Standardized Low–Molecular-Weight Heparin Bridging Regimen in Outpatients on Oral Anticoagulants Undergoing Invasive Procedure or Surgery

Abstract

Background-Bridging therapy with low-molecular-weight heparin is usually recommended in patients who must stop oral anticoagulants before surgical or invasive procedures. To date, there is no universally accepted bridging regimen tailored to the patient's thromboembolic risk. This prospective inception cohort management study was designed to assess the efficacy and safety of an individualized bridging protocol applied to outpatients. Methods and Results-Oral anticoagulants were stopped 5 days before the procedure. Low-molecular-weight heparin was started 3 to 4 days before surgery and continued for 6 days after surgery at 70 anti-factor Xa U/kg twice daily in high-thromboembolic-risk patients and prophylactic once-daily doses in moderate-to low-risk patients. Oral anticoagulation was resumed the day after the procedure with a boost dose of 50% for 2 days and maintenance doses afterward. The patients were followed up for 30 days. Of the 1262 patients included in the study (only 15% had mechanical valves), 295 (23.4%) were high-thromboembolic-risk patients and 967 (76.6%) were moderate-to low-risk patients. In the intention-to-treat analysis, there were 5 thromboembolic events (0.4%; 95% confidence interval, 0.1 to 0.9), all in high-thromboembolic-risk patients. There were 15 major (1.2%; 95% confidence interval, 0.7 to 2.0) and 53 minor (4.2%; 95% confidence interval, 3.2 to 5.5) bleeding episodes. Major bleeding was associated with twice-daily low-molecular-weight heparin administration (high-risk patients) but not with the bleeding risk of the procedure. Conclusions-This management bridging protocol, tailored to patients' thromboembolic risk, appears to be feasible, effective, and safe for many patients, but safety in patients with mechanical prosthetic valves has not been conclusively established.

Kardiologiczne konsultacje w ortopedii u chorych przyjmujących leki przeciwzakrzepowe

“…drobne zabiegi w obrębie skóry) można kontynuować leczenie przeciwzakrzepowe VKA i utrzymywać INR w zakresie terapeutycznym. Jednak u chorych obciążonych wysokim ryzykiem zakrzepowo--zatorowym nawet krótkotrwałe przerwanie terapii przeciwzakrzepowej może być niebezpieczne i niezbędna jest terapia pomostowa [4,5]. Zgodnie z wytycznymi do grupy wysokiego ryzyka zakrzepowo-zatorowego zalicza się: chorych z niezastawkowym migotaniem przedsionków i co najmniej 4 punktami w skali CHA 2 DS 2 -VASc, chorych z mechanicznymi protezami zastawek serca, chorych po implantacji biologicznej zastawki serca lub po plastyce zastawki mitralnej w ostatnich 3 miesiącach, chorych po przebytym w ostatnich 3 miesiącach epizodzie żylnej choroby zakrzepowo-zatorowej (VTE, venous thromboembolism) oraz pacjentów z trombofilią.…”

“…W terapii pomostowej można stosować heparynę niefrakcjonowaną (UFH, unfractionated heparin), ale obecnie zdecydowanie częściej wykorzystuje się LMWH podawaną podskórnie (s.c., subcutaneous) w dawce terapeutycznej. W badaniach klinicznych uzyskano dowody na lepszą skuteczność i większe bezpieczeństwo zastosowania LMWH niż UFH w terapii pomostowej w grupie chorych obciążonych wysokim ryzykiem zakrzepicy [4,5] [2]. Z kolei w podgrupie chorych po wszczepieniu sztucznej zastawki serca uzyskano dowody przemawiające za dożylnym podawaniem UFH zamiast dożylnych iniekcji LMWH [4].…”

2014 ESC/ESA Guidelines on Non-cardiac Surgery: Cardiovascular Assessment and Management

“…If the international normalized ratio (INR) is ≤1.5, surgery can be performed safely; however, in anticoagulated patients with a high risk of thrombo-embolism-for example, patients with: † AF with a CHA 2 DS 2 -VASc [Cardiac failure, Hypertension, Age ≥75 (Doubled), Diabetes, Stroke (Doubled) -Vascular disease, Age 65-74 and Sex category (Female)] score of ≥4] or † mechanical prosthetic heart valves, newly inserted biological prosthetic heart valves, or † mitral valvular repair (within the past 3 months) or † recent venous thrombo-embolism (within 3 months) or † thrombophilia, discontinuation of VKAs is hazardous and these patients will need bridging therapy with unfractionated heparin (UFH) or therapeutic-dose LMWH. 69,137 In general, there is better evidence for the efficacy and safety of LMWH, in comparison with UFH, in bridging to surgery. 69,137 LMWH is usually administered subcutaneously and weight-adjusted for once-or twice-daily administration without laboratory monitoring.…”

“…69,137 In general, there is better evidence for the efficacy and safety of LMWH, in comparison with UFH, in bridging to surgery. 69,137 LMWH is usually administered subcutaneously and weight-adjusted for once-or twice-daily administration without laboratory monitoring. In patients with a high thrombo-embolic risk, therapeutic doses of LMWH twice daily are recommended, and prophylactic once-daily doses in low-risk patients.…”

“…In patients with a high thrombo-embolic risk, therapeutic doses of LMWH twice daily are recommended, and prophylactic once-daily doses in low-risk patients. 137 The last dose of LMWH should be administered no later than 12 hours before the procedure. Further adjustment of dose is necessary in patients with moderate-to-high kidney function impairment.…”