STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With
Frans Van de Werf1, Arsen D Ristić2, Oleg V Averkov3
1Department of Cardiovascular Sciences, KU Leuven, Belgium (F.V.d.W., K.V., P.S.).
Insights
Half-dose tenecteplase in a pharmaco-invasive strategy is a viable option for older patients with ST-elevation myocardial infarction (STEMI) when primary percutaneous coronary intervention (PCI) is delayed. While effective, it carries a higher risk of intracranial hemorrhage, necessitating careful patient selection.
Area of Science:
- Cardiology
- Emergency Medicine
- Pharmacology
Background:
- ST-segment-elevation myocardial infarction (STEMI) management guidelines suggest pharmaco-invasive treatment when primary percutaneous coronary intervention (PCI) is not timely.
- Full-dose tenecteplase increases intracranial hemorrhage risk in elderly patients.
- The safety and efficacy of half-dose tenecteplase in this population remain unestablished.
Purpose of the Study:
- To evaluate the effectiveness and safety of a pharmaco-invasive strategy using half-dose tenecteplase in elderly patients with STEMI.
- To compare this strategy against primary PCI when timely intervention is unavailable.
Main Methods:
- The STREAM-2 study randomized patients aged ≥60 with STEMI to either half-dose tenecteplase followed by angiography/PCI or primary PCI.
- Efficacy endpoints included ST resolution and a 30-day composite of death, shock, heart failure, or reinfarction.
- Safety endpoints focused on stroke and non-intracranial bleeding.
Main Results:
- Pharmaco-invasive treatment with half-dose tenecteplase showed comparable ST resolution (85.2% vs. 78.4%) and similar 30-day composite clinical outcomes (12.8% vs. 13.3%) to primary PCI.
- Intracranial hemorrhage occurred in 1.5% of the pharmaco-invasive group versus 0% in the primary PCI group.
- Major non-intracranial bleeding was infrequent (<1.5%) in both groups.
Conclusions:
- A half-dose tenecteplase pharmaco-invasive strategy offers comparable efficacy to primary PCI in older STEMI patients when timely PCI is unavailable.
- This approach is a reasonable alternative, provided contraindications to fibrinolysis are respected and anticoagulation is managed carefully.
- The risk of intracranial hemorrhage is higher with this strategy compared to primary PCI.
Background:
ST-segment-elevation myocardial infarction (STEMI) guidelines recommend pharmaco-invasive treatment if timely primary percutaneous coronary intervention (PCI) is unavailable. Full-dose tenecteplase is associated with an increased risk of intracranial hemorrhage in older patients. Whether pharmaco-invasive treatment with half-dose tenecteplase is effective and safe in older patients with STEMI is unknown.
Methods:
STREAM-2 (Strategic Reperfusion in Elderly Patients Early After Myocardial Infarction) was an investigator-initiated, open-label, randomized, multicenter study. Patients ≥60 years of age with ≥2 mm ST-segment elevation in 2 contiguous leads, unable to undergo primary PCI within 1 hour, were randomly assigned (2:1) to half-dose tenecteplase followed by coronary angiography and PCI (if indicated) 6 to 24 hours after randomization, or to primary PCI. Efficacy end points of primary interest were ST resolution and the 30-day composite of death, shock, heart failure, or reinfarction. Safety assessments included stroke and nonintracranial bleeding.
Results:
Patients were assigned to pharmaco-invasive treatment (n=401) or primary PCI (n=203). Median times from randomization to tenecteplase or sheath insertion were 10 and 81 minutes, respectively. After last angiography, 85.2% of patients undergoing pharmaco-invasive treatment and 78.4% of patients undergoing primary PCI had ≥50% resolution of ST-segment elevation; their residual median sums of ST deviations were 4.5 versus 5.5 mm, respectively. Thrombolysis In Myocardial Infarction flow grade 3 at last angiography was ≈87% in both groups. The composite clinical end point occurred in 12.8% (51/400) of patients undergoing pharmaco-invasive treatment and 13.3% (27/203) of patients undergoing primary PCI (relative risk, 0.96 [95% CI, 0.62-1.48]). Six intracranial hemorrhages occurred in the pharmaco-invasive arm (1.5%): 3 were protocol violations (excess anticoagulation in 2 and uncontrolled hypertension in 1). No intracranial bleeding occurred in the primary PCI arm. The incidence of major nonintracranial bleeding was low in both groups (<1.5%).
Conclusions:
Halving the dose of tenecteplase in a pharmaco-invasive strategy in this early-presenting, older STEMI population was associated with electrocardiographic changes that were at least comparable to those after primary PCI. Similar clinical efficacy and angiographic end points occurred in both treatment groups. The risk of intracranial hemorrhage was higher with half-dose tenecteplase than with primary PCI. If timely PCI is unavailable, this pharmaco-invasive strategy is a reasonable alternative, provided that contraindications to fibrinolysis are observed and excess anticoagulation is avoided.
Registration:
URL: https://www.
Clinicaltrials:
gov; Unique identifier: NCT02777580.
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