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What evidence supports intravenous tenecteplase for the treatment of acute ischemic stroke?

Introduction

Stroke is currently the leading cause of death in the United States (US), and in the year 2018, approximately 1 in every 6 deaths from cardiovascular disease was a result of a stroke.1,2 Over 795,000 Americans have a stroke each year, and it is a major cause of serious disability for adults.1 About 87% of strokes are ischemic strokes, which can be treated with reperfusion therapy.2,3 The goal of reperfusion therapy is to restore blood flow to the regions of the brain that are not yet infarcted, which will in turn reduce stroke-related disability and mortality.3 Reperfusion therapy is performed by either a mechanical thrombectomy, intravenous thrombolysis, or both.3,4 Alteplase is currently the only Food and Drug Administration (FDA) approved thrombolytic agent for the treatment of acute ischemic stroke. However, the use of tenecteplase for the treatment of acute ischemic stroke is increasing. The purpose of this FAQ is to review differences between tenecteplase and alteplase, describe the data supporting tenecteplase in the American Heart Association/American Stroke Association (AHA/ASA) guideline update, and review evidence published after the guideline update.

Tenecteplase versus alteplase
While alteplase is approved for the treatment of acute ischemic stroke, tenecteplase is currently FDA-approved for the treatment of acute myocardial infarction but is used off-label for the treatment of acute ischemic stroke.3,5,6 Both alteplase and tenecteplase initiate fibrinolysis by binding to fibrin in a blood clot and converting the plasminogen to plasmin, although tenecteplase has greater fibrin specificity.5-7 Alteplase has an initial half-life of about 5 minutes and a terminal half-life of 60 to 72 minutes.6,7 In contrast, tenecteplase is a recombinant variant of alteplase and has a longer half-life, with an initial half-life of 24 minutes and a terminal half-life of 90 to 130 minutes.5,7 In addition, tenecteplase is resistant to the inhibition from plasminogen activator inhibitor-1 (PAI-1).7,8 These differences allow tenecteplase to be administered as one bolus dose as opposed to the one hour infusion required for administration of alteplase.7 In addition to its documented efficacy and safety, tenecteplase is less expensive than alteplase. However, the manufacturer of both alteplase and tenecteplase (Genentech) offers a product replacement program when vials are reconstituted but unused (ie, spoiled) for their labeled indications. Therefore, tenecteplase would not be eligible for this program since it is not FDA-approved for acute ischemic stroke.7,9,10

Guideline recommendations

The AHA/ASA 2019 update to the guideline for the early management of patients with acute ischemic stroke states that patients who are eligible for alteplase should be initiated on treatment right away at a dose of 0.9 mg/kg (maximum 90 mg) administered as a bolus of 10% of the dose given over 1 minute followed by a continuous infusion over 60 minutes.3 Adult patients with mild disabling and severe stroke without contraindications to thrombolytics are eligible for alteplase within 3 hours from symptom onset or from time last known to be well. Patients who present within 3 to 4.5 hours from symptom onset or from time last known to be well are eligible for alteplase depending on several factors including age, history of prior stroke, history of diabetes mellitus, National Institutes of Health Stroke Scale (NIHSS) score, and size of ischemia. Tenecteplase is included in the guideline update as an alternative treatment to alteplase in specific patient populations. The guideline recommends that selecting tenecteplase over alteplase is reasonable in patients who are also eligible for mechanical thrombectomy at a dose of 0.25 mg/kg (maximum 25 mg). Tenecteplase 0.4 mg/kg may also be considered as an alternative to alteplase in patients with minor neurological impairment and no major intracranial occlusion; however, the guideline notes that tenecteplase has not been proven superior or noninferior to alteplase. Both recommendations are class IIB (weak) and are based on moderate quality evidence.

Safety of thrombolytic agents

Intravenous thrombolytic agents have been associated with serious bleeding complications and require extensive monitoring for 24 hours after administration, which includes maintaining a blood pressure < 180/105 mm Hg and a 24-hour post infusion computed tomography (CT) or magnetic resonance imaging (MRI).3 Evidence suggests that patients who are treated with tenecteplase may not experience symptomatic intracranial hemorrhage at an increased rate compared to alteplase; however, the exact risk is unclear and may be dependent on the stroke severity and tenecteplase dose.7 Lower rates of non-cerebral bleeding have been reported with the use of tenecteplase compared to alteplase for the treatment of acute myocardial infarction.11

Literature review

Randomized controlled trials
Randomized controlled trials evaluating tenecteplase in acute ischemic stroke are summarized in the Table.12-17 Several of these studies were used to support the recommendations regarding tenecteplase in the 2019 AHA/ASA guideline update. The recommendation that it is reasonable to choose tenecteplase (single intravenous bolus of 0.25 mg/kg, maximum 25 mg) over alteplase in patients without contraindications who are also eligible for mechanical thrombectomy is based on the results of the EXTEND-IA TNK trial Part 1.3,13 This trial found that tenecteplase was both noninferior and superior to alteplase for reperfusion in patients with occlusion of the internal carotid, middle cerebral, or basilar artery prior to mechanical thrombectomy.

The second recommendation for tenecteplase in the 2019 AHA/ASA guideline update states that tenecteplase administered as a 0.4 mg/kg single bolus might be considered as an alternative to alteplase in patients with minor neurological impairment and no major intracranial occlusion.3 This recommendation is supported by multiple studies summarized in the Table.3,14-17 The guideline states that these studies found similar safety to alteplase when tenecteplase was administered within 6 hours of stroke onset, but it is unclear if tenecteplase is more or similarly effective compared to alteplase. The guideline specified that the largest study is the NOR-TEST study, which found similar efficacy (modified Rankin Scale [mRS] score of 0-1 at 3 months) and safety (symptomatic intracranial hemorrhage) of tenecteplase and alteplase in patients with minor neurological impairment and no major intracranial occlusion.3,14 In a post-hoc analysis of the NOR-TEST study in patients with moderate or severe stroke, there were no differences in favorable outcome (mRS score of 0-1) between patients treated with tenecteplase or alteplase.18

Since the publication of the guideline update, the EXTEND-IA TNK trial Part 2 was published,  which compared tenecteplase doses for acute ischemic stroke.12 A higher dose of tenecteplase 0.4 mg/kg (maximum 40 mg) was not associated with improved cerebral reperfusion compared to the 0.25 mg/kg dose (maximum 25 mg). Similar to the EXTEND-IA TNK Part 1 study, Part 2 included patients who had experienced an ischemic stroke within 4.5 hours prior to hospitalization who had a large vessel occlusion of the internal intracranial carotid, middle cerebral, or basilar artery prior to endovascular thrombectomy.

Meta-analyses
Multiple meta-analyses that evaluated tenecteplase for acute ischemic stroke have been published since the 2019 AHA/ASA guideline update.19-22 A 2021 meta-analysis by Katsanos et al evaluated tenecteplase for acute ischemic stroke specifically in patients with large vessel occlusions.19 Use of tenecteplase compared to alteplase was associated with higher successful recanalization, improved mRS score of 0 to 2, and functional improvement at 3 months. Three meta-analyses examined the use of tenecteplase in patients with acute ischemic stroke, not limited to large vessel occlusions.20-22 Two meta-analyses found higher early neurological improvement with tenecteplase compared to alteplase, and 1 meta-analysis found higher rates of recanalization with tenecteplase.21,22 Other outcomes, including rates of intracranial hemorrhage and mortality, were not significantly different between groups.19-22 The meta-analyses had several limitations, including that studies evaluated multiple doses of tenecteplase, the confidence intervals for the rate of intracranial bleeding were wide reflecting inconclusive results, additional therapies used in the studies varied (eg, endovascular treatment), the time window for thrombolytic administration since the onset of stroke varied (3 to 6 hours), and only certain subgroups of patients were included (eg, only patients with large vessel occlusions). Many meta-analyses also included the tenecteplase 0.1 mg/kg dose, which is lower than the doses recommended in the guideline and is not considered as effective as the 0.25 and 0.4 mg/kg doses.3,22

Table. Overview of evidence examining tenecteplase for acute ischemic stroke.12-17,19-22
Study design Subjects
InterventionsResultsConclusions
Meta-analyses 
Katsanos et al 202119
 
MA of 4 RCTs		N=433 patients with acute ischemic stroke and large vessel occlusionsAlteplase 0.9 mg/kg
 
Tenecteplase 0.1, 0.25, or 0.4 mg/kg		Primary
Higher mRS 0-2 at 3 months with tenecteplase vs alteplase (OR, 2.06; 95% CI, 1.15 to 3.69)

Other
Higher odds of successful recanalization (OR, 3.05; 95% CI, 1.73 to 5.4) and functional improvement (common OR, 1.84; 95% CI, 1.18 to 2.87) at 3 months with tenecteplase vs alteplase
 
Early neurological improvement, mRS 0-1, sICH, any ICH, or all-cause mortality at 3 months were not different between groups		Improved recanalization, mRS, and functional improvement with tenecteplase vs alteplase in patients with large vessel occlusions
Oliveira et al 202121
 
MA of 8 observational and RCTs		N=2031 patients with an acute ischemic strokeAlteplase 0.9 mg/kg
 
Tenecteplase 0.1, 0.25, or 0.4 mg/kg		Higher rates of recanalization and early neurological improvement were observed with tenecteplase vs alteplase (ARD, 0.11 [95% CI, 0.01 to 0.20] and 0.10 [95% CI, 0.02 to 0.17])
 
mRS of 0-2 or 0-1 at 3 months were not different between tenecteplase vs alteplase
 
Of the tenecteplase doses, the network MA found that tenecteplase 0.2 to 0.25 mg/kg was superior to alteplase for early neurological improvement (ARD, 0.16; 95% CI, 0.02 to 0.29)
 
There was no difference in ICH, sICH, or mortality		Improved recanalization and early neurological improvement with tenecteplase vs alteplase
Burgos et al 201920
 
MA of 5 RCTs adapted to a noninferiority analysis		N=1585 adults with an acute ischemic stroke Alteplase 0.9 mg/kg
 
Tenecteplase 0.1, 0.25, or 0.4 mg/kg		Primary
Cumulative rates of the disability free outcome (mRS 0-1) at 3 months were 57.9% in the tenecteplase group and 55.4% in the alteplase group; relative risk difference was 4% (95% CI, -1% to 8% [noninferiority margin, -6.5%])
 
Safety
Approximately 3% of patients in both treatment groups experienced sICH (risk difference, 0%; 95% CI, -1% to 2%; noninferiority margin, 1%)
 
The crude mortality rates were 7.6% with tenecteplase and 8.1% with alteplase (risk difference, 0%; 95% CI, -3% to 2%; noninferiority margin, 1%)		Tenecteplase is noninferior to alteplase for the treatment of acute ischemic stroke
Thelengana et al 201922
 
MA of 4 RCTs		N=1334 patients with acute ischemic strokeAlteplase 0.9 mg/kg
 
Tenecteplase 0.25 or 0.4 mg/kg		Early major neurological improvement was improved with tenecteplase vs alteplase (RR, 1.56; 95% CI, 1.0 to 2.43; p=0.05)
 
Good (mRS 0-2) or excellent (mRS 0-1) functional outcome, ICH, sICH, or mortality at 90 days were not significantly different between groups		Use of tenecteplase resulted in higher early major neurological improvement compared to alteplase
Randomized controlled trials
Campbell et al 202012
 
EXTEND-IA TNK Part 2
 
MC, open-label, blinded-outcome, RCT		N=300 adults who experienced an ischemic stroke 4.5 hours prior to hospitalization who had a large vessel occlusion of the intracranial internal carotid, middle cerebral, or basilar artery prior to endovascular thrombectomy
 
Median NIHSS scores 16 to 17 (IQR, 9 to 21)		Tenecteplase 0.4 mg/kg (max 40 mg) (n=150)
 
Tenecteplase 0.25 mg/kg (max 25 mg) (n=150)
 
Of note, 1 patient in each group received 0.5 mg/kg		Primary
Reperfusion of greater than 50% a occurred in 19.3% (29) patients in both treatment groups (p=NS)
 
Other
No difference was observed in mRS 0-2 or early neurological improvement
 
Safety
sICH: 4.7% in the tenecteplase 0.4 mg/kg group and 1.3% in the 0.25 mg/kg group
 
Death: 17% in the 0.4 mg/kg group and 15% in the 0.25 mg/kg group		A dose of 0.4 mg/kg compared to 0.25 mg/kg does not significantly improve cerebral reperfusion
Campbell et al 201813
EXTEND-IA TNK Part 1
 
MC, open-label, blinded-outcome, RCT
N=202 adults without previous severe disability who experienced an ischemic stroke within 4.5 hours prior to hospitalization who had a large vessel occlusion of the internal intracranial carotid, middle cerebral, or basilar artery prior to endovascular thrombectomy
 
Median NIHSS score: 17 (IQR, 12 to 22)		Alteplase 0.9 mg/kg (max 90 mg) (n=101)
 
Tenecteplase 0.25 mg/kg (max 25 mg) (n=101)		Primary
22% of patients treated with tenecteplase experienced reperfusion of greater than 50%a at initial angiographic assessment compared to the 10% of patients treated with alteplase (p=0.002 for noninferiority; p=0.03 for superiority)
 
Other
No difference was observed in mRS 0-2 at 90 days or early neurological improvement
 
Safety
sICH: 1% in each group
 
Death: 10% with tenecteplase vs 18% with alteplase (p=NS)		Tenecteplase before endovascular thrombectomy in patients with large vessel occlusion resulted in a higher incidence of reperfusion
and better functional outcome than alteplase
Logallo et al 201714
 
NOR-TEST
 
Open-label, MC, blinded endpoint, RCT		N=1100 patients with stroke onset within 4.5 hours without major intracranial occlusion
 
Median NIHSS score: 4 (IQR, 2 to 8) 		Alteplase 0.9 mg/kg (max 90 mg) (n=551)
 
Tenecteplase 0.4 mg/kg (max 40 mg) (n=549)		Primary
mRS 0-1 at 3 months occurred in 64% with tenecteplase and 63% with alteplase (p=NS)
 
Safety
ICH at 24-48 hours and sICH at 24-48 hours were similar between tenecteplase and alteplase (9% vs 9% and 3% vs 2%)
 
Deaths at 3 months occurred in 5% of patients in both groups		Patients treated with tenecteplase and alteplase had similar clinical and safety outcomes
Huang et al 201515
 
ATTEST
 
SC, phase 2, prospective, blinded endpoint, randomized trial		N=104 patients with supratentorial ischemic stroke treated within 4.5 hours of onset
 
Median NIHSS score: 11 to 12 (IQR, 8 to 18)		Alteplase 0.9 mg/kg (max 90 mg) (n=52)
 
Tenecteplase 0.25 mg/kg (max 25 mg) (n=52)		Primary
Percentage of penumbra salvaged at 24-48 hours was not significantly different between tenecteplase (68%) vs alteplase (68%) (p=NS)
 
Other
No difference in early neurological improvement at 24 hours or mRS of 0-1 at 30 days or 90 days
 
Safety
sICH or total ICH were not different between tenecteplase and alteplase (2% vs 4%; p=NS and 15% vs 27%; p=NS)
 
Mortality at 90 days was 17% with tenecteplase vs 12% with alteplase (p=NS)		Neurological and safety outcomes were similar between alteplase and tenecteplase
Parsons et al 201216
Australian-TNK
 
Open-label, MC, blinded RCT		N=75 adults with NIHSS score >4, mRS of 2 or less, with intracranial occlusion of anterior cerebral, middle cerebral, or posterior cerebral artery and a perfusion lesion at least 20% greater than the infarct core per neuroimaging with treatment within 6 hours of stroke onset
 
Mean NIHSS score: 14 to 14.6		Alteplase 0.9 mg/kg (max 90 mg) (n=25)
 
Tenecteplase 0.1 mg/kg (max 10 mg) (n=25)
 
Tenecteplase 0.25 mg/kg (max 25 mg) (n=25)		Primary
Percentage of reperfusion 24 hours after treatment was greater with the pooled tenecteplase groups (79.3%) compared to alteplase (55.4%) (p=0.004)
 
Mean improvement in NIHSS score at 24 hours was greater with the pooled tenecteplase groups (8) vs alteplase (3; p<0.001)
 
Other
Excellent or good recovery at 90 days (mRS of 0-2) was higher in the pooled tenecteplase groups vs alteplase (72% vs 44%; p=0.02)
 
Safety
Deaths: 12% with alteplase, 12% with tenecteplase 0.1 mg/kg, and 4% with tenecteplase 0.25 mg/kg
 
sICH were not different between pooled tenecteplase groups (4%) and alteplase (12%)		Use of tenecteplase was associated with improved reperfusion and NIHSS improvement compared to alteplase
Haley et al 201017
 
MC, double-blind, RCT		N=112 patients with acute stroke within 3 hours of onset
 
Median NIHSS: 8 to 13 (IQR, 5 to 17)		Alteplase 0.9 mg/kg (max 90 mg)
(n=31)
 
Tenecteplase 0.1 mg/kg (n=31)
 
Tenecteplase 0.25 mg/kg (n=31)
 
Tenecteplase 0.4 mg/kg (n=19)		At 3 months, mRS of 0-1 was achieved by 45.2% with tenecteplase 0.1 mg/kg, 48.4% with 0.25 mg/kg, 36.8% with 0.4 mg/kg, and 41.9% with alteplase
 
Major neurological improvement was achieved by 22.6% with tenecteplase 0.1 mg/kg, 35.5% with 0.25 mg/kg, 21.1% with 0.4 mg/kg, and 16.1% with alteplase
 
sICH and total ICH occurred in 0% and 9.7% with tenecteplase 0.1 mg/kg, 6.5% and 12.9% with 0.25 mg/kg, 15.8% and 26.3% with 0.4 mg/kg, and 3.2% and 16.1% with alteplase
 
Death within 3 months occurred in 6.5% with tenecteplase 0.1 mg/kg, 22.6% with 0.25 mg/kg, 15.8% with 0.4 mg/kg, and 25.8% with alteplase		Trial prematurely terminated for slow enrollment; the 0.4 mg/kg dose was discarded as inferior
aReperfusion=restoration of blood flow to greater than 50% of the involved territory or an absence of retrievable thrombus in the target vessel
Abbreviations: ARD=absolute risk difference; CI=confidence interval; ICH=intracranial hemorrhage; IQR=interquartile range; MA=meta-analysis, MC=multi-center, mRS=modified Rankin Scale; NIHSS=National Institutes of Health Stroke Scale; NS=not significant; OR= odds ratio; RCT=randomized controlled trial; RR=risk ratio; SC=single center; sICH= symptomatic intracranial hemorrhage.

Conclusion

Overall, evidence supports similar efficacy and safety between tenecteplase and alteplase in acute ischemic stroke. Recent meta-analyses suggest that tenecteplase may have improved rates of recanalization and early major neurological improvement compared to alteplase; however, the studies are limited by varying inclusion criteria and concomitant treatment, and different doses of tenecteplase. The optimal dose of tenecteplase is not yet defined, but a recent randomized controlled trial did not find improved reperfusion outcomes with 0.4 mg/kg compared to 0.25 mg/kg in patients with large vessel occlusions. Ongoing studies will further clarify the role of tenecteplase for acute ischemic stroke, including the ongoing TEMPO 2 study (NCT02398656) in patients with minor ischemic stroke with occlusion, the TASTE study with penumbra on perfusion imaging, the ATTEST 2 study (NCT02814409), and the TWIST study in patients with wake-up ischemic stroke (NCT03181360).7,23

References

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Prepared by:
Vivian Kadus, PharmD Candidate Class of 2022
University of Illinois at Chicago College of Pharmacy

Patricia Hartke, PharmD, BCPS
Clinical Assistant Professor, Drug Information Specialist
University of Illinois at Chicago College of Pharmacy

January 2022

The information presented is current as of December 15, 2021. This information is intended as an educational piece and should not be used as the sole source for clinical decision-making.