Paclitaxel-eluting stents compared with bare metal stents in diabetic patients with acute myocardial infarction: The harmonizing outcomes with revascularization and stents in acute myocardial infarction (HORIZONS-AMI) trial

Circulation: Cardiovascular Interventions

Volumn 4, Issue 2, 2011, Pages 130-138

  Witzenbichler, Bernhard ^a   Wöhrle, Jochen ^b   Guagliumi, Giulio ^c   Peruga, Jan Z ^d   Brodie, Bruce R ^e   Dudek, Dariusz ^f   Kornowski, Ran ^g   Hartmann, Franz ^h   Hood, Kristin L ⁱ   Parise, Helen ^j   Lansky, Alexandra J ^j   Nikolsky, Eugenia ^j   Mehran, Roxana ^j   Stone, Gregg W ^j  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b UNIVERSITY OF ULM   (Germany)

^c OSPEDALI RIUNITI   (Italy)

^d MEDICAL UNIVERSITY OF LODZ   (Poland)

^e MOSES CONE HEALTH SYSTEM   (United States)

^f JAGIELLONIAN UNIVERSITY   (Poland)

^g RABIN MEDICAL CENTER   (Israel)

^h UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

ⁱ BOSTON SCIENTIFIC CORPORATION   (United States)

^j NewYork Presbyterian Hospital   (United States)

more..

Author keywords

Diabetes mellitus; Insulin; Restenosis; Revascularization; ST segment elevation myocardial infarction; Stents

Indexed keywords

ACETYLSALICYLIC ACID; ANGIOTENSIN RECEPTOR ANTAGONIST; ANTILIPEMIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CLOPIDOGREL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; FIBRINOGEN RECEPTOR ANTAGONIST; HEPARIN; HIRULOG; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN; PACLITAXEL; THIENOPYRIDINE DERIVATIVE; METAL;

ACUTE HEART INFARCTION; ADULT; AGED; ANGIOCARDIOGRAPHY; BARE METAL STENT; DIABETES MELLITUS; DIABETIC PATIENT; DRUG ELUTING STENT; FEMALE; HEART MUSCLE REVASCULARIZATION; HEART REINFARCTION; HIGH RISK PATIENT; HUMAN; IN-STENT RESTENOSIS; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REVIEW; RISK ASSESSMENT; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STENT THROMBOSIS; STROKE; TREATMENT OUTCOME; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC ANGIOPATHY; HEART INFARCTION; MIDDLE AGED; STENT; TRANSLUMINAL CORONARY ANGIOPLASTY;

AGED; ANGIOPLASTY, BALLOON, CORONARY; DIABETIC ANGIOPATHIES; DRUG-ELUTING STENTS; FEMALE; HUMANS; MALE; METALS; MIDDLE AGED; MYOCARDIAL INFARCTION; PACLITAXEL; PROSPECTIVE STUDIES; STENTS; TREATMENT OUTCOME;

EID: 80051772903     PISSN: 19417640     EISSN: 19417632     Source Type: Journal    
DOI: 10.1161/CIRCINTERVENTIONS.110.960245     Document Type: Review

References (35)

1. Ellis SG, Stone GW, Cox DA, Hermiller J, O'Shaughnessy C, Mann T, Turco M, Caputo R, Bergin PJ, Bowman TS, Baim DS. Long-term safety and efficacy with paclitaxel-eluting stents: 5-year final results of the TAXUS IV Clinical Trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent). J Am Coll Cardiol Intv. 2009;2:1248-1259.
2. Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, Popma JJ, Parise H, Fahy M, Mehran R. Five-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol. 2009;54:894-902.
3. Lasala JM, Cox DA, Lewis SJ, Tadros PN, Haas RC, Schweiger MJ, Chhabra A, Untereker WJ, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS. Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme. EuroInterv. 2009; 5:67-77.
4. Win HK, Caldera AE, Maresh K, Lopez J, Rihal CS, Parikh MA, Granada JF, Marulkar S, Nassif D, Cohen DJ, Kleiman NS. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. JAMA. 2007;297:2001-2009. (Pubitemid 46740352)
5. Jensen LO, Maeng M, Thayssen P, Kaltoft A, Tilsted HH, Lassen JF, Hansen KN, Bottcher M, Rasmussen K, Madsen M, Johnsen SP, Sørensen HT, Thuesen L. Long-term outcomes after percutaneous coronary intervention in patients with and without diabetes mellitus in Western Denmark. Am J Cardiol. 2010;105:1513-1519.
6. Norhammar A, Lagerqvist B, Saleh N. Long-term mortality after PCI in patients with diabetes mellitus: results from the Swedish Coronary Angiography and Angioplasty Registry. EuroInterv. 2010;5:891-897.
7. Chechi T, Vittori G, Biondi Zoccai GG, Vecchio S, Falchetti E, Spaziani G, Baldereschi G, Giglioli C, Valente S, Margheri M. Single-center randomized evaluation of paclitaxel-eluting versus conventional stent in acute myocardial infarction (SELECTION). J Interv Cardiol. 2007;20: 282-291. (Pubitemid 47228553)
8. Stone GW, Lansky AJ, Pocock SJ, Gersh BJ, Dangas G, Wong SC, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Mockel M, Ochala A, Kellock A, Parise H, Mehran R. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med. 2009;360:1946-1959.
9. Iijima R, Byrne RA, Dibra A, Ndrepepa G, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Suttorp MJ, Violini R, Schomig A, Kastrati A. Drug-eluting stents versus bare-metal stents in diabetic patients with ST-segment elevation acute myocardial infarction: a pooled analysis of individual patient data from seven randomized trials. Rev Esp Cardiol. 2009;62:354-364.
10. Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009;374:1149-1159.
11. Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ, Parise H, Mehran R. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358:2218-2230. (Pubitemid 351724451)
12. Mehran R, Brodie B, Cox DA, Grines CL, Rutherford B, Bhatt DL, Dangas G, Feit F, Ohman EM, Parise H, Fahy M, Lansky AJ, Stone GW. The Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: study design and rationale. Am Heart J. 2008;156:44-56. (Pubitemid 351862292)
13. Lansky AJ, Popma JJ. Qualitative and quantitative angiography. In: Topol EJ, ed. Textbook of Interventional Cardiology. 3rd ed. Philadelphia, PA: WB Saunders; 1999:725-747.
14. Elezi S, Kastrati A, Pache J, Wehinger A, Hadamitzky M, Dirschinger J, Neumann FJ, Schomig A. Diabetes mellitus and the clinical and angio-graphic outcome after coronary stent placement. J Am Coll Cardiol. 1998;32:1866-1873. (Pubitemid 29010448)
15. Lasala JM, Cox DA, Morris DL, Breall JA, Mahoney PD, Horwitz PA, Shaw D, Hood KL, Mandinov L, Dawkins KD. Two-year results of paclitaxel-eluting stents in patients with medically treated diabetes mellitus from the TAXUS ARRIVE Program. Am J Cardiol. 2009;103: 1663-1671.
16. Mahmud E, Ormiston JA, Turco MA, Popma JJ, Weissman NJ, O'Shaughnessy C, Mann JT, Hall JJ, McGarry TF, Cannon LA, Webster MWI, Mandinov L, Baim DS. TAXUS liberté attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program. J Am Coll Cardiol Interv. 2009;2: 240-252.
17. Blagosklonny MV, Darzynkiewicz Z, Halicka HD, Pozarowski P, Demidenko ZN, Barry JJ, Kamath KR, Herrmann RA. Paclitaxel induces primary and postmitotic G1 arrest in human arterial smooth muscle cells. Cell Cycle. 2004;3:1050-1056. (Pubitemid 40268664)
18. Tierala I, Syvaenne M, Kupari M. Randomised comparison of a paclitaxel-eluting and a bare metal stent in STEMI-PCI: the HAAMU-STENT-study. Presented at the Annual Scientific Meeting of the Trans-catheter Cardiovascular Therapeutics. Washington, DC, October 22-27, 2006.
19. Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006;355:1105-1113. (Pubitemid 44394917)
20. Menichelli M, Parma A, Pucci E, Fiorilli R, De Felice F, Nazzaro M, Giulivi A, Alborino D, Azzellino A, Violini R. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol. 2007;49:1924-1930. (Pubitemid 46694284)
21. Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrie D, Slama MS, Merkely B, Erglis A, Margheri M, Varenne O, Cebrian A, Stoll HP, Snead DB, Bode C. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006;355:1093-1104. (Pubitemid 44394916)
22. Valgimigli M, Campo G, Percoco G, Bolognese L, Vassanelli C, Col-angelo S, de Cesare N, Rodriguez AE, Ferrario M, Moreno R, Piva T, Sheiban I, Pasquetto G, Prati F, Nazzaro MS, Parrinello G, Ferrari R. Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myo-cardial infarction: the MULTISTRATEGY randomized trial. JAMA. 2008;299:1788-1799. (Pubitemid 351549970)
23. Valgimigli M, Percoco G, Malagutti P, Campo G, Ferrari F, Barbieri D, Cicchitelli G, McFadden EP, Merlini F, Ansani L, Guardigli G, Bettini A, Parrinello G, Boersma E, Ferrari R. Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. JAMA. 2005;293:2109-2117. (Pubitemid 40617063)
24. Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007;356:1020-1029. (Pubitemid 46376802)
25. Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myo-cardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007;50:573-583. (Pubitemid 47198999)
26. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007;369:667-678. (Pubitemid 46281313)
27. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005;293:2126-2130. (Pubitemid 40617065)
28. Kannel WB, McGee DL. Diabetes and cardiovascular disease: the Fra-mingham Study. JAMA. 1979;241:2035-2038. (Pubitemid 9228506)
29. Kirtane AJ, Ellis SG, Dawkins K, Colombo A, Grube E, Popma J, Fahy M, Leon MB, Moses JW, Mehran R, Stone GW. Paclitaxel-eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials. J Am Coll Cardiol. 2008;51:708-715. (Pubitemid 351227416)
30. Garg P, Normand SL, Silbaugh TS, Wolf RE, Zelevinsky K, Lovett A, Varma MR, Zhou Z, Mauri L. Drug-eluting or bare-metal stenting in patients with diabetes mellitus: results from the Massachusetts Data Analysis Center Registry. Circulation. 2008;118:2277-2285
31. Douglas PS, Brennan JM, Anstrom KJ, Sedrakyan A, Eisenstein EL, Haque G, Dai D, Kong DF, Hammill B, Curtis L, Matchar D, Brindis R, Peterson ED. Clinical effectiveness of coronary stents in elderly persons: results from 262,700 Medicare patients in the American College of Cardiology-National Cardiovascular Data Registry. J Am Coll Cardiol. 2009;53:1629-1641.
32. Patterson C, Mapera S, Li HH, Madamanchi N, Hilliard E, Lineberger R, Herrmann R, Charles P. Comparative effects of paclitaxel and rapamycin on smooth muscle migration and survival: role of AKT-dependent signaling. Arterioscler Thromb Vasc Biol. 2006;26:1473-1480. (Pubitemid 44288971)
33. Finn AV, John M, Nakazawa G, Polavarapu R, Karmali V, Xu X, Cheng Q, Davis T, Raghunathan C, Acampado E, Ezell T, Lajoie S, Eppihimer M, Kolodgie FD, Virmani R, Gold HK. Differential healing after sirolimus, paclitaxel, and bare metal stent placement in combination with peroxisome proliferator-activator receptor y agonists: requirement for mTOR/Akt2 in PPARy activation. Circ Res. 2009; 105:1003-1012.
34. Killip T III, Kimball JT. Treatment of myocardial infarction in a coronary care unit: a two year experience with 250 patients. Am J Cardiol. 1967; 20:457-464.
35. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344-2351. (Pubitemid 46685903)