eISSN: 1897-4295
ISSN: 1734-9338
Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej
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vol. 14
Original paper

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

Paweł Gąsior, Marek Gierlotka, Krzysztof Szczurek-Katanski, Marcin Osuch, Magda Roleder, Michał Hawranek, Mariusz Gasior, Wojciech Wojakowski, Lech Polonski

Adv Interv Cardiol 2018; 14, 4 (54): 347–355
Online publish date: 2018/11/09
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The biodegradable polymer drug-eluting stents were developed to improve vascular healing. However, further data are needed to confirm the safety and efficacy of these stents in patients with acute myocardial infarction (AMI).

We sought to determine the 1-year clinical follow-up in patients with AMI treated with a thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus a durable coating everolimus-eluting stent (DP-EES).

Material and methods
We analyzed patients with AMI (STEMI and NSTEMI) treated with either a BP-SES (ALEX, Balton, Poland, n = 886) or DP-EES (XIENCE, Abbott, USA, n = 1054) with available 1-year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as the efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes.

After propensity score matching 672 patients treated with BP-SES and 672 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between the groups. In-hospital mortality was similar in both tested groups. One-year follow-up demonstrated comparable efficacy outcome TVR (BP-SES 7.1% vs. DP-EES 5.2%, p = 0.14), as well as similar safety outcomes of all-cause death, myocardial infarction, and definite/probable stent thrombosis.

The thin-strut biodegradable polymer coated sirolimus-eluting stent demonstrated comparable clinical outcomes at 1 year after implantation to the DP-EES. These data support the relative safety and efficacy of BP-SES in AMI patients undergoing percutaneous coronary intervention.


acute myocardial infarction, bioabsorbable polymer, drug-eluting stents

Nebeker JR, Virmani R, Bennett CL, et al. Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project. J Am Coll Cardiol 2006; 47: 175-81.
Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J 2006; 27: 2784-814.
Serruys PW, Daemen J. Are drug-eluting stents associated with a higher rate of late thrombosis than bare metal stents? Late stent thrombosis: a nuisance in both bare metal and drug-eluting stents. Circulation 2007; 115: 1433-9.
Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug eluting stents: a cause for concern. Circulation 2007; 115: 1440-55.
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: 2051-7.
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: 1110-21.
Stefanini GG, Windecker S. Stent thrombosis: no longer an issue with newer-generation drug-eluting stents? Circ Cardiovasc Interv 2012; 5: 332-5.
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: 330-6.
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. J Am Coll Cardiol Intv 2012; 5: 626-35.
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: 1314-22.
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: 2051-7.
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: 777-87.
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, ISARTEST 4, and LEADERS randomized trials. Eur Heart J 2012; 33: 1214-22.
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: 299-307.
Kukreja N, Onuma Y, Garcia-Garcia HM, et al. Interventional Cardiologists of the Thoraxcenter (2000 to 2005). The risk of stent thrombosis in patients with acute coronary syndromes treated with bare-metal and drug-eluting stents. JACC Cardiovasc Interv 2009; 2: 534-41.
Orlik B, Buszman PP, Krauze A, et al. A nuclear magnetic resonance spectroscopy as a method for evaluation of in vivo poly-l-lactide biodegradation kinetics from stent-polymer matrices: an experimental study utilizing porcine model of in-stent restenosis. J Cardiovasc Pharmacol Ther 2016; 21: 93-9.
Hawranek M, Desperak P, Ciślak A, et al. Safety and efficacy of a second-generation coronary sirolimus-eluting stent with biodegradable polymers in daily clinical practice: a 12-month follow-up of the ALEX registry. Coron Artery Dis 2016; 27: 89-94.
Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. Eur Heart J 2012; 33: 2551-67.
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: 2344-51.
Attizzani GF, Capodanno D, Ohno Y, et al. Mechanisms, pathophysiology, and clinical aspects of incomplete stent apposition. J Am Coll Cardiol 2014; 63: 1355-67.
Giustino G, Baber U, Sartori S, et al. Duration of dual antiplatelet therapy after drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Cardiol 2015; 65: 1298-310.
Navarese EP, Andreotti F, Schulze V, et al. Optimal duration of dual antiplatelet therapy after percutaneous coronary intervention with drug eluting stents: meta-analysis of randomised controlled trials. Br Med J 2015; 350: h1618-8.
Palmerini T, Benedetto U, Bacchi-Reggiani L, et al. Mortality in patients treated with extended duration dual antiplatelet therapy after drug-eluting stent implantation: a pairwise and Bayesian network meta-analysis of randomised trials. Lancet 2015; 385: 2371-82.
Kang SH, Chae IH, Park JJ, et al. Stent thrombosis with drug-eluting stents and bioresorbable scaffolds: evidence from a network meta-analysis of 147 trials. JACC Cardiovasc Interv 2016; 9: 1203-12.
D’Ascenzo F, Iannaccone M, Saint-Hilary G, et al. Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients. Eur Heart J 2017; 38: 3160-72.
Khan AR, Tripathi A, Farid TA, et al. Stent thrombosis with bioabsorbable polymer drug-eluting stents: insights from the Food and Drug Administration database. Coron Artery Dis 2017; 28: 564-9.
Smits PC, Hofma S, Togni M, et al. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet 2013; 381: 651-60.
Buccheri S, Sarno G, Lagerqvist B, et al. Bioabsorbable polymer everolimus-eluting stents in patients with acute myocardial infarction: a report from the Swedish Coronary Angiography and Angioplasty Registry. EuroIntervention 2018; 14: e562-9.
de Waha A, King LA, Stefanini GG, 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: 1425-31.
Jiménez VA, Iñiguez A, Baz JA, et al. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: the CENTURY II high risk ACS substudy. Cardiovasc Revasc Med 2016; 17: 355-61.
Christiansen E, Jensen LO, Thayssen P, et al.; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) V investigators. 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: 661-9.
Mennuni MG, Pagnotta PA, Stefanini GG. Coronary stents: the impact of technological advances on clinical outcomes. Ann Biomed Eng 2016; 44: 488-96.
Xu B, Gao R, Yang Y, et al.; PANDA III Investigators. Biodegradable polymer-based sirolimus-eluting stents with differing elution and absorption kinetics: the PANDA III trial. J Am Coll Cardiol 2016; 67: 2249-58.
Serruys PW, Silber S, Garg S, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 2010; 363: 136-46.
Koppara T, Cheng Q, Yahagi K, et al. Thrombogenicity and early vascular healing response in metallic biodegradable polymer-based and fully bioabsorbable drug-eluting stents. Circ Cardiovasc Interv 2015; 8: e002427.
Kolandaivelu K, Swaminathan R, Gibson WJ, 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: 1400-9.
Legutko J, Gil RJ, Buszman PE, et al. An optical coherence tomography study of neointimal morphology and strut coverage at different time intervals from implantation of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv 2018; 92: 302-9.
Zhang YJ, Zhu LL, Bourantas CV, et al. Impact of everolimus versus other rapamycin derivative-eluting stents on clinical outcomes in patients with coronary artery disease: a meta-analysis of 16 randomized trials. J Cardiol 2014; 64: 185-93.
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: 777-89.
Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000; 342: 1887-92.
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