Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults. Compared to the general population, OSA occurs more often in patients with coronary artery disease (CAD), with a reported prevalence of 38% to 65%. Emerging evidence indicates OSA initiates and exacerbates coronary atherosclerosis. Moreover, several observational studies indicate the presence of OSA was associated with higher rate of restenosis and repeat revascularization (mainly attributed non-culprit lesion revascularization) after percutaneous coronary intervention (PCI). OSA might initiate endothelial injury by repetitive bursts of sympathetic activity that occur with apneas and hypopneas. Moreover, untreated OSA reduces endothelial repair capacity. Whether OSA could exacerbate neointimal proliferation and plaque progression in the non-culprit lesion after drug-eluting stent (DES) implantation remains less studied. The investigators aimed to evaluate neointimal proliferation and strut coverage within stent segment as well as changes of plaque volume and morphology in the non-culprit lesion by optical coherence tomography (OCT) in patients with versus without OSA at 12-month follow-up.

Official Title
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Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep ApNea: A Serial 3-Vessel Optical Coherence Tomography Study (VISION)

Conditions
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Coronary Artery Disease, Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Other: OSA
* Other: Non-OSA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years old Patients undergoing PCI with stenting in at least one de novo lesion in a native coronary artery 3-vessel OCT was available visually (at least one pullback/vessel) Written informed consent Exclusion Criteria: Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index ≥10/h) Previous or current use of continuous positive airway pressure (CPAP) Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA or Killip≥3) STEMI within 1 week Prior PCI or CABG Chronic kidney disease [eGFR<60ml/(min*1.73m2)] Aortic-coronary ostial lesion Left main lesion Chronic total occlusion In-stent restenotic lesion A tortuous vessel and/or severely calcified lesion or severe stenosis and the OCT catheter could not pass across the lesion Massive residual thrombus on angiography despite thrombus aspiration or thrombectomy Planned elective PCI within 12 months Severe comorbidities: eg. malignancy (life expectancy <2 years) Known or planned pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| OSA<br> | Other: OSA<br>* Patients with OSA (apnea hypopnea index ≥15) based on sleep study<br>|
| Non-OSA<br> | Other: Non-OSA<br>* Patients without OSA (apnea hypopnea index <15) based on sleep study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative proliferation volume within stent segment (% of stent volume) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of total lipid volume index in the non-culprit lesion |  | 12 months | 
| Maximum area stenosis within stent segment | Defined as minimal lumen area divided by the mean of reference lumen area | 12 months | 
| Total proliferation volume within stent segment |  | 12 months | 
| Maximum proliferation area within stent segment |  | 12 months | 
| Minimal lumen area within stent segment |  | 12 months | 
| Prevalence of uncovered struts, uncovered and apposed struts, malapposed struts |  | 12 months | 
| Prevalence of neoatherosclerosis |  | 12 months | 
| Total lipid volume index | Defined as the averaged lipid angle multiplied by lipid length; including culprit and non-culprit lesions | Baseline | 
| Prevalence of TCFA | In the culprit and non-culprit lesions | Baseline | 
| Prevalence of plaque rupture | In the culprit and non-culprit lesions | Baseline | 
| Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Obstructive sleep apnea, Optical coherence tomography, Vascular response