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Major Bleeding (major + bleeding)
Terms modified by Major Bleeding Selected AbstractsA randomized, double-blind study of certoparin vs. unfractionated heparin to prevent venous thromboembolic events in acutely ill, non-surgical patients: CERTIFY StudyJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 6 2010H. RIESS Summary.,Background:,In medically ill patients, no contemporary double-blind head-to-head evaluation of low molecular weight heparin vs. unfractionated heparin (UFH) for the prevention of venous thromboembolic events is available. Objectives:,To compare the efficacy and safety of certoparin with those of UFH. Patients/Methods:,In this double-blind, randomized, controlled trial, acutely ill, non-surgical patients aged , 70 years were randomized to certoparin (3000 U of anti-factor Xa once daily) or to UFH (5000 IU t.i.d.). The primary endpoint was the composite of proximal deep vein thrombosis as assessed by bilateral compression ultrasonography, symptomatic non-fatal pulmonary embolism and venous thromboembolism-related death, and was assessed by a blinded central adjudication committee. Non-inferiority margins were set at 1.8 for the odds ratio (OR) and 3.45% for the absolute difference. Results:,Three thousand two hundred and thirty-nine patients aged 78.8 ± 6.3 years were treated for 9.1 ± 3.4 days. The incidence of the primary endpoint was 3.94% in the certoparin group and 4.52% in the UFH group, with a difference in proportions of , 0.59% [95% confidence interval (CI) ,2.09 to 0.92; P < 0.0001 for non-inferiority], and an OR of 0.87 (95% CI 0.60,1.26; P = 0.0001 for non-inferiority). Major bleeding occurred in 0.43% of certoparin-treated patients and 0.62% of UFH-treated patients (OR 0.69; 95% CI 0.26,1.83). Any bleeding occurred at 3.20% in certoparin-treated patients vs. 4.58% in UFH-treated patients (OR 0.69; 95% CI 0.48,0.99; P < 0.05), and 5.73% of certoparin-treated patients and 6.63% of UFH-treated patients experienced serious adverse events. All-cause mortality was 1.27% in certoparin-treated patients and 1.36% in UFH-treated patients. Conclusions:,In acutely ill, non-surgical elderly patients, thromboprophylaxis with certoparin (3000 U of anti-FXa once daily) was non-inferior to 5000 IU of UFH t.i.d., with a favorable safety profile. [source] Bridging therapy in patients on long-term oral anticoagulants who require surgery: the Prospective Peri-operative Enoxaparin Cohort Trial (PROSPECT)JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 11 2007A. S. DUNN Summary., Background:, The peri-operative management of patients on oral anticoagulants (OACs) is a common clinical problem. Our aim was to determine the incidence of major bleeding during peri-operative administration of treatment-dose enoxaparin and the impact of the extensiveness of the procedure on the risk of bleeding. Methods:, We performed a prospective cohort study of 260 patients at 24 North American sites on OACs for atrial fibrillation or a history of deep vein thrombosis (DVT) requiring invasive or surgical procedures whose treating physician felt that bridging therapy was required. Warfarin was withheld, and once-daily s.c. enoxaparin (1.5 mg kg,1) was given peri-operatively. Patients were followed for 28 days after OAC was therapeutic. Results:, Major bleeding was observed in nine of 260 patients (3.5%, 95% CI: 1.6,6.5). The bleeding risk varied markedly by extensiveness of procedure: the incidence of major bleeding for invasive procedures, minor surgery and major surgery was 0.7% (95% CI: 0.02,3.7), 0% (95% CI: 0,5.0), and 20.0% (95% CI: 9.1,35.7), respectively. There were five thromboembolic events in total (1.9%, 95% CI: 0.6,4.4). There were four arterial events (2.3%, 95% CI: 0.6,5.7) in 176 patients with atrial fibrillation, and one venous event (1.0%, 95% CI: 0.03,5.7) in 96 patients with prior DVT. Conclusions:, Bridging therapy with once-daily therapeutic-dose enoxaparin administered primarily in an outpatient setting has a low incidence of major bleeding for patients undergoing invasive procedures and minor surgery. Further studies are needed to optimize the bridging strategy for patients undergoing major surgery. [source] Anticoagulation with the direct thrombin inhibitor argatroban in patients presenting with acute coronary syndromes,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2009Robert W. Yeh MD Abstract Objectives: This study examined the efficacy and safety of the direct thrombin inhibitor argatroban in patients presenting with acute coronary syndromes undergoing cardiac catheterization. Background: Argatroban is a direct-thrombin inhibitor approved for use in percutaneous coronary intervention in patients with heparin-induced thrombocytopenia. Few studies have examined its use in patients undergoing cardiac catheterization for acute coronary syndromes. We performed a retrospective cohort study of patients presenting with acute coronary syndromes who received argatroban anticoagulation during cardiac catheterization. Methods: Consecutive patients presenting with acute coronary syndromes who received argatroban while undergoing cardiac catheterization from 2002 to 2005 were included. Patient characteristics and in-hospital outcomes were examined retrospectively via detailed chart review. The primary endpoints of the study were combined death, myocardial infarction or urgent revascularization, and major bleeding during the index hospitalization. Results: A total of 144 patients presenting with an acute coronary syndrome received argatroban during cardiac catheterization within the study period: 25% presented with ST-elevation myocardial infarction and 75% presented with non-ST-elevation acute coronary syndrome. The combined endpoint of death, myocardial infarction or urgent revascularization occurred in 13.2% of patients during the hospitalization. Major bleeding occurred in 2.1% of patients. Conclusions: In this cohort of patients presenting with acute coronary syndromes, patients receiving argatroban during cardiac catheterization had a moderate rate of adverse cardiac events and a very low rate of major bleeding. © 2009 Wiley-Liss, Inc. [source] Thawed cryoprecipitate stored for 6 h at room temperature: a potential alternative to factor VIII concentrate for continuous infusionHAEMOPHILIA, Issue 6 2004L. M. B. Pesquera-Lepatan Summary., Continuous infusion (CI) of factor VIII concentrates has been demonstrated to be cost-effective method in maintaining stable levels of FVIII activity in haemophilia A patients with major bleeding or undergoing major surgery. Cryoprecipitates remain the major source of FVIII in developing countries-like the Philippines because of limited availability and high cost of concentrates. To support the use of cryoprecipitate as alternative to FVIII concentrate for CI in centres with no factor concentrates, FVIII levels in 37 bags of random cryoprecipitate were measured at 0, 2, 4 and 6 h after thawing, kept at room temperature with bacteriological culture studies performed on the sixth hour. The mean FVIII content at hour 0 was 108.10 U per bag. Type ORh+ blood had lower FVIII content (±78.91 U per bag) compared with blood types ARh+ (±121.64 U per bag) and BRh+ (±117.04 U per bag). The units stored <6 months had higher FVIII content (±117.74 U per bag) compared with those stored for over 6- but <12-months (±66.77 U per bag). The mean rate of decline of FVIII activity at 2, 4 and 6 h was statistically significant at 10.35% (P = 0.000), 21.49% (P = 0.000) and 29.41% (P = 0.000) from baseline, respectively, using the paired t-test. Similar finding was found across different blood types and storage duration. Only one of 37 bags grew Staphylococcus aureus on day 10 of incubation. [source] Bleeding risk with AZD6140, a reversible P2Y12 receptor antagonist, vs. clopidogrel in patients undergoing coronary artery bypass grafting in the DISPERSE2 trialINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 4 2009S. Husted Summary AZD6140, the first reversible oral P2Y12 receptor antagonist, exhibits greater and more consistent inhibition of platelet aggregation than the irreversible thienopyridine clopidogrel. As a result of its reversible effect, AZD6140 may pose less risk for bleeding when antiplatelet treatment cannot be stopped at least 5 days before coronary artery bypass graft (CABG) surgery or other invasive procedures. The Dose conflrmation Study assessing anti-Platelet Effects of AZD6140 vs. clopidogRel in NSTEMI (DISPERSE2) trial showed overall comparable bleeding rates with antiplatelet treatment with AZD6140 90 mg twice daily or 180 mg twice daily vs. clopidogrel 75 mg once daily in 984 patients with non-ST-elevation acute coronary syndromes. A post hoc exploratory analysis of bleeding outcomes in the subset of 84 patients undergoing CABG in DISPERSE2 suggests reduced risk for total bleeding (41% and 58% vs. 62%), all major bleeding (38% and 50% vs. 62%), and life-threatening bleeding (22% and 38% vs. 54%) with AZD6140 90 mg (n = 32) and 180 mg (n = 26) vs. clopidogrel (n = 26) respectively. Trends suggested that major bleeding rates were reduced with AZD6140 (combined groups) vs. clopidogrel when treatment was stopped , 5 days prior to surgery (39% vs. 63%, p = 0.15) but not when treatment was stopped > 5 days before surgery (50% vs. 60%). This observation is consistent with the reversible binding of AZD6140 to the P2Y12 receptor. Further prospective studies are planned to assess the relationship between this potential clinical benefit of AZD6140 and the reversibility of its antiplatelet effects. [source] Development and Validation of a Risk Scoring Model to Predict Net Adverse Cardiovascular Outcomes after Primary Percutaneous Coronary Intervention in Patients Pretreated with 600 mg Clopidogrel: Rationale and Design of the RISK-PCI StudyJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2009IGOR MRDOVIC M.D., Ph.D Background: No comprehensive primary PCI (pPCI) risk model to predict net adverse cardiovascular events (NACE) has been reported with the use of clopidogrel 600 mg, which is now considered the standard loading dose. The primary hypothesis of the RISK-PCI trial is that an accurate risk prediction may be achieved by using clinical, angiographic, and procedural variables available at the time of intervention. Methods: The present single-center, longitudinal, cohort study will include 1,750 consecutive patients with ST-elevation myocardial infarction (STEMI), undergoing pPCI after pretreatment with 300 mg aspirin and 600 mg clopidogrel. The primary end-points of the trial (NACE) include major adverse cardiovascular events (MACE) and major bleeding. A logistic regression model will be developed to predict 30-day and 1-year NACE after pPCI. A risk score derived from study set data will be validated using validation set data. Results: Until June 1, 2008, 1,166 patients have been enrolled. Thirty-day follow-up is available in 1,007 patients. Conclusions: The RISK-PCI study is designed to develop an accurate risk scoring system, using variables available at the time of intervention, to predict long-term adverse outcomes after pPCI. Trial Registration: Current Controlled Trials Register,ISRCTN83474650,http://www.controlled-trials.com/ISRCTN83474650). [source] Management of Multivessel Coronary Disease after ST Elevation Myocardial Infarction Treated by Primary AngioplastyJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2008Ph.D., STEFANO RIGATTIERI M.D. Background: Optimal treatment strategy of patients with ST elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD) undergoing primary angioplasty is still unclear. Percutaneous coronary intervention (PCI) of non-culprit vessels simultaneously or soon after primary angioplasty is feasible and safe, but available data failed to consistently show a benefit in long-term clinical outcomes. Methods: We retrospectively compared in-hospital and long-term outcomes for patients with STEMI and multivessel CAD treated by primary angioplasty with (Group 1, n=64) or without (Group 2, n=46) early, staged PCI of other angiographically significant coronary lesions. In-hospital major adverse cardiovascular events (MACE) were defined as a composite of death, periprocedural myocardial infarction after staged, elective PCI, stroke, stent thrombosis, major bleeding, and vascular complications. MACE at follow-up were defined as a composite of death, stroke, stent thrombosis, any coronary revascularization, and re-hospitalization for acute coronary syndrome. Results: Group 1 patients underwent staged PCI 5.9 ± 3.5 days after primary angioplasty. The mean length of follow-up was 13 months (392 ± 236 days). The incidence of in-hospital MACE was 20.3% in Group 1 and 10.8% in Group 2 (P=0.186); the incidence of out of hospital MACE was 9.3% in Group 1 and 23.9% in Group 2 (P=0.037). In Group 1 in-hospital MACE were driven by periprocedural myocardial infarction after the elective procedure, which occurred in 15.6% of patients. Conclusions: Our data show that multivessel, staged PCI in STEMI patients is associated with a low incidence of adverse events at follow-up but with a higher incidence of in-hospital MACE, mainly driven by periprocedural myocardial infarction during the elective procedure. [source] Effect of obesity on outcomes after fondaparinux, enoxaparin, or heparin treatment for acute venous thromboembolism in the Matisse trialsJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 6 2007B. L. DAVIDSON Summary.,Background: Selecting initial anticoagulant dose by patient weight for acute pulmonary embolism and deep vein thrombosis has clinical credibility; however, uncertainty remains regarding how to dose obese patients with newer anticoagulants because outcome data are sparse. Objectives: To use the Matisse trials' comparison of sc fondaparinux once daily with control heparin therapies (intravenous unfractionated heparin for pulmonary embolism, sc enoxaparin 1 mg/kg b.i.d. for deep vein thrombosis) for initial treatment in order to compare primary outcomes (venous thromboembolism recurrence and major bleeding) in obese patients. Patients and methods: Primary outcomes were compared in subsets composed of patients weighing , and > 100 kg and with body mass index (BMI) < 30 and , 30 kg/m2. Medians and ranges for weight and BMI were compared for patients suffering either recurrence or major bleeding. Results: Twenty-two thousand and one patients received fondaparinux and 2217 received enoxaparin or unfractionated heparin. Four hundred and ninety-six patients (11%) weighed > 100 kg and 1216 (28%) had a BMI , 30. Treatment groups had similar characteristics. The upper limit in subject weight for recurrence was 166 kg (BMI 58), and for major bleeding 120 kg (BMI 39). The incidences of recurrence and major bleeding were similar for each patient subset of weight and BMI for both fondaparinux and heparin treatment groups. Among patients with a primary outcome, median weights and BMIs were also similar. Conclusions: The current recommended doses of fondaparinux and heparins for the treatment of venous thromboembolism appear to provide similar protection against recurrence and major bleeding to one another and to obese and non-obese patients. [source] Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patientsJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 4 2005S. SCHULMAN Summary., A variety of definitions of major bleeding have been used in published clinical studies, and this diversity adds to the difficulty in comparing data between trials and in performing meta-analyses. In the first step towards unified definitions of bleeding complications, the definition of major bleeding in non-surgical patients was discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis. Arising from that discussion, a definition was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs. The definition and the text that follows have been reviewed and approved by the cochairs of the subcommittee and the revised version is published here. The intention is to also seek approval of this definition from the regulatory authorities. [source] Use of activated protein c in liver transplantation patients with septic shock,LIVER TRANSPLANTATION, Issue 11 2008Laura Rinaldi Recombinant human activated protein C (rhAPC) has been approved for use in patients with severe sepsis at high risk of death. Because of the high risk of bleeding, liver transplantation (LT) patients have been excluded from the randomized control trials that evaluated efficacy and safety of rhAPC and, thus, few data are available on the use of this drug in LT patients with severe sepsis. We describe our experience with 5 LT recipients treated for septic shock with the best conventional therapy and rhAPC. Before rhAPC therapy, all the patients showed septic shock, with ,3 organ dysfunctions and thrombocytopenia with impairment of coagulation. rhAPC therapy started within 30 hours after septic shock onset in all the patients who recovered from sepsis-induced circulatory failure, improved organ dysfunction, and completed the 96 hours of rhAPC therapy. During rhAPC infusion, 4 patients received fresh frozen plasma and/or platelet concentrates because of thrombocytopenia and severe hemostasis dysfunction. No major bleeding occurred and only 1 patient presented with minor bleeding events. Liver Transpl 14:1598,1602, 2008. © 2008 AASLD. [source] Management and prevention of drug-induced major bleedingPRESCRIBER, Issue 8 2006Crispin Musumba MRCP Our series on serious ADRs focusses on rare but potentially fatal drug reactions and how to recognise and avoid them. This article considers the drugs most commonly associated with major bleeding and discusses subsequent management. Copyright © 2006 Wiley Interface Ltd [source] Safety and Efficacy of Bivalirudin in High-risk Patients Admitted Through the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 8 2009Chadwick D. Miller MD Abstract Objectives:, The objective was to assess the safety and efficacy of bivalirudin monotherapy in patients with high-risk acute coronary syndrome (ACS) presenting to the emergency department (ED). Methods:, Data from the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial were used to conduct a post hoc subgroup analysis of high-risk ACS patients (cardiac biomarker elevation or ST-segment deviation) who initially presented to the ED. The ACUITY trial randomized patients to receive heparin (unfractionated [UFH] or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Endpoints included composite ischemia, major bleeding (not coronary artery bypass graft (CABG) related), and net clinical outcome (major bleeding plus composite ischemia). Results:, Of 13,819 participants in the ACUITY trial, 6,441 presented initially to the ED, met high-risk criteria, and were included in the primary analysis. Bivalirudin alone when compared to heparin plus GPI, after adjusting for covariates, was associated with an improvement in net clinical outcome (12.3% vs. 14.3%, adjusted odds ratio [OR] = 0.81, 95% confidence interval [CI] = 0.66 to 0.99), similar composite ischemia (9.3% vs. 9.1%, adjusted OR = 0.98, 95% CI = 0.77 to 1.24), and less major bleeding (4.0% vs. 6.8%, adjusted OR = 0.57, 95% CI = 0.42 to 0.75). Bivalirudin plus GPI when compared to heparin plus GPI had similar net clinical outcome (13.8% vs. 14.3%, adjusted OR = 0.91, 95% CI = 0.75 to 1.11), composite ischemia (8.8% vs. 9.1%, adjusted OR = 0.87, 95% CI = 0.69 to 1.11), and major bleeding (6.8% vs. 6.8%, adjusted OR = 1.01, 95% CI = 0.79 to 1.30). Conclusions: Bivalirudin monotherapy decreases major bleeding while providing similar protection from ischemic events compared to heparin plus GPI in patients with high-risk ACS admitted through the ED. [source] Enoxaparin vs heparin for prevention of deep-vein thrombosis in acute ischaemic stroke: a randomized, double-blind studyACTA NEUROLOGICA SCANDINAVICA, Issue 2 2002M. Hillbom Objectives , To compare the efficacy, safety, and overall risk,benefit profile of enoxaparin and unfractionated heparin (UFH) prophylaxis of venous thromboembolic complications in patients with acute ischaemic stroke. Methods , Patients with ischaemic stroke resulting in lower-limb paralysis lasting for at least 24 h and necessitating bedrest, were randomized within 48 h of the onset of stroke, and treated with enoxaparin (40 mg subcutaneously once daily) or UFH (5000 IU subcutaneously thrice daily) for 10 ± 2 days. Main outcome measures were deep-vein thrombosis, pulmonary embolism (PE), death from any cause, intracranial haemorrhage including haemorrhagic infarction, or any other major bleeding. Results , Outcome events occurred within 3 months of stroke in 40/106 patients treated with enoxaparin (37.7%) and 52/106 patients treated with UFH (49.1%, P =0.127). Fewer patients treated with enoxaparin (14, 13.2%) than with UFH (20, 18.9%) had evidence of haemorrhagic transformation of ischaemic stroke. Conclusions , Enoxaparin administered subcutaneously once daily was as safe and effective as subcutaneous UFH given thrice daily in the prevention of thromboembolic events in patients with lower limb paralysis caused by acute ischaemic stroke. [source] Adjunctive Low Molecular Weight Heparin During Fibrinolytic Therapy in Acute ST-Segment Elevation Myocardial Infarction: A Meta-Analysis Of Randomized Control TrialsCLINICAL CARDIOLOGY, Issue 7 2009Sarabjeet Singh MD Background Recent data suggests that low molecular weight heparins (LMWHs) may be superior to unfractionated heparin (UFH) as an adjunct to fibrinolytic therapy in patients with acute ST-segment elevation myocardial infarction (STEMI). Hypothesis We evaluated cardiac outcomes and the risk of major bleeding with LMWHs vs UFH in the management of STEMI. Methods Seven randomized trials of patients with acute STEMI treated with fibrinolytic therapy and adjunctive LMWHs through the index hospitalization or weight-based UFH for at least 48 hours were identified. We analyzed both primary endpoints (death and nonfatal recurrent myocardial infarction through 30 days), and secondary endpoints (death, recurrent myocardial infarction, and major bleeding during index hospitalization at 7 days). Outcomes were computed using the Mantel-Haenszel fixed-effect model. A 2-sided alpha error of < 0.05 was considered significant. Results Compared to UFH, LMWH significantly reduced reinfarction (p < 0.001) during hospitalization at 7 days and the effect remained consistent at 30 d (p < 0.001). When analyzed for mortality at 7 days and 30 days follow-up, there were no statistically significant differences observed between the 2 groups. Additionally the LMWH group had higher risk of major bleeding (p < 0.001). Conclusions The present meta-analysis suggests in patients receiving fibrinolytic therapy for STEMI, LMWHs as an adjunctive therapy is superior to UFH in reducing reinfarction during hospitalization at 7 days and at 30 days. The mortality was not significant between the 2 groups during hospitalization at 7 days and at 30 days. However, UFH is superior to LMWHs in the reduction of major bleeding at 7 days index hospitalization. Copyright © 2009 Wiley Periodicals, Inc. [source] Antiplatelet Therapy in Cerebrovascular Disease: Implications of MATCH and CHARISMA Results for CardiologistsCLINICAL CARDIOLOGY, Issue 12 2007Dan James Fintel M.D. Abstract Cardiovascular disease is prevalent among patients with stroke; thus, cardiologists frequently treat patients at high risk for stroke. Results from recent clinical trials of antiplatelet medications, given alone or in combination, may be of special interest to cardiologists. The MATCH study demonstrated no significant difference between clopidogrel alone and clopidogrel plus aspirin in reducing risk of vascular events after stroke or transient ischemic attack. A 1.3% increased risk of major bleeding was associated with clopidogrel plus aspirin. In CHARISMA, clopidogrel plus aspirin did not reach statistical significance vs. placebo plus aspirin in reducing incidence of myocardial infarction (MI), stroke, or death from cardiovascular causes in patients with stable atherothrombotic disease; clopidogrel was associated with an increase in moderate bleeding. These results suggest that clopidogrel plus aspirin may be inappropriate as first-line therapy for secondary stroke prevention. In patients with established cardiovascular disease at risk for MI or other vascular events, physicians must weigh the benefits and risks before choosing this therapy. Selection of an antiplatelet agent must be based on patient history, including previous MI and stroke, susceptibility to bleeding, and other high-risk factors (e.g. advanced age and diabetes). Aspirin plus extended-release dipyridamole may be more effective than clopidogrel for preventing stroke in high-risk patients. This article strives to put MATCH and CHARISMA results into context by providing an overview of antiplatelet therapy, including relevant clinical trial results, a review of current practice guidelines, and a summary of an ongoing study that will improve clinical decision making. Copyright © 2007 Wiley Periodicals, Inc. [source] Evolution of Anticoagulant and Antiplatelet Therapy: Benefits and Risks of Contemporary Pharmacologic Agents and Their Implications for Myonecrosis and Bleeding in Percutaneous Coronary InterventionCLINICAL CARDIOLOGY, Issue S2 2007Hector M. Medina M.D., M.P.H. Abstract Periprocedural myonecrosis, as evidenced by elevated creatine kinase,myocardial bound (CK-MB) levels, occurs in up to 25% of patients undergoing percutaneous coronary intervention (PCI) and has been linked with an increased risk of adverse short- and long-term clinical outcomes. Such myonecrosis arises from three main pathophysiological mechanisms: procedure-related complications, lesion-specific characteristics (e.g., large thrombus burden, plaque volume), and patient-specific characteristics (e.g., genetic predisposition, arterial inflammation). Periprocedural myonecrosis has not been definitively identified as the cause of postprocedural ischemic events, although agents that reduce or prevent thrombosis,including aspirin, thienopyridines, heparin, low-molecular-weight heparins, glycoprotein IIb/IIIa inhibitors, and direct thrombin inhibitors,have been shown to reduce the incidence of ischemic outcomes in this population, as have agents that reduce inflammation (aspirin, statins). At the same time, antithrombotic agents are known to increase the risk of bleeding and the use of transfusions, which have likewise been associated with worse outcomes in these patients. Thus, optimal management of patients undergoing PCI represents a balance between minimizing the risk of ischemic outcomes and simultaneously minimizing the risk of major bleeding. It may be that patients who have only minor, untreated postprocedural elevations in CK-MB level (with no clinical or angiographic signs of ischemia) might have a better prognosis than patients who have normal CK-MB levels but who suffer major bleeding complications. Copyright © 2007 Wiley Periodicals, Inc. [source] Bleeding Complications in Acute Coronary Syndromes and Percutaneous Coronary Intervention: Predictors, Prognostic Significance, and Paradigms for Reducing RiskCLINICAL CARDIOLOGY, Issue S2 2007Steven V. Manoukian M.D. Abstract In clinical trials up to 30% of patients with acute coronary syndromes (ACS) or undergoing percutaneous coronary intervention (PCI) experience bleeding complications, and even higher rates have been reported in contemporary practice. A growing body of data suggests a strong correlation between bleeding and both short- and long-term adverse outcomes, including mortality, which is independent of baseline characteristics and remains evident in most trials, despite variations in the definition of major bleeding. Although the value of antithrombin and antiplatelet therapy in reducing the risk of ischemic events is well established, the mechanisms of action that confer the benefits of these therapies have an inherent tendency to increase the risk of bleeding complications. As a result, characterization of baseline hemorrhagic risk is critical and must be accomplished before selecting an antithrombotic therapy. Risk factors for bleeding may be divided into two categories: nonmodifiable (including age, gender, race, weight, renal insufficiency, anemia, and acuity of presentation) and modifiable (including choice of antithrombotic therapy and PCI procedural characteristics). Of these predictive factors, the choice, dosage, and duration of the antithrombin and/or antiplatelet regimen are perhaps the most readily modifiable, especially in patients with an increased risk of bleeding. This review explores the nature of the association between bleeding and adverse outcomes, including mortality; evaluates risk factors for bleeding; and examines mechanisms for reducing bleeding complications through the selection of appropriate antithrombotic therapy. Copyright © 2007 Wiley Periodicals, Inc. [source] Teenage and adult tonsillectomy: dose,response relationship between diathermy energy used and morbidityCLINICAL OTOLARYNGOLOGY, Issue 5 2007A.A.J. Cardozo Objective:, To determine whether an increase in the use of bipolar diathermy energy to perform a tonsillectomy is associated with an increase in postoperative pain and haemorrhage. Study design:, Prospective study. Setting:, District General Hospital. Methods:, In all, 101 patients above the age of 13 years who underwent a tonsillectomy that involved the use of bipolar diathermy during the study period were included. The cumulative amount of diathermy energy used to perform each tonsillectomy was calculated with the help of a digital stop clock timing device connected to the diathermy foot-pedal. Main outcome measures:, Postoperative pain scores and the incidence of secondary haemorrhage were recorded for each patient at four points in time following surgery, up to the tenth postoperative day. The haemorrhage rates were categorised into three groups (no bleeding, minor bleeding and major bleeding) according to severity. Associations between the diathermy energy used to perform each tonsillectomy and the corresponding postoperative pain scores and secondary bleeding rates were investigated. Results:, There was a statistically significant positive relationship between the total amount of bipolar diathermy energy used per tonsillectomy and the pain scores at all the four recorded points in time (rs = 0.44,0.72, P < 0.001). When the median energy consumption in the three groups (no bleeding, minor bleeding and major bleeding) were compared using the Kruskal,Wallis test, we found that there was limited evidence of a difference between the groups, but this was not statistically significant at the 5% level [H (2) = 5.374, P = 0.065, 99% CI 0.058,0.071]. Conclusions:, Increased use of bipolar diathermy during the performance of a tonsillectomy is associated with a statistically significant increased amount of postoperative pain. The dose,response relationship between diathermy energy and postoperative bleeding is less clear. This suggests that there could be other important factors such as surgical instrument characteristics and degree of tonsillar adherence that have an additional influence and are therefore possible areas for future research. [source] | ||||||||||