Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair (original) (raw)
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Anticoagulation following mitral valve repair
Journal of Cardiac Surgery, 2020
Background and Aim: Anticoagulation after mitral valve repair is controversial and guidelines are not well-established. This study evaluated the association between postoperative warfarin use and complications after mitral valve repair, including bleeding and thromboembolic incidents, readmission, and mortality. Methods: This retrospective study investigated 1097 patients who underwent elective mitral valve repair between April 2003 and March 2017, and were naïve to atrial fibrillation or prior cardiac surgery. This cohort had no other indication for or against anticoagulation. 775 patients were placed on warfarin with INR goal 2.5, and 322 patients were not anticoagulated. The association between anticoagulation and complications was assessed with univariate comparisons between groups and multiple logistic regression. Results: Postoperative warfarin use was associated with a reduced composite of bleeding and thromboembolic complications (pulmonary embolism, TIA, stroke, pericardial effusion or cardiac tamponade, GI bleeding, and reoperation for bleeding) with an odds ratio of 0.29 (95% CI 0.13-0.64, p=0.003). There was no difference in 30-day or 6-month mortality or readmission rate between groups. Long-term survival estimates were superior in the warfarin group (10-year: 92% vs. 85%; log-rank p<0.001). Conclusions: Our analysis showed that postoperative warfarin use was associated with an overall reduced composite of bleeding and thromboembolic incidents and superior long-term survival. These findings suggest that anticoagulation with warfarin following mitral valve repair may be a safe and effective means for avoiding postoperative complications, and that a large prospective randomized clinical trial is warranted.
Enoxaparin for Early Anticoagulation after Mitral Valve Repair
Cardiology and Angiology: An International Journal, 2015
Introduction: Despite recent progress and technological advances, heart valve surgery remains associated with a high rate of thromboembolic complications requiring anticoagulation, which must be both safe and effective to prevent any thromboembolic or bleeding events. Objectives: The objective of this study was to verify the efficacy and the safety of Low Molecular Weight Heparin followed by vitamin K antagonists for the early anticoagulation after mitral valve repair. Patients and Methods: This work was conducted as a prospective study. We selected 120 consecutive patients who underwent mitral valve repair and received enoxaparin as bridge between continuous unfractionated heparin and fully effective vitamin K antagonist therapy. The mean age was 63.6±13.5 years (15-84 years).
Enoxaparin for early anticoaguation after mitral valve repair
Despite recent progress and technological advances, heart valve surgery remains associated with a high rate of thromboembolic complications requiring anticoagulation, which must be both safe and effective to prevent any thromboembolic or bleeding events. Objectives: The objective of this study was to verify the efficacy and the safety of Low Molecular Weight Heparin followed by vitamin K antagonists for the early anticoagulation after mitral valve repair. Patients and Methods: This work was conducted as a prospective study. We selected 120 consecutive patients who underwent mitral valve repair and received enoxaparin as bridge between continuous unfractionated heparin and fully effective vitamin K antagonist therapy. The mean age was 63.6±13.5 years (15-84 years).
Is short-term anticoagulation necessary after mitral valve repair?
Interactive CardioVascular and Thoracic Surgery, 2006
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether oral anticoagulants are necessary after mitral valve repair. The reported search found 127 papers of which 12 represented the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group, relevant outcomes and weaknesses were tabulated. We conclude that the current European Society of Cardiology guidelines support the use of warfarin for 3 months post-mitral repair, citing an absence of studies supporting the safety of omitting warfarin. They acknowledge that this is based on expert consensus and that many surgeons do not follow this guideline. No other guidelines provide recommendations in this area. The longest follow-up studies of patients post-mitral repair report excellent results using short term warfarin, and they also show that a third of patients discharged in sinus rhythm will have an episode of atrial fibrillation shortly after. In addition, the highest risk of thromboembolism occurs in the early months post surgery. Therefore, until studies demonstrate the safety of omitting warfarin for patients undergoing mitral valve repair, 3 months of anticoagulation should remain the standard of care.
European Journal of Cardio-Thoracic Surgery, 2013
OBJECTIVES: The study aimed to determine if mitral valve repair (MVRR) or bioprosthetic mitral valve replacement (BMVR) without postoperative anticoagulation is associated with a similar risk of thromboembolism and death as anticoagulation. METHODS: We retrospectively reviewed our 2004-09 experience in 249 MVRR and bioprosthetic replacement patients (53% female; 63 year mean age). Concurrent procedures principally included antiarrhythmic surgery, aortic valve replacement, tricuspid valve repair and coronary bypass grafting. Warfarin therapy was instituted at the discretion of the surgeon. Thirty-day, a period known to have the highest risk of valve-related thromboembolism, outcomes were compared relying on the incidence of stroke and death as surrogates of thromboembolic complications. Intermediate-term survival was compared between the groups using Cox proportional hazard models. The mean follow-up was 2.9 years. Given the non-randomized warfarin use, a propensity score using patient comorbidities and concurrent procedures was created and added to the Cox models. RESULTS: One hundred and ninety-two (77%) patients were discharged on warfarin and 57 (23%) were discharged without warfarin. Thirty-day mortality in patients discharged from the index hospitalization was 1.2% and was similar for the two groups (P = 0.99). Four ischaemic perioperative strokes were detected; 3 in the warfarin group and 1 in the no warfarin group (P = 0.99). Overall survival was 84%, with 84% survival in the warfarin group and 86% in the no warfarin group (P = 0.79). Bleeding complications were comparable between the two groups (P = 0.72). In a multivariate analysis, warfarin was not related to mortality. CONCLUSIONS: Despite current guidelines recommending postoperative anticoagulation following MVRR or bioprosthetic replacement, the avoidance of warfarin does not increase perioperative complications and has no impact on intermediate survival. Accordingly, a prospective randomized study to adjudicate the role of extended warfarin thromboprophylaxis in mitral valve surgery is warranted.
Best evidence topic - Valves Is short-term anticoagulation necessary after mitral valve repair?
2000
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether oral anticoagulants are necessary after mitral valve repair. The reported search found 127 papers of which 12 represented the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group, relevant outcomes and weaknesses were tabulated. We conclude that the current European Society of Cardiology guidelines support the use of warfarin for 3 months post-mitral repair, citing an absence of studies supporting the safety of omitting warfarin. They acknowledge that this is based on expert consensus and that many surgeons do not follow this guideline. No other guidelines provide recommendations in this area. The longest follow-up studies of patients post-mitral repair report excellent results using short term warfarin, and they also show that a third of patients discharged in sinus rhythm will have an episode of atrial fibrillation shortly after. In addition, the highest risk of thromboembolism occurs in the early months post surgery. Therefore, until studies demonstrate the safety of omitting warfarin for patients undergoing mitral valve repair, 3 months of anticoagulation should remain the standard of care.
European Heart Journal - Cardiovascular Pharmacotherapy
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia and is associated with an increased risk of cardioembolic stroke. Oral anticoagulation reduces the risk of thromboembolism in patients with AF by about two-thirds compared with placebo but this comes at some cost of an increased risk of bleeding. 1-4 In this issue of the journal, Dr. Benz and co-workers from Canada aimed to systematically assess the effects of antiplatelets on clinical outcomes in patients with atrial fibrillation (AF), treated and not treated with oral anticoagulation. A total of 18 trials including 21 518 participants met the pre-specified eligibility criteria. The authors concluded that in patients with AF not receiving oral anticoagulation, antiplatelet therapy modestly reduced stroke. There was a corresponding signal for harm when used on top of anticoagulation. Irrespective of background anticoagulation use, antiplatelet therapy significantly increased bleeding, moderately reduced myocardial infarction, and did not affect mortality. Patients with acute ST-segment elevation myocardial infarction (STEMI) have an elevated risk of stroke, most of which are cardioembolic in origin because of left ventricular (LV) thrombus formation. Current guidelines recommend the use of vitamin K antagonist (VKA) for up to 3-6 months for treatment of left ventricular (LV) thrombus post-acute myocardial infarction (AMI). However, treatment with direct oral anticoagulants (DOACs) may be another treatment option. 5,6 Dr. Alcalai et al. from Israel aimed to assess the efficacy of apixaban vs. warfarin in treating LV thrombus after MI. Thirty-five patients were enrolled and the primary outcome was the presence and size of LV thrombus 3 months after initiation of anticoagulation. Thrombus completely resolved in 14 of 15 patients in the warfarin group and in 16 of 17 in the apixaban group. Two patients had major bleeding in the warfarin group while no major bleeding events were recorded in the apixaban group. The authors concluded that their small study suggested that apixaban is non-inferior to warfarin for treatment of patients with LV thrombus after acute MI. Mechanical prosthetic valve thrombosis (MPVT) is a serious and often fatal complication after heart valve replacement surgery. 7 Thrombolysis is an alternative to surgery for MPVT. Dr. De Caterina and co-workers has performed an open-label, pilot randomized clinical trial randomized adult patients (n = 120) with acute obstructive MPVT to an ultraslow thrombolytic regimen [25 mg of recombinant
Thromboembolic and Bleeding Complications Following St. Jude Medical Valve Replacement
Chest, 2005
Study objectives: Due to their inherent thrombogenicity, mechanical cardiac valves necessitate lifelong oral anticoagulation. Less intensive oral anticoagulation than recommended earlier might result in a lower incidence of bleeding complications without increasing the embolic hazard significantly. Design: Comparison of three different intensities of oral anticoagulation in a prospective, randomized multicenter design. Three months after valve replacement, patients were randomly assigned to stratum A, international normalized ratio (INR) 3.0 to 4.5; stratum B, INR 2.5 to 4.0; or stratum C, INR 2.0 to 3.5. Patients: Data from 2,735 patients following aortic valve replacement (AVR; n ؍ 2,024), mitral valve replacement (MVR; n ؍ 553), and combined AVR and MVR (n ؍ 158) with the St. Jude Medical (SJM) valve (St. Jude Medical; St. Paul, MN) between July 1993 and May 1999 were analyzed, covering a total follow-up period of 6,801 patient-years. All complications were registered prospectively. Measurements and results: Fifty-one thromboembolic events (TEs) were documented, resulting in a linearized incidence of 0.75 TEs per 100 patient-years, 22 of which were minor (0.32% per patient-year), 10 were moderate (0.15% per patient-year), and 19 were severe (0.28% per patient-year). Thromboembolism following AVR was significantly lower than after MVR (0.53% per patient-year vs 1.64% per patient-year). Patients reported 1,687 bleeding complications (24.8% per patient-year). The vast majority of bleeding complications (n ؍ 1,509; 22.2% per patient-year) were classified as minor, 140 were classified as moderate (2.06% per patient-year), and 38 were classified as severe (0.56% per patient-year). The clinically relevant incidences of moderate and severe TEs and bleeding complications were not significantly different between the three prespecified INR strata. Conclusions: The intention-to-treat analysis of the results of the German Experience With Low Intensity Anticoagulation study leads to the unexpected result that despite a sophisticated reporting system, the incidence of moderate and severe TE and bleeding complications was comparably low in all INR strata and more or less within the so-called background incidence reported for an age-related "normal" population. This study supports reexamination of the intensity of anticoagulation in patients with the SJM valve.
JACC: Cardiovascular Interventions, 2016
The study sought to examine the risk of ischemic events and bleeding episodes associated with differing antithrombotic strategies in patients undergoing transcatheter aortic valve replacement (TAVR) with concomitant atrial fibrillation (AF). BACKGROUND Guidelines recommend antiplatelet therapy (APT) post-TAVR to reduce the risk of stroke. However, data on the efficacy and safety of this recommendation in the setting of a concomitant indication for oral anticoagulation (due to atrial fibrillation [AF]) with a vitamin K antagonist (VKA) are scarce. METHODS A multicenter evaluation comprising 621 patients with AF undergoing TAVR was undertaken. Post-TAVR prescriptions were used to determine the antithrombotic regimen used according to the following 2 groups: monotherapy (MT) with VKA (n ¼ 101) or multiple antithrombotic therapy (MAT) with VKA plus 1 or 2 antiplatelet agents (aspirin or clopidogrel; n ¼ 520). Endpoint definitions were in accordance with Valve Academic Research Consortium-2 criteria. The rate of stroke, major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death), major or lifethreatening bleeding events, and death were assessed by a Cox multivariate model regression survival analysis according to the antithrombotic regime used. RESULTS During a median follow-up of 13 months (interquartile range: 3 to 31 months) there were no differences between
Association of antiplatelet and anticoagulant treatment in patients with Mechanical Prosthetic Heart Valves. Data from the observational multicentre PLECTRUM Study. Cardiology and Cardiovascular Medicine 5 (2021): 123-133. Abstract Background: Patients with a mechanical pros-thetic heart valve (MHV) need vitamin K antagonist (VKA) treatment, due to the high thrombotic risk. Guidelines disagree in relation to the need of low-dose aspirin associated treatment (VKA+apl). In the dataset of PLECTRUM study, we evaluate the number and characteristics of patients treated with VKA+apl, their bleeding and thrombotic risk. Methods: Observational retrospective multicenter study among Centers affiliated to the Italian Results: 237/2051 (11.5%) enrolled patients were treated with VKA + apl. These patients were older than patients on single VKA treatment, more frequently males, have a higher rate of cardiovascular risk factors, higher prevalence of coronary artery disease, peripheral arterial obstructive disease, Stroke/transient ischemic attack (TIA), heart failure, and atrial fibrillation. Instead, no difference was found between patients on VKA and patients on VKA + apl in relation to the site of valvular implantation (aortic, mitralic or mitro-aortic) and to the intensity of anticoagulation. The rate of major bleedings, of Stroke/TIA and of death were higher in patients on VKA +apl with respect to patients treated with VKA. Conclusions: Patients with MHV followed in Italian Anticoagulation Clinics usually receive single VKA treatment. VKA +apl is limited to patients with concomitant arterial disease or at high cardiovascular risk. VKA +apl did not reduce the stroke risk of these patients and is associated with a trend to an increased bleeding risk.