Judy Boura

A Comparison of Contemporary Definitions of Contrast Nephropathy in Patients Undergoing Percutaneous Coronary Intervention and a Proposal for a Novel Nephropathy Grading System

Contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) has multiple definitions. We attempted to identify the optimal definition of CIN. In 985 patients undergoing PCI (derivation group), we assessed the prognostic significance of 4 commonly used contemporary definitions of CIN (increases in serum creatinine after PCI [deltaCr] >1.0 mg/dl, >0.5 mg/dl, and >25% after PCI; and the American College of Cardiology National Cardiovascular Data Registry definition) with respect to 6-month major adverse cardiovascular events (MACEs) and all-cause mortality (at 863 +/- 324 days). Incidence of CIN ranged widely (2.0% to 15%) depending on the definition used. Only 2 definitions (deltaCr >0.5 mg/dl, >25%) consistently correlated with study outcomes. Using these 2 definitions, we devised a new grading system (grade 0 deltaCr <or=25% and <or=0.5 mg/dl; grade 1 deltaCr >25% but <or=0.5 mg/dl; and grade 2 deltaCr >0.5 mg/dl). Nephropathy grades (0 vs 1 vs 2) showed significant correlation with 6-month MACEs (12.4 vs 19.4 vs 28.6%, p = 0.003) and all-cause mortality (10.2 vs 10.4 vs 40.9%, p <0.0001). In multivariate analyses, the grading system showed an independent association with MACEs and mortality. The prognostic value of nephropathy grades was prospectively confirmed in an independent validation group of 539 patients. In conclusion, of the 4 contemporary definitions of CIN, only deltaCr >25% and >0.5 mg/dl consistently predicted adverse events after PCI. By unifying these 2 definitions, we devised a novel nephropathy grading system that is predictive of 6-month MACEs and all-cause mortality after PCI.

Comparison of outcomes of diabetic and nondiabetic patients undergoing primary angioplasty for acute myocardial infarction.

We sought to determine whether diabetes mellitus independently conferred poor prognosis in patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI). In 3,742 patients enrolled in the Primary Angioplasty in Myocardial Infarction (PAMI) studies with the intention of undergoing primary PCI, we compared in-hospital mortality, 6-month mortality, and 6-month major adverse cardiovascular events (MACEs), i.e., composite of death, reinfarction, or ischemic target vessel revascularization (TVR), between diabetics (n = 626, 17%) and nondiabetics (n = 3,116, 83%). We evaluated the independent impact of diabetes on outcomes after adjustment for baseline clinical and angiographic differences. Diabetics had worse baseline clinical characteristics, longer pain onset-to-hospital arrival time, and longer door-to-balloon time. They had more multivessel coronary disease and lower left ventricular ejection fractions, but better baseline Thrombolysis In Myocardial Infarction (TIMI) flow. Diabetics underwent primary PCI less often (88% vs 91%, p = 0.01). During the index hospitalization, diabetics were more likely to die (4.6% vs 2.6%, p = 0.005). During 6-month follow-up, diabetics had higher incidences of death (8.1% vs 4.2%, p <0.0001) and MACEs (18% vs 14%, p = 0.036). In multivariate analysis, diabetes was independently associated with 6-month mortality (hazard ratio 1.53, 95% confidence interval 1.03 to 2.26, p = 0.03), but not with in-hospital mortality or 6-month MACEs. We conclude that diabetics with AMI have less favorable baseline characteristics and are less likely to undergo primary PCI than nondiabetics. Despite excellent angiographic results, diabetics had significantly worse 6-month mortality.

Clinical Outcomes in Patients With the Concomitant Use of Clopidogrel and Proton Pump Inhibitors After Percutaneous Coronary Intervention An Analysis From the Guthrie Health Off-Label Stent (GHOST) Investigators

Background— The concomitant use of proton pump inhibitors (PPIs) with clopidogrel is suspected to be associated with an adverse impact on clinical outcomes in patients with coronary artery disease. We sought to evaluate whether the use of PPIs with clopidogrel was associated with worse clinical outcomes after percutaneous coronary intervention (PCI) compared with the use of clopidogrel alone. Methods and Results— We studied 2651 consecutive patients discharged alive after coronary stenting for stable or unstable coronary artery disease between 2001 and 2007. All patients received aspirin indefinitely and a thienopyridine for 1 to 12 months. Patients were categorized into 2 groups: those taking a PPI [PPI (+), n=751] and those not taking a PPI [PPI (−), n=1900] at discharge. The primary end points were the 6-month incidence of major adverse cardiovascular events (MACE) (composite of death, myocardial infarction, target vessel revascularization, and stent thrombosis) and net adverse clinical events (NACE) (composite of MACE and thrombolysis in myocardial infarction major or minor bleeding), which were evaluated using propensity-adjusted Cox regression analysis. In addition, propensity-matched analysis was performed in 685 pairs of patients. The PPI (+) group was older and had more comorbid conditions than the PPI (−) group. In propensity-adjusted as well as propensity-matched analyses, the use of PPIs was not associated with an increased risk of MACE or NACE. Conclusions— The use of PPIs with dual antiplatelet therapy was not associated with any adverse influence on MACE or NACE after PCI.

Clinical Outcomes in Patients With the Concomitant Use of Clopidogrel and Proton Pump Inhibitors After Percutaneous Coronary Intervention

Background— The concomitant use of proton pump inhibitors (PPIs) with clopidogrel is suspected to be associated with an adverse impact on clinical outcomes in patients with coronary artery disease. We sought to evaluate whether the use of PPIs with clopidogrel was associated with worse clinical outcomes after percutaneous coronary intervention (PCI) compared with the use of clopidogrel alone. Methods and Results— We studied 2651 consecutive patients discharged alive after coronary stenting for stable or unstable coronary artery disease between 2001 and 2007. All patients received aspirin indefinitely and a thienopyridine for 1 to 12 months. Patients were categorized into 2 groups: those taking a PPI [PPI (+), n=751] and those not taking a PPI [PPI (−), n=1900] at discharge. The primary end points were the 6-month incidence of major adverse cardiovascular events (MACE) (composite of death, myocardial infarction, target vessel revascularization, and stent thrombosis) and net adverse clinical events (NACE) (composite of MACE and thrombolysis in myocardial infarction major or minor bleeding), which were evaluated using propensity-adjusted Cox regression analysis. In addition, propensity-matched analysis was performed in 685 pairs of patients. The PPI (+) group was older and had more comorbid conditions than the PPI (−) group. In propensity-adjusted as well as propensity-matched analyses, the use of PPIs was not associated with an increased risk of MACE or NACE. Conclusions— The use of PPIs with dual antiplatelet therapy was not associated with any adverse influence on MACE or NACE after PCI.

Dual antiplatelet therapy for more than 12 months after percutaneous coronary intervention: insights from the Guthrie PCI Registry

Objective: To assess the impact of dual antiplatelet (DAP) therapy of >12 months on long-term death and myocardial infarction (MI) after percutaneous coronary intervention (PCI). Design, setting and patients: Prospective, single-centre, observational study of 1859 consecutive patients who underwent successful PCI of a native coronary artery and survived event-free for at least 12 months. Main outcome measures: Combined end point of death or non-fatal MI determined by survival analysis and propensity-adjusted multivariable Cox regression. Similar analyses were performed in the two stent subsets: bare metal stents (n = 835), drug-eluting stents (n = 1024); and three high-risk subsets: diabetic patients (n = 486), patients presenting with MI (n = 713), and those with ACC/AHA type C lesions (n = 717). Results: Baseline characteristics were as follows: mean (SD) age 64 (12) years, male 69%, diabetic 26%, presentation with MI 38%, mean (SD) ejection fraction 49 (12)%, mean (SD) vessel diameter 3.1 (0.5) mm. Duration of DAP was 27 (11) months in “DAP >12 months” and 4.1 (4.1) months in “DAP ⩽12 months” (p<0.001). At a median follow-up of 3.4 years after PCI, “DAP >12 months” vs “DAP ⩽12 months” had similar incidence of death or MI (9.4% vs 10.3%, log-rank p = 0.83). After multivariable adjustment, DAP therapy >12 months was not associated with lower incidence of death or MI than DAP therapy ⩽12 months (adjusted HR = 1.01; 95% CI 0.74 to 1.37, p = 0.95). Analysis of each of the five predefined subsets showed similar results. Conclusions: In patients who undergo successful native coronary PCI and survive event-free for at least 12 months, continuation of dual antiplatelet therapy beyond 12 months does not confer long-term protection from death or MI.

Incidence of myocardial infarction with shifts to and from daylight savings time.

Modulators of normal bodily functions such as the duration and quality of sleep might transiently influence cardiovascular risk. The transition to daylight savings time (DST) has been associated with a short-term increased incidence ratio (IR) of acute myocardial infarction (AMI). The present retrospective study examined the IR of AMIs that presented to our hospitals the week after DST and after the autumn switch to standard time, October 2006 to April 2012, with specific reference to the AMI type. Our study population (n = 935 patients; 59% men, 41% women) was obtained from the electronic medical records of the Royal Oak and Troy campuses of the Beaumont Hospitals in Michigan. Overall, the frequency of AMI was similar in the spring and autumn, 463 (49.5%) and 472 (50.5%), respectively. The IR for the first week after the spring shift was 1.17 (95% confidence interval 1.00 to 1.36). After the transition from DST in the autumn, the IR for the same period was lower, but not significantly different, 0.99 (95% confidence interval 0.85 to 1.16). Nevertheless, the greatest increase in AMI occurred on the first day (Sunday) after the spring shift to DST (1.71, 95% confidence interval 1.09 to 2.02; p <0.05). Also, a significantly greater incidence was found of non-ST-segment myocardial infarction after the transition to DST in the study group compared with that in the control group (p = 0.022). In conclusion, these data suggest that shifts to and from DST might transiently affect the incidence and type of acute cardiac events, albeit modestly.

Drug-Eluting Stents in Patients with Chronic Kidney Disease: A Prospective Registry Study

Background Chronic kidney disease (CKD) is strongly associated with adverse outcomes after percutaneous coronary intervention (PCI). There are limited data on the effectiveness of drug-eluting stents (DES) in patients with CKD. Methodology/Principal Findings Of 3,752 consecutive patients enrolled in the Guthrie PCI Registry between 2001 and 2006, 436 patients with CKD - defined as a creatinine clearance <60 mL/min - were included in this study. Patients who received DES were compared to those who received bare metal stents (BMS). Patients were followed for a mean duration of 3 years after the index PCI to determine the prognostic impact of stent type. Study end-points were all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis (ST) and the composite of major adverse cardiovascular events (MACE), defined as death, MI or TVR. Patients receiving DES in our study, by virtue of physician selection, had more stable coronary artery disease and had lower baseline risk of thrombotic or restenotic events. Kaplan-Meier estimates of proportions of patients reaching the end-points were significantly lower for DES vs. BMS for all-cause death (p = 0.0008), TVR (p = 0.029) and MACE (p = 0.0015), but not MI (p = 0.945) or ST (p = 0.88). Multivariable analysis with propensity adjustment demonstrated that DES implantation was an independent predictor of lower rates of all-cause death (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.25–0.92), TVR (HR 0.50, 95% CI 0.27–0.94) and MACE (HR 0.62, 95% CI 0.41–0.94). Conclusions In a contemporary PCI registry, selective use of DES in patients with CKD was safe and effective in the long term, with lower risk of all-cause death, TVR and MACE and similar risk of MI and ST as compared with BMS. The mortality benefit may be a result of selection bias and residual confounding, or represent a true finding; a hypothesis that warrants clarification by randomized clinical trials.

The role of temporary biventricular pacing in the cardiac surgical patient with severely reduced left ventricular systolic function

OBJECTIVE The objective was to evaluate the effects of atrial synchronous biventricular pacing in postoperative patients with severe cardiomyopathy. METHODS Atrial synchronous biventricular pacing epicardial leads were placed during cardiac surgery in patients with an ejection fraction of 30% or less. Patients were randomized to usual care pacing, the mode determined by the surgeon (excluding atrial synchronous biventricular pacing) with a preference for no pacing or atrial pacing (atrial inhibited pacing); atrial synchronous right ventricular pacing; or atrial synchronous biventricular pacing. Pacing was continued until cessation of hemodynamic support. At 12 hours postoperatively, patients were randomly tested in each mode (atrial inhibited, atrial synchronous right ventricular, and atrial synchronous biventricular pacing), and thermodilution outputs were measured. RESULTS Forty subjects were randomized. Groups were similar in age (66 +/- 11 years), gender (85% were male), ejection fraction (23% +/- 6%), QRS duration (111 +/- 30 ms), and surgical indication. There was no difference in stroke index or cardiac index at 12 hours, duration of inotropic or intra-aortic balloon pump support, intensive care unit, or hospital length of stay. On comparative crossover testing, stroke volume was similar with atrial inhibited pacing and atrial synchronous biventricular pacing (59.3 +/- 13.4 vs 57 +/- 12.1, respectively, P = not significant); however, atrial synchronous right ventricular pacing was inferior (56 +/- 12.9, P < .05 for comparison with atrial inhibited pacing). When compared with atrial inhibited pacing, atrial synchronous biventricular pacing showed a positive response in 17% of subjects (increase in stroke volume >or= 5%), whereas 41% had a 5% or greater decrease in stroke volume. CONCLUSION Pacing mode affects stroke volume in patients with severe cardiomyopathy. Atrial synchronous biventricular pacing was helpful in a minority, but in 41% it compromised stroke volume.

Glycosylated hemoglobin and outcomes in diabetic patients with acute myocardial infarction after successful revascularization with stent placement: findings from the guthrie health off-label stent (GHOST) investigators.

OBJECTIVE We evaluated the influence of glycemic control on cardiovascular outcomes in diabetic patients with acute myocardial infarction (AMI) who underwent successful percutaneous coronary intervention (PCI) with stent placement. BACKGROUND In patients presenting with AMI, diabetic status confers adverse cardiovascular outcomes after PCI. However, the influence of glycemic control on outcomes after successful PCI is less well studied. METHODS We examined 231 consecutive diabetes mellitus (DM) patients with AMI who underwent successful primary PCI and had evaluation of glycosylated hemoglobin (HbA1c) from 30 days before to 90 days after AMI. Patients were categorized in 2 groups, controlled DM with HbA1c ≤ 7.0 (N = 83, 36%) and uncontrolled DM with HbA1c > 7.0 (N = 148, 64%). We assessed 12-month cardiovascular outcomes in study groups. RESULTS Uncontrolled diabetics were younger, tended to be less hypertensive, and had higher baseline glomerular filtration rate and final vessel diameter compared to controlled diabetics. Uncontrolled DM patients had similar major adverse cardiovascular events (MACE; composite of all-cause death, MI, target vessel revascularization [TVR], and stent thrombosis [ST]; 20% vs. 30%, log-rank P = 0.54), death (8.8% vs. 12%, P = 0.40), MI (8.8% vs. 9.6%, P = 0.76), TVR (9.5% vs. 8.4%, P = 0.95), and ST (3.4% vs. 4.8%, P = 0.54) as the controlled diabetics. In Cox regression analysis, after adjustment for baseline differences, glycemic control had no independent influence on study outcomes. CONCLUSION Glycemic control, determined by HbA1c, does not seem to influence cardiovascular outcomes in diabetic patients with AMI after successful stent placement.

Everolimus-eluting stents versus sirolimus- or paclitaxel-eluting stents: two-year results from the Guthrie Health Off-Label Stent (GHOST) registry.

OBJECTIVES We sought to compare the safety and effectiveness of everolimus-eluting stents (EES) versus first generation drug-eluting stents (FG-DES; sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]). METHODS In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2-year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG-DES groups. Secondary end-points included all-cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end-points in 2 propensity-matched subgroups: EES versus SES; EES versus PES. RESULTS Complete 2-year follow-up was available in 1,911 (90%) patients. Compared to FG-DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10-1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22-0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months. CONCLUSIONS The use of EES compared to FG-DES appears to be associated with reductions in ST and TVR at 2-year follow-up. Improved outcomes with EES are observed in comparison with SES as well as PES.