Clinical trial NCT04022824: Vascular Responses After Percutaneous Coronary Intervention With Stenting In Patients With Obstructive Sleep Apnea
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Obstructive Sleep Apnea of Adult
Keywords: Coronary artery disease
Obstructive sleep apnea
Optical coherence tomography
Vascular response
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing PCI with stenting and 3-vessel OCT and receiving overnight sleep study (polygraphy)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Relative proliferation volume within stent segment (% of stent volume)
timeFrame: 12 months
Secondary outcomes:
measure: Change of total lipid volume index in the non-culprit lesion
timeFrame: 12 months
measure: Maximum area stenosis within stent segment
timeFrame: 12 months
measure: Total proliferation volume within stent segment
timeFrame: 12 months
measure: Maximum proliferation area within stent segment
timeFrame: 12 months
measure: Minimal lumen area within stent segment
timeFrame: 12 months
measure: Prevalence of uncovered struts, uncovered and apposed struts, malapposed struts
timeFrame: 12 months
measure: Prevalence of neoatherosclerosis
timeFrame: 12 months
measure: Total lipid volume index
timeFrame: Baseline
measure: Prevalence of TCFA
timeFrame: Baseline
measure: Prevalence of plaque rupture
timeFrame: Baseline
measure: Rate of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic-driven repeat revascularization)
timeFrame: 12 months
Other outcomes:
measure: Maximum lipid angle
timeFrame: Baseline
measure: Calcium volume
timeFrame: Baseline
measure: Macrophage volume
timeFrame: Baseline
measure: Correlation of total lipid volume index with AHI
timeFrame: Baseline
measure: Correlation of total lipid volume index with lowest SpO2
timeFrame: Baseline
measure: Correlation of total lipid volume index total time with SpO2 <90%
timeFrame: Baseline
measure: Total lipid volume index stratified by sex in both groups
timeFrame: Baseline
measure: Total lipid volume index stratified by obesity in both groups
timeFrame: Baseline
measure: Total lipid volume index stratified by diabetes in both groups
timeFrame: Baseline
measure: Rate of individual cardiovascular events
timeFrame: 12 months
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References: