Vol. 23 No. 1S (2019): Modern stents and current strategies for endovascular surgery
REVIEWS

History of development and comparative evaluation of modern stents for coronary arteries

PDF (Русский)
  • K. Smirnov,
  • A. Biryukov,
  • R. Ivanchenko,
  • D. Ovcharenko,
  • A. Voronkov,
  • I. Trusov,
  • E. Nifontov
K. Smirnov
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation
Bio
A. Biryukov
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation
R. Ivanchenko
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation
D. Ovcharenko
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation
A. Voronkov
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation
I. Trusov
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation
E. Nifontov
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation
DOI: https://doi.org/10.21688/1681-3472-2019-1S-S9-S17

Published 2023-01-23

Keywords

  • bare metal stent,
  • drug-elution stent,
  • healing score,
  • optical coherence tomography,
  • scaffolds,
  • stenting
    • ...More
    Less

How to Cite

Smirnov, K., Biryukov, A., Ivanchenko, R., Ovcharenko, D., Voronkov, A., Trusov, I., & Nifontov, E. (2023). History of development and comparative evaluation of modern stents for coronary arteries. Patologiya Krovoobrashcheniya I Kardiokhirurgiya, 23(1S), S9-S17. https://doi.org/10.21688/1681-3472-2019-1S-S9-S17

Copyright (c) 2019 Smirnov K. A., Biryukov A. V., Ivanchenko R. D., Ovcharenko D. V., Voronkov A. A., Trusov I. S., Nifontov E. M.

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

Operations of myocardial revascularization include aorta-coronary or mammarocoronary bypassing and stenting of coronary arteries. Currently, coronary stenting is the most common method of revascularization, but during the operation of this method, the incidence of late complications, such as restenoses and late coronary thrombosis, has increased. The causes of these complications depend on a number of factors, including the type of stent. While vessel wall injury correlated with restenosis in the bare metal stents (BMS) era, its impact has been minimised by the use of drug eluting stents (DES), which is likely related to the use of powerful antiproliferatives with prolonged release kinetics which profoundly inhibit the reparative response to arterial injury. However, at the same time, vessel injury secondary to drug toxicity or inflammation caused by polymer is observed following DES implantation. In the clinical practice, there is a huge variety of types and models of stents, which have different indications and contraindications for use. An important factor influencing the risk of developing late complications is neointimal vascular healing, which can be assessed using various methods of intravascular imaging, such as optical coherent tomography. The purpose of this literature review, describing the evolution of coronary stents, is to systematize the main research results on the use of various stents platforms. In addition, the review presents the modern methods of evaluating the proliferation neontimy, and introduces the concept of healing index (healing score), reflects the process of vascular healing and influencing the characteristics and duration of dual antiplatelet therapy
PDF (Русский)

References

  1. Dotter CT. Transluminally-placed coilspring endarterial tube grafts. Long-term patency in canine popliteal artery. Invest Radiol. 1969;4:329-32. PMID: 5346893.
  2. Hanawa T. Materials formetallic stents. J Artif Organs. 2009;12:73-9. PMID: 19536623. http://dx.doi.org/10.1007/s10047-008-0456-x
  3. Mehilli J., Kastrati A., Wessely R., Dibra A., Hausleiter J., Jaschke B., Dirschinger J., Schömig A., Intracoronary Stenting and Angiographic Restenosis--Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation. 2006;113:273-9. PMID: 16391155. http://dx.doi.org/10.1161/CIRCULATIONAHA.105.575977
  4. King L., Byrne R.A., Mehilli J., Schomig A., Kastrati A., Pache J. Five-year clinical outcomes of a polymer-free sirolimus-eluting stent versus a permanent polymer paclitaxel-eluting stent: final results of the intracoronary stenting and angiographic restenosis-test equivalence between two drug-eluting stents (ISAR-TEST) trial. Catheter Cardiovasc Interv. 2013;81(1):E23-8. PMID: 22431239. http://dx.doi.org/10.1002/ccd.24375
  5. Byrne R.A., Kastrati A., Tiroch K., Schulz S., Pache J., Pinieck S., Massberg S., Seyfarth M., Laugwitz K.L., Birkmeier K.A., Schömig A., Mehilli J.; ISAR-TEST-2 Investigators. 2-year clinical and angiographic outcomes from a randomized trial of polymer-free dual drug-eluting stents versus polymer-based cypher and endeavor [corrected] drug-eluting stents. J Am Coll Cardiol. 2010;55:2536-43. PMID: 20417052. http://dx.doi.org/10.1016/j.jacc.2010.03.020
  6. Byrne R.A., Kufner S., Tiroch K., Massberg S., Laugwitz K.L., Birkmeier A., Schulz S., Mehilli J.; ISAR-TEST-3 Investigators. Randomised trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis: 2-year follow-up results. Heart. 2009;95:1489-94. PMID: 19592388. http://dx.doi.org/10.1136/hrt.2009.172379
  7. Desch S., Schloma D., Mobius-Winkler S., Erbs S., Gielen S., Linke A., Yu J., Lauer B., Kleinertz K., Dänschel W., Schuler G., Thiele H. 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):452-9. PMID: 21511226. http://dx.doi.org/10.1016/j.jcin.2010.11.016
  8. Hausleiter J., Kastrati A., Mehilli J., Schuhlen H., Pache J., Dotzer F., Sattelberger U., Dirschinger J., Schömig A. Impact of lesion complexity on the capacity of a trial to detect differences in stent performance: results from the ISAR-STEREO trial. Am Heart J. 2003;146(5):882-6. PMID: 14597939. http://dx.doi.org/10.1016/S0002-8703(03)00435-6
  9. Serruys P.W., Chevalier B., Dudek D., Cequier A., Carrie D., Iniguez A., Dominici M., van der Schaaf R.J., Haude M., Wasungu L., Veldhof S., Peng L., Staehr P., Grundeken M.J., Ishibashi Y., GarciaGarcia H.M., Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet. 2015;385(9962):43-54. PMID: 25230593. http://dx.doi.org/10.1016/S0140-6736(14)61455-0
  10. Gao R., Yang Y., Han Y., Huo Y., Chen J., Yu B., Su X., Li L., Kuo H.C., Ying S.W., Cheong W.F., Zhang Y., Su X., Xu B., Popma J.J., Stone G.W.; ABSORB China Investigators. Bioresorbable vascular scaffolds versus metallic stents in patients with coronary artery disease: ABSORB China Trial. J Am Coll Cardiol. 2015;66(21):2298-309. PMID: 26471805. http://dx.doi.org/10.1016/j.jacc.2015.09.054
  11. Stone G.W., Gao R., Kimura T., Kereiakes D.J., Ellis S.G., Onuma Y., Cheong W.F., Jones-McMeans J., Su X., Zhang Z., Serruys P.W. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016;387(10025):1277-89. PMID: 26825231. http://dx.doi.org/10.1016/S0140-6736(15)01039-9
  12. Windecker S., Kolh P., Alfonso F., Collet J.P., Cremer J., Falk V., Filippatos G., Hamm C., Head S.J., Jüni P., Kappetein A.P., Kastrati A., Knuuti J., Landmesser U., Laufer G., Neumann F.J., Richter D.J., Schauerte P., Sousa Uva M., Stefanini G.G., Taggart D.P., Torracca L., Valgimigli M., Wijns W., Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35(37):2541-619. PMID: 25173339. http://dx.doi.org/10.1093/eurheartj/ehu278
  13. Van der Zwet P.M., Reiber J.H. A new approach for the quantification of complex lesion morphology: the gradient field transform; basic principles and validation results. J Am Coll Cardiol. 1994;24(1):216-24. PMID: 8006269.
  14. Foin N., Gutierrez-Chico J.L., Nakatani S., Torii R., Bourantas C.V., Sen S., Nijjer S., Petraco R., Kousera C., Ghione M., Onuma Y., Garcia-Garcia H.M., Francis D.P., Wong P., Di Mario C., Davies J.E., Serruys P.W. Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition. Circ Cardiovasc Interv. 2014;7(2):180-9. PMID: 24642998. http://dx.doi.org/10.1161/CIRCINTERVENTIONS.113.000931
  15. Finn A.V., Joner M., Nakazawa G., Kolodgie F., Newell J., John M.C., Gold H.K., Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007;115(18):2435-41.
  16. Kim B.K., Hong M.K., Shin D.H., Nam C.M., Kim J.S., Ko Y.G., Choi D., Kang T.S., Park B.E., Kang W.C., Lee S.H., Yoon J.H., Hong B.K., Kwon H.M., Jang Y.; RESET Investigators. A new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation). J Am Coll Cardiol. 2012;60(15):1340-8. PMID: 17438147. http://dx.doi.org/10.1161/CIRCULATIONAHA.107.693739
  17. Valgimigli M., Campo G., Monti M., Vranckx P., Percoco G., Tumscitz C., Castriota F., Colombo F., Tebaldi M., Fuca G., Kubbajeh M., Cangiano E., Minarelli M., Scalone A., Cavazza C., Frangione A., Borghesi M., Marchesini J., Parrinello G., Ferrari R. Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) Investigators. Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012;125(16):2015-26. PMID: 22438530. http://dx.doi.org/10.1161/CIRCULATIONAHA.111.071589
  18. Gwon H.C., Hahn J.Y., Park K.W., Song Y.B., Chae I.H., Lim D.S., Han K.R., Choi J.H., Choi S.H., Kang H.J., Koo B.K., Ahn T., Yoon J.H., Jeong M.H., Hong T.J., Chung W.Y., Choi Y.J., Hur S.H., Kwon H.M., Jeon D.W., Kim B.O., Park S.H., Lee N.H., Jeon H.K., Jang Y., Kim H.S. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012;125(3):505-13. PMID: 22179532. http://dx.doi.org/10.1161/CIRCULATIONAHA.111.059022
  19. Schulz-Schupke S., Byrne R.A., Ten Berg J.M., Neumann F.J., Han Y., Adriaenssens T., Tolg R., Seyfarth M., Maeng M., Zrenner B., Jacobshagen C., Mudra H., von Hodenberg E., Wohrle J., Angiolillo D.J., von Merzljak B., Rifatov N., Kufner S., Morath T., Feuchtenberger A., Ibrahim T., Janssen P.W., Valina C., Li Y., Desmet W., Abdel-Wahab M., Tiroch K., Hengstenberg C., Bernlochner I., Fischer M., Schunkert H., Laugwitz K.L., Schömig A., Mehilli J., Kastrati A.; Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) Trial Investigators. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting. Eur Heart J. 2015;36(20):1252-63. PMID: 25616646. http://dx.doi.org/10.1093/eurheartj/ehu523
  20. Gilard M., Barragan P., Noryani A.A., Noor H.A., Majwal T., Hovasse T., Castellant P., Schneeberger M., Maillard L., Bressolette E., Wojcik J., Delarche N., Blanchard D., Jouve B., Ormezzano O., Paganelli F., Levy G., Sainsous J., Carrie D., Furber A., Berland J., Darremont O., Le Breton H., Lyuycx-Bore A., Gommeaux A., Cassat C., Kermarrec A., Cazaux P., Druelles P., Dauphin R., Armengaud J., Dupouy P., Champagnac D., Ohlmann P., Endresen K., Benamer H., Kiss R.G., Ungi I., Boschat J., Morice M.C. 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial. J Am Coll Cardiol. 2015;65(20):777-86. PMID: 25461690. http://dx.doi.org/10.1016/j.jacc.2014.11.008
  21. Stefanini G.G., Byrne R.A., Serruys P.W., de Waha A., Meier B., Massberg S., Jüni P., Schömig A., Windecker S., Kastrati A. 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):1214-22. PMID: 22447805. http://dx.doi.org/10.1093/eurheartj/ehs086
  22. Palmerini T., Biondi-Zoccai G., Della Riva D., Stettler C., Sangiorgi D., D'Ascenzo F., Kimura T., Briguori C., Sabatè M., Kim H.S., De Waha A., Kedhi E., Smits P.C., Kaiser C., Sardella G., Marullo A., Kirtane A.J., Leon M.B., Stone G.W. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012;379(9824):1393-402. PMID: 22445239. http://dx.doi.org/10.1016/S0140-6736(12)60324-9
  23. Ahmed T.A., Bergheanu S.C., Stijnen T., Plevier J.W., Quax P.H., Jukema J.W. Clinical performance of drug-eluting stents with biodegradable polymeric coating: a meta-analysis and systematic review. EuroIntervention. 2011;7(4):505-16. PMID: 21764670. http://dx.doi.org/10.4244/EIJV7I4A81
  24. Grines C.L., Bonow R.O., Casey Jr. D.E., Gardner T.J., Lockhart P., Moliterno D., O'Gara P., Whitlow P. Prevention of premature discontinuation of dual anti-platelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, with representation from the American College of Physicians. Circulation. 2007;115(6):813-8. PMID: 17224480. http://dx.doi.org/10.1161/CIRCULATIONAHA.106.180944
  25. Buszman P., Trznadel S., Milewski K., Rzeźniczak J., Przewłocki T., Kośmider M., Wójcik J., Janczak J., Zurakowski A., Kondys M., Król M., Kinasz L., Jaklik A., Rzeszutko Ł., Kałuza G.L., Kiesz S., Gil R. Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: a prospective multicenter registry. Catheter Cardiovasc Interv. 2008;71(1):51-7. PMID: 18098182. http://dx.doi.org/10.1002/ccd.21392
  26. Kereiakes D.J., Meredith I.T., Windecker S., Lee Jobe R., Mehta S.R., Sarembock I.J., Feldman R.L., Stein B., Dubois C., Grady T., Saito S., Kimura T., Christen T., Allocco D.J., Dawkins K.D. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circulation: Cardiovascular Interventions. 2015;8(4):e002372. PMID: 25855680. http://dx.doi.org/10.1161/CIRCINTERVENTIONS.114.002372
  27. Kang S.H., Chae I.H., Park J.J., Lee H.S., Kang D.Y., Hwang S.S., Youn T.J., Kim H.S. Stent thrombosis with drug-eluting stents and bioresorbable scaffolds: evidence from a network meta-analysis of 147 trials. JACC: Cardiovascular Interventions. 2016;9(12):1203-12. PMID: 27262860. http://dx.doi.org/10.1016/j.jcin.2016.03.038
  28. Cademartiri F., Shuijf J.D., Pugliese F., Mollet N.R., Jukema W., Maffei E., Kroft L.J., Palumbo A., Ardissino D., Serruys P.W., Krestin G.P., Van der Wall E.E., de Feyter P.J., Bax J.J. Usefulness of 64-slice multislice computed tomography coronary angiography to assess in-stent restenosis. J Am Coll Cardiol. 2007;49(22):2204-10. https://doi.org/10.1016/j.jacc.2007.02.045
  29. Erbel R., Di Mario C., Bartunek J., Bonnier J., de Bruyne B., Eberli F.R., Erne P., Haude M., Heublein B., Horrigan M., Ilsley C., Böse D., Koolen J., Lüscher T.F., Weissman N., Waksman R. Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial. Lancet. 2007;369(9576):1869-75. PMID: 17544767. http://dx.doi.org/10.1016/S0140-6736(07)60853-8
  30. Eggebrecht H., Rodermann J., Hunold P., Schmermund A., Böse D., Haude M., Erbel R. Images in cardiovascular medicine. Novel magnetic resonance-compatible coronary stent: the absorbable magnesium-alloy stent. Circulation. 2005;112(18):e303-4. PMID: 16267243. http://dx.doi.org/10.1161/01.CIRCULATIONAHA.104.521641
  31. Okamura T., Onuma Y., García-García H.M., Regar E., Wykrzykowska J.J., Koolen J., Thuesen L., Windecker S., Whitbourn R., McClean D.R., Ormiston J.A., Serruys P.W.; ABSORB Cohort B Investigators. 3-Dimensional optical coherence tomography assessment of jailed side branches by bioresorbable vascular scaffolds: a proposal for classification. JACC Cardiovasc Interv. 2010;3(8):836-44. PMID: 20723856. http://dx.doi.org/10.1016/j.jcin.2010.05.011
  32. Serruys P.W., Ormiston J.A., Onuma Y., Regar E., Gonzalo N., Garcia-Garcia H.M., Nieman K., Bruining N., Dorange C., Miquel-Hébert K., Veldhof S., Webster M., Thuesen L., Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009;373(9667):897-910. PMID: 19286089. http://dx.doi.org/10.1016/S0140-6736(09)60325-1
  33. Onuma Y., Serruys P.W., Ormiston J.A., Regar E., Webster M., Thuesen L., Dudek D., Veldhof S., Rapoza R. Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2010;6(4):447–53. PMID: 20884431. http://dx.doi.org/10.4244/EIJ30V6I4A76
  34. Waksman R. Lessons learned from preclinical studies of magnesium scaffolds (Biotronik’s DREAMS program). PCR focus group on bioresorbable vascular scaffolds. Session 3: Understanding the basics of polymer bioresorption in vivo – Part II. EuroPCR, March 2012, Rotterdam, the Netherlands.
  35. Ellis S.G., Kereiakes D.J., Metzger D.C., Caputo R.P., Rizik D.G., Teirstein P.S., Litt M.R., Kini A., Kabour A., Marx S.O., Popma J.J., McGreevy R., Zhang Z., Simonton C., Stone G.W.; ABSORB III Investigators. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N Engl J Med. 2015;373(20):1905-15. PMID: 26457558. http://dx.doi.org/10.1056/NEJMoa1509038
  36. Иванченко Р.Д., Бирюков А.В., Смирнов К.А. Отдаленные результаты применения биорезорбируемого сосудистого каркаса Absorb при лечении бифуркационных поражений коронарных артерий. Патология кровообращения и кардиохирургия. 2017;21(1):50-55. http://dx.doi.org/10.21688/1681-3472-2017-1-50-55 [Ivanchenko R.D., Birukov A.V., Smirnov K.A. Long-term clinical outcomes for bifurcation treatment using a provisional T-stenting and double proximal optimization technique with Absorb bioresorbable scaffolds. Patologiya krovoobrashcheniya i kardiokhirurgiya = Circulation Pathology and Cardiac Surgery. 2017;21(1):50-55. (In Russ.). http://dx.doi.org/10.21688/1681-3472-2017-1-50-55]
  37. Neumann F.J., Sousa-Uva M., Ahlsson A., Alfonso F., Banning A.P., Benedetto U., Byrne R.A., Collet J.P., Falk V., Head S.J., Jüni P., Kastrati A., Koller A., Kristensen S.D., Niebauer J., Richter D.J., Seferovic P.M., Sibbing D., Stefanini G.G., Windecker S., Yadav R., Zembala M.O.; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2018;40(2):87-165. PMID: 30165437. http://dx.doi.org/10.1093/eurheartj/ehy394
  38. Suwannasom P., Onuma Y., Benit E., Gach O., von Birgelen C., Hofma S.H., Sotomi Y., Bo X., Zhang Y.J., Gao R., García-García H.M., Wykrzykowska J.J., de Winter R.J., Serruys P.W. Evaluation of vascular healing of polymer-free sirolimus-eluting stents in native coronary artery stenosis. A serial follow-up at three and six months with optical coherence tomography imaging. EuroIntervention. 2016;12(5):e574-e583. http://dx.doi.org/10.4244/EIJV12I5A97
  39. Garcia-Garcia H.M., Muramatsu T., Nakatani S., Lee I.S., Holm N.R., Thuesen L., van Geuns R.J., van der Ent M., Borovicanin V., Paunovic D., Onuma Y., Serruys P.W. Serial optical frequency domain imaging in STEMI patients: the follow-up report of TROFI study. Eur Heart J Cardiovasc Imaging. 2014;15(9):987-95.
  40. Raber L., Onuma Y., Brugaletta S., Garcia-Garcia H.M., Backx B., Iniguez A., Jensen L.O., Cequier-Fillat A., Pilgrim T., Christiansen E.H., Hofma S.H., Suttorp M., Serruys P.W., Sabate M., Windecker S. Arterial healing following primary PCI using the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) versus the durable polymer everolimus-eluting metallic stent (XIENCE) in patients with acute ST-elevation myocardial infarction: rationale and design of the randomised TROFI II study. EuroIntervention. 2016;12(4):482-9. PMID: 26342471. http://dx.doi.org/10.4244/EIJY15M08_03
  41. Urban P., Meredith I.T., Abizaid A., Pocock S.J., Carrié D., Naber C., Lipiecki J., Richardt G., Iñiguez A., Brunel P., Valdes-Chavarri M., Garot P., Talwar S., Berland J., Abdellaoui M., Eberli F., Oldroyd K., Zambahari R., Gregson J., Greene S., Stoll H.P., Morice M.C.; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015;373:2038-47. http://dx.doi.org/10.1056/NEJMoa1503943
  42. Haude M., Ince H., Abizaid A., Toelg R., Lemos P.A., von Birgelen C., Christiansen E.H., Wijns W., Neumann F.J., Kaiser C., Eeckhout E., Lim S.T., Escaned J., Garcia-Garcia H.M., Waksman R. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet. 2016;387(10013):31-9. PMID: 26470647. http://dx.doi.org/10.1016/S0140-6736(15)00447-X