veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study

Study Overview
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Brief Summary
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For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with very thin stents for ULM or bifurcation.

Detailed Description
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For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Previous studies do not have enough power to detect potential significant difference for ULM or bifurcation lesions. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with Biomatrix Flex, Xience Alpine, Ultimaster, Resolute Onyx and Synergy. MACE (a composite end point of death, myocardial infarction, target lesion revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.

Official Title
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veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study

Conditions
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Stent Restenosis, Stent Thrombosis, Left Main Coronary Artery Disease, Coronary Bifurcations, Very Thin Stents

Intervention / Treatment
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* Device: Xience alpine, ultimaster, resolute onyx, synergy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing PCI on unprotected left main or coronary bifurcation Exclusion Criteria: PCI performed on other coronary vessels

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group<br>Consecutive patients treated with very thin stents on ULM and bifurcation | Device: Xience alpine, ultimaster, resolute onyx, synergy<br>* PCI will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) | Major Adverse Cardiac Events (MACE) is a composite end-point which includes: death for any cause; non fatal myocardial infarction; target lesion revascularization (TLR); in-stent thrombosis. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion revascularization (TLR) | The investigators defined Target Lesion Revascularization as either repeat percutaneous or surgical revascularization for a lesion anywhere within the stent or the 5-mm borders proximal or distal to the stent. | 1 year | 
| Death | Death for any cause (both cardiologic and non-cardiologic) | 1 year | 
| non fatal myocardial infarction | non fatal myocardial infarction | 1 year | 
| Target Vessel Revascularization (TVR) | TVR is defined as any repeat PCI in the target vessel indicating the disease progression. | 1 year |