Beneficial impact of prolonged dual antiplatelet therapy after drug-eluting stent implantation.

BACKGROUND  Twelve-month dual antiplatelet therapy (DAT) with aspirin and clopidogrel after drug-eluting stent (DES) implantation is routinely recommended. It is unclear if prolonged (>12-month) DAT is also favorable. We compared the outcome of patients discontinuing DAT 12 months after off-label DES implantation versus those with DAT for >12 months. METHODS  Baseline, treatment, and outcome data of patients undergoing off-label DES implantation and free from events 11.5 months after index procedure were retrospectively retrieved. Those discontinuing DAT between 11.5 and 12.5 months (12-month DAT group) were compared to those discontinuing DAT after 12.5 months (>12-month DAT group). The primary end-point was the long-term (>24-month) rate of major adverse cerebro-cardiovascular events (MACCE). RESULTS Two hundred seventy-two patients met study inclusion criteria: 133 (48.9%) in the 12-month DAT group and 139 (51.1%) in the >12-month DAT group (who were on DAT for an average of 24 months). After an average of 36 months after DES implantation, 14 patients (5.1%) developed MACCE, with 6 (3.5%) cardiac deaths, 7 (2.2%) myocardial infarctions, no stroke, and 5 (1.8%) repeat revascularizations. The >12-month DAT group had a significantly lower risk of MACCE (1 [0.7%] vs. 13 [9.8%] in the 12-month DAT group, P < 0.001) and myocardial infarction (0 vs. 7 [5.3%], P = 0.006), with such differences confirmed at multivariable propensity-adjusted analyses. No significant differences in terms of minor or major bleedings occurred. CONCLUSIONS In this retrospective registry, patients with off-label DES implantation receiving prolonged (>12 months) DAT presented with lower rates of MACCE and myocardial infarction.

[1]  P. Damman,et al.  Duration of dual antiplatelet therapy and outcomes after coronary stenting with the genous™ bio‐engineered R stent™ in patients from the e‐healing registry , 2012, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[2]  Pierfrancesco Agostoni,et al.  Are propensity scores really superior to standard multivariable analysis? , 2011, Contemporary clinical trials.

[3]  S. Johnston,et al.  Effect of early clopidogrel discontinuation on rehospitalization in acute coronary syndrome: results from two distinct patient populations. , 2011, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[4]  Yudai Yano,et al.  The potential benefits and risks of the use of dual antiplatelet therapy beyond 6 months following sirolimus-eluting stent implantation for low-risk patients. , 2011, Journal of cardiology.

[5]  A. Gavazzi,et al.  Prevalence, predictors, and long-term prognosis of premature discontinuation of oral antiplatelet therapy after drug eluting stent implantation. , 2011, The American journal of cardiology.

[6]  M. Pencina,et al.  Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent , 2010, American heart journal.

[7]  Volkmar Falk,et al.  Guidelines on Myocardial Revascularization the Task Force on Myocardial Revascularization of the European Society of Cardiology (esc) and the European Association for Cardio-thoracic Surgery (eacts) Developed with the Special Contribution of the European Association for Percutaneous Cardiovascular I , 2022 .

[8]  S. de Servi,et al.  Real-world outcome of coronary bifurcation lesions in the drug-eluting stent era: results from the 4,314-patient Italian Society of Invasive Cardiology (SICI-GISE) Italian Multicenter Registry on Bifurcations (I-BIGIS). , 2010, American heart journal.

[9]  Q. Fang,et al.  [Effect of duration of clopidogrel use on clinical follow-up outcomes in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention]. , 2010, Zhonghua yi xue za zhi.

[10]  A. Colombo,et al.  Prolonged double antiplatelet therapy in a cohort of "de novo" diabetic patients treated with drug-eluting stent implantation. , 2010, The American journal of cardiology.

[11]  Nikki M. Carroll,et al.  Increased Risk of Bleeding in Patients on Clopidogrel Therapy After Drug-Eluting Stents Implantation: Insights From the HMO Research Network-Stent Registry (HMORN-Stent) , 2010, Circulation. Cardiovascular interventions.

[12]  M. Jeong,et al.  Duration of dual antiplatelet therapy after implantation of drug-eluting stents. , 2010, The New England journal of medicine.

[13]  L. Køber,et al.  Duration of clopidogrel treatment and risk of mortality and recurrent myocardial infarction among 11 680 patients with myocardial infarction treated with percutaneous coronary intervention: a cohort study , 2010, BMC cardiovascular disorders.

[14]  P. Smits,et al.  Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial , 2010, The Lancet.

[15]  J. Suh,et al.  Reasonable duration of Clopidogrel use after drug-eluting stent implantation in Korean patients. , 2009, The American journal of cardiology.

[16]  A. Kastrati,et al.  Stent thrombosis after drug-eluting stent implantation: incidence, timing, and relation to discontinuation of clopidogrel therapy over a 4-year period. , 2009, European heart journal.

[17]  E. Mozaffari,et al.  Clinical impact of early clopidogrel discontinuation following acute myocardial infarction hospitalization or stent implantation: analysis in a nationally representative managed-care population , 2009, Current medical research and opinion.

[18]  K. Harjai,et al.  Dual antiplatelet therapy for more than 12 months after percutaneous coronary intervention: insights from the Guthrie PCI Registry , 2009, Heart.

[19]  Deepak L. Bhatt,et al.  Comprehensive meta-analysis on drug-eluting stents versus bare-metal stents during extended follow-up. , 2009, The American journal of medicine.

[20]  C. Reid,et al.  The effect of intended duration of clopidogrel use on early and late mortality and major adverse cardiac events in patients with drug-eluting stents. , 2009, American heart journal.

[21]  F. Verheugt,et al.  Predictors of coronary stent thrombosis: the Dutch Stent Thrombosis Registry. , 2009, Journal of the American College of Cardiology.

[22]  K. Kent,et al.  Temporal relation between Clopidogrel cessation and stent thrombosis after drug-eluting stent implantation. , 2009, American Journal of Cardiology.

[23]  Liu Yuyang,et al.  Prolonged Dual Antiplatelet Therapy Improves Clinical Outcomes in High‐risk Patients Implanted with Sirolimus‐eluting Stents , 2009, Clinical cardiology.

[24]  Y. Hayashi,et al.  Antiplatelet Therapy and Stent Thrombosis After Sirolimus-Eluting Stent Implantation , 2009, Circulation.

[25]  Sunil V. Rao,et al.  Comparison of the impact of short (<1 year) and long-term (> or =1 year) clopidogrel use following percutaneous coronary intervention on mortality. , 2008, American Journal of Cardiology.

[26]  M. Pfisterer,et al.  Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis , 2008, BMJ : British Medical Journal.

[27]  I. Liu,et al.  Long-term outcomes by clopidogrel duration and stent type in a diabetic population with de novo coronary artery lesions. , 2008, Journal of the American College of Cardiology.

[28]  P Michael Ho,et al.  Incidence of death and acute myocardial infarction associated with stopping clopidogrel after acute coronary syndrome. , 2008, JAMA.

[29]  A. Colombo,et al.  Long-term follow-up of drug-eluting stents when inserted for on- and off-label indications. , 2007, The American journal of cardiology.

[30]  J. Rumsfeld,et al.  Clopidogrel and long-term outcomes after stent implantation for acute coronary syndrome. , 2007, American heart journal.

[31]  Jeroen J. Bax,et al.  Universal definition of myocardial infarction. , 2007 .

[32]  A. Colombo,et al.  Incidence and Predictors of Drug-Eluting Stent Thrombosis During and After Discontinuation of Thienopyridine Treatment , 2007, Circulation.

[33]  J. Granada,et al.  Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. , 2007, JAMA.

[34]  David O. Williams,et al.  Outcomes and complications associated with off-label and untested use of drug-eluting stents. , 2007, JAMA.

[35]  C. Di Mario,et al.  Testing prospectively the effectiveness and safety of paclitaxel-eluting stents in over 1000 very high-risk patients: design, baseline characteristics, procedural data and in-hospital outcomes of the multicenter Taxus in Real-life Usage Evaluation (TRUE) Study. , 2007, International journal of cardiology.

[36]  Ralph D'Agostino,et al.  Stent thrombosis in randomized clinical trials of drug-eluting stents. , 2007, The New England journal of medicine.

[37]  S. Pocock,et al.  Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. , 2007, The New England journal of medicine.

[38]  Marco Valgimigli,et al.  Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. , 2007, The New England journal of medicine.

[39]  P. Serruys,et al.  A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. , 2007, The New England journal of medicine.

[40]  C. Grines,et al.  Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American D , 2007, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[41]  David B Matchar,et al.  Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. , 2007, JAMA.

[42]  Patrick Hunziker,et al.  Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. , 2006, Journal of the American College of Cardiology.

[43]  F. Burzotta,et al.  A systematic review and meta-analysis on the hazards of discontinuing or not adhering to aspirin among 50,279 patients at risk for coronary artery disease. , 2006, European heart journal.

[44]  Patrice Cacoub,et al.  Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. , 2006, The New England journal of medicine.

[45]  F. Burzotta,et al.  Long-term benefits of an early invasive management in acute coronary syndromes depend on intracoronary stenting and aggressive antiplatelet treatment: a metaregression. , 2005, American heart journal.

[46]  Eric J Topol,et al.  Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. , 2002, JAMA.

[47]  S. Yusuf,et al.  Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. , 2001, The New England journal of medicine.