This somewhat befuddling study tries desperately to create a problem where there probably truly wasn’t – but as soon as the conflict-of-interest disclosures come up, it’s clear why.
This is the 1-year outcomes from STREAM, a prospective, open-label, parallel-group trial enrolling participants with acute STEMI, but unlikely to undergo primary PCI within 1 hour of diagnosis. Participants were then randomized to either still undergo emergency PCI, or to fibrinolysis followed by urgent or emergency rescue PCI. The initial 1-month composite outcome, despite an excess of deaths secondary to intracranial hemorrhage in the fibrinolysis group, did not demonstrate any disadvantage to fibrinolysis with delayed PCI. There was actually a 2% absolute decrease in the composite outcome favoring fibrinolysis – and thus the 1-year follow-up, hoping this small advantage in morbidity would translate into a measurable mortality advantage.
This was, however, not the case – as cardiac mortality was 4.0% with fibrinolysis vs. 4.1% with PCI. Adding in the ICH and other non-cardiac deaths, the all-cause mortality rose to 6.7% with fibrinolysis vs. 5.9% with PCI. Baseline characteristics probably favored the fibrinolysis group, so there’s actually a reasonable chance the mortality disadvantage owed to the fibrinolysis strategy might indeed be durable if properly powered and balanced.
Ostensibly, the authors claim to be addressing a problem of resource scarcity. Using their fibrinolysis strategy, they seem to suggest, allows elimination of the expensive healthcare delivery models predicated on timely PCI. However, a full 36% of patients failed to re-establish flow and still required emergency rescue angiography. Then, all remaining patients still underwent urgent angiography, with greater than 95% receiving a stent. So, in essence, the trade-off for increased flexibility in the timing of angiography is the added expenditure of tenecteplase – and possibly an increase in long-term mortality.
Certainly, there are many remote or resource austere settings where revascularization by thrombolysis is appropriate. However, Boehringer Ingelheim and their sponsored collaborators have produced this scientific work simply in a transparent attempt at promoting an expansion of the pharamacoinvasive group (read: sell more tenecteplase) – and, frankly, failing.
“STEMI Patients Randomized to a Pharmaco-Invasive Strategy or Primary PCI: The STREAM 1-Year Mortality Follow-Up”
http://www.ncbi.nlm.nih.gov/pubmed/25161043