Abstract Number: PB1111
Meeting: ISTH 2020 Congress
Background: Prothrombin complex concentrates (PCCs) correct quantitative thrombin generation parameters but their impact on kinetic parameters are inconsistent. Activated PCC (aPCCs) have been shown to enhance both kinetic and quantitative thrombin generation parameters. Clinical studies evaluating aPCC for DOAC-associated bleeding are sparse.
Aims: Evaluate the impact of aPCC on clinical hemostasis and laboratory coagulation parameters in patients with DOAC-associated bleeding or prior to urgent surgery.
Methods: We conducted a retrospective study of patients receiving aPCC for DOAC-associated major bleeding or prior to urgent surgery. The primary efficacy outcome was hemostatic efficacy by modified ISTH and Sarode criteria. Surgical hemostasis was assessed using a binary “normal” or “abnormal” scale. The primary safety outcome was the 30-day thromboembolic rate. Coagulation study results (international normalized ratio [INR] and activated partial thromboplastin time [aPTT]) were analyzed in an exploratory fashion.
Results: Eighty-two patients were included in the analysis; 54 patients received aPCC for major bleeding and 28 patients prior to urgent surgery; 14 patients on dabigatran, 39 on rivaroxaban, 29 on apixaban. Mean weight-based aPCC dosing was 38 IU/kg (SD ± 13.2 IU/kg). Hemostasis was deemed effective by ISTH criteria in 50% of cases and “Good” or “Moderate” by Sarode criteria in 45.2% and 14.3% of cases, respectively. Surgical hemostasis was rated “Normal” in 84% of cases when given prior to urgent surgery. Median pre-aPCC INR was 1.6 (interquartile range, IQR 0.5) and median post-aPCC INR was 1.2 (IQR 0.2) (p < 0.00001, Figure 1). Median pre-aPCC aPTT was 36 seconds (IQR 12.8), median post-aPCC aPTT was 29 seconds (IQR 9.8) (p = 0.0001). The 30-day thromboembolic rate was 6.1% (Table 1) and the 30-day overall mortality rate was 31.7%.
Conclusions: aPCC appears to result in a significant correction in coagulation parameters and provides effective hemostasis in patients with DOAC-associated bleeding or requiring urgent surgery.
|Demographics||Vascular Risk Factors||Type of Thromboembolic Event||Timing of Thromboembolic Event||aPCC Dose (IU)||Anticoagulation Re-Initiated||Thrombotic Death|
|98M||CAD, T2DM, HTN||NSTEMI + DVT||Day 10 + Day 20||3186||No||No|
|72M||CAD, CABG, T2DM, CKD, AF (CHADS2 = 1)||Bilateral femoral artery emboli||Day 0||2500 + 1000||No||No|
|92M||HTN, CHF, T2DM, CVA, bioprosthetic AV, AF (CHADS2 = 6)||TIA||Day 0||2718||No||No|
|69M||AF (CHADS2 = 4), CHF, CVA within 3 months, T2DM, PVD, recurrent VTE, IVC filter in situ, chronic atrial thrombus||Systemic embolism||Day 0||1782||No||Yes|
|83M||HTN, CHF, DLD, PVD, pulmonary HTN, AF (CHADS2 = 3), active cancer||STEMI||Day 7||3418||No||Yes|
|Table 1 Thromboembolic Events. aPCC: activated prothrombin complex concentrate, TE: thromboembolic event; CAD: coronary artery disease; T2DM: type 2 diabetes mellitus; HTN: hypertension; CABG: coronary artery bypass grafting; CKD: chronic kidney disease; AF: atrial fibrillation; CVA: cerebrovascular event; AV: aortic valve; PVD: peripheral vascular disease; VTE: venous thromboembolic event; IVC: inferior vena cava; DLD: dyslipidemia.|
[Table 1. Thromboembolic Events]
To cite this abstract in AMA style:Shaw J, Carrier M, Dowlatshahi D, Chakraborty S, Tokessy M, Buyukdere H, Castellucci L. Activated Prothrombin Complex Concentrates for the Management of Direct Oral Anticoagulant-Associated Bleeding Events and Pre-Operative Administration for Urgent Surgery: Hemostatic and Thrombotic Outcomes [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/activated-prothrombin-complex-concentrates-for-the-management-of-direct-oral-anticoagulant-associated-bleeding-events-and-pre-operative-administration-for-urgent-surgery-hemostatic-and-thrombotic-out/. Accessed January 28, 2022.
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