Chronic Oral Anticoagulation Research Articles

Implementation of the Management of Anticoagulation in the Periprocedural Period App Into an Electronic Health Record: A Prospective Cohort Study.

Appropriate perioperative management of patients on chronic oral anticoagulation (OAC)—including warfarin and the direct oral anticoagulants—is a poorly defined yet important clinical issue with potentially severe consequences in the postoperative period. We sought to prospectively evaluate the effect of the Management of Anticoagulation in the Periprocedural Period (MAPPP) mobile app as a clinical decision tool in the management of patients on chronic OAC undergoing elective procedures or surgeries. Between January 1, 2018, and January 31, 2019, 642 patients treated in our health system were included. Eligible patients met the following criteria: age >18 years old, creatinine clearance ≥15 mL/min, and on chronic OAC with adequate information regarding baseline characteristics. Our study outcome was patient’s emergency department (ED) visits within 30 days postprocedure. The MAPPP app was integrated into the electronic health record (EHR), and the end user was free to accept or decline recommended evidence-based perioperative anticoagulation management guidance. Analysis revealed that acceptance was more common in younger patients (P = .0137), patients on oral anticoagulants other than warfarin (P < .0001), and patients undergoing increased bleeding risk procedures (P = .0068). Acceptance of the MAPPP app recommendation was significantly associated with fewer ED visits (acceptance group: 4.0% vs rejection group: 8.3%, P = .0205). Logistic regression showed that intervention acceptance and female gender were significantly associated with fewer—while age ≥80 with more—30-day ED visits. Our findings indicate that newer technologies, such as the MAPPP app, integrated into clinical EHR workflow, can significantly augment evidence-based perioperative anticoagulation management and potentially result in a reduction of adverse outcomes.

Long-Term Outcome of Acute Coronary Syndromes in Patients on Chronic Oral Anticoagulants: Data from the EPICOR Study.

To analyze characteristics, management and outcomes of patients with acute coronary syndromes (ACS) receiving chronic oral anticoagulant (OAC) therapy enrolled in the EPICOR (long-tErm follow-uP of antithrombotic management patterns In acute CORonary syndrome patients) prospective, international, observational study of antithrombotic management patterns in ACS survivors (NCT01171404). This post-hoc analysis evaluated the association between OAC use at baseline (OACb) and time from hospital admission to percutaneous coronary intervention (PCI) (tHA-PCI), pre-PCI thrombolysis in myocardial infarction (TIMI) 3 flow, stent type, length of hospitalization, and clinical endpoints; death, non-fatal MI, and non-fatal stroke, a composite of these ± bleeding, over 2 years' followup. Of 10,568 ACS patients, 345 (3.3%) were on OACb (non-ST-segment elevation ACS [NSTEACS], n=268; ST-segment elevation MI [STEMI], n=77). OACb patients were older with more comorbidities. In NSTE-ACS OACb patients, tHA-PCI was longer (median 57.4 vs. 27.8 h; p=.008), and TIMI 3 flow rarer (26.0 vs. 33.5%; p=0.035). OACb patients had longer mean hospital stay (NSTEACS: 8.9 vs. 7.6 days; p<0.001; STEMI: 9.5 vs. 7.8 days; p=0.015), and higher rates of the composite endpoint (NSTE-ACS: 16.8 vs. 8.8%; p<0.0001; STEMI: 23.4 vs. 5.9%; p<0.0001). Bleeding events were more common with OACb (NSTE-ACS: 6.0 vs. 3.3%; p=0.01; STEMI: 6.5 vs. 2.8%; p=0.04). At 2-years, OACb use was associated with an increased risk of cardiovascular and bleeding events in STEMI and NSTE-ACS. NSTE-ACS patients on OACb experienced prolonged time to intervention, lower rates of TIMI 3 flow and longer hospitalization.

Heparin Bridging Therapy for Patients on Chronic Oral Anticoagulants in Periprocedural Settings.

Interruption of chronic anticoagulation due to the bleeding risk associated with an elective procedure may also lead to an elevated risk of thromboembolism. Periprocedural bridging with either unfractionated heparin or low-molecular weight heparin had been the mainstay of therapy for many patients receiving chronic warfarin treatment based on an estimation of a patient's thromboembolic risk. However, recent results from cohort studies and placebo-controlled randomized trials in the periprocedural use of heparin bridging for warfarin-treated patients reveal a consistent two- to three-fold increase in the risk of major bleeding and no benefit in terms of a reduction in the risk of stroke and systemic embolism. The most recent antithrombotic guidance statements suggest that the majority of patients on chronic warfarin, except those at high risk of thromboembolism, may safely interrupt and resume warfarin without heparin bridging in elective periprocedural settings. In addition, data from the use of heparin bridging in patients on direct oral anticoagulants during temporary interruption for an elective procedure also reveal harm and no benefits of this approach. A strategy that considers the pharmacokinetic properties of the direct oral anticoagulants, the bleeding risk of each procedure, and patient renal function would safely obviate the need for heparin bridging. In this review, the authors summarize the major studies of heparin bridging for patients on chronic oral anticoagulants that may lead to a change in practice in periprocedural antithrombotic management and define an evidence-based heparin bridging protocol for those patient groups who may be the candidates for this approach.

Chronic oral anticoagluation and risk of prostate cancer: Evidence of detection bias.

Warfarin treatment has been associated with lower risks of prostate cancer, without a specified biological mechanism. Our study tested the hypothesis that reluctance to perform prostate biopsies in men who are anticoagulated results in lower rates of diagnosed prostate cancer, leading to an apparent protective effect. Rates of prostate biopsies have decreased from 2000 to 2015, allowing calendar time to be used as the intervention. In a national population-based sample of elderly men, our study compared trends in prostate cancer incidence between 17,815 men treated with chronic oral anticoagulation for prosthetic heart valve thromboprophylaxis and a general population comparison group of 356,300 men. Cancer events were based on administrative claims. Among men enrolled in 2000-2001 and followed through 2015, prostate cancer incidence was substantially lower in the anticoagulation group (adjusted incidence rate ratio [IRR] 0.70; 95% confidence interval [CI] 0.62-0.80). Incidence decreased over time in the general population group to approach that of the anticoagulation group among men enrolled in 2008-2010 (IRR 0.86; 95% CI 0.71-1.04). Rates of prostate biopsies also decreased over time in the general population group to match the rate in the anticoagulation group. These results indicate that the apparent protective effect of warfarin treatment on the risk of prostate cancer is likely the result of detection bias from lower rates of biopsies among men who are anticoagulated.

TRIPLE VERSUS DUAL ANTITHROMBOTIC THERAPY FOR PATIENTS WHO REQUIRE ORAL ANTICOAGULATION AND UNDERGO PERCUTANEOUS CORONARY INTERVENTION: AN UPDATED META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

Patients who require chronic oral anticoagulation (OAC) due to conditions such as atrial fibrillation (AF) require additional antiplatelet therapy when they undergo percutaneous coronary intervention (PCI). Current treatment options include triple antithrombotic therapy (dual antiplatelet agent [DAPT] + OAC) or dual antithrombotic therapy (single antiplatelet agent [SAPT] + OAC). There is a need to identify an optimal antithrombotic regimen in this patient population since the choice of therapy can impact both bleeding and ischemic events. We performed an updated meta-analysis of randomized controlled trials (RCTs) comparing triple antithrombotic therapy (OAC+DAPT) vs. dual antithrombotic therapy (OAC + SAPT) after PCI, including the recently completed and largest trial to date (AUGUSTUS). Searching MEDLINE and Pubmed, we performed a meta-analysis of RCTs which enrolled patients undergoing elective or urgent (due to acute coronary syndrome) PCI who were randomized to receive triple or dual antithrombotic therapy. The triple antithrombotic therapy group was treated using a strategy of OAC with either warfarin or non-vitamin K oral anticoagulant (NOAC), and DAPT (acetylsalicylic acid + P2Y12 inhibitor). The dual antithrombotic therapy group was treated with OAC, either warfarin or NOAC, in combination with SAPT consisting of either acetylsalicylic acid or a P2Y12 inhibitor. Using random effects models, we determined pooled risk ratios (RR) of clinically significant bleeding, stent thrombosis, myocardial infarction (MI), and stroke with 95% confidence intervals (CI) comparing patients randomized to triple vs. dual antithrombotic therapy. Four RCTs examining 10,026 total patients were pooled. There was a 40% reduction in clinically relevant bleeding (RR 0.60 [95% CI; 0.49-0.73]) observed among patients treated with dual vs. triple antithrombotic therapy. Patients treated with dual antithrombotic therapy demonstrated a 17% increased risk of MI (RR 1.17 [95% CI; 0.94-1.46]) and a 20% increased risk of stent thrombosis (RR 1.20 [95% CI; 0.66-2.16]) which were statistically non-significant. The risk of stroke was similar between the two therapy arms (RR 0.93 [95% CI; 0.63-1.36]) (Figure). Among patients undergoing PCI treated chronically with OACs, dual antithrombotic therapy (OAC+SAPT) significantly reduced bleeding and had similar stroke risk compared to triple antithrombotic therapy (OAC+DAPT). While patients treated with dual antithrombotic therapy had a numeric increase in their risk of MI and stent thrombosis, this did not reach statistical significance. Thus, the lower bleeding risk observed with dual antithrombotic therapy may be associated with a trade-off for a higher risk of myocardial ischemic events.

TCT-400 Platelet Reactivity and Risk of Stent Thrombosis After Coronary Drug-Eluting Stent Implantation in Patients Treated With Oral Anticoagulation: The ADAPT-DES Study

The optimal therapeutic regimen after coronary drug-eluting stent implantation in patients requiring chronic oral anticoagulation (OAC) remains uncertain. Whether the degree of P2Y12-receptor inhibition is associated with increased risk of stent thrombosis (ST) in such patients is currently unclear

Diagnosis and management of left atrial appendage thrombus in patients with atrial fibrillation undergoing cardioversion or percutaneous left atrial procedures: results of the European Heart Rhythm Association survey.

Practices regarding indications and timing for transoesophageal echocardiography (TOE) before cardioversion (CV) of atrial fibrillation (AF) or left atrial (LA) interventional procedures, and preferred imaging techniques and pharmacotherapy, in cases of thrombus resistant to chronic oral anticoagulation (OAC) treatment, are largely unknown. The European Heart Rhythm Association (EHRA) conducted a survey to capture contemporary clinical practice in those areas of AF care. A 22-item online questionnaire was developed and distributed among the EHRA electrophysiology research network centres. The survey contained questions regarding indications, type and timing of imaging before CV or LA procedures and management of LA appendage (LAA) thrombus with special emphasis on thrombus resistant to OAC. Of 54 responding centres 63% were university hospitals. Most commonly, TOE would be performed in cases of inadequate or unclear pre-procedural anticoagulation, even in AF lasting <48 h (52% and 50%, respectively), and 15% of centres would perform TOE before AF ablation in all patients. If thrombus was diagnosed despite chronic OAC, the prevalent strategy was to change current OAC to another with different mechanism of action; 51% of centres would wait 3-4 weeks after changing the OAC before using another imaging test, and 60% of centres reported two attempts to dissolve the thrombus. Our survey showed a significant utilization of TOE before CV or AF ablation in European centres, extending beyond AF guidelines-suggested indications. When thrombus was diagnosed despite chronic pre-procedural OAC, most centres would use another anticoagulant drug with different mode of action.

Periprocedural Anticoagulation Management For Nonoperating Room Anesthesia Procedures: A Clinical Guide.

Non-operating room anesthesia presents unique challenges for anesthesiologists. Limited preprocedural optimization and unfamiliarity with the location and procedure itself add to the difficulties in delivering safe care for these patients. Management of chronic oral anticoagulation can prove especially problematic since risks of bleeding for non-operating room procedures vary widely and differ from traditional surgeries. In addition, many physicians may not be familiar with the growing number of newly approved oral anticoagulants and their periprocedural management. This review will examine common non-operating procedures, their risks of bleeding, as well as pharmacokinetics of oral anticoagulants available on the market and periprocedural management options.

Antithrombotic therapy after percutaneous revascularization in patients on chronic oral anticoagulation treatment

Antithrombotic therapy after percutaneous revascularization in patients on chronic oral anticoagulation treatment

Short-term versus long-term triple antithrombotic therapy for patients with coronary stents and requiring oral anticoagulation: a meta-analysis of randomized clinical trials.

The cornerstone therapy for patients with coronary stents is dual antiplatelet therapy (DAPT). In 5-10% of these patients, oral anticoagulation (OAC) is clearly indicated in addition to DAPT. However, the optimal duration of this triple antithrombotic therapy (TAT) remains uncertain. Scientific databases and websites were searched for randomized clinical trials (RCTs). RCTs were included if patients undergoing coronary stent placements with additional indications of chronic OAC were randomly assigned to either short-term TAT or long-term TAT. Short-term TAT was defined as no more than 6 weeks of TAT, and long-term TAT was defined as 6-12 months of TAT RESULTS: Using data from three RCTs and 1883 patients, short-term TAT was associated with decreased rates of major adverse cardiovascular events, cardiac mortality, all-cause mortality, and any-bleeding events compared to long-term TAT, but similar rates of myocardial infarction, stroke, stent thrombosis, and thrombolysis in myocardial infarction major bleeding. Furthermore, in subgroup analysis, short-term TAT was associated with decreased rates of major adverse cardiovascular events, cardiac mortality, all-cause mortality, and any-bleeding compared to 12-month TAT, but similar rates compared to 6-month TAT. In patients who require chronic OAC therapy and undergo coronary stent placement, short-term TAT was associated with better efficacy and safety outcomes compared to long-term TAT.

Feasibility of complex transfemoral electrophysiology procedures in patients with inferior vena cava filters

The presence of inferior vena cava filters (IVCFs) has been considered a relative contraindication to electrophysiology (EP) procedures that require transfemoral venous placement of multiple catheters and/or long sheaths. There are inadequate data related to complex EP procedures in this population. The purpose of this study was to describe the experience of a single high-volume center with respect to complex EP procedures in patients with IVCFs. Patients with IVCFs undergoing complex EP procedures between 2004 and 2018 were identified. Clinical characteristics, IVCF type, procedural findings, and complications were analyzed. Fifty complex ablation procedures were performed in 40 patients (mean age 63.8 ± 10.9 years; 68% men). The mean IVCF dwell time was 69.1 ± 19.1 months, and 48 patients (96%) were on chronic oral anticoagulation. Procedures included ablation of atrial fibrillation (n = 21), ventricular tachycardia (n = 20), supraventricular tachycardia (n = 3), cavotricuspid isthmus flutter (n = 3), supraventricular tachycardia and cavotricuspid isthmus flutter (n = 1), and transvenous lead extraction (n = 3). Twenty procedures included quadripolar catheters (mean 1.4 ± 0.75), and 33 procedures involved deflectable decapolar catheters (mean 1.7 ± 0.47). Long sheaths were used in 35 cases (mean 1.63 ± 0.49) and intracardiac echocardiography in 38. In 4 cases (involving 3 patients), the IVCF was occluded and could not be crossed. There were no procedural complications related to the IVCF. The substantial majority of IVCFs in patients presenting for complex EP procedures were patent and easily crossed under fluoroscopic guidance. The presence of an IVCF should not discourage operators from performing procedures that require transfemoral deployment of multiple catheters and/or sheaths.

Cell Sources for Tissue Engineering Strategies to Treat Calcific Valve Disease.

Cardiovascular calcification is an independent risk factor and an established predictor of adverse cardiovascular events. Despite concomitant factors leading to atherosclerosis and heart valve disease (VHD), the latter has been identified as an independent pathological entity. Calcific aortic valve stenosis is the most common form of VDH resulting of either congenital malformations or senile “degeneration.” About 2% of the population over 65 years is affected by aortic valve stenosis which represents a major cause of morbidity and mortality in the elderly. A multifactorial, complex and active heterotopic bone-like formation process, including extracellular matrix remodeling, osteogenesis and angiogenesis, drives heart valve “degeneration” and calcification, finally causing left ventricle outflow obstruction. Surgical heart valve replacement is the current therapeutic option for those patients diagnosed with severe VHD representing more than 20% of all cardiac surgeries nowadays. Tissue Engineering of Heart Valves (TEHV) is emerging as a valuable alternative for definitive treatment of VHD and promises to overcome either the chronic oral anticoagulation or the time-dependent deterioration and reintervention of current mechanical or biological prosthesis, respectively. Among the plethora of approaches and stablished techniques for TEHV, utilization of different cell sources may confer of additional properties, desirable and not, which need to be considered before moving from the bench to the bedside. This review aims to provide a critical appraisal of current knowledge about calcific VHD and to discuss the pros and cons of the main cell sources tested in studies addressing in vitro TEHV.

Feasibility and safety of percutaneous epicardial access for mapping and ablation for ventricular arrhythmias in patients on oral anticoagulants

This study aimed to assess the risk of procedure-related complications of percutaneous epicardial access (EpiAcc) for radiofrequency catheter ablation (RFA) of ventricular arrhythmias (VAs) in patients chronically treated oral anticoagulants (OACs) with warfarin compared to those not on OACs. We analyzed 205 patients (53 ± 16years, 155 males) undergoing percutaneous EpiAcc as part of an RFA for VAs, and compared the outcome between patients chronically on OACs with warfarin (OAC group) and those without (non-OAC group). Forty-seven patients (23%) were chronically treated on OACs before their procedure. EpiAcc in patients on OAC (OAC group) was not associated with an increased risk of cardiac tamponade (11% vs. 6%, p = 0.238) compared to non-OAC group, but a higher risk of need for blood transfusion (17% vs. 6%; p = 0.013). With respect to the OAC group, the international normalized ratio (INR) on the day of the RFA was ≥ 2.0 in 9 patients (19%) and < 2.0 in the remaining 38 patients (81%). The rate of all complication and blood transfusion were similar between them (11% vs. 21%; p = 0.496, 11% vs. 18%; p = 0.600). Percutaneous EpiAcc in patients on chronic OAC with warfarin did not significantly increase the risk of cardiac tamponade, but was associated with a higher risk of need for blood transfusion. EpiACC in patients with an INR > 2.0 is reasonable in experienced hands when clinical indications are strong.

Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation—Rationale and design of the ENVISAGE-TAVI AF trial

Transcatheter aortic valve implantation, also called transcatheter aortic valve replacement (TAVR), is the treatment of choice for patients with severe aortic stenosis and intermediate to high operative risk. A significant portion of TAVR patients have atrial fibrillation (AF) requiring chronic oral anticoagulation. In moderate- to high-risk AF patients, the direct factor Xa inhibitor edoxaban is noninferior to vitamin K antagonists (VKAs) for prevention of stroke or systemic embolism with less bleeding and cardiovascular deaths. ENVISAGE-TAVI AF (NCT02943785) is a multinational, multicenter, prospective, randomized, open-label, blinded end point evaluation study comparing edoxaban to VKA-based therapy in approximately 1,400 patients with an indication for chronic oral anticoagulation after successful transfemoral TAVR. The coprimary end points are to assess the differential effects of the 2 treatments (a) on net adverse clinical events (the composite of all-cause death, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, and major bleeding events) and (b) on major bleeding. Twelve hours to 5 days after successful TAVR, patients will be randomized to 60 mg daily oral edoxaban or any VKA (international normalized ratio: 2.0-3.0 or 1.6-2.6 [numbers inclusive] in Japan if age ≥ 70 years). Antiplatelet therapy may be administered per physician's discretion. Randomization will be stratified by edoxaban dose reduction (per local label). Treatment duration will be up to 36 months. The study is powered (80%) to detect noninferiority (margin for the hazard ratio: 1.38) for the composite primary end points, followed by superiority testing.

Complexities in the Atrial Fibrillation-Stroke Relationship: Improving Comprehension of Temporal Discordance, Magnitude Synergism, and Subclinical Atrial Fibrillation -- Three Sources of Consternation for Physicians Who Care for Patients with Atrial Fibrillation.

That clinically-documented atrial fibrillation (AF) in association with a variety of elevated clinical/laboratory risk markers is associated with an increased risk of stroke is well known -- regardless of whether the AF is paroxysmal, persistent, or permanent. Moreover, data is accumulating to suggest that the absolute rate of stroke should be expectedly higher with a greater burden of AF and greater degree of comorbid contributors. Relatedly, stroke prevention with chronic oral anticoagulation (OAC) is recommended for AF patients with appropriate risk markers by all major medical, cardiologic, and surgical guideline-writing organizations. However, at least two major clinical concerns about the above AF-stroke statements remain. First, if AF is related to stroke, why then is there not a consistent temporal relationship between a stroke and AF? Second, is there importance to and what should we do about device-detected AF (so-called subclinical AF [SCAF]) in the absence of clinically-recognized AF? This paper is designed to enhance the understanding of these issues and reduce the consternation of physicians who care for patients with AF with respect to them.

Safety of 4-factor prothrombin complex concentrate (4F-PCC) for emergent reversal of factor Xa inhibitors

BackgroundAlthough factor Xa inhibitors have become a popular choice for chronic oral anticoagulation, effective drug reversal remains difficult due to a lack of specific antidote. Currently, 4-factor prothrombin complex concentrate (4F-PCC) is considered the treatment of choice for factor Xa inhibitor-related major bleeding. However, safety of 4F-PCC and its risk of thrombosis when used for this off-label purpose remain unclear. The purpose of this retrospective study is to determine the rate of thromboembolism when 4F-PCC is used for the emergent reversal of factor Xa inhibitors.MethodsWe conducted a single-center retrospective review of medical records between 2013 and 2017. Patients were included if they received 4F-PCC to reverse rivaroxaban, apixaban, or edoxaban for emergent invasive procedures or during episodes of major bleeding defined as bleeding with hemodynamic instability, fall in hemoglobin of 2 g/dL, or bleeding requiring blood transfusion. Thrombotic events including myocardial infarction, pulmonary embolism, deep vein thrombosis, cerebral vascular accident, and arterial thrombosis of the limb or mesentery were recorded if they occurred within 14 days of 4F-PCC administration. Data was analyzed using point and interval estimation to approximate the rate and confidence interval of thromboembolic events.ResultsForty-three patients were identified in our review. Doses of 4F-PCC were determined by the treating physician and mainly ranged from 25 to 50 IU/kg. Twenty-two patients (51.2%) received both sequential compression devices (SCDs) and subcutaneous heparin for DVT prophylaxis. Twenty-one patients (48.8%) were placed on SCDs only. Three patients received concomitant FFP. Thrombotic events within 14 days of 4F-PCC administration occurred in 1 out of 43 patients (2.1%, 95% CI [0.1–12.3]). This thrombotic event was an upper extremity DVT which occurred 1 day after the patient received 1325 IU (25 IU/kg) of 4F-PCC to reverse rivaroxaban for traumatic intracranial hemorrhage. The patient was taken for emergent decompressive craniotomy after rivaroxaban reversal. In patients who did not undergo surgery or who underwent minor invasive procedures, no thrombotic events were noted.ConclusionBased on our preliminary data, the thromboembolic rate of 4F-PCC when given at a dose of 25–50 IU/kg to emergently reverse rivaroxaban and apixaban appears acceptable. Since many patients who require 4F-PCC to emergently reverse factor Xa inhibitors will be at high risk of developing thrombotic events, practitioners should be highly vigilant of these complications. Large, multicenter prospective trials are needed to further determine this risk.

Triple antithrombotic therapy after ACS and PCI in patients on chronic oral anticoagulation: update

### Learning objectives Oral anticoagulation (OAC) with vitamin K antagonists (VKAs) is indicated for the prophylaxis and treatment of venous thrombosis and pulmonary embolism as well for the prophylaxis and...

Contemporary Antithrombotic Treatment in Patients with Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: Rationale and Design of the Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF) Registry

Approximately 5 to 7% of patients undergoing percutaneous coronary intervention (PCI) for the treatment of coronary artery disease require chronic oral anticoagulation (OAC) on top of aspirin and a P2Y12 receptor antagonist, mainly due to non-valvular atrial fibrillation (AF). The advent of non-vitamin K antagonist oral anticoagulants (NOACs) increased treatment options, while there is cumulative evidence that dual combination of a NOAC and a P2Y12 receptor antagonist attenuates risk of bleeding, compared to traditional triple therapy, consisting of a vitamin K antagonist (VKA), aspirin, and a P2Y12 receptor antagonist, without significantly compromising efficacy. Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF, NCT 03362788) is an observational, nationwide study of non-valvular AF patients undergoing PCI, planning to enroll over 1-year period > 500 participants in 25 tertiary and non-tertiary PCI centers in Greece. Key data to be collected pre-discharge include demographics, detailed past medical history, and antithrombotic and concomitant treatment. Patients will be followed up at 1, 6, and 12months post hospital discharge. Αt each follow-up visit, data on antithrombotic treatment, ischemic, bleeding, and adverse events will be collected. Study's primary endpoint is clinically significant bleeding (Bleeding Academic Research Consortium, BARC ≥ 2) at 12months, between VKAs and NOACs-treated patients, analyzed using Cox proportional hazards models, by an intention-to-treat principle. An independent endpoint committee will adjudicate all clinical events. This study aims at providing "real-world" information on current antithrombotic treatment patterns and clinical outcome of patients with non-valvular AF undergoing PCI.

Percutaneous Left Atrial Appendage Closure with WATCHMAN™ device: peri-procedural and mid-term outcomes from the TRAPS Registry.

The WATCHMAN device for Left Atrial Appendage Occlusion (LAAO) has proven to be an effective alternative to oral anticoagulation (OAC) in patients with atrial fibrillation (AF), and has now been adopted in clinical practice. In the present study, we analyzed the safety and efficacy profile of the LAAO procedure at mid-term follow-up. The TRAPS Registry is an observational, multicenter registry involving four Italian centers. Consecutive patients who had undergone LAAO with WATCHMAN device were enrolled. Clinical, demographic, and procedural data were collected at the time of implantation, and follow-up data were collected to assess the clinical outcome. A total of 151 patients were included in the Registry from May 2012 to October 2015. Implantation of the device was successful in 150/151 patients, with no or minimal (< 5mm) leakage as assessed by peri-procedural transesophageal echo. In the remaining patient, early device embolization was reported, with no sequelae. Overall, intra-procedural events were reported in 5 (3.3%) patients. During a median follow-up of 16months (25th and 75th percentile, 10-25), 5 patients died of any cause. The annual rate of all-cause stroke was 2.2% (95% CI, 0.7-5.1), the rate of transient ischemic attack was 1.3% (95% CI, 0.3-3.8), and that of major bleeding 0.4% (95% CI, 0.01-2.4). LAAO for stroke prevention was safely and effectively achieved by implantation of the WATCHMAN device in patients with non-valvular AF. Moreover, regardless of the risk profile of the population, we observed low rates of death and thromboembolic and bleeding events over a median follow-up of 16months. These findings were obtained in an unselected group of consecutive patients who were variably eligible for chronic OAC therapy.

Suitability for Watchman Implantation in TAVR Patients with Atrial Fibrillation

ABSTRACTBackground: We assessed the suitability for Watchman in transcatheter aortic valve replacement (TAVR) patients with atrial fibrillation (AF). Patients who undergo TAVR and have AF are at high-risk of stroke, major bleeding, and death. The Watchman device is now available as an alternative to anticoagulation (OAC) for stroke prevention in selected patients.Methods: We reviewed medical records of 113 patients who underwent TAVR for severe aortic stenosis (AS) with high- or extreme-surgical risk. We estimated the CHA2DS2VASC and HAS-BLED scores and investigated the presence of approved indications for the Watchman device in patients with AF.Results: Of the 113 patients, 48 (43%) had AF. CHA2DS2VASC score ≥3 was seen in 46 (96%) patients. A total of 31 (65%) AF patients had a high bleeding risk, comprised of HAS-BLED score ≥4 in 29 (60%), prior bleeding in 18 (38%) and both in 16 (33%). Warfarin was used for stroke prevention in 38 (80%) patients. At least one approved indication for Watchman was found in 44 (92%) patients: prior bleeding in 18 (38%); labile international normalized ratios (INR) in 24 (50%); non-adherence to oral anticoagulation (OAC) 6 (13%); prior falls in 30 (63%) and fall risk in 37 (77%) patients.Conclusions: Chronic OAC remains the mainstay of treatment in TAVR patients with AF. More than 90% of such patients have an appropriate indication for Watchman implant, stemming from their high stroke and bleeding risk. Our findings suggest an unmet need for Watchman in this population.