Clinical trial NCT03567733: Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study
Official title: Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents". Sierra 75 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Coronary Artery Disease
Keywords: Dual antiplatelet treatment
Elderly patients
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 75 years with de novo native coronary artery lesions, candidate to undergo revascularisation with a coronary device.

Brief summary: This prospective registry is intended to evaluate the safety and efficacy of the XIENCE Sierra stent.

Detailed description: This prospective registry is intended to analyze clinical outcomes in elderly patients treated with XIENCE Sierra stent and in pre-established subgroups (stable and unstable coronary artery disease).

Eligibility criteria: Inclusion Criteria:

* Age\> 75 years.
* With indication of percutaneous revascularization.
* Presence of de novo coronary artery lesions located in a native coronary artery.
* Informed consent signed

Exclusion Criteria:

* Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention)
* Cardiac arrest before the PCI
* Life expectancy of the patient under 1 year
* Participation in another study with a drug or device in clinical research
* Clinical decision that excludes the use of drug-eluting stents
* Confirmed allergy to aspirin and / or thienopyridines.

Primary outcomes:
measure: Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). .
timeFrame: 12 month
measure: Efficacy.The incidence of clinically driven target lesion revascularization (TLR).
timeFrame: 12 month
Secondary outcomes:
measure: All death.
timeFrame: 12 month
measure: Cardiac death.
timeFrame: 12 month
measure: Target Vessel revascularization.
timeFrame: 12 month
measure: Target lesion revascularization.
timeFrame: 12 month
measure: Stent thrombosis (ARC definite/probable).
timeFrame: 12 month
measure: Major bleeding event (BARC type 2-5).
timeFrame: 12 month
measure: Stroke.
timeFrame: 12 month
measure: Procedural success.
timeFrame: 12 month
measure: Rate of patients with DAPT.
timeFrame: 1 month
measure: Rate of patients with DAPT.
timeFrame: From 1 to 3 months
measure: Rate of patients with DAPT.
timeFrame: From 3 to 6 months
measure: Rate of patients with DAPT.
timeFrame: From 6 to 12 months
measure: Collection of imaging data by Optical coherence tomography (OCT).
timeFrame: 12 month
measure: Collection of imaging data by Intravascular Ultrasound (IVUS).
timeFrame: 12 month
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Carnaxide
country: Portugal
facility: Centro Hospitalar Lisboa Occidental. Hospital de Santa Cruz
city: Espinho
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
city: Ponta Delgada
country: Portugal
facility: Hospital Do Divino Espirito Santo De Ponta Delgada
city: Ponta Delgada
country: Portugal
facility: Hospital Do Divino Espirito Santo
city: Setubal
country: Portugal
facility: Centro Hospitalar de Setubal, EPE - Hospital Sao Bernardo
city: Évora
country: Portugal
facility: Hospital do Espírito Santo de Évora
city: Elche
country: Spain
facility: Hospital Universitario Vinalopo
state: Alicante
city: Torrevieja
country: Spain
facility: Hospital de Torrevieja
state: Alicante
city: Mérida
country: Spain
facility: Hospital de Mérida
state: Badajoz
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol de Badalona
state: Barcelona
city: Puerto Real
country: Spain
facility: Hospital de Puerto Real
state: Cádiz
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Mallorca
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 Infanta Cristina
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cádiz
country: Spain
facility: Hospital Puerta Del Mar
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
city: Gijón
country: Spain
facility: Hospital de Cabueñes
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Huelva
country: Spain
facility: Hospital General Juan Ramón Jiménez
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaén
city: León
country: Spain
facility: Hospital de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Malaga
country: Spain
facility: Complejo Hospitalario Regional de Málaga
city: Murcia
country: Spain
facility: Hospital Clinico Universitario Virgen de La Arrixaca
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Nuestra Señora de la Candelaria
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Toledo
country: Spain
facility: Hospital Virgen de La Salud
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari I Politècnic La Fe
city: Vigo
country: Spain
facility: Hospital Universitario Álvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario de Araba
state: Álava
Study officials:
References:
citation: Costa F, van Klaveren D, James S, Heg D, Raber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017 Mar 11;389(10073):1025-1034. doi: 10.1016/S0140-6736(17)30397-5.
citation: Valgimigli M, 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. 2017 Aug 26
citation: Kedhi E, Stone GW, Kereiakes DJ, Serruys PW, Parise H, Fahy M, Simonton CA, Sudhir K, Sood P, Smits PC. Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials. EuroIntervention. 2012 Sep;8(5):599-606. doi: 10.4244/EIJV8I5A92.
citation: de Belder A, de la Torre Hernandez JM, Lopez-Palop R, O'Kane P, Hernandez Hernandez F, Strange J, Gimeno F, Cotton J, Diaz Fernandez JF, Carrillo Saez P, Thomas M, Pinar E, Curzen N, Baz JA, Cooter N, Lozano I, Skipper N, Robinson D, Hildick-Smith D; XIMA Investigators. A prospective randomized trial of everolimus-eluting stents versus bare-metal stents in octogenarians: the XIMA Trial (Xience or Vision Stents for the Management of Angina in the Elderly). J Am Coll Cardiol. 2014 Apr 15;63(14):1371-5. doi: 10.1016/j.jacc.2013.10.053. Epub 2013 Nov 21.
citation: Gao L, Hu X, Liu YQ, Xue Q, Wang Y. Comparison of coronary DES and BMS in octogenarians: A systematic review and meta-analysis. J Geriatr Cardiol. 2013 Dec;10(4):336-43. doi: 10.3969/j.issn.1671-5411.2013.04.004.
citation: Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez 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 HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.
citation: Morice MC, Talwar S, Gaemperli O, Richardt G, Eberli F, Meredith I, Zaman A, Fajadet J, Copt S, Greene S, Urban P. Drug-coated versus bare-metal stents for elderly patients: A predefined sub-study of the LEADERS FREE trial. Int J Cardiol. 2017 Sep 15;243:110-115. doi: 10.1016/j.ijcard.2017.04.079. Epub 2017 Apr 25.