Three years performance of Biodegradable Polymer Sirolimus Eluting Stent in all comer patients undergoing Percutaneous Coronary Intervention.
Main Article Content
Abstract
Introduction: Contemporary evidence suggest the comparable performance of biodegradable polymer sirolimus eluting stents (BPSES) with that of second generation durable polymer drug eluting stents. This study was done to evaluate the performance of BPSES in all comer patients undergoing percutaneous intervention (PCI) in real world setting over a period of three years.
Materials & Methods: This was a prospective observational study, wherein all comer consecutive patients undergoing PCI with BPSES (Yukon Choice Elite stent by Translumina Therapeutics, India) were enrolled and followed up for 3 years. The study's primary endpoint was the Device Oriented Composite Endpoint (DOCE), which included cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR); the co-primary endpoint was the Patient-Oriented Composite Endpoint (POCE), which included all-cause mortality, any MI , and any repeat revascularization and the secondary endpoint was definite or probable stent thrombosis (DST & PST).
Results: 301 patients with 502 lesions were treated with 485 BP-SES. Mean age of the study cohort was 61.6± 9.3 yrs and males were 79.1%. 18.6% patients were diabetic, 29.6% had ejection fraction less than 40% and 73.1% patients presented with acute coronary syndrome (ACS). Majority of the patient had triple vessel disease (TVD) (51.8%), multivessel PCI was done in 15.6% and complex PCI in 26.2% patients. A mean of 1.6 ±0.8 stents per patient with mean diameter 3.0 ± 0.3 mm and mean length of 27.2 ± 0.8 mm were placed. DOCE & POCE occurred in 7.9% (cardiac death-4.8%, TLR-2.6% & target vessel MI-0.4%) and 12.8% (All deaths-9.7%, any MI- 0.4% and any revascularisation-2.6%) patients respectively at three years follow-up. DST & PST rate was 0.9% and 0.4% respectively in the study cohort. All the cases of stent thrombosis occurred within 30 days. Kaplan Meier analysis revealed that diabetes mellitus, low ejection fraction (EF), acute coronary syndrome (ACS), long stents and complex intervention had no impact on occurrence of DOCE & POCE while using BP-SES in all-comer patient population.
Conclusion: Present study showed favourable long term safety and efficacy profile of BP-SES for all-comer patients undergoing PCI.
Keywords:
Biodegradable Polymer Drug Eluting Stent, Durable Polymer Drug Eluting Stent, Biodegradable Polymer Sirolimus Eluting Stent, Durable Polymer Sirolimus Eluting Stent, Bare metal stent, Percutaneous Coronary Intervention, Stent thrombosis, Yukon choice PC Elite
Article Details
How to Cite
SHRIVASTAVA, Abhinav et al.
Three years performance of Biodegradable Polymer Sirolimus Eluting Stent in all comer patients undergoing Percutaneous Coronary Intervention..
Medical Research Archives, [S.l.], v. 11, n. 11, nov. 2023.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/4573>. Date accessed: 23 nov. 2024.
doi: https://doi.org/10.18103/mra.v11i11.4573.
Section
Research Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
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25. Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, et al. 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 Art. European heart journal. 2014 Aug;35(30):2021–31.
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29. Iglesias JF, Muller O, Heg D, Roffi M, Kurz DJ, Moarof I, et al. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial [Internet]. The Lancet. 2019 Oct 5;394(10205): 1243–53. Available from: https://doi.org/10.1016/S0140-6736(19)31877-X
30. Xhepa E, Tada T, Cassese S, King L, Ott I, Fusaro M, et al. Safety and efficacy of the Yukon Choice Flex sirolimus-eluting coronary stent in an all-comers population cohort [Internet]. Indian heart journal. 2014;66(3): 345–9. Available from: https://pubmed.ncbi.nlm.nih.gov/24973842
31. Chevalier B, Smits PC, Carrié D, Mehilli J, Van Boven AJ, Regar E, et al. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Elutin. Circulation Cardiovascular interventions. 2017 Dec;10(12).
32. Kobayashi N, Ito Y, Yamawaki M, Araki M, Sakai T, Sakamoto Y, et al. Very early neointimal coverage of new biodegradable polymer drug-eluting stent compared with durable polymer everolimus-eluting stent evaluated by optical frequency domain imaging. The international journal of cardiovascular imaging. 2018 Apr;34(4):515–22.
33. Lenz T, Koch T, Joner M, Xhepa E, Wiebe J, Coughlan JJ, et al. Ten-Year Clinical Outcomes of Biodegradable Versus Durable Polymer New-Generation Drug-Eluting Stent in Patients With Coronary Artery Disease With and Without Diabetes Mellitus. Journal of the American Heart Association. 2021 Jun; 10(12):e020165.
34. Windecker S, Haude M, Neumann F-J, Stangl K, Witzenbichler B, Slagboom T, et al. Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent [Internet]. Circulation: Cardiovascular Interventions. 2015 Feb 1;8(2):e001441. Available from: https://doi.org/10.1161/CIRCINTERVENTIONS.114.001441
35. Kandzari DE, Mauri L, Koolen JJ, Massaro JM, Doros G, Garcia-Garcia HM, et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial [Internet]. The Lancet. 2017 Oct 21;390(10105):1843–52. Available from: https://doi.org/10.1016/S0140-6736(17)32249-3
36. Buiten RA, Ploumen EH, Zocca P, Doggen CJM, van der Heijden LC, Kok MM, et al. Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial. JAMA cardiology. 2019 Jul;4(7):659–69.
2. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. The New England journal of medicine. 2003 Oct;349(14):1315–23.
3. Morice M-C, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. The New England journal of medicine. 2002 Jun;346(23):1773–80.
4. Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. The New England journal of medicine. 2004 Jan;350(3):221–31.
5. Finn A V, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May;115(18):2435–41.
6. Finn A V, Kolodgie FD, Harnek J, Guerrero LJ, Acampado E, Tefera K, et al. Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation. 2005 Jul;112(2):270–8.
7. Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb;109(6):701–5.
8. Palmerini T, Benedetto U, Biondi-Zoccai G, Della Riva D, Bacchi-Reggiani L, Smits PC, et al. Long-Term Safety of Drug-Eluting and Bare-Metal Stents: Evidence From a Comprehensive Network Meta-Analysis [Internet]. Journal of the American College of Cardiology. 2015;65(23):2496–507. Available from: https://www.sciencedirect.com/science/article/pii/S073510971501918X
9. Jensen LO, Thayssen P, Christiansen EH, Maeng M, Ravkilde J, Hansen KN, et al. Safety and efficacy of everolimus-versus sirolimus-eluting stents: 5-year results from SORT OUT IV. Journal of the American College of Cardiology. 2016;67(7):751–62.
10. Palmerini T, Kirtane AJ, Serruys PW, Smits PC, Kedhi E, Kereiakes D, et al. Stent thrombosis with everolimus-eluting stents: meta-analysis of comparative randomized controlled trials. Circulation: Cardiovascular Interventions. 2012;5(3):357–64.
11. Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. New England Journal of Medicine. 2010;362(18):1663–74.
12. Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trial [Internet]. European Heart Journal. 2012 May 1;33(10):1214–22. Available from: https://doi.org/10.1093/eurheartj/ehs086
13. Bangalore S, Toklu B, Amoroso N, Fusaro M, Kumar S, Hannan EL, et al. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis. Bmj. 2013;347.
14. Mehilli J, Byrne RA, Wieczorek A, Iijima R, Schulz S, Bruskina O, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis [Internet]. European Heart Journal. 2008 Aug 1;29(16):1975–82. Available from: https://doi.org/10.1093/eurheartj/ehn253
15. Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz K-L, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial‡[Internet]. European Heart Journal. 2009 Oct 1;30(20):2441–9. Available from: https://doi.org/10.1093/eurheartj/ehp352
16. El-Hayek G, Bangalore S, Casso Dominguez A, Devireddy C, Jaber W, Kumar G, et al. Meta-analysis of randomized clinical trials comparing biodegradable polymer drug-eluting stent to second-generation durable polymer drug-eluting stents. JACC: Cardiovascular Interventions. 2017;10(5):462–73.
17. Verma B, Patel A, Katyal D, Singh VR, Singh AK, Singh A, et al. Real World Experience of a Biodegradable Polymer Sirolimus-Eluting Stent (Yukon Choice PC Elite) in Patients with Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Angioplasty: A Multicentric Observational Study (The Elite India Study). Open access Macedonian journal of medical sciences. 2019 Apr;7(7):1103–9.
18. Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, et al. Fourth universal definition of myocardial infarction (2018). European heart journal. 2019 Jan;40(3):237–69.
19. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es G-A, et al. Clinical End Points in Coronary Stent Trials [Internet]. Circulation. 2007 May 1;115(17):2344–51. Available from: https://doi.org/10.1161/CIRCULATIONAHA.106.685313
20. Chang CC, Kogame N, Onuma Y, Byrne RA, Capodanno D, Windecker S, et al. Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology [Internet]. EuroIntervention. 17AD Jan;15(13):1190–8. Available from: https://eurointervention.pcronline.com/article/defining-device-success-for-percutaneous-coronary-intervention-trials-aposition-statement-from-the-european-association-of-percutaneous-cardiovascular-interventions-of-the-european-society-of-cardiology
21. Kufner S, Byrne RA, Valeskini M, Schulz S, Ibrahim T, Hoppmann P, et al. Five-year outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease: final results from the ISAR-TEST 4 randomised trial. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2016 Mar;11(12):1372–9.
22. Byrne RA, Kastrati A, Massberg S, Wieczorek A, Laugwitz K-L, Hadamitzky M, et al. 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 [Internet]. Journal of the American College of Cardiology. 2011;58(13):1325–31. Available from: https://www.sciencedirect.com/science/article/pii/S0735109711024259
23. Kufner S, Joner M, Thannheimer A, Hoppmann P, Ibrahim T, Mayer K, et al. Ten-Year Clinical Outcomes From a Trial of Three Limus-Eluting Stents With Different Polymer Coatings in Patients With Coronary Artery Disease [Internet]. Circulation. 2019 Jan 15;139(3):325–33. Available from: https://doi.org/10.1161/CIRCULATIONAHA.118.038065
24. Kim H-S, Kang J, Hwang D, Han J-K, Yang H-M, Kang H-J, et al. Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial. Circulation. 2021 Mar;143(11):1081–91.
25. Saito S, Valdes-Chavarri M, Richardt G, Moreno R, Iniguez Romo A, Barbato E, et al. 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 Art. European heart journal. 2014 Aug;35(30):2021–31.
26. Godino C, Beneduce A, Ferrante G, Ielasi A, Pivato CA, Chiarito M, et al. One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in all-comers population. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry). International journal of cardiology. 2018 Jun;260:36–41.
27. von Birgelen C, Kok MM, van der Heijden LC, Danse PW, Schotborgh CE, Scholte M, et al. Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial. Lancet (London, England). 2016 Nov;388(10060): 2607–17.
28. Pilgrim T, Heg D, Roffi M, Tüller D, Muller O, Vuilliomenet A, et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial. Lancet (London, England). 2014 Dec; 384(9960):2111–22.
29. Iglesias JF, Muller O, Heg D, Roffi M, Kurz DJ, Moarof I, et al. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial [Internet]. The Lancet. 2019 Oct 5;394(10205): 1243–53. Available from: https://doi.org/10.1016/S0140-6736(19)31877-X
30. Xhepa E, Tada T, Cassese S, King L, Ott I, Fusaro M, et al. Safety and efficacy of the Yukon Choice Flex sirolimus-eluting coronary stent in an all-comers population cohort [Internet]. Indian heart journal. 2014;66(3): 345–9. Available from: https://pubmed.ncbi.nlm.nih.gov/24973842
31. Chevalier B, Smits PC, Carrié D, Mehilli J, Van Boven AJ, Regar E, et al. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Elutin. Circulation Cardiovascular interventions. 2017 Dec;10(12).
32. Kobayashi N, Ito Y, Yamawaki M, Araki M, Sakai T, Sakamoto Y, et al. Very early neointimal coverage of new biodegradable polymer drug-eluting stent compared with durable polymer everolimus-eluting stent evaluated by optical frequency domain imaging. The international journal of cardiovascular imaging. 2018 Apr;34(4):515–22.
33. Lenz T, Koch T, Joner M, Xhepa E, Wiebe J, Coughlan JJ, et al. Ten-Year Clinical Outcomes of Biodegradable Versus Durable Polymer New-Generation Drug-Eluting Stent in Patients With Coronary Artery Disease With and Without Diabetes Mellitus. Journal of the American Heart Association. 2021 Jun; 10(12):e020165.
34. Windecker S, Haude M, Neumann F-J, Stangl K, Witzenbichler B, Slagboom T, et al. Comparison of a Novel Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent [Internet]. Circulation: Cardiovascular Interventions. 2015 Feb 1;8(2):e001441. Available from: https://doi.org/10.1161/CIRCINTERVENTIONS.114.001441
35. Kandzari DE, Mauri L, Koolen JJ, Massaro JM, Doros G, Garcia-Garcia HM, et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial [Internet]. The Lancet. 2017 Oct 21;390(10105):1843–52. Available from: https://doi.org/10.1016/S0140-6736(17)32249-3
36. Buiten RA, Ploumen EH, Zocca P, Doggen CJM, van der Heijden LC, Kok MM, et al. Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial. JAMA cardiology. 2019 Jul;4(7):659–69.