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

Sponsor

Beijing Anzhen Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04022824

Collaborator

(none)

Enrollment

Location

42.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Obstructive Sleep Apnea of Adult	Other: OSA Other: Non-OSA

Study Design

Study Type:

Observational

Anticipated Enrollment :

84 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 18, 2018

Actual Primary Completion Date :

Nov 12, 2019

Anticipated Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
OSA	Other: OSA Patients with OSA (apnea hypopnea index ≥15) based on sleep study
Non-OSA	Other: Non-OSA Patients without OSA (apnea hypopnea index <15) based on sleep study

Arm

Intervention/Treatment

OSA

Other: OSA

Patients with OSA (apnea hypopnea index ≥15) based on sleep study

Non-OSA

Other: Non-OSA

Patients without OSA (apnea hypopnea index <15) based on sleep study

Outcome Measures

Primary Outcome Measures

Relative proliferation volume within stent segment (% of stent volume) [12 months]

Secondary Outcome Measures

Change of total lipid volume index in the non-culprit lesion [12 months]
Maximum area stenosis within stent segment [12 months]
Defined as minimal lumen area divided by the mean of reference lumen area
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 [Baseline]
Defined as the averaged lipid angle multiplied by lipid length; including culprit and non-culprit lesions
Prevalence of TCFA [Baseline]
In the culprit and non-culprit lesions
Prevalence of plaque rupture [Baseline]
In the culprit and non-culprit lesions
Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization) [12 months]

Other Outcome Measures

Maximum lipid angle [Baseline]
Calcium volume [Baseline]
Macrophage volume [Baseline]
Correlation of total lipid volume index with AHI [Baseline]
Correlation of total lipid volume index with lowest SpO2 [Baseline]
Correlation of total lipid volume index total time with SpO2 <90% [Baseline]
Total lipid volume index stratified by sex in both groups [Baseline]
Total lipid volume index stratified by obesity in both groups [Baseline]
Total lipid volume index stratified by diabetes in both groups [Baseline]
Rate of individual cardiovascular events [12 months]
Including all-cause death, cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization, non-target vessel revascularization, hospitalization for unstable angina

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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