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Prasugrel loading dose does not increase bleeding in patients with STEMI undergoing PCI
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Patients with STEMI undergoing primary PCI who were pretreated with a loading dose of clopidogrel and then administered a loading dose of prasugrel did not have increased major bleeding events, according to results of a nonrandomized, observational study.
Researchers analyzed data on 2,023 patients with STEMI who were enrolled in the COMFORTABLE or SPUM-ACS studies between September 2009 and October 2012. Of those, 21% received concurrent administration of a clopidogrel and prasugrel (Effient, Daiichi Sankyo/Eli Lilly) loading dose, 22% received a prasugrel loading dose only and the rest received a clopidogrel loading dose only.
The primary safety endpoint of the study was Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding at 30 days. This endpoint occurred in 1.9% of patients who received clopidogrel and a loading dose of prasugrel vs. 3.4% of those who received prasugrel only (adjusted HR = 0.57; 95% CI, 0.25-1.3). The concurrent loading dose and clopidogrel-only loading dose groups also had similar rates of TIMI major bleeding (1.2% vs. 1.8%, respectively), TIMI minor bleeding (0.7% vs. 1.6%), GUSTO severe bleeding (0.5% vs. 1.3%) and GUSTO moderate bleeding (0.5% vs. 0.5%) at 30 days. The researchers also assessed the HAS-BLED bleeding score and found a trend toward a lower bleeding risk among patients who received prasugrel only (P = .076). An analysis adjusted for the primary safety endpoint using the HAS-BLED score yielded consistent results for BARC types 3 to 5 bleeding at 30 days with clopidogrel and prasugrel (adjusted HR = 0.54; 95% CI, 0.23-1.27).
At 1 year, the primary safety endpoint occurred in 3.9% of patients who received clopidogrel and a loading dose of prasugrel vs. 4.3% of patients who received prasugrel only (adjusted HR = 0.91; 95% CI, 0.46-1.79).
The researchers observed no difference in the composite rate of cardiac mortality, MI or stroke at 30 days between the groups (HR = 0.66; 95% CI, 0.27-1.62).
“The findings of our study are clinically relevant as many STEMI patients referred for primary PCI are pretreated with clopidogrel in routine clinical practice,” the researchers wrote. “On the basis of the presented data, the addition of a prasugrel loading dose in clopidogrel pretreated patients may be considered to achieve more rapid, more potent and consistent inhibition of platelet aggregation.” – by Rob Volansky
Disclosure: The researchers report associations with a number of device and pharmaceutical companies. Please see the full study for a list of the authors’ relevant financial disclosures.
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