Clinical trial NCT04604197: ANGiographic Evaluation of Left Main Coronary Artery INtErvention
Official title: ANGiographic Evaluation of Left Main Coronary Artery INtErvention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Occlusion
Left Main Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Keywords: Angiography
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite endpoint: defined as : death, myocardial infarction, and stroke.
timeFrame: 36 months
Secondary outcomes:
measure: All Death
timeFrame: 36 months
measure: Cardiac Death
timeFrame: 36 months
measure: Myocardial Infarction
timeFrame: 36 months
measure: Stroke
timeFrame: 36 months
measure: Stent thrombosis (ARC definite/probable)
timeFrame: 36 months
measure: Major bleeding event (BARC type 2-5)
timeFrame: 36 months
measure: Target Vessel revascularization.
timeFrame: 36 months
measure: Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention)
timeFrame: 36 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
state: Barcelona
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
state: Bizkaia
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
state: Gipuzkoa
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Malaga
state: Malaga
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Vizcaya
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari Bellvitge
city: Ciudad Real
country: Spain
facility: Hospital Universitario de Ciudad Real
city: Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Huelva
country: Spain
facility: Hospital General Juan Ramón Jiménez
city: León
country: Spain
facility: Hospital Universitario de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Agusti
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital Universitario Virgen Arrixaca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References:
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.
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.
citation: 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.
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.
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.
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.