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| | | | | ESC 2005 | | | | | | ESC 2005
European Society of Cardiology
2005 Congress
September 3–7, 2005
Stockholm, Sweden |
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| | | |  | Targeting Early Intervention at Higher Risk Patients: Findings From RITA 3
P.A. Poole-Wilson et al
In patients with acute non-ST-elevation coronary syndrome, the benefits of an early invasive strategy vs conservative intervention guided by symptoms may vary over time. In the Randomized Intervention Trial of unstable Angina 3 (RITA 3), 895 patients were randomly assigned to coronary angiography (median 2 days after randomization) and 915 patients were randomly assigned to a symptom-guided strategy. All patients received a beta-blocker and, unless contraindicated, aspirin and enoxaparin (1 mg/kg twice a day SC for 2–8 days).
There was a significant benefit in the coprimary combined end point (death, nonfatal myocardial infarction [MI], or refractory angina) in patients who received early intervention at 4 months (risk ratio 0.66, 95% CI 0.51–0.85, P = 0.001) and at 12 months (P = 0.003) that was largely the result of a 53% reduction in the incidence of refractory angina. Death and MI were similar in both treatment groups at 4 and 12 months. Patients in both groups were at highest risk of death, MI, or refractory angina in the first 7 days (> 40 times the incidence at 5–12 months). In the first 72 hours following randomization, the event rates per 1000 patient-days for death or nonfatal MI were 5.6 in the early invasive arm vs 3.7 in the conservative arm. The rate after 28 days declined to < 0.1/1000 patient-days. At 7 days, there were 6 deaths (4 procedure-related) and 22 MIs (14 procedure-related) in the early invasive group compared with 3 deaths and 17 MIs in the conservatively managed group. At 28 days there were 15 deaths (7 procedure-related) and 24 MIs in the early invasive group vs 9 deaths and 25 MIs in the conservative intervention group.
These results underscore the very high risk of events in the first week and the substantial minority of patients who do not require intervention. The authors conclude that early intervention might best be targeted at higher risk patients because the early hazards of the procedure are then offset by reduced subsequent events.
In a separate presentation, the 5-year data from the RITA 3 trial were presented. This presentation revealed a long-term benefit of an early invasive approach: the rate of death or nonfatal MI was 16.6% in patients undergoing intervention, and 20.0% in those receiving conservative therapy. Further analysis revealed that the benefit of early intervention was mainly seen in the highest-risk patients.
Reference
Poole-Wilson PA, Pocock SJ, Abdalla M, et al, on behalf of the Randomized Intervention Trial of unstable Angina (RITA). The time course of patient management and disease events in the acute coronary syndrome; findings from the RITA 3 trial. Eur Heart J. 2005;26(abstract suppl):308.
Fox KAA, Poole-Wilson P, Clayton TC, et al. 5-year outcome of an interventional strategy in non-ST-elevation acute coronary syndrome: the British Heart Foundation RITA 3 randomised trial. Lancet. 2005;366:914-920.Back to top
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| | | | | Trends in the Use of Clopidogrel in Patients With ACS: The GRACE Experience
R.J. Goldberg et al
Clopidogrel and other antiplatelet agents are increasingly used in the management of patients with acute coronary syndromes (ACS). The aim of the Global Registry of Acute Coronary Events (GRACE) was to explore changes in the characteristics of patients treated with clopidogrel over time and whether such changes were related to international patterns of management.
Data from a multinational registry involving 43,795 patients of all ages hospitalized with ACS at 100 sites in 14 countries over a 5-year period (1999–2004) were analyzed using standardized definitions for ACS and associated outcomes. Hospital medical records were reviewed to identify the use of clopidogrel and other cardiac medications in patients hospitalized for ACS.
Patients treated for ACS in Europe were the most likely to receive clopidogrel during hospitalization (54%), followed by patients from North America (45%), Australia and New Zealand (39%), and Brazil and Argentina (38%). Use of clopidogrel was strongly associated with the performance of percutaneous coronary intervention (PCI) at all sites (range of use from 83%–91%). Clopidogrel was less frequently used in patients who did not undergo PCI (19%–27%). Clopidogrel use increased significantly over time at all sites (from 26% in 1999 to 59% in 2004), with particularly marked increases noted among patients not undergoing PCI. Younger patients, men, patients with ST-segment elevation myocardial infarction, and patients undergoing cardiac catheterization and PCI were more likely to be treated with clopidogrel. A similar profile of patients treated with clopidogrel was found across all regions.
Analyses are ongoing to determine other possible demographic differences, and the relationship of clopidogrel use to the use of other cardiac medications and hospital outcomes.
Reference
Goldberg RJ, Spencer FA, Lopez-Sendon J, et al, on behalf of the GRACE Investigators. International and time trends in the use and characteristics of patients with acute coronary syndromes treated with clopidogrel: the Global Registry of Acute Coronary Events experience. Eur Heart J. 2005;26(abstract suppl):160.
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| | | | | Fondaparinux Compared With Enoxaparin in High-risk Patients With ACS Without ST Elevation: The OASIS 5 Michelangelo Programme
S. Yusuf et al
The primary objective of this study was to evaluate whether the direct factor Xa inhibitor fondaparinux, which has recently been licensed for use in the prevention of venous thromboembolism, was at least as effective as, or superior to, enoxaparin in preventing death, myocardial infarction (MI), or refractory ischemia up to day 9 in the acute treatment of patients with unstable angina/non-ST-segment elevation MI (NSTEMI). Patients with NSTEMI and 2 of the following 3 criteria were enrolled:
1. Age > 60
2. ST deviation
3. Positive cardiac marker
Patients were randomized to receive either fondaparinux 2.5 mg once daily SC for 8 days or until hospital discharge (whichever was earlier); or enoxaparin (1 mg/kg) twice daily SC for 2 to 8 days or until clinically stable. In total, 20,078 patients were enrolled from 576 sites across 41 countries: 10,021 in the enoxaparin group vs 10,057 in the fondaparinux group. Baseline characteristics were similar between groups, as was the use of concomitant medications. The primary composite efficacy end point of death/MI/refractory ischemia (D/MI/RI) at 9 days occurred in 5.8% of patients in the enoxaparin group vs 5.9% of patients in the fondaparinux group (HR 1.01, 95% CI 0.90–1.13). The noninferiority P value was 0.0068, which met the prespecified criteria for noninferiority. Major bleeds at 9 days were significantly reduced in the fondaparinux group (2.1% vs 4.0% in the enoxaparin group [P < 0.00001]). At 6 months, the composite efficacy/safety end point of D/MI/RI and major bleeding was significantly reduced (HR 0.87, 95% CI 0.81–0.93, P < 0.00001). However, when this end point was stratified by age, the 30-day rates in the fondaparinux and enoxaparin groups were similar for patients aged less than 65 years of age (7.4% vs 7.5%; HR 0.99, 95% CI 0.84–1.16, P = 0.883). In patients aged over 65 years, the rate was significantly lower in the fondaparinux group (12.1% vs 15.4%; HR 0.77, 95% CI 0.70–0.85, P < 0.0001).
A total of 3118 patients in the fondaparinux group and 3089 in the enoxaparin group underwent percutaneous coronary intervention (PCI). Of these, 18.8% of patients in the fondaparinux group received unfractionated heparin (UFH) vs 53.8% of patients in the enoxaparin group. This confounded the results. However, the rate of catheter thrombosis in the fondaparinux group was 1.3% vs 0.5% in the enoxaparin group (P = 0.001). This led to a trial amendment to add UFH to fondaparinux in patients undergoing PCI; however, only 330 patients were treated with this regimen. This approach of adding UFH to fondaparinux if PCI is needed will be used in the ongoing OASIS-6 trial.
Reference
Yusuf S, Mehta SR. OASIS-5: efficacy and safety of fondaparinux compared to enoxaparin in 20,000 high risk patients with ACS without ST elevation: the OASIS 5 Michelangelo programme. European Society of Cardiology 2005 Hotline session.Back to top
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| | | | | The STEEPLE Study: Safety and Efficacy of IV Enoxaparin in Elective PCI: An International Randomized Evaluation
G. Montalescot et al
Unfractionated heparin (UFH) is currently the standard of care for anticoagulant therapy during percutaneous coronary intervention (PCI). However, in patients with acute coronary syndromes (ACS), enoxaparin has demonstrated superiority over UFH. The primary objective of the STEEPLE study was to demonstrate the superior safety of IV enoxaparin (0.5 mg/kg and 0.75 mg/kg) compared with IV UFH in patients undergoing nonemergent PCI, defined as non–coronary artery bypass graft (CABG)-related major and minor bleeding until 48 hours after PCI.
A total of 3528 patients from 9 countries scheduled for nonemergent femoral-access PCI were included in the study; the majority of the patients were from the United States. Patients were randomized to receive enoxaparin (0.5 or 0.75 mg/kg IV) or a UFH regimen adjusted for activated clotting time (ACT). The primary end point was the incidence of non–CABG-related major and minor bleeding, which was 31% lower in the enoxaparin 0.5 mg/kg arm vs the UFH arm (6.0% vs 8.7%, P = 0.014). The enoxaparin 0.75 mg/kg dose was also associated with a 24% reduction in the incidence of non–CABG-related major and minor bleeding (6.6% vs 8.7%, P = 0.052), which met the criteria for noninferiority.
Anticoagulation with UFH can be difficult to regulate; in this study, the number of patients reaching target anticoagulation levels was also monitored. More patients reached their target anticoagulation levels with enoxaparin than with UFH (79% and 92% for enoxaparin 0.5 and 0.75 mg/kg, respectively, vs 20% for UFH; P < 0.001).
The authors concluded that the clinical benefit observed with enoxaparin came with superior ease of use compared with UFH (ie, enoxaparin can be used in a single IV bolus before the start of PCI, and no anticoagulation monitoring is needed). They stated that IV enoxaparin offers an attractive alternative to the cumbersome and uncertain ACT-driven UFH anticoagulation used in the catheterization laboratory.
Reference
Montalescot G, et al. The STEEPLE study: safety and efficacy of intravenous enoxaparin in elective percutaneous coronary intervention: an international randomized evaluation. European Society of Cardiology 2005 Hotline session.Back to top
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| | | | | STEMI Patients Reperfused by Prehospital-Initiated Facilitated PCI Have the Highest Rate of Complete ST-Segment Recovery
H. Thiele et al
The ST-segment recovery at 90 minutes provides an indirect assessment of myocardial tissue perfusion. Although complete ST-segment recovery is associated with a favorable prognosis for patients with ST-segment elevation myocardial infarction (STEMI), the optimal reperfusion strategy is still a matter of debate, particularly in patients who present early after symptom onset. This study evaluated ST-segment recovery for patients treated by either prehospital fibrinolysis or prehospital-initiated facilitated percutaneous coronary intervention (PCI) in comparison with primary PCI.
Patients with STEMI (symptoms < 6 hours) were randomized to either prehospital fibrinolysis (group A; n = 82) or facilitated PCI after prehospital fibrinolysis (group B; n = 82). Furthermore, a control group of patients with primary PCI (group C; n = 136) was prospectively assessed. ST-segment resolution at 90 minutes was analyzed by blinded observers as percentage resolution of the initial ECG: complete (> 70%), incomplete (70%–30%), or no resolution (< 30%).
Times between the initial ECG and the follow-up ECG were similar between the treatment groups. ST-segment resolution at 90 minutes measured as a continuous parameter was 59.1 ± 45.3% in group A vs 82.8 ± 23.5% in group B (P < 0.001) and 62.6 ± 34.0% in group C (P = NS vs A; P < 0.001 vs B). The percentage of patients with complete resolution was highest in group B with 80%, vs 52% in group A and 47% in group C (P < 0.001). There was also a trend towards improved outcome in the occurrence of the combined clinical end point of death, myocardial reinfarction, stroke, and major bleeding for patients in group B (8%, vs 21% in group A and 14% in group C; P = 0.16).
These data show that prehospital-initiated facilitated PCI results in the highest percentage of complete ST-segment recovery compared with either prehospital fibrinolysis or primary PCI. The authors concluded that prehospital-initiated facilitated PCI may be the preferred reperfusion strategy for patients with STEMI.
Reference
Thiele H, Scholz M, Sick P, Boudriot E, Niebauer J, Schuler G. ST-segment recovery in patients with ST-elevation myocardial infarction reperfused by pre-hospital fibrinolysis, pre-hospital initiated facilitated PCI or primary PCI. Eur Heart J. 2005;26(abstract suppl):431.Back to top
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| | | | | Fondaparinux Compared With UFH in Patients Undergoing PCI: Results From the ASPIRE Pilot Study
S.R. Mehta et al
Percutaneous coronary intervention (PCI) is associated with unacceptably high rates of abrupt vessel closure and reocclusion despite use of concomitant pharmacologic therapy that includes antiplatelet agents and anticoagulants. The aim of this randomized, blinded, controlled, parallel-group pilot study was to determine the safety and feasibility of fondaparinux compared with unfractionated heparin (UFH) in the PCI setting.
A total of 350 patients undergoing elective or urgent PCI were randomized to receive fondaparinux (either 2.5 mg or 5.0 mg IV) or UFH. Randomization was stratified for planned vs no planned use of glycoprotein IIb/IIIa inhibitors. All patients were pretreated with aspirin and clopidogrel; study medications were administered at the time of guide wire insertion into the catheter. The primary safety outcome was total (major and minor) bleeding within 48 hours after randomization. The primary efficacy outcome was the first occurrence within 48 hours after randomization of any component of the composite end point of all-cause death, myocardial (re)infarction, urgent revascularization, and need for bail-out glycoprotein IIb/IIIa inhibitors.
The incidence of total bleeding was 6.4% in the combined fondaparinux groups vs 7.7% in the UFH group (HR 0.81, 95% CI 0.35–1.84; P = 0.61). Bleeding was less common in the fondaparinux 2.5 mg group than in the 5.0 mg group (3.4% vs 9.6%, P = 0.06). Incidence of the composite efficacy outcome was 6.0% in the combined fondaparinux groups compared with 6.0% in the UFH group, with no significant differences in efficacy between the individual fondaparinux groups compared with UFH. Fondaparinux was significantly (P = 0.02) superior to UFH in inducing a sustained reduction in markers of thrombin generation, as assessed by prothrombin fragments F1+2 measured 6 and 12 hours after PCI.
From the results of this pilot study, the authors concluded that fondaparinux is as safe and effective as UFH in patients undergoing contemporary PCI, warranting further evaluation in the treatment of arterial thrombosis.
Reference
Mehta SR, on behalf of the ASPIRE Pilot Investigators. A randomised blinded trial comparing fondaparinux with unfractionated heparin in patients undergoing contemporary percutaneous coronary intervention: the ASPIRE pilot study. Eur Heart J. 2005;26(abstract suppl):482.Back to top
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| | | | | Cost Savings With Enoxaparin Compared With UFH in Patients Undergoing Cardioversion of Nonvalvular Atrial Fibrillation: Results From the ACE Study
P.K. Schaedlich et al
The Anticoagulation in Cardioversion using Enoxaparin (ACE) study demonstrated that anticoagulation with SC enoxaparin was noninferior to IV unfractionated heparin followed by oral phenprocoumon (UFH/PPC) in preventing death and ischemic, thromboembolic, and hemorrhagic events. In contrast to UFH/PPC, therapy with enoxaparin can be initiated on an outpatient basis. The purpose of the present study was to determine the potential economic consequences of using enoxaparin instead of UFH/PPC for anticoagulation in transesophageal echocardiography (TEE)-guided early electrocardioversion (ECV) of persisting nonvalvular atrial fibrillation without intracardiac clot from the perspective of Statutory Health Insurance (SHI), the third-party payer in Germany.
The target variable (savings or incremental expenses for enoxaparin vs UFH/PPC) was quantified using a decision-analytic model considering both inpatient and outpatient sectors. The analysis encompassed 28 (range 26–30) treatment days. Phase I with 5 (range 3–12) days comprised diagnostics, initiation of anticoagulation, and ECV. Phase II with the remaining days comprised continued anticoagulation. Resource use during treatment was valuated in monetary terms according to German healthcare regulations (reference period 2003/2004).
The base-case analysis considered all patients (ie, those with any comorbidity or complication level). In phase I, inpatient and outpatient ECV was assumed in 38% and 62% of enoxaparin patients and in 100% and 0% of UFH/PPC patients, respectively. There was cost savings of EUR 338 per patient with enoxaparin (EUR 1357) compared with UFH/PPC (EUR 1695). Subgroup analysis of low-risk patients (ie, low comorbidity and complications expected only in rare cases) was based on 1-day inpatient ECV (phase I) in 1% of the enoxaparin patients and revealed savings of EUR 579 per patient with enoxaparin (EUR 892) compared with UFH/PPC (EUR 1471). Comprehensive deterministic and stochastic sensitivity analyses demonstrated the robustness of the results.
This analysis indicates a considerable potential cost savings in using enoxaparin instead of UFH/PPC for anticoagulation in patients undergoing TEE-guided ECV of atrial fibrillation without intracardiac clot.
Reference
Schaedlich PK, Schmidt-Lucke C, Huppertz E, et al, on behalf of the ACE Study Group. Cost saving anticoagulation with enoxaparin in patients undergoing cardioversion of nonvalvular atrial fibrillation – results from the Anticoagulation in Cardioversion using Enoxaparin (ACE) Study. Eur Heart J. 2005;26(abstract suppl):368.Back to top
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| | | | | A Risk Scoring System Based on Inflammatory Markers for Patients With Unstable Coronary Disease
T. Kilic et al
Inflammatory markers have independent prognostic value for patients with unstable coronary artery disease (UCAD). The aim of this study was to establish a risk scoring system for predicting long-term prognosis in UCAD patients based on inflammatory parameters.
Serum levels of high-sensitivity C-reactive protein (hs-CRP), pro-inflammatory (IL-1beta and hs-IL-6), and anti-inflammatory (IL-10) cytokines were analyzed in 80 UCAD patients, as well as calculation of pro-to-anti-inflammatory cytokine ratios. An early invasive strategy was employed for all patients, who were followed for 12 months. The primary end point of the study was new coronary events (NCE), defined as the combination of cardiac death, nonfatal myocardial infarction (MI), and recurrent rest angina requiring hospitalization.
After 1 year, there were 23 NCE, including 5 cardiac deaths (6%), 5 nonfatal MIs (6%), and 13 recurrent rest anginas (16%). CRP, IL-1beta levels, IL-1beta/IL-10, and IL-6/IL-10 ratios were significantly higher in patients with NCE than in patients without. To develop a risk score using these parameters, predictive cut-off values for NCE were estimated by ROC curve analysis. An increase above these values (hs-CRP > 0.9 mg/dL, IL-1beta > 0.13 pg/mL, IL-1beta/IL-10 > 0.03, and IL-6/IL-10 > 0.7) was scored as 1 point for each parameter. Total inflammatory risk score (TIRS) was calculated from 0 to 4 by summation of these individual point values. During the study period, only 1 NCE occurred in patients with a TIRS of 0; in contrast, the frequency of NCE was 83% in patients with a TIRS of 4. In multivariate analysis, TIRS was the most important predictor for NCE in the follow-up period.
Based on these results, the authors concluded that a risk scoring system based on inflammatory and anti-inflammatory markers may be valuable for predicting long-term prognosis in patients with UCAD.
Reference
Kilic T, Kahraman G, Agacdiken A, et al. A new risk scoring system based on inflammatory markers in patients with unstable coronary artery disease. Eur Heart J. 2005;26(abstract suppl):647. Back to top
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| | | | | Preprocedural hs-CRP Level Is Associated With Procedure-related Microembolization During Coronary Stenting
S.Y. Choi et al
Elevated high-sensitivity C-reactive protein (hs-CRP) is a biomarker for the inflammatory process that may indicate the potential for microembolization of atheromatous plaque and poor prognosis in patients with coronary artery disease. The aim of this study was to evaluate whether preprocedural hs-CRP level is associated with procedure-related myocardial injury after coronary stenting.
Within 24 hours before coronary stenting, plasma hs-CRP levels were obtained from angina patients. Patients were divided into 2 groups: normal CRP (hs-CRP < 3 mg/L) or elevated CRP (hs-CRP >= 3 mg/L). A reduction in TIMI myocardial perfusion (TMP) was defined as one or more decreases of TMP grade after percutaneous coronary intervention in comparison with preprocedural TMP. Procedure-related myocardial damage was also evaluated by measuring creatine kinase-myocardial bound (CK-MB) leakage after stenting.
There were 226 patients with 279 lesions enrolled in the study, divided into 2 groups: patients with normal CRP (n = 137, 1.28 ¡À 0.71 mg/L) and those with elevated CRP (n = 89, 6.89 ¡À 4.23 mg/L). Reductions in TMP grade were significantly more prevalent in the elevated CRP group (20 lesions, 17.4%) compared with the normal CRP group (6 lesions, 3.7%; P = 0.001). Elevated CRP was related to an increase in CK-MB after stenting: 23 patients (25.8%) in the elevated CRP group vs 21 patients (15.3%) in the normal CRP group (P = 0.041). In a multivariable analysis, the only significant predictor of reduction of TMP grade after stenting was elevated CRP (odds ratio 4.35, 95% CI 1.11¨C17.07, P = 0.035).
The authors concluded that systemically detectable inflammatory activity represented by plasma hs-CRP level is associated with procedure-related microvascular injury as assessed by reduction of TMP grade and CK-MB elevation after coronary stenting.
Reference
Choi SY, Tahk SJ, Yang HM, et al. Preprocedural hs-CRP level is related to the procedure-related microembolisation during coronary stenting. Eur Heart J. 2005;26(abstract suppl):649. Back to top
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| | | | | ELISA-2: A Randomised Comparison of Double vs Triple Antiplatelet Treatment in Patients With NSTE-ACS Undergoing PCI
S. Rasoul et al
This study looked at the utility of treatment with clopidogrel (600 mg) and aspirin compared with clopidogrel (300 mg), aspirin, and tirofiban therapy, in 328 patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention. Tirofiban was given as a 10 mg/kg bolus plus a continuous infusion of 0.15 mg/kg/min.
Patients were enrolled in the study if they had ischemic chest pain and an abnormal ECG. The primary end point of the study was the enzymatic infarct size measured by cumulative lactate dehydrogenase (LDH) release and peak creatine kinase (CK) levels, while the initial TIMI flow in the culprit vessel was the secondary end point. Angiograms were performed within 24–48 hours of enrollment.
Overall, there were 166 patients in the double therapy group (clopidogrel plus aspirin), and 162 patients in the triple therapy group (clopidogrel, aspirin, and tirofiban). Baseline characteristics were similar between groups, as were the rates of angiography and other interventions.
There was no significant difference in enzymatic infarct size between the 2 groups, but there was an improvement in TIMI flow with the triple therapy strategy. Freedom from death/myocardial infarction (MI) was 43% in the double therapy group and 54% in the triple therapy group (P = 0.098), displaying a trend towards improved survival in the triple therapy arm. There were, however, no significant differences in the rate of death, MI, stroke, or bleeding between groups. The authors concluded that further study is needed to confirm the utility of this regimen.
Reference
Rasoul S, et al. ELISA-2 – a randomised comparison of double vs. triple antiplatelet treatment in patients with NSTE ACS undergoing PCI. European Society of Cardiology 2005 Hotline session.Back to top
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| | | | | ASSENT-4 PCI: The Assessment of Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction
F. van der Werf et al
Primary percutaneous coronary intervention (PCI) has been shown to be more effective than fibrinolysis for most patients. However, the time delay in getting patients to the catheterization laboratory significantly affects outcomes; the more time elapsed before the culprit vessel is re-opened, the worse the outcome for the patient. Only a minority of patients are treated within 90 minutes, which is considered to be optimal.
The aim of this study was to test the hypothesis that very early fibrinolysis with tenecteplase prior to delayed PCI is similar in efficacy to primary PCI. Patients were included in the study if they had symptom onset within 6 hours of randomization, they had ST elevation of more than 6 mm, and the study center had the intention of performing primary PCI. Half the patients received a full-dose, single bolus of tenecteplase plus a single bolus of unfractionated heparin (UFH) followed by PCI within 3 hours; the other patients received UFH and primary PCI. Glycoprotein IIb/IIIa inhibitors were only allowed for patients receiving PCI alone. Clopidogrel was not allowed until it was determined that the patient was to receive stent implantation. The primary end point of the study was the combined end point of 90-day mortality, cardiogenic shock, and congestive heart failure. However, the authors only presented the 30-day results.
The trial was stopped prematurely earlier this year due to a high 30-day death rate in the group receiving tenecteplase before PCI, which was not fully explained by increased bleeding. The Data Safety and Monitoring Board of the study recommended that enrollment be stopped early in April 2005. At that time, there were 1667 patients enrolled in the study, 829 in the tenecteplase + PCI arm and 838 in the primary PCI arm.
After PCI, TIMI 3 flow was achieved in 87.6% of patients in the tenecteplase + PCI arm, vs 88.7% of patients in the primary PCI arm (P = NS). Overall TIMI flow was significantly improved in the primary PCI arm (P = 0.03). Similarly, reinfarction, abrupt vessel closure, and revascularization occurred more often in the tenecteplase arm. The 30-day mortality rate was 6% in the tenecteplase plus PCI arm vs 3.8% in the primary PCI arm (P = 0.04). Major bleeding was not significantly different between groups (5.7% vs 4.4%, P = 0.26).
The authors concluded that the tenecteplase + PCI arm had outcomes similar to those seen with tenecteplase in previous trials, but significantly higher rates of 30-day death compared with primary PCI alone. These were only the preliminary results of the study; however, the authors recommended against the use of tenecteplase + PCI in place of primary PCI at the current time. Final results of this study will be presented at the American Heart Association annual meeting.
Reference
van der Werf F, et al. ASSENT-4 PCI – the assessment of safety and efficacy of a new treatment strategy for acute myocardial infarction. European Society of Cardiology 2005 Hotline session.Back to top
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| | | | | The Worldwide Obesity Epidemic: Data From the REACH Registry
D.L. Bhatt et al
Previous prospective studies on patients with risk factors for atherothrombosis have focused on specific subsets of hospitalized patients in defined geographic areas. In the REduction of Atherothrombosis for Continued Health (REACH) Registry, more than 68,000 outpatients with coronary artery, cerebrovascular, or peripheral arterial disease, or with multiple risk factors, were recruited from 43 countries. Patients in the study are aged >= 45 years and have at least 3 known risk factors and/or previous history of at least 1 form of documented disease. Baseline data have been collected and patients are now being followed for up to 2 years. Baseline data include demographic, geographic, and medical characteristics, as well as medication usage.
Obesity is a well-known risk factor for atherothrombosis. Management of obesity can reduce risk and increase life expectancy. Using body mass index (BMI) as a definition of obesity, 28% of males and 35% of females were obese. Strikingly, if waist circumference was used to define obesity, this rose to 37% and 63%, respectively. The frequency of obesity among patients in the REACH Registry varied with gender, region, clinical subpopulation, and the presence of other risk factors. In particular, obesity was most common among North Americans (42% by BMI, 55% by waist circumference). In Asia, only 7% were obese if classified by BMI; however, this rose 3-fold to 21% when waist circumference was used.
Reference
Bhatt DL, Steg PG, Hirsch A, et al, on behalf of the REACH Registry Investigators. The prevalence of obesity in the international REACH Registry – a truly global epidemic with the United States leading the world. Eur Heart J. 2005;26(abstract suppl):683.
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