Five-year long-term clinical follow-up of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: The SPIRIT FIRST trial

Catheterization and Cardiovascular Interventions

Volumn 75, Issue 7, 2010, Pages 997-1003

  Wiemer, Marcus ^a   Serruys, Patrick W ^b   Miquel Hebert, Karine ^c   Neumann, Franz Josef ^d   Piek, Jan J ^e   Grube, Eberhard ^f   Haase, Jürgen ^g   Thuesen, Leif ^h   Hamm, Christian ⁱ  

^a RUHR UNIVERSITY BOCHUM   (Germany)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c ABBOTT VASCULAR   (United States)

^d UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

^e ACADEMIC MEDICAL CENTER   (Netherlands)

^f Heart Center Siegburg   (Germany)

^g Group Practice and Centre for Allergy Respiratory and Sleep Medicine   (Germany)

^h AARHUS UNIVERSITY HOSPITAL   (Denmark)

ⁱ KERCKHOFF HEART CENTER   (Germany)

Author keywords

Coronary artery disease; Drug eluting stents; Percutaneous coronary intervention

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; EVEROLIMUS;

ADULT; ARTERY LESION; ARTICLE; BARE METAL STENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG ELUTING STENT; FEASIBILITY STUDY; FEMALE; FOLLOW UP; HEART DEATH; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REVASCULARIZATION; SINGLE BLIND PROCEDURE; STENT THROMBOSIS; TARGET VESSEL REVASCULARIZATION; TREATMENT DURATION; TREATMENT OUTCOME; VASCULAR DISEASE;

EID: 77952777950     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.22428     Document Type: Article

References (28)

1. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME; TAXUS II Study Group. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003;108:788-794. (Pubitemid 37022118)
2. Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. TAXUS I: Six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation 2003;107:38-42. (Pubitemid 36070930)
3. Meredith IT, Ormiston J, Whitbourn R, Kay IP, Muller D, Bonan R, Popma JJ, Cutlip DE, Fitzgerald P, Prpic R, Kuntz RE. First-in-human study of the Endeavor ABT-578-eluting phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions: Endeavor I trial. EuroIntervention 2005;1:157-164.
4. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R; RAVEL Study Group. Randomized study with the Sirolimus-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-1780.
5. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus- eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315-1323.
6. Schampaert E, Cohen EA, Schluter M, Reeves F, Traboulsi M, Title LM, Kuntz RE, Popma JJ; C-SIRIUS Investigators. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol 2004;43:1110-1115. (Pubitemid 38352997)
7. Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: Double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003;362:1093-1099. (Pubitemid 37222332)
8. Stone GW, Ellis SG, Cox DA, Hermiller J, O'shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: The TAXUS-IV trial. Circulation 2004;109: 1942-1947.
9. Stone GW, Ellis SG, Cox DA, Hermiller J, O'shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221-231.
10. Aoki J, Colombo A, Dudek D, Banning AP, Drzewiecki J, Zmudka K, Schiele F, Russell ME, Koglin J, Serruys PW; TAXUS II Study Group. Peristent remodeling and neointimal suppression 2 years after polymer-based, paclitaxel-eluting stent implantation: Insights from serial intravascular ultrasound analysis in the TAXUS II study. Circulation 2005;112:3876-3883. (Pubitemid 43739485)
11. Morice MC, Serruys PW, Barragan P, Bode C, Van Es GA, Stoll HP, Snead D, Mauri L, Cutlip DE, Sousa E. Long-term clinical outcomes with sirolimus-eluting coronary stents-five-year results of the RAVEL trial. J Am Coll Cardiol 2007;50:1299-1304. (Pubitemid 47454687)
12. Sousa JE, Costa MA, Sousa AG, Abizaid AC, Seixas AC, Abizaid AS, Feres F, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW. Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary arteries. Circulation 2003;107:381-383. (Pubitemid 36158039)
13. Weisz G, Leon MB, Holmes DR Jr, Kereiakes DJ, Clark MR, Cohen BM, Ellis SG, Coleman P, Hill C, Shi C, Cutlip DE, Kuntz RE, Moses JW. Two-year outcomes after sirolimus-eluting stent implantation: Results from the sirolimus-eluting stent in de novo native coronary lesions (SIRIUS) trial. J Am Coll Cardiol 2006;47:1350-1355.
14. Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: A cause for concern. Circulation 2007;115:1440-1455. (Pubitemid 46648381)
15. Serruys PW, Ong AT, Piek JJ Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher A, Grube E, Haase J, Thuesen L, Hamm C, Otto-Terlouw PC. A randomized comparison of a durable polymer Everolimus elutings stent with a bare metal coronary stent: The SPIRIT first trial. EuroIntervention 2005;1:58-65.
16. Tsuchida K, Piek JJ, Neuman F, van der Giessen WJ, Wiemer M, Zeiher AM, Grube E, Haase J, Thuesen L, Hamm CW, Veldhof S, Dorange C, Serruys PW. One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings. The SPIRIT FIRST trial. EuroIntervention 2005;1: 266-272.
17. Beijk MA, Neumann FJ, Wiemer M, Grube E, Haase J, Thuesen L, Hamm C, Veldhof S, Dorange C, Serruys PW, Piek JJ. Two-year results of a durable polymer everolimus-eluting stent in de novo coronary artery stenosis (The SPIRIT FIRST trial). EuroIntervention 2005;3:206-212.
18. Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; 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. (Pubitemid 351574920)
19. Ruygrok P, Desaga M, van den Branden F, Rasmussen K, Suryapranata H, Dorange C, Veldhof S, Serruys PW. One year clinical follow-up of the XIENCE V 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.
20. Stone GW. SPIRIT IV - A prospective, randomized trial comparing an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease - One year clinical results. Presented at TCT 2009, San Francisco, CA.
21. Farb A, John M, Acampado E, Kolodgie FD, Prescott MF, Virmani R. Oral everolimus inhibits in-stent neointimal growth. Circulation 2002;106:2379-2384. (Pubitemid 35244741)
22. 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; Academic Research Consortium. Clinical end points in coronary stent trials: A case for standardized definitions. Circulation 2007;115: 2344-2351. (Pubitemid 46685903)
23. Claessen BM, Beijk MA, Legrand V, Ruzyllo W, Manari A, Varenne O, Suttorp MJ, Tjssen JGP, Miquel-Hebert K, Veldhof S, Henriques JPS, Serruys PW, Piek JJ. Two-year clinical, angiographic and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: The SPIRIT II trial. Circ Cardiovasc Intervent 2009;2:339-347.
24. Garg S, Serruys PW, Onuma Y, Dorange C, Veldhof S, Miquel- Hebert K, Sudhir K, Boland J, Huber K, Garcia E, te Riele JAM. Three year clinical follow up of the XIENCE V Everolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions. JACC Cardiovasc Interv 2009; in press.
25. Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Caputo R, Xenopoulos N, Applegate R, Gordon P, White RM, Sudhir K, Cutlip DE, Petersen JL; 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.
26. Stone GW. The XIENCE V/PROMUS Everolimus-eluting stent: Comprehensive update of the clinical trial program - Featuring the first presentation of the SPIRIT III 3-year results. Presented at TCT 2009, San Francisco, CA.
27. Silber S, Colombo A, Banning AP, Hauptmann K, Drzewiecki J, Grube E, Dudek D, Baim DS. Final 5-year results of the TAXUS II trial: A randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for de novo coronary artery lesions. Circulation 2009;120: 1498-1504.
28. Grube E, Dawkins K, Guagliumi G, Banning A, Zmudka K, Colomba A, Thuesen L, Hauptman K, Marco J, Wijns W, Joshi A Mascioli S. TAXUS VI final 5-year results: A multicentre, randomized trial comparing polymer-based moderate-release paclitaxel-eluting stent with a bare metal stent for treatment of long, complex coronary artery lesions. EuroIntervention 2009;4:572-577.