Clinical trial NCT06863155: Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
Official title: Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Keywords: Chronic oral anticoagulation
Ultrathin-strut stent
Biodegradable polymer
High-bleeding risk
Percutaneous Coronary Intervention
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under chronic oral anticoagulation undergoing PCI with implantation of a SupraFlex Cruz(r) stent

Brief summary: 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.

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.

Primary outcomes:
measure: NACE (Net Adverse Clinical Events)
timeFrame: 12 month
Secondary outcomes:
measure: MACE (Major Adverse Cardiac Events)
timeFrame: 12 months
measure: MACE (Major Adverse Cardiac Events)
timeFrame: 6 months
measure: TLF (Target Lesion Failure)
timeFrame: 12 months
measure: TLF (Target Lesion Failure)
timeFrame: 6 months
measure: Death
timeFrame: 12 months
measure: Death
timeFrame: 6 months
measure: Acute Myocardial Infarction (AMI)
timeFrame: 12 months
measure: Acute Myocardial Infarction (AMI)
timeFrame: 6 months
measure: Stroke
timeFrame: 12 months
measure: Stroke
timeFrame: 6 months
measure: Target vessel revascularization (TVR)
timeFrame: 12 months
measure: Target vessel revascularization (TVR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
city: Badajoz
country: Spain
facility: Hospital General Universitario de Merida
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
Study officials:
References:
citation: 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-2015-010028.
citation: 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.
citation: 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 coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019 Mar 9;393(10175):987-997. doi: 10.1016/S0140-6736(18)32467-X. Epub 2019 Feb 28.
citation: 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, Tebaldi M, Campo G; FIRE Trial Investigators. Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction. N Engl J Med. 2023 Sep 7;389(10):889-898. doi: 10.1056/NEJMoa2300468. Epub 2023 Aug 26.
citation: 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.2023.08.046. Epub 2023 Sep 13.