Clopidogrel pre-treatment in stable angina: for all patients > 6 h before elective coronary angiography or only for angiographically selected patients a few minutes before PCI? A randomized multicentre trial PRAGUE-8
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
18441320
PubMed Central
PMC2429977
DOI
10.1093/eurheartj/ehn169
PII: ehn169
Knihovny.cz E-zdroje
- MeSH
- angina pectoris diagnostické zobrazování terapie MeSH
- balónková koronární angioplastika metody MeSH
- chronická nemoc MeSH
- infarkt myokardu mortalita MeSH
- inhibitory agregace trombocytů aplikace a dávkování MeSH
- klopidogrel MeSH
- koronární angiografie škodlivé účinky metody MeSH
- krvácení při operaci MeSH
- lidé MeSH
- následné studie MeSH
- perioperační péče MeSH
- premedikace * MeSH
- rizikové faktory MeSH
- senioři MeSH
- tiklopidin aplikace a dávkování analogy a deriváty MeSH
- troponin metabolismus MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- inhibitory agregace trombocytů MeSH
- klopidogrel MeSH
- tiklopidin MeSH
- troponin MeSH
AIMS: To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography (CAG)+/-ad hoc percutaneous coronary intervention (PCI). METHODS AND RESULTS: Open-trial randomized 1028 patients with stable angina to group A ('non-selective'-clopidogrel 600 mg > 6 h before CAG; n = 513) or group B ('selective'-clopidogrel 600 mg in the cath-lab after CAG, only in case of PCI; n = 515). Combined primary endpoint was death/periprocedural myocardial infarction (MI)/stroke/re-intervention within 7 days. Secondary endpoints were troponin elevation and bleeding complications. Primary endpoint occurred in 0.8% group A patients vs. 1% group B (P = 0.749; 90% CI for the percentage difference -1.2-0.8). Periprocedural troponin elevation (> 3 x ULN) was detected in 2.6% group A vs. 3.3% group B (P = 0.475; 90% CI -2.5-1.0). Bleeding complications occurred in 3.5% group A patients vs. 1.4% group B (P = 0.025). After adjustment for covariates and factors that may influence the bleeding risk, patients in group A were shown to have more likely bleeding complications when compared with group B (OR = 3.03; 95% CI 1.14-8.10; P = 0.027). CONCLUSION: High (600 mg) loading dose of clopidogrel before elective CAG increased the risk of minor bleeding complications, while the benefit on periprocedural infarction was not significant. Clopidogrel can be given safely in the catheterization laboratory between CAG and PCI in chronic stable angina patients.
Zobrazit více v PubMed
Bertrand ME, Legrand V, Boland J, Fleck E, Bonnier J, Emmanuelson H, Vrolix M, Missault L, Chierchia S, Casaccia M, Niccoli L, Oto A, White C, Webb-Peploe M, Van Belle E, McFadden EP. Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting—the full anticoagulation versus aspirin and ticlopidine (FANTASTIC) study. Circulation. 1998;98:1597–1603. PubMed
Schömig A, Neumann FJ, Kastrati A, Schuhlen H, Blasini R, Hadamitzky M, Walter H, ZitzmannRoth EM, Richardt G, Alt E, Schmitt C, Ulm K. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med. 1996;334:1084–1089. PubMed
Bertrand ME, Rupprecht HJ, Urban P, Gershlick AH for the CLASSICS Investigators. Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting: the CLopidogrel ASpirin Stent International Cooperative Study (CLASSICS) Circulation. 2000;102:624–629. PubMed
Steinhubl SR, Berger PB, Mann JT, Fry ETA, DeLago A, Wilmer C, Topol EJ for the CREDO Investigators. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA. 2002;288:2411–2420. PubMed
Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Maimberg K, Rupprecht HJ, Zhao F, Chrolavicius S, Copland I, Fox KAA. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001;358:527–533. PubMed
Patti G, Colonna G, Pasceri V, Pepe LL, Montinaro A, Di Sciascio G. Randomized trial of high loading dose of clopidogrel for reduction of periprocedural myocardial infarction in patients undergoing coronary intervention: results from the ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2005;111:2099–2106. PubMed
Zeymer U, Arntz HR, Darius H, Huber K, Senges J. Efficacy and safety of clopidogrel 600 mg administered pre-hospitally to improve primary percutaneous coronary intervention in patients with acute myocardial infarction (CIPAMI): Study Rationale and Design. Cardiology. 2006;108:265–272. PubMed
Cuisset T, Frere C, Quilici J, Morange PE, Nait-Saidi L, Carvajal J, Lehmann A, Lambert M, Bonnet JL, Alessi MC. Benefit of a 600-mg loading dose of clopidogrel on platelet reactivity and clinical outcomes in patients with non-ST-segment elevation acute coronary syndrome undergoing coronary stenting. J Am Coll Cardiol. 2006;48:1339–1345. PubMed
Montalescot G, Sideris G, Meuleman C, Bal-Dit-Sollier C, Lellouche N, Steg PG, Slama M, Milleron O, Collet JP, Henry P, Beygui F, Drouet L. A randomized comparison of high clopidogrel loading doses in patients with non-ST-segment elevation acute coronary syndromes: the ALBION (Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis) trial. J Am Coll Cardiol. 2006;48:931–938. PubMed
Kastrati A, Mehilli J, Neumann FJ, Dotzer F, ten Berg JN, Bollwein H, Graf I, Ibrahim M, Pache J, Seyfarth M, Schuhlen H, Dirschinger J, Berger PB, Schomig A. Abciximab in patients with acute coronary syndromes undergoing percutaneous coronary intervention after clopidogrel pretreatment: the ISAR-REACT 2 randomized trial. JAMA. 2006;295:1531–1538. PubMed
Mehta SR. Clopidogrel in non-ST-segment elevation acute coronary syndromes. Eur Heart J Suppl. 2006;8:G25–G30.
Rao AK, Pratt C, Berke A, Jaffe A, Ockene I, Schreiber TL, Bell WR, Knatterud G, Robertson TL, Terrin ML. Thrombolysis in Myocardial Infarction (TIMI) Trial—phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol. 1988;11:1–11. PubMed
Hauck WW. A proposal for interpreting and reporting negative studies. Stat Med. 1986;5:203–209. PubMed
Wolfram RM, Torgusson RL, Hassani SE, Xue ZY, Gevorkian N, Pichard AD, Satler LF, Kent KM, Waksman R. Clopidogrel loading dose (300 versus 600 mg) strategies for patients with stable angina pectoris subjected to percutaneous coronary intervention. Am J Cardiol. 2006;97:984–989. PubMed
Kandzari DE, Berger PB, Kastrati A, Steinhubl SR, Mehilli J, Dotzer F, ten Berg JM, Neumann FJ, Bollwein H, Dirschinger J, Schomig A. Influence of treatment duration with a 600-mg dose of clopidogrel before percutaneous coronary revascularization. J Am Coll Cardiol. 2004;44:2133–2136. PubMed
Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W for the Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005;26:804–847. PubMed
Cuisset T, Frere C, Quilici J, Morange PE, Nait-Saidi L, Mielot C, Bali L, Lambert M, Alessi MC, Bonnet JL. High post-treatment platelet reactivity is associated with a high incidence of myonecrosis after stenting for non-ST elevation acute coronary syndromes. Thromb Haemost. 2007;97:282–287. PubMed
Hochholzer W, Trenk D, Bestehorn HP, Fischer B, Valina CM, Ferenc M, Gick M, Caputo A, Buttner HJ, Neumann FJ. Impact of the degree of peri-interventional platelet inhibition after loading with clopidogrel on early clinical outcome of elective coronary stent placement. J Am Coll Cardiol. 2006;48:1742–1750. PubMed
Geisler T, Langer H, Wydymus M, Gohring K, Zurn C, Bigalke B, Stellos K, May AE, Gawaz M. Low response to clopidogrel is associated with cardiovascular outcome after coronary stent implantation. Eur Heart J. 2006;27:2420–2425. PubMed
Hochholzer W, Trenk D, Frundi D, Blanke P, Fischer B, Andris K, Bestehorn HP, Buttner HJ, Neumann FJ. Time dependence of platelet inhibition after a 600-mg loading dose of clopidogrel in a large, unselected cohort of candidates for percutaneous coronary intervention. Circulation. 2005;111:2560–2564. PubMed
Bhatt DL, Flather MD, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Fabry-Ribaudo L, Hu T, Topol EJ, Fox KAA for the CHARISMA Investigators. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA Trial. J Am Coll Cardiol. 49:1982–1988. PubMed
Kang W, Theman TE, Reed JF, 3rd, Stoltzfus J, Weger N. The effect of preoperative clopidogrel on bleeding after coronary artery bypass surgery. J Surg Educ. 2007;64:88–92. PubMed
Shim JK, Choi YS, Oh YJ, Bang SO, Yoo KJ, Kwak YL. Effects of preoperative aspirin and clopidogrel therapy on perioperative blood loss and blood transfusion requirements in patients undergoing off-pump coronary artery bypass graft surgery. J Thorac Cardiovasc Surg. 2007;134:59–64. PubMed
Kojecky V, Coufal Z. Clinically manifest gastrointestinal bleeding in patients subject to coronary angiography. Vnitr Lek. 2007;53:147–150. PubMed