Safety and efficacy of thrombectomy in patients undergoing primary percutaneous coronary intervention for acute ST elevation MI: a meta-analysis of randomized controlled trials.

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.

Receipt of cardiac medications upon discharge among men and women with acute coronary syndrome and nonobstructive coronary artery disease.

BACKGROUND: Management of acute coronary syndrome (ACS) patients with nonobstructive epicardial coronary artery disease (CAD) remains poorly understood. HYPOTHESIS: Acute coronary syndrome patients with nonobstructive CAD are less likely to receive effective cardiac medications upon discharge from the hospital. METHODS: We identified patients hospitalized with ACS that underwent coronary angiography and had a 6-month follow-up. Patients were grouped by CAD severity: nonobstructive CAD (<50% blockage in all vessels) or obstructive CAD (> or =50% blockage in > or = 1 vessels). Data were collected on demographics, medications at discharge, and adverse outcomes at 6 months, for all patients. RESULTS: Of the 2264 ACS patients included in the study: 123 patients had nonobstructive CAD and 2141 had obstructive CAD. Cardiac risk factors including hypertension and diabetes were common among patients with nonobstructive CAD. Men and women with nonobstructive CAD were less likely to receive cardiac medications compared to patients with obstructive CAD including aspirin (87.8% vs 95.0%, P = 0.001), beta-blockers (74.0% vs 89.2%, P < 0.001), or statins (69.1% vs 81.2%, P = 0.001). No gender-related differences in discharge medications were observed for patients with nonobstructive CAD. However, women with nonobstructive CAD had similar rates of cardiac-related rehospitalization as men with obstructive CAD (23.3% and 25.9%, respectively). CONCLUSIONS: Patients with nonobstructive CAD are less likely to receive evidence-based medications compared to patients with obstructive CAD, despite the presence of CAD risk factors and occurrence of an ACS event. Further research is warranted to determine if receipt of effective cardiac medications among patients with nonobstructive CAD would reduce cardiac-related events.

Does simplicity compromise accuracy in ACS risk prediction? A retrospective analysis of the TIMI and GRACE risk scores.

BACKGROUND: The Thrombolysis in Myocardial Infarction (TIMI) risk scores for Unstable Angina/Non-ST-elevation myocardial infarction (UA/NSTEMI) and ST-elevation myocardial infarction (STEMI) and the Global Registry of Acute Coronary Events (GRACE) risk scores for in-hospital and 6-month mortality are established tools for assessing risk in Acute Coronary Syndrome (ACS) patients. The objective of our study was to compare the discriminative abilities of the TIMI and GRACE risk scores in a broad-spectrum, unselected ACS population and to assess the relative contributions of model simplicity and model composition to any observed differences between the two scoring systems. METHODOLOGY/PRINCIPAL FINDINGS: ACS patients admitted to the University of Michigan between 1999 and 2005 were divided into UA/NSTEMI (n = 2753) and STEMI (n = 698) subpopulations. The predictive abilities of the TIMI and GRACE scores for in-hospital and 6-month mortality were assessed by calibration and discrimination. There were 137 in-hospital deaths (4%), and among the survivors, 234 (7.4%) died by 6 months post-discharge. In the UA/NSTEMI population, the GRACE risk scores demonstrated better discrimination than the TIMI UA/NSTEMI score for in-hospital (C = 0.85, 95% CI: 0.81-0.89, versus 0.54, 95% CI: 0.48-0.60; p<0.01) and 6-month (C = 0.79, 95% CI: 0.76-0.83, versus 0.56, 95% CI: 0.52-0.60; p<0.01) mortality. Among STEMI patients, the GRACE and TIMI STEMI scores demonstrated comparably excellent discrimination for in-hospital (C = 0.84, 95% CI: 0.78-0.90 versus 0.83, 95% CI: 0.78-0.89; p = 0.83) and 6-month (C = 0.72, 95% CI: 0.63-0.81, versus 0.71, 95% CI: 0.64-0.79; p = 0.79) mortality. An analysis of refitted multivariate models demonstrated a marked improvement in the discriminative power of the TIMI UA/NSTEMI model with the incorporation of heart failure and hemodynamic variables. Study limitations included unaccounted for confounders inherent to observational, single institution studies with moderate sample sizes. CONCLUSIONS/SIGNIFICANCE: The GRACE scores provided superior discrimination as compared with the TIMI UA/NSTEMI score in predicting in-hospital and 6-month mortality in UA/NSTEMI patients, although the GRACE and TIMI STEMI scores performed equally well in STEMI patients. The observed discriminative deficit of the TIMI UA/NSTEMI score likely results from the omission of key risk factors rather than from the relative simplicity of the scoring system.

The relative renal safety of iodixanol compared with low-osmolar contrast media: a meta-analysis of randomized controlled trials.

OBJECTIVES: We sought to compare the nephrotoxicity of the iso-osmolar contrast medium, iodixanol, to low-osmolar contrast media (LOCM). BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) is a common cause of in-hospital renal failure. A prior meta-analysis suggested that iodixanol (Visipaque, GE Healthcare, Princeton, New Jersey) was associated with less CI-AKI than LOCM, but this study was limited by ascertainment bias and did not include the most recent randomized controlled trials. METHODS: We searched Medline, Embase, ISI Web of Knowledge, Google Scholar, Current Contents, and International Pharmaceutical Abstracts databases, and the Cochrane Central Register of Controlled Trials from 1980 to November 30, 2008, for randomized controlled trials that compared the incidence of CI-AKI with either iodixanol or LOCM. Random-effects models were used to calculate summary risk ratios (RR) for CI-AKI, need for hemodialysis, and death. RESULTS: A total of 16 trials including 2,763 subjects were pooled. There was no significant difference in the incidence of CI-AKI in the iodixanol group than in the LOCM group overall (summary RR: 0.79, 95% confidence interval [CI]: 0.56 to 1.12, p = 0.19). There was no significant difference in the rates of post-procedure hemodialysis or death. There was a reduction in CI-AKI when iodixanol was compared with ioxaglate (RR: 0.58, 95% CI: 0.37 to 0.92; p = 0.022) and iohexol (RR: 0.19, 95% CI: 0.07 to 0.56; p = 0.002), but no difference when compared with iopamidol (RR: 1.20, 95% CI: 0.66 to 2.18; p = 0.55), iopromide (RR: 0.93, 95% CI: 0.47 to 1.85; p = 0.84), or ioversol (RR: 0.92, 95% CI: 0.60 to 1.39; p = 0.68). CONCLUSIONS: This meta-analysis including 2,763 subjects suggests that iodixanol, when compared with LOCM overall, is not associated with less CI-AKI. The relative renal safety of LOCM compared with iodixanol may vary based on the specific type of LOCM.

The chimeric monoclonal antibody abciximab: a systematic review of its safety in contemporary practice.

BACKGROUND: Abciximab is a monoclonal antibody that prevents platelet aggregation by blocking platelet glycoprotein (GP) IIb/IIIa receptor. OBJECTIVE: To study the safety profile of this agent in contemporary clinical practice. METHODS: We evaluated efficacy and safety end points (major and minor bleeding, thrombocytopenia) in patients treated with abciximab and compared them to those treated with placebo in main randomized clinical trials of patients with acute coronary syndromes (ACS) or those undergoing percutaneous coronary intervention (PCI). RESULTS/CONCLUSION: Use of abciximab is associated with an improved outcome in high-risk patients undergoing PCI but with a worse outcome in ACS patients treated conservatively. Use of abciximab is associated with an acceptable safety profile even when used on a background of aspirin and high doses of thienopyridine but has a potential to increase thrombocytopenia and minor bleeding. Small molecule GP IIb/IIIa antagonists are increasingly preferred over abciximab in clinical practice, and recent observational data have demonstrated these agents to have a similar efficacy and safety profile. As an increasing number of agents are being evaluated for peri-PCI anti-thrombotic therapy, the role of abciximab is likely to be further restricted to the highest risk patients.

Association between admission neutrophil to lymphocyte ratio and outcomes in patients with acute coronary syndrome.

The neutrophil/lymphocyte ratio (NLR) has recently been described as a predictor of mortality in patients who undergo percutaneous coronary intervention. The aim of this study was to investigate the utility of admission NLRs in predicting outcomes in patients with acute coronary syndromes (ACS). A total of 2,833 patients admitted to the University of Michigan Health System with diagnoses of ACS from December 1998 to October 2004 were followed. Patients were divided into tertiles according to NLR. The primary end point was all-cause in-hospital and 6-month mortality. The ACS cohort comprised 564 patients with ST-segment elevation myocardial infarctions and 2,269 patients with non-ST-segment elevation ACS. Patients in tertile 3 had higher in-hospital (8.5% vs 1.8%) and 6-month (11.5% vs 2.5%) mortality compared with those in tertile 1 (p <0.001). After adjusting for Global Registry of Acute Coronary Events risk profile, patients in the highest tertile were at an exaggerated risk for in-hospital (odds ratio 2.04, p = 0.013) and 6-month (odds ratio 3.88, p <0.001) mortality. Admission NLR is an independent predictor of in-hospital and 6-month mortality in patients with ACS. This relatively inexpensive marker of inflammation can aid in the risk stratification and prognosis of patients diagnosed with ACS.

GP IIb/IIIa inhibitors during primary percutaneous coronary intervention for STEMI: new trial and registry data.

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.