Perioperative Bridging Therapy Research Articles

Impact of perioperative low-molecular-weight heparin therapy on clinical events of elderly patients with prior coronary stents implanted > 12 months undergoing non-cardiac surgery: a randomized, placebo-controlled trial

BackgroundLittle is known about the safety and efficacy of discontinuing antiplatelet therapy via LMWH bridging therapy in elderly patients with coronary stents implanted for > 12 months undergoing non-cardiac surgery. This randomized trial was designed to compare the clinical benefits and risks of antiplatelet drug discontinuation via LMWH bridging therapy.MethodsPatients were randomized 1:1 to receive subcutaneous injections of either dalteparin sodium or placebo. The primary efficacy endpoint was cardiac or cerebrovascular events. The primary safety endpoint was major bleeding.ResultsAmong 2476 randomized patients, the variables (sex, age, body mass index, comorbidities, medications, and procedural characteristics) and percutaneous coronary intervention information were not significantly different between the bridging and non-bridging groups. During the follow-up period, the rate of the combined endpoint in the bridging group was significantly lower than in the non-bridging group (5.79% vs. 8.42%, p = 0.012). The incidence of myocardial injury in the bridging group was significantly lower than in the non-bridging group (3.14% vs. 5.19%, p = 0.011). Deep vein thrombosis occurred more frequently in the non-bridging group (1.21% vs. 0.4%, p = 0.024), and there was a trend toward a higher rate of pulmonary embolism (0.32% vs. 0.08%, p = 0.177). There was no significant difference between the groups in the rates of acute myocardial infarction (0.81% vs. 1.38%), cardiac death (0.24% vs. 0.41%), stroke (0.16% vs. 0.24%), or major bleeding (1.22% vs. 1.45%). Multivariable analysis showed that LMWH bridging, creatinine clearance < 30 mL/min, preoperative hemoglobin < 10 g/dL, and diabetes mellitus were independent predictors of ischemic events. LMWH bridging and a preoperative platelet count of < 70 × 109/L were independent predictors of minor bleeding events.ConclusionsThis study showed the safety and efficacy of perioperative LMWH bridging therapy in elderly patients with coronary stents implanted > 12 months undergoing non-cardiac surgery. An alternative approach might be the use of bridging therapy with half-dose LMWH.Trial registrationISRCTN65203415.

Bridging therapy according to new clinical guidelines: A review

In modern world it is really important to know how to manage patients taking anticoagulant or antiplatelet therapy. There is an increasing number of patients, who have gone through PCI or any other cardiac intervention and who also need another surgery which cannot be postponed till the end of dual antiplatelet therapy. The number of patients who take oral anticoagulant has also increased last years. Algorithms of perioperative bridging therapy and antiplatelet therapy discontinuation can help to decrease both ischemic and hemorrhagic complications. Multidisciplinary risk assessment remains a critical component of perioperative care.

Perioperative bridging anticoagulation in patients with oral cancer surgery: a multicenter retrospective study

The number of patients administered oral antithrombotic drugs who require elective surgery has increased. Perioperative heparin bridging needs to be considered for patients at a high risk of thromboembolism. The present study investigated the effects of perioperative heparin bridging therapy on perioperative complications (postoperative bleeding and thrombotic events) in oral cancer surgery. The medical records of 98 patients who underwent oral cancer surgery with perioperative bridging therapy were retrospectively analyzed. Postoperative hemorrhage occurred in 16 patients (16.3%) and thrombotic events (deep venous thrombosis) in 5 (5.1%), which were higher than in other surgeries. A multivariate analysis identified the administration of prostaglandins as the only significant independent risk factor for postoperative hemorrhage, and a longer duration of postoperative heparin bridging therapy was associated with the incidence of deep venous thrombosis. The present results suggest a higher incidence of thrombotic and bleeding events in patients who underwent oral cancer surgery with heparin bridging, and the nature of surgery (such as revascularization and prolonged bed rest) may be a contributing factor. Future studies are needed to establish whether heparin bridging is effective in oral cancer surgery.

Impact of perioperative antithrombotic strategies on clinical events in non-cardiac surgery.

Antithrombotic therapy including antiplatelet agents and anticoagulants are prescribed for secondary prevention in patients with established cardiovascular disease. Although antithrombotic therapy is often interrupted before non-cardiac surgery with or without perioperative bridging anticoagulation, the impact on thrombotic and bleeding events remains uncertain. A total of 360 patients chronically treated with antithrombotic therapy for secondary prevention underwent elective non-cardiac surgery under general anesthesia, with the complete interruption of antithrombotic agents. The study endpoints included all-cause death, thrombotic events, and major bleeding complications after surgical procedures. Of 360 patients, 190 (52.8%) and 200 (55.6%) received antiplatelet and anticoagulation perioperatively. Atrial fibrillation (32.8%) and coronary artery disease (22.5%) were the major indications for antithrombotic regimens. Antithrombotic therapy was interrupted from 5 [2, 7] days before the surgery to 4 [2, 7] days postoperatively. Perioperative bridging therapy with unfractionated heparin was employed in 113 (31.4%) patients. During the hospitalization, one (0.3%) patient died due to non-cardiovascular causes. Thrombotic events and major bleeding occurred in two (0.6%) and eight (2.2%) patients. Bridging therapy with heparin was significantly associated with an increased risk of bleeding events (5.3% vs. 0.8%, p = 0.02). Pre-operative bridging therapy with heparin and operative duration were significantly associated with bleeding complications. In the present study, complete interruption of antithrombotic therapy resulted in a few thrombotic events in patients undergoing elective non-cardiac surgery. Bridging therapy with heparin and longer operative duration were significantly associated with post-operative bleeding complications.

Impact of perioperative interruption of antithrombotic therapy on thrombotic and bleeding events in non-cardiac surgery

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Antithrombotic therapy including antiplatelet agents and anticoagulants are prescribed for secondary prevention in patients with established cardiovascular disease. Although antithrombotic therapy is often interrupted before non-cardiac surgery with or without perioperative bridging anticoagulation, the impact on thrombotic and bleeding events remains uncertain. Purpose The aim of this study was to clarify the impact of perioperative interruption of anticoagulants on thrombotic and bleeding events in patients with established CVD undergoing elective non-cardiac surgery. Methods A total of 330 patients chronically treated with antithrombotic therapy for secondary prevention underwent elective non-cardiac surgery under general anesthesia, with the complete interruption of antithrombotic agents. The study endpoints included all-cause death, thrombotic events, and major bleeding complications after surgical procedures. Results Of 330 patients, 171 (51.8%) and 159 (48.2%) received antiplatelet agents and anticoagulants perioperatively. Atrial fibrillation (31.8%) and coronary artery disease (20.3%) were the major indications for antithrombotic regimens. Antithrombotic therapy was interrupted from 5 [2, 7] days before the surgery to 4 [2, 7] days postoperatively. Perioperative bridging therapy with unfractionated heparin was employed in 99 (30.0%) patients. During the hospitalization, 3 (0.9%) patients died due to non-cardiovascular causes. Thrombotic events and major bleeding occurred in 2 (0.6%) and 9 (2.7%) patients. Bridging therapy with heparin was non-significantly associated with an increased risk of bleeding events (5.1% vs. 1.7%, p = 0.09). In univariable and multivariable analyses, pre-operative hemoglobin level and operative duration were significantly associated with bleeding complications. Conclusions In the present study, complete interruption of antithrombotic therapy resulted in a few thrombotic events with a numerically higher rate of bleeding events in patients undergoing elective non-cardiac surgery. Pre-operative hemoglobin level and operative duration were significantly associated with post-operative bleeding complications.

Antiplatelet Therapy with Cangrelor in Patients Undergoing Surgery after Coronary Stent Implantation: A Real-World Bridging Protocol Experience.

Objective The aim of the study is to describe the real-world use of the P2Y 12 inhibitor cangrelor as a bridging strategy in patients at high thrombotic risk after percutaneous coronary intervention (PCI) and referred to surgery requiring perioperative withdrawal of dual antiplatelet therapy (DAPT). Materials and Methods We collected data from nine Italian centers on patients with previous PCI who were still on DAPT and undergoing nondeferrable surgery requiring DAPT discontinuation. A perioperative standardized bridging protocol with cangrelor was used. Results Between December 2017 and April 2019, 24 patients (mean age 72 years; male 79%) were enrolled. All patients were at high thrombotic risk after PCI and required nondeferrable intermediate to high bleeding risk surgery requiring DAPT discontinuation (4.6 ± 1.7 days). Cangrelor infusion was started at a bridging dose (0.75 µg/kg/min) 3 days before planned surgery and was discontinued 6.6 ± 1.5 hours prior to surgical incision. In 55% of patients, cangrelor was resumed at 9 ± 6 hours following surgery for a mean of 39 ± 38 hours. One cardiac death was reported after 3 hours of cangrelor discontinuation prior to surgery. No ischemic outcomes occurred after surgery and up to 30-days follow-up. The mean hemoglobin drop was <2 g/dL; nine patients received blood transfusions consistent with the type of surgery, but no life-threatening or fatal bleeding occurred. Conclusion Perioperative bridging therapy with cangrelor is a feasible approach for stented patients at high thrombotic risk and referred to surgery requiring DAPT discontinuation. Larger studies are warranted to support the safety of this strategy.

The impact of perioperative heparin bridging therapy in lung cancer surgery.

The impact of perioperative heparin bridging (HB) for lung surgery in patients on anti-clotting drugs remains unclear. We performed a retrospective study to assess its effect on surgical safety by comparing HB and non-HB groups. This study included 274 consecutive patients on anti-clotting drugs who underwent surgery for lung cancer. Of these, 77 received HB and 197 did not. Propensity score matching extracted 124 patients, consisting of 62 patients with HB and 62 patients without HB. Endpoints were surgical safety. There was no statistically significant difference in the outcomes of surgical safety outcomes between the HB and non-HB group after propensity-score matching, operative time (172 vs. 203min, p = 0.131), volume of blood loss (60 vs. 70ml, p = 0.335), need for intraoperative RBC transfusion (3.2 vs. 6.5%, p = 0.680), chest tube drainage volume on the 1st postoperative day (200 vs. 200ml, p = 0.796), and chest tube placement duration (3 vs. 3days, p = 0.606). The influence of perioperative HB on postoperative thromboembolic or bleeding events in lung cancer surgery is not obvious, but its surgical safety appears to be acceptable.

Perioperative management of anticoagulant therapy.

About 10% of patients taking a chronic, oral anticoagulant therapy require an invasive procedure that can be associated with an increased risk for peri-interventional or perioperative bleeding. Depending on the risk for thromboembolism and the risk for bleeding, the physician has to decide whether the anticoagulant therapy should be interrupted or continued. Patient characteristics such as age, renal function and drug interactions must be considered. The perioperative handling of the oral anticoagulant therapy differs according to the periprocedural bleeding risk. Patients requiring a procedure with a minor risk for bleeding do not need to pause their anticoagulant therapy. For procedures with an increased risk for perioperative bleeding, the anticoagulant therapy should be adequately paused. For patients on a coumarin derivative with a high risk for a thromboembolic event, a perioperative bridging therapy with a low molecular weight heparin is recommended. Due to an increased risk for perioperative bleeding in patients on a bridging therapy, it is not recommended in patients with a low risk for thromboembolism. For patients taking a non-vitamin K oral anticoagulant, a bridging therapy is not recommended due to the fast onset and offset of the medication.

USE OF INTRAVENOUS CANGRELOR/DAPT BRIDGE THERAPY FOR POST-PCI PATIENTS UNDERGOING GASTROINTESTINAL SURGERY

Unavoidable early interruption of dual antiplatelet therapy (DAPT) after percutaneous intervention (PCI) often creates a clinical dilemma. Perioperative bridge therapy using intravenous cangrelor may offer a potential solution, although evidence for its use in non-cardiac procedures is limited. A

Intravenous Antiplatelet Therapy Bridging in Patients Undergoing Cardiac or Non-Cardiac Surgery Following Percutaneous Coronary Intervention.

The effect of perioperative bridging therapy on risks of ischemic cardiac events and major bleeding complications in patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) remains undefined. We report on 60 consecutive patients between 2010 and 2017 who required cardiac (CS; n = 15) or non-cardiac (NCS; n = 45) surgeries following PCI at our institution. Short-acting intravenous (IV) antiplatelet (APT) bridging with eptifibatide, tirofiban and cangrelor were instituted after DAPT interruption. All patients were men with multiple atherosclerosis risk factors. An acute coronary syndrome indication (56.7%) was the most common PCI indication in the CS and NCS groups. Drug-eluting stents were used in 93.33% and 95.56% of the above groups, respectively. The median duration from PCI to CS and NCS were 11.17 and 18.25 months, respectively and 38.33% of all surgeries were performed within 6 months of the index PCI. Most patients were on background aspirin (83.33%) and clopidogrel (81.67%) and median duration of DAPT interruption was 7 days. Median duration of perioperative IV APT bridging was 3 days for CS and 5 days for NCS groups. In the CS group, two patients (13.33%) had non-fata myocardial infarction (MI), and four (26.67%) had clinically significant bleeding. No patients had perioperative stent thrombosis. In the NCS group, one patient (2.22%) had stent thrombosis; four (6.67%) had myocardial infarction, and five (11.11%) clinically significant bleeding. Despite using IV APT as bridging therapy during perioperative DAPT interruption in post-PCI patients, postoperative cardiac events and bleeding complications can still occur.

Efficacy and safety of peri-procedural bridging therapy with low molecular weight heparin in atrial fibrillation patients under vitamin K antagonists.

The clinical effect of peri-operative bridging therapy in atrial fibrillation (AF) patients remains unclear given that it may increase bleeding risk without providing significant benefits. We aimed to investigate peri-procedural events in relation to peri-operative use of bridging therapy in AF patients under Vitamin K Antagonists (VKAs). We included AF patients stable the previous 6 months on VKAs. During a median follow-up of 6.5 years (IQR 4.3-7.9), we recorded all invasive procedures and the peri-operative clinical management. All peri-procedural events (ischaemic stroke/transient ischaemic attack/systemic embolism, clinically relevant non-major bleeding and major bleeding) and severe peri-procedural events (ischaemic stroke/transient ischaemic attack/systemic embolism and major bleeding) suffered until the 30-days post-intervention period were recorded. We included 1361 patients (48.7% male, median age 76 [IQR 71-81] years). There were 1100 (70.9%) procedures performed using bridging therapy. The rate of any (4.5% vs. 0.7%, P < 0.001) and severe (2.3% vs. 0.0%, P = 0.002) peri-procedural events were higher in patients receiving bridging therapy. Adjusted logistic regressions demonstrated that the bleeding risk of the procedure was related with higher risk of severe peri-procedural events (OR 3.51, 95% CI 1.54-8.01) and peri-procedural events (OR 2.77, 95% CI 1.56-4.91). Importantly, the use of bridging therapy was also independently associated with higher risk of any peri-procedural events (OR 4.32, 95% CI 1.28-14.51). In this study including AF patients under VKA therapy, the use of bridging therapy as part of the clinical management during an invasive procedure was independently associated with higher risk of any peri-procedural event.

Evaluation of a Standardized Perioperative Management Protocol in the Adult Hematology Anticoagulation Management Service.

In North America, 250,000 patients on vitamin K antagonists require surgical procedures each year. Temporary interruption of oral anticoagulation and perioperative bridging therapy with unfractionated heparin or low-molecular-weight heparin are recommended by the American College of Chest Physicians 2012 for select patients. The study objectives are to evaluate adherence and nonadherence to the Johns Hopkins clinic guidelines for perioperative management of anticoagulation and identify bleeding or thromboembolic events during perioperative management of anticoagulation. This is a retrospective study of patients who required perioperative management of anticoagulation for an invasive procedure from May 2009 to March 2014. Individualized perioperative anticoagulation management plans were prospectively developed for each patient according to the standardized Johns Hopkins perioperative bridging recommendations and documented in the medical record. Adherence to these standardized Johns Hopkins clinic guidelines, the incidence of thromboembolic events, and bleeding and adverse events during perioperative management were retrieved from the medical record. In 294 perioperative management cases, there was 1 (0.3%) thromboembolism, 3 (1%) major bleeds, and 21 (7%) minor bleeds. One patient experienced facial swelling after starting enoxaparin. There was no difference in thromboembolic (0 vs 1, P = 1.00), major (1 vs 2, P = 1.00), or minor bleeding (14 vs 7, P = 1.00) events in patients managed by providers who were adherent to guidelines when compared with providers who were nonadherent. Our study shows that using a standardized guideline for perioperative management of anticoagulation to inform but not to dictate clinical practice leads to low rates of both thromboembolism and bleeding.

Anticoagulation Bridge Therapy in Patients with Atrial Fibrillation: Recent Updates Providing a Rebalance of Risk and Benefit.

In 2011 we reviewed clinical updates and controversies surrounding anticoagulation bridge therapy in patients with atrial fibrillation (AF). Since then, options for oral anticoagulation have expanded with the addition of four direct oral anticoagulant (DOAC) agents available in the United States. Nonetheless, vitamin K antagonist (VKA) therapy continues to be the treatment of choice for patients who are poor candidates for a DOAC and for whom bridge therapy remains a therapeutic dilemma. This literature review identifies evidence and guideline and consensus statements from the last 5 years to provide updated recommendations and insight into bridge therapy for patients using a VKA for AF. Since our last review, at least four major international guidelines have been updated plus a new consensus document addressing bridge therapy was released. Prospective trials and one randomized controlled trial have provided guidance for perioperative bridge therapy. The clinical trial data showed that bridging with heparin is associated with a significant bleeding risk compared with not bridging; furthermore, data suggested that actual perioperative thromboembolic risk may be lower than previously estimated. Notably, patients at high risk for stroke have not been adequately represented. These findings highlight the importance of assessing thrombosis and bleeding risk before making bridging decisions. Thrombosis and bleeding risk tools have emerged to facilitate this assessment and have been incorporated into guideline recommendations. Results from ongoing trials are expected to provide more guidance on safe and effective perioperative management approaches for patients at high risk for stroke.

Perioperative bridging therapy in patients with atrial fibrillation on Warfarin: Examining current practice and implementing evidence based changes

Perioperative bridging therapy in patients with atrial fibrillation on Warfarin: Examining current practice and implementing evidence based changes

Bridge therapy or standard treatment for urgent surgery after coronary stent implantation: Analysis of 314 patients

Intravenous administration of a short acting glycoprotein IIb/IIIa inhibitor has been proposed as a bridge to surgery in patients on dual antiplatelet treatment, but data in comparison with other treatment options are not available. We conducted a retrospective analysis of consecutive patients who underwent un-deferrable, non-emergency surgery after coronary stenting. The bridge therapy was performed after discontinuation of the oral P2Y12 inhibitor by using i.v. tirofiban infusion. Net Adverse Clinical Events (NACE) was the primary outcome.We analyzed 314 consecutive patients: the bridge strategy was performed in 87 patients, whereas 227 were treated with other treatment options and represent the control group. Thirty-day NACE occurred in 8% of patients in the bridge group and in 22.5% in the control group (p<0.01). Bridge therapy was associated with decreased 30-day NACE rate [Odds ratio (OR) 0.30; 95% confidence interval (CI) 0.13–0.39; p<0.01], particularly when the time interval between stenting and surgery was ≤60days (OR 0.09, 95% CI 0.01–0.72; p=0.02). There were no cases of stent thrombosis in the bridge group and 3 (1.3%) in the control group. Bridge therapy was associated with decreased events rates as compared to both patients with and without P2Y12 inhibitors discontinuation in the control group. After adjustment for the most relevant covariates, the favorable effect of the bridge therapy was not materially modified.In conclusion, perioperative bridge therapy using tirofiban was associated with reduced 30-day NACE rate, particularly when surgery was performed within 60days after stent implantation.

Abstract 384: Monitoring of Preoperative Anticoagulation Status in Post-PCI Patients on Warfarin Undergoing Non-Cardiac Surgery: Risk of Major Adverse Cardiac Events and Transfusion

Background: There is limited data on an optimal approach to preoperative INR screening in patients prescribed warfarin, with current guidelines lacking definitive recommendations on timing or need of INR assessment. Outcomes for these patients are largely unknown. Accordingly, we describe rates of pre-operative INR testing rates and its association with postoperative major adverse cardiac events (MACE) and transfusions among post-PCI patients on warfarin undergoing non-cardiac surgery (NCS). Methods: We identified all post-PCI VA patients undergoing NCS from 2004-2011 who were prescribed warfarin. Among these, we assessed rates and results of INR assessment (&gt;1.5, ≤ 1.5, or unknown) within 5 days of NCS. We measured the association of INR status with 30d MACE and post-operative RBC transfusions, using multivariable regression analysis to adjust for cardiovascular and operative risk factors. We also adjusted for the use of perioperative bridging therapy with heparin products. Results: Among 1,357 post-PCI patients on warfarin undergoing NCS, 534 (39.3%) had an INR drawn within 5 days of surgery. INR was high (&gt;1.5) in 166 (31.1%) and low (≤ 1.5) in 368 (68.9%). Unadjusted MACE rates were similar between those without an INR (5.3%), with a low INR (8.2%), and with a high INR (6.0%) (p-value = 0.17). PRBC transfusion was higher in those with a high INR (17.5%) compared to low (12.5%) or no INR (9.5%) (p-value=0.008). After adjustment, MACE was significantly associated with ESRD, prior MI, use of bridging therapy, and inpatient surgery status, but not INR status (Table). PRBC transfusion was associated with a high INR (OR 3.95, CI 1.91-8.17) and use of bridging therapy with heparin (OR 1.81, CI 1.07-3.05). Conclusions: Strategies for monitoring and managing cardiac patients on warfarin are heterogeneous in the pre-operative period, with nearly half of patients undergoing NCS without pre-operative INR evaluation. The presence of a high INR value predicted pRBC transfusion, but not MACE. Our study suggests a role for pre-operative screening of INR in patients on warfarin to assess risk for post-operative bleeding.

Bridge with intravenous antiplatelet therapy during temporary withdrawal of oral agents for surgical procedures: a systematic review

Patients needing surgery within 1 year after drug-eluting cardiac stent implantation are challenging to manage because of an increased thrombotic and bleeding risk. A "bridge therapy" with short-acting antiplatelet agents in the perioperative period is an option. We assessed the outcome and safety of such a bridge therapy in cardiovascular and non-cardiovascular surgery. We performed a comprehensive search of MEDLINE, EMBASE, the Cochrane Library, and ongoing trial registers, irrespective of type of design. Our primary outcome was the success rate of bridge therapy in terms of freedom from cardiac ischaemic adverse events, whereas secondary outcome was freedom from bleeding/transfusion. We also performed combined success rate for each bridge therapy drug (tirofiban, eptifibatide, and cangrelor). We included eight case series and one randomised controlled trial. Among the 420 patients included, the technique was effective 96.2 % of the times [95 % confidence interval (CI) 94.4-98.0 %]. The success rate was 100 % for tirofiban (4 studies), 93.8 % for eptifibatide (4 studies), and 96.2 % for cangrelor (1 study). Freedom from bleeding/transfusion events was observed in 72.6 % of the times (95 % CI 68.4-76.9 %), and was higher with cangrelor (88.7 %; 95 % CI 82.7-94.7 %) than with other drugs (81.0 % for tirofiban and 58.6 % for eptifibatide). Evidence from case series and one randomised controlled trial suggests that, in patients with recent coronary stenting undergoing major surgery, perioperative bridge therapy with intravenous antiplatelet agents is an effective and safe treatment option to ensure low rate of ischaemic events.

Effects of Preoperative Vitamin K On the INR in Bridging Therapy

AbstractAbstract 3407Patients who require interruption of their warfarin therapy before surgery need a safe and effective bridging protocol. Objective:We investigated whether routine incorporation of oral Vitamin K three days before surgery would improve perioperative management. Patients/Methods:Patients on chronic warfarin therapy requiring perioperative bridging therapy were the participants in this observational study. Results from two bridging protocols, 30 cases each, with and without oral Vitamin K, were analyzed. Day of Surgery was considered Day 0. The first cohort (control arm) only received oral Vitamin K preoperatively if their INR was >1.5 on Day -1. The intervention cohort (Vitamin K group) routinely received 2.5mg of oral Vitamin K on Day -3. Primary outcome was INR on Day -1. Secondary outcomes were number of patients with INRs ≥1.5 on Day -1 or Day 0, number of surgeries delayed, number of postoperative bleeding or thrombotic incidents and INR on Day 4. Results: On Day -1, the INR for the Vitamin K group was 1.16, compared with 1.28 for the control group (p=0.037). On re-bridging, Day 4 INR was similar in the two groups; 1.37 in the Vitamin K group, and 1.35 in the control group but there was an increase in the dose needed to achieve these levels for the Vitamin K group (24.2% over usual dose for the Vitamin K group vs 7.2% for the control). Only the control group had patients with INRs ≥1.5 on Day -1 (n=5), INRs ≥1.5 on Day 0 (n=2), or had postoperative bleeding incidents (n=2). Neither group had delayed surgeries or postoperative thrombosis. Conclusions:Adding Vitamin K on Day -3 into bridging protocols leads to a safe preoperative INR and may limit other complications, but this may come at the expense of increased dosing requirements postoperatively. Disclosures:No relevant conflicts of interest to declare.

Meta-Analysis of Safety and Efficacy of Uninterrupted Warfarin Compared to Heparin-Based Bridging Therapy During Implantation of Cardiac Rhythm Devices

Optimal management of perioperative anticoagulation in patients undergoing pacemaker or implantable cardioverter-defibrillator implantation is not yet established. We performed a meta-analysis of the published literature to assess the safety and efficacy of perioperative heparin-based bridging therapy versus uninterrupted warfarin therapy in patients undergoing pacemaker or implantable cardioverter-defibrillator implantation. We performed a systematic review of MEDLINE (1950 to 2012), EMBASE (1988 to 2012), Cochrane Controlled Trials Register (fourth quarter 2011), and reports presented at scientific meetings (1994 to 2011). Randomized controlled trials, case-control, or cohort studies comparing the safety and efficacy of uninterrupted warfarin therapy to heparin-based bridging therapy were eligible. Outcomes reported in eligible studies were rates of bleeding and thromboembolic events. Of 3,195 reports initially reviewed, we identified 8 studies enrolling 2,321 patients for the meta-analysis. Maintenance of therapeutic warfarin was associated with significantly lower bleeding postoperatively compared to heparin-based bridging therapy (odds ratio 0.30, 95% confidence interval 0.18 to 0.50, p <0.01). There was no significant difference in risk of thromboembolic events between these 2 strategies (odds ratio 0.65, 95% confidence interval 0.14 to 3.02, p = 0.58). In conclusion, strategy of uninterrupted warfarin therapy throughout pacemaker or implantable cardioverter-defibrillator implantation is associated with decreased risk of bleeding without increasing risk of thromboembolic events. This strategy is a viable alternative to heparin-based bridging therapy.

Perioperative bridging therapy with low molecular weight heparin for patients with inherited thrombophilia and antiphospholipid syndrome on long-term acenokumarol therapy

The aim of the study is to present our own perioperative bridging therapy with low molecular weight heparin (LMWH) for surgical patients with thrombophilia on long-term acenokumarol therapy [oral anticoagulant (OAC)]. In some European countries, the drug used in secondary antithrombotic prophylaxis is acenokumarol. Forty-two patients with inherited thrombophilia and 21 with antiphospholipid syndrome underwent surgery. All patients were on long-term OAC. This OAC was interrupted 2 days before elective surgery and since that day half of the individual therapeutic dose of LMWH was administered. On day of surgery, the LMWH therapeutic dose was divided into two parts. Starting with day 2 after surgery, the patient was again given half of the individual dose of LMWH every 24 h. On day 4, OAC was additionally included. Both drugs were administered until stabilization of international normalized ratio (INR) values within the therapeutic target for 2 consecutive days. LMWH was then interrupted, whereas OAC continued. No symptoms or episodes of venous thromboembolism were observed. No intraoperative or postoperative hemorrhagic complications were reported. The results suggest that our perioperative bridging therapy is safe and effective for prevention of thromboembolic and hemorrhagic complications.