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BackgroundIn contrast with the setting of acute myocardial infarction, there are limited data regarding the impact of diabetes mellitus on clinical outcomes in contemporary cohorts of patients with chronic coronary syndromes. We aimed to investigate the prevalence and prognostic impact of diabetes according to geographical regions and ethnicity.Methods and resultsCLARIFY is an observational registry of patients with chronic coronary syndromes, enrolled across 45 countries in Europe, Asia, America, Middle East, Australia, and Africa in 2009–2010, and followed up yearly for 5 years. Chronic coronary syndromes were defined by ≥1 of the following criteria: prior myocardial infarction, evidence of coronary stenosis >50%, proven symptomatic myocardial ischaemia, or prior revascularization procedure.Among 32 694 patients, 9502 (29%) had diabetes, with a regional prevalence ranging from below 20% in Northern Europe to ∼60% in the Gulf countries. In a multivariable-adjusted Cox proportional hazards model, diabetes was associated with increased risks for the primary outcome (cardiovascular death, myocardial infarction, or stroke) with an adjusted hazard ratio of 1.28 (95% confidence interval 1.18, 1.39) and for all secondary outcomes (all-cause and cardiovascular mortality, myocardial infarction, stroke, heart failure, and coronary revascularization). Differences on outcomes according to geography and ethnicity were modest.ConclusionIn patients with chronic coronary syndromes, diabetes is independently associated with mortality and cardiovascular events, including heart failure, which is not accounted by demographics, prior medical history, left ventricular ejection fraction, or use of secondary prevention medication. This is observed across multiple geographic regions and ethnicities, despite marked disparities in the prevalence of diabetes.ClinicalTrials identifierISRCTN43070564

This study investigated the effect of clopidogrel treatment on inflammatory activity as evidenced by the change in high-sensitivity C-reactive protein (hsCRP) levels in a broad population of patients who are at high risk of atherothrombotic events. The predictive value of hsCRP levels for a treatment benefit of clopidogrel was also explored.The study included 8021 patients with established atherosclerotic disease or multiple cardiovascular risk factors enrolled in the CHARISMA trial. Patients were randomly assigned either to clopidogrel plus aspirin or placebo plus aspirin. HsCRP was measured at study entry and at study termination (median 28emsp14;months). The predefined primary composite endpoint was myocardial infarction, stroke, or death from cardiovascular causes.There was a stepwise increase in the event rate of the combined primary endpoint with increasing quartiles of hsCRP at baseline (4.0%, 6.1%, 7.4% and 8.7% for the highest quartile). In both treatment groups the changes in hsCRP levels over time were identical. In patients with low hsCRP levels (3 mg/l) clopidogrel treatment was associated with a lower event rate compared with placebo (4.0% vs 6.0%, log rank p=0.005). In contrast no treatment effect was observed in patients with high hsCRP levels (8.1% vs 8.0%, ns).In this broad population, hsCRP is a powerful predictor of ischaemic events. Compared with placebo, clopidogrel was without effect on inflammatory markers. The reduction in cardiovascular events by antiplatelet treatment with clopidogrel was isolated to patients with low levels of hsCRP.

Aims We aimed to determine the relationship between body mass index (BMI) and cardiovascular events among individuals with or at-risk of atherothrombotic disease. Methods and results This was a prospective observational study of 15 532 patients enrolled in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial who were randomly assigned to clopidogrel or placebo, and followed-up for a median of 28 months for the occurrence of the primary endpoint (cardiovascular death, myocardial infarction, or stroke), all-cause mortality, and bleeding complications. Compared with the highest BMI quartile, the primary endpoint, cardiovascular, and all-cause mortality all occurred more frequently among patients in the lowest BMI quartile (about a third lower). The relationship between continuous BMI and adverse cardiovascular outcomes were presented as two linear spline terms with 29 kg/m2 as the cut-point for all-cause mortality. Lower BMI was associated with an increase in moderate and severe bleeding complications, largely accounted for by those receiving dual-antiplatelet agents with the highest tertile aspirin dose. Conclusion Adverse cardiovascular events and bleeding complications occurred more frequently among individuals with or at-risk for atherothrombotic disease and low BMI. Further studies should be directed to these patients to improve outcomes. The CHARISMA trial is registered with ClinicalTrials.gov, NCT00050817.

Background— Incomplete inhibition of platelet thromboxane generation, as measured by elevated urinary 11-dehydro thromboxane B 2 concentrations, has been associated with an increased risk of cardiovascular events. We aimed to determine the external validity of this association in aspirin-treated patients enrolled in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) trial and to determine whether there are any modifiable factors or interventions that lower urinary 11-dehydro thromboxane B 2 concentrations that could thereby reduce cardiovascular risk. Methods and Results— Urinary 11-dehydro thromboxane B 2 concentrations were measured in 3261 aspirin-treated patients at least 1 month after they had been randomly assigned to placebo or clopidogrel. Baseline urinary 11-dehydro thromboxane B 2 concentrations in the highest quartile were associated with an increased risk of stroke, myocardial infarction, or cardiovascular death compared with the lowest quartile (adjusted hazard ratio 1.66, 95% CI 1.06 to 2.61, P =0.03). Increasing age, female sex, history of peripheral artery disease, current smoking, and oral hypoglycemic or angiotensin-converting enzyme inhibitor therapy were independently associated with higher urinary concentrations of 11-dehydro thromboxane B 2 , whereas aspirin dose ≥150 mg/d, history of treatment with nonsteroidal antiinflammatory drugs, history of hypercholesterolemia, and statin treatment were associated with lower concentrations. Randomization to clopidogrel (versus placebo) did not reduce the hazard of cardiovascular events in patients in the highest quartile of urinary 11-dehydro thromboxane B 2 levels. Conclusions— In aspirin-treated patients, urinary concentrations of 11-dehydro thromboxane B 2 are an externally valid and potentially modifiable determinant of stroke, myocardial infarction, or cardiovascular death in patients at risk for atherothrombotic events.

Objectives The purpose of this study was to evaluate the potential impact of clopidogrel and statin interaction in a randomized, placebo-controlled trial with long-term follow-up. Background There are conflicting data regarding whether statins predominantly metabolized by CYP3A4 reduce the metabolism of clopidogrel to its active metabolite and diminish its clinical efficacy. Methods The CHARISMA trial was a randomized trial comparing long-term 75 mg/day clopidogrel versus placebo in patients with cardiovascular disease or multiple risk factors on aspirin. The primary end point was a composite of myocardial infarction, stroke, or cardiovascular death at median follow-up of 28 months. We performed a secondary analysis evaluating the interaction of clopidogrel versus placebo with statin administration, categorizing baseline statin use to those predominantly CYP3A4 metabolized (atorvastatin, lovastatin, simvastatin; CYP3A4-MET) or others (pravastatin, fluvastatin; non–CYP3A4-MET). Results Of 15,603 patients enrolled, 10,078 received a statin at baseline (8,245 CYP3A4-MET, 1,748 non–CYP3A4-MET) and 5,496 did not. For the overall population, the primary end point was 6.8% with clopidogrel and 7.3% with placebo (hazard ratio [HR] 0.93; p = 0.22). This was similar among patients on CYP3A4-MET (5.9% clopidogrel, 6.6% placebo, HR 0.89; p = 0.18) or non–CYP3A4-MET statin (5.7% clopidogrel, 7.2% placebo, HR 0.78; p = 0.19). There was no interaction between statin types and randomized treatment (p = 0.69). Patients on atorvastatin (n = 4,127) (5.7% clopidogrel, 7.1% placebo, HR 0.80; p = 0.06) or pravastatin (n = 1,440) (5.1% clopidogrel, 7.0% placebo, HR 0.72; p = 0.13) had similar event rates. Conclusions Despite theoretic concerns and ex vivo testing suggesting a potential negative interaction with concomitant clopidogrel and CYP3A4-MET statin administration, there was no evidence of an interaction clinically in a large placebo-controlled trial with long-term follow-up.

Objectives The purpose of this study was to determine the possible benefit of dual antiplatelet therapy in patients with prior myocardial infarction (MI), ischemic stroke, or symptomatic peripheral arterial disease (PAD). Background Dual antiplatelet therapy with clopidogrel plus aspirin has been validated in the settings of acute coronary syndromes and coronary stenting. The value of this combination was recently evaluated in the CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance) trial, where no statistically significant benefit was found in the overall broad population of stable patients studied. Methods We identified the subgroup in the CHARISMA trial who were enrolled with documented prior MI, ischemic stroke, or symptomatic PAD. Results A total of 9,478 patients met the inclusion criteria for this analysis. The median duration of follow-up was 27.6 months. The rate of cardiovascular death, MI, or stroke was significantly lower in the clopidogrel plus aspirin arm than in the placebo plus aspirin arm: 7.3% versus 8.8% (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.72 to 0.96, p = 0.01). Additionally, hospitalizations for ischemia were significantly decreased, 11.4% versus 13.2% (HR 0.86, 95% CI 0.76 to 0.96, p = 0.008). There was no significant difference in the rate of severe bleeding: 1.7% versus 1.5% (HR 1.12, 95% CI 0.81 to 1.53, p = 0.50); moderate bleeding was significantly increased: 2.0% versus 1.3% (HR 1.60, 95% CI 1.16 to 2.20, p = 0.004). Conclusions In this analysis of the CHARISMA trial, the large number of patients with documented prior MI, ischemic stroke, or symptomatic PAD appeared to derive significant benefit from dual antiplatelet therapy with clopidogrel plus aspirin. Such patients may benefit from intensification of antithrombotic therapy beyond aspirin alone, a concept that future trials will need to validate. (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance [CHARISMA]; http://clinicaltrials.gov/ct/show/NCT00050817?order=1 ; NCT00050817 )

Background - It is unclear whether routine or selective functional testing is optimal following percutaneous coronary intervention (PCI) in high-risk patients. Objectives - The aim of this trial was to compare exercise endurance, functional status, and quality of life (QOL) among high-risk patients randomized to either routine or selective functional testing following PCI. Methods - We randomized 84 patients to either routine or selective functional testing. Patients had one or more of the following: multivessel PCI, diabetes mellitus, left ventricular ejection fraction ≤ 35%, and/or PCl of the proximal left anterior descending artery. Patients in the routine arm (n=41) underwent maximum endurance exercise treadmill testing (ETT) with nuclear perfusion imaging at 1.5 and 6 months. Patients in the selective arm (n = 43) only underwent functional testing for a clinical indication. All patients underwent a maximum endurance ETT at 9 months. Exercise endurance, functional status, and QOL were assessed at 9 months. Results - Most patients were middle-aged men (58 ± 10 years old; 87% male) who underwent PCI with stenting (94%).Among routine functional testing patients, 27.0% and 41.9% had a positive functional test at 1.5 and 6 months, respectively. Exercise endurance was improved in the routine vs. selective arm at 9 months (metabolic equivalents: 10.3 ± 2.6 vs. 8.6 ± 3.0, P= 0.013). There was no difference in improvement from baseline for the Duke Activity Status Index, the Seattle Angina Questionnaire, or the SF-36. Nine-month cumulative incidences of cardiac procedures and clinical events were not significantly different. Conclusions - Routine functional testing following PCI in high-risk patients may lead to improved exercise endurance but not improved QOL.

Cardiovascular diseases is a major cause of deaths in many developed countries. To treat cardiovascular diseases, minimally invasive cardiac intervention is widely used as an effective yet complicated solution. Training of cardiac intervention thus plays a crucial role. This paper addresses the use of Virtual Reality (VR) technology for the simulated training of cardiac intervention. In particular, the paper describes the architecture of a simulation system for virtual cardiac intervention. The framework proposed consists of hardware component, software component and methodology component. As an enabling technology, Graphics Processing Unit (GPU) is applied in this work to enhance cardiac modeling, cardiac visualization, and cardiac interaction with the VR simulation environment

Background Dual antiplatelet therapy with clopidogrel plus low-dose aspirin has not been studied in a broad population of patients at high risk for atherothrombotic events. Methods We randomly assigned 15,603 patients with either clinically evident cardiovascular disease or multiple risk factors to receive clopidogrel (75 mg per day) plus low-dose aspirin (75 to 162 mg per day) or placebo plus low-dose aspirin and followed them for a median of 28 months. The primary efficacy end point was a composite of myocardial infarction, stroke, or death from cardiovascular causes. Results The rate of the primary efficacy end point was 6.8 percent with clopidogrel plus aspirin and 7.3 percent with placebo plus aspirin (relative risk, 0.93; 95 percent confidence interval, 0.83 to 1.05; P = 0.22). The respective rate of the principal secondary efficacy end point, which included hospitalizations for ischemic events, was 16.7 percent and 17.9 percent (relative risk, 0.92; 95 percent confidence interval, 0.86 to 0.995; P = 0.04), and the rate of severe bleeding was 1.7 percent and 1.3 percent (relative risk, 1.25; 95 percent confidence interval, 0.97 to 1.61 percent; P = 0.09). The rate of the primary end point among patients with multiple risk factors was 6.6 percent with clopidogrel and 5.5 percent with placebo (relative risk, 1.2; 95 percent confidence interval, 0.91 to 1.59; P = 0.20) and the rate of death from cardiovascular causes also was higher with clopidogrel (3.9 percent vs. 2.2 percent, P = 0.01). In the subgroup with clinically evident atherothrombosis, the rate was 6.9 percent with clopidogrel and 7.9 percent with placebo (relative risk, 0.88; 95 percent confidence interval, 0.77 to 0.998; P = 0.046). Conclusions In this trial, there was a suggestion of benefit with clopidogrel treatment in patients with symptomatic atherothrombosis and a suggestion of harm in patients with multiple risk factors. Overall, clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes. (ClinicalTrials.gov number, NCT00050817.)

The clinical utility of routine functional testing following percutaneous coronary intervention (PCI) among patients with and without coronary stenting is unclear. We established an international registry to evaluate the functional testing strategies following successful PCI. Among patients treated with stents, adverse cardiovascular outcomes were similar between those who underwent routine or clinically-driven functional testing. Conversely, among those who were not treated with stents, the rate of death, myocardial infarction or unstable angina was lower than those who underwent routine functional testing (14.8% vs. 6.6%; P =0.033). Our study suggests that routine functional testing may be beneficial to patients not treated with stents. Background: The role of routine functional testing following successful PCI is unclear. By improving patient outcomes with coronary stenting, the value of such a strategy may diminish. Hypothesis: To determine the clinical utility of routine functional testing following PCI between patients with and without stenting. Methods: The routine versus selective exercise testing after angioplasty (ROSETTA) Registry was established to evaluate the utilization of functional testing following PCI. Use of functional testing, either routine or selective (clinically-driven), was left to the discretion of the attending physician. Results: Of 791 patients enrolled, 462 (58%) underwent coronary stenting. Stented patients were less likely to suffer from concomitant diseases but had more complex angiographic morphological characteristics. Between the groups of patients with and without stents, there was no difference in the proportion of patients undergoing routine functional testing (24% vs. 36%) or subsequent cardiac procedures (18.4% vs. 16.0%). Among patients with stents, outcomes at 6 months were similar between the groups undergoing routine and selective functional testing, including death (0% vs. 1.7%), myocardial infarction (0.9% vs. 2.0%), unstable angina (9.9% vs. 13.7%), repeat angiography (16.2% vs. 16.9%) and revascularization procedures (11.7% vs. 10.8%). However, among non-stented patients, selective functional testing was associated with a higher occurrence of death, myocardial infarction or unstable angina (14.8% vs. 6.6%; P =0.033). There was also no difference in the rates of repeat coronary angiography or revascularization procedures between these two strategies. Conclusion: Although routine functional testing has little impact on outcomes among patients treated with coronary stents, non-stented patients may derive particular benefit.

Background: Ethnic differences in coronary mortality have been documented, and South Asians from the Indian subcontinent are particularly vulnerable. Hypothesis: This study sought to determine whether there was a difference in the utilization of invasive cardiac procedures and long-term mortality in survivors of myocardial infarction (MI) among Chinese, Malays, and South Asians in Singapore. Methods: All MI events in the country were identified and defined by the Singapore Myocardial Infarction Register, which uses modified procedures of the World Health Organization MONICA Project. Information on utilization of coronary angiography, coronary angioplasty, coronary artery bypass graft, and survival was obtained by data linkage with national billing and death registries. Hazard ratios (HR) were calculated using the Cox proportional hazards model with adjustment for baseline characteristics. Results: From 1991 to 1999, there were 10,294 patients who survived ≥3 days of MI. Of these, 40.6% underwent coronary angiography and 16.5% a revascularization procedure ≤28 days. Malays received substantially less angiography (34.0%) and revascularization (11.4%) than Chinese (41.9%, 17.9%) and South Asians (40.0%, 16.3%). The ethnic disparity increased during the 1990s, particularly in the performance of coronary angiography (p = 0.038). While fatality declined during the study period for Chinese and South Asians, the rate remained stable for Malays. After a median follow-up period of 4.1 years, survival was lowest among Malays (adjusted HR, 1.28; 95% confidence interval, 1.15--1.42, compared with Chinese). Conclusion: Ethnic inequalities in invasive cardiac procedures exist in Singapore and were exacerbated in the 1990s. Inequalities in medical care may contribute to the poorer long-term survival among Malays.

We conducted a randomized feasibility pilot study comparing combined fibrinolysis with immediate rescue angioplasty vs. primary angioplasty with adjunctive abciximab in patients with acute myocardial infarction (AMI). Seventy patients with ST segment elevation AMI of ≤ 6 hr were randomized to either 50 mg of alteplase and abciximab (n = 34) or primary angioplasty with adjunctive abciximab (n = 36). Coronary angiography was performed at 60 min in the combined lytic group and TIMI 3 flow was present in 65% of patients as compared to 25% (P = 0.001) in the primary angioplasty group prior to intervention. Treatment success, defined as TIMI 3 flow, was achieved in 83% of patients in the primary angioplasty group (P = 0.075 compared to 65% in combined lytic group before rescue angioplasty). There was no difference in overall treatment success between primary angioplasty and combined lytic group with rescue angioplasty (83% vs. 94%; P = NS). Major adverse cardiac events at 1 month were not significant (15% vs. 11%; P = NS), but there was a trend toward more events in the combined lytic group at 6 months (32% vs. 14%; P = 0.066), particularly in target vessel revascularization. In this feasibility pilot study, high rate of TIMI 3 flow was attained in patients with AMI with both combined fibrinolysis and primary angioplasty with adjunctive abciximab. A larger randomized trial is currently ongoing to compare these two strategies. Cathet Cardiovasc Intervent 2004;62:445–452. © 2004 Wiley-Liss, Inc.

The purpose of this study was to determine the impact of these 2 reperfusion strategies (reduced-dose alteplase plus abciximab or direct angioplasty plus abciximab) on fibrinolytic and thrombin generation activities. The effect of reduced-dose alteplase plus abciximab and direct angioplasty plus abciximab on hemostatic factors is unknown. Of 70 patients with acute myocardial infarction ofor = 6 hours, 34 were randomized to reduced-dose alteplase (35 to 50 mg in 1 hour) and 36 to direct angioplasty. A standard bolus and infusion dose of abciximab was administered to all patients. Blood specimens were collected at baseline, and at 1, 4, 12, and 24 hours. The following parameters were assayed: fibrinogen, plasminogen and antiplasmin activities, tissue plasminogen activator antigen, D-dimer, prothrombin fragments F1 + 2, and thrombin/antithrombin III complexes. Among patients treated with reduced-dose alteplase plus abciximab, the fibrinogen level decreased by 28.4% in the first hour (11.7 +/- 3.4 vs 7.8 +/- 2.5 micromol/L, p0.001). Correspondingly, plasminogen and antiplasmin activities decreased by 43.8% (p0.001) and 59.1% (p0.001), respectively. Prothrombin fragments F1 + 2 increased from 2.2 +/- 1.7 to 4.2 +/- 1.6 nmol/L (1 hour) (p0.001) and thrombin/antithrombin III increased from 16.3 +/- 15.0 to 33.5 +/- 19.9 microg/L (1 hour) (p0.001). Conversely, in the direct angioplasty group, there was a marginal elevation in fibrinogen level at 1 hour (10.2 +/- 2.4 vs 10.6 +/- 2.0 micromol/L, p = 0.064) despite a significant reduction in plasminogen and an increase in tissue plasminogen activator levels. There was no significant change in prothrombin fragments F1 + 2 and thrombin/antithrombin III levels. Thus, there was considerable fibrinolytic activity with reduced-dose alteplase plus abciximab; thrombin generation was not prevented. Among patients treated with direct angioplasty, there was some endogenous fibrinolytic activity, but there was no significant thrombin generation.

To compare 6-month post-percutaneous transluminal coronary angioplasty (PTCA) outcomes and cardiac procedure use among patients with and without prior coronary artery bypass graft (CABG) surgery, we examined 791 patients who were enrolled in the Routine versus Selective Exercise Treadmill Testing after Angioplasty (ROSETTA) Registry. The ROSETTA Registry is a prospective, multicenter registry that examines the use of functional testing after successful PTCA. Most patients were men (76%, mean age 61 ± 11 years) who underwent single-vessel PTCA (85%) with stent implantation (58%). Baseline and procedural characteristics differed between patients with a prior CABG (n = 131) and patients with no prior CABG (n = 660), including Canadian Cardiovascular Society angina class III to IV (60% vs 49%, respectively, p = 0.03) and stenosis involving the proximal left anterior descending coronary artery (10% vs 22%, p = 0.004). Event rates among patients with prior CABG were higher than among patients with no prior CABG, including unstable angina (19% vs 11%, p = 0.02), myocardial infarction (2% vs 1%, p = 0.2), death (4% vs 2%, p = 0.08), and composite clinical events (22% vs 12%, p = 0.003). Furthermore, patients with prior CABG had higher rates of follow-up cardiac procedures, including angiography (24% vs 14%, p = 0.008) and PTCA (13% vs 7%, p = 0.04), but not repeat CABG (2% vs 3%, p = 0.8). A multivariate analysis that included baseline clinical and procedural characteristics demonstrated that prior CABG was a significant independent predictor of clinical events and cardiac procedure use (odds ratio 2.3, 95% confidence interval 1.5 to 3.5, p = 0.0001). Within the prior CABG group, patients with a PTCA of a bypass graft had a higher composite clinical event rate than patients with a PTCA of a native vessel (32% vs 17%, p = 0.05). In contrast, patients with a PTCA of a native vessel had event rates similar to those of patients with no prior CABG (17% vs 12%, p = 0.2). Thus, post-CABG patients have an increased risk of developing a cardiac event or needing a follow-up cardiac procedure during the 6 months after PTCA.

Purpose Hypertension is an important risk factor for coronary artery disease. However, the impact of hypertension on the outcomes of patients undergoing percutaneous transluminal coronary angioplasty (PTCA) is unknown. Our purpose was to evaluate the association between hypertension and adverse outcomes and repeat cardiac procedures during the 6-month period after PTCA. Methods We studied 791 patients who were enrolled in the Routine Versus Selective Exercise Treadmill Testing After Angioplasty (ROSETTA) registry. This registry is a prospective multicenter study examining the use of functional testing after a successful PTCA. Results We compared 411 hypertensive patients (mean age 60.1 ± 10 years, 31.1% female) with 380 normotensive patients (mean age 59.1 ± 12 years, 16.2% female). Patients with hypertension had a higher 6-month rate of composite clinical events (unstable angina, myocardial infarction, death) than did normotensive patients (16.5% vs 10.5%, P =.017). In addition, there was a trend for hypertensive patients to have higher rates of cardiac procedures (angiography, repeat PTCA, coronary artery bypass graft surgery) compared with normotensive patients (19.8% vs 14.9%, P =.074). However, functional testing after PTCA was lower among hypertensive subjects (44.4% vs 54.0%, P =.008). Among the 411 hypertensive patients, a regression analysis showed that several variables were independently associated with increased 6-month adverse event rates, including pre-PTCA Killip class III-IV (odds ratio [OR] 5.7, 95% CI 1.7-19.0), Canadian Cardiovascular Society angina class III-IV (OR 2.1, 95% CI 1.1-4.2), unstable angina as the reason for PTCA (OR 2.3, 95% CI 1.2-4.3), peripheral vascular disease (OR 3.2, 95% CI 1.5-6.4), PTCA of a bypass graft (OR 3.1, 95% CI 1.2-7.6), and calcium antagonist usage at admission for the index PTCA (OR 1.9, 95% CI 1.1-3.4). Conclusions During the 6-month period after a successful PTCA, patients with hypertension have significantly higher adverse event rates than do those without hypertension. Several clinical variables may help identify which hypertensive patients are at higher risk for clinical events. (Am Heart J 2002;143:124-9.)

Unlike various atherosclerotic risk factors in which the population attributable to risk fell marginally from the period 1952 to 1974 to the period 1975 to 1998, it rose for diabetes ([1][1]). This adverse trend is worrisome as the prevalence of diabetes is rapidly growing worldwide, rising from 171

A VR simulator provides low-cost, realistic training for intracardiac techniques for determining the heart's mechanical and electrical activities. A geometric method models interaction between a catheter and the heart wall. Boundary-enhanced voxelization accelerates detection of catheter-heart interaction. A tactile interface incorporates a VR catheter unit to track the catheter's movement.

Objective Diabetes mellitus is associated with high rates of restenosis and adverse outcomes after percutaneous transluminal coronary angioplasty (PTCA). It is unclear whether coronary stenting reduces adverse events in diabetic patients after PTCA. Our purpose was to determine whether coronary stenting improves clinical event rates in diabetic patients after PTCA. Methods The Routine Versus Selective Exercise Treadmill Testing After Angioplasty (ROSETTA) registry was a prospective multicenter observational study examining functional testing and adverse outcomes after successful PTCA. Results Among the 791 patients enrolled, 180 were diabetic. A total of 90 diabetics received stents while the remaining 90 patients did not. Baseline clinical characteristics were similar between the 2 groups of patients. However, patients with stents were more likely to have complex lesions, whereas those without stents were more likely to undergo atherectomy and have greater residual coronary stenosis. At 6-month follow-up, the composite end point defined as cardiac death, unstable angina, myocardial infarction, need for repeat PTCA, or coronary artery bypass graft surgery (CABG) occurred in 25.0% of stented and 22.2% of nonstented diabetic patients ( P not significant [NS]). A multivariate logistic regression analysis showed that coronary stenting was not associated with a reduced incidence of the composite end point among diabetic patients (odds ratio 0.97, 95% CI 0.46-2.05, P NS). Conclusion Coronary stenting does not improve clinical event rates in diabetic patients after PTCA. (Am Heart J 2001; 142:960-4.)

Background Among patients receiving thrombolytic therapy for myocardial infarction, the outcome for those with a history of infarction is dramatically worse than for those with their first event. Methods and Results We performed a post hoc analysis of patients with a history of myocardial infarction enrolled in the Global Utilization of Streptokinase and TPA for Occluded arteries (GUSTO)-I trial, focusing on the impact of the location of their current and prior events on mortality rates. Within the first 24 hours, mortality rate was greatest among patients with a current infarction in a territory remote from their previous event. By 48 hours after examination, mortality rates among patients with a second anterior infarct had overtaken that among patients with a current inferior/prior anterior infarct. This hierarchy of risk persisted at both 30 days and 1 year (mortality rate at 1 year: current anterior/prior inferior 23.2% ± 1.4%, current anterior/prior anterior 20% ± 1.5%, current inferior/prior anterior 17% ± 1.2%, current inferior/prior inferior 10.8% ± 0.9%). Conclusions In patients with ST-elevation myocardial infarction on a background of prior infarction, the location of current and prior events predicts a hierarchy of short- and long-term risk of death. (Am Heart J 2000;140:29-33.)

Although fibrinolysis has improved survival of patients after myocardial infarction (MI), such therapy is less likely to be administered to patients with diabetes. Furthermore, these patients present later (15 min) than nondiabetics. Moreover, even with the use of early potent fibrinolytic agents, patients with diabetes continued to suffer excessive morbidity and mortality. This finding is not related to the ability of fibrinolytic agents to restore complete reperfusion or increased risk of reocclusion of the infarct-related artery. Instead, the impaired ventricular performance at the noninfarct areas and metabolic derangements during the acute phase of MI may account for the adverse outcome. The efficacy of percutaneous coronary revascularization procedures for treatment of acute MI requires further evaluation. Therapeutic approaches should consider correcting these abnormalities to afford greater survival benefit for this subset of high-risk patients.

Heparin-induced thrombocytopenia (HIT) is a potentially serious complication of heparin therapy and is being encountered more frequently in patients with cardiovascular disease as use of anticoagulant therapy becomes more widespread. Our understanding of the pathophysiology of this immune-mediated condition has improved in recent years, with heparin–platelet factor 4 complex as the culprit antigen in most patients. New sensitive laboratory assays for the pathogenic antibody are now available and should permit an earlier, more reliable diagnosis, but their optimal application remains to be defined. For patients in whom HIT is diagnosed, immediate discontinuation of heparin infusions and elimination of heparin from all flushes and ports are mandatory. Further management of patients with HIT is problematic at present, as there are no readily available alternative anticoagulant agents in the United States with proven efficacy in acute coronary disease. The direct thrombin inhibitors appear to be the most promising alternatives to heparin, when continued use of heparin is contraindicated, and the results of several multicenter trials evaluating their application in patients with HIT are awaited.

The primary objective of this study was to characterize a large cohort of patients receiving thrombolytic therapy for acute myocardial infarction with respect to the group with a prior event. Patients were randomly assigned to 1 of 4 thrombolytic strategies. Baseline characteristics, 30-day outcomes, and 1-year mortality were compared between patients with (n = 6,704) and without (n = 34,143) prior myocardial infarction. Patients with prior myocardial infarction presented to the hospital earlier than those having their first event, but institution of thrombolytic therapy was delayed. Mortality at 30 days (11.7% vs 5.9%, p = 0.001) and 1 year (17.3% vs 8.2%, p

Several of the adverse events that occur in acute coronary syndromes and after percutaneous coronary revascularization procedures are believed to be mediated by platelets. Recently, using molecular biology techniques, the platelet glycoprotein IIb/IIIa receptor was identified as the final common pathway for platelet aggregation. Thus, blocking the action of this receptor would seem to be an attractive proposition for reducing ischemic complications. A monoclonal antibody was the first agent in this new pharmacological family to be designed, but several peptide and peptide-like substances have subsequently been developed. This paper reviews the development of this class of agents and the various preclinical and clinical trials that have been undertaken. Early studies evaluated such agents during percutaneous coronary revascularization procedures. Because of the overwhelming benefits observed in such patients, together with the current limitations of treatments for acute coronary syndromes, the scope of investigations has been extended. Preliminary reports have been encouraging.