%) received eptifibatide and 100 (2.3%) received abciximab. Prior to matching, patients who received eptifibatide had higher pre-procedural hemoglobin levels (11.3 g/dL vs. 10.7 g/dL; P < 0.001) and less frequently had a history of myocardial infarction (36.5% vs. 52.0%; P = 0.005). After matching, there were no significant differences in in-hospital outcomes between eptifibatide and abciximab including transfusion (aOR: 1.15; 95%CI: 0.55-2.40; P = 0.70), bleeding (1.47; 0.64-3.40; P = 0.36), major bleeding (4.68; 0.42-52.3; P = 0.21), repeat PCI (0.38; 0.03-4.23; P = 0.43), and death (1.53; 0.2-9.05; P = 0.64).Conclusions: Despite being contraindicated in dialysis, eptifibatide was used approximately 3.5 times more frequently than abciximab among dialysis patients undergoing PCI but was associated with similar in-hospital outcomes. [ABSTRACT FROM AUTHOR]

Objective: To determine the predictors of periprocedural blood transfusion and the association of transfusion on outcomes in high risk patients undergoing endoluminal percutaneous vascular interventions (PVI) for peripheral arterial disease. Methods/Results: Between 2010–2014 at 47 hospitals participating in a statewide quality registry, 4.2% (n = 985) of 23,273 patients received a periprocedural blood transfusion. Transfusion rates varied from 0 to 15% amongst the hospitals in the registry. Using multiple logistic regression, factors associated with increased transfusion included female gender (OR = 1.9; 95% CI: 1.6–2.1), low creatinine clearance (1.3; 1.1–1.6), pre-procedural anemia (4.7; 3.9–5.7), family history of CAD (1.2; 1.1–1.5), CHF (1.4; 1.2–1.6), COPD (1.2; 1.1–1.4), CVD or TIA (1.2; 1.1–1.4), renal failure CRD (1.5; 1.2–1.9), pre-procedural heparin use (1.8; 1.4–2.3), warfarin use (1.2; 1.0–1.5), critical limb ischemia (1.7; 1.5–2.1), aorta-iliac procedure (1.9; 1.5–2.5), below knee procedure (1.3; 1.1–1.5), urgent procedure (1.7; 1.3–2.2), and emergent procedure (8.3; 5.6–12.4). Using inverse weighted propensity matching to adjust for confounders, transfusion was a significant risk factor for death (15.4; 7.5–31), MI (67; 29–150), TIA/stroke (24; 8–73) and ARF (19; 6.2–57). A focused QI program was associated with a 28% decrease in administration of blood transfusion (p = 0.001) over 4 years. Conclusion: In a large statewide PVI registry, post procedure transfusion was highly correlated with a specific set of clinical risk factors, and with in-hospital major morbidity and mortality. However, using a focused QI program, a significant reduction in transfusion is possible. [ABSTRACT FROM AUTHOR]

Patients with end-stage renal disease commonly develop acute coronary syndromes (ACS). Little is known about the natural history of ACS in patients receiving dialysis. We evaluated the presentation, management, and outcomes of patients with ACS who were receiving dialysis before presentation for an ACS and were enrolled in the Global Registry of Acute Coronary Events (GRACE) at 123 hospitals in 14 countries from 1999 to 2007. Of 55,189 patients, 579 were required dialysis at presentation. Non–ST-segment elevation myocardial infarction was the most common ACS presentation in patients receiving dialysis, occurring in 50% (290 of 579) of patients versus 33% (17,955 of 54,610) of those not receiving dialysis. Patients receiving dialysis had greater in-hospital mortality rates (12% vs 4.8%; p <0.0001) and, among those who survived to discharge, greater 6-month mortality rates (13% vs 4.2%; p <0.0001), recurrent myocardial infarction (7.6% vs 2.9%; p <0.0001), and unplanned rehospitalization (31% vs 18%; p <0.0001). The outcome in patients receiving dialysis was worse than that predicted by their calculated GRACE risk score for in-hospital mortality (7.8% predicted vs 12% observed; p <0.05), 6-month mortality/myocardial infarction (10% predicted vs 21% observed; p <0.05). In conclusion, in the present large multinational study, approximately 1% of patients with ACS were receiving dialysis. They were more likely to present with non–ST-segment elevation myocardial infarction, and had markedly greater in-hospital and 6-month mortality. The GRACE risk score underestimated the risk of major events in patients receiving dialysis. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate the effect of age on procedure type, periprocedural management, and in-hospital outcomes of patients undergoing lower-extremity (LE) peripheral vascular intervention (PVI). Background: Surgical therapy of peripheral arterial disease is associated with significant morbidity and mortality in the elderly. There are limited data related to the influence of advanced age on the outcome of patients undergoing percutaneous LE PVI. Methods: Clinical presentation, comorbidities, and in-hospital outcomes of patients undergoing LE PVI in a multicenter, multidisciplinary registry were compared between 3 age groups: <70 years, between 70 and 80 years, and ≥80 years (elderly group). Results: In our cohort, 7,769 patients underwent LE PVI. The elderly patients were more likely to be female and to have a greater burden of comorbidities. Procedural success was lower in the elderly group (74.2% for age ≥80 years vs. 78% for age 70 to <80 years and 81.4% in patients age <70 years, respectively; p < 0.0001). Unadjusted rates of procedure-related vascular access complications, post-procedure transfusion, contrast-induced nephropathy, amputation, and major adverse cardiac events were higher in elderly patients. After adjustment for baseline covariates, the elderly patients were more likely to experience vascular access complications; however, advanced age was not found to be associated with major adverse cardiac events, transfusion, contrast-induced nephropathy, or amputation. Conclusions: Contemporary PVI can be performed in elderly patients with high procedural and technical success with low rates of periprocedural complications including mortality. These findings may support the notion of using PVI as a preferred revascularization strategy in the treatment of severe peripheral arterial disease in the elderly population. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate the prevalence, risk factors, outcomes, and predictors of mortality of retroperitoneal hematoma (RPH) following percutaneous coronary intervention. Background: Retroperitoneal hematoma is a serious complication of invasive cardiovascular procedures. Methods: The study sample included 112,340 consecutive patients undergoing percutaneous coronary intervention in a large, multicenter registry between October 2002 and December 2007. End points evaluated included the development of RPH and mortality. Results: Retroperitoneal hematoma occurred in 482 (0.4%) patients. Of these, 92.3% were treated medically and 7.7% underwent surgical repair. Female sex, body surface area <1.8 m2, emergency procedure, history of chronic obstructive pulmonary disease, cardiogenic shock, pre-procedural IV heparin, pre-procedural glycoprotein IIb/IIIa inhibitors, adoption of sheath size ≥8-F, and use of vascular closure devices were independent predictors of RPH, whereas the use of bivalirudin was associated with a lower risk. The development of RPH was associated with a higher frequency of post-procedure myocardial infarction (5.81% vs. 1.67%, p < 0.0001), infection and/or sepsis (17.43% vs. 3.00%, p < 0.0001), and heart failure (8.00% vs. 1.63%, p < 0.0001). In-hospital mortality was significantly higher in patients who developed RPH than in patients who did not (6.64% vs. 1.07%, p < 0.0001). Among patients with RPH, independent predictors of death were history of myocardial infarction, cardiogenic shock, pre-procedural creatinine ≥1.5 mg/dl, and left ventricular ejection fraction <50%. Conclusions: Retroperitoneal hematoma is an uncommon complication of contemporary percutaneous coronary intervention associated with high morbidity and mortality. The identification of risk factors for the development of RPH could lead to modification of procedure strategies aimed toward reducing its incidence. [ABSTRACT FROM AUTHOR]

Background: Saphenous vein grafts develop an aggressive atherosclerotic process and the efficacy of drug eluting stents (DES) in treating saphenous vein graft (SVG) lesions has not been convincingly demonstrated. The aim of this study was to review and analyze the current literature for controlled studies comparing DES versus bare metal stents (BMS) for treatment of SVG stenoses. Methodology/Principal Findings: We searched several scientific databases and conference proceedings up to March 15, 2010 for controlled studies comparing target vessel revascularization (TVR) between DES and BMS. Summary odds ratios (OR) for the primary endpoint TVR and secondary endpoints infarction, stent thrombosis and death were calculated using random-effect models. A total of 29 studies (3 randomized controlled trials RCT) involving 7549 (202 in RCT) patients were included. The need for target vessel revascularization in the DES group tended to be lower compared to BMS for the 3 RCT (OR 0.50 [0.24-1.00]; p = 0.051) and for observational studies (0.62 [0.49-0.79]; p,0.001). There was no significant difference in the risk for myocardial infarction in the RCT (OR 1.25 [0.22-6.99]; p = 0.250) but a lower risk for DES based on the observational studies 0.68 [0.49-0.95]; p = 0.023. The risk for stent thrombosis was found to be non-different in the RCT (OR 0.78 [0.03-21.73], p = 0.885) while it was in favor of DES in the observational studies (0.58 [0.38 - 0.84]; p,0.001). The mortality was not significantly different between DES and BMS in the RCT's (OR 2.22 [0.17 - 29.50]; p = 0.546) while the observation studies showed a decreased mortality in the DES group (0.69 [0.55-0.85]; p,0.001). Conclusion: DES may decrease TVR rate in treatment of SVG stenoses. No differences in reinfarction rate, stent thrombosis or mortality was found between the DES and BMS groups in the RCT's while the observational data showed lower risk for myocardial infarction, stent thrombosis and death in the DES group. This may be a result of patient selection bias in the observational studies or represent a true finding that was not the detected in the RCT analysis due to limited statistical power. [ABSTRACT FROM AUTHOR]

Background: Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI) in patients with acute ST elevation myocardial infarction (STEMI) have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI. Methods: Seventeen randomized trials (n = 3,909 patients) of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG), thrombolysis in myocardial infarction (TIMI) grade flow, and post procedural ST segment resolution (STR) using random-effects and fixed-effects models. Results: There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42) among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007), MBG 3 (730/1526 vs. 486/1513, OR 2.42, P < 0.001), STR (923/1500 vs. 715/1494, OR 2.30, P < 0.001), and with a higher risk of stroke (14/1403 vs. 3/1413, OR 2.88, 95% CI 1.06-7.85, P = 0.04). Outcomes differed significantly between different device classes with a trend towards lower mortality with manual aspiration thrombectomy (MAT) (21/949 vs.36/953, OR 0.59, 95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards higher mortality (20/416 vs.10/418, OR 2.07, 95% CI 0.95-4.48, P = 0.07). Conclusions: Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices. [ABSTRACT FROM AUTHOR]