Relationship of late loss in lumen diameter to coronary restenosis in sirolimus-eluting stents

Circulation

Volumn 111, Issue 3, 2005, Pages 321-327

  Mauri, Laura ^a,b,c   Orav, E John ^a,b   O'Malley, A James ^b   Moses, Jeffrey W ^d   Leon, Martin B ^d   Holmes Jr , David R ^e   Teirstein, Paul S ^f   Schofer, Joachim ^g   Breithardt, Günter ^h   Cutlip, Donald E ^b,c,i   Kereiakes, Dean J ^j   Shi, Chunxue ^c   Firth, Brian G ^k   Donohoe, Dennis J ^a,b   Kuntz, Richard E ^a,b,c  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c HARVARD CLINICAL RESEARCH INSTITUTE   (United States)

^d LENOX HILL HEART AND VASCULAR INSTITUTE   (United States)

^e MAYO CLINIC   (United States)

^f SCRIPPS CLINIC   (United States)

^g Ctr Cardiol and Vasc Intervention   (Germany)

^h UNIVERSITY HOSPITAL MÜNSTER   (Germany)

ⁱ BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^j Ohio Heart and Vascular Center   (United States)

^k Department of Medical Affairs and Health Ecomomics Worldwide   (United States)

more..

Author keywords

Angioplasty; Restenosis; Stents

Indexed keywords

RAPAMYCIN;

ARTICLE; BLOOD VESSEL DIAMETER; CINEANGIOGRAPHY; CONTROLLED STUDY; CORONARY ARTERY OBSTRUCTION; CORONARY BLOOD VESSEL; DRUG ELUTING STENT; HUMAN; IMPLANTATION; IN-STENT RESTENOSIS; MAJOR CLINICAL STUDY; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RELIABILITY;

CORONARY RESTENOSIS; FOLLOW-UP STUDIES; HUMANS; PROBABILITY; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS; REGRESSION ANALYSIS; SIROLIMUS; STENTS;

EID: 19944430230     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.CIR.0000153356.72810.97     Document Type: Article

References (40)

1. Kuntz RE, Baim DS. Defining coronary restenosis: newer clinical and angiographic paradigms. Circulation. 1993;88:1310-1323.
2. Kimura T, Yokoi H, Nakagawa Y, Tamura T, Kaburagi S, Sawada Y, Sato Y, Hamasaki N, Nosaka H, Nobuyoshi M. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med. 1996;334:561-566.
3. Gordon PC, Friedrich SP, Piana RN, Kugelmass AD, Leidig GA, Gibson CM, Cohen DJ, Carrozza JP, Kuntz RE, Baim DS. Is 40% to 70% diameter narrowing at the site of previous stenting or directional coronary atherectomy clinically significant? Am J Cardiol. 1994;74:26-32.
4. Cutlip DE, Chauhan MS, Baim DS, Ho KK, Popma JJ, Carrozza JP, Cohen DJ, Kuntz RE. Clinical restenosis after coronary stenting: perspectives from multicenter clinical trials. J Am Coll Cardiol. 2002;40:2082-2089.
5. Baim DS, Cutlip DE, Midei M, Linnemeier TJ, Schreiber T, Cox D, Kereiakes D, Popma JJ, Robertson L, Prince R, Lansky AJ, Ho KK, Kuntz RE. Final results of a randomized trial comparing the MULTI-LINK stent with the Palmaz-Schatz stent for narrowings in native coronary arteries. Am J Cardiol. 2001;87:157-162.
6. Baim DS, Cutlip DE, O'Shaughnessy CD, Hermiller JB, Kereiakes DJ, Giambartolomei A, Katz S, Lansky AJ, Fitzpatrick M, Popma JJ, Ho KK, Leon MB, Kuntz RE. Final results of a randomized trial comparing the NIR stent to the Palmaz-Schatz stent for narrowings in native coronary arteries. Am J Cardiol. 2001;87:152-156.
7. Mauri L, Bonan R, Weiner BH, Legrand V, Bassand JP, Popma JJ, Niemyski P, Prpic R, Ho KK, Chauhan MS, Cutlip DE, Bertrand OF, Kuntz RE. Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial. Am J Cardiol. 2002;90:1079-1083.
8. Mauri L, Reisman M, Buchbinder M, Popma JJ, Sharma SK, Cutlip DE, Ho KK, Prpic R, Zimetbaum PJ, Kuntz RE. Comparison of rotational atherectomy with conventional balloon angioplasty in the prevention of restenosis of small coronary arteries: results of the Dilatation vs Ablation Revascularization Trial Targeting Restenosis (DART). Am Heart J. 2003;145:847-854.
9. Baim DS, Cutlip DE, Sharma SK, Ho KK, Fortuna R, Schreiber TL, Feldman RL, Shani J, Senerchia C, Zhang Y, Lansky AJ, Popma JJ, Kuntz RE. Final results of the Balloon vs Optimal Atherectomy Trial (BOAT). Circulation. 1998;97:322-331.
10. 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. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315-1323.
11. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russel ME. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350:221-230.
12. Lemos PA, Serruys PW, van Domburg RT, Saia F, Arampatzis CA, Hoye A, Degertekin M, Tanabe K, Daemen J, Liu TK, McFadden E, Sianos G, Hofma SH, Smits PC, van der Giessen WJ, de Feyter PJ. Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the "real world": the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Circulation. 2004;109:190-195.
13. Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004;109:1244-1249.
14. Hoye A, Tanabe K, Lemos PA, Aoki J, Saia F, Arampatzis C, Degertekin M, Hofma SH, Sianos G, McFadden E, van der Giessen WJ, Smits PC, de Feyter PJ, van Domburg RT, Serruys PW. Significant reduction in restenosis after the use of sirolimus-eluting stents in the treatment of chronic total occlusions. J Am Coll Cardiol. 2004;43:1954-1958.
15. Saia F, Lemos PA, Hoye A, Sianos G, Arampatzis CA, de Feyter PJ, van der Giessen WJ, Smits PC, van Domburg RT, Serruys PW. Clinical outcomes for sirolimus-eluting stent implantation and vascular brachytherapy for the treatment of in-stent restenosis. Catheter Cardiovasc Interv. 2004;62:283-288.
16. Tanabe K, Serruys PW, Grube E, Smits PC, Selbach G, van der Giessen WJ, Staberock M, de Feyter P, Muller R, Regar E, Degertekin M, Ligthart JM, Disco C, Backx B, Russell ME. TAXUS III trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation. 2003;107:559-564.
17. Moussa I, Leon MB, Baim DS, O'Neill WW, Popma JJ, Buchbinder M, Midwall J, Simonton CA, Keim E, Wang P, Kuntz RE, Moses JW. Impact of sirolimus-eluting stents on outcome in diabetic patients: a SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) substudy. Circulation. 2004;109:2273-2278.
18. Cohen DJ, Bakhai A, Shi C, Githiora L, Lavelle T, Berezin RH, Leon MB, Moses JW, Carrozza JP Jr, Zidar JP, Kuntz RE. Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) Trial. Circulation. 2004;110:508-514.
19. Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G. 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.
20. Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G, Deligonul U, Topol EJ, Bulle TM, for the Multivessel Angioplasty Prognosis Study Group. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease: implications for patient selection. Circulation. 1990;82:1193-1202.
21. Ryan TJ, Faxon DP, Gunnar RM, Kennedy JW, King SB III, Loop FD, Peterson KL, Reeves TJ, Williams DO, Winters WL Jr. Guidelines for percutaneous transluminal coronary angioplasty: a report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty). Circulation. 1988;78:486-502.
22. Popma JJ. Coronary angiography and intravascular ultrasonography. In: Braunwald E, Zipes DP, Libby P, eds. Heart Disease. 6th ed. New York, NY: WB Saunders; 2001:414.
23. van der Zwet PM, Reiber JH. A new approach for the quantification of complex lesion morphology: the gradient field transform: basic principles and validation results. J Am Coll Cardiol. 1994;24:216-224.
24. 23a. Popma JJ, Leon MB, Moses JW, Holmes DR Jr, Cox N, Fitzpatrick M, Douglas J, Lambert C, Mooney M, Yakubov S, Kuntz RE. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries. Circulation. 2004;110:3773-3780.
25. Efron B, Tibshirani RJ. An Introduction to the Bootstrap. New York, NY: Chapman & Hal; 1993.
26. Kuntz RE, Gibson CM, Nobuyoshi M, Baim DS. Generalized model of restenosis after conventional balloon angioplasty, stenting and directional atherectomy. J Am Coll Cardiol. 1993;21:15-25.
27. Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser R, Almond D, Teirstein PS, Fish RD, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S, for the Stent Restenosis Study Investigators. A randomized comparison of coronary-stem placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med. 1994;331:496-501.
28. Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, Berlardi J, Sigwart U, Columbo A, Goy JJ, van den Heuvel P, Delcan J, Morel MA. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med. 1994;331:489-495.
29. Kuntz RE, Safian RD, Levine MJ, Reis GJ, Diver DJ, Baim DS. Novel approach to the analysis of restenosis after the use of three new coronary devices. J Am Coll Cardiol. 1992;19:1493-1499.
30. Gordon PC, Gibson CM, Cohen DJ, Carrozza JP, Kuntz RE, Baim DS. Mechanisms of restenosis and redilation within coronary stents: quantitative angiographic assessment. J Am Coll Cardiol. 1993;21:1166-1174.
31. Post MJ, de Smet BJ, van der Helm Y, Borst C, Kuntz RE. Arterial remodeling after balloon angioplasty or stenting in an atherosclerotic experimental model. Circulation. 1997;96:996-1003.
32. Rensing BJ, Hermans WR, Deckers JW, de Feyter PJ, Tijssen JG, Serruys PW. Lumen narrowing after percutaneous transluminal coronary balloon angioplasty follows a near gaussian distribution: a quantitative angiographic study in 1,445 successfully dilated lesions. J Am Coll Cardiol. 1992;19:939-945.
33. Kereiakes DJ, Cox DA, Hermiller JB, Midei MG, Bachinsky WB, Nukta ED, Leon MB, Fink S, Marin L, Lansky AJ. Usefulness of a cobalt chromium coronary stent alloy. Am J Cardiol. 2003;92:463-466.
34. Kastrati A, Mehilli J, Dirschinger J, Dotzer F, Schuhlen H, Neumann FJ, Fleckenstein M, Pfafferott C, Seyfarth M, Schomig A. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial. Circulation. 2001;103:2816-2821.
35. Kastrati A, Dirschinger J, Boekstegers P, Elezi S, Schuhlen H, Pache J, Steinbeck G, Schmitt C, Ulm K, Neumann FJ, Schomig A. Influence of stent design on 1-year outcome after coronary stent placement: a randomized comparison of five stent types in 1,147 unselected patients. Catheter Cardiovasc Interv. 2000;50:290-297.
36. Lansky AJ, Roubin GS, O'Shaughnessy CD, Moore PB, Dean LS, Raizner AE, Safian RD, Zidar JP, Kerr JL, Popma JJ, Mehran R, Kuntz RE, Leon MB. Randomized comparison of GR-II stent and Palmaz-Schatz stent for elective treatment of coronary stenoses. Circulation. 2000;102:1364-1368.
37. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773-1780.
38. O'Malley AJ, Normand SL, Kuntz RE. Application of models for multivariate mixed outcomes to medical device trials: coronary artery stenting. Stat Med. 2003;22:313-336.
39. 32P radioactive beta-emitting stent implantation in patients with coronary artery disease: the Milan Dose-Response Study. Circulation. 2000;101:18-26.
40. Serruys PW. ACTION trial. Presented at: European Society of Cardiology Congress, Berlin, Germany, August 31 to September 4, 2002.