Management of patients on long-term oral anticoagulant therapy undergoing elective surgery: survey of the clinical practice in the Italian anticoagulation clinics

Baudo, F.; Cataldo, F; Mostarda, G; Ghirarduzzi, Angelo; Molinatti, M; Pengo, Vittorio; Poli, Daniela; Tosetto, Alberto; Tiraferri, Eros; Morra, Enrica

doi:10.1007/s11739-007-0078-y

Cited by 7 publications

(5 citation statements)

References 20 publications

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“…Regarding thromboembolism, no patient experienced a symptomatic TE during the 6‐week follow‐up, with the study cohort representing the more common indications for chronic anticoagulation and almost half of our patients were at least moderate to high‐risk for TE (see Table I). Patients with prosthetic valves, however, were not assessed echocardiographically for valve thrombosis, and given the low rates of symptomatic TE (0·4–2·0%) in previous warfarin interruption cohort studies, it would take a much larger study than this to definitively show that rapid reversal of warfarin does not lead to higher rates of TE in the valve replacement cohort (Kearon & Hirsh, 1997; Dunn & Turpie, 2003; Baudo et al , 2007; Dunn et al , 2007).…”

Section: Discussionmentioning

confidence: 99%

“…Current guidelines, and variability in practice, reflect the complexity of this process and the lack of well‐designed prospective studies assessing the optimal approach, with the risks and benefits of each not yet clearly defined (Ageno et al , 2004; Garcia et al , 2004; Baudo et al , 2007; Kirkorian et al , 2007; Douketis, 2008, 2011). The recent American College of Chest Physicians (8th Edition) guidelines recognize the variable risk profile of both patients and procedures (Douketis et al , 2008).…”

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confidence: 99%

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Short‐term warfarin reversal for elective surgery – using low‐dose intravenous vitamin K: safe, reliable and convenient*

Burbury¹,

Milner

Snooks

et al. 2011

Br J Haematol

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Summary Peri‐procedural management of warfarin reflects an intricate balance between the restoration of haemostasis and appropriate thromboprophylaxis. This prospective single‐arm study assessed the safety and efficacy of a convenient schedule, incorporating low‐dose intravenous vitamin K (vitKIV) for short‐term warfarin reversal prior to elective surgery, as well as vitK‐dependent factor levels (vitK‐Factors) and International Normalized Ratio (INR) pre‐ and post‐vitKIV. One seventy eight patients on long‐term warfarin received 3 mg vitKIV 12–18 h pre‐procedure with no adverse reactions. 167/178 (94%) achieved an INR ≤ 1·5 post‐vitKIV on the day of surgery, while all achieved INR ≤ 1·7. Four patients had procedure‐associated major bleeding, but importantly had achieved a pre‐procedure INR < 1·5 and vitK‐Factors >0·30 iu/ml. No patient suffered a symptomatic thromboembolism during the 6‐week follow‐up. Median days to re‐establish a therapeutic INR were 4 (range 2–11). VitKIV near normalized all vitK‐Factors, with a uniform pattern of depletion and repletion in association with an increase and decrease in INR, respectively; and from the data, INR < 1·5 correlated with vitK‐Factors >0·30 iu/ml. Low‐dose vitKIV for short‐term warfarin reversal was reliable and safe, and successfully lowered the INR to an acceptable level for planned surgery, with no excess of bleeding, thromboembolism, delayed discharge, or resistance to warfarin. The protocol was simple and convenient for both the patients and the healthcare institution.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Short‐term warfarin reversal for elective surgery – using low‐dose intravenous vitamin K: safe, reliable and convenient*

Burbury¹,

Milner

Snooks

et al. 2011

Br J Haematol

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“…23 Moreover, the regimens studied are based on therapeutic doses of LMWH, and subtherapeutic doses of LMWH are not assessed for efficacy. 12 We used subtherapeutic doses of enoxaparin or nadroparin on the basis of the results of a registry 24 and consensus of a task force of FCSA investigators. 17 The results of the registry showed that with a mean dose of 64.4 anti-factor Xa U LMWH twice daily, the incidence of bleeding and thromboembolism was in line with that reported in the published literature referring to therapeutic-dose regimens.…”

Section: Discussionmentioning

confidence: 99%

“…Doses lower than the therapeutic dose of LMWH were used in protocol A (70 anti-factor Xa U/kg twice daily) because reduced doses minimized complications as previously reported. 18 To improve compliance and avoid errors in dividing the dosage of prefilled syringes, protocol A (Table 1) was designed to satisfy both the original per-kilogram dosage and the commercially available dosages in prefilled syringes. The prophylactic LMWH dosage in protocol B was that recommended in the prevention of venous thromboembolism in orthopedic surgery, weight-adjusted for nadroparin (57 anti-factor Xa U/Kg once daily).…”

Section: Pengo Et Almentioning

confidence: 99%

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

Cucchini²,

et al. 2009

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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.

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“…Although there was a great deal of heterogeneity in study designs, bleeding definitions, types of surgery, and patient populations, the major bleeding rates were reported to be 0.4-6.7%. 29,[31][32][33][34][35][36][37][38][39][40][41][42] A number of bleeding risk assessment tools have been developed for the purpose of determining an individual's inherent risk for bleeding. 24,25,[43][44][45] The HEMORR 2 HAGES and HAS-BLED tools ( Table 1) were recently developed specifically for the purpose of guiding anticoagulant management in patients with atrial fibrillation.…”

Section: Assessment Of Bleeding Riskmentioning

confidence: 99%

Striking a Balance Between the Risks and Benefits of Anticoagulation Bridge Therapy in Patients with Atrial Fibrillation: Clinical Updates and Remaining Controversies

2011

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Long-term anticoagulation with a vitamin K antagonist (VKA) or the new agent dabigatran is recommended to decrease stroke risk in patients with atrial fibrillation. When patients with atrial fibrillation undergo initiation or interruption of VKA therapy, or experience an isolated subtherapeutic international normalized ratio (INR), bridge therapy with a parenteral anticoagulant may be considered. To describe the literature for anticoagulation bridge therapy in patients with atrial fibrillation, we conducted a MEDLINE search (1966-February 2011) of the English-language literature to identify related studies. Ongoing clinical trials were identified through a search of the ClinicalTrials.gov registry. Major national and international guidelines were gathered and evaluated. Additional literature was obtained through review of relevant references of the identified articles. Bridging is not supported by guidelines or clinical trials for patients starting VKA therapy for atrial fibrillation. A subtherapeutic INR value during long-term VKA therapy may be associated with increased thromboembolic events, but the benefit of bridging has not been demonstrated. When VKA therapy is interrupted for procedures, retrospective and cohort data suggest that the decision to bridge should be based on a patient's thromboembolic and bleeding risks associated with the procedure. Typically, it is recommended to use bridge therapy in patients with atrial fibrillation at high risk for thromboembolism, but the benefit of bridging is less clear in patients at low risk. Not all procedures necessitate anticoagulation interruption. Recent trials suggest that VKAs can be continued when patients are undergoing cardiac device procedures and some types of radiofrequency ablation. Several clinical trials are ongoing that will provide more definitive guidance for perioperative anticoagulation management of patients with atrial fibrillation. Patients taking dabigatran are unlikely to require bridge therapy because of a predictable anticoagulant effect and rapid onset of action. However, evidence for optimal perioperative management of dabigatran is needed.

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Management of patients on long-term oral anticoagulant therapy undergoing elective surgery: survey of the clinical practice in the Italian anticoagulation clinics

Cited by 7 publications

References 20 publications

Short‐term warfarin reversal for elective surgery – using low‐dose intravenous vitamin K: safe, reliable and convenient*

Short‐term warfarin reversal for elective surgery – using low‐dose intravenous vitamin K: safe, reliable and convenient*

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

Striking a Balance Between the Risks and Benefits of Anticoagulation Bridge Therapy in Patients with Atrial Fibrillation: Clinical Updates and Remaining Controversies

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