Effectiveness of Two-Year Clopidogrel plus Aspirin in Abolishing the Risk of Very Late Thrombosis After Drug-Eluting Stent Implantation (from the TYCOON [Two-Year ClOpidOgrel Need] Study)

Department of Heart and Great Vessels Attilio Reale, La Sapienza University, Rome, Italy.
The American journal of cardiology (Impact Factor: 3.28). 11/2009; 104(10):1357-61. DOI: 10.1016/j.amjcard.2009.07.002
Source: PubMed


It remains unclear whether dual antiplatelet therapy >12 months might carry a better prognosis after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). To address the hypothesis that in the real world the risk of very late thrombosis after PCI with DESs can be decreased by an extended use of clopidogrel, we set up the Two-Year ClOpidOgrel Need (TYCOON) registry and prospectively investigated the impact on very late thrombosis of 12- versus 24-month dual antiplatelet regimens in an unselected population. The registry enrolled 897 consecutive patients who underwent PCI with stenting from January 1, 2003, to December 31, 2004, and had dual antiplatelet therapy. All patients had a 4-year clinical follow-up. In the 447 patients with DES implantation, the dual antiplatelet regimen after PCI was given for 12 months in the 173 patients treated in 2003 (12-month group) and for 24 months in the 274 patients treated in 2004 (24-month group). Comparison between groups did not reveal any significant difference in baseline clinical characteristics, angiographic and procedural features, and major adverse cardiac events. During follow-up, there were 5 cases of stent thrombosis after PCI in the 12-month DES group and 1 case in the 24-month DES group (p = 0.02). Specifically, there were 2 cases of subacute thrombosis (1 in each group), no case of late thrombosis, and 4 cases of very late thrombosis occurring at 13, 15, 17, and 23 months after DES implantation in the 12-month group only. In conclusion, a 2-year dual antiplatelet regimen with aspirin and clopidogrel can prevent the occurrence of very late stent thrombosis after PCI with DESs.

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    • "Two-thirds of the late DES thromboses are were linked to the discontinuation of antiplatelet drugs.[6] However, the benefit of prolonged DAPT beyond 12 months is not clearly demonstrated.[7],[8] "
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    ABSTRACT: In-stent thrombosis after cessation of antiplatelet medications in patients with drug-eluting stents (DES) is a significant problem in medical practice, particularly in the perioperative period. We report a case of an 87-year-old man with a medical history of hypertension, coronary artery disease and chronic atrophic gastritis. Very late thrombosis of a sirolimus-eluting stent occurred 1207 days after implantation, seven months after discontinuation of clopidogrel, and the interruption of aspirin 13 days in preparation of an elective endoscopic gastrointestinal procedure presented with acute myocardial infarction. The patient was treated with thrombectomy and successfully revascularized with superimposition of two sirolimus-eluting stents. Medications administered in the catheterization laboratory included low molecular weight heparin and nitroglycerin. Flow was defined as grade 2 according to the thrombolysis in myocardial infarction scale. Electrocardiogram after the procedure revealed persistent, but decreased, ST-segment elevation in the anterolateral leads. The patient recovered and was discharged on aspirin and clopidogrel indefinitely. There was no cardiac event during the two year follow-up period. This case underlines the importance of maintaining the balance of thrombosis and bleeding during perioperation of non-cardiac procedure and the possible need for continuation of aspirin therapy during periendoscopic procedures among patients with low bleeding risks who received DES.
    Journal of Geriatric Cardiology 09/2014; 11(3):274-7. DOI:10.11909/j.issn.1671-5411.2014.03.006 · 1.40 Impact Factor
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    • "The risk of early thrombosis events amongst patients with the DES is remarkably reduced by dual antiplatelet therapy.9, 10 According to the current guidelines, antiplatelet therapy is needed for at least 9 to 12 months after the implantation of the DES;11 still, reports of late and very late stent thrombotic events have raised doubts about whether this regimen is sufficient.12, 13 One recent report suggested that although a two-year dual antiplatelet regimen with Aspirin and Clopidogrel could prevent the occurrence of very late stent thrombosis after percutaneous coronary intervention (PCI) with the DES,14 the role of a longer use of Clopidogrel in preventing very late stent thrombosis (one year after angioplasty) needs to be proved. In a recent study, the use of dual antiplatelet therapy for more than 12 months in patients with the DES was not more effective than Aspirin monotherapy in reducing the rate of myocardial infarction or cardiac death.15 "
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    ABSTRACT: Impact of 12 months' versus 24 months' use of dual antiplatelet therapy on the prevalence of stent thrombosis in patients undergoing percutaneous coronary intervention (PCI) with the drug-eluting stent (DES) is not clear. As a result, duration of dual antiplatelet therapy is still under debate among interventionists. From March 2007 until August 2008, all consecutive patients with successful PCI who received at least one DES and were treated with dual antiplatelet therapy (Clopidogrel + Aspirin) were included. All the patients were followed up for more than 24 months (mean = 35.27 ± 6.91 months) and surveyed for very late stent thrombosis and major cardiovascular events. From 961 patients eligible for the study, 399 (42%) discontinued Clopidogrel after 12 months and 562 (58%) continued Clopidogrel for 24 months. The clinical and procedural variables were compared between the two groups. In the 12 months' use group, two cases of definite thrombosis occurred at 18 and 13 months post PCI. In the 24 months' use group, 2 cases of definite thrombosis occurred at 14 and 28 months post PCI, one of them with stenting in a bifurcation lesion. Five cases of probable stent thrombosis were detected at 21, 28, 32, 33, and 34 months after the procedure. It is of note that amongst the 10 cases of stent thrombosis, only 1(10%) thrombosis occurred when the patient was on Clopidogrel and Aspirin and all the other 9 (90%) cases of thrombosis appeared after the discontinuation of the dual antiplatelet therapy. Extended use of dual antiplatelet therapy (for more than 12 months) was not significantly more effective than Aspirin monotherapy in reducing the risk of myocardial infarction or stent thrombosis, death from cardiac cause, and stroke.
    Journal of Tehran University Heart Center 05/2012; 7(2):47-52.
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    • "Alternatively, it has been suggested that patients treated with clopidogrel for 24 months had improved cumulative survival compared to those treated for 12 months [61]. However, it has been shown in a randomized trial of 2,701 patients who were free of major adverse cardiovascular and cerebrovascular events (MACCE) and major bleeding events for 12 months alter PCI receiving 12 versus 24 months of clopidogrel that the cumulative occurrence of definite ST at 24 months after DES was identical in patients who continued clopidogrel until 24 months (0.4% versus 0.4%; P = 0.76) [62]. "
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    ABSTRACT: Some concerns have been raised regarding the risk of late and very late stent thrombosis (ST) following drug-eluting stent implantation. Despite remaining an uncommon complication of percutaneous coronary intervention, when ST occurs, it can be catastrophic to the individual, commonly presenting as acute ST elevation myocardial infarction or sudden cardiac death. The incidence and predictors of ST have been reported in the literature and the role of dual antiplatelet therapies in the avoidance of such a complication remains vital. Ongoing studies are assessing the role of these therapies including platelet reactivity testing, genetic testing and optimum duration of therapy. In addition, newer polymer-free and bioabsorbable stents are under investigation in the quest to potentially minimise the risk of ST.
    03/2012; 2012(5):956962. DOI:10.1155/2012/956962
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