Chapter 33
Zotarolimus-Eluting Stents
Jorge Sanz-Sánchez,
Pier Pasquale Leone,
Ridhima Goel,
Giulio G. Stefanini,
Jorge Sanz-Sánchez
Search for more papers by this authorPier Pasquale Leone
Search for more papers by this authorRidhima Goel
Search for more papers by this authorGiulio G. Stefanini
Search for more papers by this authorJorge Sanz-Sánchez,
Pier Pasquale Leone,
Ridhima Goel,
Giulio G. Stefanini,
Jorge Sanz-Sánchez
Search for more papers by this authorPier Pasquale Leone
Search for more papers by this authorRidhima Goel
Search for more papers by this authorGiulio G. Stefanini
Search for more papers by this authorBook Editor(s):George D. Dangas MD, MACC, MSCAI, FAHA, FESC,
Carlo Di Mario MD, PhD, FRCP, FACC, FSCAI, FESC,
Holger Thiele MD,
Peter Barlis MBBS, MPH, PHD, FACC, FESC, FRACP,
Tayo Addo MD, Bimmer Claessen MD, Christian Hengstenberg MD, Nicholas Kipshidze MD,
George D. Dangas MD, MACC, MSCAI, FAHA, FESC
Professor of Medicine (Cardiology) & Surgery (Vascular) Professor of Cardiology Adjunct Professor of Internal Medicine
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, NY, USA
National Kapodistrian University of Athens, Greece
Medical University of Vienna, Austria
Search for more papers by this authorCarlo Di Mario MD, PhD, FRCP, FACC, FSCAI, FESC
Professor of Cardiology Director of the Structural Interventional Cardiology Division Honorary Consultant
University of Florence
University Hospital Careggi, Florence, Italy
Cardiologist Royal Brompton Hospital, London, UK
Search for more papers by this authorHolger Thiele MD
Professor of Cardiology at University of Leipzig
Heart Center Leipzig at University of Leipzig, Leipzig, Germany
Search for more papers by this authorPeter Barlis MBBS, MPH, PHD, FACC, FESC, FRACP
Professor of Cardiology Interventional Cardiologist
University of Melbourne, Melbourne, Victoria, Australia
St Vincent's & Northern Hospitals Victoria, Australia
Search for more papers by this authorSummary
This chapter reviews the technological iterations of zotarolimus-eluting stents (ZES) for the treatment of coronary artery disease, with a focus on its pivotal features, clinical efficacy and safety data. Performance of ZES is discussed in detail in a broad spectrum of patients and clinical settings, including challenging scenarios such as left main stem, small coronary vessels, high-bleeding risk and diabetic patients. As summarized in this chapter, a large amount of observational and randomized data supports the performance of ZES, which is comparable to other contemporary drug-eluting stents.
References
- Stefanini GG , Byrne RA , Windecker S , Kastrati A . State of the art: coronary artery stents - past, present and future . EuroIntervention. 2017 ; 13 ( 6 ): 706 – 716 .
- Stefanini GG , Holmes DR Jr . Drug-eluting coronary-artery stents . N Engl J Med. 2013 ; 368 ( 3 ): 254 – 265 .
- Bridges J , Cutlip D . Advances in drug eluting stents - focus on the Endeavor(®) zotarolimus stent . Med Devices (Auckl). 2009 ; 2 : 1 – 8 .
- Udipi K , Melder RJ , Chen M , et al . The next generation Endeavor Resolute Stent: role of the BioLinx Polymer System . EuroIntervention. 2007 ; 3 ( 1 ): 137 – 139 .
- Banerjee S . The resolute™ integrity zotarolimus-eluting stent in coronary artery disease: a review . Cardiol Ther. 2013 ; 2 ( 1 ): 17 – 25 .
- Price MJ , Saito S , Shlofmitz RA , et al . First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter . JACC Cardiovasc Interv. 2017 ; 10 ( 14 ): 1381 – 1388 .
- Serruys PW , Silber S , Garg S , et al . Comparison of zotarolimus-eluting and everolimus-eluting coronary stents . N Engl J Med. 2010 ; 363 ( 2 ): 136 – 146 .
- Iqbal J , Serruys PW , Silber S , et al . Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial . Circ Cardiovasc Interv. 2015 ; 8 ( 6 ): e002230 .
- von Birgelen C , Basalus MW , Tandjung K , et al . A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial . J Am Coll Cardiol. 2012 ; 59 ( 15 ): 1350 – 1361 .
- Park KW , Kang SH , Kang HJ , et al . A randomized comparison of platinum chromium-based everolimus-eluting stents versus cobalt chromium-based Zotarolimus-Eluting stents in all-comers receiving percutaneous coronary intervention: HOST-ASSURE (harmonizing optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen), a randomized, controlled, noninferiority trial . J Am Coll Cardiol. 2014 ; 63 ( 25 Pt A ): 2805 – 2816 .
- Yeh RW , Silber S , Chen L , et al . 5-Year Safety and Efficacy of Resolute Zotarolimus-Eluting Stent: The RESOLUTE Global Clinical Trial Program . JACC Cardiovasc Interv. 2017 ; 10 ( 3 ): 247 – 254 .
- von Birgelen C , Sen H , Lam MK , et al . Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial [published correction appears in The Lancet . 2014 Feb 1; 383(9915):412] . The Lancet. 2014 ; 383 ( 9915 ): 413 – 423 .
- Zocca P , Kok MM , Tandjung K , et al . 5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents: Final Report of the DUTCH PEERS (TWENTE II) Trial . JACC Cardiovasc Interv. 2018 ; 11 ( 5 ): 462 – 469 .
- Raungaard B , Jensen LO , Tilsted HH , et al . Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial [published correction appears in The Lancet . 2015 Apr 18; 385 (9977):1510] . The Lancet. 2015 ; 385 ( 9977 ): 1527 – 1535 .
- Raungaard B , Christiansen EH , Bøtker HE , et al . Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: 3-Year Clinical Outcomes in the Randomized SORT OUT VI Trial . JACC Cardiovasc Interv. 2017 ; 10 ( 3 ): 255 – 264 .
- Konigstein M , Smits PC , Love MP , et al . Randomized Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents: 2-Year Clinical Outcomes From the BIONICS and NIREUS Trials . JACC Cardiovasc Interv 2020 ; 13 ( 1 ): 86 – 93
- Price MJ , Shlofmitz RA , Spriggs DJ , et al . Safety and efficacy of the next generation Resolute Onyx zotarolimus-eluting stent: Primary outcome of the RESOLUTE ONYX core trial . Catheter Cardiovasc Interv. 2018 ; 92 ( 2 ): 253 – 259 .
- von Birgelen C , Zocca P , Buiten RA , et al . Thin composite wire strut, durable polymer-coated (Resolute Onyx) versus ultrathin cobalt-chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in allcomers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial . The Lancet. 2018 ; 392 ( 10154 ): 1235 – 1245 .
- Bundhun PK , Yanamala CM , Huang WQ . Comparing stent throm- bosis associated with zotarolimus eluting stents versus everolimus eluting stents at 1 year follow up: a systematic review and meta-analysis of 6 randomized controlled trials . BMC Cardiovasc Disord. 2017 ; 17 ( 1 ): 84 .
- Roleder T , Kedhi E , Berta B , et al . Short-term stent coverage of second-generation zotarolimus-eluting durable polymer stents: Onyx one-month optical coherence tomography study . Postepy Kardiol Interwencyjnej. 2019 ; 15 ( 2 ): 143 – 150 .
- Tam CC , Chan K , Lam S , et al . One-year clinical outcomes of patients implanted with a Resolute Onyx zotarolimus-eluting stent . J Int Med Res. 2018 ; 46 ( 1 ): 457 – 463 .
- Kim Y , Oh SS , Jeong MH , et al . Comparison of short-term clinical outcomes between resolute Onyx zotarolimus-eluting stents and everolimus-eluting stent in patients with acute myocardial infarc- tion: results from the Korea acute myocardial infarction registry (KAMIR) . Cardiol J. 2019 ; 26 ( 5 ): 469 – 476 .
- Urban P , Mehran R , Colleran R , et al . Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk . Eur Heart J. 2019 ; 40 ( 31 ): 2632 – 2653 .
- Varenne O , Cook S , Sideris G , et al . Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial . The Lancet. 2018 ; 391 ( 10115 ): 41 – 50 .
- Urban P , Meredith IT , Abizaid A , et al . Polymer-free drug-coated coronary stents in patients at high bleeding risk . N Engl J Med. 2015 ; 373 : 2038 – 47 .
- Zocca P , Kok MM , van der Heijden LC , et al . High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial . Cardiovasc Drugs Ther. 2018 ; 32 ( 6 ): 567 – 576 .
- Silber S , Kirtane AJ , Belardi JA , et al . Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation . Eur Heart J 2014 ; 35 : 1949 – 1956 .
- Windecker S , Latib A , Kedhi E , et al . Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk . N Engl J Med. 2020 ; 382 ( 13 ): 1208 – 1218 .
- Di Mario C , Serruys PW , Silber S , et al . Long-term outcomes after Resolute zotarolimus-eluting stent implantation in patients with ST-segment elevation acute myocardial infarction: insights from the RESOLUTE All Comers Trial and the RESOLUTE Global Clinical Trial Program . EuroIntervention. 2016 ; 12 ( 10 ): 1207 – 1214 .
- Postma W , Fabris E , Van der Ent M , et al . Resolute zotarolimus-eluting stent in ST-elevation myocardial infarction (resolute-STEMI): A prespecified prospective register from the DAPT-STEMI trial . Catheter Cardiovasc Interv. 2020 ; 95 ( 4 ): 706 – 710 .
- Kedhi E , Fabris E , van der Ent M , et al . Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial . BMJ. 2018 ; 363 : k3793 .
- Chichareon P , Modolo R , Collet C , et al . Efficacy and Safety of Stents in ST-Segment Elevation Myocardial Infarction . J Am Coll Cardiol. 2019 ; 74 ( 21 ): 2572 – 2584 .
- Neumann FJ , Sousa-Uva M , Ahlsson A , et al . 2018 ESC/EACTS Guidelines on myocardial revascularization . Eur Heart J . 2019 ; 40 ( 2 ): 87 – 165 .
- Mehilli J , Richardt G , Valgimigli M , et al . Zotarolimus- versus everolimus-eluting stents for unprotected left main coronary artery disease . J Am Coll Cardiol. 2013 ; 62 ( 22 ): 2075 – 2082 .
- Lee PH , Kwon O , Ahn JM , et al . Safety and Effectiveness of Second-Generation Drug-Eluting Stents in Patients With Left Main Coronary Artery Disease . J Am Coll Cardiol. 2018 ; 71 ( 8 ): 832 – 841 .
- Ng J , Foin N , Ang HY , et al . Over-expansion capacity and stent design model: an update with contemporary DES platforms . Int J Cardiol. 2016 ; 221 : 171 – 179 .
- Caputo R , Leon M , Serruys P , et al . Performance of the resolute zotarolimus-eluting stent in small vessels . Catheter Cardiovasc Interv. 2014 ; 84 ( 1 ): 17 – 23 .
- Saito S , Maehara A , Vlachojannis GJ , et al . RESOLUTE Japan Investigators. Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients – long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study . Circ J. 2015 ; 79 ( 1 ): 96 – 103 .
- Buiten RA , Ploumen EH , Zocca P , 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 Cardiol. 2019 ; 4 ( 7 ): 659 – 669 .
- Price MJ , Saito S , Shlofmitz RA , et al . First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter . JACC Cardiovasc Interv. 2017 ; 10 ( 14 ): 1381 – 1388 .
- Parikh MA , Soverow J , Leon MB , et al . Outcomes of stenting extra- small (≤2.25 mm) vessels using the resolute zotarolimus-eluting stent (R-ZES) . EuroIntervention. 2016 ; 12 ( 10 ): 1215 – 1221 .
- Cannon LA , Simon DI , Kereiakes D , et al . The XIENCE nano ever- olimus eluting coronary stent system for the treatment of small coronary arteries: the spirit small vessel trial . Catheter Cardiovasc Interv. 2012 ; 80 ( 4 ): 546 – 553 .
- Kelbæk H , Yeh RW , Engstrøm T , et al . Five-year clinical outcomes for the Resolute zotarolimus-eluting stent in total coronary occlusions [published online ahead of print, 2019 Nov 19]. EuroIntervention . 2019 ; EIJ-D-19-00866.
- Kandzari DE , Lembo NJ , Carlson HD , et al . Procedural, clinical, and health status outcomes in chronic total coronary occlusion revascularization: Results from the PERSPECTIVE study . Catheter Cardiovasc Interv . 2019 ; 1 – 10 .
- Markovic S , Lützner M , Dragomir S , Rottbauer W , Wöhrle J . Angiographic and clinical outcomes after recanalization of coronary chronic total occlusions with the Orsiro sirolimus-eluting stent compared with the resolute zotarolimus-eluting stent . Coron Artery Dis. 2017 ; 28 ( 5 ): 376 – 380 .
- Lee PH , Cho MS , Lee SW , et al . Everolimus- versus zotarolimus-eluting stent following percutaneous coronary chronic total occlusion intervention . Int J Cardiol. 2017 ; 241 : 128 – 132 .
- Kereiakes DJ , Cutlip DE , Applegate RJ , et al . Outcomes in Diabetic and Nondiabetic Patients Treated With Everolimus- or Paclitaxel-Eluting Stents . J Am Coll Cardiol. 2010 ; 56 : 2084 – 2089 .
- Lee TT , Feinberg L , Baim DS , et al . Effect of diabetes mellitus on five-year clinical outcomes after single-vessel coronary stenting (a pooled analysis of coronary stent clinical trials) . Am J Cardiol. 2006 ; 98 : 718 – 721 .
- Konigstein M , Ben-Yehuda O , Smits PC , et al . Outcomes Among Diabetic Patients Undergoing Percutaneous Coronary Intervention With Contemporary Drug-Eluting Stents: Analysis From the BIONICS Randomized Trial . JACC Cardiovasc Interv. 2018 ; 11 ( 24 ): 2467 – 2476 .
- Kwon O , Lee JB , Ahn JM , et al . Clinical outcomes of contemporary drug-eluting stents in patients with and without diabetes mellitus: Multigroup propensity-score analysis using data from stent-specific, multicenter, prospective registries [published online ahead of print, 3 Sep 2019]. Catheter Cardiovasc Interv . 2019 ; 10 .1002/ccd.28462.
- Mahajan AM , Claessen BE , Chandrasekhar J , et al . Outcomes by Gender and Ethnicity After Percutaneous Coronary Intervention . Am J Cardiol. 2019 ; 123 ( 12 ): 1941 – 1948 . doi: 10.1016/j.amjcard.2019.03.019
- Iantorno M , Torguson R , Kolm P , et al . Relation of Sex and Race to Outcomes in Patients Undergoing Percutaneous Intervention With Drug-Eluting Stents . Am J Cardiol. 2019 ; 123 ( 6 ): 913 – 918 .
- Kok MM , van der Heijden LC , Sen H , et al . Sex Difference in Chest Pain After Implantation of Newer Generation Coronary Drug-Eluting Stents: A Patient-Level Pooled Analysis From the TWENTE and DUTCH PEERS Trials . JACC Cardiovasc Interv. 2016 ; 9 ( 6 ): 553 – 561 .
- Kufner S , Sorges J , Mehilli J , et al . Randomized Trial of Polymer-Free Sirolimus- and Probucol-Eluting Stents Versus Durable Polymer Zotarolimus-Eluting Stents: 5-Year Results of the ISAR-TEST-5 Trial . JACC Cardiovasc Interv 2016 ; 9 ( 8 ): 784 – 92
- Kandzari DE , Smits PC , Love MP , et al . Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) . Circulation. 2017 ; 136 ( 14 ): 1304 – 1314 .
- Rozemeijer R , Stein M , Voskuil M , et al . Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent . Circulation. 2019 ; 139 ( 1 ): 67 – 77 .
- Hong SJ , Ahn CM , Kim BK , et al . Prospective randomized comparison of clinical and angiographic outcomes between everolimus-eluting vs. zotarolimus-eluting stents for treatment of coronary restenosis in drug-eluting stents: intravascular ultrasound volumetric analysis (RESTENT-ISR trial) . Eur Heart J. 2016 ; 37 ( 45 ): 3409 – 3418 .
- Valgimigli M , Bueno H , Byrne RA , et al . 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: the task force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European association for cardio-thoracic surgery (EACTS) . Eur Heart J . 2018 ; 39 ( 3 ): 213 – 260 .
- Levine GN , Bates ER , Blankenship JC , et al . 2015 ACC/AHA/scai focused update on primary percutaneous coronary intervention for patients with st-elevation myocardial infarction: an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction . 2016 .
- Colombo A , Chieffo A , Frasheri A , et al . Second-generation drug-eluting stent implantation followed by 6- versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial . J Am Coll Cardiol. 2014 ; 64 ( 20 ): 2086 – 2097 .
- Valgimigli M , Patialiakas A , Thury A , et al . Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates . J Am Coll Cardiol. 2015 ; 65 ( 8 ): 805 – 815 .
