Randomized comparison of 6-versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention: Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY)

American Heart Journal

Volumn 160, Issue 5, 2010, Pages 804-811

  Valgimigli, Marco ^a,b   Campo, Gianluca ^a   Percoco, Gianfranco ^c   Monti, Monia ^d   Ferrari, Fabrizio ^a   Tumscitz, Carlo ^a   Zuffi, Andrea ^e   Colombo, Federico ^e   Kubbajeh, Moh'D ^c   Cavazza, Caterina ^a   Cangiano, Elisa ^a   Tebaldi, Matteo ^a   Minarelli, Monica ^a   Arcozzi, Chiara ^a   Scalone, Antonella ^a   Frangione, Alice ^c   Borghesi, Marco ^a   Marchesini, Jlenia ^a   Parrinello, Giovanni ^f   Ferrari, Roberto ^a,b  

^a UNIVERSITY OF FERRARA   (Italy)

^b IRCCS   (Italy)

^c Delta Hospital   (Italy)

^d Academic Research Unit   (Italy)

^e MARIA CECILIA HOSPITAL   (Italy)

^f UNIVERSITY OF BRESCIA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

'TAXUS'; ACETYLSALICYLIC ACID; CLOPIDOGREL; CREATINE KINASE MB; EVEROLIMUS; FIBRINOGEN RECEPTOR ANTAGONIST; HEPARIN; HIRULOG; PACLITAXEL; PLACEBO; TICLOPIDINE; TROPONIN I; TROPONIN T; UNCLASSIFIED DRUG; ZOTAROLIMUS;

ACUTE CORONARY SYNDROME; ANTICOAGULANT THERAPY; ANTICOAGULATION; ANTIINTIMAL HYPERPLASIA POTENCY; BARE METAL STENT; BLEEDING; CARDIOVASCULAR FUNCTION; CLINICAL TRIAL; CORONARY STENT; DRUG ELUTING STENT; DRUG POTENCY; DRUG WITHDRAWAL; EPITHELIUM HYPERPLASIA; HEART DEATH; HEART INFARCTION; HUMAN; IN-STENT RESTENOSIS; LOADING DRUG DOSE; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; REVIEW; SAMPLE SIZE; STENT INDUCED INTIMAL HYPERPLASIA; STENT THROMBOSIS; STROKE; TARGET VESSEL REVASCULARIZATION; TREATMENT DURATION;

EID: 78649364826     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2010.07.034     Document Type: Article

References (21)

1. Chhatriwalla A.K., and Bhatt D.L. Should dual antiplatelet therapy after drug-eluting stents be continued for more than 1 year? Dual antiplatelet therapy after drug-eluting stents should be continued for more than one year and preferably indefinitely Circ Cardiovasc Interv 1 2008 217 225
2. Colombo A., and Gerber R.T. Should dual antiplatelet therapy after drug-eluting stents be continued for more than 1 year? Dual antiplatelet therapy after drug-eluting stents should not be continued for more than 1 year and preferably indefinitely Circ Cardiovasc Interv 1 2008 226 232
3. Mehta S.R., Yusuf S., and Peters R.J. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study Lancet 358 2001 527 533
4. Steinhubl S.R., Berger P.B., and Mann J.T. III Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial Jama 288 2002 2411 2420
5. Steinhubl S.R., and Topol E.J. Risk reduction with long-term clopidogrel following percutaneous coronary intervention Eur Heart J 25 2004 2169 2170 author reply 2170-1
6. Eriksson P. Long-term clopidogrel therapy after percutaneous coronary intervention in PCI-CURE and CREDO: the "Emperor's New Clothes" revisited Eur Heart J 25 2004 720 722
7. Serruys P.W., Kutryk M.J., and Ong A.T. Coronary-artery stents N Engl J Med 354 2006 483 495
8. Finn A.V., Joner M., and Nakazawa G. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization Circulation 115 2007 2435 2441
9. Finn A.V., Nakazawa G., and Joner M. Vascular responses to drug eluting stents: importance of delayed healing Arterioscler Thromb Vasc Biol 27 2007 1500 1510
10. Joner M., Finn A.V., and Farb A. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk J Am Coll Cardiol 48 2006 193 202
11. Luscher T.F., Steffel J., and Eberli F.R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications Circulation 115 2007 1051 1058
12. Nebeker J.R., Virmani R., and Bennett C.L. Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project J Am Coll Cardiol 47 2006 175 181
13. Airoldi F., Colombo A., and Morici N. Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment Circulation 116 2007 745 754
14. Eisenstein E.L., Anstrom K.J., and Kong D.F. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation Jama 297 2007 159 168
15. Camenzind E., Steg P.G., and Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern Circulation 115 2007 1440 1455 discussion 1455
16. Pfisterer M., Brunner-La Rocca H.P., and Buser P.T. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents J Am Coll Cardiol 48 2006 2584 2591
17. Schulz S., Schuster T., and Mehilli J. Stent thrombosis after drug-eluting stent implantation: incidence, timing, and relation to discontinuation of clopidogrel therapy over a 4-year period Eur Heart J 30 2009 2714 2721
18. Roy P., Bonello L., and Torguson R. Temporal relation between Clopidogrel cessation and stent thrombosis after drug-eluting stent implantation Am J Cardiol 103 2009 801 805
19. Kimura T., Morimoto T., and Nakagawa Y. Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation Circulation 119 2009 987 995
20. Grines C.L., Bonow R.O., and Casey D.E. Jr. 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 Dental Association, with representation from the American College of Physicians Circulation 115 2007 813 818
21. Serebruany V.L., and Atar D. Assessment of bleeding events in clinical trials-proposal of a new classification Am J Cardiol 99 2007 288 290