Safety of Bivalirudin Combined with Ticagrelor in the Emergency PCI in Patients with Acute ST-Segment Elevation Myocardial Infarction
Wang ZD, Chen YX, Liu M, Li P, Liang XW, Zhu XZ, Xie WC, Liao W (2022) · Clinical and Applied Thrombosis/Hemostasis · n=210
Характеристика исследования
- Дизайн
- single-center randomized controlled trial of bivalirudin vs unfractionated heparin both combined with ticagrelor in emergency PCI for STEMI patients (Yulin First People's Hospital, Guangxi, China; n=210 randomized 1:1)
- Размер выборки (n)
- 210
- Вмешательство
- Bivalirudin (n=105) + ticagrelor 180 mg loading then 90 mg BID during emergency PCI for STEMI
- Компаратор
- Unfractionated heparin (n=105) + same ticagrelor regimen
- Первичная конечная точка
- 30-day hemorrhage events (major and mild), major adverse cardiac events (MACE), and mortality
- Основной результат
- Mild hemorrhage 3.8% (bivalirudin) vs 12.4% (heparin), p=0.040 — significant reduction; major hemorrhage rates similar (1 case each arm); 1 death in heparin group, 0 in bivalirudin group; no MI, revascularization, or stroke in either arm at 30 days
- Длительность наблюдения
- 30 days
- PMID
- 36520539
Ключевые выводы
- 210-patient randomized trial of bivalirudin vs heparin with ticagrelor in STEMI PCI
- Significantly reduced mild hemorrhage with bivalirudin (3.8% vs 12.4%, p=0.04)
- No increase in MACE at 30 days
- Single-center Chinese real-world data add to the global bivalirudin literature
- Reinforces synthetic hirudin-derivative drug-pathway clinical evidence
Ограничения
- Single-center (Yulin Guangxi) — generalizability limited
- 30-day follow-up only — no long-term outcomes
- Open-label (no blinding)
- Modest sample size for MACE detection (n=210)
- Not applicable to whole-leech hirudotherapy
Клиническое значение
Wang 2022 adds Chinese real-world RCT data to the bivalirudin literature, demonstrating reduced mild-hemorrhage rates without ischemic-event penalty when combined with ticagrelor in STEMI PCI. For ASH, the trial is a contemporary reference point for the synthetic hirudin-derivative drug pathway — distinct from K040187 device-leech US clinical practice. Not applicable to US hirudotherapy clinical practice.
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