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Open Access 01-09-2018 | Original Paper

Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents

Authors: Christoph Varenhorst, Martin Lindholm, Giovanna Sarno, Göran Olivecrona, Ulf Jensen, Johan Nilsson, Jörg Carlsson, Stefan James, Bo Lagerqvist

Published in: Clinical Research in Cardiology | Issue 9/2018

Abstract

Objectives

Old-generation drug-eluting coronary stents (o-DES) have despite being safe and effective been associated with an increased propensity of late stent thrombosis (ST). We evaluated ST rates in o-DES, new-generation DES (n-DES) and bare metal stents (BMS) the first year (< 1 year) and beyond 1 year (> 1 year).

Methods

We evaluated all implantations with BMS, o-DES (Cordis Cypher, Boston Scientific Taxus Liberté and Medtronic Endeavor) and n-DES in the Swedish coronary angiography and angioplasty registry (SCAAR) between 1 January 2007 and 8 January 2014 (n = 207 291). All cases of ST (n = 2 268) until 31 December 2014 were analyzed.

Results

The overall risk of ST was lower in both n-DES and o-DES compared with BMS up to 1 year (n-DES versus BMS: adjusted risk ratio (RR) 0.48 (0.41–0.58) and o-DES versus BMS: 0.56 (0.46–0.67), both p < 0.001). From 1 year after stent implantation and onward, the risk for ST was higher in o-DES compared with BMS [adjusted RR, 1.82 (1.47–2.25], p < 0.001). N-DES were associated with similar low ST rates as BMS from 1 year and onward [adjusted RR 1.21 (0.94–1.56), p = 0.135].

Conclusion

New-generation DES were associated with lower ST rates in comparison to BMS during the first-year post-stenting. After 1 year, n-DES and BMS were associated with similar ST rates.

Trial Registration

This study was a retrospective observational study and as such did not require clinical trial database registration.

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Nabel EG, Braunwald E (2012) A tale of coronary artery disease and myocardial infarction. N Engl J Med 366:54–63CrossRefPubMed

Stefanini GG, Holmes DR Jr. (2013) Drug-eluting coronary-artery stents. N Engl J Med 368:254–265CrossRefPubMed

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, Investigators T-I (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350:221–231CrossRefPubMed

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, Investigators S (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349:1315–1323CrossRefPubMed

Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD (2004) Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation 109:701–705CrossRefPubMed

Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL (2006) Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med 119:1056–1061CrossRefPubMed

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 (2007) 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 369:667–678CrossRefPubMed

Lagerqvist B, James SK, Stenestrand U, Lindback J, Nilsson T, Wallentin L, Group SS (2007) Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 356:1009–1019CrossRefPubMed

James SK, Stenestrand U, Lindback J, Carlsson J, Schersten F, Nilsson T, Wallentin L, Lagerqvist B, Group SS (2009) Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden. N Engl J Med 360:1933–1945CrossRefPubMed

10.

O’Brien B, Zafar H, Ibrahim A, Zafar J, Sharif F (2016) Coronary stent materials and coatings: a technology and performance update. Ann Biomed Eng 44:523–535CrossRefPubMed

11.

Nakazawa G (2011) Stent thrombosis of drug eluting stent: pathological perspective. J Cardiol 58:84–91CrossRefPubMed

12.

Nakazawa G, Otsuka F, Nakano M, Vorpahl M, Yazdani SK, Ladich E, Kolodgie FD, Finn AV, Virmani R (2011) The pathology of neoatherosclerosis in human coronary implants bare-metal and drug-eluting stents. J Am Coll Cardiol 57:1314–1322CrossRefPubMedPubMedCentral

13.

Jernberg T, Attebring MF, Hambraeus K, Ivert T, James S, Jeppsson A, Lagerqvist B, Lindahl B, Stenestrand U, Wallentin L (2010) The Swedish web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart 96:1617–1621CrossRefPubMed

14.

Meredith IT, Teirstein PS, Bouchard A, Carrie D, Mollmann H, Oldroyd KG, Hall J, Allocco DJ, Dawkins KD, Stone GW (2014) Three-year results comparing platinum-chromium PROMUS element and cobalt-chromium XIENCE V everolimus-eluting stents in de novo coronary artery narrowing (from the PLATINUM Trial). Am J Cardiol 113:1117–1123CrossRefPubMed

15.

Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD (2015) Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv 8 e002372

16.

Danzi GB, Piccolo R, Chevalier B, Urban P, Fath-Ordoubadi F, Carrie D, Wiemer M, Serra A, Wijns W, Kala P, Stabile A, Goicolea Ruigomez J, Sagic D, Laanmets P, Strupp G, West N, Nobori I (2016) Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients. Heart

17.

Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, Carrie D, Ando K, Merkely B, Kornowski R, Eltchaninoff H, James S, Wijns W, Investigators CI (2014) A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical evaluation of new terumo drug-eluting coronary stent system in the treatment of patients with coronary artery disease) trial. Eur Heart J 35:2021–2031CrossRefPubMedPubMedCentral

18.

Cassese S, Kufner S, Xhepa E, Byrne RA, Kreutzer J, Ibrahim T, Tiroch K, Valgimigli M, Tolg R, Fusaro M, Schunkert H, Laugwitz KL, Mehilli J, Kastrati A (2016) Three-year efficacy and safety of new- versus early-generation drug-eluting stents for unprotected left main coronary artery disease insights from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 trials. Clin Res Cardiol 105:575–584CrossRefPubMed

19.

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, Botker HE, Ravkilde J, Sanchez R, Aaroe J, Madsen M, Sorensen HT, Thuesen L, Lassen JF, Scandinavian Organization for Randomized Trials With Clinical Outcome IVI (2012) Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the scandinavian organization for randomized trials with clinical outcome IV (SORT OUT IV). Circulation 125:1246–1255CrossRefPubMed

20.

Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC (2010) Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet 375:201–209CrossRefPubMed

21.

Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S (2010) Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 363:136–146CrossRefPubMed

22.

Taniwaki M, Stefanini GG, Silber S, Richardt G, Vranckx P, Serruys PW, Buszman PE, Kelbaek H, Windecker S, Investigators RA-C (2014) 4-year clinical outcomes and predictors of repeat revascularization in patients treated with new-generation drug-eluting stents: a report from the RESOLUTE All-Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent with an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). J Am Coll Cardiol 63:1617–1625CrossRefPubMed

23.

Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gomez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW (2012) Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet 380:1482–1490CrossRefPubMed

24.

Raber L, Kelbaek H, Ostojic M, Baumbach A, Heg D, Tuller D, von Birgelen C, Roffi M, Moschovitis A, Khattab AA, Wenaweser P, Bonvini R, Pedrazzini G, Kornowski R, Weber K, Trelle S, Luscher TF, Taniwaki M, Matter CM, Meier B, Juni P, Windecker S, Investigators CAT (2012) Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial. JAMA 308:777–787CrossRefPubMed

25.

Sabate M, Raber L, Heg D, Brugaletta S, Kelbaek H, Cequier A, Ostojic M, Iniguez A, Tuller D, Serra A, Baumbach A, von Birgelen C, Hernandez-Antolin R, Roffi M, Mainar V, Valgimigli M, Serruys PW, Juni P, Windecker S (2014) Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials. JACC Cardiovasc Interv 7:55–63CrossRefPubMed

26.

Palmerini T, Benedetto U, Biondi-Zoccai G, Della Riva D, Bacchi-Reggiani L, Smits PC, Vlachojannis GJ, Jensen LO, Christiansen EH, Berencsi K, Valgimigli M, Orlandi C, Petrou M, Rapezzi C, Stone GW (2015) Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol 65:2496–2507CrossRefPubMed

27.

Holmes DR Jr, Kereiakes DJ, Garg S, Serruys PW, Dehmer GJ, Ellis SG, Williams DO, Kimura T, Moliterno DJ (2010) Stent thrombosis. J Am Coll Cardiol 56:1357–1365CrossRefPubMed

28.

Lee SY, Hong MK, Shin DH, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Kim HS, Valgimigli M, Palmerini T, Stone GW (2017) Clinical outcomes of dual antiplatelet therapy after implantation of drug-eluting stents in patients with different cardiovascular risk factors. Clin Res Cardiol 106:165–173CrossRefPubMed

29.

Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM, Investigators T-T (2007) Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 357:2001–2015CrossRefPubMed

30.

Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA, Investigators P, Freij A, Thorsen M (2009) Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 361:1045–1057CrossRefPubMed

31.

Sahlen A, Varenhorst C, Lagerqvist B, Renlund H, Wallentin L, James SK, Jernberg T (2016) Contemporary use of ticagrelor in patients with acute coronary syndrome: insights from Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART). Eur Heart J Cardiovasc Pharmacother 2:5–12CrossRefPubMed

32.

Piccolo R, Pilgrim T, Heg D, Franzone A, Rat-Wirtzler J, Raber L, Silber S, Serruys PW, Juni P, Windecker S (2015) Comparative effectiveness and safety of new-generation versus early-generation drug-eluting stents according to complexity of coronary artery disease: a patient-level pooled analysis of 6,081 Patients. JACC Cardiovasc Interv 8:1657–1666CrossRefPubMed

33.

Bonaa KH, Mannsverk J, Wiseth R, Aaberge L, Myreng Y, Nygard O, Nilsen DW, Klow NE, Uchto M, Trovik T, Bendz B, Stavnes S, Bjornerheim R, Larsen AI, Slette M, Steigen T, Jakobsen OJ, Bleie O, Fossum E, Hanssen TA, Dahl-Eriksen O, Njolstad I, Rasmussen K, Wilsgaard T, Nordrehaug JE, Investigators N (2016) Drug-eluting or bare-metal stents for coronary artery disease. N Engl J Med 375:1242–1252CrossRefPubMed

34.

Sarno G, Lagerqvist B, Frobert O, Nilsson J, Olivecrona G, Omerovic E, Saleh N, Venetzanos D, James S (2012) Lower risk of stent thrombosis and restenosis with unrestricted use of ‘new-generation’ drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J 33:606–613CrossRefPubMed

35.

Sarno G, Lagerqvist B, Nilsson J, Frobert O, Hambraeus K, Varenhorst C, Jensen UJ, Todt T, Gotberg M, James SK (2014) Stent thrombosis in new-generation drug-eluting stents in patients with STEMI undergoing primary PCI: a report from SCAAR. J Am Coll Cardiol 64:16–24CrossRefPubMed

Title: Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents
Authors: Christoph Varenhorst
Martin Lindholm
Giovanna Sarno
Göran Olivecrona
Ulf Jensen
Johan Nilsson
Jörg Carlsson
Stefan James
Bo Lagerqvist
Publication date: 01-09-2018
Publisher: Springer Berlin Heidelberg
Published in: Clinical Research in Cardiology / Issue 9/2018
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-018-1252-0

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Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents

Abstract

Objectives

Methods

Results

Conclusion

Trial Registration

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Abstract

Objectives

Methods

Results

Conclusion

Trial Registration

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