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- Holm, Niels R, et al.
(författare)
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OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.
- 2023
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Ingår i: The New England journal of medicine. - 1533-4406. ; 389:16, s. 1477-1487
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Tidskriftsartikel (refereegranskat)abstract
- Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain.We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P=0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group.Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).
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| 4. |
- Nyström, Thomas, et al.
(författare)
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Heart rate variability in type 2 diabetic subjects randomized to liraglutide or glimepiride treatment, both in combination with metformin : A randomized, open, parallel-group study
- 2019
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Ingår i: Endocrinology, Diabetes & Metabolism. - : John Wiley & Sons. - 2398-9238. ; 2:2
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Tidskriftsartikel (refereegranskat)abstract
- Aims: Reduced heart rate variability (HRV) and increased heart rate (HR) are associated with cardiovascular (CV) mortality. In the Liraglutide Effect and Action in Diabetes outcome trial, it was demonstrated a lower rate of CV events in type 2 diabetes (T2D) patients treated with liraglutide compared to placebo. We aimed to investigate the effects of liraglutide compared with glimepiride treatment in T2D patients on the CV risk parameters HR and HRV.Methods: This was a post hoc study whereas sixty-two T2D individuals (45 males) were randomized to once daily 1.8 mg liraglutide or once daily 4 mg glimepiride, both in combination with 1 g metformin. HR and measurement of sympathetic activity, that is standard deviation (SD) of beat-to-beat (NN) intervals (SDNN), was assessed by 24-hour Holter monitoring system. Parasympathetic activity was analysed by root mean square of successive differences (RMSSD) in NN intervals and high-frequency (HF), low-frequency (LF) and very low-frequency power.Results: Baseline clinical characteristics for liraglutide (n = 33) and glimepiride (n = 29) groups were well matched. There was a persistent increase in diurnal HR followed by a significantly increased HR at daytime 5.4 beats per minute, P = 0.011 in the liraglutide-treated group. There was no treatment change between groups in SDNN and RMSSD, or in HF and LF frequency power analysis.Conclusions: Liraglutide treatment increased diurnal variation in hourly mean HR followed by an increase in mean daytime HR, independently of changes in sympathetic or parasympathetic activity.
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| 5. |
- Santos-Pardo, Irene, et al.
(författare)
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Effects of exenatide on coronary stent's endothelialization in subjects with type 2 diabetes: a randomized controlled trial. The Rebuild study.
- 2023
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Ingår i: Cardiovascular diabetology. - 1475-2840. ; 22:1
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Tidskriftsartikel (refereegranskat)abstract
- Subjects with type 2 diabetes (T2D) have a higher risk of in-stent restenosis and stent thrombosis. The activation of the glucagon-like peptide-1 receptor (GLP-1R) has been suggested to induce several effects on the vasculature that may reduce the risk of stent failure following an angioplasty. The aim of this study is to evaluate the effect of the GLP-1R agonist exenatide on endothelialization of a modern drug-eluting stent (DES) in subjects with T2D.38 subjects with T2D who were eligible for revascularization with implantation of DES were randomized to treatment with exenatide (once weekly) plus standard treatment, or to standard treatment alone. After 12weeks, a new coronary angiography was performed to evaluate the percentage of strut coverage (primary endpoint) and the presence of neo-atherosclerosis by optical coherence tomography. This study was approved by the Stockholm's Ethical Review Board.The two groups were well balanced regarding baseline clinical characteristics. Strut coverage was 95% (88.7-98.5%) in the exenatide group and 91.4% (88.8-98.5%) in the control group (p=0.692). There were no significant differences between groups neither in the thickness of neo-intima (0.2mm in both groups, p=0.471), nor the maximal in-stent obstruction by neo-intima (15.5% in exenatide group vs 14.7% in control group, p=0.801). No significant differences were detected in the rate of target lesion revascularization between groups (p=0.224).Twelve weeks treatment with exenatide did not lead to a significantly better stent coverage in people with T2D. No significant differences in the occurrence of neo-atherosclerosis were detected between groups.The study was registered at www.gov (Rebuild Study, NCT02621489).
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- Santos Pardo, Irene
(författare)
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On cardiovascular complications in people with type 2 diabetes : Aspects of incretin-based therapy and glycemic control
- 2024
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: Hyperglycemia, insulin resistance, and the presence of advanced glycation end products are key features of type 2 diabetes (T2DM) and the leading mechanisms behind the increased cardiovascular risk observed in people with this condition. Percutaneous coronary revascularization has been associated with higher risk of stent failure in people with diabetes mellitus (DM), having greater risk of both in-stent restenosis (ISR) and stent thrombosis (ST). Moreover, the role of glycemic control in stent failure outcomes is uncertain. Glucagon-like pepetide-1 receptor (GLP-1R) agonists (GLP-1RA), a family of glucose-lowering agents, have demonstrated cardioprotective actions with reductions of relative risk of about 16% in subjects with T2DM compared with placebo. Preclinical data have indicated beneficial effects on the cardiac function and vascular healing associated with activation of GLP-1R. However, the specific mechanisms and actions of this class of drugs remain unexplored. Methods: Studies I and II were randomized clinical trials including subjects with T2DM, both open label but assessor-blinded. Study I compared the effects of liraglutide with those of glimepiride on the subclinical systolic and diastolic cardiac function, represented by the longitudinal functional reserve index (LFRI). Study II studied the effects of exenatide over standard treatment on stent strut coverage and the extent of neointima hyperplasia in participants with coronary artery disease revascularized with a contemporary drug-eluting stent (DES). Studies III and IV were observational, retrospective studies with data derived from several Swedish national registers. Study III included all patients with DM revascularized percutaneously with DES in 2007-2017, whereas Study IV comprised only T2DM subjects in whom a DES was implanted in 2010-2020. The primary endpoint for Studies III and IV was stent failure, defined as the occurrence of ISR and ST. The exposure variable in Study III was incretin treatment, i.e., treatment with a GLP-1RA or dipeptidyl peptidase 4 inhibitor. In Study IV, the exposure variable was the level of glycemic control by stratified glycated hemoglobin A1c levels. Results: No differences in LFRIsystolic or LFRIdiastolic were observed between the liraglutide and glimepiride groups in Study I. No significant effect on improved endothelialization of DES or neointima thickness was found for exenatide compared with standard treatment in Study II. A similar risk of stent failure was detected for those treated with incretins and the control group in Study III. An association was found between the risk of stent failure and glycemic control in persons with T2DM, the subgroups with worse glycemic control exhibiting the highest risk. Conclusions: There is no compelling evidence for beneficial effects of GLP-1RA on cardiac function and/or improvement of heart failure (Study I). GLP-1RA treatment did not show any signs of improved endothelialization or reduced risk of stent failure in either Studies II or III. Poor glycemic control associated with the risk of stent failure, driven by ISR (Study IV).
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| 7. |
- Santos-Pardo, Irene, et al.
(författare)
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Risk of stent failure in patients with diabetes treated with glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors : A nationwide observational study
- 2021
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Ingår i: International Journal of Cardiology. - : Elsevier. - 0167-5273 .- 1874-1754. ; 330, s. 23-29
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Tidskriftsartikel (refereegranskat)abstract
- Background: Incretins are a group of glucose-lowering drugs with favourable cardiovascular (CV) effects against neoatherosclerosis. Incretins' potential effect in stent failure is unknown. The aim of this study is to determine if incretin treatment decreases the risk of stent-thrombosis (ST), and/or in-stent restenosis (ISR) after percutaneous coronary intervention (PCI) with implanted drug-eluting stents (DES).Methods: Observational study including all diabetes patients who underwent PCI with DES in Sweden from 2007 to 2017. By merging 5 national registers, the information on patient characteristics, outcomes and drug dispenses was retrieved. Cox regression analysis with estimated hazard ratios (HRs) adjusted for confounders with 95% confidence intervals (Cis) was used to analyse for the occurrence of ST/ISR, and major adverse cardiovascular events (MACE). A subgroup analysis for the type of incretin treatment was performed.Results: In total 18,505 diabetes patients (30% women) underwent PCI, and 32,463 DES were implanted. Of those, 10% (3449 DES in 1943 patients) were treated with incretins. Median follow-up time was 995 clays (Control Group) vs. 771 days (Incretin Group). No significant difference in the risk of ST/ISR was found neither for the main study group (HR:0.98 95% CI:0.80-1.19) nor for the subgroups. No reduction of the risk of MACE (HR:0.96 95% CI:0.88-1.06) was observed. There was a 26% lower risk for CV death in favour of incretin treated patients (HR:0.74 95% 0:057-0.95).Conclusion: In diabetes patients who underwent PCI incretin treatment was not associated with lower risk of stent failure, but with lower risk of CV death.
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