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.
Связанные исследования
Hirulog in the treatment of unstable angina. Results of the Thrombin Inhibition in Myocardial Ischemia (TIMI) 7 trial
Fuchs J, Cannon CP (1995)
Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial
Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW (2009)
Experience with pharmacologic leeching with bivalirudin for adjunct treatment of venous congestion of head and neck reconstructive flaps
Harun A, Kruer RM, Lee A, Boahene K, Byrne PJ, Richmon JD (2018)
Heparin and Bivalirudin in Percutaneous Coronary Intervention for Acute Coronary Syndromes: A Review Article
Wang G, Qi K, Li X, Zuo S, Zhang R, Zhao Y, Sun S, Zhang J, Liu X (2024)