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.
ObjectiveThe 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).DesignMeta-analysis using data from randomised trial found by searches on PubMed, the Cochrane Library, ClinicalTrials.gov and websites of major cardiovascular congresses.SettingOnly randomised trials comparing DES with DCB were included.ParticipantsPatients with ISR in the included trials.InterventionsNew-generation DES versus DCB.OutcomesThe 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.ResultsFive 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).ConclusionsInterventions 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.
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.
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