Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study): Retrospective and Prospective Follow-up Study

Study Overview
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Brief Summary
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The investigator aimed to evaluate the long-term (up to 10 years) follow-up of the patients who enrolled the IVUS-XPL study (Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions), which was shown the superiority of IVUS-guided stent implantation at 1 year in terms of major adverse cardiac events.

Detailed Description
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The investigator will follow-up (up to 10 years) the patients who enrolled the IVUS-XPL study (Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions).

Official Title
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Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study): Retrospective and Prospective Follow-up Study

Conditions
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Myocardial Ischemia(Implanted Drug-eluting Stents Because of Ischemic Heart Disease(Stable Angina, Acute Coronary Syndrome))

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. The patients who enrolled in the XPL-IVUS study. 2. Provision of informed consent Exclusion Criteria: 1. This observational study does not have any specific exclusion criteria.

Ages Eligible for Study
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Minimum Age: 20 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVUS-guidance group<br>The patients who underwent drug-eluting stents implantation with IVUS guidance. | |
| Angiography-guidance group<br>The patients who underwent drug-eluting stents implantation with angiography guidance without IVUS. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years and at 10 years | Major adverse cardiac events will be included the composite of cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization. | At 5 years | 
| The composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years and at 10 years | Major adverse cardiac events will be included the composite of cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization. | At 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | 
| Cardiac death at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | 
| All-cause of death at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | 
| All-cause of death at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | 
| Target-lesion related myocardial infarction at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | 
| Target-lesion related myocardial infarction at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | 
| Any myocardial infarction at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | 
| Any myocardial infarction at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | 
| Target-lesion revascularization at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | 
| Target-lesion revascularization at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | 
| Any revascularization at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | 
| Any revascularization at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | 
| Target-lesion related stent thrombosis at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | 
| Target-lesion related stent thrombosis at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | 
| Any stent thrombosis at 5 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 5 years | 
| Any stent thrombosis at 10 years | Secondary outcome will include both the each component of primary outcome and non-target lesion-related adverse events. | At 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical outcome; IVUS; Stent