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PubMed2003

A retrospective evaluation of the management of excessive anticoagulation in an established clinical pharmacy anticoagulation service compared to traditional care.

BACKGROUND: Analysis of the outcomes associated with episodes of excessive anticoagulation (international normalized ratio [INR] > 6.0) managed by physicians in a group model health maintenance organization (HMO) revealed opportunities for improvement. A centralized, telephone follow-up Clinical Pharmacy Anticoagulation Service (CPAS) was later implemented in the same HMO. We sought to compare the outcomes of excessive anticoagulation episodes managed by CPAS pharmacists to traditional physician management. METHODS: Computerized laboratory information was used to identify episodes of excessive anticoagulation managed by CPAS clinical pharmacists during the 6-month study. Pertinent data were collected through retrospective medical record review. Results were compared to a similar analysis conducted prior to CPAS implementation (traditional management). RESULTS: A total of 313 INR episodes >6.0 were identified in the CPAS group compared to 301 in the traditional management group. 6.3% of patients in the traditional management group experienced major bleeding compared to 1.3% in the CPAS group (p = 0.001). The majority of excessive anticoagulation episodes in both groups were managed by temporarily withholding warfarin therapy. Phytonadione was administered more frequently in the traditional management group than the CPAS group, 17.0% vs. 6.4%, respectively (p < 0.001). Traditional management patients also received higher doses of phytonadione than CPAS patients, 13.0 mg vs. 3.3 mg, respectively (p < 0.001). Aggressive use of phytonadione in the traditional management group resulted in two episodes of iatrogenic thromboembolism while no such episodes occurred in the CPAS group. CONCLUSIONS: The management of excessive anticoagulation by a centralized telephone follow-up anticoagulation service staffed by clinical pharmacists resulted in improved clinical outcomes compared to traditional management.

Aged↗
PubMed1997

The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. The Duration of Anticoagulation Trial Study Group.

BACKGROUND: A consensus has not been reached about the optimal duration of oral anticoagulant therapy after a second episode of venous thromboembolism. METHODS: In a multicenter trial, we compared six months of oral anticoagulant therapy with anticoagulant therapy continued indefinitely in patients who had had a second episode of venous thromboembolism. Of 227 patients enrolled, 111 were randomly assigned to six months of anticoagulation and 116 were assigned to receive anticoagulant therapy indefinitely; for both groups, the target international normalized ratio was 2.0 to 2.85. The initial episodes of deep-vein thrombosis (n = 193) and pulmonary embolism (n = 34), as well as recurrent episodes, were all objectively confirmed. RESULTS: After four years of follow-up, there were 26 recurrences of venous thromboembolism that fulfilled the diagnostic criteria, 23 in the group assigned to six months of therapy (20.7 percent) and 3 in the group assigned to continuing therapy (2.6 percent). The relative risk of recurrence in the group assigned to six months of therapy, as compared with the group assigned to therapy of indefinite duration, was 8.0 (95 percent confidence interval, 2.5 to 25.9). There were 13 major hemorrhages, 3 in the six-month group, (2.7 percent) and 10 in the infinite-treatment group (8.6 percent). The relative risk of major hemorrhage in the six-month group, as compared with the infinite-treatment group was 0.3 (95 percent confidence interval, 0.1 to 1.1). There was no difference in mortality between the two groups. CONCLUSIONS: Prophylactic oral anticoagulation that was continued for an indefinite period after a second episode of venous thromboembolism was associated with a much lower rate of recurrence during four years of follow-up than treatment for six months. However, there was a trend toward a higher risk of major hemorrhage when anticoagulation was continued indefinitely.

Administration, Oral↗
PubMed1994

Quality of oral anticoagulant control and treatment in Sweden. Duration of Anticoagulation (DURAC) Trial Study Group.

OBJECTIVES: To define laboratory-dependent and clinical factors that negatively influence the precision and safety of oral anticoagulation and to determine whether this creates differences in clinical outcome between the participating hospitals. DESIGN: Laboratory. The clinical chemistry laboratories of participating hospitals performed prothrombin time tests on blinded, standardized plasma samples on six occasions. Clinical. Patients with a first or second episode of venous thromboembolism were randomized to different durations of oral anticoagulation; the target was an international normalized ratio (INR) of 2.0-2.85. SETTING: Multicentre study at the departments of medicine of 16 Swedish hospitals. SUBJECTS: In total, 1124 patients with venous thromboembolism were followed for 600 patient-years of oral anticoagulation. Main exclusion criteria were previously known malignancy or venous ulcer, known congenital deficiency of an inhibitor of coagulation and unwillingness to participate. MAIN OUTCOME MEASURES: Laboratory. Interlaboratory variation was measured with coefficient of variation. Clinical. End-points were recurrent venous thromboembolism and haemorrhages requiring hospitalization or treatment with blood products or vitamin K. RESULTS: Laboratory. The interlaboratory variation in prothrombin time analyses was 11.3% at a mean INR of 3.8. No difference was detected between laboratories using the two prevalent thromboplastin reagents in Sweden or between those using the Behnk Coagulator and ACL instruments. INR results. Seventy-five per cent of the INR values were > or = 2.0, and 58% were within the target range. The time spent within the target range was between 57 and 74% at the worst and best hospital, respectively. Referral of patients to satellite clinics and fear of treating patients living in distant villages too intensively were factors that decreased the number of effectively anticoagulated patients. The percentage of patients effectively anticoagulated was lower amongst those < 50 than those > or = 50 years of age and also lower during the 1st year than during the 2nd and 3rd. Clinical events. These were eight objectively verified events of recurrent venous thromboembolism [1.3 in 100 patient-years or 0.7%; 95% confidence limits (CL): 0.2 1.2]. Seventeen haemorrhagic events occurred, corresponding to 2.8 per 100 patient-years or 1.5% (CL: 0.8, 2.2); two fatal haemorrhages corresponding to 0.3 per 100 patient-years or 0.2% (CL: 0.0, 0.4). The difference in the incidence of these complications between hospitals with > 60 and < or = 60% of patients effectively anticoagulated did not reach statistical significance. Patients with haemorrhagic complications were not older than the rest. CONCLUSIONS: The performance of the laboratories was acceptable. Clinically important differences between the hospitals were not observed. The incidences of thromboembolic and haemorrhagic complications were low, even in comparison with other randomized trials concerning venous thromboembolism. However, it might be possible to reduce the risk of haemorrhage further with increased centralization and improved education of patients as well as medical staff, and perhaps to reduce the risk of recurrent venous thromboembolism by aiming at a more intensive range of anticoagulation during the 1st month.

Administration, Oral↗
PubMed2004

Transitioning from traditional to novel anticoagulants: the impact of oral direct thrombin inhibitors on anticoagulation management.

Limitations of traditional anticoagulants have led to the need for structured services to provide anticoagulation monitoring. Anticoagulation management services have historically filled this role. Novel antithrombotic agents currently in development have the potential to improve on the limitations of vitamin K antagonists and injectable forms of heparin and to change the field of anticoagulation management. Of the emerging agents, oral direct thrombin inhibitors present the most promise and have a more practical clinical profile. The introduction of the oral direct thrombin inhibitors may present both an opportunity and a threat to anticoagulation management services and anticoagulation service providers. Traditional anticoagulation monitoring services will have to retool for the future if they are to remain relevant in the new era of novel antithrombotic.agents.

Administration, Oral↗
PubMed2000

Efficacy of oral anticoagulants compared with aspirin after infrainguinal bypass surgery (The Dutch Bypass Oral Anticoagulants or Aspirin Study): a randomised trial.

BACKGROUND: Oral anticoagulants and aspirin are antithrombotic drugs that are commonly used in patients with vascular disease. We investigated whether either of these treatments prevented more effectively than the other bypass complications after infrainguinal bypass surgery. METHODS: We did a multicentre, randomised, open trial. 2690 patients who had undergone infrainguinal grafting were randomly assigned oral anticoagulants (target international normalised ratio 3.0-4.5, n=1339) or aspirin (80 mg daily, n=1351). We followed up patients for a mean of 21 months. The primary outcome was graft occlusion. FINDINGS: 308 graft occlusions occurred in the oral-anticoagulants group compared with 322 in the aspirin group (hazard ratio 0.95 [95% CI 0.82-1.11]), which suggested no overall advantage for either treatment. Oral anticoagulants were beneficial in patients with vein grafts (0.69 [0.54-0.88]), whereas aspirin had better results for nonvenous grafts (1.26 [1.03-1.55]). The composite outcome of vascular death, myocardial infarction, stroke, or amputation occurred 248 times in the oral-anticoagulants group and 275 times in the aspirin group (0.89 [0.75-1.06]). Patients treated with oral anticoagulants had more major bleeding episodes than those treated with aspirin (108 vs 56; 1.96 [1.42-2.71]). INTERPRETATION: Oral anticoagulation was better for the prevention of infrainguinal-vein-graft occlusion and for lowering the rate of ischaemic events. Aspirin was better for the prevention of non-venous graft occlusion, and was associated with fewer bleeding episodes.

Acenocoumarol↗
PubMed2005

[Dental extractions in patients taking anticoagulants: is alteration of the anticoagulant regime necessary?].

A major concern in the management of patients under anticoagulants is the potential for excessive bleeding after dental procedures. Recommendations for the administration of oral anticoagulants in conjunction with oral surgery range from complete withdrawal of anticoagulants to the maintenance of an unchanged therapy. Rising evidences show that the alteration of anticoagulation is not necessary for patients with INR of 4 or less previous to tooth extractions. Topical antifibrinolytics as tranexamic acid control successfully alveolar bleeding. It is time to stop interrupting anticoagulant therapy for oral surgery. A theoretical risk of hemorrhage after dental surgery in patients at therapeutic levels of anticoagulation exists but it is minimal and is greatly overweighed by the risk of thromboembolism after alteration of the anticoagulant therapy.

Anticoagulants↗
PubMed1994

Monitoring anticoagulant control in general practice: comparison of management in areas with and without access to hospital anticoagulant.

BACKGROUND: Hospital anticoagulant clinics are available only in some areas. There is little information on the contribution of general practitioners to oral anticoagulant monitoring, and whether their management varies with access to hospital clinics. AIM: A study was undertaken to compare general practice management of anticoagulant therapy in two health boards with contrasting access to hospital clinics. METHOD: A postal questionnaire was sent to the senior partners in all 198 practices in Lothian and Fife, Scotland. RESULTS: Lack of access to hospital clinics in Lothian health board resulted in more practices reporting taking sole responsibility for anticoagulant control than in Fife where there was access (P < 0.001). However, there was no significant difference in management policies. Overall, 93% of practices used a protocol for thrombotest target ranges, but 75% had no policy on review frequency and only 2% assessed complication or failure rates. Reduced access to hospital clinics was associated with a decreased likelihood of favouring hospital involvement. Sole responsibility for anticoagulant management was undertaken by 56% of general practices, although only 21% of doctors viewed this as ideal. Most general practitioners felt that they should monitor patients on anticoagulant therapy but should refer to hospital those with problematic control. CONCLUSION: Access to hospital clinics affected the degree of involvement of general practitioners in oral anticoagulant monitoring, but did not considerably alter their management practice.

Anticoagulants↗
PubMed1991

Tissue anticoagulants in the human placenta: preliminary study with a heparin-like anticoagulant and review of the literature.

In this study a new heparin-like anticoagulant in the human placenta is described and an extensive review of the literature is given. An anticoagulant with a heparin-like activity was isolated from an extract of the human placenta. A two-stage purification procedure was applied: affinity chromatography on heparin-Sepharose and ion-exchange chromatography on DEAE-trisacryl. The isolated anticoagulant fraction was found to prolong both thrombin clotting time and activated partial thromboplastin time and to increase the activity of antithrombin III and heparin cofactor II. The placental-tissue anticoagulants described in the literature are divided by the author into five groups: (1) acidic peptides of low molecular weight; (2) thrombomodulin; (3) phospholipid-binding protein anticoagulants; (4) heparin-like anticoagulants, and (5) others. The anticoagulant described in the present study has been classified to the 4th group.

Annexins↗
PubMed1994

Effect of long-term oral anticoagulant treatment on mortality and cardiovascular morbidity after myocardial infarction. Anticoagulants in the Secondary Prevention of Events in Coronary Thrombosis (ASPECT) Research Group.

The use of long-term oral anticoagulant treatment after myocardial infarction remains controversial because of conflicting findings on mortality in previous trials and the increased risk of bleeding associated with anticoagulants. We have carried out a randomised, placebo-controlled, double-blind, multicentre trial in 3404 hospital survivors of myocardial infarction. Eligible patients were randomly assigned to anticoagulant (nicoumalone or phenprocoumon) or placebo treatment within 6 weeks of discharge. The target prothrombin time was 2.8-4.8 international normalised ratio. During mean follow-up of 37 (range 6-76) months there were 170 deaths among 1700 anticoagulant-treated patients and 189 in 1704 placebo-treated patients (hazard ratio 0.90 [95% CI 0.73-1.11]). Anticoagulant treatment led to significant reductions by comparison with placebo treatment in recurrent myocardial infarction (114 vs 242 patients; hazard ratio 0.47 [0.38-0.59]) and cerebrovascular events (37 vs 62; 0.60 [0.40-0.90]). Major bleeding complications were seen in 73 patients who received anticoagulants and 19 who received placebo. We conclude that long-term oral anticoagulant treatment after myocardial infarction in low-risk patients has a limited effect on mortality but achieves substantial benefit by reducing the risk of cerebrovascular events and recurrent myocardial infarction.

Acenocoumarol↗
PubMed2004

Safety and efficacy of enoxaparin compared with unfractionated heparin and oral anticoagulants for prevention of thromboembolic complications in cardioversion of nonvalvular atrial fibrillation: the Anticoagulation in Cardioversion using Enoxaparin (ACE) trial.

BACKGROUND: Anticoagulation in cardioversion of atrial fibrillation is currently performed with unfractionated heparin (UFH) and oral anticoagulants, with or without guidance by transesophageal echocardiography (TEE). Low-molecular-weight heparins may reduce the risk of bleeding, may obviate the need for intravenous access, and do not require frequent anticoagulation monitoring. METHODS AND RESULTS: In a randomized, prospective multicenter trial, we compared the safety and efficacy of enoxaparin administered subcutaneously with intravenous UFH followed by the oral anticoagulant phenprocoumon in 496 patients scheduled for cardioversion of atrial fibrillation of >48 hours' and < or =1 year's duration. Patients were stratified to cardioversion with (n=431) and without (n=65) guidance by TEE. The study aimed to demonstrate noninferiority of enoxaparin compared with UFH+phenprocoumon with regard to the incidence of embolic events, all-cause death, and major bleeding complications. Secondary end points included successful cardioversion, maintenance of sinus rhythm until study end, and minor bleeding complications. Of 496 randomized patients, 428 were analyzed per protocol. Enoxaparin was noninferior to UFH+phenprocoumon with regard to the incidence of the composite primary end point in a per-protocol analysis (7 of 216 patients versus 12 of 212 patients, respectively; P=0.016) and in an intention-to-treat analysis (7 of 248 patients versus 12 of 248 patients, respectively; P=0.013). There was no significant difference between the 2 groups in the number of patients reverted to sinus rhythm. CONCLUSIONS: Enoxaparin is noninferior to UFH+phenprocoumon for prevention of ischemic and embolic events, bleeding complications, and death in TEE-guided cardioversion of atrial fibrillation. Its easier application and more stable anticoagulation may make it the preferred drug for initiation of anticoagulation in this setting.

Administration, Oral↗
PubMedDate not supplied

Comparison of an anticoagulation clinic with usual medical care: anticoagulation control, patient outcomes, and health care costs.

BACKGROUND: The outcomes of an inception cohort of patients seen at an anticoagulation clinic (AC) were published previously. The temporary closure of this clinic allowed the evaluation of 2 more inception cohorts: usual medical care and an AC. OBJECTIVE: To compare newly anticoagulated patients who were treated with usual medical care with those treated at an AC for patient characteristics, anticoagulation control, bleeding and thromboembolic events, and differences in costs for hospitalizations and emergency department visits. RESULTS: Rates are expressed as percentage per patient-year. Patients treated at an AC who received lower-range anticoagulation had fewer international normalized ratios greater than 5.0 (7.0% vs 14.7%), spent more time in range (40.0% vs 37.0%), and spent less time at an international normalized ratio greater than 5 (3.5% vs 9.8%). Patients treated at an AC who received higher-range anticoagulation had more international normalized ratios within range (50.4% vs 35.0%), had fewer international normalized ratios less than 2.0 (13.0% vs 23.8%), and spent more time within range (64.0% vs 51.0%). The AC group had lower rates (expressed as percentage per patient-year) of significant bleeding (8.1% vs 35.0%), major to fatal bleeding (1.6% vs 3.9%), and thromboembolic events (3.3% vs 11.8%); the AC group also demonstrated a trend toward a lower mortality rate (0% vs 2.9%; P= .09). Significantly lower annual rates of warfarin sodium-related hospitalizations (5% vs 19%) and emergency department visits (6% vs 22%) reduced annual health care costs by $132086 per 100 patients. Additionally, a lower rate of warfarin-unrelated emergency department visits (46.8% vs 168.0%) produced an additional annual savings in health care costs of $29 72 per 100 patients. CONCLUSIONS: A clinical pharmacist-run AC improved anticoagulation control, reduced bleeding and thromboembolic event rates, and saved $162058 per 100 patients annually in reduced hospitalizations and emergency department visits.

Aged↗
PubMed1993

Tranexamic acid as a mouthwash in anticoagulant-treated patients undergoing oral surgery. An alternative method to discontinuing anticoagulant therapy.

A double-blind randomized study was carried out to evaluate the clinical hemostatic effect of tranexamic acid mouthwash after dental extraction in 30 patients who received anticoagulant agents. Surgery was performed with a reduction in the level of anticoagulant therapy in the control group and with no change in the level of anticoagulant therapy in the group who received the tranexamic acid. After the extraction the surgical field was irrigated with a 5% solution of tranexamic acid in the group of 15 patients whose anticoagulant treatment had not been discontinued and with a placebo solution in the group of 15 patients for whom the anticoagulant therapy was reduced. Patients were instructed to rinse their mouths with 10 ml of the assigned solution for 2 minutes four times a day for 7 days. There was no significant difference between the two treatment groups in the bleeding incidence after oral surgery. We conclude that the anticoagulant treatment does not need to be withdrawn before oral surgery provided that local antifibrinolytic therapy is instituted.

Anticoagulants↗
PubMed2004

Results of an open-label, prospective study of anticoagulant therapy for atrial fibrillation in an outpatient anticoagulation clinic.

OBJECTIVE: The goal of this study was to investigate the complications and control of warfarin treatment in patients with nonvalvular atrial fibrillation (NVAF) newly referred to an outpatient anticoagulation clinic. METHODS: This study included new patients with NVAF who were referred to an anticoagulation clinic for warfarin therapy over a recruitment period of 21 months. To reflect real-world clinical practice, patient selection for anticoagulation and patient management were left to the referring physicians, who were blinded to their patients' participation in the study. Patients were interviewed in person at the first clinic visit and then by telephone every 4 to 6 weeks. They were questioned about any bleeding or thromboembolic events. RESULTS: A total of 402 patients were included (100% of all new referrals over 21 months). The mean (SD) age was 72.3 (10.3) years, and 224 (56%) patients were men. The mean (SD) international normalized ratio (INR) was 2.4 (0.31). Patients were followed up for a mean (SD) of 19 (8.1) months (range, 1.0-31.0 months). They spent a mean (SD) 66% (18.3) of time in the target range of INR (ie, 2.0-3.0). Annual event rates were 1.7% (95% CI, 0.4%-3.0%) for major bleeding, 16.6% (95% CI, 13.0%-20.2%) for minor bleeding, 1.2% (95% CI, 0.1%-2.3%) for ischemic stroke, and 0.3% (95% CI, 0.2%-0.8%) for transient ischemic attacks. There were no cases of hemorrhagic stroke or fatal bleeding. Variability of INR and number of medications were identified as risk factors for bleeding (P = 0.03 and P = 0.001, respectively). There was no significant association between age and bleeding. CONCLUSIONS: Based on this analysis, the risks of long-term oral anticoagulation therapy in an outpatient anticoagulation clinic appear to reflect the results of clinical trials. Rates of ischemic stroke, major bleeding, and anticoagulation control were comparable. There was no age-related risk of complications.

Adult↗
PubMed1996

Oral surgery in anticoagulated patients without reducing the dose of oral anticoagulant: a prospective randomized study.

PURPOSE: This study assessed the risk associated with several schedules of perioperative treatment with coumadin in anticoagulated patients who underwent oral surgery. PATIENTS AND METHODS: A prospective, randomized study compared bleeding complications with six perioperative schedules in 92 patients chronically treated with acenocoumarol. In three of the perioperative schedules, the dose was reduced before surgery and calcium heparin was added. In the other three, oral anticoagulation was not modified and heparin was not used. The groups also differed regarding the antifibrinolytic agents used and the postoperative measures applied. RESULTS: Those schedules in which the oral anticoagulation was not modified preoperatively and an antifibrinolytic agent was applied locally both during and after surgery were not associated with a significantly higher odds ratio of bleeding complications than those in whom oral anticoagulation was reduced and calcium heparin was added preoperatively. CONCLUSIONS: In orally anticoagulated patients who undergo oral surgery, schedules that maintain the oral anticoagulant regimen and use local tranexamic acid as an antifibrinolytic agent postoperatively for 2 days are safe, simple, and less troublesome.

Acenocoumarol↗
PubMed1999

Anticoagulation services: quality improvement direction pursuing a certification process. Anticoagulation Provider Certification Working Group.

There is still in a certification process for anticoagulant therapy providers. The primary, and certainly most important, goal is to improve patient care. Defining measurable competencies to which the anticoagulation provider is made accountable is but one mechanism to help improve quality in patient care. Great improvements have been achieved in the field of anticoagulation. For example, determining optimum intensity levels, for the traditional as well as the newer indications for treatment, have yielded greater efficacy and safety. Additionally, the acceptance of the INR reporting system has greatly reduced hemorrhagic and thromboembolic complications. However, the process of care, that is, how patients are managed and by whom, remains a variable that is difficult to quantify and measure. Anticoagulation providers are comprised of professionals from three major disciplines, namely, medicine, nursing, and pharmacy. This multidisciplinary approach enriches the quality of care for patients. However, this very fact presents a dilemma when seeking an appropriate certifying body. Nevertheless, keeping quality patient care as the primary focus, a multidisciplinary group has developed a body of knowledge that is unique to anticoagulant and antithrombotic therapies. The foundation of this project stems from the Fourth American College of Chest Physicians Consensus Conference on Antithrombotic Therapy and the recently published paper by Ansell et al. on consensus guidelines for coordinated outpatient oral anticoagulation therapy management. This work in progress includes a mission statement and outlines five major knowledge domains along with measurable competencies for each section. This effort will help standardized the process of care across the country.

Anticoagulants↗
PubMed1997

Long-term anticoagulation of outpatients with adverse events to oral anticoagulants using low-molecular-weight heparin.

Bleeding complications are one of the major risks during oral anticoagulation. If further anticoagulation is indicated, low-molecular-weight heparin (LMWH) may offer an alternative treatment in those patients. In a prospective, nonrandomized study, 120 patients have been switched from oral anticoagulants to LMWH because of bleeding complications or other severe side effects during treatment with vitamin K antagonists. Indication for further anticoagulation was prophylaxis of recurrent thromboembolism, artificial heart valve replacement, atrial fibrillation with embolism and cardiomyopathy. The treatment period ranged from 2 months to 10.8 years. No fatal embolism occurred. One major but not severe episode of gastrointestinal bleeding occurred in a patient with an as yet unknown colon carcinoma. The cumulative treatment period amounts to 250 years. No drop in platelet count occurred in any patient. No other side effects were observed. LMWH was injected subcutaneously at doses ranging from 2500 to 15,000 anti-factor Xa units per day by the patient himself. The dose was adjusted on the basis of body weight, bleeding risk and thromboembolic risk. The results indicate that LMWH may be effectively and safely used as alternative anticoagulant regimen in patients with side effects or other complications on oral anticoagulants.

Administration, Oral↗
PubMed1998

Anticoagulation management clinics for the outpatient control of oral anticoagulants.

Oral anticoagulant therapy has a high risk-benefit profile and is labor intensive to manage. A better understanding of the indications for anticoagulation and of prothrombin time monitoring has led to improved outcomes. The development of anticoagulation management services has also improved the overall management of anticoagulation and the resulting clinical outcomes. By reducing adverse events, anticoagulation management services also result in more cost-effective therapy. Although these results have been generated by mostly nonrandomized observational studies, until better quality investigations are available, the preponderance of current clinical evidence strongly supports the value of a coordinated approach to care by an anticoagulation management service.

Administration, Oral↗
PubMed2001

Oral anticoagulant therapy during and after coronary angioplasty the intensity and duration of anticoagulation are essential to reduce thrombotic complications.

BACKGROUND: In the randomized Balloon Angioplasty and Anticoagulation Study (BAAS), the addition of oral anticoagulants to aspirin significantly reduced early and late events after coronary angioplasty. However, bleeding episodes were increased. The present report studied the intensity and the duration of anticoagulation as predictors of thrombotic and bleeding events. METHODS AND RESULTS: A total of 530 patients, 34% of whom received a stent, were treated with aspirin plus coumarins. Half of the patients were randomized to angiographic follow-up. The target international normalized ratio (INR) was 2.1 to 4.8 during angioplasty and 6-month follow-up. Thrombotic events were death, myocardial infarction, target lesion revascularization, and thrombotic stroke. Bleeding complications were hemorrhagic stroke, major extracranial bleeding, and false aneurysm. "Optimal" anticoagulation was defined as an INR in the target range for at least 70% of the follow-up time. There were 17 early thrombotic events (3.2%), 7 early bleeding episodes (1.3%), and 10 false aneurysms (1.9%). The incidence rate for both early thrombotic and bleeding events was lowest in patients in the target range. A total of 61 late thrombotic events occurred (11.6%). Optimal anticoagulation was an independent predictor of late thrombotic events (relative risk, 0.33; 95% CI, 0.19 to 0.57) and was associated with a 0.21 mm (95% CI, 0.17 to 0.42) larger vessel lumen at 6 months. Late bleeding episodes (1.4%) were lowest in patients in the target range. CONCLUSIONS: Coumarins started before coronary angioplasty with a target INR of 2.1 to 4.8 led to the lowest procedural event rate, without an increase in bleeding episodes. During follow-up, optimal anticoagulation was associated with a decrease in the incidence of late events by 67% and a significant improvement in 6-month angiographic outcome.

Administration, Oral↗