Gender Differences in the One-Year Outcomes of Prasugrel versus Ticagrelor in Acute Myocardial Infarction Treated With Primary Angioplasty: A Posthoc Analysis of the PRAGUE-18 Study

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Authors

KALA Petr MOTOVSKA Zuzana HLINOMAZ Ota HROMADKA Milan KNOT Jiří VARVAROVSKY Ivo DUSEK Jaroslav MIKLIK Roman JARKOVSKÝ Jiří SIMEK Stanislav BRANNY Marian MROZEK Jan CERVINKA Pavel OSTRANSKY Jiri ROKYTA Richard TOUSEK Frantisek WIDIMSKY Petr

Year of publication 2018
Type Conference abstract
MU Faculty or unit

Faculty of Medicine

Citation
Description Introduction: Prasugrel and ticagrelor have shown similar primary net-clinical endpoint (cardiovascular death, spontaneous MI, stroke, severe bleeding or revascularization at day 7) and similar clinical effectivity in the PRAGUE-18 study at one year. Hypothesis: Impact of gender on the clinical outcome up to 12 months. Methods: A total of 1,230 patients with acute MI (931 males; 75.7%) treated with primary PCI were randomized to prasugrel or ticagrelor with an intended treatment duration of 12 months. Key secondary efficacy endpoint (EP) was cardiovascular death, spontaneous MI, stroke within 30 days and at one year. Results: Females were older (64.9 vs 60.9 years; p<0.001), more often hypertensive (63.2% vs 47.4%; p<0.001) and diabetics (27.8% vs 17.9%; p<0.001) and there were less smokers (58.9% vs 66.8%; p=0.015). Females suffered significantly longer time interval from symptom onset to the admission to PCI center (3.3hrs vs 2.5hrs; p=0.001). In females, the primary net-clinical EP at 7 days was not different from males (4.4% vs 3.9%; p=0.645) but at 30 days, the rate of MI and combined key efficacy EP occurred significantly more often(5.4% vs 2.7%; p=0.030 [HR 5.234; 95% CI, 1.902-14.401] and 3.3% vs 0.6%; p=0.001 [HR 2.007 95% CI, 1.072-3.759], respectively). At 12 months, there was no significant difference between the groups, though a strong trend to higher rate of MI and bleeding was found (HR 1.968, 95% CI 0.985-3.929; p=0.055 and HR 1.399 95% CI 0.970-2.020; p=0.073, respectively). End of potent P2Y12 treatment within one year was observed more often in females than males, though not statistically significant (58.5% vs 52.0%; p=0.053). No significant difference was found in the economically driven switch to clopidogrel (43.1% vs 37.8%; p=0.103). Conclusions: In the PRAGUE-18 study, the female patients were at higher baseline clinical risk, had significantly higher rate of MI and cardiovascular death/MI/stroke at 30 days and tended to have a higher rate of repeated MI and bleeding complications at 12 months. Longer pre-hospital ischemic time in females requires special attention.
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