THE EFFECTS OF CLINICAL, LABORATORY, and ANGIOGRAPHIC FACTORS ON STENT THROMBOSIS and MAJOR ADVERSE CARDIAC EVENTS IN PACLITAXEL ELUTING STENTS

Hasan Çağlayan Kandemir, Nart Zafer Baytugan

 

ABSTRACT

Background: Drug-eluting stents (DES) have higher marked efficacy and lower revascularization requirements compared to bare metal stents (BMS). We aimed to determine the mid-term outcomes of patients implanted with first-generation DES “paclitaxel-eluting stents” (PES).

 Methods: Patients with at least 1 PES implanted in our cardiology clinic were received in the non-randomized group. Inclusion criteria were all patients undergoing percutaneous coronary intervention and PES implantation. The mean follow-up time was 35.14 + 13.4 months.

Results: A total of 302 patients (401 lesions and 337 PES) were enrolled in the study. The mean age was 61.86 + 10.27 years. Major adverse cardiac and cerebrovascular events (MACE) occurred at 17.9%, and the stent thrombosis rate was 4%. Independent predictors of stent thrombosis were serum creatinine levels [OR 1.59; 95% CI, 1.03-2.46, p=0.03] and mean platelet volume [OR 1.59; 95% CI, 1.03–2.46, p= 0.03]. Also, poor functional capacity [OR 2.46: 95% CI, 1.42- 4.26, p<0.001] and positive ischemia test [OR 3.43: 95% CI, (1.73-6.82), p<0.001] were predictors of MACE’s.

Conclusions: We have demonstrated that PES is safe and effective in the mid-term for use in coronary artery disease.

 

KEYWORDS

Paclitaxel, restenosis, thrombosis, real-world
 

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REFERENCES


1.     Ahadi F, Azadi M, Biglari M, Bodaghi M, Khaleghian A. Evaluation of coronary stents: A review of types, materials, processing techniques, design, and problems. Heliyon. 2023;9(2):e13575. doi: 10.1016/j.heliyon.2023.e13575.

 

 

2.     Chhabra L, Zain MA, Siddiqui WJ. Coronary Stents. 2023 Jan 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan

 

 

3.     Kuramitsu S, Sonoda S, Ando K, Otake H, Natsuaki M, Anai R, et al. Drug-eluting stent thrombosis: current and future perspectives. Cardiovasc Interv Ther. 2021;36(2):158-68. doi: 10.1007/s12928-021-00754-x.

 

 

4.     Condello F, Spaccarotella  C, Sorrentino S, Indolfi C, Stefanini GG, Polimeni A. Stent thrombosis and restenosis with contemporary drug-eluting stents: predictors and current evidence.  J Clin Med. 2023;12(3):1238. doi: 10.3390/jcm12031238.

 

 

5.     Laskey WK, Yancy CW, Maisel WH. Thrombosis in coronary drug-eluting stents: report from the meeting of the Circulatory System Medical Devices Advisory Panel of the Food and Drug Administration Center for Devices and Radiologic Health, December 7– 8, 2006.Circulation. 2007;115:2352–7. doi: 10.1161/CIRCULATIONAHA.107.688416.

 

 

6.     Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018;39(2):119-77. doi: 10.1093/eurheartj/ehx393.

 

 

7.     Collet J.-P., Thiele H. Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation and coexistent atrial fibrillation-Dual versus triple antithrombotic therapy. Eur. Heart J.Eur Heart J. 2021;42(20):2020-1. doi: 10.1093/eurheartj/ehaa909.

 

 

8.     Bosco E, Hsueh L, McConeghy KW, Gravenstein S, Saade E. Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review. BMC Med Res Methodol. 2021;21(1):241. doi: 10.1186/s12874-021-01440-5.

 

 

9.     Sousa A, Costa R, Moreira AC, Cano M, Maldonado G, Costa RA, et al. Long-term clinical outcomes of the drug-eluting stents in the real world (DESIRE) Registry. J Interven Cardiol. 2008;21(4):307– 14.doi: 10.1111/j.1540-8183.2008.00379.x.

 

 

10.  Marzocchi A, Saia F, Piovaccari G, Manari A, Aurier E, Benassi A, et al. Long-term safety and efficacy of drug-eluting stents two-year results of the REAL (REgistro AngiopLastiche dell’Emilia Romagna) Multicenter Registry. Circulation. 2007;115(25):3181-8. doi: 10.1161/CIRCULATIONAHA.106.667592.

 

 

11.  Lasala JM, Cox DA, Dobies D,Muhlestein JB, Katopodis JN, Revtyak G,et al. Usage patterns and 2-year outcomes with the TAXUS Express Stent: Results of the US ARRIVE 1 Registry. Catheter  Cardiovasc Interv. 2008;72(4):433–45.doi: 10.1002/ccd.21618.

 

 

12.   Yamaji K, Räber L, Zanchin T, Spitzer E, Zanchin C, Pilgrim T, et al. Ten-year clinical outcomes of first-generation drug-eluting stents: the Sirolimus-Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) VERY LATE trial. Eur Heart J. 2016;37(45):3386-95.doi: 10.1093/eurheartj/ehw343.

 

 

13.  Galløe AM, Kelbæk H, Thuesen L, Hansen HS, Ravkilde J, Hansen PR, et al. 10-year clinical outcome after randomization to treatment by sirolimus- or paclitaxel-eluting coronary ctents. J Am Coll Cardiol. 2017;69(6):616-24. doi: 10.1016/j.jacc.2016.11.055.

 

 

14.  Räber L, Wohlwend L, Wigger M,Togni M, Wandel S, Wenaweser P,et al. Five-year clinical and angiographic outcomes of a randomized comparison of sirolimus-eluting and paclitaxel-eluting stents: results of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization LATE trial. Circulation. 2011;123(24):2819-28. doi:10.1161/CIRCULATIONAHA.110.004762. 

 

 

15.  Simsek C, Magro M, Boersma E, Onuma Y, Nauta ST, Gaspersz MP,et al. The unrestricted use of sirolimus- and paclitaxel-eluting stents results in better clinical outcomes during 6-year follow-up than bare-metal stents: an analysis of the RESEARCH (Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital) and T-SEARCH (Taxus-Stent Evaluated At Rotterdam Cardiology Hospital) registries. JACC Cardiovasc Interv. 2010;3(10):1051-8. doi: 10.1016/j.jcin.2010.08.003.

 

 

16.  Park H, Kang DY, Kim SO, Lee J, Kim JH, Hyun J et al.  Ten-year outcomes of early generation sirolimus- versus paclitaxel-eluting stents in patients with left main coronary artery disease. Catheter Cardiovasc Interv. 2021;98(5):E705-14. doi: 10.1002/ccd.29930.

 

 

17.  Giacoppo D, Alvarez-Covarrubias HA, Koch T, Cassese S, Xhepa E, Kessler T, et al. Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial. Eur Heart J. 2023; 44(15):1343-57. doi: 10.1093/eurheartj/ehad026.

 

 

18.  Thuijs DJFM, Kappetein AP, Serruys PW, Mohr FW, Morice MC, Mack MJ, et al. Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial. Lancet. 2019;394(10206):1325-34. doi: 10.1016/S0140-6736(19)31997-X.

 

 

19.   S. Cook, E. Ladich, G. Nakazawa, Eshtehardi P, Neidhart M, Vogel R, et al. Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation. 2009;120(5):391-9. doi: 10.1161/CIRCULATIONAHA.109.854398.

 

 

20.  De la Torre-Herna´ndez JM, Alfonso F, Herna´ndez F, Elizaga J, Sanmartin M, Pinar E,et al. Drug-eluting stent thrombosis: Results from the multicenter Spanish Registry ESTROFA. J Am Coll Cardiol. 2008;51(10):986–90.doi: 10.1016/j.jacc.2007.10.057.

 

 

21.  Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, Rumsfeld JS, et al. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: Results from the PREMIER Registry. Circulation. 2006;113(24):2803-09.doi: 10.1161/CIRCULATIONAHA.106.618066

 

 

22.  Pfisterer M, Brunner-La Rocca HP, Rickenbacher P, Hunziker P, Mueller C, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: An observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006;48(12):2584–91.doi: 10.1016/j.jacc.2006.10.026.

 

 

23.  Tanzilli G, Greco C, Pelliccia F, Pasceri V, Barillà F, Paravati V, et al. Effectiveness of two-year clopidogrel + aspirin in abolishing the risk of very late thrombosis after drug-eluting stent implantation (from the TYCOON [two-year ClOpidOgrel need] study). Am J Cardiol. 2009;104(10):1357-61. doi: 10.1016/j.amjcard.2009.07.002.

 

 

24.  Slottow TLP, Steinberg DH, Roy PK, Buch AN, Okabe T, Xue Z,et al. Observations and outcomes of definite and probable drug-eluting stent thrombosis seen at a single hospital in a four-year period. Am J Cardiol. 2008;102(3):298–03. doi: 10.1016/j.amjcard.2008.03.055.

 

 

25.  Gyöngyösi M, Christ G, Lang I, Kreiner G, Sochor H, Probst P, et al. AUTAX Investigators. 2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study JACC Cardiovasc Interv. 2009;2(8):718-27.doi: 10.1016/j.jcin.2009.05.019.

 

 

26.   Waksman R, Kirtane AJ, Torguson R, Cohen DJ, Ryan T, Räber L, et al. Correlates and outcomes of late and very late drug-eluting stent thrombosis: results from DESERT (International Drug-Eluting Stent Event Registry of Thrombosis). JACC Cardiovasc Interv. 2014;7(10):1093-102. doi: 10.1016/j.jcin.2014.04.017

 

 

27.  Bundhun PK, Wu ZJ, Chen MH.  Is there any significant difference in stent thrombosis between sirolimus and paclitaxel eluting stents?: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2016;95(5):e2651.

 

 

doi: 10.1097/MD.0000000000002651.

 

 

28.  Sleiman E, Tabet R, Karam B, Ayad D, Royzman R.  Extremely late in-stent thrombosis 12 years after implantation of a drug-eluting stent. Cureus. 2020;12(7):e9053. doi: 10.7759/cureus.9053..

 

 

29.  Barbato E, Mehilli J, Sibbing D, Siontis GCM, Collet JP, Thiele H,et al. ESC Scientific Document Group. Questions and answers on antithrombotic therapy and revascularization strategies in non-ST-elevation acute coronary syndrome (NSTE-ACS): a companion document of the 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021;42(14):1368-78.doi: 10.1093/eurheartj/ehaa601.

 

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