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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Other: OSA; Other: Non-OSA

• Study Type: Observational
• Enrollment (Anticipated): 84

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Recruiting
    • Beijing Anzhen Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PCI with stenting and 3-vessel OCT and receiving overnight sleep study (polygraphy)

Description

Inclusion Criteria:

1. 18 to 80 years old
2. Patients undergoing PCI with stenting in at least one de novo lesion in a native coronary artery
3. 3-vessel OCT was available visually (at least one pullback/vessel)
4. Written informed consent

Exclusion Criteria:

1. Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index ≥10/h)
2. Previous or current use of continuous positive airway pressure (CPAP)
3. Cardiogenic shock (systolic arterial pressure <90mmHg), congestive heart failure (NYHA or Killip≥3)
4. STEMI within 1 week
5. Prior PCI or CABG
6. Chronic kidney disease [eGFR<60ml/(min*1.73m2)]
7. Aortic-coronary ostial lesion
8. Left main lesion
9. Chronic total occlusion
10. In-stent restenotic lesion
11. A tortuous vessel and/or severely calcified lesion or severe stenosis and the OCT catheter could not pass across the lesion
12. Massive residual thrombus on angiography despite thrombus aspiration or thrombectomy
13. Planned elective PCI within 12 months
14. Severe comorbidities: eg. malignancy (life expectancy <2 years)
15. Known or planned pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Including all-cause death, cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization, non-target vessel revascularization, hospitalization for unstable angina	12 months

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): November 12, 2019
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 14, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Coronary artery disease; Obstructive sleep apnea; Optical coherence tomography; Vascular response
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2017034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No