ANGiographic Evaluation of Left Main Coronary Artery INtErvention

Coronary Artery Disease Clinical Trial

— ANGELINE  

Official title:

ANGiographic Evaluation of Left Main Coronary Artery INtErvention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04604197
• Other study ID #: EPIC23-ANGELINE
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2023
• Source: Fundación EPIC
• Contact: Iñigo Lozano, MD, PhD
• Phone: +34987876135
• Email: ilozano[@]fundacionepic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Occlusion
• Coronary Stenosis
• Left Main Coronary Artery Disease
• Myocardial Ischemia

Intervention

Other:
• Angiography and Clinical Follow up
Angiography and Clinical Follow up
• Clinical Follow up
Clinical Follow up

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Albacete	Albacete
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario San Juan de Alicante	Alicante
Spain	Hospital Universitari Germans Trias I Pujol	Badalona	Barcelona
Spain	Hospital Universitario de Cruces	Barakaldo	Bizkaia
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Universitari Bellvitge	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Universitario de Ciudad Real	Ciudad Real
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital Universitario de A Coruña	Coruña
Spain	Hospital Universitario Donostia	Donostia	Gipuzkoa
Spain	Hospital Galdakao-Usansolo	Galdakao	Vizcaya
Spain	Hospital Universitario de Cabueñes	Gijón
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Hospital General Juan Ramón Jiménez	Huelva
Spain	Hospital Universitario de León	León
Spain	Hospital Universitario Lucus Agusti	Lugo
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital Universitario Regional de Malaga	Málaga	Malaga
Spain	Hospital Universitario Virgen Arrixaca	Murcia
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago De Compostela
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint: defined as : death, myocardial infarction, and stroke.	Composite endpoint: defined as : death, myocardial infarction, and stroke.	36 months
Secondary	All Death	Occurrence of Death	36 months
Secondary	Cardiac Death	Occurrence of Cardiac Death	36 months
Secondary	Myocardial Infarction	Occurrence of Myocardial Infarction	36 months
Secondary	Stroke	Occurrence of Stroke	36 months
Secondary	Stent thrombosis (ARC definite/probable)	Occurrence of thrombosis (ARC definite/probable)	36 months
Secondary	Major bleeding event (BARC type 2-5)	Occurrence of Major bleeding event (BARC type 2-5)	36 months
Secondary	Target Vessel revascularization.	Occurrence of Target Vessel revascularization.	36 months
Secondary	Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention)	Occurrence of New revascularization by CABG or PCI	36 months