Survival in STEMI patients at 1 year similar with PCI, pharmaco-invasive strategy

DALLAS — Patients with STEMI who underwent primary PCI had a similar rate of survival at 1 year when compared with those treated with a pharmaco-invasive strategy, according to new data from the STREAM trial.

Perspective from Christopher Cannon, MD

Researchers studied 1,892 patients with STEMI who presented within 3 hours of symptom onset and were unable to undergo primary PCI within 1 hour. Peter Sinnaeve, MD, with the University of Leuven in Belgium, and colleagues randomly assigned patients to standard primary PCI (n=948) or a pharmaco-invasive (PI) strategy (n=944) that consisted of bolus tenecteplase (TNK), clopidogrel and enoxaparin.

Follow-up at 1 year revealed similar rates of all-cause (PI, 6.7% vs. PCI, 5.9%; P=.52) and cardiac mortality (PI, 4% vs. PCI, 4.1%; P=.93). Also comparable was the rate of mortality between 30 days and 1 year (PI, 2.1% vs. PCI, 1.5%).

Sinnaeve said that after about 20% of enrollment, the steering committee was notified by the Data Safety Monitoring Board about an unacceptable high risk of intracranial hemorrhage in patients aged older than 75 years. “The amendment that halved the TNK dose improved outcomes in the pharmaco-invasive arm,” Sinnaeve said at a press conference, adding that there was a small but nonsignificant excess in noncardiac mortality in the pharmaco-invasive arm after day 30.

Earlier results from the study showed a nonsignificant trend at 30 days in the primary combined endpoint of death, shock, congestive HF and reinfarction favoring the PI group (12.4% vs. 14.3%; P=.21). Similarly, differences in rates of congestive HF (PI, 6.1% vs. PCI, 7.6%; P=.18) and shock (PI, 4.4% vs. PCI, 5.9%; P=.13) did not reach statistical significance. However, there was a significantly higher rate of aborted infarction in the PI group (11.1% vs. 6.9%; P<.01), which suggested to the researchers that there was more salvage of ischemic myocardium due to earlier reperfusion in the PI group (median time: PI, 100 minutes vs. PCI, 178 minutes; P<.001).

“Taken together, the pharmaco-invasive strategy used in the STREAM trial was similar to primary PCI and offers an alternative reperfusion therapy strategy to a substantial proportion of patients worldwide,” Sinnaeve concluded. – by Brian Ellis

For more information:

Sinnaeve P. LBCT.04. Therapeutic advances in coronary and peripheral vascular disease. Presented at: the American Heart Association Scientific Sessions; Nov. 16-20, 2013; Dallas.

Disclosure: Sinnaeve reports serving on the speakers’ bureau of Bayer, Boehringer Ingelheim, Bristol-Myers Squibb and Pfizer, and receiving honoraria from Johnson & Johnson.

Perspective

Christopher Cannon, MD

There had been great enthusiasm about the earliest possible opening of the artery in STEMI, and the idea of using a fibrinolytic pre-cath lab to do that seemed very reasonable. However, the balance of the increased bleeding risk of adding a fibrinolytic agent to PCI could work against it.

In this study, the relatively modest amount of earlier opening of the artery with the fibrinolytic didn’t seem to have a big clinical impact. It doesn’t detract from the need to open arteries quickly. It is just that adding the fibrinolytic, in a setting where time to reperfusion with ‘regular’ primary PCI has been markedly reduced from all the system efforts, the modest increment in earlier opening beyond that, combined with increased bleeding risk, doesn’t turn into a clinical benefit.

Christopher Cannon, MD

Executive Director, Cardiometabolic Trials,

Harvard Clinical Research Institute, Boston

Disclosures: Cannon reports financial ties with multiple device and pharmaceutical companies.