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)

Authors

  • Bhupendra Verma Department of Cardiology, Ujala Superspeciality Hospital, Kashipur, Uttarakhand, India
  • Akhilesh Patel Abhigya Heart Care Centre, Gorakhpur, Uttar Pradesh, India
  • Deepak Katyal Department of Cardiology, Columbia Asia Hospital, Patiala, Punjab, India
  • Vivek Raj Singh Vardhan Heart Clinic, Varanasi, Uttar Pradesh, India
  • Avinash Kumar Singh Department of Cardiology, Khushlok Hospital, Bareilly, Uttar Pradesh, India
  • Amrita Singh Department of Cardiology, Ujala Superspeciality Hospital, Kashipur, Uttarakhand, India
  • Manu Kumar Department of Cardiology, Ujala Superspeciality Hospital, Kashipur, Uttarakhand, India
  • Pratap Nagarkoti Department of Cardiology, Ujala Superspeciality Hospital, Kashipur, Uttarakhand, India

DOI:

https://doi.org/10.3889/oamjms.2019.241

Keywords:

BPDES, STEMI, Percutaneous coronary intervention, Third generation stents, Drug-eluting stents, Deliverability, Stent thrombosis

Abstract

BACKGROUND: The durable polymer drug-eluting stents (DPDES) reduce the risk of repeated target vessel revascularisation (TLR) compared with BMS, but are associated with increased risk of late adverse events. In broadly inclusive populations, the biodegradable-polymer drug-eluting stents (BPDES) have favourable results compared with DPDES in the long term. However, its use in primary angioplasty has not been adequately studied, and data of real-world clinical experience is lacking.

AIM: Aim of this study was to assess the safety and efficacy of Yukon Choice PC Elite sirolimus-eluting stent (a novel BPDES) in STEMI patients undergoing primary angioplasty.

METHODS: We have presented here one-year clinical follow-up data of the Yukon Choice PC Elite sirolimus-eluting stent in patients undergoing primary angioplasty. A total of 636 patients were enrolled in this single arm, prospective observational study from five centres.

RESULTS: This multicentric observational study showed excellent safety and efficacy profile of the novel device at one year follow up. The device-oriented composite endpoint (DOCE) of cardiac death, target-vessel reinfarction, and target-lesion revascularisation (TLR) was 2.7%, and the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, and any revascularisation was 4.2% at one year. Definite or probable stent thrombosis rate was 0.6%, and no events were recorded beyond 6 months of follow up.

CONCLUSIONS: In patients with STEMI undergoing primary angioplasty, the use of Yukon Choice PC Elite (biodegradable polymer sirolimus-eluting stent) has excellent results at one year. It, therefore, represents an attractive alternative to second generation DES in this high-risk population.

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References

Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003; 361:13-20. https://doi.org/10.1016/S0140-6736(03)12113-7

Verma B, Singh A, Saxena AK, Kumar M. Deflated Balloon-Facilitated Direct Stenting in Primary Angioplasty (The DBDS Technique): A Pilot Study. Cardiol Res. 2018; 9(5):284-292. https://doi.org/10.14740/cr770w PMid:30344826 PMCid:PMC6188044

Nordmann AJ, Hengstler P, Harr T, Young J, Bucher HC. Clinical outcomes of primary stenting versus balloon angioplasty in patients with myocardial infarction: a meta-analysis of randomized controlled trials. Am J Med 2004; 116(4):253-262. https://doi.org/10.1016/j.amjmed.2003.08.035 PMid:14969654

Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, et al. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007; 28(22):2706-2713. https://doi.org/10.1093/eurheartj/ehm402 PMid:17901079

De Luca G, Dirksen MT, Spaulding C, Kelbaek H, Schalij M, Thuesen L, et al. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med. 2012; 172(8):611-621. https://doi.org/10.1001/archinternmed.2012.758 PMid:22529227

Kalesan B, Pilgrim T, Heinimann K, Raber L, Stefanini GG, Valgimigli M, et al. Comparison of drug-eluting stents with bare metal stents in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012; 33:977-87. https://doi.org/10.1093/eurheartj/ehs036 PMid:22362513

Byrne RA, Joner M, Kastrati A. Polymer coatings and delayed arterial healing following drug- eluting stent implantation. Minerva Cardioangiol. 2009; 57(5):567-84. PMid:19838148

Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, et al. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008; 118(11):1138-45. https://doi.org/10.1161/CIRCULATIONAHA.107.762047 PMid:18725485

Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006; 48:193e202.

Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, et al. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009; 2(5):445-52. https://doi.org/10.1016/j.jcin.2009.01.012 PMid:19463469

Breet NJ, van Werkum JW, Bouman HJ, Kelder JC, Hackeng CM, ten Berg JM. The relationship between platelet reactivity and infarct-related artery patency in patients presenting with a ST-elevation myocardial infarction. Thromb Haemost. 2011; 106(2):331-6. https://doi.org/10.1160/TH10-08-0528

Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, et al. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011; 123(13):1400-9. https://doi.org/10.1161/CIRCULATIONAHA.110.003210 PMid:21422389 PMCid:PMC3131199

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. Eur Heart J. 2008; 29(16):1975-82. https://doi.org/10.1093/eurheartj/ehn253 PMid:18550554

Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, et al. Angiographic Results: test efficacy of 3 limus-eluting stents I. Randomized, noninferiority 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). Eur Heart J. 2009; 30(20):2441-9. https://doi.org/10.1093/eurheartj/ehp352 PMid:19720642

Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, et al. Eur Heart J. 2012; 33(10):1214-22. https://doi.org/10.1093/eurheartj/ehs086 PMid:22447805

Schömig A, Dibra A, Windecker S, et al. A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol. 2007; 50:1373. https://doi.org/10.1016/j.jacc.2007.06.047 PMid:17903638

Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007; 370:937. https://doi.org/10.1016/S0140-6736(07)61444-5

Rasmussen K, Maeng M, Kaltoft A, et al. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial. Lancet. 2010; 375:1090. https://doi.org/10.1016/S0140-6736(10)60208-5

de Waha A, Dibra A, Byrne RA, et al. Everolimus-eluting versus sirolimus-eluting stents: a meta-analysis of randomized trials. Circ Cardiovasc Interv. 2011; 4:371. https://doi.org/10.1161/CIRCINTERVENTIONS.111.963256 PMid:21791671

Bangalore S, Kumar S, Fusaro M, et al. Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 2012; 125:2873. https://doi.org/10.1161/CIRCULATIONAHA.112.097014 PMid:22586281

Yatscoff RW, Wang P, Chan K, Hicks D, Zimmerman J. Rapamycin: Distribution, pharmacokinetics, and therapeutic range investigations. Ther Drug Monit. 1995; 17:666-671. https://doi.org/10.1097/00007691-199512000-00020 PMid:8588238

Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115(17):2344-51. https://doi.org/10.1161/CIRCULATIONAHA.106.685313 PMid:17470709

Misra A, Chowbey P, Makkar BM, Vikram NK, Wasir JS, Chadha D, et al. Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. J Assoc Physicians India. 2009; 57:163-70. PMid:19582986

Byrne RA, Kastrati A, Massberg S, Wieczorek A, Laugwitz KL, 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.J Am Coll Cardiol. 2011; 58(13):1325-31. https://doi.org/10.1016/j.jacc.2011.06.027 PMid:21920260

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. 2016; 11(12):1372-1373. https://doi.org/10.4244/EIJY14M11_02 PMid:25405657

Desch S, Schloma D, Möbius-Winkler S, Erbs S, Gielen S, Linke A, et al. Randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus: the LIPSIA Yukon trial. JACC Cardiovasc Interv. 2011; 4(4):452-459. https://doi.org/10.1016/j.jcin.2010.11.016 PMid:21511226

Stiermaier T, Heinz A, Schloma D, Kleinertz K, Dänschel W, Erbs S, et al. Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial). Catheter Cardiovasc Interv. 2014; 83(3):418-424. https://doi.org/10.1002/ccd.25131 PMid:23873579

Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, et al. Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: The intracoronary stenting and angiographic results: Test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents (ISAR-TEST 5) trial. Circulation. 2011; 124:624-632. https://doi.org/10.1161/CIRCULATIONAHA.111.026732 PMid:21768546

Colleran R, Kufner S, Harada Y, Giacoppo D, Cassese S, Repp J, et al. Five-year follow-up of polymer-free sirolimus- and probucol-eluting stents versus new generation zotarolimus-eluting stents in patients presenting with st-elevation myocardial infarction. Catheter Cardiovasc Interv. 2017; 89(3):367-374. https://doi.org/10.1002/ccd.26597 PMid:27377301

Sabate M, Cequier A, I-iguez A, Serra A, Hernandez-Antolin R, Mainar V, et al. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012; 380(9852):1482-90. https://doi.org/10.1016/S0140-6736(12)61223-9

Barbato E, Marco J, Wijns W. Direct stenting. Eur Heart J. 2003; 24:394-403. https://doi.org/10.1016/S0195-668X(02)00802-3

Remkes WS, Somi S, Roolvink V, Rasoul S, Ottervanger JP, Gosselink AT, et al. Direct drug-eluting stenting to reduce stent restenosis: a randomized comparison of direct stent implantation to conventional stenting with pre-dilation or provisional stenting in elective PCI patients. JACC Cardiovasc Interv. 2014; 7(7):751-8. https://doi.org/10.1016/j.jcin.2014.02.012 PMid:25060017

Räber L, Kelbæk H, Ostojic M, Baumbach A, Heg D, Tüller D, et al. 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. 2012; 308(8):777-87. https://doi.org/10.1001/jama.2012.10065 PMid:22910755

Sabaté M, Räber L, Heg D, Brugaletta S, Kelbaek H, Cequier A, et al. 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. 2014; 7(1):55-63. https://doi.org/10.1016/j.jcin.2013.07.012 PMid:24332419

Räber L, Kelbæk H, Taniwaki M, Ostojic M, Heg D, Baumbach A, et al. Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial. Circ Cardiovasc Interv. 2014; 7(3):355-64. https://doi.org/10.1161/CIRCINTERVENTIONS.113.001440 PMid:24847017

Sabaté M, Brugaletta S, Cequier A, I-iguez A, Serra A, Hernádez-Antolín R, et al. The EXAMINATION trial (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction): 2-year results from a multicenter randomized controlled trial. JACC Cardiovasc Interv. 2014; 7:64-71. https://doi.org/10.1016/j.jcin.2013.09.006 PMid:24332423

Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, et al. Clinical outcomes in patients with STsegment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial. Lancet. 2016; 387(10016):357-366. https://doi.org/10.1016/S0140-6736(15)00548-6

de Waha A, King LA, Stefanini GG, Byrne RA, Serruys PW, Meier B, et al. Long-term outcomes of biodegradable versus durable polymer drug-eluting stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of individual patient data from three randomised trials. EuroIntervention. 2015; 10(12):1425-31. https://doi.org/10.4244/EIJV10I12A247 PMid:24602961

Park DW, Park SW, Park KH, Lee BK, Kim YH, Lee CW, et al. Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up. Am J Cardiol. 2006; 98(3):352-6. https://doi.org/10.1016/j.amjcard.2006.02.039 PMid:16860022

Published

2019-04-13

How to Cite

1.
Verma B, Patel A, Katyal D, Singh VR, Singh AK, Singh A, Kumar M, Nagarkoti P. 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 Maced J Med Sci [Internet]. 2019 Apr. 13 [cited 2024 Jun. 17];7(7):1103-9. Available from: https://oamjms.eu/index.php/mjms/article/view/oamjms.2019.241

Issue

Section

B - Clinical Sciences