Meta-Analysis of Studies of Patients in the United Arab Emirates With ST-Elevation Myocardial Infarction Treated With Thrombolytic Agents

doi:10.1016/j.amjcard.2010.08.010

The American Journal of Cardiology

Volume 106, Issue 12, 15 December 2010, Pages 1692-1695

https://doi.org/10.1016/j.amjcard.2010.08.010 Get rights and content

We performed a meta-analysis of 6 studies we conducted in the United Arab Emirates from 1995 to 2009. These included 1,262 patients with ST-elevation myocardial infarction treated with thrombolytic drugs <6 hours after onset of symptoms and signs of myocardial infarction. All patients were treated with tenecteplase or alteplase to induce coronary thrombolysis. Characteristics of patients in all studies were quite similar. Overall mean age was 47 years, 98% were men, 28% had diabetes, 25% were hypertensive, 20% were hyperlipidemic, 56% were smokers, and 9% had sustained previous myocardial infarction. Incidence of adverse outcomes of 30-day mortality (3%), reinfarction (2.5%), stroke (0.4%), or major bleeding (0%) was low compared to global experience with recanalization regardless of how it was induced. There was no incidence of major bleeding requiring transfusion or laparotomy. In conclusion, in predominantly young men in the United Arab Emirates who were admitted and treated early after onset of an acute ST elevation myocardial infarction, recanalization induced by thrombolysis was an attractive therapeutic approach.

Section snippets

Methods

From 1995 through 2009 we participated in 4 international, multicenter, randomized, controlled, clinical trials and 2 collaborative studies with the University of Vermont, Burlington, in which pharmacologic thrombolysis for treatment of acute STEMI was employed with alteplase (tissue plasminogen activator [t-PA]) or tenecteplase (TNK). The first of the randomized trials was the Continuous Infusion Versus Double Bolus Alteplase (COBALT) study.³ The other 3 were the Assessment of the Safety and

Discussion

Our results show strikingly low early morbidity and mortality after treatment with t-PA or TNK. Our patients were quite young, a feature likely to contribute to the low mortality. Mortality data from ASSENT III⁶ were higher than in the other studies (6.52% vs 1.27% to 3.21%), although patient demographics were similar. This was not statistically significant because of the small number of patients (Table 5). Our patients were predominantly men and treated promptly (within an average of 3.5 hours

Acknowledgment

We thank Vasanta Lakshmi, PGDHA, for her transcription services and the entire team of the coronary care unit and emergency department of Rashid Hospital.

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Cited by (5)

Biosimilarity. Do not confuse biosimilar and biocopy. Example of tenecteplase
2023, Annales Pharmaceutiques Francaises
Non-innovator biological products (NIBPs) or ‘biocopies’ are available in several countries at lower prices than biosimilars. These drugs, sometimes so-called ‘biosimilars’, may not meet all of the quality criteria expected of clinically equivalent products. NIBPs can exhibit major differences in physicochemical and pharmacological properties compared with their reference biological but may be presented to prescribers based on clinical trial data and claimed clinical equivalence. Tenecteplase (TNK-tpA) is a recombinant derivative of tissue plasminogen activator, used as a third-generation thrombolytic agent for treatment of acute myocardial infarction. A TNK-tPA presented as biosimilar to the originator (Metalyse®, Boehringer Ingelheim; TNKase®, Roche/Genentech) is now available for use in India (Elaxim®, Gennova Pharmaceuticals). Elaxim® is not approved in Europe or the USA but has been proposed in several countries as a replacement for the originator. Based on available literature, we discuss why this biocopy cannot be considered biosimilar to the originator tenecteplase. We describe clear differences in physicochemical and pharmacological properties. For example, the biocopy demonstrates clot lysis activity that is substantially lower than the originator and contains high concentrations of foreign proteins that confer potential for immunological reactions. Clinical data on the biocopy are limited; randomized trials to demonstrate the absence of difference in efficacy and safety between the biocopy and originator have not been conducted. This example demonstrates that confirmation of similarity, by close examination of pharmaceutical quality attributes, and preclinical and clinical data, is mandatory before presenting to prescribers a biological product as clinically equivalent.
Des produits biologiques non innovants (MIBP) ou « biocopies » sont disponibles dans plusieurs pays à des prix inférieurs à ceux des biosimilaires. Ces soi-disant « biosimilaires », autorisés dans les pays à faible revenu, peuvent ne pas répondre à tous les critères de qualité attendus pour des produits cliniquement équivalents. Les MIBP peuvent ainsi présenter des différences majeures des propriétés physicochimiques et pharmacologiques par rapport à leur produit de référence, mais peuvent n’être présentés aux prescripteurs essentiellement que sur la base d’essais cliniques cherchant à prouver l’équivalence clinique revendiquée. La ténectéplase (TNK-tpA) est un dérivé recombinant de l’activateur tissulaire du plasminogène, utilisé comme agent thrombolytique de troisième génération pour le traitement de l’infarctus aigu du myocarde. Un TNK-tPA présenté comme biosimilaire au princeps (Metalyse®, Boehringer Ingelheim; TNKase®, Roche/Genentech) est désormais disponible en Inde (Elaxim®, Gennova Pharmaceuticals). Elaxim® n’est pas homologué en Europe ni aux États-Unis mais a été proposé dans plusieurs pays en remplacement du princeps. Sur la base de la littérature disponible, nous discutons des raisons pour lesquelles cette biocopie ne peut pas être considérée comme biosimilaire à la ténectéplase d’origine. Nous décrivons des différences notables dans les propriétés physicochimiques et pharmacologiques. Par exemple, la biocopie démontre une activité de lyse du caillot qui est sensiblement inférieure à celle de l’original et contient des concentrations élevées de protéines étrangères qui confèrent un potentiel de réactions immunologiques. Les données cliniques sur la biocopie sont limitées; des essais randomisés pour démontrer l’absence de différence d’efficacité et de sécurité entre la biocopie et le princeps n’ont pas été menés. Cet exemple démontre que la confirmation de la similarité, par un examen attentif des attributs de qualité pharmaceutique et des données précliniques et cliniques, est obligatoire avant de présenter aux prescripteurs un produit biologique comme cliniquement équivalent.
Comparison of characteristics, management practices, and outcomes of patients between the global registry and the gulf registry of acute coronary events
2011, American Journal of Cardiology
Citation Excerpt :
Potential explanations for the higher rates of short-term complications in Gulf RACE include differences in the receipt of different treatment procedures and more prolonged delays in seeking medical care.21 Similar findings to our study were observed in a meta-analysis based on data from the Gulf region, which found that most patients with STEMI were managed by thrombolytics and had favorable outcomes.22 A study comparing patients enrolled in the United States to their Canadian counterparts in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries I (GUSTO-I) trial reported that, despite a greater use of invasive cardiac procedures in the United States, favorable outcomes were observed only when comparing long-term mortality rates, although short-term mortality rates were comparable.23
The Arab Middle East is a unique region of the developing world where little is known about the outcomes of patients hospitalized with an acute coronary syndrome (ACS), despite playing an important role in the global burden of cardiovascular disease. The primary objectives of this observational study were to compare patients with ACS hospitalized in the Arab Middle East to patients enrolled in a multinational non-Arabian ACS registry. The study cohort consisted of patients hospitalized in 2007 with an ACS including 4,445 from the Global Registry of Acute Coronary Events (GRACE) and 6,706 from the Gulf Registry of Acute Coronary Events (Gulf RACE). Average age of patients in Gulf RACE was nearly a decade younger than that in GRACE (56 vs 66 years). Patients in Gulf RACE were more likely to be men, diabetic, and smoke and less likely to be hypertensive compared to patients in GRACE. Patients in Gulf RACE had higher odds of receiving aspirin and a lower likelihood of receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, β blockers, and clopidogrel during their index hospitalization. Although most eligible patients with ST-elevation myocardial infarction in Gulf RACE received thrombolytics, most of their counterparts in GRACE underwent a primary percutaneous coronary intervention. Multivariable adjusted in-hospital case–fatality rates were not significantly different between patients in Gulf RACE and those in GRACE. In conclusion, despite differences in patient characteristics and treatment practices, short-term mortality rates were comparable in patients with ACS enrolled in these 2 registries. Future studies should explore the effects of these differences on long-term prognosis and other pertinent patient outcomes.
Clinical Profile of Patients Presenting with Acute Myocardial Infarction in United Arab Emirates: A Tertiary Care Center Government Hospital Experience
2021, Dubai Medical Journal
Fibrinolysis in acute myocardial infarction: State of the art research
2017, Acute Coronary Syndrome (ACS): Diagnosis, Management and Research Insights
Characteristics of patients with diabetes having normal coronary arteries
2015, Angiology

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Coronary artery diseaseMeta-Analysis of Studies of Patients in the United Arab Emirates With ST-Elevation Myocardial Infarction Treated With Thrombolytic Agents

Section snippets

Methods

Discussion

Acknowledgment

Am Heart J

Lancet

Am J Cardiol

Am J Cardiol

Lancet

Diabetes Res Clin Practice

Am J Cardiol

Lancet

Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction

Lancet

Relationship between delay in performing direct coronary angioplasty and early clinical outcome in patients with acute myocardial infarction: results from the global use of Strategies to Open Occluded Arteries in Acute Coronary Syndrome (GUSTO) Trial

Circulation

A comparison of continuous infusion of alteplase with double bolus administration for acute myocardial infarction

N Engl J Med

Coronary artery disease
Meta-Analysis of Studies of Patients in the United Arab Emirates With ST-Elevation Myocardial Infarction Treated With Thrombolytic Agents