Outcomes after revascularisation with everolimus- And sirolimus-eluting stents in patients with acute coronary syndromes and stable angina pectoris: A substudy of the SORT OUT IV trial

EuroIntervention

Volumn 10, Issue 2, 2014, Pages 212-223

  Antonsen, Lisbeth ^a   Thayssen, Per ^a   Hansen, Henrik S ^a   Maeng, Michael ^a   Tilsted, Hans Henrik ^b   Bøtker, Hans E ^b   Ravkilde, Jan ^b   Madsen, Morten ^b   Sørensen, Henrik T ^b   Thuesen, Leif ^b   Lassen, Jens F ^b   Jensen, Lisette O ^a  

^a ODENSE UNIVERSITY HOSPITAL   (Denmark)

^b AARHUS UNIVERSITY HOSPITAL   (Denmark)

Author keywords

Acute coronary syndromes; Clinical outcomes; Everolimus eluting stents; Sirolimus eluting stents; Stable angina pectoris

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; EVEROLIMUS; FIBRINOGEN RECEPTOR ANTAGONIST; HEPARIN; RAPAMYCIN; ANTITHROMBOCYTIC AGENT;

ACUTE CORONARY SYNDROME; ADULT; AGED; ARTICLE; CARDIOVASCULAR RISK; CHARLSON COMORBIDITY INDEX; CLINICAL EFFECTIVENESS; COMORBIDITY; COMPARATIVE STUDY; CONTROLLED STUDY; DEVICE SAFETY; DRUG ELUTING STENT; FEMALE; HEART DEATH; HEART INFARCTION; HUMAN; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; REVASCULARIZATION; RISK ASSESSMENT; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STABLE ANGINA PECTORIS; STENT THROMBOSIS; THERAPY EFFECT; ANALOGS AND DERIVATIVES; ANGINA, STABLE; CHI SQUARE DISTRIBUTION; CLINICAL TRIAL; CORONARY STENOSIS; CORONARY THROMBOSIS; DENMARK; MIDDLE AGED; MORTALITY; MYOCARDIAL INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; PROPORTIONAL HAZARDS MODEL; PROSPECTIVE STUDY; PROSTHESIS; RISK; RISK FACTOR; TIME; TREATMENT OUTCOME;

ACUTE CORONARY SYNDROME; AGED; ANGINA, STABLE; CHI-SQUARE DISTRIBUTION; CORONARY STENOSIS; CORONARY THROMBOSIS; DENMARK; DRUG-ELUTING STENTS; FEMALE; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; ODDS RATIO; PERCUTANEOUS CORONARY INTERVENTION; PLATELET AGGREGATION INHIBITORS; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; RISK FACTORS; SIROLIMUS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84905484108     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV10I2A35     Document Type: Article

References (45)

1. Kastrati A, Mehilli J, Pache J, Kaiser C, Valgimigli M, Kelbæk H, Menichelli M, Sabaté M, Suttorp MJ, Baumgart D, Seyfarth M, Pfisterer ME, Schömig A. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007;356:1030-9.
2. Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock ST, Mehran R, Leon MB. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007;356:998-1008. (Pubitemid 46376800)
3. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans. Delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006;48:193-202. (Pubitemid 43929240)
4. Räber L, Jüni P, Nüesch E, Kalesan B, Wenaweser P, Moschovitis A, Khattab AA, Bahlo M, Togni M, Cook S, Vogel R, Seiler C, Meier B, Windecker S. Long-term comparison of everolimus-eluting and sirolimus-eluting stents for coronary revascularisation. J Am Coll Cardiol. 2011;57:2143-51.
5. Alfonso F, Fernandez C. Second-generation drug-eluting stents. Moving the field forward. J Am Coll Cardiol. 2011;58:26-9.
6. Stone GW, Rizvi A, Sudhir K, Newman W, Applegate RJ, Cannon LA, Maddux JT, Cutlip DE, Simonton CA, Sood P, Kereiakes DJ; SPIRIT Investigators. Randomized comparison of everolimus- and paclitaxel-eluting stents. 2-year follow-up from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial. J Am Coll Cardiol. 2011;58:19-25.
7. Smits PC, Kedhi E, Royaards KJ, Joesoef KS, Wassing J, Rademaker-Havinga TA, McFadden E. 2-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice. COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTÉ stent in all-comers: a randomized open label trial). J Am Coll Cardiol. 2011;58:11-8.
8. Aldous S, Smyth D, Blake J, McClean D, Elliott J. The real world experience of the everolimus-eluting coronary stent system: audit of everolimus-eluting coronary stents. J Interv Cardiol. 2011;24:241-6.
9. Baber U, Mehran R, Sharma SK, Brar S, Yu J, Suh JW, Kim HS, Park SJ, Kastrati A, De Waha A, Krishnan P, Moreno P, Sweeny J, Kim MC, Kini AS, Dangas GD. Impact of the everolimus-eluting stent on stent thrombosis. A meta-analysis of 13 randomised trials. J Am Coll Cardiol. 2011;58:1569-77.
10. Joner M, Nakazawa G, Finn AV, Quee SC, Coleman L, Acampado E, Wilson PS, Skorija K, Cheng Q, Xu X, Gold HK, Kolodgie FD, Virmani R. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol. 2008;52:333-42. (Pubitemid 352001347)
11. De Waha A, Dibra A, Byrne RA, Ndrepepa G, Mehilli J, Fusaro M, Laugwitz KL, Massberg S, Schömig A, Kastrati A. Everolimus-eluting versus sirolimus-eluting stents. A meta-analysis of randomised trials. Circ Cardiovasc Interv. 2011;4:371-7.
12. Byrne RA, Kastrati A, Massberg S, Wieczorek A, Laugwitz KL, Hadamitzky M, Schulz S, Pache J, Fusaro M, Hausleiter M, Schömig A, Mehilli J. Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease. 3-year outcomes from a randomized clinical trial. J Am Coll Cardiol. 2011;58:1325-31.
13. Burzotta F, Trani C, Todaro D, Mariani L, Talarico GP, Tommasino A, Giammarinaro M, Niccoli G, Porto I, Leone AM, Mongiardo R, Mazzari MA, Schiavoni G, Crea F. Prospective randomised comparison of sirolimus- or everolimus-eluting stent to treat bifurcated lesions by provisional approach. JACC Cardiovasc Interv. 2011;4:327-35.
14. Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Seung KB, Yang TH, Lee SG, Lee JH, Seong IW, Cheong SS, Lee BK, Lee NH, Lee SW, Lee SW, Lee K, Kim HS, Jeon DS, Kim MK, Nah DY, Tahk SJ, Park SJ. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions. A randomised LONGDES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial. JACC Cardiovasc Interv. 2011;4:1096-103.
15. Kim WJ, Lee SW, Park SW, Kim YH, Yun SC, Lee JY, Park DW, Kang SJ, Lee CW, Lee JH, Choi SW, Seong IW, Lee BK, Lee NH, Cho YH, Shin WY, Lee SJ, Lee SW, Hyon MS, Bang DW, Park WJ, Kim HS, Chae JK, Lee K, Park HK, Park CB, Lee SG, Kim MK, Park KH, Choi YJ, Cheong SS, Yang TH, Jang JS, Her SH, Park SJ; ESSENCE-DIABETES Study Investigators. Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): results from the ESSENCE-DIABETES trial. Circulation. 2011;124:886-92.
16. Park KW, Chae IH, Lim DS, Han KR, Yang HM, Lee HY, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Jo SH, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee, NH, Jeon DW, Gwon HC, Jang YS, Kim HS. Everolimuseluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: the EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) randomized trial. J Am Coll Cardiol. 2011;58:1844-54.
17. Jensen LO, Thayssen P, Tilsted HH, Ravkilde J, Junker A, Hansen HS, Hansen KN, Pedersen KE, Sørensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome SORT OUT IV investigators. Rationale and design of a randomized clinical comparison of everolimus-eluting (Xience v/Promus) and sirolimus-eluting (cypher select+) coronary stents in unselected patients with coronary heart disease. Cardiology. 2010;116:73-8.
18. Jensen LO, Thayssen P, Hansen HS, Christiansen EH, Tilsted HH, Krusell LR, Villadsen AB, Junker A, Hansen KN, Kaltoft A, Maeng M, Pedersen KE, Kristensen SD, Bøtker HE, Ravkilde J, Sanchez R, Aarøe J, Madsen M, Sørensen HT, Thuesen L, Lassen JF; Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV) Investigators. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012;125:1246-55.
19. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, Van Es GA, Steg G, 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;115:2344-51. (Pubitemid 46685903)
20. Mosbech J, Joergensen J, Madsen M, Rostgaard K, Thornberg K, Poulsen TD. The national patient registry. Evaluation of data quality. Ugeskr Laeger. 1995;157:3741-5.
21. Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994;47:1245-51. (Pubitemid 24361532)
22. Frank L. Epidemiology. When an entire country is a cohort. Science. 2000;287:2398-9. (Pubitemid 30185417)
23. Kaltoft A, Jensen LO, Maeng M, Tilsted HH, Thayssen P, Bottcher M, Lassen JF, Krusell LR, Rasmussen K, Hansen KN, Pedersen L, Johnsen SP, Soerensen HT, Thuesen L. Two year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry). J Am Coll Cardiol. 2009;53:658-64.
24. Jensen LO, Maeng M, Kaltoft A, Thayssen P, Hansen HH, Bottcher M, Lassen JF, Krusell LR, Rasmussen K, Hansen KN, Pedersen L, Johnsen SP, Soerensen HT, Thuesen L. Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions. J Am Coll Cardiol. 2007;50:463-70. (Pubitemid 47088133)
25. Andersen TF, Madsen M, Joergensen J, Mellemkjoer L, Olsen JH. The Danish National Hospital Register. A valuable source of data for modern health sciences. Dan Med Bull. 1999;46:263-8. (Pubitemid 29299976)
26. Juel K, Helweg-Larsen K. The Danish registers of causes of death. Dan Med Bull. 1999;46:354-7. (Pubitemid 29439149)
27. Gooley TA, Leisenring W, Crowley J, Storer BE. Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Stat Med. 1999;18:695-706. (Pubitemid 29126745)
28. Chitkara K, Pujara K. Drug-eluting Stents in Acute Coronary Syndrome: Is There a Risk of Stent Thrombosis with Second-Generation Stents? Eur J Cardiovasc Med. 2010;1:20-24.
29. Inoue K. Drug-eluting stents are not indicated for patients with acute coronary syndrome - should drug-eluting stents be indicated for patients with acute coronary syndrome? Circ J. 2010;74:2232-8.
30. Planer D, Smits PC, Keraiakes DJ, Kedhi E, Fahy M, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011;4:1104-15.
31. Claessen BE, Beijk MA, Legrand V, Ruzyllo W, Manari A, Varenne O, Suttorp MJ, Tijssen JG, Miguel-Hebert K, Veldhof S, Henriques JP, Serreys 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 Interv. 2009;2:339-47.
32. 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;119:680-6.
33. 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;299:1903-13. (Pubitemid 351574920)
34. Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010;362:1663-74.
35. Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010;375:201-9.
36. Kalesan B, Stefanini GG, Räber L, Schmutz M, Baumgartner S, Hitz S, Baldinger SH, Pilgrim T, Moschovitis A, Wenaweser P, Büllesfeld L, Khattab AA, Meier B, Jüni P, Windecker S. Long-term comparison of everolimus- and sirolimus-eluting stents in patients with acute coronary syndromes. JACC Cardiovasc Interv. 2010;5:145-54.
37. Silber S, Windecker S, Vranckx P, Serruys PW; RESOLUTE All Comers investigators. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial. Lancet. 2011;377:1241-7.
38. von Birgelen C, Basalus MW, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JH, Linssen GC, Saïd SA, Kleijne MA, Sen H, Löwik MM, van der Palen J, Verhorst PM, de Man FH. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. J Am Coll Cardiol. 2012;59:1350-61.
39. Kedhi E, Gomes M, Joesoef KS, Wassing J, Goedhart D, McFadden E, Smits PC. Everolimus-eluting stents and paclitaxeleluting stents in patients presenting with myocardial infarction: insights from the two-year results of the COMPARE prospective randomised controlled trial. EuroIntervention. 2012;7:1376-85.
40. Mahmoudi M, Delhaye C, Waksman R. Safety and efficacy of drug-eluting stents and bare metal stents in acute coronary syndrome. Cardiovasc Revasc Med. 2011;12:385-90.
41. Kukreja N, Onuma Y, Garcia-Garcia HM, Daemen J, Domburg RV, Serruys PW. The risk of stent thrombosis in patients with acute coronary syndromes treated with bare-metal and drug-eluting stents. JACC Cardiovasc Interv. 2009;2:534-41.
42. 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 pratice: data from a large two-institutional cohort study. Lancet. 2007;369:667-78. (Pubitemid 46281313)
43. Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, Coleman L, Wong GK, Edelman ER. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011;123:1400-9.
44. Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D Ascenzo F, Kimura T, Briguori C, Sabatè M, Kim HS, De Waha A, Smits PC, Kaiser C, Sardella G, Marullo A, Kirtane AJ, Leon MB, Stone GW. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379:1393-402.
45. Räber L, Magro M, Stefanini GG, Kalesan B, van Domburg RT, Onuma Y, Wenaweser P, Daemen J, Meier B, Jüni P, Serruys PW, Windecker S. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents. A prospective cohort study. Circulation. 2012;125:1110-21.