ANGiographic Evaluation of Left Main Coronary Artery INtErvention
- Conditions
- Coronary Artery DiseaseCoronary OcclusionLeft Main Coronary Artery DiseaseCoronary DiseaseCoronary Artery Stenosis
- Interventions
- Other: Clinical Follow upOther: Angiography and Clinical Follow up
- Registration Number
- NCT04604197
- Lead Sponsor
- Fundación EPIC
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinical Follow up Clinical Follow up After PCI. The patient is randomized to a Clinical Follow to 36 months Angiography and Clinical Follow up 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
- Primary Outcome Measures
Name Time Method Composite endpoint: defined as : death, myocardial infarction, and stroke. 36 months Composite endpoint: defined as : death, myocardial infarction, and stroke.
- Secondary Outcome Measures
Name Time Method All Death 36 months Occurrence of Death
Cardiac Death 36 months Occurrence of Cardiac Death
Target Vessel revascularization. 36 months Occurrence of Target Vessel revascularization.
Myocardial Infarction 36 months Occurrence of Myocardial Infarction
Stroke 36 months Occurrence of Stroke
Stent thrombosis (ARC definite/probable) 36 months Occurrence of thrombosis (ARC definite/probable)
Major bleeding event (BARC type 2-5) 36 months Occurrence of Major bleeding event (BARC type 2-5)
Revascularization by CABG ( Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention) 36 months Occurrence of New revascularization by CABG or PCI
Trial Locations
- Locations (30)
Hospital Universitari Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Universitari Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Universitario de A Coruña
🇪🇸Coruña, Spain
Hospital Universitario Reina Sofia
🇪🇸Córdoba, 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 La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Universitari Germans Trias I Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario de Cruces
🇪🇸Barakaldo, Bizkaia, Spain
Hospital Universitario Donostia
🇪🇸Donostia, Gipuzkoa, Spain
Hospital Universitario Regional de Malaga
🇪🇸Málaga, Malaga, Spain
Hospital Galdakao-Usansolo
🇪🇸Galdakao, Vizcaya, Spain
Hospital General Universitario de Albacete
🇪🇸Albacete, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario San Juan de Alicante
🇪🇸Alicante, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, 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 Valladolid
🇪🇸Valladolid, Spain