管浩
中国医学科学院阜外医院 心内科
BACKGROUND:The hybrid strategy of a combination of drug-eluting stent (DES) and drug-coated balloon (DCB) is promising for the treatment of de novo diffuse coronary artery disease (CAD).HYPOTHESIS:To investigate the efficacy and functional results of hybrid strategy.METHODS:This case series study included patients treated with a hybrid approach for de novo diffuse CAD between February 2017 and November 2021. Postprocedural quantitative flow ratio (QFR) was used to evaluate the functional results. The primary endpoint was procedural success rate. The secondary endpoints were major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) (including peri-procedural MI), and target vessel revascularization.RESULTS:A total of 109 patients with 114 lesions were treated. DES and DCB were commonly used in larger proximal segments and smaller distal segments, respectively. The mean QFR value was 0.9 ± 0.1 and 105 patients (96.3%) had values >0.8 in all the treated vessels. Procedural success was achieved in 106 (97.2%) patients. No cases of cardiac death were reported at a median follow-up of 19 months. Spontaneous MI occurred in three (2.8%) patients and target vessel revascularization in six (5.5%) patients. Estimated 2-year rate of MACE excluding peri-procedural MI was higher in the group with lower QFR value (12.1 ± 5.7% vs. 5.6 ± 4.4%, log-rank p = .035) (cut-off value 0.9).CONCLUSION:Hybrid strategy is a promising approach for the treatment of de novo diffuse CAD. Postprocedural QFR has some implications for prognosis and may be helpful in guiding this approach.
Clinical cardiology 2023
Importance:Tongxinluo, a traditional Chinese medicine compound, has shown promise in in vitro, animal, and small human studies for myocardial infarction, but has not been rigorously evaluated in large randomized clinical trials.Objective:To investigate whether Tongxinluo could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI).Design, Setting, and Participants:Randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.Interventions:Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months (a loading dose of 2.08 g after randomization, followed by the maintenance dose of 1.04 g, 3 times a day), in addition to STEMI guideline-directed treatments.Main Outcomes and Measures:The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.Results:Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group (relative risk [RR], 0.64 [95% CI, 0.47 to 0.88]; risk difference [RD], -1.8% [95% CI, -3.2% to -0.6%]). Individual components of 30-day MACCEs, including cardiac death (56 [3.0%] vs 80 [4.2%]; RR, 0.70 [95% CI, 0.50 to 0.99]; RD, -1.2% [95% CI, -2.5% to -0.1%]), were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs (100 [5.3%] vs 157 [8.3%]; HR, 0.64 [95% CI, 0.49 to 0.82]; RD, -3.0% [95% CI, -4.6% to -1.4%]) and cardiac death (85 [4.5%] vs 116 [6.1%]; HR, 0.73 [95% CI, 0.55 to 0.97]; RD, -1.6% [95% CI, -3.1% to -0.2%]). There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis (<24 hours; 1-30 days; 1-12 months). More adverse drug reactions occurred in the Tongxinluo group than the placebo group (40 [2.1%] vs 21 [1.1%]; P = .02), mainly driven by gastrointestinal symptoms.Conclusions and Relevance:In patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.Trial Registration:ClinicalTrials.gov Identifier: NCT03792035.
JAMA 2023
Background:Patients with diabetes are a high-risk group for coronary in-stent restenosis (ISR), so it would be valuable to identify biomarkers to predict their prognosis. The plasma big endothelin-1 (big ET-1) level is closely related to cardiovascular adverse events; however, for patients with ISR and diabetes who undergo percutaneous coronary intervention (PCI), whether big ET-1 is independently correlated with prognosis is still uncertain.Methods:Patients with drug-eluting stent (DES) restenosis who underwent successful re-PCI from January 2017 to December 2018 at the Chinese Academy of Medical Sciences Fuwai Hospital were enrolled and followed up for 3 years. The patients were divided into the tertiles of baseline big ET-1. The primary end points were major adverse cardiovascular events (MACEs): cardiac death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), and stroke. A Cox multivariate proportional hazard model and the C-statistic were used to evaluate the potential predictive value of big ET-1 beyond traditional and angiographic risk factors.Results:A total of 1,574 patients with ISR were included in this study, of whom 795 were diabetic. In patients with ISR and diabetes, after an average follow-up of 2.96 ± 0.56 years, with the first tertile of big ET-1 as a reference, the hazard ratio [HR] (95% CI) of MACEs after adjustment for traditional and angiographic risk factors was 1.24 (0.51-3.05) for the second tertile and 2.60 (1.16-5.81) for the third. Big ET-1 improved the predictive value for MACEs over traditional risk factors (C-statistic: 0.64 vs. 0.60, p = 0.03). Big ET-1 was not significantly associated with the risk of MACEs in patients without diabetes.Conclusion:Increased plasma big ET-1 was associated with a higher risk of adverse cardiovascular prognosis independent of traditional and angiographic risk factors, and therefore, it might be used as a predictive biomarker, in patients with ISR and diabetes.
Frontiers in cardiovascular medicine 2022
OBJECTIVES:To investigate the procedure success rate and clinical outcomes of in-stent restenotic chronic total occlusion (ISR-CTO) percutaneous coronary intervention (PCI).BACKGROUND:Few studies have reported the short- and long-term clinical outcomes of ISR-CTO PCI.METHOD:Patients who underwent ISR-CTO (n = 212) or de-novo CTO (n = 2,447) PCI at Fuwai Hospital from 2010 to 2013 were enrolled. Thirty-day and 5-year clinical outcomes were analyzed. The primary outcome was the incidence of all-cause death, myocardial infarction (MI), and heart failure at follow-up. The secondary outcome was the recanalization result (reasonable, suboptimal, or failed recanalization).RESULTS:ISR-CTO PCI had a higher rate of suboptimal recanalization than de-novo CTO PCI (p < .01). The syntax score before PCI (odds ratio (OR): 1.06; 95% confidence interval (CI): 1.02-1.10; p = .002) and occlusion length ≥ 20 mm (OR: 2.70:95% CI: 1.46-4.98; p = .001) were predictors of suboptimal recanalization in ISR-CTO PCI. Cardiac death (p = .03) and 30-day all-cause mortality (p = .05) were higher among patients who underwent ISR-CTO PCI. The ISR-CTO group had a higher rate of MI (p = .07) at 5 years. Suboptimal recanalization (hazard ratio: 2.56; 95% CI: 1.13-5.83; p = .025) was an independent predictor of long-term major adverse events in ISR-CTO.CONCLUSIONS:Suboptimal recanalization, 30-day cardiac death, and long-term MI rates are higher for ISR-CTO PCI than de-novo CTO PCI. Suboptimal recanalization is an independent predictor of long-term major adverse events after ISR-CTO PCI.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 2021
BACKGROUND:The pathophysiology of isolated coronary artery ectasia (CAE) with the coronary slow flow (CSF) phenomenon is still unclear. The purpose of this study was to investigate the risk factors for isolated CAE complicated with CSF.METHODS:A total of 126 patients with isolated CAE were selected retrospectively. The patients were grouped into the no CSF (NCSF) group (n = 55) and the CSF group (n = 71) according to the corrected thrombolysis in myocardial infarction (TIMI) frame count (CTFC). Data on demographics, laboratory measurements, left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDd), CTFC and diameters of three coronary arteries were collected.RESULTS:The proportions of males (84.5% vs. 61.8%, p = 0.004) and patients with a smoking history (63.4% vs. 43.6%, p = 0.021) were higher in the CSF group than in the NCSF group. The neutrophil-to-lymphocyte ratio (NLR) (2.08(1.68-3.21) vs. 1.89 ± 0.58, p = 0.001), mean diameter of coronary arteries (mean D) (5.50 ± 0.85 vs. 5.18 ± 0.91, p < 0.001), and uric acid (URIC) level (370.78 ± 109.79 vs. 329.15 ± 79.71, p = 0.019) were significantly higher in the CSF group, while the lymphocyte-to-monocyte ratio (LMR) (4.81 ± 1.66 vs. 5.96 ± 1.75, p < 0.001) and albumin (ALB) level (44.13 ± 4.10 vs. 45.69 ± 4.11, p = 0.036) were lower. Multivariable logistic analysis showed that the LMR (odds ratio: 0.614, 95% CI: 0.464-0.814, p = 0.001), mean D (odds ratio: 2.643, 95% CI: 1.54-4.51, p < 0.001) and URIC level (odds ratio: 1.006, 95% CI: 1.001-1.012, p = 0.018) were independent predictors of CSF in CAE.CONCLUSIONS:The LMR was a negative independent predictor of CSF in isolated CAE, while URIC level and mean D were positive independent predictors.
BMC cardiovascular disorders 2021
Objective: To evaluate the safety and long-term clinical efficacy of percutaneous coronary intervention (PCI) in patients with in-stent chronic total occlusion (IS-CTO) lesions. Metheds: This is a retrospective analysis. Patients with IS-CTO who underwent PCI in Fuwai hospital from January 2010 to December 2013 were enrolled. A total of 212 patients who met the inclusion criteria were included in the IS-CTO group, 212 matched patients with primary CTO lesions were included in the de novo CTO group. The incidence of complications and the success rate of PCI were compared between the two groups. Successful PCI was defined as successfully implantation of stent(s) at target CTO lesions. The primary endpoint was defined as a composite event of cardiac death and myocardial infarction (MI). Secondary endpoints including PCI success, all-cause death, cardiac death, MI, target vessel related MI, revascularization, target vessel revascularization, heart failure for rehospitalization. The patients were followed up for 5 years after PCI. Results: A total of 424 cases were included. The mean age was (57.8±10.5) years, there were 364 males in this cohort. The left ventricular ejection fraction was significantly lower ((58.7±9.2)% vs. (61.0±7.7)%, P=0.01) and the SYNTAX scores was significantly higher (19.4±8.3 vs. 15.3±10.0, P<0.01) in IS-CTO group than that in de novo CTO group. The proportion of patients with target CTO lesions in left anterior descending artery was significantly higher (42.9% (50/212) vs. 23.6% (91/212), P<0.01) in IS-CTO group than that in de novo CTO group. The rate of successful PCI (71.7% (152/212) vs. 69.8% (148/212), P=0.70) and complication (40.6% (86/212) vs. 36.3% (77/212), P=0.37) was similar between the two groups. The incidence of primary endpoint at 5 years was significantly higher in IS-CTO group (10.8% (23/212) vs. 4.7% (10/212), P=0.02), which was driven by higher incidence of MI (9.0% (19/212) vs. 4.2% (9/212), P=0.05). There were a trend of higher secondary endpoints in IS-CTO group (all P>0.05). Conclusion: The safety and effectiveness of PCI are acceptable in patients with IS-CTO, but the risk of long-term cardiac death and MI is higher among patients with IS-CTO as compared to patients with primary CTO lesions.
Zhonghua xin xue guan bing za zhi 2021
