Term Oral Anticoagulation Research Articles

Post-operative atrial fibrillation after cardiac surgery: Challenges throughout the patient journey.

Atrial fibrillation (AF) is the most common complication of cardiac surgery, occurring in up to half of patients. Post-operative AF (POAF) refers to new-onset AF in a patient without a history of AF that occurs within the first 4 weeks after cardiac surgery. POAF is associated with short-term mortality and morbidity, but its long-term significance is unclear. This article reviews existing evidence and research challenges for the management of POAF in patients who have had cardiac surgery. Specific challenges are discussed in four phases of care. Pre-operatively, clinicians need to be able to identify high-risk patients, and initiate prophylaxis to prevent POAF. In hospital, when POAF is detected, clinicians need to manage symptoms, stabilize hemodynamics and prevent increases in length of stay. In the month after discharge, the focus is on minimizing symptoms and preventing readmission. Some patients require short term oral anticoagulation for stroke prevention. Over the long term (2-3 months after surgery and beyond), clinicians need to identify which patients with POAF have paroxysmal or persistent AF and can benefit from evidence-based therapies for AF, including long-term oral anticoagulation.

New Onset Atrial Fibrillation in STEMI Patients: Main Prognostic Factors and Clinical Outcome.

The indications for the treatment of patients with known atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) are clear, while less is available about the management of new-onset AF (NOAF) during ST-segment elevation myocardial infarction (STEMI). The aim of this study is to evaluate mortality and clinical outcome of this high-risk subgroup of patients. We analyzed 1455 consecutive patients undergoing PCI for STEMI. NOAF was detected in 102 subjects, 62.7% males, with a mean age of 74.8 ± 10.6 years. The mean ejection fraction (EF) was 43.5 ± 12.1% and the mean atrial volume was increased (58 ± 20.9 mL). NOAF occurred mainly in the peri-acute phase and had a very variable duration (8.1 ± 12.5 min). During hospitalization, all the patients were treated with enoxaparin, but only 21.6% of them were discharged with long term oral anticoagulation. The majority of patients had a CHA2DS2-VASc score >2 and a HAS-BLED score of 2 or 3. The in-hospital mortality was 14.2%, while the 1-year mortality was 17.2% and long-term mortality 32.1% (median follow-up 1820 days). We identified age as an independent predictor of mortality both at short- and long-term follow-ups, while EF was the only independent predictor for in-hospital mortality and arrhythmia duration for 1-year mortality. At the 1-year follow-up, we recorded three ischemic strokes and no bleeding complications.

Abstract 12297: Kissing Left Atrial Appendage Closure Devices for Peri-Device Leak

Introduction: Left atrial appendage closure (LAAC) therapy is approved for stroke prevention in nonvalvular atrial fibrillation (AF) for patients intolerant in long term oral anticoagulation (OAC). Peri-device leak (PDL) is the achilles heel to optimal LAAC and increases stroke risk. Here, we describe the novel use of a second LAAC device for closure of a large PDL in a bilobar appendage. Case: A 66-year-old male with a history of nonvalvular AF with recurrent bleeding on OAC with Watchman 2.5 implant six years prior, presented to our facility for a repeat AF ablation. Pre-procedural imaging showed a PDL of 12 mm with an uncovered posterior lobe, with the Watchman 2.5 covering only the anterior lobe of the appendage. The PDL was closed with a 20 mm Amulet device delivered through a steerable sheath abutting the existing Watchman 2.5 device. The steerability of the sheath allowed for optimal placement of the Amulet device to allow for complete closure. Patient was discharged home on six weeks of dual antiplatelet therapy. Discussion: In our case, a second LAAC device was chosen due to the large size of the PDL. Smaller leaks can be closed using endovascular coils and/or occluder plugs. Larger leaks require additional consideration for closure strategies such as a second LAAC device Conclusions: Our case is the first reported case utilizing a second LAAC device for PDL closure alongside the first device. Steerability of the new Amulet sheath allowed for optimal device placement for complete closure. Additional research is needed on how PDL’s should be addressed for optimal LAAC. Figure 1: Imaging showing PDL into uncovered posterior lobe Figure 2: Complete LAAC with kissing Watchman 2.5 and Amulet

The Incidence and Clinical Outcomes of Acute Ischemic Strokes in Patients with Atrial Fibrillation on long term Oral Anticoagulation at OLSU-S (P16-10.004)

The Incidence and Clinical Outcomes of Acute Ischemic Strokes in Patients with Atrial Fibrillation on long term Oral Anticoagulation at OLSU-S (P16-10.004)

PO-698-08 COMPARING CARDIAC COMPUTED TOMOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY IN POST-OPERATIVE LEAK AFTER LEFT ATRIAL APPENDAGE CLOSURE DEVICE PLACEMENT

Left atrial appendage closure (LAAC) devices are a practical replacement to long term oral anticoagulation in the appropriate patient. Incomplete occlusion and resulting device leak are important clinical endpoints which may prompt anticoagulation continuation. During the coronavirus pandemic, cardiac computed tomography (CCT) was used as an alternative to transesophageal echocardiogram (TEE) for pre-planning and post-operative confirmation. A residual leak of >5mm on TEE has been used as a cutoff for anticoagulation continuation, but CCT is less codified for device leak quantification and its significance.

New onset atrial fibrillation in STEMI patients: main prognostic factors and clinical outcome

Abstract Background New onset atrial fibrillation (NOAF) is not a so rare condition among patients hospitalized for ST-segment elevation myocardial infarction (STEMI). Several studies showed that NOAF during an acute coronary syndrome (ACS) leads to increased mortality, both at short and long term. The indications for the treatment of patients with known AF undergoing percutaneous coronary interventions (PCI) are clear, while less is available about the management of NOAF during ACS and in particular during STEMI. The purpose of this study is therefore to evaluate mortality and clinical outcome of this high risk subgroup of patients. Methods We analysed 1455 consecutive patients undergoing coronary angiography and/or PCI for STEMI. CHA2DS2-VASc and HAS-BLED scores were calculated for all patients. In-hospital, 1-year and long-term follow up mortality was evaluated for all patients. Cerebral ischemic and hemorrhagic events were also evaluated as clinical endpoints at 1 year. Results NOAF was detected in 102 subjects, 62.7% males, with a mean age of 74.8±10.6 years. We found a high prevalence of main cardiovascular risk factors such as hypertension, dyslipidemia, smoke and renal failure. Mean ejection fraction (EF) was 43.5±12.1% and the mean atrial volume was increased (58±20.9 ml). The most represented type of MI at admission was anterior STEMI (46%). NOAF occurred mainly in the peri-acute phase and had a very variable duration (8.1±12.5 min). During hospitalization all patients were treated with Enoxaparin, but only 25.2% of them were discharged with long term oral anticoagulation (16.7% warfarin, 4.9% direct oral anticoagulant). The majority of patients had a CHA2DS2-VASc score >2 and a HAS-BLED score of 2 or 3. In-hospital mortality was 14.2%, while 1-year mortality was 17.2% and long term mortality 32.1% (median follow-up time 1820 days, range 341 to 3985). Through a logistic regression analysis we identified age as an independent predictor of mortality both at short and long term follow up, while EF was the only independent predictor for in-hospital mortality and arrhythmia duration for 1-year mortality. At 1-year follow up we recorded three ischemic strokes, while no bleeding complications. Conclusions STEMI patients who develop NOAF are a very high-risk population and are characterized by increased short and long term mortality. NOAF should be diagnosed and treated as soon as possible with a correct indication to long term OAC based on the ratio between ischemic and hemorrhagic risk. Funding Acknowledgement Type of funding sources: None.

1292 Aortic Valve Neocuspidization Using Glutaraldehyde-Treated Autologous Pericardium: A Literature Review

Abstract Background Aortic Valve Neocuspidization using glutaraldehyde-treated autologous pericardium was first performed by Ozaki et al. in 2007. This technique has become an alternative to tissue and mechanical valve as long-term anticoagulation is not required and shows promising midterm results and durability. Method A comprehensive search was performed on the major database using search terms “Ozaki technique” AND “Aortic Valve Neocuspidization” AND “AV Neocuspidization” AND “Autologous pericardium” AND “glutaraldehyde-treated autologous pericardium”. Articles up to 1st of August 2020 were included in this study. Results A total of 9 studies with a total of 1342 patients were included. The mean age was 67.36 and 54.23% were male. 66.32% and 23.92% of patients had aortic stenosis and aortic regurgitation, respectively. 66% of patients had a native tricuspid aortic valve and 31.37 % patients’ native aortic valve was bicuspid. Three studies reported their experience performing Aortic Valve Neocuspidization via mini sternotomy. Conclusions Aortic Valve Neocuspidization is an alternative to biological and mechanical prostheses for surgical aortic valve replacement. The short and mid-term outcome are comparable without the need for long term oral anticoagulation. Long term follow-up data is required for this novel approach to be widely adopted.

Frequency, Trend, Predictors, and Impact of Gastrointestinal Bleeding in Atrial Fibrillation Hospitalizations

Anticoagulation alone or in combination with other treatment strategies are implemented to reduce the risk of stroke in patients with atrial fibrillation (AF). Gastrointestinal bleeding (GIB) is a common complication of oral anticoagulation with a prevalence of 1% to 3% in patients on long term oral anticoagulation. We analyzed the national inpatient sample database from the year 2005 to 2015 to report evidence on the frequency, trends, predictors, clinical outcomes, and economic burden of GIB among AF hospitalizations. A total of 34,260,000 AF hospitalizations without GIB and 1,846,259 hospitalizations with GIB (5.39%) were included. The trend of AF hospitalizations with GIB per 100 AF hospitalizations remained stable from the year 2005 to 2015 (p value = 0.0562). AF hospitalizations with GIB had a higher frequency of congestive heart failure, long term kidney disease, long term liver disease, anemia, and alcohol abuse compared with AF hospitalizations without GIB. AF hospitalizations with GIB had a higher odds of in-hospital mortality (Odds ratio (OR) 1.47; 95% Confidence interval (CI): 1.46 to 1.48, p-value <0.0001), mechanical ventilation (OR 1.69; 95% CI: 1.68 to 1.70, p-value <0.0001), and blood transfusion (OR 7.2; 95% CI: 7.17 to 7.22, P-value <0.0001) compared with AF hospitalizations without GIB. AF hospitalizations with GIB had a lower odds of stroke (OR 0.51; 95% CI: 0.51 to 0.52, p-value <0.0001) compared with AF hospitalizations without GIB. Further, AF hospitalizations with GIB had a higher median length of stay and cost of hospitalization compared with AF hospitalizations without GIB. In conclusion, the frequency of GIB is 5.4% in AF hospitalizations and the frequency of GIB remained stable in the last decade as shown in this analysis. When GIB occurs, it is associated with higher resource utilization. This study addresses a significant knowledge gap highlighting national temporal trends of GIB and associated outcomes in AF hospitalizations.

Endocardial versus epicardial left atrial appendage exclusion for stroke prevention in patients with atrial fibrillation: Midterm follow-up.

Left atrial appendage closure (LAAC) became an alternative method for stroke prevention in patients with non-valvular atrial fibrillation (AF) intolerant to long term oral anticoagulation therapy. This study aimed to compare endocardial (Amulet and LAmbere occluders) and epicardial (Lariat) LAAC techniques. A retrospective, observational case-control study included 223 consecutive CHA2 DS2 -VAS score-matched patients with AF who underwent LAAC in two centers. There were 55 matched cases with the mean CHA2DS2-VASs score 4.4 ± 1.22 (p = 1). Overall follow-up was 308.2 patient-years. The Endocardial group patients were older and more often females with congestive heart failure and peripheral vascular disease. The epicardial group more frequently had a stroke/transient ischemic attack history. There were no differences in hypertension, diabetes mellitus, and indications for procedure between both groups. The mean HAS-BLED score was significantly higher in the endocardial group than in the epicardial group (4.3 ± 0.9 vs. 3.7 ± 1.3, p = .011). There were no differences in annual rates of thromboembolic events (2.6% vs 0.5%) and annual stroke (0.87% vs. 0%) between the endocardial and epicardial groups. Endocardial and Epicardial LAAC techniques show comparable implantation outcomes and safety profile and stroke prevention in patients with AF. Future randomized studies are needed to corroborate these initial results and assess long term mortality.

284Outcomes after left atrial appendage occlusion with AMPLATZER Amulet and WATCHMAN device: Results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)

Abstract Aims Left atrial appendage occlusion (LAAO) is a therapeutic option for patients with non-valvular atrial fibrillation (NVAF) and high risk of bleeding. This study reports outcomes of patients enrolled in the prospective multicentre, investigator initiated real life registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure). Methods and results Data of all consecutive 521 patients (64.7% adult males, 35.3% adult females, mean age: 75.1 (SD 7.9) years with non-valvular atrial fibrillation undergoing interventional left atrial appendage occlusion procedure in the ORIGINAL prospective registry were analysed. The CHA2DS2-VASc and HAS-BLED scores were 4.3 (SD 1.5) and 3.7 (SD 1.1), respectively. 78.9% of the patients had a history of bleeding. 89.3% of the patients were considered as non-eligible for long term oral anticoagulation. A left atrial appendage occlusion device was successfully implanted in 97.5% of cases. A mean follow-up of 463 days could be reached in 386 patients. Among these, the distribution of the follow-up length reached was as follows: 1 year 205, 2 years 118, 3 years 65 and 4 years 17 patients. In the follow-up the annual frequency of stroke was very low (0.4%), which resulted in the 4.98% absolute risk reduction in the amount of thromboembolic strokes, which would have been expected according to the calculated CHA2DS2-VASc score in the hypothetic group not receiving any anticoagulant therapy. The occurrence of major and minor bleeding in the follow-up was 1.55% and 3.37% respectively. Conclusions In this prospective multicentre study we included the patients who are at high risk of stroke and bleeding. The annual ischemic stroke rate was 0.4%, the LAA could be sealed in 97.5%. Six months after the LAA closure only 3.63% of all patients were further on treated using oral anticoagulation. Considering the stroke reduction rates, the implantation of an LAAO device proves to be effective and safe in the clinical routine in the studied population. Acknowledgement/Funding None

Systematic Review of Contiguous Vessel and Valve Injury Associated with Endocardial Left Atrial Appendage Occlusion Devices.

Endocardial LAAO has been increasingly utilized in atrial fibrillation (AF) patients who are not suitable for long term oral anticoagulation. While overall procedural complications have decreased, rare complications like contiguous vessel and valve injury may be more frequently seen in the future with increase in the procedure volume. We performed a systematic search using predefined terms which reviewed all cases published in literature of contiguous vessel (pulmonary artery, pulmonary vein and left circumflex artery) and mitral valve injury caused by LAAO devices. Our results showed that Amplatzer Cardiac Plug (ACP) and Amplatzer Amulet devices were the most commonly used devices. Pulmonary artery perforation was the most commonly seen collateral vessel injury associated with LAAO. Close proximity of left atrial appendage to pulmonary artery was noted in all cases of pulmonary artery injury. Pulmonary artery injury commonly manifests as pericardial tamponade with hemodynamic collapse and is often fatal. Most common denominator of all the reviewed cases was the presence of an oversized LAAO device. In conclusion, collateral vessels and valve injury can be seen after LAAO mostly with double lobe devices such as ACP or Amulet. Increased awareness by the operators along with proper imaging and investigations could potentially mitigate such rare complications associated with LAAO.

Cognitive impairment, adverse events and mortality among elderly patients treated with long-term oral anticoagulation: A monocentric prospective study

Oral anticoagulants (AC) represent the leading cause of iatrogenic morbimortality in France. AC are widely prescribed among the elderly. The assessment of the cognitive impairment (CI) is not included within the common thrombotic and bleeding risk scores. The objective of this study was to examine an association between CI and adverse events in patients receiving long term oral AC. A prospective monocentric cohort study was conducted in patients (> 60 years-old) on oral AC. Death, hemorrhages, falls, hospital readmission and thromboembolic events were collected over 6 months follow-up. Patients were included during an hospitalization for any medical or surgical condition and divided into three groups, according to their Mini Mental State Examination (MMSE): Group 1 (absence of CI) MMSE > 26, Group 2 (mild CI) 23 < MMSE < 27, Group 3 (significant CI) MMSE < 24. Regardless of the kind of oral AC, among 120 patients (mean age: 82,2 ± 8,8 years), the all-causes mortality ( n = 25) was significantly higher in the Group 3 ( n = 17, P = 0,006); this also applies to the incidence of falls ( n = 34, P = 0,009) or major hemorrhages ( n = 10, P = 0,023). There was no thromboembolic event. Minor hemorrhages and hospital readmissions were not different in the 3 groups. After 6 months of follow up, the cognitive impairment was associated with mortality, major hemorrhages and falls among the elderly receiving oral AC. A systematic assessment of cognitive functions of these patients seems to be essential to analyze the global risk and the risks related to the AC treatment.

PCI IN PATIENTS ON LONG TERM ANTICOAGULATION PRESENTING WITH STEMI

There is an increasing number of encounters of STEMI patients who are on long term oral anticoagulants. However, all randomized trials involving primary PCI for STEMI have excluded these patients. HCUP's Nationwide Inpatient Sample (NIS) was utilized. STEMI and long term anticoagulant use were

Assessment of Knowledge Regarding Oral Anticoagulation Therapy (OAT) among Stroke Survivors

There has been a dramatic increase in the number of patients undergoing long term oral anticoagulation therapy (OAT) with warfarin in recent years. Successful anticoagulation treatment is dependent on the patient’s knowledge of OAT. The present study was undertaken to assess the knowledge regarding OAT among stroke survivors and to determine the association between knowledge and selected socio-personal and clinical variables. The study revealed that only 5 percent of sample had good knowledge and the knowledge level was more among males and those who had previous exposure to lecture class/information pamphlet regarding OAT. Patients had poor knowledge in the area of dietary interaction of warfarin followed by precautions to be taken while on OAT and signs of side effects of OAT.

Management of pulmonary embolism

Introduction. Pulmonary embolism is a common condition with high morbidity and mortality, particularly if misdiagnosed or untreated. It has non-specific clinical manifestations, often presenting with symptoms similar to other cardiovascular or common respiratory diseases. Dyspnea is the most common symptom. The main goals of pulmonary embolism therapy are to stop blood clots from getting bigger and prevent formation of new clots. The aim of this article was to review the clinical presentation, incidence, diagnostic algorithms and prevention of pulmonary embolism. Management of pulmonary embolism. The management of pulmonary embolism depends on patients? hemodynamic stability (hemodynamically stabile and hemodynamically unstable patients), as well as on specific conditions (population who cannot receive the same therapy as the previously mentioned patients). The management is largely focused on medical therapy of pulmonary embolism, as the first line therapy (emergency) and then on medical options for this disease. Special attention was given to urgent intravenous thrombolytic therapy in hemodynamically unstable patients, considering that these patients are the most vitally compromised, in shock and with high mortality rate. The initial treatment in hemodynamically stable patients consists of low molecular weight heparin and unfractionated heparin, which is later replaced by long term oral anticoagulation therapy. Its duration depends on the nature of the basic disease. Some populations cannot receive any thrombolytic therapy (pregnant women, patients suffering from malignant diseases and heparin-induced thrombocytopenia). These patients may receive low molecular weight heparin, unfractionated heparin and warfarin; patients with malignant diseases receive life-long anticoagulation therapy; argatroban or lepirudin are used in the management of heparin-induced thrombocytopenia. Conclusion. Prevention of pulmonary embolism is lifesaving. It includes prophylactic medical regimens and ?mechanical? supportive therapy (elastic graduated compression stockings, inferior vena cava filters).

CRT-800.43 Left Atrial Appendage Occlusion for Atrial Fibrillation: Eligibility in a Typical Oral Anticoagulation Clinic

Left atrial appendage occlusion (LAAO) is an alternative to oral anticoagulation in patients with non-valvular atrial fibrillation (NAF), high thromboembolic risk based on CHADS2 or CHADS-VASc scores and are unable to take long term oral anticoagulation. The purpose of this study is to establish the

Stroke prevention in atrial fibrillation with left atrial appendage closure.

Patients with atrial fibrillation (AF) are at risk for stroke and thromboembolism. Oral anticoagulants (OAC) are effective therapies to reduce the risk of stroke; however, these agents also increase the risk of bleeding complications. Concerns over bleeding contribute to significant under treatment and leave a substantial proportion of patients at risk for a serious or life-threatening stroke. Identification of the left atrial appendage (LAA) as the major site of pathogenic thrombus formation in AF patients has led to the development of devices which exclude the appendage from the systemic circulation. These devices offer a potential alternative treatment for some AF patients who cannot tolerate long term OAC. This article will review the pathogenesis of LAA thrombus formation and identify the patient population most likely to benefit from LAA closure devices. Finally, we will review LAA closure techniques (both surgical and percutaneous), evaluate published outcomes data, and discuss the indications and risk/benefit considerations of each approach.

Risk and Benefits of Triple Therapy in Patients Undergoing Coronary Stent Implantation Requiring Oral Anticoagulation: A Meta-Analysis of 16 Studies.

Patients with coronary artery disease who undergo stent implantation and have concomitant indication for long-term oral anticoagulation represent a considerable proportion of the overall population. To date there is still no consensus about the optimal antithrombotic strategy to choose in this kind of patients, due to the difficult balance between an increased risk of bleeding and thromboembolic complications. Therefore, the aim of this study was to perform a meta-analysis to evaluate the risk and benefits of triple antithrombotic therapy versus dual antithrombotic therapy in patients undergoing coronary stent implantation, requiring long-term oral anticoagulation. We performed formal searches of PubMed, EMBASE, Cochrane central register of controlled trials and major international scientific session abstracts from January 1990 to September 2015 regarding the use of triple antithrombotic therapy (TT) versus dual therapy (DT) in patients undergoing percutaneous coronary stent implantation that required chronic oral anticoagulation. Data regarding study design, inclusion/exclusion criteria, number of patients, and selected endpoints was extracted by 2 investigators. Disagreements were resolved by consensus. Sixteen trials with a total of 21716 patients undergoing coronary stent implantation with indication to long term oral anticoagulation, were finally included. A total of 6950 received TT, whereas 14766 received DT alone. The follow-up period ranged from 180 to 730days. Data regarding mortality were available in 21658 patients (99.7%). All cause mortality was observed in 10.4% patients in TT versus 16.3% in DT (OR [95% CI] =0.73 [0.66-0.80], p <0.001; p het <0.001). In addition, TT was associated with a reduced incidence of MI (6.4 versus 9.8%, OR [95% CI] = 0.74 [0.65-0.84], p < 0.001; phet < 0.001) and ischemic stroke (1.8 versus 3.9%, OR [95% CI] = 0.55 [0.45-0.68], p < 0.001; p het = 0.07). As expected, TT was associated with a significant increase in major bleeding events (10.8 versus 8.5%, OR [95% CI] = 1.38 [1.25-1.53], p < 0.001; p het = 0.02). By meta regression analysis we found that benefits in mortality with TT were inversely related with the risk of bleedings (beta [95% CI] = 2.25 (1.55; 2.95), p < 0.00001). The benefits with TT regarding overall mortality, recurrent MI and ischemic stroke were also confirmed in a pre-specified analysis versus DAPT or oral anticoagulation in association with a single antiplatelet agent. This meta-analysis showed that among patients undergoing coronary stent implantation, requiring chronic OAC, the use of a TT is associated with a significant reduction in overall mortality, recurrent MI and ischemic stroke. As expected, we found a higher incidence of bleedings in patients treated with triple therapy. The benefits in mortality were lost in patients at high-risk for bleedings.

International normalized ratio self-testing and self-management: improving patient outcomes.

Long term oral anti-coagulation with vitamin K antagonists is a risk factor of hemorrhagic or thromebomlic complications. Periodic laboratory testing of international normalized ratio (INR) and a subsequent dose adjustment are therefore mandatory. The use of home testing devices to measure INR has been suggested as a potential way to improve the comfort and compliance of the patients and their families, the frequency of monitoring and, finally, the management and safety of long-term oral anticoagulation. In pediatric patients, increased doses to obtain and maintain the therapeutic target INR, more frequent adjustments and INR testing, multiple medication, inconstant nutritional intake, difficult venepunctures, and the need to go to the laboratory for testing (interruption of school and parents’ work attendance) highlight those difficulties. After reviewing the most relevant published studies of self-testing and self-management of INR for adult patients and children on oral anticoagulation, it seems that these are valuable and effective strategies of INR control. Despite an unclear relationship between INR control and clinical effects, these self-strategies provide a better control of the anticoagulant effect, improve patients and their family quality of life, and are an appealing solution in term of cost-effectiveness. Structured education and knowledge evaluation by trained health care professionals is required for children, to be able to adjust their dose treatment safely and accurately. However, further data are necessary in order to best define those patients who might better benefit from this multidisciplinary approach.

0484: The LEADERS FREE Trial: a double blind randomized comparison of a BMS and a polymer-free Drug Coated Stent (DCS) in 2,466 patients at high bleeding risk and treated with one month DAPT only

A sizeable proportion of patients treated with PCI are unable to take dual antiplatelet therapy (DAPT) for the guideline-recommended time period of 6-12 months. Optimal treatment of pts at high bleeding risk thus remains uncertain. The BioFreedom™ DCS (Biosensors, Europe SA, Morges, Switzerland) is polymer- and carrier-free, releases Biolimus A9 into the vessel wall over a period of 4 weeks, and then technically becomes a BMS. 2,466 pts at high bleeding risk from 68 centers in Europe, Asia, and Canada were enrolled over an 18 months period in a double-blinded randomized 1:1 comparison of the Gazelle™ BMS vs. the BioFreedom DCS (both Biosensors, Morges, CH) with a 1 month course of DAPT only in both arms. At 1 year, the primary endpoints are: safety: a composite of cardiovascular death, MI and stent thrombosis, and efficacy: the rate of ci-TLR. In the trial population, the most frequently used inclusion criteria were: advanced age (64%), need for long term oral anticoagulation (36%), anemia, recent bleeding or transfusion (20%), renal insufficiency (18%), planned surgery (15%) and concomitant cancer (9%). When compared to those included in ‘all-comer’ trials, pts were markedly older (75 years) and had more co-morbidiites (diabetes 33%, atrial fibrillation 33%, peripheral vascular disease 15%, heart failure 13%, prior stroke 9% and COPD 11%) 1.5 lesions/pts were treated and 1.7 stents/pts were implanted for a total stent length of 32mm/patient. Technical procedure success was 95%. 71% of pts were discharged on DAPT alone, 27% of DAPT+oral anticoagulation and 2% on a single antiplatelet agent + oral anticoagulation. The trial focuses on a never previously studied high bleeding risk population characterized by advanced age and more comorbid conditions. It is the 1st evaluation of a DCS with clinical endpoints and comprises the shortest ever DAPT course with an active stent to be evaluated for both safety and efficacy.