ABSTRACT
INTRODUCTION: The current evidence for chronic oral antispastic medication use after coronary artery bypass grafting using radial artery grafts (RA-CABG) is controversial. Calcium channel blockers, such as diltiazem, are the most commonly used antispastic medications after RA-CABG; other options include nitrates and nicorandil, but to date no sufficiently powered randomized controlled trials have been conducted to compare their efficacy. METHODS: This is a single-center, open-label, parallel three-arm, pilot randomized controlled trial. Patients without contraindications to any study medications and who successfully underwent RA-CABG surgery will be consecutively screened. Eligible patients will be randomized in a ratio of 1:1:1 (a total of 150 patients, 50 per arm) to receive nicorandil 5 mg orally thrice daily, diltiazem 180 mg orally once daily, or isosorbide mononitrate 50 mg orally once daily for 24 weeks. The primary outcomes are RA graft failure at week 1 and week 24. The secondary outcomes include major adverse cardiovascular event (MACE, a composite of all-cause death, myocardial infarction, stroke, and unplanned revascularization) and angina recurrence. The safety outcomes include hypotension occurrence, withdrawal of renin angiotensin aldosterone system inhibitors, serious adverse events, and other concerned adverse events within 24 weeks. CONCLUSION: This pilot trial will compare the preliminary effects of nicorandil, diltiazem, and isosorbide mononitrate on angiographic and clinical outcomes in patients who have undergone RA-CABG. Recruitment began in June 2020, and the estimated primary completion date is early 2023. Results of this study will provide much needed information for design of large confirmatory trials on the effectiveness of oral antispastic medications after RA-CABG.
Subject(s)
Diltiazem , Nicorandil , Humans , Nicorandil/therapeutic use , Nicorandil/pharmacology , Diltiazem/therapeutic use , Diltiazem/pharmacology , Pilot Projects , Radial Artery/transplantation , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/methods , Treatment Outcome , Randomized Controlled Trials as TopicABSTRACT
Background: The actual patency rate of the radial artery (RA) grafts 1 week and 1 year after coronary artery bypass grafting (CABG) has not been extensively reported on. We used coronary computed tomography angiography (CCTA) to evaluate the patency rate of RA grafts and compared it with that of saphenous vein (SV) grafts. Methods: In this observational cohort study, 80 patients who underwent urgent or elective CABG with RA and SV grafts at Ruijin Hospital from August 2019 to June 2021 were included. Follow-up CCTA scans were completed about 1 year postoperation in the out-patient clinic. We graded the grafts into four classes: A, excellent; B, graft diameter <50% of target coronary artery; O, occluded; and S, string sign. Both S and O were defined as graft failure. Results: The patients' mean age was 58.48±8.06 years, and 87.5% (70/80) of the patients were male. The 1-week patency rate of the left internal mammary artery (LIMA), RA, and SV grafts were 98.7% (75/76), 76.3% (61/80), and 93.8% (75/80), respectively. At 1 year, the patency rate of the LIMA, RA, and SV grafts were 97.4% (74/76), 80.0% (64/80), and 81.3% (65/80), respectively. The RA graft patency rate was lower than was the SV graft patency rate perioperatively [relative risk (RR): 0.918; 95% confidence interval (CI): 0.852-0.990; P=0.007]. Moreover, 63.6% (7/11) of RA grafts graded S and 25.0% (2/8) of RA grafts graded O were defined as patent (graded A or B) at 1 year postoperation. Compared with SV grafts, more RA grafts improved (RA: 12/80, 15.0%; SV: 0%) and fewer RA grafts deteriorated (RV: 10/80, 12.5%; SV: 19/80, 23.8%) from 1 week to 1 year (P=0.001). The patency rate of the 2 types of grafts became similar at 1 year postoperation (RR: 0.560; 95% CI: 0.113-2.781; P>0.99). Conclusions: RA grafts had a lower patency rate than did SV grafts 1 week after operation. However, because of the "revival" phenomena and lower attrition rate, the patency rate of the two kinds of grafts did not show any significant difference at 1 year.
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Background: Dual antiplatelet therapy (DAPT) is recommended in patients undergoing off-pump coronary artery bypass graft surgery (OPCAB). Clopidogrel is less effective among patients with loss-of-function (LoF) of CYP2C19 alleles, while ticagrelor has direct effects on P2Y12 receptor. Whether a CYP2C19 genotype plus platelet aggregation test (PAgT)-guided DAPT after CABG could improve clinical outcomes remain uncertain. Materials and methods: From August 2019 to December 2020, 1,134 consecutive patients who underwent OPCAB received DAPT for 1 year after surgery in Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. According to the actual treatment they received in real-world, 382 (33.7%) of them received a traditional DAPT: aspirin 100 mg qd + clopidogrel 75 mg qd, no matter the CYP2C19 genotype and response in platelet aggregation test (PAgT). The other 752 (66.3%) patients received an individual DAPT based on CYP2C19 genotype and PAgT: aspirin 100 mg qd + clopidogrel 75 mg qd if CYP2C19 was extensive metabolizer, or moderate metabolizer but normal response in PAgT; aspirin 100 mg qd + ticagrelor 90 mg bid if CYP2C19 was poor metabolizer, or moderate metabolizer but no or low response in PAgT. One-year follow-up was achieved for all patients. The primary outcome was major adverse cardiovascular events (MACE), a composite of cardiovascular death, myocardial infarction, and stroke. The safety outcome was thrombolysis in myocardial infarction (TIMI) criteria major bleeding. Results: Compared with the traditional DAPT group, the risk of MACE in the individual DAPT group was significantly lower (5.5 vs. 9.2%, HR 0.583; 95% CI, 0.371-0.915; P = 0.019), mainly due to the decreased risk of MI (1.7 vs. 4.2%, HR 0.407; 95% CI, 0.196-0.846; P = 0.016). The risk of TIMI major bleeding events was similar between the two groups (5.3 vs. 6.0%, RR 0.883; 95% CI, 0.537-1.453; P = 0.626). Conclusion: For patients who underwent OPCAB, individual DAPT (CYP2C19 genotype plus PAgT-guided strategy) was associated with a lower risk of MACE and a similar risk of major bleeding.
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OBJECTIVE: This study aimed to detect the predictors of vein graft disease (VGD) progression between 1 week and 1 year after surgery and to evaluate the impact of secondary prevention medications. METHODS: A total of 218 consecutive patients underwent surgical coronary revascularization were evaluated by coronary computed tomography angiography both at 1-week and 1-year follow-up. Logistic regression analyses were performed to investigate the predictors of VGD progression. A risk score (0-4) was set up to evaluate implementation result of secondary prevention measures according to 1-year follow-up result. Association between VGD progression and the risk score was assessed. RESULTS: VGD progression occurred in 11.3% of saphenous vein grafts (SVG) and 22.1% of patients. At the patient level, poor vein graft (odds ratio [OR] = 4.25), noncontrolled hyperlipidemia (OR = 3.01), and diabetes mellitus (DM) (OR = 2.96) were predictors, while diameter of SVG (mm, OR = 0.35) was protective factor. At the graft level, DM (OR = 3.52), noncontrolled hyperlipidemia (OR = 2.33), and peripheral artery disease (PAD) (OR = 2.20) were predictors, while number of SVGs (OR = 0.63), diameter of SVG (mm, OR = 0.39), and mean graft flow >25 ml/min (OR = 0.35) were protective factors. VGD progression was significantly associated with the risk score at both the patient (OR = 1.52) and the graft level (OR = 1.38). CONCLUSIONS: Poor vein graft, noncontrolled hyperlipidemia and DM were predictors of VGD progression between 1 week and 1 year after surgery at the patient level, while larger SVG diameter was a protective factor. DM, PAD and noncontrolled hyperlipidemia were predictors at the graft level, while a number of SVGs, larger SVG diameter, and mean graft flow >25 ml/min were protective factors. Implementation failure of secondary prevention medications was associated with VGD progression from as early as 1 year after surgery.
Subject(s)
Coronary Artery Bypass , Saphenous Vein , Coronary Angiography , Coronary Artery Bypass/methods , Disease Progression , Follow-Up Studies , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/prevention & control , Humans , Saphenous Vein/transplantation , Secondary Prevention , Treatment Outcome , Vascular PatencyABSTRACT
Respiratory infections are complicated biological processes associated with an unbalanced microbial community and a wide range of pathogens. To date, robust approaches are still required for distinguishing the pathogenic microorganisms from the colonizing ones in the clinical specimens with complex infection. In this study, we retrospectively analyzed the data of conventional culture testing and metagenomic next-generation sequencing (mNGS) of the sputum samples collected from 50 pulmonary infected patients after cardiac surgery from December 2020 and June 2021 in Ruijin Hospital. Taxonomic classification of the sputum metagenomes showed that the numbers of species belonging to bacteria, fungi, and viruses were 682, 58, and 21, respectively. The full spectrum of microorganisms present in the sputum microbiome covered all the species identified by culture, including 12 bacterial species and two fungal species. Based on species-level microbiome profiling, a reference catalog of microbial abundance detection limits was constructed to assess the pathogenic risks of individual microorganisms in the specimens. The proposed screening procedure detected 64 bacterial pathogens, 10 fungal pathogens, and three viruses. In particular, certain opportunistic pathogenic strains can be distinguished from the colonizing ones in the individual specimens. Strain-level identification and phylogenetic analysis were further performed to decipher molecular epidemiological characteristics of four opportunistic etiologic agents, including Klebsiella pneumoniae, Corynebacterium striatum, Staphylococcus aureus, and Candida albicans. Our findings provide a novel metagenomic insight into precision diagnosis for clinically relevant microbes, especially for opportunistic pathogens in the clinical setting.