1.A novel biodegradable polymer-coated sirolimus-eluting stent: 1-year results of the HELIOS registry.
Bo ZHENG ; Yi LIU ; Ruining ZHANG ; Wangwei YANG ; Fangju SU ; Rutao WANG ; Dapeng CHEN ; Guidong SHEN ; Yumin QIU ; Lianmin WANG ; Chang CHEN ; Zhongwei WU ; Fei LI ; Jiayi LI ; Chengxiang LI ; Chao GAO ; Ling TAO
Chinese Medical Journal 2023;136(15):1848-1854
BACKGROUND:
The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer. The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.
METHODS:
The HELIOS registry is a prospective, multicenter, cohort study conducted at 38 centers across China between November 2018 and December 2019. A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, non-fatal target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 1-year follow-up. Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.
RESULTS:
A total of 2998 (98.0%) patients completed the 1-year follow-up. The 1-year incidence of TLF was 3.10% (94/2998, 95% closed interval: 2.54-3.78%). The rates of cardiac death, non-fatal target vessel MI and clinically indicated TLR were 2.33% (70/2998), 0.20% (6/2998), and 0.70% (21/2998), respectively. The rate of stent thrombosis was 0.33% (10/2998). Age ≥60 years, diabetes mellitus, family history of coronary artery disease, acute myocardial infarction at admission, and device success were independent predictors of TLF at 1 year.
CONCLUSION:
The 1-year incidence rates of TLF and stent thrombosis were 3.10% and 0.33%, respectively, in patients treated with HELIOS stents. Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03916432.
Humans
;
Middle Aged
;
Sirolimus/therapeutic use*
;
Drug-Eluting Stents/adverse effects*
;
Prospective Studies
;
Cohort Studies
;
Treatment Outcome
;
Risk Factors
;
Time Factors
;
Percutaneous Coronary Intervention/adverse effects*
;
Cardiovascular Agents/therapeutic use*
;
Coronary Artery Disease/therapy*
;
Myocardial Infarction/etiology*
;
Thrombosis/complications*
;
Polymers
;
Registries
4.Protection of side-branch ostium by the jailed balloon technique validated by three-dimensional optical coherence tomography.
Jian Guo CUI ; Qin Hua JIN ; Xun WU ; Xia YANG ; Geng QIAN ; Yun Dai CHEN
Chinese Journal of Cardiology 2023;51(2):136-142
Objective: To evaluate the protective effect of jailed balloon technique on side branch (SB) ostium using three-dimensional optical coherence tomography(OCT). Methods: This is a retrospective study. Consecutive coronary disease patients with coronary artery bifurcation lesions who underwent percutaneous coronary intervention (PCI) and completed pre-and post-procedural OCT examinations at the Chinese People's Liberation Army General Hospital from September 2019 to March 2022 were enrolled. Patients were divided into the jailed balloon technique group and the unprotected group according to the options applied for the SB. The SB ostium area difference was calculated from OCT images (SB ostium area difference=post-PCI SB ostium area-pre-PCI SB ostium area). The SB ostium area differences were compared between the two groups and compared further in the subgroup of true bifurcation lesions and non-true bifurcation lesions. In the jailed balloon group, the SB ostium area difference was compared between the active jailed balloon technique and the conventional jailed balloon technique, between the jailed balloon>2.0 mm diameter and the jailed balloon≤2.0 mm diameter, and between the higher balloon pressure (>4 atm, 1 atm=101.325 kPa) and the lower balloon pressure (≤4 atm). Multivariate linear regression analysis was used to explore the correlation between the technical parameters of the jailed balloon technique and the SB protection effect. Results: A total of 176 patients with 236 bifurcation lesions were enrolled, aged (60.7±9.3) years, and there were 128 male patients (72.7%). There were 67 patients in the jailed balloon technique group with 71 bifurcation lesions and 123 patients in the unprotected group with 165 bifurcation lesions. Fourteen patients had 2 to 3 lesions, which were treated in different ways, so they appeared in the unprotected group and the jailed balloon technique group at the same time. The area difference in SB ostium was greater in the jailed balloon group than in the unprotected group (0.07 (-0.43, 1.05)mm2 vs.-0.33 (-0.83, 0.26)mm2, P<0.001), and the results were consistent in the true bifurcation lesion subgroup (0.29 (-0.35, 0.96)mm2 vs.-0.26 (-0.64, 0.29)mm2, P=0.004), while the difference between the two groups in the non-true bifurcation lesion subgroup was not statistically significant (P=0.136). In the jailed balloon technique group, the SB ostium area difference was greater in patients treated with the active jailed balloon technique than in those treated with the conventional jailed balloon technique ((0.43±1.36)mm2 vs. (-0.22±0.52)mm2, P=0.013). The difference in SB ostium area was greater in those using>2.0 mm diameter jailed balloons than in those using≤2.0 mm diameter jailed balloons (0.25 (-0.51, 1.31) mm2 vs.-0.01 (-0.45, 0.63) mm2, P=0.020), while SB ostium area difference was similar between those endowed with higher balloon pressure (>4 atm) compared to those with lower balloon pressure (≤4 atm) (P=0.731). Multivariate linear regression analysis showed that there was a positive correlation between jailed balloon diameter and SB ostium area difference (r=0.344, P=0.019). Conclusions: The jailed balloon technique significantly protects SB ostium, especially in patients with true bifurcation lesions. The active jailed balloon technique and larger diameter balloons may provide more protection to the SB.
Humans
;
Male
;
Angioplasty, Balloon, Coronary/methods*
;
Percutaneous Coronary Intervention
;
Tomography, Optical Coherence/methods*
;
Retrospective Studies
;
Treatment Outcome
;
Stents
;
Coronary Artery Disease/therapy*
;
Coronary Vessels/pathology*
;
Coronary Angiography
5.Effectiveness and safety of Shexiang Baoxin Pill (MUSKARDIA) in patients with stable coronary artery disease and concomitant diabetes mellitus: a subgroup analysis of a randomized clinical trial.
Jingmin ZHOU ; Haiming SHI ; Fusui JI ; Yang WU ; Yulan ZHAO ; Jun QIAN ; Junbo GE
Chinese Medical Journal 2023;136(1):82-87
BACKGROUND:
Preliminary studies have indicated that Shexiang Baoxin Pill (MUSKARDIA) has a coronary artery dilation effect and increases the coronary blood flow, relieving the symptoms of angina. This study aimed to evaluate the benefit of MUSKARDIA on patients with stable coronary artery disease (CAD) and diabetes mellitus (DM).
METHODS:
This was a subgroup analysis of a multicenter, randomized, placebo-controlled phase IV trial. CAD patients with a medical history of DM or baseline fasting blood glucose (FBG) ≥7.0 mmol/L were grouped according to the treatment (standard therapy plus MUSKARDIA or placebo). The primary outcome was major adverse cardiovascular events (MACEs), which was the composite outcome of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The secondary outcome was the composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or heart failure, and coronary angioplasty.
RESULTS:
MACEs occurred in 2.6% (9/340) and 4.8% (18/376) of patients in the MUSKARDIA and placebo groups, respectively ( P = 0.192). Secondary composite outcome was significantly less frequent with MUSKARDIA than with placebo (15.3% [52/340] vs . 22.6% [85/376], P = 0.017). Risk of MACEs (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.31-1.57) was comparable between two groups. In patients with uncontrolled DM (≥4 measurements of FBG ≥7 mmol/L in five times of follow-up), the risk of secondary outcome was significantly lower with MUSKARDIA (5/83, 6.0%) than with placebo (15/91, 16.5%) (HR = 0.35, 95%CI: 0.13-0.95).
CONCLUSION:
As an add-on to standard therapy, MUSKARDIA shows a trend of reduced MACEs in patients with stable CAD and DM. Furthermore, MUSKARDIA may reduce the frequency of all-cause death, hospitalization, and coronary angioplasty in this population, especially in those with uncontrolled DM.
TRIAL REGISTRATION
ChiCTR.org.cn, ChiCTR-TRC-12003513.
Humans
;
Coronary Artery Disease/complications*
;
Diabetes Mellitus, Type 2/drug therapy*
;
Myocardial Infarction/complications*
;
Stroke/epidemiology*
6.Advances in diagnosis and treatment of familial hypercholesterolemia.
Hua ZHENG ; Si Jie JIANG ; Li Long LIN
Journal of Southern Medical University 2023;43(1):153-156
Familial hypercholesterolemia (FH) is an autosomal dominant inherited disease caused by abnormal lipoprotein metabolism. Patients with FH have a significantly increased risk of coronary artery disease (CAD) due to long-term exposure to high levels of low-density lipoprotein (LDL). The diagnosis of FH relies heavily on gene detection, and examination of LDL receptor (LDLR) function is of great significance in its treatment. This review summarizes the current advances in the screening, diagnosis, and treatment of FH and functional analysis of LDLR gene mutations.
Humans
;
Hyperlipoproteinemia Type II/therapy*
;
Coronary Artery Disease
;
Lipoproteins, LDL
;
Mutation
7.Drug-coated balloon-only strategy for percutaneous coronary intervention of de novo left main coronary artery disease: the importance of proper lesion preparation.
Sanna USKELA ; Antti ERANTI ; Jussi M KÄRKKÄINEN ; Tuomas T RISSANEN
Frontiers of Medicine 2023;17(1):75-84
This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines.
Humans
;
Male
;
Aged
;
Aged, 80 and over
;
Female
;
Coronary Artery Disease/therapy*
;
Percutaneous Coronary Intervention
;
Angioplasty, Balloon, Coronary/adverse effects*
;
Retrospective Studies
;
Treatment Outcome
8.Mechanisms of traditional Chinese medicine formulas and active ingredients in regulation of macrophage subsets involved in inflammation and repair of coronary heart disease.
Guang YANG ; Chao LIU ; Lan-Chun LIU ; Jun HU ; Jie WANG
China Journal of Chinese Materia Medica 2023;48(12):3255-3262
Coronary artery disease(CAD) caused by atherosclerosis(AS) is a major contributor to the global burden of disease. The pathogenesis of CAD is complex, and the subset and function of cardiac macrophages are important factors affecting the occurrence and development of AS and the prognosis of CAD. Recent studies have shown that some traditional Chinese medicine(TCM) formulas and active ingredients can regulate macrophage subsets involved in the inflammation, injury, and repair process of CAD. This paper summarized the significant role of macrophages in AS and myocardial infarction. Based on the plasticity of macrophages, this paper elaborated that traditional Chinese medicine prevented and attenuated AS by regulating macrophage subsets, reducing the level of inflammatory factors, and promoting macrophage autophagy.Traditional Chinese medicine participated in the cardiac repair process after myocardial infarction by accelerating the recruitment of M2 macrophages, inhibiting the polarization of M1 macrophages mediated by glycolysis, inhibiting M1 macrophage-mediated cardiac nerve remodeling, and promoting M2 macrophage-mediated angiogenesis. In addition, in vitro studies on the regulation of macrophage subsets by the active ingredients of traditional Chinese medicine were also reviewed. It was pointed out that nuclear factor kappa B(NF-κB), adenosine 5'-monophosphate(AMP)-activated protein kinase(AMPK), phosphoinositide 3-kinase/protein kinase B(PI3K/Akt), chemokine(C-C motif) ligand 2/C-C chemokine receptor type 2(CCL2/CCR2) were the key targets and pathways for the regulation of macrophages by TCM.
Humans
;
Phosphatidylinositol 3-Kinases
;
Medicine, Chinese Traditional
;
Myocardial Infarction
;
Coronary Artery Disease
;
Inflammation/drug therapy*
;
AMP-Activated Protein Kinases
;
Macrophages
;
NF-kappa B
9.Clinical efficacy of Kuanxiong aerosol in the treatment of coronary microvascular disease assessed by coronary angiography-derived index of microcirculatory resistance: three cases report.
Bei Li XIE ; Ming Wang LIU ; Bo Ce SONG ; Yu Long BIE ; Fu Hai ZHAO
Chinese Journal of Cardiology 2023;51(4):415-417

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