Incidence Of Major Bleeding Complications Research Articles

Anticoagulation management during veno-venous ECMO support because of ARDS: Single-center experience

BackgroundPatients with severe acute respiratory distress syndrome (ARDS) show a high mortality rate of up to 60 %. In such cases, extracorporeal membrane oxygenation (ECMO) support is often required, which would necessitate anticoagulation therapy, predominantly with heparin. Some bleeding events occurred more frequently in patients during the COVID-19 pandemic who were on venovenous (V-V) ECMO, so it is necessary to investigate whether anticoagulation management should be adjusted. MethodsWe collected data on 90 patients with severe ARDS who underwent ECMO support at the University Hospital Magdeburg between 2014 and 2022. In order to estimate the role of anticoagulation therapy as a cause of bleeding, patients were divided into two groups based on their mean activated partial thromboplastin time (aPTT): one group with a mean aPTT of more than 58 s (45 patients) and another with a mean aPTT of less than 58 s (45 patients). Demographic data, data before, during ECMO support, and bleeding complications were retrospectively recorded. We compared laboratory parameters before ECMO, essential coagulation parameters on days 3, 7, 10 of ECMO support, before the bleeding event occurred, and analyzed hospital survival in both groups. ResultsThe incidence of major bleeding complications was significantly higher in the group of patients with higher aPTT (68.9 % vs 33.3 %, p < 0.001), the differences in the occurrence of hemothorax were especially significant (28.9 % vs 2.2 %, p < 0.001). We observed better hospital patients’ survival in the group with lower aPTT (40.0 % vs 68.9 %, p = 0.006). The results of the bivariate analysis indicate that the independent predictors of hospital mortality in adult patients receiving V-V ECMO support due to severe ARDS were COVID-19 (OR: 3.504; 95 % confidence interval [CI]: 1.415–8.681, p = 0.007) acute liver failure (OR: 8.0000; 95 % CI: 1.692–37.822; p = 0.009), high antithrombin level (%) (OR: 1.036; 95 % CI: 1.003–1.071, p = 0.035). A high mean aPTT level increased the risk of major bleeding (OR: 1.080; 95 % CI: 1.016–1.148, p = 0.014) without a significant increase in mortality. ConclusionProlonged aPTT during V-V ECMO support in patients with ARDS significantly impacts the risk of major bleeding, especially hemothorax, without significant increase in hospital mortality.

Complication comparison in intermediate-to-high risk venous thromboembolism patients, treated with high vs standard dose apixaban and rivaroxaban after low molecular weight heparin

Abstract Background In patients with intermediate-to-high risk venous thromboembolism (VTE), current guidelines recommend initial treatment with low molecular weight heparin (LMWH), followed by an oral anticoagulant. However, the studies supporting these guidelines have only focused on the use of Edoxaban and Dabigatran after 5 days of LMWH treatment. To date there are no studies supporting similarly implemented guidelines for Apixaban and Rivaroxaban. Purpose To investigate the incidence of bleeding complications and thrombosis in intermediate-to-high risk VTE patients, when treated with either lead-in high or standard dose Rivaroxaban or Apixaban, following initial LMWH treatment. Methods Through a real-life retrospective study of 844 intermediate-to-high risk VTE patients, 584 were initially treated with LMWH and subsequently Apixaban or Rivaroxaban and divided into two groups. The first group of 514 patients, received high dose Apixaban or Rivaroxaban (10mg x 2 for 7 days and 15mg x 2 for 21 days respectively) before being reduced to their standard doses. The remaining 70 patients, instead transitioned directly to the standard doses (5mg x 2 and 20mg x 1 respectively) from LMWH. All patients started treatment between 2018 and 2023, and all complications were recorded until one year following initiation of treatment. Treatment complications include recurrent VTE, separated into deep vein thrombosis and pulmonary embolism, and bleeding complications in the form of fatal, non-fatal, minor and a drop in haemoglobin. The recurrence of VTE and incidence of bleeding complications were evaluated as the primary efficacy outcome and safety outcome respectively. Results Overall, 4.7% of patients treated with initial high dose Apixaban or Rivaroxaban suffered major bleeding complications as opposed to 2.9% treated with the standard dose (p=&amp;lt;0.05). Out of all complications, 5 were fatal, all of which were part of the high dose group and included 3 cerebral and 2 gastrointestinal bleeds. However, minor bleeding complications were more frequent in the standard dose group, presenting in 26.1% of patients, while, paradoxically, the high dose group had similar complications in only 15.8% of patients (p=&amp;lt;0.05). Although treated with a higher dose, 6/478 (1,26%) incurred a recurrent thrombus within a year of treatment, while the standard dose group had no cases of recurrence, though this was not a statistically significant result. Conclusion Directly transitioning from LMWH to standard dose Apixaban/Rivaroxaban in intermediate-to-high risk VTE, leads to a statistically significant reduced incidence of major bleeding complications, without an increased risk of recurrent thrombosis.

Safety of routine protamine in the reversal of heparin in percutaneous coronary intervention: A systematic review and meta-analysis

ObjectivesTo determine the safety and efficacy of protamine in the reversal of heparin in percutaneous coronary intervention (PCI). BackgroundHeparin is routinely used for anticoagulation in PCI. Protamine is not used routinely to reverse heparin's effects in PCI, partly due to the perceived risk of stent thrombosis. MethodsRelevant studies published in English were searched for in PubMed, Embase, and Cochrane databases from inception to April 26th, 2023. Our primary outcome of interest was stent thrombosis in patients receiving PCI for all indications. Secondary outcomes included mortality, major bleeding complications, and hospitalization length. Dichotomous outcomes were analyzed using a Mantel-Haenszel random-effects model and expressed as odds ratios (OR) with their 95% confidence intervals (CI), while continuous outcomes were analyzed using an inverse variance random-effects model expressed as mean differences (MD) with their 95% CI. Results11 studies were included in our analysis. Protamine use was not associated with stent thrombosis: OR 0.58, 95% CI: 0.33, 1.01 (p = 0.05) nor with mortality (p = 0.89). Protamine administration was associated with a decreased incidence of major bleeding complications: OR 0.48; 95% CI: 0.25, 0.95 (p = 0.03) and decreased length of hospitalization (p < 0.0001). ConclusionsIn patients pre-treated with dual antiplatelet therapy (DAPT), protamine may be a safe and efficacious option to facilitate earlier sheath removal, reduce major bleeding complications, and reduce length of hospitalization without increased risk of stent thrombosis.

Bleeding and thrombotic complications associated with anticoagulation prior to lung transplantation: a case series.

BackgroundScarce data is available on therapeutic anticoagulation (AC) in patients undergoing pulmonary transplantation. We describe our institutional experience with AC-induced coagulopathy in recipients at the time of transplantation and evaluate its impact on posttransplant outcomes.MethodsRecords of adult patients on therapeutic AC at the time of lung transplantation from January 2014 to July 2021 were reviewed. Administration of preoperative pharmacologic reversal was assessed, with adequate reversal defined as international normalized ratio (INR) ≤1.5. We evaluated the incidence of major bleeding complications [delayed sternal closure, reoperation due to bleeding, chest tube output ≥1,500 cc, ≥4 units of packed red blood cells, ≥4 units of platelets, or ≥5 units of fresh frozen plasma (FFP)], major thrombotic complications [venous thromboembolism (VTE) or other major thrombosis on imaging], and inpatient mortality.ResultsOf 602 lung transplant recipients, 10 patients taking preoperative warfarin were included in the study. While most patients received pharmacologic reversal preoperatively (n=9, 90%), successful reversal was rarely achieved (n=3, 30%). Inadequate INR reversal was associated with major bleeding events (n=6, 60%). Major thrombotic complications were more frequent (n=7, 70%) than bleeding events. Notably, all fatalities within the cohort (n=2, 20%) were associated with thrombotic, but not bleeding, complications.ConclusionsThis is the first known report on the incidence and impact of AC-induced coagulopathy in patients undergoing lung transplantation. Major thrombotic events are frequent and associated with high mortality. Routine surveillance and treatment may be warranted.

Meta-analysis of randomized controlled trials on primary ambulatory thromboprophylaxis in patients with ovarian cancer receiving chemotherapy

Ovarian cancer (OC) is highly associated with venous thromboembolism (VTE). The OC cells stimulate thrombin generation, and chemotherapy potentiates the prothrombotic effect of cancer cells by damaging endothelium and enhancing hypercoagulability. Recently, primary ambulatory thromboprophylaxis (PATP) has been studied as a potential treatment in cancer patients undergoing chemotherapy with an aim of reducing the incidence of VTE and potentially prolonging survival. A meta-analysis was performed of randomized controlled trials of PATP vs control in patients with OC receiving chemotherapy. The primary outcome measure was the incidence of VTE. The secondary outcome measure was the incidence of major bleeding complications. Two articles published between 2012 and 2020 fulfilled selection criteria. The incidence of VTE was 0.9% in the PATP group and 1.8% in the control group. However, the pooled risk ratio was not statistically significant at 0.69 (95% CI: 0.08 to 5.67; P = 0.73). The absolute risk difference was −0.03 (95% CI, −0.17 to 0.11; P = 0.66). There was no statistically significant reduction in VTE by providing PATP to patients with OC receiving chemotherapy. Routine PATP should not be recommended in ambulatory OC patients. Future randomized trials are necessary to define the high-risk subset of OC patients who may benefit from PATP.

Differences between surviving and non-surviving venous thromboembolism COVID-19 patients: a systematic review

BackgroundTo our knowledge, the treatment, outcome, clinical presentation, risk stratification of patients with venous thromboembolism and COVID-19 have not been well characterized.MethodsWe searched for systematic reviews, cohorts, case series, case reports, editor letters, and venous thromboembolism COVID-19 patients’ abstracts following PRISMA and PROSPERO statements. We analyzed therapeutic approaches and clinical outcomes of venous thromboembolism COVID-19 patients. Inclusion: COVID-19 patients with venous thromboembolism confirmed by an imaging method (venous doppler ultrasound, ventilation-perfusion lung scan, computed tomography pulmonary angiogram, pulmonary angiography). We assessed and reported the original Pulmonary Embolism Severity Index for each pulmonary embolism patient. In addition, we defined major bleedings according to the International Society of Thrombosis and Haemostasis criteria.ResultsWe performed a systematic review from August 9 to August 30, 2020. We collected 1,535 papers from PubMed, Scopus, Web of Science, Wiley, and Opengrey. We extracted data from 89 studies that describe 143 patients. Unfractionated and low-molecular-weight heparin was used as parenteral anticoagulation in 85/143 (59%) cases. The Food and Drug Administration-approved alteplase regimen guided the advanced treatment in 39/143 (27%) patients. The mortality was high (21.6%, CI 95% 15.2-29.3). The incidence of major bleeding complications was 1 (0.9%) in the survival group and 1 (3.2%) in the death group. Pulmonary Embolism Severity Index was class I in 11.6% and II in 22.3% in survivors compared to 0% and 6.5% in non-survivors, respectively. Patients who experienced venous thromboembolism events at home were more likely to live than in-hospital events.ConclusionsWe determined a high mortality incidence of pulmonary embolism and a low rate of bleeding. Unfractionated and low-molecular-weight heparin drove parenteral anticoagulation and alteplase the advanced treatment in both groups. The original Pulmonary Embolism Severity Index could be helpful in the risk stratification.

Therapeutic efficacy of heparin and direct factor Xa inhibitors in cancer-associated cryptogenic ischemic stroke with venous thromboembolism

BackgroundAnticoagulation therapy, especially using heparin or recently developed oral direct factor Xa inhibitors (DiXals), is recommended as first-line treatment for cancer-related venous thromboembolism (VTE). However, the preventive efficacy of these anticoagulants for cancer-associated ischemic stroke is still unknown. We retrospectively investigated the efficacy of subcutaneous unfractionated heparin (UFH) and DiXals for preventing the recurrence of cancer-associated cryptogenic ischemic stroke with VTE. MethodsWe retrospectively studied consecutive patients with cancer-associated cryptogenic ischemic stroke and comorbid VTE who received subcutaneous UFH or oral DiXaIs at 9 hospitals. ResultFifty-three patients (24 treated with UFH and 29 treated with DiXaIs) were enrolled. Of these, 47 demonstrated systemic metastasis (cancer stage IV). During 30-day follow-up after initiation of anticoagulation therapy, recurrent ischemic stroke was observed in only 1 patient (4%) in the UFH group and in 9 patients (31%) in the DiXal group. The incidence of major bleeding complications was similar between the 2 groups (4% and 10%, respectively). The cumulative risk of ischemic stroke recurrence within 30 days was lower with UFH than with DiXals (competing risk analysis, p = 0.008). In the DiXal group, patients who experienced recurrence showed significantly higher D-dimer levels than those without recurrence. ConclusionIn patients with cancer-associated cryptogenic ischemic stroke and comorbid VTE, UFH demonstrated a lower rate of recurrent ischemic stroke than DiXaIs, and there were no differences in bleeding risk between the 2 treatments. D-dimer levels at stroke onset increased the risk of recurrence in the DiXal group but not in the UFH group.

Periprocedural management of anticoagulation therapy and in-hospital outcomes in patients with warfarin indication undergoing percutaneous coronary intervention. Data from the WAR-STENT registry

In patients with an indication for oral anticoagulation (OAC) with warfarin, the management of OAC peri-procedure of percutaneous coronary intervention (PCI) is still not fully defined. To investigate clinical practice and outcomes associated with continuation vs interruption of OAC, with or without bridging with low-molecular-weight heparin (LMWH), we examined the database of the observational, prospective, multicenter Italian WAR-STENT registry. The WAR-STENT registry was conducted in 2008-2010 in 37 Italian centers and included 411 consecutive patients in 157 of whom the peri-procedural international normalized ratio (INR) value was available. In relation to the continuation vs interruption of OAC, patients were divided into group 1 (n = 106) and group 2 (n = 51) respectively, and compared. The basal characteristics of the two groups were similar. The most frequent indication for OAC was atrial fibrillation and for PCI acute coronary syndromes, respectively. The pre-procedural mean value of INR was significantly different in group 1 vs group 2 (2.3 ± 0.4 vs 1.5 ± 0.2; p <0.001), while the use of antithrombotic drugs did not differ, except for LMWH which, albeit limited to only 14% of cases, was used significantly more frequently in group 2 (14% vs 2%; p=0.006). The radial approach was used significantly more often in group 1 vs group 2 (72% vs 45%; p=0.002). The in-hospital incidence of major bleeding complications was similar in groups 1 and 2 (4% vs 8%; p=0.27), as well as the occurrence of major adverse cardio-cerebrovascular events, including cardiovascular death, non-fatal myocardial infarction, re-revascularization of the treated vessel, stent thrombosis, stroke and venous thromboembolism (6% vs 6%; p=0.95). There was a tendency towards a higher incidence of minor access-site bleeding complications in group 1 patients treated by the femoral route. In unselected patients with an indication for OAC with warfarin and undergoing PCI, the continuation vs interruption of OAC (essentially without LMWH bridging) strategies appears similar in terms of efficacy and safety. In consideration of the superior convenience, peri-procedural continuation of OAC should therefore generally be preferred, with the possible exception of patients in whom the femoral approach is required for the procedure.

Amyloid precursor protein 770 is specifically expressed and released from platelets

Platelets not only play an essential role in hemostasis after vascular injury but are also involved in the development of coronary artery disease (CAD) and cerebrovascular lesions. Patients with CAD and cerebral ischemia are recommended to undergo antiplatelet therapy, but they have an increased incidence of major bleeding complications. Both assessment of the platelet activation status and response to antiplatelet therapy in each patient are highly desired. β-Amyloid precursor protein (APP) 770 is expressed in vascular endothelial cells, and its extracellular region, a soluble form of APP770 (sAPP770, also called nexin-2), is proteolytically cleaved for shedding. Abundant sAPP770 is also released from activated platelets. In this study, we used peripheral blood samples from patients with CAD and control subjects and evaluated sAPP770 as a specific biomarker for platelet activation. First, the plasma levels of sAPP770 correlated well with those of the soluble form CD40 ligand (CD40L), an established biomarker for platelet activation. Additionally, flow cytometry analysis using peripheral blood cells showed that CD40L expression is up-regulated in activated T cells, whereas APP770 expression is negligible in all blood cell types except platelets. Following stimulation with collagen or ADP, aggregating platelets immediately released sAPP770. Finally, patients with dual antiplatelet therapy showed significantly lower levels of plasma sAPP770 than those with no therapy. Taken together, our data show that plasma sAPP770 could be a promising biomarker for platelet activation.

Limb Salvage After Percutaneous Mechanical Thrombectomy in Patients with Acute Lower Limb Ischemia: A Retrospective Analysis from Two Institutions

To evaluate the short-term outcomes of percutaneous mechanical thrombectomy (PMT) in patients with acute lower limb ischemia (ALI) and to analyze the effect of ALI of different etiologies on the limb salvage. From January 2015 to December 2017, a retrospective analysis was performed on 112 patients (mean age: 66.5 years; 117 limbs in total; 66 limbs in 61 males) with ALI treated with PMT at 2 vascular institutions. Of the 117 limbs, 44 (41 patients) had acute arterial embolism, 36 (34 patients) had acute arterial thrombosis, and 37 (37 patients) had acute stent (31 limbs in 31 patients) or graft (6 limbs in 6 patients) thrombosis. The primary end point was limb salvage rate, and subgroups were analyzed by etiological factors. The secondary end points included patency rates, major bleeding complications, 30-day mortality, and reintervention rates. The 30-day mortality rate was 3.6%. The incidence of major bleeding complications was 2.7%. During the follow-up, the limb salvage rates at 1year and 2years were 83.8% and 74.7%, respectively. Subgroup analysis showed that the limb salvage rate in patients with acute arterial embolism was 92.9% at 2years after PMT, which was higher than that in patients with acute arterial thrombosis (73.3%, P=0.04, hazard ratio [HR]: 3.6, 95% confidence interval [CI]: 1.1-11.7) and acute stent/graft thrombosis (62.5%, P=0.01, HR: 4.7, 95% CI: 1.5-13.6). PMT in patients with ALI is effective in preventing amputations over the 3-year study period with a reasonable safety profile, especially in patients with acute arterial embolism.

Outcomes of Catheter-Directed Therapy Plus Anticoagulation Versus Anticoagulation Alone for Submassive and Massive Pulmonary Embolism

BackgroundCatheter-directed therapy (CDT) offers an alternative treatment to systemic thrombolysis for patients with massive and submassive pulmonary embolism. MethodsA retrospective review of 105 consecutive massive and submassive pulmonary embolisms over 2 years was performed. Thirty-six patients (9 massive, 27 submassive) were treated with CDT, consisting of aspiration thrombectomy (18), ultrasound-assisted thrombolysis (8), or both (10). Forty-three patients (8 massive, 35 submassive) were treated with heparin anticoagulation alone. Primary outcome was improvement of RV/LV ratio 24-48 hours after treatment. Safety outcomes included 90-day mortality, bleeding complications, and hospital readmissions. Subgroup analysis based on severity of RV dilation was performed. ResultsMean RV/LV ratio decreased from 1.91±0.61 to 1.28±0.45 (P < .001) in the CDT group and from 1.40 ± 0.37 to 1.25 ± 0.32 (P = .01) in the anticoagulation group. In submassive pulmonary embolisms with mild and moderate RV dilation (RV/LV ratio 0.9-1.9), RV/LV ratio was significantly lower in the CDT group at 24-48 hours (1.05 ± 0.38 vs 1.20 ± 0.31, P < .001). In submassive pulmonary embolisms with severe RV dilation (RV/LV ratio >1.9), no difference was noted between the 2 treatment groups. Ninety-day mortality (11% and 14%, p = 0.7) and incidence of major bleeding complications did not significantly differ between the 2 groups. Thirty-day readmission rates were 8% in the CDT group and 26% in the anticoagulation group (P = .04). ConclusionCDT for acute massive and submassive pulmonary embolism significantly improves RV/LV ratio at 24-48 hours compared with anticoagulation alone and may lower hospital readmission rates. CDT may be more advantageous in patients with mild to moderate RV dilation.

Efficacy versus Complications in Arterial Thrombolysis

Acute peripheral arterial occlusions threaten life and limb. Thrombolysis is an established, minimally invasive alternative treatment for surgical thromboembolectomy. Yet, there is no consensus regarding an optimal thrombolysis protocol, and current knowledge is largely based on studies from the 1990s. This study reviews a contemporary cohort of patients treated with thrombolysis and aims to evaluate the treatment results and to identify possible predictors for outcome and (bleeding) complications. The electronic health record data of all consecutive patients who underwent thrombolysis for acute limb ischemia due to thromboembolic lower extremity arterial occlusions between April 2006 and June 2012 were analyzed. End points were change in clinical stage of ischemia, incidence of bleeding complications, duration of thrombolysis, predictors of outcome and complications, and mortality and amputation-free rates after 30-day and 6-months follow-up. In total, 109 cases were included. Clinical improvement was observed in 79%. Amputation-free rates at 30 days and 6months were 94% and 90%, respectively. The incidence of major bleeding complications was 13%. Median duration of thrombolysis was 27 (4-68) hr. Mortality rates at 30 days and 6 months were 7% and 16%, respectively; none bleeding related. In addition to age, popliteal artery occlusions and a progressed chronic vascular stage are predictive for a worse outcome. Age, female sex, and cardiac history were risk factors for bleeding. Treatment of peripheral arterial occlusions with high-dose thrombolysis on an intensive-care unit yields high clinical success rates, but major bleeding complications are often observed. Strict clinical observation remains essential since intensive monitoring of hemostatic parameters during thrombolysis does not predict bleeding complications.

Central venous catheter placement in coagulopathic patients: risk factors and incidence of bleeding complications.

Central venous catheters are frequently inserted into patients with coagulation disorders. It is unclear whether preprocedural correction of hemostasis is beneficial. We determined the incidence of bleeding complications after central venous catheter placement in patients who had severe coagulopathy and identified potential risk factors for bleeding. The MEDLINE and Cochrane Library databases were systematically searched through November 2015. To be included, articles must have reported on hemorrhagic complications with specification of abnormal coagulation testing results. Severe coagulopathy was defined as a reduced platelet count of 50 × 109 /L or less, and/or an elevated international normalized ratio of 1.5 or greater, and/or a partial thromboplastin time of 45 seconds or greater. We included one randomized controlled trial and 21 observational studies. In total, there were 13,256 catheter insertions, including 4213 in patients with severe coagulopathy. Before 3150 central venous catheter placements, coagulopathy was not corrected. The bleeding incidence varied from 0 to 32%. The severity of coagulopathy did not predict the risk of bleeding. No study demonstrated a beneficial effect from the prophylactic administration of platelets or fresh-frozen plasma to prevent bleeding complications. Retrospective observational studies suggested that no preprocedural correction is required up to a platelet count of 20 × 109 /L and an international normalized ratio of 3.0. The incidence of major bleeding complications after central venous catheter placement is low, even in coagulopathic patients. Based on a systematic research of the literature, strong evidence supporting the correction of hemostatic defects before central venous catheter insertion is lacking. However, well-powered randomized controlled trials will be necessary to determine the minimal platelet count, the maximal international normalized ratio, and an activated partial thromboplastin time that is safe before central venous catheter insertion.

Catheter-directed, ultrasound-assisted thrombolysis is a safe and effective treatment for pulmonary embolism, even in high-risk patients.

We sought to assess the early success and safety of catheter-directed, ultrasound-assisted (CDUA) thrombolysis for acute pulmonary embolism (PE) in patients deemed to be "high risk" for thrombolytic therapy. A retrospective evaluation of patients who underwent CDUA pulmonary thrombolysis in our practice during 39 months is reported. There were 91 patients considered, all of whom presented with acute PE as diagnosed by computed tomography angiography. The ratio of the right ventricle to left ventricle diameter (RVaxial:LVaxial) was noted, as were preprocedure pulmonary artery pressures (PAPs). Demographic data, significant medical history, and procedure details were recorded. Standard thrombolysis protocol was followed (1 mg of tissue plasminogen activator per hour per catheter after an initial 2-mg bolus per catheter). Minitab 17 (Minitab Inc, State College, PA) was used for data analysis. There were 91 patients who had a computed tomography diagnosis of acute PE and pulmonary hypertension (PAP >25 mm Hg). Seventeen patients (19%) were deemed to be at high risk for bleeding, predicted by recent hemorrhage, major surgery within 3 weeks, acute myocardial infarction, and cardiac arrest with cardiopulmonary resuscitation within 1 week. The high-risk patients in our study were noted to have higher RV:LV ratios and lower oxygen saturations on admission (P< .05). On computed tomography angiography, the mean pretherapy RVaxial:LVaxial ratio was 1.5± 0.4. The mean pretherapy PAP was 56.2± 15.2 mm Hg. After 18.5± 3.5 hours of thrombolysis, the mean post-therapy PAP was 34.3± 10.4 mm Hg, with a pressure drop of 21.9± 4.8 mm Hg (39% decrease; P< .001). In total, seven patients (8%) suffered bleeding complications that required intervention-four gastrointestinal bleeds, a rectus sheath hematoma, and one gross hematuria. Three of the seven complications occurred in the high-risk group (3/17) and the other four in the general population of patients (4/74; P= .118). Minor bleeding complications (n= 14 [15%]) did not require intervention and included puncture site hematomas, ecchymosis, and mild traumatic hematuria. Considering all bleeding complications, increasing RVaxial:LVaxial ratio was a predictor of any bleeding complication, independent of all risk factors (P= .005). CDUA thrombolysis for acute PE effectively reduced mean PAPs. Given the low incidence of major bleeding complications, even in those deemed to be clinically at high risk for bleeding, we additionally conclude that this procedure can be performed safely. Although larger studies with longer follow-up are necessary, CDUA pulmonary thrombolysis for the management of acute submassive PE appears to be effective in decreasing right-sided heart strain and can be performed with an acceptable risk profile.

Use of new anticoagulants for the treatment of venous thromboembolism in the context of the results of the XALIA study — clinical trials and routine clinical practice

The introduction of new non-vitamin K antagonist oral anticoagulants (NOAC) has had a significant impact on the treatment regimen of patients with venous thromboembolism. Phase 3 studies with the use of this group of drugs, including both direct factor II inhibitors and direct factor Xa inhibitors, have shown that the safety and effectiveness of this type of treatment are similar to vitamin K antagonists that have been used for a long time. Due to the eligibility of randomly selected patients that meet strict and specific inclusion criteria for pre-marketing studies, studies based on the assessment of the effectiveness and clinical safety of the above-mentioned drugs in the routine clinical practice are becoming extremely important. XALIA, the first international, multicenter, prospective clinical study on the use of the direct coagulation inhibitor — rivaroxaban in the routine clinical practice is an example of these types of studies. The aim of the study was to compare the results of the anticoagulant therapy in patients with deep vein thrombosis and patients with combined deep vein thrombosis and pulmonary embolism using rivaroxaban and standard anticoagulation regimen in the routine clinical practice. The results of the XALIA study confirm the findings of previous prospective, randomized studies in the population characterized by a broad spectrum of patients, indicating the safety and effectiveness of rivaroxaban in the treatment of venous thromboembolism in the routine clinical practice. The incidence of major bleeding complications in the group of patients receiving rivaroxaban was 0.7% compared to 0.8% of patients treated using standard anticoagulants. The proportion of recurrence of venous thromboembolism was low and similar to the results obtained in the EINSTEIN DVT study [XALIA — 1.4% vs. EINSTEIN DVT — 2.1%]. No cases of fatal bleeding were reported in the XALIA study and the calculated proportion of major bleeding complications in patients taking rivaroxaban was 1.2 per year, the proportion of recurrence and death from any cause was 2.4% and 0.8%, respectively. The obtained results confirm previous observations suggesting a low risk of recurrence as well as a high safety of the anticoagulant therapy in patients with deep vein thrombosis using rivaroxaban — this time in the study related to the routine clinical practice.

Efficacy of a balloon-expandable vascular access system in transfemoral TAVI patients.

Vascular complications (VC) are a serious and frequent complication of transfemoral transcatheter aortic valve implantation (TAVI) and result in increased morbidity and mortality. It has been suggested that newly developed vascular sheaths may increase the ability to perform transfemoral TAVI in patients with normal and access-limiting peripheral artery disease (PAD) and reduce vascular complications. We sought to assess the safety and efficacy of the 19 French (F) SoloPath balloon-expandable transfemoral vascular access system in patients who underwent transfemoral TAVI at our center between 2011 and 2014. Single-center retrospective study of 90 patients who underwent transfemoral TAVI with the use of the SoloPath sheath. Patients were categorized into two groups according to a sheath to femoral artery ratio (SFAR) of less than or equal to 1.05, or greater than 1.05. Overall, the incidence of major bleeding complications was low, 4.4%. No significant differences were found in technical or procedural success rates (100% in both groups and 100% vs. 91.3; P = 0.09; respectively), total vascular complications (20.8 vs. 21.7; P = 0.92) or total bleeding complications (20.8 vs. 30.4; P = 0.36 between those with SFAR greater or less than 1.05. The use of the SoloPath balloon-expandable sheath is feasible and safe even in patients with SFAR > 1.05, showing no increased vascular or bleeding complications compared to patients with larger vascular access. © 2016 Wiley Periodicals, Inc.

Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair

ObjectiveTo verify the rate of thromboembolic and hemorrhagic complications during the first 6 months after mitral valve repair and to assess whether the type of antithrombotic therapy influenced clinical outcome. MethodsRetrospective data were retrieved from 19 centers. Inclusion criteria were isolated mitral valve repair with ring implantation. Exclusion criteria were ongoing or past atrial fibrillation and any combined intraoperative surgical procedures. The study cohort consisted of 1882 patients (aged 58 ± 15 years; 36% women), and included 1517 treated with an oral anticoagulant (VKA group) and 365 with antiplatelet drugs (APLT group). Primary efficacy outcome was the incidence of arterial thromboembolic events within 6 months and primary safety outcome was the incidence of major bleeding within 6 months. Propensity matching was performed to obtain 2 comparable cohorts (858 vs 286). ResultsNo differences were detected for arterial embolic complications in matched cohort (1.6% VKA vs 2.1% APLT; P = .50). Conversely, patients in the APLT group showed lower incidence of major bleeding complications (3.9% vs 0.7%; P = .01). Six-month mortality rate was significantly higher in the VKA group (2.7% vs 0.3%; P = .02). Multivariable analysis in the matched cohort found VKA as independent predictor of major bleeding complications and mortality at 6 months. ConclusionsVitamin K antagonist therapy was not superior to antiplatelet therapy to prevent thromboembolic complications after mitral valve repair. Our data suggest that oral anticoagulation may carry a higher bleeding risk compared with antiplatelet therapy, although these results should be confirmed in an adequately powered randomized controlled trial.

Abstract 19660: Scoring System to Predict Major Bleeding Complications in Atrial Fibrillation Patients With Oral Anticoagulant After Drug-eluting Stent Implantation

Background: We aimed to introduce scoring system to predict major bleeding complications after triple antithrombotic therapy (TAT) in patients with atrial fibrillation (AF) and drug-eluting stent (DES) implantation. Methods: Between April 2007 and December 2011, 119 patients with AF and DES implantation were enrolled in this study. All of these patients received oral anticoagulant therapy and dual antiplatelet therapy (DAPT). We investigated the incidence of major bleeding complications including intracranial and gastrointestinal bleeding. Each variables which seem to be associated with major bleeding complications were analyzed using the univariate logistic regression model. All variables tested in univariate analysis with p&lt;0.10 were included in multivariate logistic regression model. The scores for each variables were transformed from regression coefficients and computed in a total score. Results: The mean follow-up period was 43.6 ± 25.5 month. The incidence of major bleeding was 17.6%. In multivariate analysis, age &gt; 75 (OR 3.67, 95%CI 1.01-13.3, p = 0.048), continuation of DAPT (OR 7.85, 95%CI 1.50-41.2, p = 0.015), INR &gt; 2.2 (OR 9.19, 95%CI 2.65-31.9, p &lt; 0.001) were predictors of major bleeding complications. Each item’s score ranged from 0 to 2 and the total score ranged from 0 to 5. The area under the receiver operating characteristics curve revealed that there was 82.8% accuracy in the total scores predicting the likelihood of major bleeding complications. The rate of major bleeding complications was 2.3% in low-risk group (scores 0-1), 20.0% in moderate-risk group (scores 2-3), and 53.3% in high-risk group (scores 4-5) (p&lt;0.001). Conclusions: This scoring system is useful for the risk stratification of major bleeding complications in AF patients with TAT after DES implantation.

Recombinant soluble thrombomodulin: coagulation takes another chance to reduce sepsis mortality

The striking coagulopathy in patients with severe sepsis and the increasing insight into the intricate link between inflammation and coagulation has been an inspiration for many researchers and pharmaceutical companies to explore potential therapeutic interventions for severe sepsis [1]. Indeed, in view of the high incidence of severe sepsis and sepsis mortality ranging from 20 to 50%, there is a urgent need for better treatment options [2]. As dysfunctional physiological anticoagulant regulators, such as antithrombin, activated protein C, and tissue factor pathway inhibitor, were shown to be key players in the sepsis-associated activation of coagulation, and animal studies supported the hypothesis that restoration of these pathways resulted in attenuation of coagulopathy and organ dysfunction and reduced mortality, large clinical studies were performed to establish the beneficial effect of these interventions in patients with severe sepsis [2-5]. Although some of these studies demonstrated some advantage in subgroups of patients with most extreme coagulopathies an overall reduction in mortality was not confirmed. This article is protected by copyright. All rights reserved

0133: The first human experience with novel nano surface modified Cobra PzF stent

Stenting options for patients at high risk of bleeding (elderly, AF, ACS) are sub-optimal. BMS are not as effective as DES in reducing restenosis but DES require long term DAPT, which increases bleeding risk. Recent animal studies have demonstrated that the nano PzF surface modified stent (Cobra PzF, CeloNova) is thrombo-resistant, and is associated with a rapid reendothelialization. 100 patients (71 men) with mean age 71.4±2 year old of all comer patients were prospectively included to evaluate the safety and the efficacy of the Cobra PzF stent. Patients presented with multiple co-morbidities including 22% DM, 10% AF, 17% EF<40%, 10% VKA, 28% ACS, 10% STEMI and 26% diffused and multivessel diseases. 166 Cobra PzF stents were implanted in 151 lesions (74% B1 lesions) via a radial route (72%) with a 6F-guiding catheter. 1.66 stent/pt was implanted for a mean stent length of 18.7± 0.5mm and a mean diameter of 3.1±0.3mm. Target lesions in left main (2%), LAD Diag (43%), CxMg (23%), RCA (32%), including bifurcated kissed lesions (12%) were treated with 50% direct stenting. The device was successfully implanted in 100% of targeted lesions to achieve a complete revascularization in all cases. In-hospital, there were no adverse events (Death, MI, TLR, cerebral events, stent thrombosis) or incidence of major bleeding complications or transfusions. At one month, no events were reported. 6-month results showed 4% of MACE (terminal cardiac insufficiency and 3 restenosis successfully treated). Those Results are very promising in real world and complex patients (Diabetes, AF, Acute MI, Unstable Angina, Bifurcation, VKA). The COBRA PzF stent is safe and effective in routine practice. These preliminary data and the rapid reendothelialization observed in preclinical will serve as an impetus for a multi-center randomized study of short DAPT.