The association of diabetes mellitus with neointimal formation following deployment of second-generation drug-eluting stents: an optical coherence tomographic study.

OBJECTIVES: The purpose of this study was to evaluate the association of diabetes mellitus (DM) with neointimal formation after implantation of second-generation drug-eluting stent (DES) visualized by optical coherence tomography (OCT). METHODS: Patients with single de novo coronary artery disease treated with second-generation DES between June 2014 and June 2017 in our department underwent OCT examination at 1-year follow-up and were enrolled in this retrospective study. The primary end point was in-stent mean neointimal thickness (MNT), and secondary end points included uncovered stent strut, minimal lumen area (MLA), neointimal burden, neointimal hyperplasia (NIH) patterns and stent thrombosis (ST) after 1 year of OCT follow-up. RESULTS: A total of 68 patents with DM (DM group) and 216 patients without DM (non-DM group) were enrolled. At 1-year follow-up, the DM group compared with the non-DM group, showed: MNT [160 (85-245) µm vs. 120 (60-220) µm, P = 0.038] and neointimal burden [21.4 (8.3-30.1)% vs. 14.0 (5.7-26.1)%, P = 0.023] to be significantly increased. Concurrently, MLA [4.60 (3.53-6.06) mm vs. 5.76 (4.28-7.20) mm2, P = 0. 0.002] was significantly reduced. Interestingly, the degree of uncovered struts (7.3 ± 7.1% vs. 7.7 ± 6.7%, P = 0.704), NIH patterns (P = 0.984), and ST (7.9% vs. 7.4%, P = 0.88) were comparable between the two groups. After propensity score matching, the MNT [160 (90-240) µm vs. 110 (60-220) µm, P = 0.048] and neointimal burden [21.4 (8.3-30.1)% vs. 15.4 (5.6-26.3)%, P = 0.044] remained significantly different in the DM compared to the non-DM group. CONCLUSION: DM leads to significant increase in MNT and neointimal burden even with second-generation DES, nevertheless stent strut coverage, ST and NIH characteristics remained comparable among the cohorts at 1-year.

Comparison of new-generation drug-eluting stents versus drug-coated balloon for in-stent restenosis: a meta-analysis of randomised controlled trials.

OBJECTIVE: The study sought to compare angiographic and clinical outcomes of new-generation drug-eluting stents (DES) versus drug-coated balloon (DCB) in patients with coronary in-stent restenosis (ISR). DESIGN: Meta-analysis using data from randomised trial found by searches on PubMed, the Cochrane Library, ClinicalTrials.gov and websites of major cardiovascular congresses. SETTING: Only randomised trials comparing DES with DCB were included. PARTICIPANTS: Patients with ISR in the included trials. INTERVENTIONS: New-generation DES versus DCB. OUTCOMES: The angiographic and clinical outcomes including cardiac death, all-cause death, myocardial infarction, target lesion revascularisation (TLR), target vessel revascularisation (TVR), major adverse cardiac events (MACE) and stent thrombosis were investigated. RESULTS: Five trials including 913 patients were eligible and included. Pooled analysis in angiographic results identified that new-generation DES were associated with higher acute luminal gain (-0.31 mm, 95% CI -0.42 to -0.20, P<0.001) and lower per cent diameter stenosis (risk ratio (RR): 0.28, 95% CI 0.02 to 0.55, P=0.04). DES significantly reduced the risk of TLR (RR: 1.96, 95% CI 1.17 to 3.28, P=0.01) compared with DCB; however, there was no statistical differences for MACE (RR: 1.21, 95% CI 0.67 to 2.17, P=0.53), myocardial infarction (RR: 1.16, 95% CI 0.55 to 2.48, P=0.69) and cardiac death (RR: 1.80, 95% CI 0.60 to 5.39, P=0.29). CONCLUSIONS: Interventions with new-generation DES appear to be associated with significant reduction in per cent diameter stenosis and TLR at short-term follow-up, but had similar MACE, myocardial infarction and cardiac death for patients with coronary ISR compared with DCB. Appropriately powered studies with longer term follow-up are warranted to confirm these findings.

Optical coherence tomography assessment of a complex bifurcation lesion treated with double kissing Crush technique: A case report.

The DEFINITION (Impact of the complexity of bifurcation lesions treated with drug-eluting stents) study has provided a novel classification to evaluate the complexity of coronary bifurcation lesion according to coronary angiography, but angiographic imaging due to its low resolution and inherited limitation may result in an inaccurate adjudication.We used optical coherence tomography (OCT) to further evaluate the coronary characteristics in a patient with "simple" bifurcation lesion which was classified by the DEFINITION criteria. However, a "complex" bifurcation lesion was defined and confirmed according to the OCT results.A double kissing Crush stenting approach was adopted to treat this "complex" case finally. The immediate and long-term angiographic and OCT results were excellent.OCT may be useful imaging modality to classify complexity of coronary bifurcation lesion and subsequently guide its treatment strategy.

Clinical and multimodality imaging results at 6 months of a bioresorbable sirolimus-eluting scaffold for patients with single de novo coronary artery lesions: the NeoVas first-in-man trial.

AIMS: The study sought to investigate clinical and multimodality imaging assessment of a bioresorbable sirolimus-eluting scaffold (NeoVas, Lepu Medical, Beijing, China) for patients with single de novo coronary artery lesions. METHODS AND RESULTS: The NeoVas first-in-man study was a prospective, open-label study which enrolled 31 patients with single de novo lesions treated with a bioresorbable sirolimus-eluting scaffold. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation (TLR). Angiography, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging were performed at baseline and six months. Procedural success and device success were 100% (31/31 patients). At six months, the rate of TLF was 3.2%, with only one patient having clinically indicated TLR. No scaffold thrombosis was observed. The angiographic six-month in-scaffold late loss was 0.26±0.32 mm. The minimal scaffold area decreased from 7.11±1.56 mm2 post procedure to 6.74±1.38 mm2 at six months, as measured by IVUS. The OCT results showed that the neointimal hyperplasia area was low (1.56±0.46 mm2), with a high proportion of scaffold strut coverage (95.7%). CONCLUSIONS: This first-in-man study shows feasibility, promising clinical and multimodality imaging results up to six months for the NeoVas bioresorbable sirolimus-eluting scaffold in the treatment of patients with simple de novo lesions, with an acceptable in-scaffold late loss, low neointimal hyperplasia, and a high percentage of scaffold strut coverage.