Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation

Overview

Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.

Detailed description

Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.

Interventions

• Device Supraflex Cruz Sirolimus-eluting Stent
  PCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation.

Primary outcome measures

• NACE (Net Adverse Clinical Events) [Time frame: 12 month]

Secondary outcome measures (12)

• MACE (Major Adverse Cardiac Events) [Time frame: 12 months]
• MACE (Major Adverse Cardiac Events) [Time frame: 6 months]
• TLF (Target Lesion Failure) [Time frame: 12 months]
• TLF (Target Lesion Failure) [Time frame: 6 months]
• Death [Time frame: 12 months]
• Death [Time frame: 6 months]
• Acute Myocardial Infarction (AMI) [Time frame: 12 months]
• Acute Myocardial Infarction (AMI) [Time frame: 6 months]
• Stroke [Time frame: 12 months]
• Stroke [Time frame: 6 months]
• Target vessel revascularization (TVR) [Time frame: 12 months]
• Target vessel revascularization (TVR) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

Patients must meet all inclusion criteria:

• Patients with Signed informed consent and
• Patients with >=18 years old and
• Patients with chronically receiving oral anticoagulation treatment with any type of anticoagulant for any reason and
• Patients with de novo Coronary artery disease requiring both elective or urgent percutaneous revascularization due to stable coronary artery disease or acute coronary syndrome with or without ST-segment elevation, and in which an ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer has been used

Exclusion criteria

Patients do not have to meet any exclusion criteria

• Patients treated percutaneously with any type of stent other than the SupraFlex Cruz® in the 6 months prior to the index procedure in which he or she is included.
• Use in the same procedure or in a scheduled procedure of other stents different from the one evaluated for the treatment of another vessel(s).
• Patients treatment for restenosis or stent thrombosis.
• Patients presentation in cardiogenic shock or after cardiorespiratory arrest.
• Patients with allergy to any of the components of the stent to be used.
• Patients with impossibility for follow-up.
• Patients with life expectancy less than 1 year.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Spain · 13 centers

• Hospital General Universitario de Albacete — Albacete
• Hospital Universitario San Juan de Alicante — Alicante
• Hospital General Universitario de Merida — Badajoz
• Hospital General Universitari de Castelló — Castelló
• H.G.U. de Ciudad Real. — Ciudad Real
• Hospital General Universitari d'Elx — Elche
• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
• Hospital Universitario de Canarias — Laguna
• … and 5 more centers

Publications

• Lemos PA, Chandwani P, Saxena S, Ramachandran PK, Abhyankar A, Campos CM, Marchini JF, Galon MZ, Verma P, Sandhu MS, Parikh N, Bhupali A, Jain S, Prajapati J. Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry. BMJ Open. 2016 Feb 17;6(2):e010028. doi: 10.1136/bmjopen-2015-01 PMID 26888727
• Choudhury A, Garg S, Smith J, Sharp A, Nabais de Araujo S, Chauhan A, Patel N, Wrigley B, Chattopadhyay S, Zaman AG. Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months' results from the S-FLEX UK registry. BMJ Open. 2019 Oct 11;9(10):e026578. doi: 10.1136/bmjopen-2018-026578. PMID 31604782
• Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting cor PMID 30827782
• Biscaglia S, Guiducci V, Escaned J, Moreno R, Lanzilotti V, Santarelli A, Cerrato E, Sacchetta G, Jurado-Roman A, Menozzi A, Amat Santos I, Diez Gil JL, Ruozzi M, Barbierato M, Fileti L, Picchi A, Lodolini V, Biondi-Zoccai G, Maietti E, Pavasini R, Cimaglia P, Tumscitz C, Erriquez A, Penzo C, Colaiori I, Pignatelli G, Casella G, Iannopollo G, Menozzi M, Varbella F, Caretta G, Dudek D, Barbato E, T PMID 37634150
• Paradies V, Maurina M, Tonino P, Hofma SH, Vos J, van Kuijk JP, Oemrawsingh RM, Mafragi AA, Spano F, Pisters R, Polad J, Ijsselmuiden S, Cambero MM, Smits PC. Comparison of Supraflex Cruz 60 mum Versus Ultimaster Tansei 80 mum Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial. Am J Cardiol. 2023 Nov 1;206:230-237. doi: 10.1016/j.amjcard.2023.08.0 PMID 37708755

Identifiers

NCT: NCT06863155 · rEPIC13-ACO-FLEX

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗