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Biomedical subjects

Michael E Farkouh

Publications and source records attributed to Michael E Farkouh.

15 recordsLinked to original sources
PubMed2006

Cardiovascular effects of selective COX-2 inhibition: is there a class effect? The International COX-2 Study Group.

The International COX-2 Study Group, a panel of independent physicians and scientists, convened January 28-30, 2005, in Washington, DC, to discuss the issues concerning the cardiovascular (CV) profile of coxibs. The purpose of the meeting was to review potential mechanisms by which inhibition of COX-2 by selective and nonselective NSAID could increase risk of CV events, to evaluate the similarities and differences between drugs based on mechanism and pharmacology, and to propose potential trial methodology to more definitively answer questions regarding cardiovascular risk.

Arthritis, Rheumatoid↗
PubMed2006

An early revascularization strategy is associated with a survival benefit for diabetic patients in cardiogenic shock after acute myocardial infarction.

BACKGROUND: The role of diabetes mellitus (DM) in cardiogenic shock (CS) complicating an acute myocardial infarction (AMI) is not well understood. Previous studies have reported an in-hospital mortality rate for patients with DM and CS of about 60%. OBJECTIVES: This study compares the 1-year mortality rates of patients with DM and those without (NDM) and evaluates early revascularization (ERV) compared with initial medical stabilization (IMS) in patients with DM and CS. METHODS: Baseline characteristics, clinical and hemodynamic measures, and management were compared for 90 patients (31%) with DM and 198 with NDM (69%) who were randomized to ERV or IMS in the SHOCK Trial. RESULTS: When compared with NDM, patients with DM were of similar age but had higher rates of prior MI (44.4 vs. 27.8%, p = 0.007) and hypertension (56.2 vs. 42.5%, p = 0.04). The DM group had a lower rate of fibrinolytic therapy (44.4 vs. 60.1%, p = 0.02). In patients randomized to ERV, patients with DM had a higher rate of coronary artery bypass grafting (CABG) (50.0 vs. 30.9%, p = 0.03) despite similar rates of triple-vessel disease. The 1-year mortality rates in both groups were equivalent (58.9%). One-year mortality was not associated with diabetes (hazard ratio [HR] 1.02, 95% CI, 0.73-1.42, p = 0.91). The benefit of an ERV strategy was similar (HR [DM] 0.62; HR [NDM] 0.75, p = 0.58). Even after adjusting for the imbalance in CABG rates, 1-year mortality was not associated with DM. CONCLUSION: Diabetes mellitus is not a predictor of 1-year mortality in CS after AMI. The benefit from an ERV strategy is similar for DM and NDM. The management strategies and influence of DM on mortality in CS deserve further evaluation.

Aged↗
PubMed2006

Stress testing and troponin in unstable coronary syndromes: the status trial-clinical outcomes and resource use.

Cardiac troponins are markers used to diagnose acute myocardial infarction, but their value in guiding management in low- to intermediate-risk patients is not well established. Using a randomized design, the authors compared a strategy using stress testing with blinded troponins vs a troponin I-guided strategy for risk stratification and management of 241 patients with intermediate-risk unstable angina. Fewer stress-tested patients required coronary care unit admission and repeat hospitalization for acute coronary syndrome, at a lower cost. There was no significant difference in rates of death and myocardial infarction due to acute coronary syndrome at 6 months' follow-up. For patients with intermediate-risk acute coronary syndrome, stress testing is as safe as, and more cost-effective than, a troponin I-guided strategy. Patients with marginal troponin I elevations can safely undergo stress testing. Further studies combining stress testing and a troponin I-guided strategy are warranted.

Aged↗
PubMed2006

Treatment disparities in the care of patients with and without diabetes presenting with non-ST-segment elevation acute coronary syndromes.

OBJECTIVE: The objective of this study was to characterize treatment patterns among patients with diabetes presenting with non-ST-segment elevation (NSTE) acute coronary syndromes (ACSs). RESEARCH DESIGN AND METHODS: We compared adherence to treatment recommendations from the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines for NSTE ACS among 46,410 patients from 413 U.S. hospitals that were included in the Can Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) quality improvement initiative. Patients were stratified as nondiabetic, non-insulin-dependent diabetic (type 2 diabetic), and insulin-treated diabetic. RESULTS: Insulin-treated diabetic patients were less likely than nondiabetic patients to receive aspirin (adjusted odds ratio 0.83 [95% CI 0.74-0.93]), beta-blockers (0.89 [0.83-0.96]), heparin (0.90 [0.83-0.98]), and glycoprotein IIb/IIIa inhibitors (0.86 [0.79-0.93]). Type 2 diabetic patients were treated similarly to nondiabetic patients. After adjustment for differences in clinical characteristics, insulin-treated diabetic patients were significantly less likely than nondiabetic patients to receive cardiac catheterization within 48 h of presentation (0.80 [0.74-0.86]) or percutaneous coronary intervention (0.87 [0.82-0.94]). Compared with nondiabetic patients, insulin-treated diabetic and type 2 diabetic patients were more likely to undergo coronary artery bypass grafting (1.34 [1.21-1.49] and 1.35 [1.26-1.44]). In-hospital mortality rates were higher in insulin-treated diabetic (6.8%) and type 2 diabetic (5.4%) than in nondiabetic (4.4%) patients. CONCLUSIONS: Diabetic patients have a higher risk of mortality than nondiabetic patients, yet physicians adhere to the ACC/AHA NSTE ACS guidelines less often when treating diabetic patients, particularly insulin-treated diabetic patients. Increased use of guideline-recommended therapies and early invasive management strategies in diabetic patients may improve their outcomes.

Acute Disease↗
PubMed2005

Effect of exercise treadmill testing and stress imaging on the triage of patients with chest pain: CHEER substudy.

OBJECTIVE: To determine whether stress imaging for patients who are unsuitable for exercise treadmill testing (ETT) as part of a chest pain unit (CPU) triage strategy resulted in incremental benefit in clinical outcomes and relative costs compared with patients randomized to routine hospital admission. PATIENTS AND METHODS: Clinical outcomes and medical resource utilization were examined at the Mayo Clinic in Rochester, Minn, for 212 intermediate-risk patients with unstable angina randomized to a CPU and compared with 212 patients randomized to routine admission from November 21, 1995, to March 18, 1997. Patients in stable condition in the CPU underwent ETT; if patients were unsuitable for ETT, stress imaging was performed. Costs for CPU evaluation and outcomes were assessed during a 6-month follow-up. RESULTS: During the observation period, 60 patients (28%) were admitted to the hospital. Of the 152 remaining patients, 125 (82%) underwent ETT (91 had normal results), and 27 (18%) underwent stress imaging (3 had normal results). Patients with normal ETT or stress imaging results had no primary events at 6-month follow-up. Patients admitted to the hospital who underwent stress imaging had an insignificantly higher 6-month event rate compared with patients who underwent ETT (16.7% vs 8.1%; P=.38). The standardized resource-based relative-value units (RBRVUs) for patients who underwent ETT and stress imaging during follow-up were 19.4 and 56.4 RBRVUs, respectively, compared with 51.4 (ETT) and 52.1 (stress imaging) RBRVUs for similar numbers of patients randomized to routine admission. CONCLUSIONS: Exercise treadmill testing safely stratified most intermediate-risk patients with unstable angina and was less costly than routine admission. Patients not suitable for ETT are likely to have abnormal stress imaging results. They represent a higher-risk cohort that could be routinely admitted to the hospital without reducing the effectiveness of the CPU strategy.

Angina, Unstable↗
PubMed2005

Elevated homocysteine levels in patients with end-stage renal disease.

PURPOSE: To examine the effect of hemodialysis on plasma homocysteine levels, and the relationship of these values to clinical cardiovascular events in patients with end-stage renal disease (ESRD). METHODS: Adults undergoing chronic hemodialysis were studied at baseline and at six months. Their clinical histories were obtained at the baseline visit, and measurements of plasma homocysteine concentration were made immediately prior to and following routine dialysis. The occurrence of clinical cardiovascular events was assessed over six months. RESULTS: We enrolled 147 patients (85 men and 62 women, age 58 +/- 15 years) who required hemodialysis for 3.4 +/- 3.4 years (mean +/- SD). The median homocysteine level for this population (including both pre- and post-dialysis values) was 17.3 micromoles/L. Mean pre-dialysis plasma homocysteine levels of patients with clinical cardiovascular disease did not differ significantly from those without the disease (22.5 +/- 9.9 vs. 25.4 +/- 24.5 micromoles/L, respectively), nor did post-dialysis levels differ between these populations. During six months follow-up, rates of ischemic events were not related to hyperhomocysteinemia. The difference between mean pre- and post-dialysis homocysteine levels (26.3 +/- 19.7 and 15.6 +/- 11.4 micromoles/L, respectively) and the decline in homocysteine over the course of a single dialysis treatment session (10.3 +/- 10.2 micromoles/L) were highly significant (p<0.0005). CONCLUSIONS: Plasma homocysteine levels were elevated in 82% of 147 patients with ESRD and fell to the normal range in a majority of patients during a single dialysis treatment session. Mean pre-dialysis levels did not change significantly over six months, however, and plasma homocysteine levels did not predict cardiovascular events in this population. There was also a trend towards worse outcomes in patients with lower homocysteine levels, which correlates to findings from recent studies. Further studies are needed to clarify the association between hyperhomocysteinemia and coronary risk in patients with ESRD.

Adult↗
PubMed2004

The incremental value of troponin-I testing in patients with intermediate risk unstable angina.

BACKGROUND: Classification of patients with unstable angina (UA) by Agency for Health Care Policy and Research (AHCPR) guidelines in the emergency department reliably stratifies risk of death or myocardial infarction (MI) for triage to outpatient evaluation (low-risk), hospitalization (high-risk), or additional testing (intermediate-risk). Cardiac troponin-I elevation may identify patients at higher risk, but the incremental value may vary with AHCPR clinical risk. HYPOTHESIS: The objective of this study was to determine whether cardiac troponin-I had any additional value beyond triage based upon history, physical examination, and electrocardiogram, in the evaluation of patients with UA. METHODS: In all, 212 consecutive patients with UA and normal serum creatine kinase (CK)-MB levels and elevated troponin-I were risk stratified by AHCPR guidelines to evaluate the incremental value of adding routine troponin-I measurements to our current model for risk stratification. RESULTS: Primary events (death/nonfatal MI) occurred in 35% of high-risk, 15% of intermediate-risk, and 0% of low-risk patients (p < 0.001 by chi-square for trend). High troponin-I (> or =2.0 ng/dl) occurred in 48% of high-risk, 21% of intermediate-risk, and 19% of low-risk patients. The remaining patients in each risk group had indeterminate troponin-I levels (> or =0.4 < 2 ng/dl). Of those with high troponin-I, a primary event occurred in 36, 42, and 0% in the respective high-, intermediate-, and low-risk groups (p < 0.001). High troponin-I levels corresponded with a statistically significant increased rate of primary events only in patients at AHCPR intermediate risk: 42.4 vs. 7.3%, p < 0.001. CONCLUSION: The AHCPR guidelines risk stratify patients with UA. High troponin-I adds significant (p < 0.001) prognostic value in the patients at AHCPR intermediate risk and should be evaluated further in larger trials of such patients.

Acute Disease↗
PubMed2004

Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial: study design and rationale.

BACKGROUND: Patients with acute coronary syndromes (ACS; unstable angina and non-ST-segment elevation myocardial infarction) are at significant risk for death and myocardial infarction. Early angiography followed by revascularization is considered the treatment of choice for moderate- to high-risk patients with ACS. However, despite the integration of newer therapies including stents, glycoprotein IIb/IIIa inhibitors, and thienopyridines, the rate of adverse ischemic events still remains unacceptably high, and the intensive pharmacologic regimens used to stabilize the disrupted atherosclerotic plaque and support angioplasty and surgical revascularization procedures elicit a high rate of bleeding complications. Pilot trials suggest that the thrombin-specific anticoagulant bivalirudin may improve clinical outcomes in ACS. STUDY DESIGN: In the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial, 13,800 patients with moderate- to high-risk ACS are being prospectively randomly assigned at up to 600 centers to unfractionated heparin or enoxaparin + IIb/IIIa inhibition, versus bivalirudin + IIb/IIIa inhibition, versus bivalirudin + provisional IIb/IIIa inhibition. All patients undergo cardiac catheterization within 72 hours, followed by percutaneous or surgical revascularization when appropriate. In a second random assignment, patients assigned to receive IIb/IIIa inhibitors are subrandomized to upstream drug initiation, versus IIb/IIIa inhibitor administration during angioplasty only. The primary study end point is the composite of death, myocardial infarction, unplanned revascularization for ischemia, and major bleeding at 30 days. Clinical follow-up will continue for 1 year. CONCLUSIONS: The ACUITY trial is the largest study yet performed in patients with ACS undergoing an invasive strategy. In addition to evaluating the utility of bivalirudin in ACS, this study will also provide important guidance regarding the necessity for and timing of IIb/IIIa inhibitor administration.

Angina, Unstable↗
PubMed2004

Cardiovascular disease in diabetics: pharmacology and revascularization.

Diabetes has become a public health crisis. With the incidence of obesity rising in the United States, the number of diabetics will grow considerably. Of greatest concern is the impact this trend will have on cardiovascular disease. Diabetics demonstrate accelerated coronary atherosclerosis, and the prognosis is worse following cardiac events. Moreover, our interventions have achieved uneven success in treating this subset of patients. This paper will review the metabolic abnormalities that promote atherosclerosis in diabetics and the current methods for treating and preventing the development of coronary artery disease in diabetics, principally through a combination of medications and revascularization.

Cardiovascular Diseases↗
PubMed2002

The vulnerable plaque and acute coronary syndromes.

The interaction between the vulnerable atherosclerotic plaque and thrombus formation, a process referred to as atherothrombosis, is the cornerstone of acute coronary syndromes. Advances in noninvasive imaging have helped to identify novel approaches to plaque stabilization, with the potential to prevent plaque rupture, including lifestyle modification and dietary adjustments, as well as pharmacologic interventions such as statins. Following an acute coronary event, strategies combining mechanical and pharmacologic therapies provide considerable advances in prevention of subsequent cardiac events. Pharmacologic strategies to prevent and treat thrombotic complications related to acute coronary syndromes have been developed to dissolve preformed thrombi and to inhibit thrombogenesis. These regimens focus on inhibiting thrombin, preventing thrombi generation, blocking the initiation of coagulation, inhibiting platelet activation, and increasing fibrinolysis.

Anticholesteremic Agents↗
PubMedDate not supplied

Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial.

BACKGROUND: The potential for cyclo-oxygenase 2 (COX2)-selective inhibitors to increase the risk for myocardial infarction is controversial. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) aimed to assess gastrointestinal and cardiovascular safety of the COX2 inhibitor lumiracoxib compared with two non-steroidal anti-inflammatory drugs, naproxen and ibuprofen. METHODS: 18325 patients age 50 years or older with osteoarthritis were randomised to lumiracoxib 400 mg once daily (n=9156), naproxen 500 mg twice daily (4754), or ibuprofen 800 mg three times daily (4415) in two substudies of identical design. Randomisation was stratified for low-dose aspirin use and age. The primary cardiovascular endpoint was the Antiplatelet Trialists' Collaboration endpoint of non-fatal and silent myocardial infarction, stroke, or cardiovascular death. Analysis was by intention to treat. FINDINGS: 81 (0.44%) patients did not start treatment and 7120 (39%) did not complete the study. At 1-year follow-up, incidence of the primary endpoint was low, both with lumiracoxib (59 events [0.65%]) and the non-steroidal anti-inflammatory drugs (50 events [0.55%]; hazard ratio 1.14 [95% CI 0.78-1.66], p=0.5074). Incidence of myocardial infarction (clinical and silent) in the overall population in the individual substudies was 0.38% with lumiracoxib (18 events) versus 0.21% with naproxen (ten) and 0.11% with lumiracoxib (five) versus 0.16% with ibuprofen (seven). In the naproxen substudy, rates of myocardial infarction (clinical and silent) did not differ significantly compared with lumiracoxib in the population not taking low-dose aspirin (hazard ratio 2.37 [95% CI 0.74-7.55], p=0.1454), overall (1.77 [0.82-3.84], p=0.1471), and in patients taking aspirin (1.36 [0.47-3.93], p=0.5658). In the ibuprofen substudy, these rates did not differ between lumiracoxib and ibuprofen in the population not taking low-dose aspirin (0.75 [0.20-2.79], p=0.6669), overall (0.66 [0.21-2.09], p=0.4833), and in patients taking aspirin (0.47 [0.04-5.14], p=0.5328). INTERPRETATION: The primary endpoint, including incidence of myocardial infarction, did not differ between lumiracoxib and either ibuprofen or naproxen, irrespective of aspirin use. This finding suggests that lumiracoxib is an appropriate treatment for patients with osteoarthritis, who are often at high cardiovascular risk and taking low-dose aspirin.

Aged↗