Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials.

The cardiovascular safety of liraglutide, a glucagon-like peptide-1 receptor agonist approved for weight management at a dose of 3.0 mg, was evaluated post hoc using data from 5908 participants in 5 randomized, double-blind, placebo-controlled clinical trials. Participants were randomized to liraglutide or a comparator group (placebo or orlistat). The objective was to evaluate whether cardiovascular risk was increased with liraglutide treatment. The primary composite outcome of this time-to-event analysis was the first occurrence of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke. These cardiovascular events were adjudicated prospectively for three of the trials and retrospectively for two trials by an event adjudication committee. The primary outcome was analyzed using a Cox proportional hazards model, stratified by trial. With liraglutide 3.0 mg, 8 participants had positively adjudicated cardiovascular events (1.54 events/1000 person-years) compared to 10 participants in the comparators group (3.65 events/1000 person-years). The hazard ratio for liraglutide 3.0 mg compared to comparators was 0.42 (95% confidence interval, 0.17-1.08). In this analysis, liraglutide 3.0 mg treatment was not associated with excess cardiovascular risk. However, the wide confidence intervals and retrospective adjudication of events in two of the trials are limitations of the analysis.

Liraglutide for weight management: a critical review of the evidence.

OBJECTIVE: To review the efficacy, safety, and clinical applicability of liraglutide for weight management from phase III clinical trials. METHODS: A search of the English language literature was performed using PubMed search terms: "liraglutide", "glucagon-like peptide-1 receptor agonist", and "randomized clinical trial". Articles and bibliographies relevant to the subject were reviewed and additional references known to the authors were included. RESULTS: Five randomized, placebo-controlled trials of liraglutide for weight management were identified. In addition to recommended diet and physical activity, liraglutide consistently resulted in a 4 to 6 kg weight loss, with a greater proportion of patients achieving at least 5 and 10% weight loss compared with placebo. The most common adverse effects were gastrointestinal and primarily occurred early in the treatment course. Comparative data suggest that weight loss with liraglutide is greater than that seen with orlistat or lorcaserin, but slightly less that seen with phentermine/topiramate. Liraglutide 1.8 mg was recently shown to have cardiovascular benefit in a large outcomes trial; applicability of these results for the 3.0 mg formulation in a more diverse weight loss population at high cardiovascular risk is not currently known. Barriers to real-world clinical use as a first-line agent include gastrointestinal side effects, high cost, and need for injection. CONCLUSIONS: Liraglutide helps to induce and sustain weight loss in patients with obesity. Its efficacy is comparable to other available agents but it offers the unique benefit of improved glycemic control. Additional studies are needed to determine its long term efficacy and safety profile.

LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial.

BACKGROUND: Epidemiological data on obesity are needed, particularly in patients with type 2 diabetes mellitus (T2DM) and high cardiovascular (CV) risk. We used the baseline data of liraglutide effect and action in diabetes: evaluation of CV outcome results-A long term Evaluation (LEADER) (a clinical trial to assess the CV safety of liraglutide) to investigate: (i) prevalence of overweight and obesity; (ii) relationship of the major cardiometabolic risk factors with anthropometric measures of adiposity [body mass index (BMI) and waist circumference (WC)]; and (iii) cardiometabolic treatment intensity in relation to BMI and WC. METHODS: LEADER enrolled two distinct populations of high-risk patients with T2DM in 32 countries: (1) aged ≥50 years with prior CV disease; (2) aged ≥60 years with one or more CV risk factors. Associations of metabolic variables, demographic variables and treatment intensity with anthropometric measurements (BMI and WC) were explored using regression models (ClinicalTrials.gov identifier: NCT01179048). RESULTS: Mean BMI was 32.5 ± 6.3 kg/m(2) and only 9.1 % had BMI <25 kg/m(2). The prevalence of healthy WC was also extremely low (6.4 % according to International Joint Interim Statement for the Harmonization of the Metabolic Syndrome criteria). Obesity was associated with being younger, female, previous smoker, Caucasian, American, with shorter diabetes duration, uncontrolled blood pressure (BP), antihypertensive agents, insulin plus oral antihyperglycaemic treatment, higher levels of triglycerides and lower levels of high-density lipoprotein cholesterol. CONCLUSIONS: Overweight and obesity are prevalent in high CV risk patients with T2DM. BMI and WC are related to the major cardiometabolic risk factors. Furthermore, treatment intensity, such as insulin, statins or oral antihypertensive drugs, is higher in those who are overweight or obese; while BP and lipid control in these patients are remarkably suboptimal. LEADER confers a unique opportunity to explore the longitudinal effect of weight on CV risk factors and hard endpoints.

LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations.

AIMS: To report preliminary data on baseline serum calcitonin concentrations and associated clinical characteristics in a global population with type 2 diabetes before liraglutide or placebo randomization. METHODS: The ongoing LEADER trial has enrolled 9340 people with type 2 diabetes and at high risk of cardiovascular disease at 410 centres worldwide. People with baseline serum calcitonin ≤ 50 ng/l were randomized to liraglutide once daily or placebo and will be followed for up to 5 years. Serum calcitonin was measured at baseline and will be measured annually thereafter. An independent committee of thyroid experts will oversee calcitonin monitoring throughout the trial and will review all calcitonin concentrations ≥ 20 ng/l. RESULTS: The mean age of participants was 64.3 ± 7.2 years, 64.3% were men, and mean the body mass index was 32.5 ± 6.3 kg/m(2). The median (interquartile range) baseline serum calcitonin values were 3.9 (1.0 to >7.6) ng/l in men and 1.0 (1.0 to >1) ng/l in women. Serum calcitonin was >10 ng/l in 14.6% of men and in 0.96% of women. In sex-specific multivariable linear analysis of covariance models, a reduced glomerular filtration rate (GFR) was associated with higher serum calcitonin concentrations that were statistically significant. A 20 ml/min/1.73 m(2) decrease in estimated GFR (eGFR) was associated with a 14% increase in serum calcitonin in women and an 11% increase in men. CONCLUSIONS: In the LEADER population, the prevalence of elevated serum calcitonin concentrations at baseline was high, and there was an inverse association between eGFR and serum calcitonin concentrations.

Increase in interleukin-6 following arterial injury is related to insulin resistance, the -174G-->C polymorphism and complex plaque morphology.

Interleukin-6 (IL-6) is associated with many disease states in humans. We prospectively sought to determine whether IL-6 levels increased following percutaneous coronary intervention (PCI) in the absence of myonecrosis. Additionally, we systematically assessed other clinical and anatomic factors associated with IL-6 levels in a population of patients with coronary atherosclerosis undergoing PCI. Blood samples were collected from 117 patients at baseline, 8 and 16 h following PCI. Samples were assayed for IL-6, creatine kinase-myocardial band (CK-MB), troponin-I (Tn-I), high sensitivity C-reactive protein, glucose, haemoglobin A1c, and a lipid profile. Genotyping of the -174G-->C polymorphism of the IL-6 gene was performed. IL-6 levels increased following PCI among the study group (slope = 0.4 pg/mL/h, P = 0.001). IL-6 levels increased to a similar degree in the absence of myonecrosis. Patients with the XC genotype (either having the GC or the CC allele) had higher IL-6-values at baseline compared to GG genotype patients (4.9 +/- 6.4 vs. 2.6 +/- 1.8 pg/mL, P = 0.02). Multivariable predictors of detectable baseline IL-6 levels included XC genotype (odds ratio [OR]: 4.14, 95% CI 1.58-10.82, P = 0.004), ACC/AHA type C lesion classification (OR: 4.08, 95% CI 1.54-10.84, P = 0.005), elevated baseline Tn-I (OR: 3.31, 95% CI 1.16-9.43, P = 0.025), diabetes (OR: 3.00, 95% CI 1.11-8.09, P = 0.030), and waist circumference (OR: 1.49, 95% CI 1.08-2.06, P = 0.015). Predictors of peak IL-6 following PCI included the XC genotype (estimate 1.4, 95% CI 1.06-1.87, P = 0.019), homeostasis model assessment (estimate 0.99, 95% 0.982-0.999, P = 0.042) and baseline Tn-I > upper limit of normal (estimate 0.7, 95% CI 0.50-0.96, P = 0.039). Lastly, IL-6 increased following PCI even in the absence of myonecrosis as measured by Tn-I elevation. IL-6 levels are also related to the -174G-->C polymorphism, arterial injury, lesion complexity, and insulin resistance.

Neointimal hyperplasia after arterial injury is increased in a rat model of non-insulin-dependent diabetes mellitus.

BACKGROUND: The key biological determinants that promote restenosis in the setting of diabetes have not been elucidated. There is no accepted animal model to study restenosis in diabetes. METHODS AND RESULTS: We evaluated 2 models of diabetes mellitus: (1) streptozotocin (STZ)-treated Sprague-Dawley rats (type I diabetes) versus regular Sprague-Dawley rats and (2) obese Zucker rats (type II diabetes) versus lean Zucker rats. Neointimal hyperplasia was assessed after carotid balloon injury at 21 days by computerized morphometry. There was no difference in neointimal area in the STZ-treated rats compared with controls, irrespective of insulin administration or dose of STZ. Neointimal area was increased >2-fold in obese Zucker rats compared with lean Zucker rats (0.21+/-0.06 versus 0.08+/-0.03 mm(2), P<0.01). The neointimal area was markedly increased in the obese Zucker rats 7 days after injury (0.058+/-0.024 versus 0.033+/-0.009 mm(2), P<0.05) and persisted through 21 days. In both obese and lean Zucker rats, cell proliferation peaked in the media at 3 days (118.66+/-84.28 versus 27.50+/-12.75 bromodeoxyuridine-labeled cells per cross section). In the intima, cell proliferation markedly increased beginning at day 3 and persisted through day 14 in the obese and lean Zucker rats (202.27+/-98.86 versus 35.71+/-20.54 bromodeoxyuridine-labeled cells at 7 days). CONCLUSIONS: The type II diabetic rat model, typifying insulin resistance, is associated with a propensity for neointima. The obese Zucker rat model may be an ideal diabetic model to further characterize the diabetic vascular response to injury.

Procedural outcomes and long-term survival among patients undergoing percutaneous coronary intervention of a chronic total occlusion in native coronary arteries: a 20-year experience.

OBJECTIVES: The study compared procedural outcomes and long-term survival for patients undergoing percutaneous coronary intervention (PCI) of a chronic total coronary artery occlusion (CTO) with a matched non-CTO cohort to determine whether successful PCI of a CTO is associated with improved survival. BACKGROUND: Percutaneous coronary intervention of a CTO is a common occurrence, and the long-term survival for patients with successful PCI of a CTO has not been clearly defined. METHODS: Between June 1980 and December 1999, a total of 2,007 consecutive patients underwent PCI for a CTO. Utilizing propensity scoring methods, a matched non-CTO cohort of 2,007 patients was identified and compared to the CTO group. The cohorts were stratified into successful and failed procedures. RESULTS: The in-hospital major adverse cardiac event (MACE) rate was 3.8% in the CTO cohort. Technical success has improved over the last 10 years (overall 74.4%, slope 1.0%/yr, p = 0.02, R2 = 49.9%) as did procedural success (overall 69.9%, slope 1.2%/yr, p = 0.02, R2 = 51.5%) without a concomitant increase in in-hospital MACE rates (slope 0.1%/yr, p = 0.7). There was a distinct 10-year survival advantage for successful CTO treatment compared with failed CTO treatment (73.5% vs. 65.1%, p = 0.001). The CTO versus non-CTO 10-year survival was the same (71.2% vs. 71.4%, p = 0.9). Diabetics in the CTO cohort had a lower 10-year survival compared with nondiabetics (58.3% vs. 74.3%, p < 0.0001). CONCLUSIONS: These data represent follow-up of the largest reported series of patients undergoing PCI for a CTO. The 10-year survival rates for matched non-CTO and the CTO cohorts were similar. Success rates have continued to improve without an accompanying increase in MACE rates. A successfully revascularized CTO confers a significant 10-year survival advantage compared with failed revascularization.

Optimizing percutaneous coronary revascularization in diabetic women: analysis from the EPISTENT trial.

Clinical studies have demonstrated that diabetic women have an increased risk of death and nonfatal myocardial infarction (MI) after percutaneous coronary intervention (PCI). However, there have been few data regarding the outcome of diabetic women in the current era of percutaneous coronary revascularization. Using the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting Trial (EPISTENT) database, we determined morbidity and mortality for diabetic women undergoing PCT in the current era using stents and the glycoprotein IIb/IIIa inhibitor, abciximab. There were no mortality differences in the diabetic women treated with stent-placebo, stent-abciximab, or balloon-abciximab at 30 days and 6 months. However, the primary end point of 1-year death, MI, or target vessel revascularization (TVR) was lowered in the diabetic women from 34.5% in the stent-placebo group and 28.9% in the balloon-abciximab group to 13. 3% in the stent-abciximab group (p = 0.02 for stent-stent comparison, and p = 0.09 for stent-abciximab vs. balloon-abciximab comparison). Also, 1-year TVR rates were lowered from 21.1% in the stent-placebo group and 26.7% in the balloon-abciximab group to 4.5% in the stent-abciximab group (p = 0.02 for stent-stent comparison, and p = 0.004 for stent-abciximab vs. balloon-abciximab comparison). The combination of stenting and abciximab therapy among diabetic women resulted in a significant reduction in 1-year rate of death, MI, or TVR compared with stent-placebo or balloon-abciximab therapy.

Immediate coronary artery bypass surgery after platelet inhibition with eptifibatide: results from PURSUIT. Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrelin Therapy.

BACKGROUND: The platelet GP IIb/IIIa inhibitor eptifibatide improves outcomes in patients with acute coronary syndromes. Patients requiring emergent coronary artery bypass grafting, however, may be at increased risk for bleeding if exposed to eptifibatide. Data from the PURSUIT trial were reviewed to assess this risk in patients undergoing coronary surgery immediately after exposure to eptifibatide. METHODS: In PURSUIT, 10,948 patients who presented with non-ST segment elevation acute coronary syndromes were prospectively randomized to receive eptifibatide (180 microg/kg bolus plus 2 microg/kg/min infusion) or placebo. A total of 78 patients underwent immediate coronary artery bypass surgery within 2 hours of cessation of study drug (placebo, n = 46; eptifibatide, n = 32). Clinical outcome, bleeding, and transfusion requirements within this subset were examined. RESULTS: Major bleeding was not different between groups, occurring in 64% of patients receiving placebo and 63% of patients receiving eptifibatide. The incidence of blood transfusion was similar as well (57% vs 59%). Postoperative thrombocytopenia occurred less often after eptifibatide exposure. Perioperative myocardial infarction was significantly reduced in patients who received eptifibatide (46% vs 22%, p < 0.05). There was no difference in perioperative stroke (2.2% vs 6.3%) or mortality (6.3% vs 6.5%). CONCLUSIONS: Patients may safely undergo coronary artery bypass surgery within 2 hours of discontinuation of eptifibatide. Eptifibatide infusion in the immediate preoperative period had no adverse clinical effects, but did significantly decrease the incidence of perioperative myocardial infarction. Additionally, platelet counts after surgery were higher in the group of patients who received eptifibatide, perhaps indicative of a platelet-sparing effect during cardiopulmonary bypass.

Proteinuria is a key determinant of death in patients with diabetes after isolated coronary artery bypass grafting.

BACKGROUND: Proteinuria is a marker for underlying diabetic nephropathy and may be a surrogate marker for advanced atherosclerosis. It is unknown if proteinuria is a determinant of death in patients with diabetes after coronary artery bypass grafting. We hypothesized that diabetic patients with evidence of proteinuria would have increased mortality and clinical event rates after isolated coronary artery bypass grafting compared with nonproteinuric diabetic patients. METHODS AND RESULTS: We performed an observational of study of 905 diabetic patients with urinalysis and available follow-up data (nonproteinuria, n = 651; proteinuria, n = 254) after isolated coronary artery bypass grafting at the Cleveland Clinic Foundation between January 1989 and December 1992. The proteinuria group was further prospectively stratified into low-concentration (n = 225) and high-concentration (n = 29) groups. The end points of this study were all-cause mortality and the composite end point of death, nonfatal myocardial infarction, and need for repeat revascularization. The mean follow-up time was 66 months. The 5-year mortality rate for the nonproteinuria and proteinuria groups was 20.2% and 29.1% (P <.001), respectively. The 5-year rate of death, nonfatal myocardial infarction, and need for repeat revascularization for the nonproteinuria and proteinuria groups was 25.2% and 36.2% (P <.001), respectively. Significant multivariate predictors of 5-year mortality included age, not using a left internal mammary artery graft to the left anterior descending coronary artery, proteinuria, lower body weight, and increased creatinine level. CONCLUSIONS: Among diabetic patients, proteinuria appears to be an important predictor of death after isolated coronary artery bypass grafting.

Abciximab reduces mortality in diabetics following percutaneous coronary intervention.

OBJECTIVES: We sought to determine whether abciximab therapy at the time of percutaneous coronary intervention (PCI) would favorably affect one-year mortality in patients with diabetes. BACKGROUND: Diabetics are known to have increased late mortality following PCI. METHODS: Data from three placebo-controlled trials of PCI, EPIC, EPILOG, and EPISTENT, were pooled. The one-year mortality rate for patients with a clinical diagnosis of diabetes mellitus was compared with the rate for nondiabetic patients treated with either abciximab or placebo. RESULTS: In the 1,462 diabetic patients, abciximab decreased the mortality from 4.5% to 2.5%, p = 0.031, and in the 5,072 nondiabetic patients, from 2.6% to 1.9%, p = 0.099. In patients with the clinical syndrome of insulin resistance--defined as diabetes, hypertension, and obesity--mortality was reduced by abciximab treatment from 5.1% to 2.3%, p = 0.044. The beneficial reduction in mortality with abciximab use in diabetics classified as insulin-requiring was from 8.1% to 4.2%, p = 0.073. Mortality in diabetics who underwent multivessel intervention was reduced from 7.7% to 0.9% with use of abciximab, p = 0.018. In a Cox proportional hazards survival model, the risk ratio for mortality with abciximab use compared with placebo was 0.642 (95% confidence interval 0.458-0.900, p = 0.010). CONCLUSIONS: Abciximab decreases the mortality of diabetic patients to the level of placebo-treated nondiabetic patients. This beneficial effect is noteworthy in those diabetic patients who are also hypertensive and obese and in diabetics undergoing multivessel intervention. Besides its potential role in reducing repeat intervention for stented diabetic patients, abciximab therapy should be strongly considered in diabetic patients undergoing PCI to improve their survival.

Enhanced efficacy of eptifibatide administration in patients with acute coronary syndrome requiring in-hospital coronary artery bypass grafting. PURSUIT Investigators.

BACKGROUND: Patients with a recent episode of non-ST-segment elevation acute coronary syndrome before CABG have higher rates of operative morbidity and mortality than patients with stable coronary syndromes. The efficacy of administering eptifibatide to these patients undergoing in-hospital CABG is unknown. METHODS AND RESULTS: The Platelet Glycoprotein IIb-IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) trial randomized 10 948 patients to receive either eptifibatide or placebo. There were 1558 study participants who underwent in-hospital CABG: 692 received placebo, and 866 received eptifibatide. The main substudy analysis end point was death or myocardial infarction (MI) rates at the 6-month follow-up. The 30-day death or MI rates were 30. 8% and 26.1% for the placebo and eptifibatide groups, respectively (P:=0.041). The benefit of eptifibatide administration persisted through 6-months of follow-up (32.7% versus 27.6% for placebo versus eptifibatide, respectively; P:=0.029). There was a greater reduction in the 6-month death or MI rate for patients who received eptifibatide within 72 hours of CABG (33.6% versus 23.8%; P:=0.002) compared with the >72-hour group (31.6% versus 32%; P:=1.0). The incidence of major bleeding was 56.6% for placebo-treated patients versus 58.2% for eptifibatide-treated patients (P:=0.7). CONCLUSIONS: Eptifibatide administration in patients undergoing in-hospital CABG with a recent episode of a non-ST-segment elevation acute coronary syndrome results in a significant reduction in death or MI that is evident at 7 days and persists through the 6-month follow-up without a significant increase in perioperative bleeding rates.

Optimizing the percutaneous interventional outcomes for patients with diabetes mellitus: results of the EPISTENT (Evaluation of platelet IIb/IIIa inhibitor for stenting trial) diabetic substudy.

BACKGROUND: Stenting likely decreases the need for target-vessel revascularization procedures in diabetic patients compared with balloon angioplasty. However, the efficacy of stenting with platelet glycoprotein IIb/IIIa blockade has not yet been assessed in diabetics. METHODS AND RESULTS: We analyzed the outcomes of 491 diabetic patients within the multicenter Evaluation of Platelet IIb/IIIa Inhibitor for Stenting Trial (EPISTENT). Diabetic patients were a prospectively defined subset: 173 were randomized to stent-placebo, 162 to stent-abciximab, and 156 to balloon angioplasty-abciximab. The main end point for this analysis was combined 6-month death, myocardial infarction (MI), or target-vessel revascularization (TVR). The composite end point occurred in 25.2% of stent-placebo, 23.4% of balloon-abciximab, and 13.0% of stent-abciximab patients (P=0.005). Abciximab therapy, irrespective of revascularization strategy (stent or balloon angioplasty), resulted in a significant reduction in the 6-month death or MI rate: 12.7% for stent-placebo, 7.8% for balloon angioplasty-abciximab, and 6.2% for the stent-abciximab group (P=0.029). The 6-month TVR rate was 16.6% for stent-placebo, 18.4% for balloon-abciximab, and 8.1% for stent-abciximab (P=0.021). Compared with stent-placebo, stent-abciximab therapy was associated with a significant increase in angiographic net gain (0.88 versus 0.55 mm; P=0.011) and a decrease in the late loss index (0.40 versus 0.60 mm; P=0.061). The 1-year mortality rate for diabetics was 4.1% for stent-placebo and 1. 2% for stent-abciximab patients (P=0.11). CONCLUSIONS: The combination of stenting and abciximab therapy among diabetics resulted in a significant reduction in 6-month rates of death, MI, and TVR compared with stent-placebo or balloon-abciximab therapy.

Chest pain--a strong predictor of adverse cardiac events following precutaneous intervention (from the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting Trial [EPISENT])].

Postprocedural chest pain remains a common problem, and irrespective of electrocardiographic changes, is associated with a higher incidence of early cardiac events. A return to the catheterization laboratory is unlikely to benefit patients with postprocedural chest pain without electrocardiographic changes with documented irreversible intraprocedural complications, or those with late postprocedural pain.

Diabetes mellitus: biological determinants of atherosclerosis and restenosis.

Diabetes mellitus is a potent risk factor for the development of atherosclerosis. Patients with diabetes account for approximately 20% of patients presenting with acute coronary syndromes or for percutaneous coronary intervention. Furthermore, the incidence of diabetes continues to increase world-wide, such that substantial medical resources are allocated for the care of patients with diabetic cardiovascular complications. Although great strides have been made in reducing cardiovascular events in recent years, there has been little improvement in outcomes for patients with diabetes mellitus. This review will focus in the underlying patho-biology and the current status of therapeutic interventional strategies for patients with diabetes mellitus.

Intracoronary stenting: an overview for the clinician.

Intracoronary stenting reduces restenosis rates and effectively treats abrupt vessel closure, two frequent complications following percutaneous coronary angioplasty (PTCA). But it has drawbacks, such as in-stent restenosis, high cost, and lack of long-term follow-up data. This paper discusses current indications and the future role of stenting.

Catheter-based reperfusion of unprotected left main stenosis during an acute myocardial infarction (the ULTIMA experience). Unprotected Left Main Trunk Intervention Multi-center Assessment.

The ULTIMA registry was a prospective, multicenter, international registry of 277 patients who underwent percutaneous coronary interventions of unprotected left main trunk stenosis. The 40 patients who underwent an emergency percutaneous left main intervention for acute myocardial infarction are the focus of this study. We compared the results of primary angioplasty with primary stenting, characterizing both the short-term (in-hospital) and long-term (12-month) outcomes. Of the 40 patients, 23 underwent primary angioplasty, whereas 17 underwent primary stenting. The angiographic success rate was an 88% for the cohort. The in-hospital death or coronary artery bypass grafting rate was 65% for the entire group, 74% for the percutaneous transluminal coronary angioplasty group (PTCA), and 53% for the stent group (p = 0.2). The in-hospital death rate was 55% for the entire cohort, 70% for the PTCA group, and 35% for the stent group (p = 0.1). The 12-month rate of death or bypass surgery was 83% and 58% for the PTCA and stent groups, respectively (p = 0.047). The 12-month survival rate was 35% and 53% for the PTCA and stent groups, respectively (p = 0.18). Bypass surgery was required in 6 patients in the PTCA group and 2 patients in the stent group (p = 0.07). Patients undergoing percutaneous interventions for unprotected left main myocardial stenosis during an acute myocardial infarction are critically ill; an initial percutaneous revascularization approach appears feasible and may be the preferred revascularization strategy. Primary stenting was associated with improved clinical outcomes.

The importance of proteinuria as a determinant of mortality following percutaneous coronary revascularization in diabetics.

OBJECTIVES: The aims of this study were to compare mortality and clinical events following percutaneous coronary intervention (PCI) between nondiabetics and diabetics with and without proteinuria. BACKGROUND: Diabetics have increased rates of late myocardial infarction, repeat revascularization and mortality when compared with nondiabetics following PCI. Proteinuria is a marker for diabetic nephropathy and potentially a surrogate marker for advanced atherosclerosis. It is unknown if proteinuria is a predictor of outcome in diabetics following PCI. METHODS: We performed an observational study of 2,784 patients who underwent PCI at the Cleveland Clinic between January 1993 and December 1995. There were 2,247 nondiabetics and 537 diabetics with urinalysis and follow-up data available (proteinuria n = 217, nonproteinuria n = 320). The diabetic proteinuria group was further prospectively stratified into low concentration (n = 182) and high concentration (n = 35). The end points were all-cause mortality and the composite end point of death, nonfatal myocardial infarction (MI) and need for revascularization. RESULTS: The mean follow-up time was 20.2 months. The two-year mortality rate was 7.3% and 13.5% for nondiabetics and diabetics, respectively (p < 0.001). The two-year mortality rate was 9.1% and 20.3% for the nonproteinuria and proteinuria groups, respectively (p < 0.001). There was a graded increase in mortality comparing the diabetic group. The two-year mortality rate was 9.1%, 16.2% and 43.1% for the nonproteinuria, low concentration and high concentration groups, respectively (p < 0.001). The difference in survival between the nondiabetic and nonproteinuric diabetics was not significant (p = 0.8). CONCLUSIONS: The presence of proteinuria is the key determinant of risk following PCI for diabetics. Diabetics without evidence of proteinuria have similar survival compared with nondiabetics.

Effectiveness of percutaneous coronary interventions to prevent recurrent coronary events in patients on chronic hemodialysis.

Patients on chronic hemodialysis undergoing percutaneous coronary revascularization have similar rates of procedural success and in-hospital event rates when compared with a matched cohort. However, patients on chronic hemodialysis have a marked increase in 36-month target vessel revascularization, myocardial infarction, and death rates.