Evaluation of microcirculatory protection in percutaneous revascularisation: A stent implantation technique and device comparison.

BACKGROUND: Coronary microvascular dysfunction (CMD) after percutaneous coronary intervention (PCI) is prognostically important and may also be a cause of persistent angina. The stent balloon inflation technique or material properties may influence the degree of CMD post-PCI. METHODS: Thirty-six patients with stable angina attending for elective PCI were randomized to either slow drug eluting stent (DES) implantation technique (DES slow group): +2 atm. every 5 s., maintained for a further 30 s or a standard stent implantation technique (DES std group): rapid inflation and deflation. PressureWire X with thermodilution at rest and hyperemia and optical coherence tomography (OCT) were performed pre- and post-PCI. Combined primary endpoints were changes in index of microvascular resistance (delta IMR) and coronary flow reserve (delta CFR) following PCI. The secondary endpoints included differences in cardiac troponin I (delta cTnI) at 6 h post-PCI, Seattle angina questionnaire (SAQ) at 1, 3, 6, and 12 months and OCT measures of stent results immediately post-PCI and at 3 months. RESULTS: Both groups were well matched, with similar baseline characteristics and OCT-defined plaque characteristics. Delta IMR was significantly better in the DES slow PCI arm with a median difference of -4.14 (95% CI -10.49, -0.39, p = 0.04). Delta CFR was also numerically higher with a median difference of 0.47 (95% CI -0.52, 1.31, p = 0.46). This did not translate to improved delta median cTnI (1.5 (34.8) vs. 0 (27.5) ng/L, p = 0.75) or median SAQ score at 3 months, (85 (20) vs. 95 (17.5), p = 0.47). CONCLUSION: Slow stent implantation is associated with less CMD after elective PCI in patients with stable angina.

A randomized, placebo-controlled, double-blind trial to evaluate efficacy and safety of Shen-Yuan-Dan capsules, a traditional Chinese medicine, for treatment of peri-procedure myocardial injury following percutaneous coronary intervention.

BACKGROUND: Peri-procedural myocardial injury (PMI) is a common complication of percutaneous coronary intervention (PCI), which cannot be entirely avoided using available treatments. The findings of earlier research have shown that Shen-Yuan-Dan (SYD) capsules, a traditional Chinese medicine, can potentially alleviating PMI. This study aimed to confirm further this hypothesis in a rigorous, well-designed randomized controlled study. METHODS: Our clinical trial was randomized, double-blinded, and placebo-controlled. A total of 181 patients with unstable angina (UA) undergoing elective PCI were randomized to pretreatment with SYD or a placebo under the basis of conventional treatment; 87 patients were pretreated with SYD (4 capsules, 3 times a day, with a further 4 capsules 2 h before PCI) 3 days before the procedure, and 94 patients were given a placebo. No patients received reloading statins before PCI, and SYD or placebo was maintained for 1 month after PCI. The primary endpoint was the incidence of PMI. The secondary endpoint was calculating the incidence rate of all 30-day major adverse cardiovascular events (all-cause mortality, non-fatal myocardial infarction, unplanned revascularization). The safety outcomes, including abnormalities in electrocardiogram and serum biochemical examinations caused by drug use, were also tested. RESULTS: The levels of creatine kinase-myocardial band (CK-MB) in both the SYD and placebo groups were increased at 4 h and 24 h after PCI compared with before the procedure (P < 0.05). The incidence rate of PMI in the SYD group (10.3 %) was lower than that in the placebo group (34 %) (absolute difference, 23.7 % [95 % CI, 11.7-34.8 %], P < 0.01). After taking SYD, the relative risk reduction (RRR) and absolute risk reduction (ARR) were 69.7 % and 24.3 %, respectively; further, number needed to treat (NNT) was 4.2. The 30-day major adverse cardiovascular event (MACE) rate was not statistically different between the SYD and placebo groups (6.9 % vs. 9.6 %, P = 0.352). There were no abnormal situations during the trial. CONCLUSION: These findings showed that pretreatment with SYD could safely reduce the incidence rate of PMI in patients with UA undergoing elective PCI. Further study on the effects of SYD and how it can improve adverse cardiovascular events outcomes is needed.

Effects of Danhong Injection () on Peri-Procedural Myocardial Injury and Microcirculatory Resistance in Patients with Unstable Angina Undergoing Elective Percutaneous Coronary Intervention: A Pilot Randomized Study.

OBJECTIVE: To evaluate the effect of Danhong Injection (, DH) on the index of microcirculatory resistance (IMR) and myocardial injury in patients with unstable angina undergoing elective percutaneous coronary intervention (PCI). METHODS: Seventy-eight patients with unstable angina were randomly divided into DH group (39 cases) and the control group (39 cases) during elective PCI. Randomization was performed using a random-number table. The DH group received DH at a dosage of 40 mL (mixed with 250 mL saline, covered by a light-proof bag, intravenous drip) during PCI and daily for 7 consecutive days, while the control group only received the same dosage of saline. Both groups received standardized treatment. The IMR and fractional flow reserve (FFR) were measured at maximal hyperemia before and after PCI. Myocardial markers, including myoglobin, creatine kinase (CK), creatine kinase MB (CK-MB), and coronary troponin T (cTnT) values were measured at baseline and 24 h after PCI. RESULTS: Among the 78 patients enrolled, the baseline and procedural characteristics were similar between the two groups. There was no significant difference in pre-PCI myocardial markers and coronary physiological indexes between the two groups. However, post-PCI CK and CK-MB levels in the DH group were significantly lower than those in the control group (111.97 ± 80.97 vs. 165.47 ± 102.99, P=0.013; 13.08 ± 6.90 vs. 19.75 ± 15.49, P=0.016). Post-PCI myoglobin and cTNT-positive tend to be lower in the DH group than in the control group but did not reach statistical significance (88.07 ± 52.36 vs. 108.13 ± 90.94, P=0.52; 2.56% vs.7.69%, P=0.065). Compared with the control group, the post-IMR levels of the DH group tended to decrease, but there was no statistical difference (20.73 ± 13.15 vs. 26.37 ± 12.31, P=0.05). There were no statistical differences in post-FFR in both groups. The peri-procedural myocardial injury of the DH group was significantly lower than that of the control group (2.56% vs. 15.38%, P=0.025). During the 30-d follow-up period, no major adverse cardiovascular events occurred in either group. CONCLUSION: This study demonstrated benefit of DH in reducing myocardial injury and potential preserving microvascular function in patients with unstable angina undergoing elective PCI.

Efficacy and safety of Shen-Yuan-Dan capsules for peri-procedural myocardial injury following percutaneous coronary intervention: study protocol for a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Peri-procedural myocardial injury (PMI) during percutaneous coronary intervention (PCI) will result in an unfavorable clinical prognosis in patients, thus urgently necessitating effective drug treatment measures. Shen-Yuan-Dan (SYD) capsules are a traditional Chinese medicine (TCM) preparation that have been found to have potential myocardial protection effects during the peri-procedural phase of PCI in previous clinical and basic research; however, there is a lack of rigorous, randomized, and controlled studies. The aim of this study is to evaluate the efficacy and safety of SYD in decreasing PMI. METHODS: This is a randomized, double-blind, placebo-controlled clinical trial. A total of 284 patients with unstable angina will be randomized into test and control groups. The two groups will be given SYD or a placebo (three times each day, four capsules each time) 3 days before PCI on the basis of conventional treatment. Twelve hours before PCI, an additional 4 capsules will be given, and drug treatment is planned to be maintained for 1 month after surgery. Dynamic changes in the myocardial enzyme in four time-points (before PCI, and 4, 24, 48 hours after PCI) in both groups of patients that will be observed. The follow-up period will be 1 month. The primary observation markers are planned to evaluate the efficacy and safety of SYD in decreasing PMI. The secondary observation markers will be to evaluate the major adverse cardiovascular events (MACEs) status at day 30 after PCI, (all-cause mortality, non-fatal myocardial infarction, repeated revascularization of target blood vessel) and Seattle Angina Questionnaire scores. GRACE scores will be used for risk stratification, and the intervention efficacy of SYD on PMI patients with different risks will be retrospectively evaluated. DISCUSSION: This study will provide a rigorous clinical evidence to evaluate the efficacy and safety of SYD in decreasing PMI and the results are worth anticipating. TRIAL REGISTRATION: The design of this trial has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-IPR-17011069).

Role of metabolic manipulator trimetazidine in limiting percutaneous coronary intervention-induced myocardial injury.

BACKGROUND: Trimetazidine (TMZ) is a metabolic modulator that shifts substrate utilization from fatty acid to carbohydrates, thereby, increasing myocardial glucose oxidation and improving myocardial ischemia. We evaluated whether TMZ is effective in reducing myocardial injury after percutaneous coronary intervention (PCI). METHODS: Patients with stable angina undergoing elective PCI were divided into two groups, one who received oral TMZ (35 mg BD) started 7 days before PCI (n = 48) and second who did not receive any TMZ (in addition to the standard therapy (n = 52)). Troponin-I (cTnI) and creatine kinase-MB (CK-MB) were measured before, 8, and 24 h after PCI. The primary end point was a difference in post-PCI cTnI and CK-MB levels (vs baseline). Frequency of cTnI release in the two groups, total amount of cTnI release, and difference in TIMI flow grade before and after the procedure were also assessed. RESULTS: Baseline demographics in the groups were comparable. Despite similar baseline levels, post-procedural cTnI was lower at 8 h (0.13 vs 0.56 ng/ml, p = 0.03) and 24 h (0.2 vs 1.13 ng/ml, p = 0.004) in the TMZ group. Decline or no change in cTnI was significantly more common in the TMZ group (26% vs 2%, p < 0.01). Total cTnI released after PCI, as assessed by area under curve was significantly lower in the TMZ group (15.84 vs 3.32 ng h/ml, p = 0.005). Although CK-MB levels were also lower in the TMZ group, the difference was not statistically significant. Incidence of post-PCI TIMI 1 or 2 flow was significantly lesser in the TMZ group. CONCLUSIONS: Oral TMZ started 7 days before PCI was effective in limiting PCI-induced myocardial injury with lower cTnI levels and higher prevalence of TIMI-3 flow.

Effects of Danhong Injection () on Peri-Procedural Myocardial Injury and Microcirculatory Resistance in Patients with Unstable Angina Undergoing Elective Percutaneous Coronary Intervention: A Pilot Randomized Study / 中国结合医学杂志

OBJECTIVE@#To evaluate the effect of Danhong Injection (, DH) on the index of microcirculatory resistance (IMR) and myocardial injury in patients with unstable angina undergoing elective percutaneous coronary intervention (PCI).@*METHODS@#Seventy-eight patients with unstable angina were randomly divided into DH group (39 cases) and the control group (39 cases) during elective PCI. Randomization was performed using a random-number table. The DH group received DH at a dosage of 40 mL (mixed with 250 mL saline, covered by a light-proof bag, intravenous drip) during PCI and daily for 7 consecutive days, while the control group only received the same dosage of saline. Both groups received standardized treatment. The IMR and fractional flow reserve (FFR) were measured at maximal hyperemia before and after PCI. Myocardial markers, including myoglobin, creatine kinase (CK), creatine kinase MB (CK-MB), and coronary troponin T (cTnT) values were measured at baseline and 24 h after PCI.@*RESULTS@#Among the 78 patients enrolled, the baseline and procedural characteristics were similar between the two groups. There was no significant difference in pre-PCI myocardial markers and coronary physiological indexes between the two groups. However, post-PCI CK and CK-MB levels in the DH group were significantly lower than those in the control group (111.97 ± 80.97 vs. 165.47 ± 102.99, P=0.013; 13.08 ± 6.90 vs. 19.75 ± 15.49, P=0.016). Post-PCI myoglobin and cTNT-positive tend to be lower in the DH group than in the control group but did not reach statistical significance (88.07 ± 52.36 vs. 108.13 ± 90.94, P=0.52; 2.56% vs.7.69%, P=0.065). Compared with the control group, the post-IMR levels of the DH group tended to decrease, but there was no statistical difference (20.73 ± 13.15 vs. 26.37 ± 12.31, P=0.05). There were no statistical differences in post-FFR in both groups. The peri-procedural myocardial injury of the DH group was significantly lower than that of the control group (2.56% vs. 15.38%, P=0.025). During the 30-d follow-up period, no major adverse cardiovascular events occurred in either group.@*CONCLUSION@#This study demonstrated benefit of DH in reducing myocardial injury and potential preserving microvascular function in patients with unstable angina undergoing elective PCI.

Correlation Study of CYP2C19 Genotypes on Peri-procedural Myocardial Infarction in Patients With Percutaneous Coronary Intervention / 中国循环杂志

Objective: To analyze the risk factors for peri-procedural myocardial infarction (PMI) in patients with percutaneous coronary intervention (PCI) and to study the impact of CYP2C19 genotypes on PMI. Methods: A total of 283 coronary artery disease (CAD) patients received elective PCI were enrolled, the patients were with normal level of cTnI prior PCI, without adverse reaction post PCI and cTnI levels were re-examined at 24 hours after PCI. The patients were divided into 2 groups: PMI group,n=83 and Non-PMI group,n=200. CYP2C19 genotypes were detected by DNA microarray chip method and based on its result, the patients were classiifed into 3 genotypes: Extensive metabolism type, Intermediate metabolism type and Poor metabolism type. The patients with ADP inhibition rate ≤ 20% was deifned as heightened platelet reactivity (HPR) which was measured by thrombelastograph. Baseline clinical condition was compared between 2 groups and the impact of CYP2C19 genotypes with other risk factors for PMI occurrence were studied. Results: The occurrence rate of PMI was 29.3% (83/283); the age, gender, BMI, smoking, blood levels of TG, LDL-C and uric acid, history of hypertension and diabetes were similar between 2 groups,P>0.05. Compared with Non-PMI group, PMI group had more implanted stents (2.1 ± 0.9) vs (1.5 ± 0.6) and longer total length of stents 56 (36-71) mm vs 33 (23-51) mm, bothP<0.05; lower ADP inhibition rate (36.0 ± 29.8) % vs (43.9 ± 26.4) %,P=0.02 and higher HPR occurrence rate 39.8% vs 22.0%,P=0.01. The ratios of CYP2C19 genotypes of Extensive metabolism, Intermediate metabolism and Poor metabolism were 37.5%, 45.2% and 17.3% respectively, while PMI patients in each genotype were 21.7%, 29.7% and 44.9% respectively. Logistic regression analysis indicated that HPR (OR=2.18, 95% CI 1.19-4.01,P=0.02), total length of stents (OR=1.03, 95% CI 1.00-1.06,P=0.007) and CYP2C19 Poor metabolism genotype (OR=2.8, 95% CI 1.24-6.28,P=0.01) were the risk factors for PMI occurrence. Conclusion: HPR, total length of stents and CYP2C19 poor metabolism genotype were the risk factors of PMI occurrence, while poor metabolism genotype might be the most important endogenous reason for PMI occurrence.

Investigation of Mobidity, Prognosis and the Effect of Myocardial Infacfion in Patieuts With Small Side Branch Occlusion During Coronary Bifurcation Intervention / 中国循环杂志

Objective: To investigate the prognostic factor for small side branch (SB) occlusion during coronary bifurcation intervention with the incidence rate of peri-procedural myocardial injury (PMI) in relevant patients. Methods: A total of 925 consecutive patients who received coronary bifurcation intervention were enrolled and there were 949 SB lesions ≤ 2.0 mm conifrmed by quantitative coronary angiography (QCA). The patients were divided into 2 groups: SB occlusion group,n=85, including 86 bifurcation lesions and Non-SB occlusion group,n=840, including 863 bifurcation lesions. The clinical characteristics, QCA findings and PCI procedural conditions were studied by Multivariate logistic regression analyses to explore the independent predictors of SB occlusion and to compare the incidence rate of PMI. Results: The total SB occlusion rate was 9.1% (86/949). SB occlusion group had the higher incidence rate of PMI (26/83, 31.3%) vs (77/821, 9.4%) and peri-operative MI mortality(6/83, 7.2%) vs (11/821, 1.3%) than Non-SB occlusion group, both P Conclusion: Coronary bifurcation lesion patients with SB occlusion had the higher risk of PMI during the interventional procedure.