A clinical and angiographic study of the XIENCE v everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease. Study design and rationale of the EXECUTIVE trial

Journal of Cardiovascular Medicine

Volumn 11, Issue 4, 2010, Pages 299-309

  Ribichini, Flavio ^a   Ansalone, Gerardo ^b   Bartorelli, Antonio ^c   Beqaraj, Federico ^d   Berni, Andrea ^e   Colangelo, Salvatore ^f   D'Amico, Maurizio ^g   Rovere, Francesco Della ^h   Fiscella, Antonio ⁱ   Gabrielli, Gabriele ^j   Indolfi, Ciro ^k   La Vecchia, Luigi ^l   Loschiavo, Paolo ^m   Marinoni, Giampietro ⁿ   Marzocchi, Antonio ^o   Milazzo, Diego ^p   Romano, Michele ^q   Sangiorgio, Pietro ^r   Sheiban, Imad ^s   Tamburino, Corrado ^t   Tuccillo, Bernardino ^u   Villani, Rosvaldo ^v   Cappi, Barbara ^w   Quijada, Maria Josè Lopera ^w   Vassanelli, Corrado ^a   more..

^a UNIVERSITY OF VERONA   (Italy)

^b Ospedale Madre G Vannini   (Italy)

^c CENTRO CARDIOLOGICO MONZINO   (Italy)

^d MARIA VITTORIA HOSPITAL   (Italy)

^e SAPIENZA UNIVERSITY OF ROME   (Italy)

^f Ospedale S Giovanni Bosco   (Italy)

^g MOLINETTE HOSPITAL   (Italy)

^h GALLIERA HOSPITAL   (Italy)

ⁱ CANNIZZARO HOSPITAL   (Italy)

^j OSPEDALI RIUNITI   (Italy)

^k UNIVERSITY MAGNA GRAECIA OF CATANZARO   (Italy)

^l Ospedale di Vicenza   (Spain)

^m SANDRO PERTINI HOSPITAL   (Italy)

ⁿ AO della Provincia di Pavia Ospedale di Voghera   (Italy)

^o UNIVERSITY OF BOLOGNA   (Italy)

^p Azienda Ospedaliera San Giovanni di Dio   (Italy)

^q Azienda Ospedaliera Carlo Poma   (United States)

^r MAGGIORE HOSPITAL   (Italy)

^s Azienda Ospedaliera Universitaria San Giovanni Battista   (Italy)

^t UNIVERSITY OF CATANIA   (Italy)

^u Ospedale Loreto Mare   (Italy)

^v AO della Provincia di Pavia Ospedale di Vigevano   (Italy)

^w ABBOTT DIAGNOSTICS   (Italy)

more..

Author keywords

Coronary artery disease; Drug eluting stent; Multivessel disease; Randomized clinical trial

Indexed keywords

EVEROLIMUS;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG ELUTING STENT; DRUG SAFETY; HEART INJURY; HUMAN; LABORATORY TEST; MAJOR CLINICAL STUDY; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; REVASCULARIZATION;

ANGIOGRAPHY; BLOOD VESSEL PROSTHESIS IMPLANTATION; CORONARY ARTERY DISEASE; COST-BENEFIT ANALYSIS; DRUG-ELUTING STENTS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MYOCARDIAL REVASCULARIZATION; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SIROLIMUS;

EID: 77949464550     PISSN: 15582027     EISSN: None     Source Type: Journal    
DOI: 10.2459/JCM.0b013e3283331e69     Document Type: Article

References (34)

1. Bell MR, Gersh BJ, Schaff HV, Holmes DR Jr, Fisher LD, Alderman EL, et al. Effect of completeness of revascularization on long-term outcome of patients with three-vessel disease undergoing coronary artery bypass surgery: a report from the Coronary Artery Surgery Study (CASS) registry. Circulation 1992; 86:446-457.
2. Silber S, Albertsson P, Avilé s FF, Camici PG, Colombo A, Hamm C, et al. Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J 2005; 26:804-847.
3. Serruys PW, Unger F, Sousa JE, Jatene A, Bonnier HJ, Schonberger JP, et al. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med 2001; 344:1117-1124.
4. Booth J, Clayton T, Pepper J, Nugara F, Flather M, Sigwart U, et al., SoS Investigators. Randomized, controlled trial of coronary artery bypass surgery versus percutaneous coronary intervention in patients with multivessel coronary artery disease: six-year follow-up from the Stent or Surgery trial (SoS). Circulation 2008; 118:381-388.
5. Rodriguez AE, Baldi J, Fernandez Pereira C, Navia J, Rodriguez Alemparte M, Delacasa A, et al. Five-year follow-up of the Argentine randomized trial of coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II). J Am Coll Cardiol 2005; 46:582-588.
6. Morrison DA, Sethi G, Sacks J, Henderson W, Grover F, Sedlis S, et al., Angina with Extremely Serious Operative Mortality Evaluation (AWESOME). Percutaneous coronary intervention versus coronary artery bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass: a multicenter, randomized trial. Investigators of the Department of Veterans Affairs Cooperative Study #385, the Angina with Extremely Serious Operative Mortality Evaluation (AWESOME). J Am Coll Cardiol 2001; 38:143-149.
7. Daemen J, Boersma E, Flather M, Booth J, Stables R, Rodriguez A, et al. Long-term safety and efficacy of percutaneous coronary intervention with stenting and coronary artery bypass surgery for multivessel coronary artery disease: a meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS trials. Circulation 2008; 118:1146-1154.
8. Hlatky MA, Boothroyd DB, Bravata DM, Boersma E, Booth J, Brooks MM, et al. Coronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease: a collaborative analysis of individual patient data from ten randomised trials. Lancet 2009; 373:1190-1197.
9. Ong ATL, Serruys PW, Mohr FW, Morice MC, Kappeten AP, Holmes DR, et al. The SYNergy Between Percutaneous Coronary Intervention with TAXus and Cardiac Surgery (SYNTAX) study: design, rationale, and run-in phase. Am Heart J 2006; 151:1194-1204.
10. Farkouh ME, Dangas G, Leon MB, Smith C, Nesto R, Buse JB, et al. Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of multivessel disease (FREEDOM) trial. Am Heart J 2008; 155:215-223.
11. Kapur A, Malik IS, Bagger JP, Anderson JR, Kooner JS, Thomas M, et al. The Coronary Artery Revascularisation in Diabetes (CARDia) trial: background, aims, and design. Am Heart J 2005; 149:13-19.
12. Serruys PW, Lemos PA, van Hout BA, Arterial Revascularisation Therapies Study part II Steering Committee and Investigators. Sirolimus eluting stent implantation for patients with multivessel disease: rationale for the Arterial Revascularisation Therapies study part II (ARTS II). Heart 2004; 90:995-998.
13. Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, et al., for the SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009; 360:961-972.
14. Beatt KJ. The Coronary Artery Revascularisation in Diabetes (CARDia) trial. Presented at TCT 2008. http://www.tctmd.com/Show.aspx?id=70382 (accessed 18 October 2009).
15. Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, et al. Sirolimus vs paclitaxel-eluting stents in de novo coronary artery lesions. The REALITY trial: a randomized controlled trial. JAMA 2006; 295:895-904.
16. Windecker S, Remondino A, Eberli FR, Jüni P, Räber L, Wenaweser P, et al. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med 2005; 353:653-662.
17. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002; 346:1773-1780.
18. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, et al., for the SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in native coronary arteries. N Engl J Med 2003; 349:1315-1323.
19. Schofer J, Schluter M, Gershilck AH, Wijns W, Garcia E, Schampaert E, et al., for the E-SIRIUS Investigators. Sirolimus-eluting stents for the treatment of patients with long atherosclerotic lesions in small coronary arteries: a double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003; 362:1093-1099.
20. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, et al., for the TAXUS-IV Investigators. A Polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004; 350:221-231.
21. Dawkins KD, Grube E, GuagliumiG, Banning AP, Zmudka K, Colombo A, et al., on behalf of the TAXUS VI Investigators. Clinical efficacy of polymerbased paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial. Circulation 2005; 112:3306-3313.
22. Nakazawa G, Finn AV, Ladich E, Ribichini F, Coleman L, Kolodgie FD, et al. Drug eluting stent safety: findings from preclinical studies. Expert Rev Cardiovasc Ther 2008; 6:1379-1391.
23. Serruys PW, Ruygrok P, Neuzner J, Desaga M, van den Branden F, Rasmussen K, et al. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: the SPIRIT II trial. Eurointervention 2006; 2:286-294.
24. Ruygrok P, Desaga M, van den Branden F, Rasmussen K, Suryapranata H, Dorange C, et al. One year clinical follow-up of the XIENCE V EECSS everolimus-eluting stent system in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II study. Eurointervention 2007; 3:315-320.
25. Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, et al., SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA 2008; 299:1903-1913.
26. Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, et al., SPIRIT III Investigators. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial. Circulation 2009; 119:680-686.
27. van den Brand MJ, Rensing BJ, Morel MA, Foley DP, de Valk V, Breeman A, et al. The effect of completeness of revascularization on event-free survival at one year in the ARTS trial. J Am Coll Cardiol 2002; 39:559-564.
28. Nashef SAM, Roques F, Gauducheau E, Lemeshow S, Salamon R, the EuroSCORE study group. European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg 1999; 16:9-13.
29. Sianos G, Morel M-A, Kappetein AP, Morice M-C, Colombo A, Dawkins K, et al. The SYNTAX score: an angiographic tool grading the complexity of coronary artery disease. Eurointervention 2005; 2:219-227.
30. Pocock SJ, Lansky AJ, Mehran R, Popma JJ, Fahy MP, Na Y, et al. Angiographic surrogate end points in drug-eluting stent trials. J Am Coll Cardiol 2008; 51:23-32.
31. Mauri L, Orav J, Kuntz RE. Late loss in lumen diameter and binary restenosis for drug-eluting stent comparisons. Circulation 2005; 111:3435-3442.
32. Ellis SG, Popma JJ, Lasala JM, Koglin JJ, Cox DA, Hermiller J, et al. Relationship between angiographic late loss and target lesion revascularization after coronary stent implantation. Analysis from the Taxus-IV trial. J Am Coll Cardiol 2005; 45:1193-1200.
33. Cutlip DE, Windeker S, Merhan R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials. A case for standardized definitions. Circulation 2007; 115:2344-2351.
34. Hintze J. NCSS and PASS. Number Cruncher Statistical Systems. Kaysville, Utah; 2001 (release date 2 August 2002).