TCT-53 Role of Single OCT Morphological Variable in the CLIMA Trial (Relationship between Coronary pLaque morphology of the left anterIor descending artery and long terM clinicAl outcome)

Abstract Aims The CLIMA study, on the relationship between coronary plaque morphology of the left anterior descending artery and twelve months clinical outcome, was designed to explore the predictive value of multiple high-risk plaque features in the same coronary lesion [minimum lumen area (MLA), fibrous cap thickness (FCT), lipid arc circumferential extension, and presence of optical coherence tomography (OCT)-defined macrophages] as detected by OCT. Composite of cardiac death and target segment myocardial infarction was the primary clinical endpoint. Methods and results From January 2013 to December 2016, 1003 patients undergoing OCT evaluation of the untreated proximal left anterior descending coronary artery in the context of clinically indicated coronary angiogram were prospectively enrolled at 11 independent centres (clinicaltrial.gov identifier NCT02883088). At 1-year, the primary clinical endpoint was observed in 37 patients (3.7%). In a total of 1776 lipid plaques, presence of MLA <3.5 mm2 [hazard ratio (HR) 2.1, 95% confidence interval (CI) 1.1–4.0], FCT <75 µm (HR 4.7, 95% CI 2.4–9.0), lipid arc circumferential extension >180° (HR 2.4, 95% CI 1.2–4.8), and OCT-defined macrophages (HR 2.7, 95% CI 1.2–6.1) were all associated with increased risk of the primary endpoint. The pre-specified combination of plaque features (simultaneous presence of the four OCT criteria in the same plaque) was observed in 18.9% of patients experiencing the primary endpoint and was an independent predictor of events (HR 7.54, 95% CI 3.1–18.6). Conclusion The simultaneous presence of four high-risk OCT plaque features was found to be associated with a higher risk of major coronary events.

Download Full-text

P467 Can induction and maintenance serum vedolizumab levels predict long-term clinical outcome in inflammatory bowel disease (IBD)?

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.596 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S413-S414 ◽

Cited By ~ 1

Author(s):

C Miller ◽

H Morgan ◽

A Steel ◽

M Wahed

Keyword(s):

Clinical Outcome ◽

Clinical Remission ◽

Statistical Significance ◽

Therapeutic Drug ◽

Fisher Exact Test ◽

Positive Outcomes ◽

Mayo Score ◽

Serum Trough

Abstract Background Vedolizumab (VDZ) is an established IBD therapy, however, the role of therapeutic drug levels (TDM) is not fully established.1 Our aim was to assess whether week 6 and maintenance serum trough VDZ levels predict the clinical outcome at week 52. Methods A retrospective review of patients with Crohn’s disease (CD) or ulcerative colitis (UC) on VDZ was performed. Twenty-one IBD patients with serum VDZ trough level monitoring between January 2016 and December 2017 were identified. All patients received VDZ induction and maintenance as per standard protocol. Patients were excluded if complete dataset of VDZ levels was not available. Clinical remission was defined as a partial Mayo score < 2 for patients with UC or a Harvey–Bradshaw index (HBI) score < 4 for those with CD. A trough VDZ level ≥ 27 μg/ml cut-off was used to evaluate remission outcomes for both induction and average maintenance VDZ levels. Statistically, analysis was carried out using the Fisher exact test. Key demographics are 57% CD, 43% UC; Baseline HBI score: 11; Baseline Partial Mayo score: 9; Concurrent Immunomodulator: 55% Results: ( 1) Week 6 induction levels: At week 52, 69% of patients were in clinical remission. Those patients in remission had a higher mean and median trough VDZ levels (Figure A). When the induction serum trough VDZ level ≥ 27 μg/ml 30% more patients were in clinical remission at week 52, although this failed to reach statistical significance (p = 0.40) (Figure C). (2) Average maintenance VDZ levels: At week 52, 63% of patients were in clinical remission. Those patients in remission had a higher mean and median average maintenance trough VDZ levels (Figure B). When the average maintenance trough VDZ level was ≥ 27 μg/ml 17% more patients were in clinical remission, this failed to reach statistical significance (p = .0.39) (Figure D). Conclusion High levels of clinical remission in both CD and UC were seen. In our study, we could use a similar cut-off for induction trough VDZ levels to those used in the literature that correlated with positive outcomes.1 Although the observed levels used to predict remission did not reach statistical significance, this may represent a type 2 error in view of the small numbers of patient. Furthermore, it was not possible to assess whether there is a difference between CD and UC. For maintenance levels, our cut-off of 27 μg/ml was higher than that used in the literature that correlated with positive outcomes.1 Our data suggest there is some correlation between trough VDZ levels for both induction and average maintenance levels and long-term clinical remission. Our induction cut-off was similar to currently available data associated with positive outcomes.1 Further studies are required to fully establish the role of TDM. References

Download Full-text