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Clinical impact of angiographically insignificant suboptimal poststent findings detected by optical coherence tomography after drug-eluting stent implantation.

ABSTRACT: BACKGROUND:Although optical coherence tomography (OCT)-detected suboptimal findings (SF-OCT) such as malapposition, edge dissection, tissue protrusion, thrombus and small minimal stent area (MSA) are frequently observed after the implantation of drug-eluting stents (DES), their clinical implications are controversial. HYPOTHESIS:Clinical outcomes may differ between patients with SF-OCTs and without SF-OCTs after DES implantation. METHODS:A total of 576 patients undergoing OCT analysis after DES implantation were divided into SF-OCT group (n = 379, 379 lesions) and No SF-OCT group (n = 197, 197 lesions). The study population had no significant abnormal finding in final angiography. Quantification was performed for each SF-OCT. The incidences of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, target vessel revascularization, and stent thrombosis) were compared between the two groups. A median follow-up duration was 21.5 months. RESULTS:Among 379 patients with SF-OCT, 32.4% had multiple SF-OCTs. Malapposition (32.1%, IQR of maximal depth 315-580 ?m) was the most frequent, followed by small MSA (31.6%), edge dissection (12.5%, IQR of maximal flap of opening 0.27-0.52 mm), thrombus (7.6%, IQR of diameter 1.31-1.97mm) and tissue protrusion (6.8%, IQR of diameter 1.05-1.67 mm). The SF-OCT group showed smaller stent diameter and longer stent length, and lower in-stent lumen expansion rate. The incidence of MACE did not differ between the two groups (3.0% for No SF-OCT vs. 5.0% for SF-OCT; HR 1.601; 95% CI 0.639 to 4.011; P = 0.310). CONCLUSIONS:The presence of angiographically insignificant SF-OCTs were not associated with clinical outcomes in this study.

SUBMITTER: Cho JY

PROVIDER: S-EPMC7571690 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Clinical impact of angiographically insignificant suboptimal poststent findings detected by optical coherence tomography after drug-eluting stent implantation.

Cho Jae Young JY Kook Hyungdon H Yu Cheol Woong CW

PloS one 20201019 10

<h4>Background</h4>Although optical coherence tomography (OCT)-detected suboptimal findings (SF-OCT) such as malapposition, edge dissection, tissue protrusion, thrombus and small minimal stent area (MSA) are frequently observed after the implantation of drug-eluting stents (DES), their clinical implications are controversial.<h4>Hypothesis</h4>Clinical outcomes may differ between patients with SF-OCTs and without SF-OCTs after DES implantation.<h4>Methods</h4>A total of 576 patients undergoing O ...[more]

PMID: 33075066

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Project description:BackgroundThird generation drug-eluting stents (DES) potentially offer better technical performance and reduced neointimal proliferation than previous generation DES. The XLIMIT non-inferiority trial evaluated the performance of the Xlimus (a novel sirolimus-eluting coronary stent system) in terms of endothelialization and tissue healing compared to the bioresorbable polymer Synergy DES.MethodsA total of 177 patients undergoing percutaneous coronary intervention (PCI) were randomized in a 2:1 ratio (2 Xlimus: 1 Synergy). The primary endpoints, defined as the in-stent neointimal volume weighted by the sum of the lengths of the implanted stent (ISNV) and the in-stent neointimal percent volume obstruction (%VO) were evaluated at 6-9 months by means of optical coherence tomography (OCT). Additional OCT parameters as well as clinical endpoints were also collected.ResultsMost of the patients were males (77.4%), and the mean age was 64 years. One third of the population had stable angina/silent ischemia. A total of 300 stents (237 lesions) were analyzed: 198 (152 lesions) were in the Xlimus group, and 102 (85 lesions) in the Synergy group. The ISNV in the Xlimus group was 30.7 ± 24.5 mm3 while in the Synergy group it was 26.5 ± 26.7 mm3: the difference between the two means was 0.08 (-0, 04-0, 45), p = 0.018, thus meeting the non-inferiority hypothesis. The %VO was 16.3% ± 10.4% and 13.3% ± 10.8% in the Xlimus and Synergy groups, respectively: the difference between the two means was 3.0 (-0, 06-4, 2), (p = 0.01), thus meeting the non-inferiority hypothesis. No difference was found with respect to the secondary OCT endpoints as well as for clinical endpoints.ConclusionsThe study results confirm that the biological interaction of the Xlimus and Synergy DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters at follow-up: as such, the Xlimus is non-inferior to the Synergy.Clinical trial registrationClinicalTrials.gov, identifier (NCT03745053).

Project description:ObjectivesThis study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus-eluting stents (EES) in patients with acute coronary syndromes (ACS).BackgroundWhether BP-EES induce better vascular healing compared to contemporary DP-EES remains controversial, especially for ACS.MethodsIn this prospective, randomized, non-inferiority trial, we used OCT to compare 6-month vascular healing in patients with ACS randomized to BP versus DP-EES: percent strut coverage (primary endpoint, non-inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated.ResultsA total of 104 patients with ACS were randomly assigned to BP-EES (n = 52) versus DP-EES (n = 52). Of these, 86 patients (40 BP-EES and 46 DP-EES) were included in the final OCT analyses. Six-month percent strut coverage of BP-EES (83.6 ± 11.4%) was not non-inferior compared to those of DP-EES (81.6 ± 13.9%), difference 2.0% (lower 95% confidence interval-2.6%), pnon-inferiority = 0.07. There were no differences in neointimal thickness 70.0 ± 33.9 μm versus 67.2 ± 33.9 μm, p = 0.71; and percent NIH volume 7.5 ± 4.7% versus 7.3 ± 5.3%, p = 0.85. By multivariable linear regression analysis, stent type was not associated with percent strut coverage or percent NIH volume; however, percent baseline embedded struts or stent expansion was positively associated with percent NIH volume. Greater NIH volume was observed in lipidic compared with non-lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005).ConclusionsSix-month strut coverage of BP-EES was not non-inferior compared to those of DP-EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing.

Dataset Information

Clinical impact of angiographically insignificant suboptimal poststent findings detected by optical coherence tomography after drug-eluting stent implantation.

Publications

Clinical impact of angiographically insignificant suboptimal poststent findings detected by optical coherence tomography after drug-eluting stent implantation.

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