Top

Published in:

01-02-2021 | Heart Surgery | Original Paper

Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial

Authors: Gert Richardt, Mohammad Abdelghani, Abdelhakim Allali, Ralph Toelg, Mohamed Abdellaoui, Florian Krackhardt, Rune Wiseth, Marie-Claude Morice, Samuel Copt, Hans-Peter Stoll, Philip Urban

Published in: Clinical Research in Cardiology | Issue 2/2021

Abstract

Aims

To compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS.

Methods

This is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR).

Results

Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178–1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079—0.996], p = 0.036), and BARC 3–5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012–12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947).

Conclusions

Among patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.

Graphic abstract

Available only for authorised users

Hawn MT, Graham LA, Richman JS, Itani KM, Henderson WG, Maddox TM (2013) Risk of major adverse cardiac events following noncardiac surgery in patients with coronary stents. JAMA 310(14):1462–1472. https://doi.org/10.1001/jama.2013.278787CrossRefPubMed

Gandhi NK, Abdel-Karim AR, Banerjee S, Brilakis ES (2011) Frequency and risk of noncardiac surgery after drug-eluting stent implantation. Catheter Cardiovasc Interv 77(7):972–976. https://doi.org/10.1002/ccd.22744CrossRefPubMed

Hawn MT, Graham LA, Richman JR, Itani KM, Plomondon ME, Altom LK et al (2012) The incidence and timing of noncardiac surgery after cardiac stent implantation. J Am Coll Surg. 214(4):658–666. https://doi.org/10.1016/j.jamcollsurg.2011.12.011(discussion 66-7)CrossRefPubMed

Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R et al (2010) Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med 362(18):1663–1674. https://doi.org/10.1056/NEJMoa0910496CrossRefPubMed

Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S et al (2007) Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 357(20):2001–2015. https://doi.org/10.1056/NEJMoa0706482CrossRefPubMed

Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D et al (2019) Defining high bleeding risk in patients undergoing percutaneous coronary intervention. Circulation 140(3):240–261. https://doi.org/10.1161/CIRCULATIONAHA.119.040167CrossRefPubMedPubMedCentral

Colleran R, Kastrati A (2018) Percutaneous coronary intervention: balloons, stents and scaffolds. Clin Res Cardiol 107(Suppl 2):55–63. https://doi.org/10.1007/s00392-018-1328-xCrossRefPubMed

Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A et al (2018) 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 39(3):213–260. https://doi.org/10.1093/eurheartj/ehx419CrossRefPubMed

Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B et al (2011) 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol 58(24):e44–122. https://doi.org/10.1016/j.jacc.2011.08.007CrossRefPubMed

10.

Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA et al (2016) 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 68(10):1082–1115. https://doi.org/10.1016/j.jacc.2016.03.513CrossRefPubMed

11.

Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B et al (2014) 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol 64(22):e77–137. https://doi.org/10.1016/j.jacc.2014.07.944CrossRefPubMed

12.

Varenhorst C, Lindholm M, Sarno G, Olivecrona G, Jensen U, Nilsson J et al (2018) Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents. Clin Res Cardiol 107(9):816–823. https://doi.org/10.1007/s00392-018-1252-0CrossRefPubMedPubMedCentral

13.

Hidvegi R, Puelacher C, Gualandro DM, Lampart A, Lurati Buse G, Hammerer-Lerchner A et al (2020) Obesity paradox and perioperative myocardial infarction/injury in non-cardiac surgery. Clin Res Cardiol. https://doi.org/10.1007/s00392-020-01605-0CrossRefPubMed

14.

Berger PB, Kleiman NS, Pencina MJ, Hsieh WH, Steinhubl SR, Jeremias A et al (2010) Frequency of major noncardiac surgery and subsequent adverse events in the year after drug-eluting stent placement results from the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) Registry. JACC Cardiovasc Interv 3(9):920–927. https://doi.org/10.1016/j.jcin.2010.03.021CrossRefPubMed

15.

Kaluza GL, Joseph J, Lee JR, Raizner ME, Raizner AE (2000) Catastrophic outcomes of noncardiac surgery soon after coronary stenting. J Am Coll Cardiol 35(5):1288–1294CrossRef

16.

Siller-Matula JM, Petre A, Delle-Karth G, Huber K, Ay C, Lordkipanidze M et al (2017) Impact of preoperative use of P2Y12 receptor inhibitors on clinical outcomes in cardiac and non-cardiac surgery: a systematic review and meta-analysis. Eur Heart J Acute Cardiovasc Care 6(8):753–770. https://doi.org/10.1177/2048872615585516CrossRefPubMed

17.

Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C et al (2015) Polymer-free drug-coated coronary stents in patients at high bleeding risk. N Engl J Med 373(21):2038–2047. https://doi.org/10.1056/NEJMoa1503943CrossRefPubMed

18.

Tada N, Virmani R, Grant G, Bartlett L, Black A, Clavijo C et al (2010) Polymer-free biolimus a9-coated stent demonstrates more sustained intimal inhibition, improved healing, and reduced inflammation compared with a polymer-coated sirolimus-eluting cypher stent in a porcine model. Circ Cardiovasc Interv 3(2):174–183. https://doi.org/10.1161/CIRCINTERVENTIONS.109.877522CrossRefPubMed

19.

Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A et al (2017) 2-year outcomes of high bleeding risk patients after polymer-free drug-coated stents. J Am Coll Cardiol 69(2):162–171. https://doi.org/10.1016/j.jacc.2016.10.009CrossRefPubMed

20.

Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD et al (2012) Third universal definition of myocardial infarction. J Am Coll Cardiol 60(16):1581–1598. https://doi.org/10.1016/j.jacc.2012.08.001CrossRefPubMed

21.

Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA et al (2007) Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115(17):2344–2351. https://doi.org/10.1161/CIRCULATIONAHA.106.685313CrossRefPubMed

22.

Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J et al (2011) Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation 123(23):2736–2747. https://doi.org/10.1161/CIRCULATIONAHA.110.009449CrossRefPubMed

23.

Merritt JC, Bhatt DL (2004) The efficacy and safety of perioperative antiplatelet therapy. J Thromb Thrombolysis 17(1):21–27. https://doi.org/10.1023/B:THRO.0000036025.07348.f1CrossRefPubMed

24.

Burger W, Chemnitius JM, Kneissl GD, Rucker G (2005) Low-dose aspirin for secondary cardiovascular prevention—cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation—review and meta-analysis. J Intern Med 257(5):399–414. https://doi.org/10.1111/j.1365-2796.2005.01477.xCrossRefPubMed

25.

Mehran R, Baber U, Steg PG, Ariti C, Weisz G, Witzenbichler B et al (2013) Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. Lancet 382(9906):1714–1722. https://doi.org/10.1016/S0140-6736(13)61720-1CrossRefPubMed

26.

Richardt G, Maillard L, Nazzaro MS, Abdel-Wahab M, Carrie D, Iniguez A et al (2019) Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial. Clin Res Cardiol 108(1):31–38. https://doi.org/10.1007/s00392-018-1308-1CrossRefPubMed

27.

Kaiser C, Galatius S, Erne P, Eberli F, Alber H, Rickli H et al (2010) Drug-eluting versus bare-metal stents in large coronary arteries. N Engl J Med 363(24):2310–2319. https://doi.org/10.1056/NEJMoa1009406CrossRefPubMed

28.

Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R et al (2020) Polymer-based or polymer-free stents in patients at high bleeding risk. N Engl J Med 382(13):1208–1218. https://doi.org/10.1056/NEJMoa1910021CrossRefPubMed

29.

Lipiecki J, Brunel P, Morice MC, Roguelov C, Walsh SJ, Richardt G et al (2018) Biolimus A9 polymer-free coated stents in high bleeding risk patients undergoing complex PCI: evidence from the LEADERS FREE randomised clinical trial. EuroIntervention 14(4):e418–e425. https://doi.org/10.4244/EIJ-D-18-00293CrossRefPubMed

30.

Egholm G, Kristensen SD, Thim T, Olesen KK, Madsen M, Jensen SE et al (2016) Risk associated with surgery within 12 months after coronary drug-eluting stent implantation. J Am Coll Cardiol 68(24):2622–2632. https://doi.org/10.1016/j.jacc.2016.09.967CrossRefPubMed

31.

Holcomb CN, Graham LA, Richman JS, Rhyne RR, Itani KM, Maddox TM et al (2014) The incremental risk of noncardiac surgery on adverse cardiac events following coronary stenting. J Am Coll Cardiol 64(25):2730–2739. https://doi.org/10.1016/j.jacc.2014.09.072CrossRefPubMed

32.

Mahmoud KD, Sanon S, Habermann EB, Lennon RJ, Thomsen KM, Wood DL et al (2016) Perioperative cardiovascular risk of prior coronary stent implantation among patients undergoing noncardiac surgery. J Am Coll Cardiol 67(9):1038–1049. https://doi.org/10.1016/j.jacc.2015.11.063CrossRefPubMed

33.

Wijeysundera DN, Wijeysundera HC, Yun L, Wasowicz M, Beattie WS, Velianou JL et al (2012) Risk of elective major noncardiac surgery after coronary stent insertion: a population-based study. Circulation 126(11):1355–1362. https://doi.org/10.1161/CIRCULATIONAHA.112.102715CrossRefPubMed

Title: Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial
Authors: Gert Richardt
Mohammad Abdelghani
Abdelhakim Allali
Ralph Toelg
Mohamed Abdellaoui
Florian Krackhardt
Rune Wiseth
Marie-Claude Morice
Samuel Copt
Hans-Peter Stoll
Philip Urban
Publication date: 01-02-2021
Publisher: Springer Berlin Heidelberg
Keywords: Heart Surgery
Myocardial Infarction
Heart Surgery
Published in: Clinical Research in Cardiology / Issue 2/2021
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-020-01672-3

ACC 2024 Congress Coverage

Heart Failure Video

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial

Abstract

Aims

Methods

Results

Conclusions

Graphic abstract

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Aims

Methods

Results

Conclusions

Graphic abstract

Please log in to get access to this content

Other articles of this Issue 2/2021

Causes of death after treatment of small coronary artery disease with paclitaxel-coated balloons

Instant rule-out of suspected non-ST-segment elevation myocardial infarction using high-sensitivity cardiac troponin T with Copeptin versus a single low high-sensitivity cardiac troponin T: findings from a large pooled individual data analysis on 10,329 patients

Genetically determined intelligence and coronary artery disease risk

Long-term safety of paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease: the SPARTAN DCB study

Impact of real-time angiographic co-registered optical coherence tomography on percutaneous coronary intervention: the OPTICO-integration II trial

Acute myocardial infarction due to coronary stent thrombosis in a symptomatic COVID-19 patient

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page