Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study

NCT03567733 | Completed DMC

• 1 other identifier: SIERRA 75 EPIC-05
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 44

Brief Summary

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

Conditions

Ischemic Heart Disease; Coronary Artery Disease

Keywords

Dual antiplatelet treatment; Elderly patients

Outcome Measures

Primary Outcomes (2)

• Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). .

  The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). .

  12 month

• Efficacy.The incidence of clinically driven target lesion revascularization (TLR).

  The incidence of clinically driven target lesion revascularization (TLR).

  12 month

Secondary Outcomes (14)

• All death.

  12 month

• Cardiac death.

  12 month

• Target Vessel revascularization.

  12 month

• Target lesion revascularization.

  12 month

• Stent thrombosis (ARC definite/probable).

  12 month

Study Arms (1)

Coronary Artery Disease

Drug- eluting Stent

Device: XIENCE Sierra

Interventions

XIENCE Sierra DEVICE

Percutaneous coronary intervention

Coronary Artery Disease

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (44)

Hospital Garcia de Orta

Almada, 2805-267, Portugal

Location

Centro Hospitalar Lisboa Occidental. Hospital de Santa Cruz

Carnaxide, 2790-134, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

Espinho, 4401-860, Portugal

Location

Hospital do Espírito Santo de Évora

Evora, 7000, Portugal

Location

Hospital Do Divino Espirito Santo De Ponta Delgada

Ponta Delgada, 9500-370, Portugal

Location

Hospital Do Divino Espirito Santo

Ponta Delgada, 9500-370, Portugal

Location

Centro Hospitalar de Setubal, EPE - Hospital Sao Bernardo

Setúbal, 2910-446, Portugal

Location

Hospital Universitario Vinalopo

Elche, Alicante, 03293, Spain

Location

Hospital de Torrevieja

Torrevieja, Alicante, 03186, Spain

Location

Hospital de Mérida

Mérida, Badajoz, 06800, Spain

Location

Hospital Universitari Germans Trias I Pujol de Badalona

Badalona, Barcelona, 08916, Spain

Location

Hospital de Puerto Real

Puerto Real, Cádiz, 11510, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, Mallorca, 07120, Spain

Location

Hospital General Universitario de Albacete

Albacete, 02006, Spain

Location

Hospital Universitario San Juan de Alicante

Alicante, 03550, Spain

Location

Hospital Infanta Cristina

Badajoz, 06080, Spain

Location

Hospital Universitario de Cruces

Barakaldo, 48903, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, 48960, Spain

Location

Hospital de Cabueñes

Gijón, 33394, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

Location

Hospital General Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital de León

León, 24080, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

Complejo Hospitalario Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Clinico Universitario Virgen de La Arrixaca

Murcia, 30120, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, 38320, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Virgen de La Salud

Toledo, 45004, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari I Politècnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Álvaro Cunqueiro

Vigo, 36312, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Hospital Universitario de Araba

Vitoria-Gasteiz, Álava, 01009, Spain

Location

Related Publications (8)

• 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.

  PMID: 28290994 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22995087 BACKGROUND

• 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.

  PMID: 24216285 BACKGROUND

• 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.

  PMID: 24454326 BACKGROUND

• 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.

  PMID: 26466021 BACKGROUND

• 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.

  PMID: 28579168 BACKGROUND

• de la Torre Hernandez JM, Palop RL, Jimenez Mazuecos JM, Saez PC, Gutierez-Barrios A, Pinar E, Cid B, Fernandez L, Camarero TG, Urbano-Carrillo C, Oteo Dominguez JF, Jimenez Diaz VA, Gomez Menchero AE, Fernandez EG, Cordoba Soriano JG, Ocaranza R, Ucar EA, Roman KGS, Leal S, Caceres GM, Linares Vicente JA, Ferre GF, Carrillo X, Rama Merchan JC, Costa C, Sanchis J, Fernandes R, Rodrigues A, Vegas Valle JM, Pereira H, de Prado AP. Prospective application of a bleeding and ischemic risks-adjusted antithrombotic protocol in elderly patients revascularized with everolimus-eluting stents: EPIC05-Sierra75 study. J Geriatr Cardiol. 2022 May 28;19(5):354-366. doi: 10.11909/j.issn.1671-5411.2022.05.009.

  PMID: 35722037 RESULT

Related Links

• Related Info
• Study Results

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 26, 2018
• Study Start: June 18, 2018
• Primary Completion: September 1, 2020
• Study Completion: October 21, 2020
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (37); PT (7)