Current medical management of stable coronary artery disease before and after elective percutaneous coronary intervention.

BACKGROUND: Percutaneous coronary intervention (PCI) for stable coronary artery disease (CAD) is not superior to optimal medical therapy. It remains unclear if patients who receive PCI for stable CAD are receiving appropriate medical therapy. METHODS: We evaluated the medical management of 60,386 patients who underwent PCI for stable CAD between 2004 and 2009. We excluded patients with contraindications to aspirin, clopidogrel, statins, or ß-blockers (BBs). We defined essential medical therapy of stable CAD as treatment with aspirin, statin, and BB before PCI and treatment with aspirin, clopidogrel, and statin after PCI. RESULTS: Essential medical therapy was used in 53.0% of patients before PCI and 82.1% at discharge. Aspirin was used in 94.8% patients before PCI and 98.3% of after PCI. Statins were used in 69.5% of patients before PCI and 84.5% after PCI. ß-Blockers were used in 72.8% of patients before PCI. Clopidogrel was used in 97.3% of patients after PCI. Patients with a history of myocardial infarction or revascularization before PCI had better medical therapy compared with patients without such a history (62.8% vs 34.3% [P < .001] before PCI and 83.6% vs 79.1% [P < .001] after PCI). After adjusting for confounders and clustering, women (odds ratio 0.74, 95% CI 0.71-0.78) and patients on dialysis (odds ratio 0.68, 95% CI 0.57-0.80) were less likely to receive a statin at discharge. CONCLUSIONS: Medical therapy remains underused before and after PCI for stable CAD. Women are less likely to receive statin therapy. There are significant opportunities to optimize medical therapy in patients with stable CAD.

The changing definition of contrast-induced nephropathy and its clinical implications: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

BACKGROUND: The traditional definition of contrast-induced nephropathy (CIN) has been an absolute rise of serum creatinine (Cr) of ≥0.5 mg/dL, although most recent clinical trials have included a ≥25% increase from baseline Cr. The clinical implication of this definition change remains unknown. METHODS AND RESULTS: We compared the association of the two definitions with risk of death or need for dialysis among 58,957 patients undergoing percutaneous coronary intervention in 2007 to 2008 in a large collaborative registry. Patients with a preexisting history of renal failure requiring dialysis were excluded. Contrast-induced nephropathy as defined by a rise in Cr ≥0.5 mg/dL (CIN(Traditional)) developed in 1,601, whereas CIN defined either as Cr ≥0.5 mg/dL or ≥25% increase in baseline Cr (CIN(New)) developed in 4,308 patients. Patients meeting the definition of CIN(New) but not CIN(Traditional) were classified as CIN(Incremental) (n = 2,707). Compared with CIN(New), CIN(Traditional) was more commonly seen in patients with abnormal renal function, which was more likely to develop in patients with normal renal function at baseline. Compared with CIN(Incremental), patients meeting the definition of CIN(Traditional) were more likely to die (16.7% vs 1.7%) and require in-hospital dialysis (9.8% vs 0%). CONCLUSIONS: Our data suggest that the traditional definition of CIN (a rise in Cr of ≥0.5 mg/dL) in patients undergoing PCI is superior to ≥25% increase in Cr at identifying patients at greater risk for adverse renal and cardiac events.

Cause and circumstance of in-hospital mortality among patients undergoing contemporary percutaneous coronary intervention: a root-cause analysis.

BACKGROUND: Prior studies suggest that most deaths in patients undergoing percutaneous coronary intervention (PCI) are related to procedural complications. Mortality associated with PCI has steadily declined during the past decade, and the cause and circumstance of death among patients undergoing PCI in the contemporary era remain unknown. METHODS AND RESULTS: We evaluated all patients undergoing PCI at the University of Michigan from 2001 to 2009. There were 85 deaths among a total of 5520 patients undergoing PCI during this time period. By using a standardized data collection form, 3 cardiologists (2 interventional, H.S.G. and D.S.M.; 1 noninvasive, A.M.B.) determined the cause and circumstance of death, in addition to grading the preventability of death. Left ventricular failure was the most common cause of death (35.3%, n=30), followed by neurological compromise (16.5%, n=14) and arrhythmia (12.1%, n=12). The circumstance of death was mostly acute cardiac (52.9%, n=45), with a procedural complication composing a small fraction (7.1%, n=6). Reviewers determined 93% of deaths to be mostly or entirely unpreventable. CONCLUSIONS: Procedural complications are responsible for a small fraction of deaths among patients undergoing contemporary PCI. Measures to further enhance procedural safety are unlikely to translate into meaningful reductions in PCI mortality.

Contemporary use and effectiveness of N-acetylcysteine in preventing contrast-induced nephropathy among patients undergoing percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to examine the use of and outcomes associated with use of N-acetylcysteine (NAC) in real-world practice. BACKGROUND: The role of NAC in the prevention of contrast-induced nephropathy (CIN) is controversial, leading to widely varying recommendations for its use. METHODS: Use of NAC was assessed in consecutive patients undergoing nonemergent percutaneous coronary intervention from 2006 to 2009 in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium, a large multicenter quality improvement collaborative. We examined the overall prevalence of NAC use in these patients and then used propensity matching to link its use with clinical outcomes, including CIN, nephropathy-requiring dialysis, and death. RESULTS: Of the 90,578 percutaneous coronary interventions performed during the study period, NAC was used in 10,574 (11.6%) procedures, with its use steadily increasing over the study period. Patients treated with NAC were slightly older and more likely to have baseline renal insufficiency and other comorbidities. In propensity-matched, risk-adjusted models, we found no differences in outcomes between patients treated with NAC and those not receiving NAC for CIN (5.5% vs. 5.5%, p = 0.99), nephropathy-requiring dialysis (0.6% vs. 0.6%, p = 0.69), or death (0.6% vs. 0.8%, p = 0.15). These findings were consistent across many prespecified subgroups. CONCLUSIONS: Use of NAC is common and has steadily increased over the study period but does not seem to be associated with improved clinical outcomes in real-world practice.

Renal function-based contrast dosing to define safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions.

OBJECTIVES: The aim of this study was to evaluate the association between calculated creatinine clearance (CCC)-based contrast dose and renal complications in patients undergoing percutaneous coronary interventions (PCI). BACKGROUND: Excess volumes of contrast media are associated with renal complications in patients undergoing cardiac procedures. Because contrast media are excreted by the kidney, we hypothesized that a dose estimation on the basis of CCC would provide a simple strategy to define a safe dose of contrast media. METHODS: We assessed the association between CCC-based contrast dose and the risk of contrast-induced nephropathy (CIN) and need for in-hospital dialysis in 58,957 patients undergoing PCI and enrolled in the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry from 2007 to 2008. Patients receiving dialysis at the time of the procedure were excluded. RESULTS: The risk of CIN and nephropathy requiring dialysis (NRD) was directly associated with increasing contrast volume adjusted for renal function. The risk for CIN and NRD approached significance when the ratio of contrast dose/CCC exceeded 2 (adjusted odds ratio [OR] for CIN: 1.16, 95% confidence interval [CI]: 0.98 to 1.37, adjusted OR for NRD: 1.72, 95% CI: 0.9 to 3.27) and was dramatically elevated in patients exceeding a contrast to CCC ratio of 3 (adjusted OR for CIN: 1.46, 95% CI: 1.27 to 1.66, adjusted OR for NRD: 1.89, 95% CI: 1.21 to 2.94). CONCLUSIONS: Our study supports the need for minimizing contrast dose in patients with renal dysfunction. A contrast dose on the basis of estimated renal function with a planned contrast volume restricted to less than thrice and preferably twice the CCC might be valuable in reducing the risk of CIN and NRD.

Outcome of contemporary percutaneous coronary intervention in the elderly and the very elderly: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

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.

Trends and disparities in referral to cardiac rehabilitation after percutaneous coronary intervention.

BACKGROUND: Despite the known benefits of cardiac rehabilitation in patients with coronary artery disease, referral rates to rehabilitation programs remain low. We determined the incidence and determinants of cardiac rehabilitation referral rates for patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: The incidence and predictors of referral to cardiac rehabilitation were assessed among 145,661 consecutive patients undergoing PCI and surviving to hospital discharge across 31 hospitals in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium between 2003 and 2008. The 6-year cardiac rehabilitation referral rate was 60.2%. Younger age, male gender, white race, and presentation with acute or severe disease (ie, acute myocardial infarction [AMI] in the previous 24 hours and ST-elevation myocardial infarction) were associated with increased referral to rehabilitation (all P < .0001). Most medical comorbidities were associated with decreased referral. Referral rates for cardiac rehabilitation were below the rates of other AMI quality-of-care indicators and more variable across hospital sites. Race-specific referral rates differed significantly in the lowest referring hospitals (P < .0001) but not in the highest referring hospitals (P = .16). Women had a 0.7% relative decrease in referral as compared to men (P = .0188) in the highest referring hospitals but a 26.7% relative decrease in referral in the lowest referring hospitals (P = .02). CONCLUSIONS: Over one third of patients undergoing PCI are not referred for cardiac rehabilitation. Referral rates are below the rates of other AMI quality-of-care performance measures and more variable across sites. Racial and gender disparities in referral to rehabilitation exist but are concentrated at the lowest referring hospitals.

The association of sex with outcomes among patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction in the contemporary era: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

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.

The relative renal safety of iodixanol and low-osmolar contrast media in patients undergoing percutaneous coronary intervention. Insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

Contrast-induced acute kidney injury (CI-AKI) is a common complication of percutaneous coronary intervention (PCI). Current guidelines support the use of iodixanol (Visipaque®, GE Healthcare, Princeton, New Jersey) in patients at high risk for CI-AKI. Recent trials and meta-analyses have shown no difference in CI-AKI when iodixanol is compared to low-osmolar contrast media (LOCM). We evaluated the incidence of CI-AKI, in-hospital dialysis and in-hospital death in 58,957 patients who underwent PCI in 2007 and 2008 in a large regional consortium of 31 hospitals and who were treated with iodixanol (n = 17,814) or LOCM (n = 41,143). Propensity-matched analysis was performed to adjust for differences in baseline variables. Patients treated with iodixanol compared to those treated with LOCM were slightly older, had more medical comorbidities and a higher baseline creatinine (1.35 ± 1.07 mg/dL versus 1.10 ± 0.85 mg/dL; p < 0.0001). In propensity-matched, risk-adjusted models, there was no significant difference between iodixanol and LOCM in the risk of CIAKI (4.54% vs. 4.14%; p = 0.14), need for dialysis (0.37% vs. 0.43%; p = 0.35) or death (1.46% vs. 1.39%; p = 0.18). Among patients undergoing PCI, the use of iodixanol was more frequent in older patients with more comorbidities and worse baseline renal function. There was no difference in the adjusted risk of CI-AKI among patients treated with iodixanol compared with those treated with LOCM.

Retroperitoneal hematoma after percutaneous coronary intervention: prevalence, risk factors, management, outcomes, and predictors of mortality: a report from the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry.

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 m(2), emergency procedure, history of chronic obstructive pulmonary disease, cardiogenic shock, pre-procedural IV heparin, pre-procedural glycoprotein IIb/IIIa inhibitors, adoption of sheath size >or=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 >or=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.

Gender differences in adverse outcomes after contemporary percutaneous coronary intervention: an analysis from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) percutaneous coronary intervention registry.

BACKGROUND: Prior studies have shown a relationship between female gender and adverse outcomes after percutaneous coronary interventions (PCIs). Whether this relationship still exists with contemporary PCI remains to be determined. METHODS: We evaluated gender differences in clinical outcomes in a large registry of contemporary PCI. Data were prospectively collected from 22,725 consecutive PCIs in a multicenter regional consortium (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) between January 2002 and December 2003. The primary end point was in-hospital all-cause mortality; other clinical outcomes evaluated included in-hospital death, vascular complications, transfusion, postprocedure myocardial infarction, stroke, and a combined major cardiovascular adverse event (MACE) end point including myocardial infarction, death, stroke, emergency coronary artery bypass grafting, and repeated PCI at the same site. Independent predictors of adverse outcomes were identified using multivariate logistic regression analysis. RESULTS: Compared with men, women were older, had a higher prevalence of comorbidities, and had a significantly higher frequency of adverse outcomes after PCI. After adjustment for baseline demographics, comorbidities, clinical presentation, and lesion characteristics, female gender was associated with an increased risk of in-hospital death, vascular complication, blood transfusion, stroke, and MACE. The relationship between female gender and increased risk of death and MACE was no longer present after further adjustment for kidney function and low body surface area. CONCLUSIONS: Differences in mortality rates between men and women no longer exist after PCI. However, our data suggest that technological advancements have not completely offset the relationship between gender and adverse outcomes after PCI.

Association between the use of 4 recommended drug categories and patient perceptions of health status following an ACS event.

BACKGROUND: Four categories of medication have been shown to reduce mortality following an acute coronary syndrome (ACS) event: (a) antiplatelets, (b) beta-blockers, (c) statins, and (d) angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). OBJECTIVE: To determine the association between use of 1 or more of 4 categories of evidence-based medications and patient-perceived health status. METHODS: Data from the registry of a large university-based health system were used for an analysis of prescribing at discharge following an inpatient hospitalization for ACS. Use of evidence-based medications and patientperceived health status were measured in a telephone survey administered 6 to 12 months (mean [SD] = 10 [3.5] months) after hospital discharge. Surveys were conducted from January 2002 through March 2005. Subjects were included in the survey if they were prescribed at least 1 of the 4 evidence-based drug categories at the time of discharge. Each patient was assigned to 1 of 5 groups (range: 0 to 4) based on the number of drug categories self-reported by the patient as current at the time of the survey. Patient-perceived health status was assessed using the question "How would you rate your health at the present time?" using a 5-point scale from excellent (1) to poor (5). Mean perceived health status scores for each of the 4 evidence-based medication categories were compared using Analysis of Variance (ANOVA). Multivariate logistic regression determined the association between patient-perceived health status-dichotomized to excellent/ very good/good versus fair/poor - and the evidence-based medication group, controlling for patient demographics and comorbidities. P values of < 0.05 were considered statistically significant. RESULTS: A total of 393 of 1,206 patients (32.6%) responded to the survey between 6 and 12 months after discharge for an ACS event. The mean (SD) patient-perceived health status ranged from 3.3 (1.1) for patients with no (0) self-reported evidence-based medications (n = 14) to 2.5 (1.0) for patients with 4 evidence-based medications (n = 130, P = 0.028), indicating higher self-perceived health status for patients who were taking more of the evidence-based medications. Using patients with no (0) evidencebased medications as the comparator, the odds of higher patient-perceived health status were multiplied by 8.2 (95% confidence interval [CI] = 1.7- 37.9, P = 0.007) for those with 4 medications, 9.3 (95% CI = 2.0-43.4, P = 0.004) for those with 3 medications, 4.9 (95% CI = 1.1-22.6, P = 0.041) for those with 2 medications, and not significantly different for those with 1 medication (odds ratio = 2.5, 95% CI = 0.4-14.4, P = 0.316). Younger age, prior myocardial infarction, and recurrent ACS events occurring between discharge and the survey date were significantly associated with poorer perceived health status. CONCLUSION: Better patient-perceived health status was associated with use of a greater number of evidence-based medications for patients with ACS.

Percutaneous coronary intervention complications and guide catheter size: bigger is not better.

OBJECTIVES: We evaluated the association between guiding catheter size and complications of percutaneous coronary intervention (PCI). BACKGROUND: The association between guiding catheter size and complications of PCI in contemporary practice remains controversial. METHODS: Procedure and outcome variables from 103,070 consecutive patients that underwent PCI with 6-F (n = 64,335), 7-F (n = 32,676), and 8-F (n = 6,059) guide catheters were compared. RESULTS: Compared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with incrementally more contrast agent use, and more post-PCI complications including contrast-induced nephropathy, vascular access site complications, bleeding, transfusion, major adverse cardiac event, and death. After multivariate analysis, the use of larger guides were associated with a higher risk of contrast-induced nephropathy (7-F odds ratio [OR]: 1.18, p = 0.0004; 8-F OR: 1.44, p < 0.0001), vascular complications (7-F OR: 1.19, p = 0.0002, 8-F OR: 1.68, p < 0.0001), decline in hemoglobin >3 g/dl (7-F OR: 1.12, p < 0.0001, 8-F OR: 1.72, p < 0.0001), and post-procedure blood transfusion (7-F OR: 1.08, p = 0.03; 8-F OR: 1.80, p < 0.0001), whereas major adverse cardiac events (7-F OR: 1.06, p = 0.13; 8-F OR: 1.37, p < 0.0001) and in-hospital mortality (7-F OR: 1.11, p = 0.13; 8-F OR: 1.34, p = 0.03) were increased with 8-F but not 7-F guides. CONCLUSIONS: Compared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with more contrast medium use, renal complications, bleeding, vascular access site complications, greater need for post-procedure transfusion, and 8-F guides with increased nephropathy requiring dialysis, in-hospital major adverse cardiac events, and mortality. These data suggest that selection of smaller guide catheters may result in improved clinical outcome in patients undergoing contemporary PCI.

Characteristics and in-hospital outcomes of patients with cardiac tamponade complicating type A acute aortic dissection.

Cardiac tamponade (TMP) is a life-threatening complication of acute type A aortic dissection (AAD). The purpose of this study was to assess the clinical characteristics and in-hospital outcomes of TMP in the setting of AAD on the basis of the findings in the large cohort of the International Registry of Acute Aortic Dissection (IRAD). Six hundred seventy-four patients (mean age 61.8 +/- 14.2 years) with AAD in IRAD were studied. TMP was suspected on clinical grounds and confirmed by diagnostic imaging. Univariate testing was followed by multivariate logistic regression analysis to determine the association of TMP. TMP was detected in 126 patients with AAD (18.7%). Age did not differ between patients with and without TMP. Those with TMP less often had previous cardiac surgery (7.0% vs 17.1%, p = 0.007). Syncope (37.8% vs 13.7%, p <0.0001) and altered mental status (31.2% vs 10.6%, p <0.0001) were more common in patients with AAD with TMP than without TMP. Patients with TMP were more likely to have widened mediastina on chest x-ray (72.6% vs 60.3%, p = 0.02) and to have periaortic hematomas (44.7% vs 21.2%, p <0.0001). In-hospital outcomes were significantly worse in patients with TMP. The mortality of patients with TMP remained significantly higher, even after adjustment for baseline clinical characteristics (p <0.001). On logistic regression, altered mental status, hypotension, and early mortality were identified as independent correlates of TMP. In conclusion, TMP is not uncommon in patients with AAD. Syncope, altered mental status, and a widened mediastinum on chest x-ray on presentation suggest TMP, the presence of which warrants urgent operative therapy to improve outcome.

Satisfaction with current health status in patients with a history of acute coronary syndrome.

OBJECTIVE: To describe satisfaction with current health status in patients with a recent history of an acute coronary syndrome (ACS) event and to determine the association between satisfaction and patient-specific variables. RESEARCH DESIGN AND METHODS: Patients from an ACS registry who were discharged from a university affiliated hospital over a 3-year period were mailed the study questionnaire. MAIN OUTCOMES MEASURES: Data included demographics, cardiac-specific measures, and general health status (SF-8 PCS, MCS and the EQ-5D VAS) and health status preference weight (EQ-5D Health Index). Satisfaction with current health status was assessed by a single question derived for this study with a 5-point Likert scale from 'not satisfied at all' to 'highly satisfied.' ANOVA determined the association between levels of satisfaction and health status scores. A multivariate linear regression model determined the association of patient, disease, and treatment variables with satisfaction. Independent variables were determined to be significant if the p-value in the model was <0.05. RESULTS: Respondents (490, 40.3% response rate) averaged 65.2 +/- 11.3 years of age; 71% male; 92% Caucasian; 64% with MI history; and 17% had their most recent cardiac event within 6 months. 63% of respondents were either mostly satisfied or highly satisfied with there current health status. Based on level of satisfaction, the mean PCS ranged from 36.9 +/- 8.9 to 63.0 +/- 6.2; mean MCS from 38.3 +/- 13.1 to 55.7 +/- 5.7; mean EQ-5D VAS from 37.0 +/- 21.7 to 90.8 +/- 20.7, and mean EQ-5D Health Index from 0.38 +/- 0.3 to 0.93 +/- 0.14, all ANOVA models p < 0.001. Statistically significant independent variables in the multivariate linear regression model included the number of symptoms, DASI cardiac function score, perceived severity of disease, and age. Satisfaction with current health state was associated with older age, fewer symptoms, better DASI cardiac function scores, and lower perceived severity of illness. CONCLUSION: Health-related quality of life, or health status, and satisfaction with health status have a direct, positive association. Greater burden of illness and younger age were significantly associated with dissatisfaction with health status. Extrapolation of results is limited to determining association but not causation due to the cross sectional study design.

The relative safety and efficacy of abciximab and eptifibatide in patients undergoing primary percutaneous coronary intervention: insights from a large regional registry of contemporary percutaneous coronary intervention.

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.

Acute type B aortic dissection: does aortic arch involvement affect management and outcomes? Insights from the International Registry of Acute Aortic Dissection (IRAD).

BACKGROUND: Stanford Type B acute aortic dissection (TB-AAD) spares the ascending aorta and is optimally managed with medical therapy in the absence of complications. However, the treatment of TB-AAD with aortic arch involvement (AAI) remains an unresolved issue. METHODS AND RESULTS: We examined 498 patients with TB-AAD enrolled in the International Registry of Acute Aortic Dissection (IRAD) between 1996 and 2003. Kaplan-Meier mortality curves were constructed and multivariate regression models were performed to identify independent predictors of AAI and to evaluate whether AAI was an independent predictor of follow-up mortality. We found that 371 (74.5%) patients with TB-AAD did not have AAI versus 127 (25.5%) with AAI. Independent predictors of AAI were a history of previous aortic surgery (OR 3.4; 95% CI, 1.6 to 7.6; P=0.002), absence of back pain (OR 1.6; 95% CI, 1.1 to 2.5; P=0.05), and any pulse deficit (1.9; 95% CI, 1.1 to 3.3, P=0.03). Mortality for patients without AAI was 9.4%+/-4.3% and 21.0%+/-6.9% at 1 and 3 years versus 9.2%+/-7.7% and 19.9%+/-11.1% with AAI, respectively (mean follow-up overall, 2.3 years, log rank P=0.82). AAI was not an independent predictor of long-term mortality. CONCLUSIONS: Patients with TB-AAD and aortic arch involvement do not differ with regards to mortality at 3 years. Whether or not AAI involvement impacts other measures of morbidity such as freedom from operation or endovascular intervention deserves further study.

Partial thrombosis of the false lumen in patients with acute type B aortic dissection.

BACKGROUND: Patency or thrombosis of the false lumen in type B acute aortic dissection has been found to predict outcomes. The prognostic implications of partial thrombosis of the false lumen have not yet been elucidated. METHODS: We examined 201 patients with type B acute aortic dissection who were enrolled in the International Registry of Acute Aortic Dissection between 1996 and 2003 and who survived to hospital discharge. Kaplan-Meier mortality curves were stratified according to the status of the false lumen (patent, partial thrombosis, or complete thrombosis) as determined during the index hospitalization. Cox proportional-hazards analysis was performed to identify independent predictors of death. RESULTS: During the index hospitalization, 114 patients (56.7%) had a patent false lumen, 68 patients (33.8%) had partial thrombosis of the false lumen, and 19 (9.5%) had complete thrombosis of the false lumen. The mean (+/-SD) 3-year mortality rate for patients with a patent false lumen was 13.7+/-7.1%, for those with partial thrombosis was 31.6+/-12.4%, and for those with complete thrombosis was 22.6+/-22.6% (median follow-up, 2.8 years; P=0.003 by the log-rank test). Independent predictors of postdischarge mortality were partial thrombosis of the false lumen (relative risk, 2.69; 95% confidence interval [CI], 1.45 to 4.98; P=0.002), a history of aortic aneurysm (relative risk, 2.05; 95% CI, 1.07 to 3.93; P=0.03), and a history of atherosclerosis (relative risk, 1.87; 95% CI, 1.01 to 3.47; P=0.05). CONCLUSIONS: Mortality is high after discharge from the hospital among patients with type B acute aortic dissection. Partial thrombosis of the false lumen, as compared with complete patency, is a significant independent predictor of postdischarge mortality in these patients.