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Biodegradable polymer-coated thin strut sirolimus- -eluting stent versus durable polymer-coated everolimus-eluting stent in the diabetic population
Affiliations- Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
- Department of Cardiology, University Hospital, Institute of Medical Sciences, University of Opole, Poland
- Scanmed Gliwice, Zygmunta Starego 24, 44-100 Gliwice, Poland
- 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia, Katowice, Silesian Centre for Heart Diseases, Zabrze, Poland;, Poland
open access
Abstract
Background: The number of patients with diabetes mellitus (DM) presenting with coronary artery disease is increasing and accounts for more than 30% of patients undergoing percutaneous coronary interventions (PCI). The biodegradable polymer drug-eluting stents were developed to improve vascular healing. It was sought herein, to determine 1-year clinical follow-up in patients with DM treated with the thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus durable coating everolimus-eluting stent (DP-EES).
Methods: Patients were retrospectively analyzed with DM were treated with either a BP-SES (ALEX™, Balton, Poland, n = 670) or a DP-EES (XIENCE™, Abbott, USA, n = 884) with available 1 year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes.
Results: After propensity score matching 527 patients treated with BP-SES and 527 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. In-hospital mortality was 3.23% in BP-SES vs. 2.09% in DP-EES group (p = 0.25). One-year followup demonstrated comparable efficacy outcome TVR (BP-SES 6.64% vs. DP-EES 5.88%; p = 0.611), as well as similar safety outcomes of all-cause death (BP-SES 10.06% vs. DP-EES 7.59%; p = 0.158), myocardial infarction (BP-SES 7.959% vs. DP-EES 6.83%; p = 0.813), and definite/probable stent thrombosis (BP-SES 1.14% vs. DP-EES 0.76%; p = 0.525).
Conclusions: The thin-strut biodegradable polymer coated, sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to DP-EES. These data support the relative safety and efficacy of BP-SES in diabetic patients undergoing PCI.
Abstract
Background: The number of patients with diabetes mellitus (DM) presenting with coronary artery disease is increasing and accounts for more than 30% of patients undergoing percutaneous coronary interventions (PCI). The biodegradable polymer drug-eluting stents were developed to improve vascular healing. It was sought herein, to determine 1-year clinical follow-up in patients with DM treated with the thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus durable coating everolimus-eluting stent (DP-EES).
Methods: Patients were retrospectively analyzed with DM were treated with either a BP-SES (ALEX™, Balton, Poland, n = 670) or a DP-EES (XIENCE™, Abbott, USA, n = 884) with available 1 year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes.
Results: After propensity score matching 527 patients treated with BP-SES and 527 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. In-hospital mortality was 3.23% in BP-SES vs. 2.09% in DP-EES group (p = 0.25). One-year followup demonstrated comparable efficacy outcome TVR (BP-SES 6.64% vs. DP-EES 5.88%; p = 0.611), as well as similar safety outcomes of all-cause death (BP-SES 10.06% vs. DP-EES 7.59%; p = 0.158), myocardial infarction (BP-SES 7.959% vs. DP-EES 6.83%; p = 0.813), and definite/probable stent thrombosis (BP-SES 1.14% vs. DP-EES 0.76%; p = 0.525).
Conclusions: The thin-strut biodegradable polymer coated, sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to DP-EES. These data support the relative safety and efficacy of BP-SES in diabetic patients undergoing PCI.
Keywords
drug-eluting stents, percutaneous coronary intervention, diabetes mellitus
About this articleTitle
Biodegradable polymer-coated thin strut sirolimus- -eluting stent versus durable polymer-coated everolimus-eluting stent in the diabetic population
Journal
Issue
Article type
Original Article
Pages
235-243
Published online
2019-12-09
Page views
1542
Article views/downloads
1155
DOI
Pubmed
Bibliographic record
Cardiol J 2021;28(2):235-243.
Keywords
drug-eluting stents
percutaneous coronary intervention
diabetes mellitus
Authors
Pawel Gasior
Marek Gierlotka
Krzysztof Szczurek-Katanski
Marcin Osuch
Magda Roleder
Michał Hawranek
Wojciech Wojakowski
Lech Polonski
References (33)- Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: US Department of Health and Human Services; 2014.
- Orasanu G, Plutzky J. The pathologic continuum of diabetic vascular disease. J Am Coll Cardiol. 2009; 53(5 Suppl): S35–S42.
- Rask-Madsen C, King GL. Mechanisms of Disease: endothelial dysfunction in insulin resistance and diabetes. Nat Clin Pract Endocrinol Metab. 2007; 3(1): 46–56.
- Farkouh M, Domanski M, Sleeper L, et al. Strategies for Multivessel Revascularization in Patients with Diabetes. N Engl J Med. 2012; 367(25): 2375–2384.
- Räber L, Magro M, Stefanini GG, et al. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study. Circulation. 2012; 125(9): 1110–1121.
- Stefanini GG, Windecker S. Stent thrombosis: no longer an issue with newer-generation drug-eluting stents? Circ Cardiovasc Interv. 2012; 5(3): 332–335.
- Dores H, Raposo L, Campante Teles R, et al. Stent thrombosis with second- versus first-generation drug-eluting stents in real-world percutaneous coronary intervention: analysis of 3806 consecutive procedures from a large-volume single-center prospective registry. J Invasive Cardiol. 2013; 25(7): 330–336.
- Naidu SS, Krucoff MW, Rutledge DR, et al. Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8,061-patient XIENCE V United States study. JACC Cardiovasc Interv. 2012; 5(6): 626–635.
- Nakazawa G, Otsuka F, Nakano M, et al. The pathology of neoatherosclerosis in human coronary implants bare-metal and drug-eluting stents. J Am Coll Cardiol. 2011; 57(11): 1314–1322.
- Park SJ, Kang SJ, Virmani R, et al. In-stent neoatherosclerosis: a final common pathway of late stent failure. J Am Coll Cardiol. 2012; 59(23): 2051–2057.
- Räber L, Kelbæk H, Ostojic M, 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): 777–787.
- Stefanini GG, Byrne RA, Serruys PW, 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 trials. Eur Heart J. 2012; 33(10): 1214–1222.
- Palmerini T, Biondi-Zoccai G, Della Riva D, et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2014; 63(4): 299–307.
- Kip KE, Faxon DP, Detre KM, et al. Coronary angioplasty in diabetic patients. The National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation. 1996; 94(8): 1818–1825.
- Gasior P, Gierlotka M, Szczurek-Katanski K, et al. Bioresorbable polymer-coated thin strut sirolimus-eluting stent vs durable polymer-coated everolimus-eluting stent in daily clinical practice: Propensity matched one-year results from interventional cardiology network registry. Catheter Cardiovasc Interv. 2019; 93(7): E362–E368.
- Gąsior P, Gierlotka M, Szczurek-Katanski K, et al. Safety and efficacy of biodegradable polymer-coated thin strut sirolimus-eluting stent vs. durable polymer-coated everolimus-eluting stent in patients with acute myocardial infarction. Postepy Kardiol Interwencyjnej. 2018; 14(4): 347–355.
- Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. Eur Heart J. 2012; 33(20): 2551–2567.
- Cutlip DE, Windecker S, Mehran R, et al. Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115(17): 2344–2351.
- Preis SR, Hwang SJ, Coady S, et al. Trends in all-cause and cardiovascular disease mortality among women and men with and without diabetes mellitus in the Framingham Heart Study, 1950 to 2005. Circulation. 2009; 119(13): 1728–1735.
- Fang J, Alderman MH. Impact of the increasing burden of diabetes on acute myocardial infarction in New York City: 1990-2000. Diabetes. 2006; 55(3): 768–773.
- Flaherty JD, Davidson CJ. Diabetes and coronary revascularization. JAMA. 2005; 293(12): 1501–1508.
- Sabaté M, Jiménez-Quevedo P, Angiolillo DJ, et al. Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial. Circulation. 2005; 112(14): 2175–2183.
- Woods TC. Dysregulation of the mammalian target of rapamycin and p27Kip1 promotes intimal hyperplasia in diabetes mellitus. Pharmaceuticals (Basel). 2013; 6(6): 716–727.
- Dangas GD, Claessen BE, Caixeta A, et al. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010; 56(23): 1897–1907.
- Nakazawa G, Nakano M, Otsuka F, et al. Evaluation of polymer-based comparator drug-eluting stents using a rabbit model of iliac artery atherosclerosis. Circ Cardiovasc Interv. 2011; 4(1): 38–46.
- Kang SJ, Lee CW, Song H, et al. OCT analysis in patients with very late stent thrombosis. JACC Cardiovasc Imaging. 2013; 6(6): 695–703.
- Lupi A, Gabrio Secco G, Rognoni A, et al. Meta-analysis of bioabsorbable versus durable polymer drug-eluting stents in 20,005 patients with coronary artery disease: an update. Catheter Cardiovasc Interv. 2014; 83(6): E193–E206.
- Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007; 3(6): 853–876.
- Kaul U, Bhagwat A, Pinto B, et al. Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic population: two-year follow-up of the TUXEDO-India trial. EuroIntervention. 2017; 13(10): 1194–1201.
- Christiansen EH, Jensen LO, Thayssen P, et al. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial. Lancet. 2013; 381(9867): 661–669.
- Stefanini GG, Byrne RA, Serruys PW, 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 trials. Eur Heart J. 2012; 33(10): 1214–1222.
- Serruys PW, Farooq V, Kalesan B, et al. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013; 6(8): 777–789.
- Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000; 342(25): 1887–1892.
