What data is available for tenecteplase versus alteplase for STEMI and pulmonary embolism?

Comment by InpharmD Researcher

For the treatment of ST-elevation myocardial infarction (STEMI), there appears to be a lack of considerable differences in efficacy between tenecteplase and alteplase. However, due to a decreased risk for major bleeding, increased fibrin-specificity, and ease of administration compared to alteplase, tenecteplase may be ideal in the setting of STEMI. Due to the lack of head-to-head comparative trials and similar efficacy observed in meta-analyses between alteplase and tenecteplase in the treatment of pulmonary embolism (PE), there is limited evidence to support the use of one agent over another. While guidelines suggest initiating systemic thrombolytic therapy in patients with submassive PE, one thrombolytic agent is not recommended over the other. Similar to STEMI, tenecteplase may provide improved feasibility compared to alteplase; although it has not yet been approved for this indication.

Background

According to 2013 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) guidelines on the management of ST-elevation myocardial infarction (STEMI), in the absence of contraindications, fibrinolytic therapy should be given to patients with STEMI and onset of ischemic symptoms within the previous 12 hours when it is anticipated that primary percutaneous coronary intervention (PCI) cannot be performed within 120 minutes of first medical contact. In the absence of contraindications and when PCI is not available, fibrinolytic therapy is reasonable for patients with STEMI if there is clinical and/or electrocardiogram evidence of ongoing ischemia within 12 to 24 hours of symptom onset and a large area of myocardium at risk or hemodynamic instability. Fibrin-specific agents are preferred when available (i.e., tenecteplase, reteplase, or alteplase), but preference for one specific agent over another is not addressed. Of note, tenecteplase is given as a single intravenous weight-based bolus and is identified to have increased fibrin specificity compared to reteplase and alteplase. Additionally, available data have found the patency rate (90-minute thrombolysis in myocardial infarction [TIMI] 2 or 3 flow) to be 85% with tenecteplase compared to 73% to 84% with alteplase. [1]

According to 2008 American College of Chest Physicians (ACCP) guidelines on acute STEMI, for patients with ischemic symptoms characteristic of acute MI of ≤ 12-hour duration and persistent STE, it is recommended to administer streptokinase, anistreplase, alteplase, reteplase, or tenecteplase over no fibrinolytic therapy (all Grade 1A). For patients with symptom duration ≤ 6 hours, it is recommended to administer alteplase (Grade 1A) or tenecteplase (Grade 1 A). Of note, for patients receiving fibrinolytic therapy, it is suggested to use a bolus agent (e.g., tenecteplase) to facilitate the ease of administration and potentially reduce the risk of intracranial hemorrhage (ICH)-related bleeding (tenecteplase). This recommendation is based on results observed in the ASSENT-2 trial (see Table 5). [2]

According to 2016 CHEST guidelines, a systemically administered thrombolytic regimen is recommended in patients with acute pulmonary embolism (PE) associated with hypotension (e.g., systolic blood pressure <90 mm Hg) who do not have a high bleeding risk. On the other hand, the guideline does not recommend thrombolytic therapy in patients with acute PE without hypotension. In selected patients with acute PE who continue to deteriorate regardless of the underlying anticoagulant therapy but have yet to develop hypotension and have a low bleeding risk, the panel suggests systemically administered thrombolytic therapy over no such therapy. Preference for a specific agent is not addressed. [3]

According to 2020 American Society of Hematology (ASH) guidelines, thrombolysis therapy, in addition to anticoagulation, is a reasonable consideration in submassive PE, defined as right ventricular dysfunction without hemodynamic instability. Patients with low bleeding risk, such as those with younger age, or high decompensation risk due to concurrent cardiopulmonary disease are potential candidates. The guideline does not provide further data or a preference for one thrombolytic over another. In general, systemic thrombolysis is preferred over catheter-directed therapy unless in patients with a high risk of bleeding, contraindications to systemic thrombolytic therapy, and/or persistent hemodynamic instability despite systemic thrombolysis. [4]

The 2019 European Society of Cardiology guidelines for management of acute PE recommend rescue thrombolytic therapy for patients who deteriorate hemodynamically (Class I). The guideline states that thrombolytic agents are associated with a significant reduction in mortality and recurrent PE combined in patients with high-risk PE, mostly in cardiogenic shock. Intravenous administration of recombinant tissue-type plasminogen activator (rtPA; 100 mg infused over 2 hours) remains the preferable agent and strategy. On the other hand, even investigated in clinical trials, tenecteplase has not yet been approved for this indication. The authors state the impact of early thrombolysis for (intermediate or high-risk) acute PE on long-term benefits on clinical symptoms, functional limitation, or chronic thromboembolic pulmonary hypertension is still unclear. [5]

A 2020 review examining the use of systemic thrombolytic therapy for massive and submassive PE included 67 articles, of which 24 clinical trials related explicitly to either intravenous (IV) tenecteplase or alteplase. The authors noted the absence of direct comparative data between the two agents yet suggest potential benefits of fibrin-specific, second- (alteplase) and third- (tenecteplase) generation given as 2-hour IV infusion and IV push, respectively, over first-generation, non-fibrin-specific thrombolytic (e.g., urokinase, streptokinase) which typically requires prolonged IV infusions (12- to 24-hour) and may delay clot lysis while increasing the risk of bleeding. The authors concluded a lack of clinical data to draw preference over another between fibrin-specific thrombolytics for either massive or submissive PE. [6]

According to a systematic review in 2016, IV thrombolysis or mechanical thrombectomy can be used to treat hemodynamically unstable PE patients. As a third-generation thrombolytic, tenecteplase is approved for the treatment of acute coronary syndromes. It has also been evaluated in patients with acute PE. While there were no head-to-head comparison trials between thrombolytic agents, eight clinical trials assessed the effectiveness of thrombolytic agents, including tenecteplase, in patients with intermediate-risk PE. Overall, thrombolytic agents were found to be associated with lower all-cause mortality compared with anticoagulants (2.17% versus 3.89%, respectively), but they increased the risk of major bleeding (9.24% versus 3.42%) and intracranial hemorrhage (1.46% versus 0.19%). [7]

A 2003 review on early thrombolysis treatment suggested that there are no differences in mortality, total stroke, hemorrhagic stroke, or reinfarction between tenecteplase and alteplase, but tenecteplase may result in fewer major bleeds compared with alteplase. According to another review published in 2009, tenecteplase is easy to use in the ambulance and has a decreased risk of major non-cerebral bleeds due to its highest in-class fibrin specificity and binding. It was indicated that nitrates do not affect tenecteplase levels, whereas they do with alteplase levels. [8], [9]

References:

[1] O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013;82(1):E1-E27. doi:10.1002/ccd.24776
[2] Goodman SG, Menon V, Cannon CP, Steg G, Ohman EM, Harrington RA. Acute ST-segment elevation myocardial infarction: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) [published correction appears in Chest. 2008 Oct;134(4):892]. Chest. 2008;133(6 Suppl):708S-775S. doi:10.1378/chest.08-0665
[3] Kearon C, Akl EA, Ornelas J, et al. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report [published correction appears in Chest. 2016 Oct;150(4):988]. Chest. 2016;149(2):315-352. doi:10.1016/j.chest.2015.11.026
[4] Ortel TL, Neumann I, Ageno W, et al. American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. Blood Adv. 2020;4(19):4693-4738. doi:10.1182/bloodadvances.2020001830
[5] Konstantinides SV, Meyer G, Becattini C, et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS): The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC). Eur Respir J. 2019;54(3):1901647. Published 2019 Oct 9. doi:10.1183/13993003.01647-2019
[6] Igneri LA, Hammer JM. Systemic Thrombolytic Therapy for Massive and Submassive Pulmonary Embolism. J Pharm Pract. 2020;33(1):74-89. doi:10.1177/0897190018767769
[7] Martin C, Sobolewski K, Bridgeman P, Boutsikaris D. Systemic Thrombolysis for Pulmonary Embolism: A Review. P T. 2016;41(12):770-775
[8] Boland A, Dundar Y, Bagust A, et al. Early thrombolysis for the treatment of acute myocardial infarction: a systematic review and economic evaluation. 2003. In: NIHR Health Technology Assessment programme: Executive Summaries. Southampton (UK): NIHR Journals Library; 2003-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK62221/
[9] Melandri G, Vagnarelli F, Calabrese D, Semprini F, Nanni S, Branzi A. Review of tenecteplase (TNKase) in the treatment of acute myocardial infarction. Vasc Health Risk Manag. 2009;5(1):249-256. doi:10.2147/vhrm.s3848

Literature Review

A search of the published medical literature revealed 6 studies investigating the researchable question:

What data is available for tenecteplase versus alteplase for STEMI and pulmonary embolism?

Level of evidence

A - Multiple high-quality studies with consistent results  Read more→



Please see Tables 1-6 for your response.


Comparative efficacy and safety of reperfusion therapy with fibrinolytic agents in patients with ST-segment elevation myocardial infarction: a systematic review and network meta-analysis

Design

Network meta-analysis

Objective

To compare the effects of various fibrinolytic drugs on clinical outcomes in patients with ST-elevation myocardial infarction (STEMI)

Included studies

40 RCTs

Patient Population

N= 128,071

Alteplase accelerated (tPA_acc) + parenteral anticoagulants (PAC) vs. Tenecteplase (TNK) + PAC (n = 18,338)

Patient Characteristics

Adults with STEMI indicated for reperfusion therapy with fibrinolytic agents

Outcome Measures

Primary: all-cause mortality within 30-35 days, major bleeding

Secondary: recurrent infarction, stroke, hemorrhagic stroke

Results

Endpoints

Pairwise meta-analysis RR* (95% CI)

Heterogeneity (I2)

All-cause mortality within 30-35 days

Fixed effect

Random effect

 

1.01 (0.90 to 1.13)

1.03 (0.81 to 1.31)

 

15%

Major bleeding

Fixed effect

Random effect

 

0.80 (0.71 to 0.90)

0.75 (0.50 to 1.13)

 

20.3%

Recurrent infarction

Fixed effect

Random effect

 

1.08 (0.93 to 1.24)

1.05 (0.78 to 1.41)

 

18.3%

All-type stroke

Fixed effect

Random effect

 

1.08 (0.87 to 1.35)

1.08 (0.87 to 1.34)

 

0%

Hemorrhagic stroke

Fixed effect

Random effect

 

0.99 (0.74 to 1.33)

0.99 (0.74 to 1.33)

 

0%

*tPA_acc + PAC vs. TNK + PAC

RR, risk ratio; CI, confidence interval

Study Author Conclusions

There were significant differences among fibrinolytic regimens in treating STEMI. A tenecteplase-based regimen is associated with lower bleeding risks and similar mortality benefits compared to other fibrinolytics.

InpharmD Researcher Critique

This meta-analysis only included RCTs, but it is limited to the indirect comparisons made.

References:

Jinatongthai P, Kongwatcharapong J, Foo CY, et al. Comparative efficacy and safety of reperfusion therapy with fibrinolytic agents in patients with ST-segment elevation myocardial infarction: a systematic review and network meta-analysis. Lancet. 2017;390(10096):747-759. doi:10.1016/S0140-6736(17)31441-1

Comparative Efficacy and Safety of Thrombolytic Agents for Pulmonary Embolism: A Bayesian Network Meta-Analysis

Design

Bayesian network meta-analysis

Objective

To evaluate the efficacy and safety of different thrombolytic agents in the treatment of all types of acute pulmonary embolism (PE): hemodynamically unstable PE (massive PE) and hemodynamically stable PE (submassive PE and low-risk PE)

Included Studies

29 RCTs

Patient Population

N= 3,067

Patient Characteristics

Patients with any type of acute PE treated with thrombolytic and anticoagulant therapy

Outcome Measures

Primary: mortality, recurrent PE, and pulmonary artery systolic pressure (PASP)

Secondary: bleeding

Results

Endpoint

RR or mean difference* (95% credible interval)

Alteplase SUCRA

Tenecteplase SUCRA

Mortality

1.36 (0.34 to 5.41) 38.84 29.89

Recurrent PE

1.70 (0.29 to 17.62) 74.47 49.46

PASP

5.99 (-13.60 to 26.02) 69.03 39.78

Major Bleeding

3.00 (0.77 to 9.17) 64.36 10.49
Minor Bleeding 1.84 (0.62 to 5.27)  40.01 9.53

*Tenecteplase vs. alteplase

CI, confidence interval; RR, risk ratio; SUCRA, surface under the cumulative ranking curve

Study Author Conclusions

For patients with acute PE, four thrombolytic agents (alteplase, reteplase, streptokinase, and urokinase) appeared to be superior in efficacy compared with anticoagulant alone due to a reduction in mortality and no increase in major and minor bleeding risk. Alteplase may be a better choice compared with anticoagulant alone because it not only reduced mortality but also reduced PE recurrence rate and treated PASP. Tenecteplase did not reduce mortality compared with anticoagulants alone and may not be a good choice of thrombolytic agents due to an increase in minor bleeding compared with streptokinase and anticoagulants alone

InpharmD Researcher Critique

The included studies had a short-term follow-up and did not look into any long-term outcomes in PE patients. Furthermore, a subgroup analysis was not performed for the thrombolytic dose due to the small number of included studies.

References:

Li HY, Wang YB, Ren XY, Wang J, Wang HS, Jin YH. Comparative Efficacy and Safety of Thrombolytic Agents for Pulmonary Embolism: A Bayesian Network Meta-Analysis. Pharmacology. 2023;108(2):111-126. doi:10.1159/000527668

 

A Systematic Review and Meta-Analysis of the Safety and Effectiveness of Tenecteplase Versus Alteplase in Treatment of Patients with ST-Elevation Myocardial Infarction

Design

Meta-analysis

Objective

To assess the safety and effectiveness of tenecteplase versus alteplase in the treatment of ST-elevation myocardial infarction (STEMI)
Included Studies 5 RCTs
Patient Population N= 17,379

Patient Characteristics

STEMI patients treated with tenecteplase or alteplase

Outcome Measures

Primary: mortality, reinfarction, cardiogenic shock, bleeding, stroke, and intracranial hemorrhage (ICH)

Secondary: thrombolysis in myocardial infarction (TIMI) grade 3 flow, TIMI grade 2/3 flow

Results

Endpoints

RR* (95% CI)

p-value

Heterogeneity (I2)

30-day mortality

1.01 (0.90 to 1.14)

0.82

0%

Reinfarction

1.07 (0.92 to 1.24)

0.36

0%
Cardiogenic shock 0.97 (0.84 to 1.13) 0.73 0%

Bleeding

0.92 (0.87 to 0.96)

0.0007

55%

Stroke

1.09 (0.87 to 1.36) 0.47 0%
ICH at 30 days 1.00 (0.74 to 1.36) 0.99

0%

TIMI grade 3 flow at 90 minutes 1.11 (0.89 to 1.37) 0.35

0%

TIMI grade 2/3 flow at 90 minutes 1.19 (1.05 to 1.36) 0.0009

51%

*Tenecteplase versus alteplase

CI, confidence interval; RR, risk ratio

Study Author Conclusions

In comparison with alteplase, tenecteplase is recommended due to its easier use and higher safety in reducing the risk of bleeding.

InpharmD Researcher Critique

Many outcomes had zero heterogeneity between studies, indicating the potential for similar biases and confounding factors within studies included for the respective outcomes.



References:

Bashzar S, Nikfar S, Sabermahani A. A Systematic Review and Meta-Analysis of the Safety and Effectiveness of Tenecteplase Versus Alteplase in Treatment of Patients with ST-Elevation Myocardial Infarction. J Adv Med Biomed Res. 202; 28(130):265-275. doi:10.30699/jambs.28.130.265

Safety and efficacy of tenecteplase versus alteplase in acute coronary syndrome: a systematic review and meta-analysis of randomized trials

Design

Meta-analysis

Objective

To compare the efficacy and safety profile of alteplase and tenecteplase

Included Studies

3 RCTs

Patient Population

N= 17,325 

Tenecteplase (n= 8,651)

Alteplase (n= 8,674)

Patient Characteristics

Patients with acute coronary syndrome (ACS) or acute pulmonary embolism (PE) having received tenecteplase (30–50 mg) or weight-adjusted alteplase (80–100 mg)

Outcome Measures

Primary safety outcome: incidence of major bleeding

Secondary safety outcome: incidence of intracranial hemorrhage

Efficacy outcome: all-cause mortality within 30 days

Results

Endpoint

Tenecteplase (n= 8651)

Alteplase (n= 8674)

Risk ratio (95% CI)

p-Value Heterogeneity (I2)

Major bleeding

4.8% (399/8651) 5.8% (507/8674) 0.79 (0.69 to 0.90) 0.0002 0%

Intracranial hemorrhage

0.91% (79/8651) 0.95% (82/8674) 0.96 (0.71 to 1.31) 0.82 0%
30-day mortality 6.2% (535/8651) 6.1% (528/8674) 

1.02 (0.91 to 1.15)

0.80 1%

Study Author Conclusions

The available evidence suggests that weight-adjusted tenecteplase is superior to weight-adjusted alteplase in terms of safety, with a lower risk of major bleeding. More limited evidence suggests that tenecteplase and alteplase are equivalent in terms of efficacy.

InpharmD Researcher Critique

While a relatively small number of studies were included, the overall population was large enough to allow for precise estimation of safety differences between the two groups. All studies were included only patients with ACS, limiting generalizability to acute PE. 
References:

Guillermin A, Yan DJ, Perrier A, Marti C. Safety and efficacy of tenecteplase versus alteplase in acute coronary syndrome: a systematic review and meta-analysis of randomized trials. Arch Med Sci. 2016;12(6):1181-1187. doi:10.5114/aoms.2016.58929

 

Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial

Design

Double-blind, randomized, controlled trial and post-hoc analysis

N= 16,949

Objective

To assess the efficacy and safety of tenecteplase compared with alteplase

Study Groups

Alteplase (n= 8,488)

Tenecteplase (n= 8,461)

One-year follow-up (n= 15,724)

Alteplase (n= 7,885)

Tenecteplase (n= 7,839)

Inclusion Criteria

Aged 18 years or older; symptoms of acute myocardial infarction within 6 hours before randomization; ST-segment elevations of 0.1 mV or more in two or more limb leads or 0.2 mV or more in two or more contiguous precordial leads, or left bundle-branch block

Exclusion Criteria

Hypertension (systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg); use of abciximab or other glycoprotein IIb/IIIa antagonists within preceding 12 hours; biopsy of parenchymal organ; substantial trauma within 2 months of admission; any major head trauma or any trauma occurred after onset of current myocardial infarction; history of stroke (including transient ischemic attack), or dementia; known structural damage of the central nervous system; on oral anticoagulation with international normalized ratio > 1.3; sustained cardiopulmonary resuscitation > 10 minutes within previous 2 weeks; pregnancy, lactation, parturition in past 30 days

Methods

Patients were randomized to receive a bodyweight-adjusted bolus of tenecteplase plus bolus and infusion of placebo, or a bolus and infusion of alteplase plus bolus of placebo. Tenecteplase was administered over 5-10 seconds according to body weight: 30 mg for patients < 60 kg, 35 for patients 60.0-69.9 kg, 40 mg for patients 70.0-79.9 kg, 45 mg for patients 80.0-89.9 kg, and 50 mg for patients ≥ 90 kg. Alteplase was given as a 15 mg bolus, followed by a 0.75 mg/kg (max 50 mg) infusion over 30 minutes and a 0.50 mg/kg (max 35 mg) infusion over 60 minutes. All patients received 150-325 mg aspirin orally and intravenous heparin (bolus of 4,000 U and infusion of 800 U/h for patients ≤ 67 kg; 5,000 U bolus and infusion of 1,000 U/h for patients > 67 kg) adjusted to maintain an activated partial thromboplastin time of 50-75 seconds for 48-72 hours.

Duration

Recruitment: October 1997 to November 1998

One-year follow-up: 1999

Outcome Measures

Primary: all-cause mortality at 30 days

Secondary: net clinical benefit (absence of death or non-fatal stroke at 30 days), major non-fatal cardiac events in hospital, stroke

One-year follow-up: 

Baseline Characteristics

 

Tenecteplase (n = 8,461)

Alteplase (n= 8,488)

   

Median age, years (interquartile range [IQR])

61 (52 to 70) 61 (52 to 70)    

Female

22.9% 23.3%    

History

Hypertension

Diabetes

Smoker

Previous infarction

Previous bypass surgery


37.7%

16.4%

44.3%

15.8%

5.5%


38.5%

15.7%

43.7%

16.1%

6.2%

   

Median vitals (IQR)

Systolic blood pressure, mm Hg

Diastolic blood pressure, mm Hg

Heart rate, beats/min


133 (120 to 150)

80 (70 to 90)

72 (62 to 85)


133 (119 to 150)

80 (70 to 90)

73 (62 to 85)

   

Location of infarction

Anterior

Inferior

Other


39.4%

55.4%

5.0%


40.2%

54.8%

4.8%

   

Killip class

I

II

III

IV

 

87.8%

10.5%

1.1%

0.4%


88.0%

10.3%

1.2%

0.4%

   

Median time between symptoms onset and treatment, hours (IQR)

2.7 (1.9 to 3.8) 2.8 (1.9 to 3.9)    

Results

Endpoints

Tenecteplase (n = 8,461)

Alteplase (n = 8,488)

RR (90% CI)

p-value

Primary analysis

Unadjusted analysis

Logistic regression

6.179%

6.160%

6.089%

6.151%

6.176%

6.140%

1.004 (0.914 to 1.104)

0.997 (0.904 to 1.101)

0.992 (0.903 to 1.089)

0.0059

0.0060

0.0025

Endpoints

Tenecteplase (n= 8,461)

Alteplase (n= 8,488)

RR (95% CI)

p-value

Death or non-fatal stroke

7.11%

7.04%

1.01 (0.91 to 1.13)

-

Major non-fatal cardiac events

Reinfarction

Recurrent angina

Sustained hypotension

Cardiogenic shock

Major arrhythmias

Pericarditis

Invasive cardiac procedures

PTCA

Stent placement

CABG

IABP

Killip class >1

Tamponade or cardiac rupture

Acute mitral regurgitation

Ventricular septum defect

Anaphylaxis

Pulmonary embolism

 


4.1%

19.4%

15.9%

3.9%

20.5%

3.0%

-

24.0%

19.0%

5.5%

2.6%

6.1%

0.6%

0.6%

0.3%

0.1%

0.09%


3.8%

19.5%

16.1%

4.0%

21.2%

2.6%

-

23.9%

19.7%

6.2%

2.7%

7.0%

0.7%

0.7%

0.3%

0.2%

0.04%


1.078 (0.929 to 1.250)

0.995 (0.935 to 1.058)

0.988 (0.921 to 1.058)

0.965 (0.832 to 1.119)

0.968 (0.913 to 1.027)

1.124 (0.941 to 1.343)

-

1.006 (0.953 to 1.061)

0.968 (0.910 to 1.029)

0.884 (0.783 to 0.999)

0.968 (0.805 to 1.163)

0.991 (0.982 to 0.999)

0.816 (0.558 to 1.193)

0.886 (0.613 to 1.281)

0.817 (0.466 to 1.434)

0.376 (0.147 to 0.961)

2.675 (0.710 to 10.080)


0.325

0.877

0.737

0.664

0.281

0.209

-

0.843

0.302

0.049

0.736

0.026

0.332

0.571

0.568

0.052

0.145

Stroke

Intracranial hemorrhage

Ischemic stroke

Hemorrhagic conversion

Unclassified

1.78%

0.93%

0.72%

0.07%

0.13%

1.66%

0.94%

0.64%

0.09%

0.08%

1.074 (0.856 to 1.349)

0.991 (0.727 to 1.350)

1.133 (0.787 to 1.632)

0.752 (0.261 to 2.168)

1.576 (0.611 to 4.065)

0.555

1.000

0.514

0.790

0.358

One year follow-up

Tenecteplase (n= 7,885)

Alteplase (n= 7,839)

RR (95% CI)

 

Mortality

9.2%

9.1%

1.01 (0.91 to 1.12)

 

Mortality rate from day 30 to 365

2.8% 2.6% 1.07 (0.88 to 1.30)  

CI, confidence interval; RR, relative risk

Adverse Events

Common Adverse Events: bleeding (26.43% vs. 28.95%; p< 0.0003), need for blood transfusion (4.3% vs. 5.5%; p= 0.0002)

Serious Adverse Events: See results

Percentage that Discontinued due to Adverse Events: N/A

Study Author Conclusions

Tenecteplase and alteplase were equivalent for 30-day mortality. The ease of administration of tenecteplase may facilitate more rapid treatment in and out of hospital. One year after randomization, mortality rates remain similar in patients with acute myocardial infarction treated with an accelerated infusion of alteplase or a single bolus of tenecteplase.

InpharmD Researcher Critique

A one-year follow-up was performed to assess patients' status, further strengthening the results of this study. However, vital status was only obtained from 92.8% of patients in the original trial.



References:

[1] Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators, Van De Werf F, Adgey J, et al. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Lancet. 1999;354(9180):716-722. doi:10.1016/s0140-6736(99)07403-6
[2] Sinnaeve P, Alexander J, Belmans A, et al. One-year follow-up of the ASSENT-2 trial: a double-blind, randomized comparison of single-bolus tenecteplase and front-loaded alteplase in 16,949 patients with ST-elevation acute myocardial infarction. Am Heart J. 2003;146(1):27-32. doi:10.1016/S0002-8703(03)00117-0

 

Comparison of Tenecteplase versus Alteplase in STEMI Patients Treated with Ticagrelor: A Cross-Sectional Study

Design

Cross-sectional, retrospective

N= 150

Objective

To investigate the effectiveness and safety of tenecteplase against alteplase in patients with STEMI receiving a loading dose of ticagrelor

Study Groups

Alteplase (n= 60)

Tenecteplase (n= 90)

Inclusion Criteria

Age 18 to 75, received fibrinolytic for STEMI

Exclusion Criteria

Patients who died during transfer, coronary angiography could not be performed due to bleeding, CABG surgery decided as a result of coronary angiography, records could not be reached

Methods

The study population consisted of patients who were planned for emergency reperfusion with fibrinolytic therapy due to STEMI; fibrinolytic therapy was not administered to patients with absolute or relative contraindications. Fibrinolytic agents were administered to patients who could not reach the center where PCI was performed within 120 minutes from the moment of admission to the emergency department. Prior to fibrinolytic, a loading dose of 300 mg aspirin, 0.3 cc intravenous enoxaparin and 180 mg ticagrelor was given. Doing of tenecteplase (TNK) and alteplase (t-PA) were: TNK: 30–50 mg single bolus weight-adjusted, followed by a 0.75 mg/kg (up to 50 mg) infusion over 30 min; t-PA: 15 mg bolus, followed by 0.50 mg/kg (up to 35 mg) infusion over 60 min. Patients were transferred to an advanced center for catheterization and PCI within 24 hours after fibrinolytic therapy. 

Successful reperfusion was defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade 2-3 in the infarct-related artery before and after lytic-facilitated PCI. A maintenance dose of 90 mg ticagrelor twice daily was given post stenting. 

Duration

2017 to 2021

Outcome Measures

Primary: Major Adverse Cardiac Event (MACE): TIMI flow grade 1, major bleeding, in-hospital mortality

Baseline Characteristics

 

Alteplase (n= 60)

Tenecteplase (n= 90)

 p-value

Age, years (mean) 

60.62 ± 13.83 60.14 ± 11.32 0.839

Male

36 (60%) 63 (70%)  0.205
Hypertension 31 (51.7%) 27 (30%) 0.008
Diabetes mellitus 22 (36.7%) 28 (31.1%)  0.480
Atrium fibrillation 16 (26.7%) 11 (12.2%)  0.624
Stroke 6 (10%) 3 (3.3%)  0.09
Heart failure 13 (21.7%) 9 (10%) 0.048
Left Ventricular Hypertrophy 16 (26.7%) 9 (10%) 0.007

Results

Endpoint

Alteplase

Tenecteplase

p-Value

MACE

TIMI 1

Bleeding

In-Hospital Mortality

27 (45%)

12 (20%)

7 (11.7%)

10 (16.7%)

20 (22.2%)

12 (13.3%)

2 (2.2%)

8 (8.9%)

0.003

0.07

0.017

0.151

Univariate logistic regression analysis (unadjusted model) showed that type of thrombolytic therapy was related to an increased risk of MACE (HR 2,864, 95% CI 1,406 to 5,821; p=0.004)

Multivariate logistic regression analysis showed that type of thrombolytic therapy predicted the MACE (after adjustment for all confounders that contribute to MACE): HR 3,078, 95% CI 1,333 to 7,110; p=0.008

Adverse Events

Not disclosed

Study Author Conclusions

In patients with STEMI, where pPCI was not possible within the target time interval after admission to the hospital, simultaneous administration of tenecteplase and ticagrelor resulted in a substantial decrease in in-hospital mortality, major bleeding, and TIMI flow grade 1 rate compared to alteplase. 

InpharmD Researcher Critique

The single center and retrospective design of the study limits the ability to draw definite conclusions from the results due to the inability to control for confounding variables. In addition, bleeding-related adverse events were not reported, which may be an important safety consideration. While the study shows a possible benefit of tenecteplase over alteplase in patients with STEMI, the results should be interpreted with caution due to the inherent limitations of the study design. 



References:

Günlü S, Demir M. Comparison of tenecteplase versus alteplase in STEMI patients treated with ticagrelor: A cross-sectional study. Am J Emerg Med. 2022;58:52-56. doi:10.1016/j.ajem.2022.05.021