Tom 16, Nr 4 (2019)
Farmakoterapia chorób układu krążenia
Opublikowany online: 2019-12-02
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Riwaroksaban — następny krok w leczeniu choroby niedokrwiennej serca
Choroby Serca i Naczyń 2019;16(4):207-219.
Streszczenie
Opublikowane w 2017 roku wyniki badania COMPASS otworzyły nowe możliwości leczenia chorych z przewlekłym zespołem wieńcowym (CCS). Riwaroksaban w dawce 2 × 2,5 mg + kwas acetylosalicylowy (ASA) w dawce 100 mg w porównaniu z ASA w dawce 100 mg zredukował złożony punkt końcowy (udar mózgu, zawał serca lub zgon sercowo-naczyniowy) z 5,4% do 4,1% (p < 0,001). Tym niewątpliwym korzyściom towarzyszył niewielki wzrost powikłań krwotocznych (major and minor bleeding), wynoszący 1,9% w porównaniu z 3,1% (p < 0,001), przy czym poważne powikłania krwotoczne, takie jak krwawienia zakończone zgonem, krwawienia wewnątrzczaszkowe lub do innych ważnych narządów wewnętrznych, nie różniły się istotnie od wartości obserwowanych u chorych leczonych jedynie ASA. Badanie COMPASS przełamuje podejmowane od wielu lat próby skojarzonej terapii lekami przeciwkrzepliwymi (warfaryna, acenokumarol) z ASA chorych ze stabilną chorobą wieńcową. Badania te, mimo istotnej redukcji liczby zdarzeń sercowo-naczyniowych (MACE), ze względu na nieakceptowalnie wysoki odsetek powikłań krwotocznych nie są rekomendowane w leczeniu choroby niedokrwiennej serca. W świetle wyników badania COMPASS u chorych z CCS optymalne leczenie (OMT) powinno, obok statyny, inhibitorów konwertazy angiotensyny i ASA, zawierać riwaroksaban w dawce 2 × 2,5 mg. U chorych z implantowanym stentem podwójna terapia przeciwzakrzepowa (DAT) oparta na „naczyniowych” dawkach riwaroksabanu i leku z grupy P2Y12 (DAT) w prewencji zakrzepicy w stencie jest równie skuteczna i bezpieczna jak klasyczna podwójna terapia przeciwpłytkowa (DAPT). Nowa jakość po wprowadzeniu riwaroksabanu do leczenia chorych z CCS może się okazać szczególnie przydatna u pacjentów ze zmianami niekrytycznymi (40–70%) w tętnicach wieńcowych, ze współistniejącą cukrzycą oraz „oporną” na leczenie farmakologiczne i rewaskularyzacyjne dławicą piersiową.
Słowa kluczowe: riwaroksabandawki naczynioweprzewlekły zespół wieńcowy
Referencje
- Eikelboom JW, Connolly S, Bosch J, et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017; 377(14): 1319–1330.
- Anand SS, Bosch J, Eikelboom JW, et al. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018; 391(10117): 219–229.
- Anand SS, Bosch J, Eikelboom JW, et al. COMPASS Investigators, COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018; 391(10117): 205–218.
- Timmis AD. Plaque stabilisation in acute coronary syndromes: clinical considerations. Heart. 2003; 89(10): 1268–1272.
- Naghavi M, Libby P, Falk E, et al. From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: part I. Circulation. 2010; 108(14): 1664–1672.
- Torrado J, Buckley L, Durán A, et al. Restenosis, stent thrombosis, and bleeding complications: navigating between Scylla and Charybdis. J Am Coll Cardiol. 2018; 71(15): 1676–1695.
- Kramer MCA, Rittersma SZH, de Winter RJ, et al. Relationship of thrombus healing to underlying plaque morphology in sudden coronary death. J Am Coll Cardiol. 2010; 55(2): 122–132.
- Lavoie AJ, Bayturan O, Uno K, et al. Plaque progression in coronary arteries with minimal luminal obstruction in intravascular ultrasound atherosclerosis trials. Am J Cardiol. 2010; 105(12): 1679–1683.
- Takano M, Inami S, Ishibashi F, et al. Angioscopic follow-up study of coronary ruptured plaques in nonculprit lesions. J Am Coll Cardiol. 2005; 45(5): 652–658.
- Grüntzig AR, Senning A, Siegenthaler WE, et al. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979; 301(2): 61–68.
- Tonascia J, Gordis L, Schmerler H. Retrospective evidence favoring use of anticoagulants for myocardial infarctions. N Engl J Med. 1975; 292(26): 1362–1366.
- Modan B, Shani M, Schor S, et al. Reduction of hospital mortality from acute myocardial infarction by anticoagulant therapy. N Engl J Med. 1975; 292(26): 1359–1362.
- A double-blind trial to assess long-term oral anticoagulant therapy in elderly patients after myocardial infarction. Report of the Sixty Plus Reinfarction Study Research Group. Lancet. 1980; 2(8202): 989–994.
- Smith P, Arnesen H, Holme I. The effect of warfarin on mortality and reinfarction after myocardial infarction. N Engl J Med. 1990; 323(3): 147–152.
- Meade TW, Miller GJ. Combined use of aspirin and warfarin in primary prevention of ischemic heart disease in men at high risk. Am J Cardiol. 1995; 75(6): 23B–26B.
- Smith PJ, Hurlen M, Abdelnoor M, et al. Warfarin, aspirin, or both after myocardial infarction. N Engl J Med. 2002; 347(13): 969–974.
- MacCallum PK, Brennan PJ, Meade TW, et al. Low-dose warfarin and low-dose aspirin in the primary prevention of ischemic heart disease. Am J Cardiol. 1990; 65(6): 7C–711C.
- Meade TW, Wilkes HC, Stirling Y, et al. Randomized controlled trial of low dose warfarin in the primary prevention of ischaemic heart disease in men at high risk: design and pilot study. Eur Heart J. 1988; 9(8): 836–843.
- Williams MJ, Morison IM, Parker JH, et al. Progression of the culprit lesion in unstable coronary artery disease with warfarin and aspirin versus aspirin alone: preliminary study. J Am Coll Cardiol. 1997; 30(2): 364–369.
- Husted SE, Ziegler BK, Kher A. Long-term anticoagulant therapy in patients with coronary artery disease. Eur Heart J. 2006; 27(8): 913–919.
- Anand SS, Yusuf S, Xie C, et al. Warfarin Antiplatelet Vascular Evaluation Trial Investigators. Oral anticoagulant and antiplatelet therapy and peripheral arterial disease. N Engl J Med. 2007; 357(3): 217–227.
- Mega JL, Braunwald E, Mohanavelu S, et al. ATLAS ACS-TIMI 46 study group. Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial. Lancet. 2009; 374(9683): 29–38.
- Mega JL, Braunwald E, Wiviott SD, et al. ATLAS ACS 2–TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012; 366(1): 9–19.
- Krantz MJ, Kaul S. The ATLAS ACS 2–TIMI 51 trial and the burden of missing data. J Am Coll Cardiol. 2013; 62(9): 777–781.
- Windecker S, Kolh P P, Alfonso F, et al. [2014 ESC/EACTS Guidelines on myocardial revascularization]. [Article in Polish]. Kardiol Pol. 2014; 72(12): 1253–1279.
- Neumann FJ, Sousa-Uva M, Ahlsson A, et al. ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019; 40(2): 87–165.
- Gibson CM, Levitan B, Gibson WJ, et al. Fatal or irreversible bleeding and ischemic events with rivaroxaban in acute coronary syndrome. J Am Coll Cardiol. 2018; 72(2): 129–136.
- Daaboul Y, Korjian S, Plotnikov AN, et al. Rivaroxaban and post-stroke neurological outcomes in patients with acute coronary syndrome. J Am Coll Cardiol. 2018; 71(9): 1048–1049.
- Chiarito M, Cao D, Cannata F, et al. Direct oral anticoagulants in addition to antiplatelet therapy for secondary prevention after acute coronary syndromes: a systematic review and meta-analysis. JAMA Cardiol. 2018; 3(3): 234–241.
- Povsic TJ, Roe MT, Ohman EM, et al. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study. Am Heart J. 2016; 174: 120–128.
- Ohman EM, Roe MT, Steg PG, et al. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017; 389(10081): 1799–1808.
- Knuuti J, Wijns W, Saraste A, et al. ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2019.
- Sharma M, Hart RG, Smith EE, et al. Rationale, design and baseline characteristics of participants in the cardiovascular outcomes for people using anticoagulation strategies (COMPASS) trial. Can J Cardiol. 2017; 33(8): 1027–1035.
- Yusuf S, Sleight P, Pogue J, et al. Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000; 342(3): 145–153.
- Fox KM. EURopean trial On reduction of cardiac events with Perindopril in stable coronary Artery disease Investigators. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet. 2003; 362(9386): 782–788.
- Bhatt D, Eagle K, Ohman M, et al. REACH Registry Investigators. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010; 304(12): 1350–1357.
- Smolderen KG, Bell A, Lei Y, et al. REACH registry investigators, REACH Registry Investigators, REACH Registry Investigators. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. 2007; 297(11): 1197–1206.
- Alberts MJ, Bhatt DL, Mas JL, et al. REduction of Atherothrombosis for Continued Health Registry Investigators. Three-year follow-up and event rates in the international REduction of Atherothrombosis for Continued Health Registry. Eur Heart J. 2009; 30(19): 2318–2326.
- Płatek A, Szymański F. [Rivaroxaban — a new pleiotropic drug with broad action spectrum]. [Article in Polish]. Choroby Serca i Naczyń. 2019;16 (1): DOI:10.5603/ChSiN 2019.0003. 2019; 16(1): 34–40.
- Filipiak K. [The commentary. Pleiotropic — what does it mean and does this term also apply ro rivaroxaban]. [Article in Polish]. Choroby Serca i Naczyń. 2019; 16(1): 41–44.
- Barylski M, Mamcarz A, Siebert J. [A new antithrombotic paradigm in the treatment of atherosclerotic diseases Expert group consensus endorsed the Polish Society Working Group on Cardiovascular Pharmacotherapy on the place of rivaroxaban un the treatment of stable coronary disease or symptomatic peripherial artery disease]. [Article in Polish]. Choroby Serca I Naczyń. 2019; 16(1): 1–16.
- Chen Bo, Cheng Q, Yang K, et al. Thrombin mediates severe neurovascular injury during ischemia. Stroke. 2010; 41(10): 2348–2352.
- Sorbets E, Steg PG, Young R, et al. CLARIFY investigators. β-blockers, calcium antagonists, and mortality in stable coronary artery disease: an international cohort study. Eur Heart J. 2019; 40(18): 1399–1407.
- Palmerini T, Sangiorgi D, Valgimigli M, et al. Short- versus long-term dual antiplatelet therapy after drug-eluting stent implantation: an individual patient data pairwise and network meta-analysis. J Am Coll Cardiol. 2015; 65(11): 1092–1102.
- Palmerini T, Benedetto U, Biondi-Zoccai G, et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012; 379(9824): 1393–1402.
- Sen H, Lam M, Löwik M, et al. Clinical events and patient-reported chest pain in all-comers treated with resolute integrity and promus element stents. JACC: Cardiovascular Interventions. 2015; 8(7): 889–899.
- Giustino G, Baber U, Sartori S, et al. Duration of dual antiplatelet therapy after drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Cardiol. 2015; 65(13): 1298–1310.
- Bangalore S, Toklu B, Patel N, et al. Newer-generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug-eluting stents for coronary artery disease. Circulation. 2018; 138(20): 2216–2226.
- Zamman A, Kogame N, Chang C, et al. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019; 393(10175): 987–997.
- Maddox TM, Stanislawski MA, Grunwald GK, et al. Nonobstructive coronary artery disease and risk of myocardial infarction. JAMA. 2014; 312(17): 1754–1763.
- Stone GW, Maehara A, Lansky AJ, et al. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011; 364(3): 226–235.
- Rajkumar CA, Nijjer SS, Cole GD, et al. 'Faith healing' and ''subtraction anxiety' in unblinded trials of procedures: lessons from DEFER and FAME-2 for end points in the ISCHEMIA trial. Circ Cardiovasc Qual Outcomes. 2018; 11(3): e004665.
- Hiczkiewicz J. Analiza wybranych czynników wpływających na kolejne interwencje wieńcowe u pacjentów z chorobą niedokrwienną serca. Doświadczenia Oddziału KardiologicznonWielospecjalistycznego Szpitala SP ZOZ w Nowej Soli. Rozprawa habilitacyjna. Wydawnictwo UMP, Poznań 2019.
- Weintraub WS, Boden WE, Zhang Z, et al. Department of Veterans Affairs Cooperative Studies Program No. 424 (COURAGE Trial) Investigators and Study Coordinators, COURAGE Trial Research Group. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008; 359(7): 677–687.
- Abdallah MS, Wang K, Magnuson EA, et al. FREEDOM Trial Investigators. Quality of life after PCI vs CABG among patients with diabetes and multivessel coronary artery disease: a randomized clinical trial. JAMA. 2013; 310(15): 1581–1590.
- Marzilli M, Merz CN, Boden WE, et al. Obstructive coronary atherosclerosis and ischemic heart disease: an elusive link! J Am Coll Cardiol. 2012; 60(11): 951–956.
- Huqi A, Morrone D, Guarini G, et al. Stress testing after complete and successful coronary revascularization. Can J Cardiol. 2016; 32(8): 986.e23–986.e29.
- Bonaca MP, Bhatt DL, Cohen M, et al. for the PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015; 372: 1791–1800.
- Steg PG, Bhatt DL, Simon T, et al. for the THEMIS Steering Committee and Investigators. Ticagrelor in patients with stable coronary disease and diabetes. N Engl J Med. 2019; 381: 1309–1320.
