From the Guidelines
Alteplase in STEMI trials show that primary PCI is superior to fibrinolysis with alteplase in reducing mortality and morbidity.
Key Findings
- The DANAMI-2 trial 1 demonstrated a statistically significant reduction in the primary endpoint of death, reinfarction, and stroke at 30 days for patients treated with primary PCI (8.0% for primary PCI vs. 13.7% for fibrinolysis, p < 0.001).
- A meta-analysis involving six randomized trials 1 compared the strategy of transfer for primary PCI versus on-site thrombolysis, and found that the combined end point of death, reinfarction, or stroke was reduced by 42% favoring the transfer for PCI strategy (p < 0.001).
- The PRAGUE-2 study 1 showed that the primary end point of 30-day mortality was 10% in the streptokinase group compared with 6.8% in the PCI group (p 0.12), and death/reinfarction/stroke at 30 days was 15.2% in the streptokinase group versus 8.4% in the PCI group (p < 0.003).
Comparison of Alteplase with Primary PCI
- The FINESSE trial 1 showed that neither PCI preceded by abciximab and reteplase nor PCI preceded by abciximab alone was superior to abciximab used at the time of PCI among patients presenting within 4 hours of medical contact.
- The CARESS-in-AMI trial 1 studied 600 STEMI patients and found that high-risk STEMI patients treated at non-PCI hospitals with a preparatory pharmacological strategy of half-dose fibrinolytic therapy, abciximab, heparin, and ASA have improved outcomes when transferred immediately to a PCI facility rather than when medical therapy is continued with transfer for rescue PCI only if there is evidence of failed reperfusion.
Clinical Implications
- Primary PCI is the preferred treatment for STEMI patients if it can be performed in a timely manner by an experienced team.
- Alteplase can be used as a fibrinolytic agent in patients who are not candidates for primary PCI or in whom primary PCI is not available.
- Transfer for primary PCI should be considered for high-risk STEMI patients treated at non-PCI hospitals with a preparatory pharmacological strategy.
From the Research
Results of Trials on Alteplase in STEMI
- The efficacy and safety of Alteplase in patients with STEMI have been evaluated in several studies 2, 3, 4, 5.
- A phase 3, double-blind, randomized trial compared the efficacy and safety of Altelyse (bio-similar Alteplase) versus Actilyse (brand name Alteplase) in patients with STEMI, and found that Altelyse was non-inferior to Actilyse with respect to total ST-segment resolution after 90 min 2.
- The EARLY-MYO trial compared the efficacy and safety of a pharmaco-invasive strategy with half-dose Alteplase versus primary angioplasty in patients with STEMI, and found that the pharmaco-invasive strategy was non-inferior (and even superior) to primary angioplasty for the primary endpoint of complete epicardial and myocardial reperfusion 3.
- A study compared coronary flow and bleeding complications in patients with STEMI after administration of Alteplase or streptokinase, and found that Alteplase provided higher coronary flow (TIMI-3) and lower frequency of hypotension, with no significant difference in major bleeding 4.
- A randomized clinical trial evaluated the effect of low-dose intracoronary Alteplase during primary percutaneous coronary intervention on microvascular obstruction in patients with acute myocardial infarction, and found that adjunctive low-dose intracoronary Alteplase did not reduce microvascular obstruction 5.
Efficacy of Alteplase
- The studies suggest that Alteplase is effective in achieving coronary reperfusion and reducing microvascular obstruction in patients with STEMI 2, 3, 4.
- However, the results of the study on low-dose intracoronary Alteplase during primary percutaneous coronary intervention suggest that this treatment strategy may not be effective in reducing microvascular obstruction 5.
Safety of Alteplase
- The studies suggest that Alteplase is generally safe and well-tolerated in patients with STEMI, with a low risk of major bleeding and other adverse events 2, 3, 4, 5.
- However, the study on low-dose intracoronary Alteplase during primary percutaneous coronary intervention found that this treatment strategy was associated with a higher risk of major adverse cardiac events 5.