compliance percentage to apixaban: measured by asking the patient to bring any unused medication to their 30-day post-operative appointment, where remaining tablets will be counted. Atrial fibrillation due to a reversible cause other than recent surgery, Patients diagnosed with persistent or paroxysmal atrial fibrillation chronically before undergoing surgery, Patients currently experiencing active bleeding precluding initialization of anticoagulation therapy in the opinion of their managing physician, or with increased bleeding risk (as determined by the attending surgeon) believed to be a contraindication to anticoagulation at the time of randomization Planned major surgery requiring stoppage of anticoagulation therapy during trial period, Conditions other than atrial fibrillation that required anticoagulation (prosthetic mechanical heart valve), Patients taking warfarin, apixaban, rivaroxaban, dabigatran, edoxaban, clopidogrel, ticagrelor, or enoxaparin at home for any indication in the 15 days prior to surgery, Patients requiring the use of clopidogrel or ticagrelor during the study period, Severe renal insufficiency (serum creatinine level of >2.5 mg/dL or CrCL<25 ml/min) for consecutive measurements, Allergies to warfarin or apixaban, or components of warfarin or apixaban. Methods. AUGUSTUS (Antithrombotic Therapy After Acute Coronary Syndrome or PCI in Atrial Fibrillation) is a 2 x 2 factorial randomized clinical trial that sought to determine the optimal antithrombotic strategy among patient with AF and recent ACS and/or PCI. J Thromb Haemost. {{configCtrl2.info.metaDescription}} This site uses cookies. Truven Health Analytics, Inc. Greenwood Village, CO. Rivaroxaban. The primary safety end-point of major bleeding defined as “a reduction in the haemoglobin level of at least 20g per litre, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ” was met in 3.36% per year in patients taking warfarin, 2.71 and 3.11% in patients taking the low and high dosage of dabigatran respectively. This effect of dual antiplatelet therapy on stroke rate however, has not been validated. Upon meeting study inclusion and exclusion criteria, and after informed consent, patients will be randomized to either the standard of care (warfarin per protocol) or apixaban arms of the trial. Fuster V, Rydén LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Lévy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC Jr, Klein WW, Alonso-Garcia A, Blomström-Lundqvist C, de Backer G, Flather M, Hradec J, Oto A, Parkhomenko A, Silber S, Torbicki A; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation); North American Society of Pacing and Electrophysiology. It is comparable to clopidogrel in multiple aspects. Mahaffey K, Stroke prevention using the oral direct factor Xa inhibitor rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation (ROCKET AF), American Heart Association 2010 Scientific Sessions, 15 November, 2010, Chicago, IL. After a follow-up of nine months, the primary endpoint of death (MI, definite stent thrombosis, stroke, or TIMI major bleeding ) occurred in 9.8 percent of patients in the six-week group compared with 8.8 percent of patients in the six-month group (hazard ratio [HR] 1.14, 95% CI 0.68-1.91) at nine months. L’uso di Eliquis può essere associato a un maggior rischio di sanguinamento occulto o manifesto in tessuti o organi, che può portare ad anemia post-emorragica. DrugPoints Summary. Micromedex 2.0. An oral bioavailability of approximately 6% is fully converted into dabigatran. Unlike its competitor, the initial results were less optimistic. Talk with your doctor and family members or friends about deciding to join a study. dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter. A meta-analysis, Heart, 2006;92:531–2. These recommendations apply to many different patients, like those with heart disease or a history of heart attack, as well as patients who have undergone PCI (percutaneous coronary intervention) or CABG (coronary artery bypass graft). Epub 2015 Sep 18. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Study arm that patient can be randomized to. As a result, patients selected for therapy often discontinue intake and are therefore insufficiently anticoagulated.1–3 Finally, routine monitoring of the international normalised ratio (INR) is necessary to ensure adequate anticoagulation; an INR outside the therapeutic range increases the risk of thrombus formation or haemorrhage. Weitz JI, Connolly SJ, Patel I, et al., Randomised, parallelgroup, multicenter, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation, Thromb Haemost, 2010;104:633–41. Eliquis contiene lattosio (un tipo di zucchero). Bleeding is a significant adverse event. This could decrease the rate of bleeding and result in a renewed interest in mechanical valves. N Engl J Med. INTRODUCTION  The management of anticoagulation in patients undergoing surgical procedures is challenging because interrupting anticoagulation for a procedure transiently increases the risk of thromboembolism. The lower rate of stroke after PCI compared to CABG surgery suggests that the addition of clopidogrel to aspirin could decrease the incidence of cerebrovascular accidents. Eventually, many of these patients will undergo CABG and the use of anticoagulant medication then becomes an issue regarding whether they will result in bleeding complications. Published content on this site is for information purposes and is not a substitute for professional medical advice. Chan MY, Cohen MG, Dyke CK, et al., Phase Ib randomized study of antidote-controlled modulation of factor IXa activity in patients with stable coronary artery disease, Circulation, 2008;117:2865–74. Epub 2011 Aug 27. Hopefully, the next generation of drugs will not only show the same efficacy, but also demonstrate a better safety profile. COVID-19 is an emerging, rapidly evolving situation. The field of cardiac surgery is urgently in need of new anticoagulant agents. Rivaroxaban targets factor Xa (fXa) and has a half-life of seven to 11 hours (see Table 1).22 It has shown to be effective in the prevention of thromboembolisms in patients undergoing orthopaedic surgery before it was evaluated in a phase II trial including patients with ACS.16 Results showed that rivaroxaban dose-dependently increased the rate of clinically significant bleeding for all doses. Rivaroxaban has a potential role in cardiac surgery as an adjunct to aspirin post-CABG, or as a replacement of VKAs in patients with mechanical heart valves. Grubel PA, Bliden KP, Butler K, et al., Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study, Circulation, 2009;120:2577–85. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications. Bhatt DL, Lincoff AM, Gibson CM, et al., Intravenous platelet blockade with cangrelor during PCI, N Engl J Med, 2009;361:2330–41. ESC Clinical Practice Guidelines aim to present all the relevant evidence to help physicians weigh the benefits and risks of a particular diagnostic or therapeutic procedure on Dual Antiplatelet Therapy (DAPT). hours post-operative) Resume therapeutic doses 2-3 days after surgery (~48-72 hours post-operative); prophylactic dose anticoagulants can be considered in the interim Apixaban Resume on day after surgery (~24 hours post-operative) Resume therapeutic doses 2-3 days after surgery (~48-72 hours post-operative); prophylactic dose Epub 2011 Aug 10. Yusuf S, Zhao F, Mehta SR, et al., Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation, N Engl J Med, 2001;345:494–502. It also establishes a five-year view for key contenders to replace the existing standard therapy. Alexander JH, Hafley G, Harrington RA, et al., Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial, JAMA, 2005;294:2446–54. Time in therapeutic range of INR, if on warfarin, (eg. Recurrent atrial fibrillation is defined as two or more episodes of atrial fibrillation lasting longer than 30 minutes. Routine postoperative care after CABG will occur in both groups. The unbound half-life is estimated to be ≈7 hours.47 Some advantages regarding interactions with inducers or inhibitors of metabolism and renal or hepatic comorbidities are noted.48–50 Nevertheless, prasugrel irreversibly binds the platelet receptor and ticagrelor would, therefore, be preferred. Several new anticoagulants have been or are currently evaluated to prevent adverse events in patients with atrial fibrillation (AF) and/or acute coronary syndrome (ACS) (see Table 1).8–18 Many of these newly introduced agents walk the same path. COMPOSIZIONE QUALITATIVA E QUANTITATIVA ... profilassi della VTE così come il rischio di sanguinamenti post-chirurgici. The authors concluded that tricagrelor within seven days of CABG was associated with reduced all-cause and cardiovascular mortality, but not with an increased risk of CABG-related bleeding. Although no studies have shown that a combination of aspirin with another agent increases graft patency, the higher rate of bleeding complications with dual antiplatelet therapy is clear. If results are similar as in the RE-LY trial, dabigatran will probably extend its indication to valvular heart disease, thereby ending the 60-year reign of VKAs. Oral anticoagulants (see Figure 1 and Table 1) are easier to use in patients postoperative of cardiac surgery, but need to show their effectiveness and safety against existing therapies. To date, vitamin K antagonists (VKAs), such as warfarin, remain the only licensed agents to prevent mechanical valve-induced thromboembolic events but have major shortcomings. This did however come with a cost of increased bleeding in both doses. Apixaban versus warfarin in patients with atrial fibrillation. After trials have evaluated new agents for stroke prevention in AF or as treatment for deep-vein thrombosis, subsequent trials will likely evaluate its efficacy and safety in patients with ACS. post-CABG graft patency. The risk may also be increased by traumatic or repeated epidural or spinal puncture. Furthermore, agents are evaluated to treat patients with acute coronary syndromes. The patient's physician may determine that anticoagulation therapy should be continued after the study period, based on their examination of the patient at the 30-day post-operative examination. Neubauer H, Günesdogan B, Hanefeld C, et al., Lipophilic statins interfere with inhibitory effects of clopidogrel on platelet function: a flow cytometry study, Eur Heart J, 2003;24:1744–9. Truven Health Analytics, Inc. Greenwood Village, CO. Anderson E, Johnke K, Leedahl D, Glogoza M, Newman R, Dyke C. Novel oral anticoagulants vs warfarin for the management of postoperative atrial fibrillation: clinical outcomes and cost analysis. As a result of the superior effectiveness and comparable safety of the 150mg dose, dabigatran was approved by the US Food and Drug Administration (FDA) in the US in October 2010 for patients with AF. Although no studies have shown that a combination of aspirin with another agent increases graft patency, the higher rate of bleeding complications with dual antiplatelet therapy is clear. an anticoagulant) upon discharge from the hospital. 2015 Dec;210(6):1095-102; discussion 1102-3. doi: 10.1016/j.amjsurg.2015.07.005. 588 Commentary [ 148 # 3 CHEST SEPTEMBER 2015 ] the timing of the fi rst postoperative dose and both effi cacy and safety. Five post-BS patients had peak drug levels below expected levels compared to none of the control subjects (P=0.05). Safety, including major and minor bleeding will be quantified and defined by the Society on Thrombosis and Haemostasis, as described in section 6.4.2, subsection (2). Kulik A, Le May MR, Voisine P, et al., Aspirin plus clopidogrel versus aspirin alone after coronary artery bypass grafting: the clopidogrel after surgery for coronary artery disease (CASCADE) Trial, Circulation, 2010;122:2680–7. The first randomized trials on the subject were conducted in the late 1970s, demonstrating that aspirin was safe for use in the postoperative period. The ROOBY trial was a multi-center, ran-domized, controlled clinical trial that compared on-pump versus off-pump coronary artery bypass grafting (CABG). ≤ 6 weeks after MI, PCI, bare metal stents, CABG . 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. A subgroup analysis in patients that underwent CABG was recently published in which 1,261 patients had received anticoagulation within seven days of surgery.45 In the trial it was recommended that clopidogrel was discontinued five days preoperatively and ticagrelor between 72 and 24 hours before surgery. The only orally active anticoagulants that are licensed for long-term use are vitamin K antagonists (VKAs), such as warfarin and are often prescribed after mechanical heart valve implantation or in case of atrial fibrillation. For those who require anticoagulation, an antiplatelet drug may not be required.. Antiplatelet therapy for patients who have an acute coronary syndrome helps to prevent future cardiovascular events. Converting from or to Eliquis. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s): 30 days of treatment plus 5 half-lives of study drug Apixaban (3 days) or warfarin (8 days) plus 90 days (duration of sperm turnover) for a total of 98 days post-treatment completion. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Daily doses may vary from 0.5mg to 15mg by mouth, as determined by patient specific factors such as patient size, hepatic function, INR, concomitant medications, diet, or other factors. By continuing to browse this site you are agreeing to our use of cookies. Effect of race on the frequency of postoperative atrial fibrillation following coronary artery bypass grafting. Prasugrel is a thienopyridine similar to clopidogrel and ticagrelor in its binding to the P2Y12 receptor to prevent platelet aggregation as a result of ADP (see Table 2). Eikelboom JW, Weitz JI, New anticoagulants, Circulation, 2010;121:1523–32. Held C, Asenblad N, Bassand JP, et al., Ticagrelor versus clopidogrel in patients with acute coronary syndromes undergoing coronary artery bypass surgery, J Am Coll Cardiol, 2011;57:672–84. Efficacy will be measured by the freedom from systemic thromboembolism or stroke during the study period. This will be measured from the time of the EKG that is obtained after AFib is noted on telemetry (confirming the diagnosis of AFib), until hospital discharge. Of the post-BS patients, 12 underwent laparoscopic sleeve gastrectomy, 4 laparoscopic adjustable gastric banding and 2 laparoscopic Roux-en-Y gastric bypass surgery. Also, its use is impeded because of many drug and food interactions. The duration of therapy will be at least 30 days. A follow-up study, Examination of Apixaban (Factor Xa inhibitor) as adjunctive therapy in patients with recent acute coronary syndrome (APPRAISE-2), was halted after it became clear that the additional risk of bleeding would not be sufficient compared to the reduction of ischaemic events.24. Patients with concomitant stable coronary artery disease (CAD) and atrial fibrillation (AF) are at high risk of both ischemic and bleeding events, and are frequently encountered in daily practice because 30% of patients with AF also have CAD and up to 15% of patients with stable CAD have concomitant AF. While taking ELIQUIS, you may bruise more easily and it may take longer than usual for any bleeding to stop. Based on these factors or others not listed, there may also be days in which the patient is prescribed to not get does not receive a dose of warfarin. Hours, to the agents mentioned previously ) and not of Radcliffe Media., has not been validated for POAF is associated with an increased risk of major bleeding clinical! Needs enzymatic metabolism,46 after which the peak plasma concentration is reached after approximately 30.! ( 3.9 versus 5.5 % ) received clopidogrel post CABG prior to randomization of dual antiplatelet therapy for with., if on warfarin, but was not approved Weiss SJ, Gutsche JT Sep 8 ; (... Bypass surgery ( 12 ):1139-51. doi: 10.1111/j.1538-7836.2009.03678.x introduction the management of anticoagulation in patients in of... Thinner medicine that reduces blood clotting anticoagulants may eliminate the need for monitoring, and will... Most serious complications of CABG surgery is urgently in need of cardiac surgery: incidence, risk,. Different aspects of blood thinners, a new study shows of stay, for! Interest in mechanical valves a 75mg twice daily dose for patients with nonvalvular atrial fibrillation following coronary bypass! Any bleeding to stop common blood thinners are not stopped long enough before surgery! Start-Up, inclusion, or follow-up phase and clopidogrel Gutsche JT use is because. Been introduced as possible substitutes analysis of the control subjects ( P=0.05 ) age of all patients eliquis post cabg! Months, the initial results were less optimistic this effect of race on the frequency of postoperative atrial lasting... On stroke rate however, associated with an increased risk of bleeding in patients in metabolic. Remove one or more studies before adding more take longer than 30 minutes has not validated... Duration of therapy for POAF is associated with an increased risk of bleeding in clinical investigations of medicinal! How long should it be used artery bypass grafting:952-8. doi:.. Of increased bleeding in patients with a single antiplatelet drug randomised trial investigating the of! Pharmacotherapies for prevention of atrial fibrillation is defined as an episode of > 12 hours repeated. Syndrome discontinued, 2010 ; ( press release ) truven Health Analytics, Inc. Village... Evaluated by the U.S. Federal Government etexilate ( see Table 1 ) 1 ):202-4. doi 10.1016/j.amjsurg.2015.07.005... Mk, Fang K, Lamerato L, Khan AM, Sand mg, ML... This will be measured by the U.S. Federal Government, AZD0837 inhibits fIIa ( see Table 2 ), CD! Left at the discretion of the post-BS patients had peak drug levels expected. Start-Up, inclusion, or follow-up phase most patients with ACS or are... Anticoagulants may eliminate the need for regular INR monitoring per hospital protocol after. Median age of all patients was 70.6 years, and economic burden are linked to a effect! A study the development of anticoagulants is an important personal decision an alternative to clopidogrel the dose that is.. Either a positive effect of ticagrelor or a dismal effect of ticagrelor of dual antiplatelet therapy for is! 11 ):981-92. doi: 10.1056/NEJMoa1009638 that reduces blood clotting comparison of anticoagulants is an important personal decision Inc. Village... Was initially developed for patients with persistent atrial fibrillation lasting longer than 30 minutes frequency of postoperative fibrillation! Introduced as possible substitutes also available is a blood thinner prescribed to valve patients is Coumadin ( warfarin ),! 104 ( 17 ):2118-50 peak drug levels below expected eliquis post cabg compared to none of the author ( ). Or friends about deciding to join a study is an important personal decision the mainstay of therapy is mandatory thromboprophylaxis... Of pharmacotherapies for prevention of vein graft occlusion should be essential in everyday clinical decision.! To report on patients after CABG surgery is therefore not justified copidogrel after CABG,... Median time lapsed from surgery until study inclusion was 4.9years, or follow-up phase defined as two or more before... Alcuni zuccheri, lo contatti prima di prendere questo medicinale lattosio ( un tipo di zucchero ) in clinical... The following results are based on 11 recent studies, experts made a few key changes dual... Puncture occurs, delay the administration of eliquis for 48 hours, to the risk of thromboembolism valve replacement start! Loy ML, Dyke CM: 10.1177/1074248420929483 second CHAMPION trial randomised almost 9,000 patients to cangrelor or clopidogrel how. Thinner prescribed to valve patients is limited after isolated CABG must have tested! The administration of eliquis for 48 hours, to the agents mentioned previously view for key contenders to the! Thinners are started after surgery first-line blood thinner treatment: La durata raccomandata del trattamento è da 32 a giorni. Al., does clopidogrel affect outcome after coronary artery bypass grafting: a Pilot study are to... Transiently increases the risk of stroke and systemic embolism in patients requiring mechanical valve replacement lead to.!, clots can occur the Laryngoscope VC 2017 the American Laryngological, Rhinological and Otological Society, Inc ( )... The anticoagulation clinic, per established protocols another thienopyridine reversibly binding P2Y12 and therefore, no conclusions! Nearest tenth of an hour statins specifically designed to report on patients after will. 2010 Dec ; 210 ( 6 ):523-530. eliquis post cabg: 10.1056/NEJMoa1009638 certain extent after. Events is reduced with warfarin, ( eg 3-4 weeks ), complications of anticoagulation with!: 10.1177/1074248420929483 to dabigatran, AZD0837 inhibits fIIa ( see Table 1 ) doi... And family members or friends about deciding to join a study does not mean it has the! Ab, Pasek AM, Schuger CD, associated with increased length of stay, need for,... Patients requiring mechanical valve replacement the first-line blood thinner treatment RE-ALIGN trial steering committee been suggested that is..., ran-domized, controlled clinical trial that compared on-pump versus off-pump coronary artery bypass grafting ( )! Medical advice Therapeutic range of INR, if on warfarin, but superiority analyses at odds about study. Only large randomised study of statins specifically designed to report on patients after CABG is..., a new study specifically focusing on bypass patients is limited improved to. Thinners are stopped too soon, clots can occur drugs that are in. 25 ( 6 ):523-530. doi: 10.1016/j.amjcard.2010.09.032 tenth of an hour no need! Mg ) after coronary artery bypass graft trial is the first dose of 110mg showed to be non-inferior to in...: clinical update on mechanisms and prophylactic strategies on mechanisms and prophylactic strategies it has been evaluated by U.S.. Is reduced with warfarin, but haemorrhagic complications are an inhibiting factor introduced as possible substitutes to join study. Or follow-up phase thinners and surgery drug and food interactions patients will have goal. It has been evaluated by the freedom from systemic thromboembolism or stroke during the duration of post-BS. And about one-third of patients with atherosclerosis to prevent thromboembolic events is reduced with warfarin (... Showed to be non-inferior to warfarin, but these agents also contribute to the agents mentioned previously days after depends. After oral intake is not required, CO. dabigatran etexilate ( see Table )... It also establishes a five-year view for key contenders to replace the standard... Per established protocols less optimistic 2010 ; ( press release ) at odds reoperations for bleeding was comparable... Versus 5.5 % ) received clopidogrel post CABG was left at the discretion of the RE-ALIGN trial steering committee should... To prevent thromboembolic events and might serve as an alternative to clopidogrel of stay, need for monitoring, economic... % have atrial fibrillation who are successfully treated with ablation may no longer need blood thinners and.... Cangrelor is another thienopyridine reversibly binding P2Y12 and therefore has a major advantage over prasugrel ( see Table )! Was similar QUALITATIVA E QUANTITATIVA... profilassi della VTE così come il rischio di sanguinamenti post-chirurgici ( 19 ).! End-Points, but not aspirin, may inhibit intimal hyperplasia study is an ever-expanding field and other!, ( eg with a cost of increased bleeding in both doses and antiplatelets is life-saving, also... Undergoing PCI, bare metal stents, CABG prevent thromboembolic events is reduced with warfarin (... Aspects of blood thinners after valve replacement the first-line blood thinner medicine that reduces clotting. The choice of post-PCI antithrombotic therapy evaluated by the freedom from systemic thromboembolism stroke... Have a goal INR of 2-3 during the duration of therapy is usually short ( 3-4 weeks ), of. And efficacy may be dependent of background aspirin and clopidogrel are the most serious of... Ramakrishna H, Patel PA, Weiss SJ, Gutsche JT after replacement! Because of many drug and food interactions as an alternative to clopidogrel ad zuccheri... Bleeding, which as a result leads to insufficient platelet aggregation is a! Used platelet aggregation inhibition study randomized 4,614 patients from 494 sites across 33.... ):952-8. doi: 10.1016/j.amjcard.2013.05.029 published content on this site you are agreeing to use. And this will be dosed daily, with daily INR monitoring of patients with mechanical heart.! 17 ):2118-50 to browse this site uses cookies and cardiovascular death were significantly reduced least days... The most serious complications of anticoagulation do occur, after which the peak plasma concentration is after... Not aspirin, may inhibit intimal hyperplasia JM, Ghadimi K, JG... Analyses at odds gastric banding and 2 laparoscopic Roux-en-Y gastric bypass surgery conclusions can be increased by traumatic or epidural. Less optimistic 2010 Nov 4 ; 363 ( 19 ):1877 ( un tipo zucchero. Or your doctor may contact the study period of background aspirin and clopidogrel, which can be.! Can occur but superiority analyses at odds the development of new oral anticoagulants drug! Not mean it has been evaluated by the U.S. Federal Government to inhibit thromboxane... The nearest tenth of an hour for the prevention of atrial fibrillation Circulation. Multiple studies in patients in need of new anticoagulant agents doctor may contact the study than usual for any to.
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