Ilkka Tierala

Drug-eluting stents in acute myocardial infarction: updated meta-analysis of randomized trials

BackgroundUse of drug-eluting stents in patients with acute myocardial infarction (AMI) remains an “off label” indication due to concerns regarding their performance in this patient subset.MethodsWe searched Medline, the Cochrane Central Register of Controlled Trials, and Internet-based sources of information on clinical trials in cardiology for randomized trials comparing drug-eluting stents with bare-metal stents in patients with AMI. Hazard ratios for the composite of death or recurrent myocardial infarction, (primary safety endpoint), reintervention (primary efficacy endpoint), death, recurrent myocardial infarction, and stent thrombosis were calculated performing a meta-analysis of 14 randomized trials with 7,781 patients.ResultsThere was no difference in the hazard of death or recurrent myocardial infarction (hazard ratio, 0.91; [95% CI 0.75–1.09]) between patients treated with drug-eluting stents versus patients treated with bare-metal stents. Treatment with drug-eluting stents resulted in a significant reduction in the hazard of reintervention (0.41 [95% CI 0.32–0.52]). The hazards of death (0.90 [95% CI 0.71–1.15]), myocardial infarction (0.81 [95% CI 0.63–1.04]), and stent thrombosis (0.84 [95% CI 0.61–1.17]) were not significantly different between patients treated with drug-eluting stents versus patients treated with bare-metal stents.ConclusionsUse of drug-eluting stents in patients with AMI is safe and markedly reduces the need for reintervention as compared to bare-metal stents.

Stents liberadores de fármacos frente a stents convencionales en pacientes diabéticos con infarto agudo de miocardio con elevación del segmento ST: un análisis combinado de los datos de pacientes individuales de 7 ensayos aleatorizados

Introduccion y objetivos. Los resultados obtenidos con los stents liberadores de farmacos (SLF) en el grupo de pacientes de alto riesgo formado por los pacientes diabeticos con infarto agudo de miocardio con elevacion del segmento ST (IAMCEST) tratados con angioplastia primaria no se han estudiado con anterioridad. Nuestro objetivo fue evaluar la eficacia y la seguridad de los SLF en pacientes diabeticos con IAMCEST. Metodos. Llevamos a cabo un analisis combinado de los datos de pacientes individuales de siete ensayos aleatorizados en los que se comparo el empleo de stents liberadores de sirolimus o de paclitaxel (SLF) con el de stents convencionales (SC) en el contexto de un IAMCEST. Se incluyo en este analisis a 389 pacientes con diabetes mellitus de un grupo total de 2.476. Los objetivos del estudio fueron la revascularizacion de la lesion diana, la trombosis del stent, la muerte y la variable combinada de muerte o infarto de miocardio recurrente durante un periodo de seguimiento de 12-24 meses. Resultados. Hubo 206 pacientes diabeticos tratados con SLF y 183 tratados con SC. El riesgo de que se practicara una revascularizacion de la lesion diana fue significativamente inferior en los pacientes tratados con SLF en comparacion con los pacientes tratados con SC (razon de riesgos [HR] = 0,44; intervalo de confianza [IC] del 95%, 0,23-0,88; p = 0,02). El riesgo de trombosis del stent no presento diferencias significativas entre los pacientes tratados con SLF y los tratados con SC (HR = 0,33; IC del 95%, 0,09-1,13; p = 0,08). De forma analoga, el riesgo de la variable de valoracion combinada formada por la muerte y el infarto de miocardio no presento diferencias significativas entre los pacientes tratados con SLF y los tratados con SC (HR = 0,64; IC del 95%, 0,36-1,13; p = 0,12). Conclusiones. En comparacion con los SC, los SLF mejoran los resultados clinicos en los pacientes diabeticos a los que se practica una angioplastia primaria por un IAMCEST, al reducir la necesidad de reintervencion sin incrementar la tasa de mortalidad o infarto de miocardio.

Drug-eluting stents versus bare-metal stents in diabetic patients with ST-segment elevation acute myocardial infarction: a pooled analysis of individual patient data from seven randomized trials.

INTRODUCTION AND OBJECTIVES The performance of drug-eluting stents (DESs) in high-risk patients with diabetes and acute ST-elevation myocardial infarction (STEMI) who have undergone primary angioplasty has not been previously studied. The objective was to evaluate the efficacy and safety of DESs in diabetic patients with STEMI. METHODS We performed a pooled analysis of individual patient data from seven randomized trials that compared DESs (i.e., sirolimus- or paclitaxel-eluting stents) with bare-metal stents (BMSs) in patients with STEMI. The analysis involved 389 patients with diabetes mellitus from a total of 2476 patients. The outcomes of interest were target-lesion revascularization, stent thrombosis, death and the composite endpoint of death or recurrent myocardial infarction during a follow-up of 12-24 months. RESULTS Overall, 206 diabetic patients received a DES and 183, a BMS. The risk of target-lesion revascularization was significantly lower in patients treated with a DES compared to those treated with a BMS (hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.23-0.88; P=.02). There was no significant difference in the risk of stent thrombosis between those treated with a DES or a BMS (HR 0.33, 95% CI 0.09-1.13; P=.08). Similarly, the risk of the combined endpoint of death or myocardial infarction was not significantly different between patients treated with a DES or a BMS (HR 0.64, 95% CI 0.36-1.13; P=.12). CONCLUSIONS Compared with BMSs, DES use improved clinical outcomes in diabetic patients undergoing primary angioplasty for STEMI: the need for reintervention was reduced, with no increase in mortality or myocardial infarction.

Overview of systematic reviews on invasive treatment of stable coronary artery disease.

OBJECTIVES The aim of the study was to evaluate the validity of the systematic reviews as a source of best evidence and to present and interpret the evidence of the systematic reviews on effectiveness of surgery and percutaneous interventions for stable coronary artery disease. METHODS Electronic databases were searched without language restriction from January 1966 to March 2004. The databases used included the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, DARE, the Health Technology Assessment Database, MEDLINE(R), MEDLINE(R) In-Process & Other Non-Indexed Citations. We included systematic reviews of randomized clinical trials on patients with stable coronary heart disease undergoing percutaneous coronary intervention or coronary artery bypass surgery in comparison with medical treatment or a comparison between invasive techniques. At least one of the following outcomes had to be reported: death, myocardial infarction, angina pectoris, revascularization. The methodological quality was assessed using a modified version of the scale devised by Oxman and Guyatt (1991). A standardized data-extraction form was used. The method used to evaluate clinical relevance was carried out with updated method guidelines from the Cochrane Back Research Group. Quantitative synthesis of the effectiveness data is presented. RESULTS We found nineteen systematic reviews. The median score of validity was 13 points (range, 6-17 points), with a maximum of 18 points. Coronary artery bypass surgery gives better relief of angina, and the need for repeated procedures is reduced after bypass surgery compared with percutaneous interventions. There is inconsistent evidence as to whether bypass surgery improves survival compared with percutaneous intervention. A smaller need for repeated procedures exists after bare metal stent and even more so after drug-eluting stent placement than after percutaneous intervention without stent placement. However, according to the current evidence, these treatment alternatives do not differ in terms of mortality or myocardial infarction. CONCLUSIONS We found some high-quality systematic reviews. There was evidence on the potential of invasive treatments to provide symptomatic relief. Surgery seems to provide a longer-lasting effect than percutaneous interventions with bare metal stents or without stents. Evidence in favor of drug-eluting stents so far is based on short-term follow-up and mostly on patients with single-vessel disease.

Proinflammatory HLA-DRB1*01-haplotype predisposes to ST-elevation myocardial infarction

BACKGROUND Major histocompatibility complex (MHC) gene region harbours haplotypes that associate with coronary artery disease (CAD). Their role in ST-elevation infarction (STEMI) or on the inflammatory level is not known. METHODS Four candidate MHC markers were analyzed by real-time quantitative PCR and constructed into haplotypes from patients with STEMI (n = 162), matched controls with no CAD (n = 319) and general population sample (n = 149). High sensitivity C-reactive protein (hsCRP) was assessed in a follow-up visit from patients (n = 86) and at inclusion from other study subjects. RESULTS The haplotype with one copy of HLA-DRB1*01, C4A, C4B but no HLA-B*35 doubled the risk of STEMI (OR = 2.15, 95%CI = 1.11-4.15, p = 0.020 for patients vs. controls, and OR = 2.26, 95%CI = 0.97-5.24, p = 0.052 for patients vs. population sample). The association between patients and controls persisted in multivariate analyses. The frequency of the haplotype was 5.86% (n = 19/324) in patients, 2.82% (n = 18/638) in controls and 2.68% (n = 8/298) in population sample. None of the individual MHC markers alone showed significant association with STEMI. In multivariate analyses, the haplotype carriers had higher hsCRP levels in patients (median 3.37 mg/L in carriers vs. 1.14 mg/L in non-carriers, p = 0.019) and in controls (median 2.90 mg/L vs. 1.21 mg/L, p = 0.009, respectively). CONCLUSION The MHC haplotype associates with STEMI and elevated baseline hsCRP levels. The results are in concordance with previous data on non-STEMI patients, implying that a HLA-DRB1*01--related haplotype increases the risk of CAD, possibly though increased inflammation.

QRS duration in high-resolution methods and standard ECG in risk assessment after first and recurrent myocardial infarctions

Background: Prolonged QRS duration (QRSd) is associated with increased mortality after myocardial infarction (MI). Only little data exist about its predictive ability and relationships to clinical variables in the present era of active treatment of myocardial ischemia and cardiac dysfunction. We investigated whether QRSd in high‐resolution methods and standard ECG predict arrhythmic events and cardiac death in post‐infarction patients with cardiac dysfunction and how it relates to clinical variables, with a special emphasis on history of previous MI.

Effectiveness and safety of paclitaxel-eluting stents in patients with ST-segment elevation acute myocardial infarction

AIMS The efficacy of paclitaxel-eluting stents (PES) in patients with ST-segment elevation acute myocardial infarction (STEMI) has not been demonstrated yet. The aim of the present study was to evaluate the efficacy and safety of PES in patients with STEMI. METHODS AND RESULTS A meta-analysis from three randomised trials that compared PES and bare-metal stents in patients with STEMI was performed. Overall, 925 patients were included: 459 allocated to PES, and 466 to bare-metal stents (BMS). The rates of major adverse events (i.e. death, reinfarction, and target vessel revascularisation at 6-12 month follow-up) was compared for patients with PES and BMS. Compared to patients with BMS, a significant reduction in the incidence of events (9.1% vs. 13.9%, p=0.02; OR 0.62; 95%, CI: 0.41-0.93), and target vessel revascularisation (4.7% vs. 8.3%, p=0.03; OR 0.54; 95%, CI 0.31-0.94) was found in patients with PES. The rates of death and reinfarction were similar in BMS and DES patients. CONCLUSIONS The use of PES in patients with STEMI is associated with a significant reduction in MACE and need for new revascularisations.

Early abciximab administration before primary percutaneous coronary intervention improves clinical outcome in elderly patients transferred with ST-elevation myocardial infarction: Data from the EUROTRANSFER registry

BACKGROUND Limited data are available concerning benefits and risks of early abciximab (EA) administration before primary percutaneous coronary intervention (PPCI) in elderly ST-segment elevation myocardial infarction (STEMI) patients. The objective of the study was to assess the impact of EA before PPCI in elderly (>or=65 years) patients. METHODS AND RESULTS We identified 545 patients <65 years (354 with EA administration (>30 min before PPCI), 191 late abciximab (LA)), and 541 patients >or=65 years of age (373 EA, 168 LA) in the EUROTRANSFER Registry database. Elderly patients were more likely to have comorbidities, angiographic PCI complications, and bleeding events. EA promotes infarct-related artery patency before PPCI and improves myocardial reperfusion after PPCI in both age groups, but the risk of 30-day death (EA vs. LA: <65 years, 2.0% vs. 1.6%; p=0.999; >or=65 years, 5.9% vs. 14.3%; p=0.001) and 30-day death+reinfarction (EA vs. LA: <65 years, 2.5% vs. 2.1%; p=0.999; >or=65 years, 7.5% vs. 17.3%; p=0.001) was reduced in elderly patients only. There was no difference in bleedings, especially major bleedings requiring transfusion (EA vs. LA: patients <65 years, 2.3% vs. 0%, p=0.055; >or=65 years, 2.4% vs. 3%; p=0.448) between groups. CONCLUSIONS Patients >or=65 years of age have a substantially increased risk of angiographic PCI complications, death and bleeding events compared with their younger counterparts. Strategy of EA before PPCI improves reperfusion parameters and clinical outcome in elderly patients and is not associated with elevated risk of major bleeding.

Analysing current trends in care of acute myocardial infarction using PERFECT data

Abstract Introduction: This article in the supplement issue on the Performance, Effectiveness, and Costs of Treatment episodes (PERFECT)-project describes the PERFECT AMI (acute myocardial infarction) Database, which is developed to measure the performance of hospitals and hospital districts in Finland. We analyse annual trends and regional differences in performance indicators and whether the utilisation of services and costs of hospital care are related to improvement in survival of AMI patients. Material and methods. The study population consists of ten annual cohorts (1998–2007) of patients hospitalised for AMI. Results. Since 1998 the treatment pattern has changed rather radically, the utilisation rate of percutaneous coronary intervention (PCI) has increased and coronary procedures have been performed earlier after myocardial infarction. Outcome measured by various measures of mortality has improved considerably. However, trends in the development of the use of services and outcomes are not similar between hospital districts. An increase in cost was positively and statistically significantly related to decrease in mortality, but the effect was not very strong. Conclusion. There is potential for decreased mortality from actions that do not increase the costs and for enhancing performance in the regions and hospitals with poor performance.

Late QRS Activity in Signal‐Averaged Magnetocardiography, Body Surface Potential Mapping, and Orthogonal ECG in Postinfarction Ventricular Tachycardia Patients

Background: Delayed electrical activity necessary for re‐entrant ventricular tachycardia (VT) is detectable noninvasively with high resolution techniques. We compared high resolution signalaveraged analysis of magnetocardiography (MCG), body surface potential mapping (BSPM), and orthogonal three‐lead ECG (SA‐ECG) in the identification of patients prone to VT after myocardial infarction (Ml).