ANGiographic Evaluation of Left Main Coronary Artery INtErvention

Study Overview
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Brief Summary
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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
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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.

Official Title
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ANGiographic Evaluation of Left Main Coronary Artery INtErvention

Conditions
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Coronary Occlusion, Left Main Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease

Intervention / Treatment
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* Other: Angiography and Clinical Follow up
* Other: Clinical Follow up


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angiography and Clinical Follow up<br>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<br>* Angiography and Clinical Follow up<br>|
| Active Comparator: Clinical Follow up<br>After PCI. The patient is randomized to a Clinical Follow to 36 months | Other: Clinical Follow up<br>* Clinical Follow up<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiography