ANGiographic Evaluation of Left Main Coronary Artery INtErvention (ANGELINE)

To assess if an angiographic follow-up at 6 months after Percutaneous Coronary Intervention in Left Main Coronary Artery Disease decrease the composite objective of death, myocardial infarction, and stroke at 36 months.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Disease; Coronary Occlusion; Left Main Coronary Artery Disease; Coronary Artery Stenosis
• Intervention / Treatment: Other: Angiography and Clinical Follow up; Other: Clinical Follow up

Detailed Description

Percutaneous coronary intervention (PCI) with drug-eluting stents in left main (LM) disease has demonstrated similar results than surgical revascularization in patients with SYNTAX score < 33, being the main drawback of PCI a higher rate of new revascularization. A small study found a reduction in the composite end-point of cardiac death, myocardial infarction and urgent revascularization with a routine angiographic follow-up. The investigators have designed a prospective, randomized, controlled, two-arm multicenter study in patients aged 18-85 with LM disease and SYNTAX score <33 and in cases ≥ 33 based on the Heart Team decision to assess the benefit of a routine angiographic follow-up 6 months after LM stenting. After the index procedure and before hospital discharge the patient will be randomized to routine invasive angiographic follow-up at 6 months plus clinical follow-up at 6 months, 1, 2 and 3 years vs. the control arm, which would be followed clinically at 6 months, 1, 2 and 3 years. Based on our calculations, an adequately powered trial would require 1009 patients per arm but due to the uncertainty of the results and the current economical restrictions we have designed a pilot study in 400 patients to find out the convenience of an adequately powered trial. All the lesions should be treated with an everolimus eluting stent with permanent fluoropolymer. It will be desirable to achieve complete revascularization and it will be highly recommended to perform the procedures guided with an intravascular image technique (OCT or IVUS (IntraVascular UltraSound) according to operator´s criteria). The main outcome will be death, myocardial infarction and cerebrovascular accident at 3 years. The initial percutaneous technique and the decision about the convenience and way of revascularization in case of restenosis in the follow-up will be left at the operator´s discretion, according in the most adequate way to the current guidelines. Nonetheless, the investigators are strongly encouraged to rely on intravascular techniques, based on either imaging or physiology. In those cases with in-stent hyperplasia with doubts about possible restenosis, FFR and RFR (Resting full-cycle ratio) will be performed, with low threshold to achieve a high rate of ruling out the restenosis.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: +34987876135; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: Iñigo Lozano, MD, PhD; Phone Number: +34987876135; Email: ilozano@fundacionepic.org

Study Locations

• Spain
  • Albacete, Spain, 02006
    • Recruiting
    • Hospital General Universitario de Albacete
  • Alicante, Spain, 03010
    • Recruiting
    • Hospital General Universitario de Alicante
  • Alicante, Spain
    • Recruiting
    • Hospital Universitario San Juan de Alicante
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
  • Barcelona, Spain, 08907
    • Recruiting
    • Hospital Universitari Bellvitge
  • Ciudad Real, Spain, 13005
    • Recruiting
    • Hospital Universitario de Ciudad Real
  • Coruña, Spain, 15006
    • Recruiting
    • Hospital Universitario de A Coruna
  • Córdoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
  • Gijón, Spain, 33394
    • Recruiting
    • Hospital Universitario de Cabueñes
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
  • Huelva, Spain, 21005
    • Recruiting
    • Hospital General Juan Ramon Jimenez
  • León, Spain, 24071
    • Recruiting
    • Hospital Universitario de Leon
  • Lugo, Spain, 27003
    • Recruiting
    • Hospital Universitario Lucus Agusti
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Recruiting
    • Hospital Universitario La Princesa
  • Murcia, Spain, 30120
    • Recruiting
    • Hospital Universitario Virgen Arrixaca
  • Santander, Spain, 39008
    • Recruiting
    • Hospital Universitario Marques de Valdecilla
  • Santiago De Compostela, Spain, 15706
    • Recruiting
    • Hospital Clínico Universitario de Santiago de Compostela
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clínico Universitario de Valladolid
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Clinico Universitario Lozano Blesa
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Miguel Servet
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Hospital Universitari Germans Trias i Pujol
  • Bizkaia
    • Barakaldo, Bizkaia, Spain, 48903
      • Recruiting
      • Hospital Universitario de Cruces
  • Gipuzkoa
    • Donostia, Gipuzkoa, Spain, 20014
      • Recruiting
      • Hospital Universitario Donostia
  • Malaga
    • Málaga, Malaga, Spain, 29010
      • Recruiting
      • Hospital Universitario Regional de Malaga
  • Vizcaya
    • Galdakao, Vizcaya, Spain, 48960
      • Recruiting
      • Hospital Galdakao-Usansolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 18- 85 years at the date of the PCI.
• With PCI for presenting de novo lesions in the Left Main Artery by implanting a cobalt-chrome stent with everolimus-eluting fluoropolymer.
• Informed consent signed.

Exclusion Criteria:

• Refusal to participate in the study.
• Patients with left main disease who have been admitted with STEMI and have undergone primary angioplasty in a culprit lesion different than the left main. The left main lesion has been treated as a stage procedure and discharged with left ventricular ejection fraction < 35 %.
• Previous coronary surgery.
• Creatinine clearance <40 ml / min.
• Contraindication for double antiaggregation after PCI.
• Patients life expectancy <36 months.
• Included in other studies or clinical trials.
• Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Angiography and Clinical Follow up; After PCI. The patient is randomized to an angiographic follow-up at 6 months and a Clinical Follow to 36 months	Other: Angiography and Clinical Follow up; Angiography and Clinical Follow up
Active Comparator: Clinical Follow up; After PCI. The patient is randomized to a Clinical Follow to 36 months	Other: Clinical Follow up; Clinical Follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint: defined as : death, myocardial infarction, and stroke.	Composite endpoint: defined as : death, myocardial infarction, and stroke.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Death	Occurrence of Death	36 months
Cardiac Death	Occurrence of Cardiac Death	36 months
Myocardial Infarction	Occurrence of Myocardial Infarction	36 months
Stroke	Occurrence of Stroke	36 months
Stent thrombosis (ARC definite/probable)	Occurrence of thrombosis (ARC definite/probable)	36 months
Major bleeding event (BARC type 2-5)	Occurrence of Major bleeding event (BARC type 2-5)	36 months
Target Vessel revascularization.	Occurrence of Target Vessel revascularization.	36 months
Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention)	Occurrence of New revascularization by CABG or PCI	36 months

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• Cavalcante R, Sotomi Y, Lee CW, Ahn JM, Farooq V, Tateishi H, Tenekecioglu E, Zeng Y, Suwannasom P, Collet C, Albuquerque FN, Onuma Y, Park SJ, Serruys PW. Outcomes After Percutaneous Coronary Intervention or Bypass Surgery in Patients With Unprotected Left Main Disease. J Am Coll Cardiol. 2016 Sep 6;68(10):999-1009. doi: 10.1016/j.jacc.2016.06.024.
• Puri R, de la Torre Hernandez JM, Auffret V. Routine Surveillance Coronary Angiography Post-PCI: Should We ReACT and Change Our Routine? JACC Cardiovasc Interv. 2017 Jan 23;10(2):118-120. doi: 10.1016/j.jcin.2016.11.020. Epub 2016 Dec 28. No abstract available.
• Aurigemma C, Burzotta F, Porto I, Niccoli G, Leone AM, Crea F, Trani C. Clinical impact of routine angiographic follow-up after percutaneous coronary interventions on unprotected left main. Cardiol J. 2018;25(5):582-588. doi: 10.5603/CJ.a2018.0092. Epub 2018 Aug 29.
• Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM 3rd, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman P, Bochenek A, Schampaert E, Page P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP; EXCEL Trial Investigators. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8;375(23):2223-2235. doi: 10.1056/NEJMoa1610227. Epub 2016 Oct 31. Erratum In: N Engl J Med. 2019 Oct 31;381(18):1789.
• Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31. Erratum In: Lancet. 2016 Dec 3;388(10061):2742.
• Stone GW, Kappetein AP, Sabik JF, Pocock SJ, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Brown WM 3rd, Lembo NJ, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman PE, Bochenek A, Schampaert E, Page P, Modolo R, Gregson J, Simonton CA, Mehran R, Kosmidou I, Genereux P, Crowley A, Dressler O, Serruys PW; EXCEL Trial Investigators. Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. N Engl J Med. 2019 Nov 7;381(19):1820-1830. doi: 10.1056/NEJMoa1909406. Epub 2019 Sep 28. Erratum In: N Engl J Med. 2020 Mar 12;382(11):1078.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Angiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Occlusion; Coronary Stenosis
• Other Study ID Numbers: EPIC23-ANGELINE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No