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The aim of article was to assess the risk for random errors in outcomes graded as high certainty of evidence (CoE). We randomly selected 100 Cochrane reviews with dichotomous outcomes rated as high CoE using Grading of Recommendations Assessment, Development, and Evaluation. To detect increased risks for random errors, two investigators independently conducted trial sequential analysis using conventional thresholds for type I (α = 0.05) and type II (β = 0.10) errors. We dually regraded all outcomes with increased risks for random errors and conducted multivariate logistic regression analyses to determine predictors of increased risks for random errors. Overall, 38% (95% confidence interval: 28–47%) of high CoE outcomes had increased risks for random errors. Outcomes assessing harms were more frequently affected than outcomes assessing benefits (47% vs. 12%). Regrading of outcomes with increased random errors showed that 74% should have been downgraded based on current guidance. Regression analyses rendered small absolute risk differences (P = 0.009) and low number of events (P = 0.001) as significant predictors of increased risks for random errors. Decisionmakers need to be aware that outcomes rated as high CoE often have increased risks for false-positive or false-negative findings.

About 30% of angina patients have persisting symptoms despite successful revascularization and antianginal therapy. Moreover, in stable patients, percutaneous coronary intervention (PCI) does not improve survival as compared with medical therapy alone. Trimetazidine, an antianginal agent devoid of hemodynamic effect, may help reducing symptoms and improving outcomes after PCI. The ATPCI study is investigating the efficacy and safety of adding trimetazidine to standard-of-care in angina patients who had a recent PCI. ATPCI is a randomized, double-blind, parallel-group, placebo-controlled, event-driven study in patients with coronary artery disease having undergone PCI because of stable angina (elective PCI) or unstable angina/NSTEMI (urgent PCI). After PCI, patients were randomized to trimetazidine (35 mg bid) or placebo on top of standard-of-care including event prevention drugs and antianginal treatment. Patients will be followed for 2 to 4 years. The primary efficacy endpoint is a composite of cardiac death, hospitalization for a cardiac event and recurrence or persistence of angina. Safety events related to trimetazidine use will be monitored. Recruitment lasted from September 2014 to June 2016. A total of 6007 patients were enrolled (58% and 42% after elective and urgent PCI, respectively). Mean age was 61 years, 77% were males, and median durations of coronary artery disease were 1 and 5 months (if urgent or elective PCI, respectively). Almost all patients received drugs for event prevention and antianginal therapy at baseline. The ATPCI study will shed further light on the management of contemporary angina patients after PCI. Results are expected in 2019.

Abstract Aims The aim of this study was to investigate the impact on 10-year survival of patient-reported anginal status at 1 year following percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in patients with left main coronary artery disease (LMCAD) and/or three-vessel CAD (3VD). Methods and results In this post hoc analysis of the randomized SYNTAX Extended Survival study, patients were classified as having residual angina (RA) if their self-reported Seattle Angina Questionnaire angina frequency (SAQ-AF) scale was ≤90 at the 1-year follow-up post-revascularization with PCI or CABG. The primary endpoint of all-cause death at 10 years was compared between the RA and no-RA groups. A sensitivity analysis was performed using a 6-month SAQ-AF. At 1 year, 373 (26.1%) out of 1428 patients reported RA. Whilst RA at 1 year was an independent correlate of repeat revascularization at 5 years [18.3 vs. 11.5%; adjusted hazard ratio (HR): 1.54; 95% confidence interval (CI): 1.10–2.15], it was not associated with all-cause death at 10 years (22.1 vs. 21.6%; adjusted HR: 1.11; 95% CI: 0.83–1.47). These results were consistent when stratified by the modality of revascularization (PCI or CABG) or by anginal frequency. The sensitivity analysis replicating the analyses based on 6-month angina status resulted in similar findings. Conclusion Among patients with LMCAD and/or 3VD, patient-reported RA at 1 year post-revascularization was independently associated with repeat revascularization at 5 years; however, it did not significantly increase 10-year mortality, irrespective of the primary modality of revascularization or severity of RA. Graphical Abstract Graphical Abstract Residual angina, which was common (26.1%) at 1 year after coronary revascularization, was associated with repeat revascularization events up to 5 years, but not with all-cause death up to 10 years.

Despite the success of current medical and surgical management of ischemic heart disease, a growing number of patients have diffuse obstructive coronary artery disease that is not amenable to coronary-artery bypass grafting or catheter-based interventions. This problem has stimulated interest in developing alternative therapeutic approaches. Early attempts at indirect myocardial revascularization had limited success. Beck's use of omentopexy, reported in 1935, 1 and Vinberg's use of thoracic-artery implantation, reported in 1954, 2 were attempts to provide direct myocardial perfusion and were based on the description by Wearn et al., in 1933, 3 of a sinusoidal network in the human heart. In 1965, Sen . . .

In the 1950s, Goldman and associates 1 and Massimo and Boffi 2 proposed that natural or artificial conduits could be implanted in the subendocardium to direct left ventricular blood through the coronary sinusoids and into ischemic areas of the myocardium. In 1968, after extensive experiments in animals, Sen and colleagues 3 described transmyocardial revascularization through transmural channels created with a 16-gauge intravenous cannula. In 1981, Mirhoseini and Cayton 4 used a laser to create transmyocardial channels in animals; five years later, Okada and colleagues 5 did the same in humans. Investigators have continued to test transmyocardial revascularization in both animals 6 – 9 and humans. 10 In a . . .

F-18 fluorodeoxyglucose ( 18F-FDG) positron emission tomography (PET) is a useful tool for the detection of local inflamed atherosclerotic lesions. This study used hybrid PET/computed tomography (CT) to examine the effects of 2 doses of atorvastatin on 18F-FDG uptake in atherosclerotic plaques in Japanese adults with stable angina pectoris who were scheduled to undergo percutaneous coronary intervention (PCI). This was a prospective, randomized, investigator-blinded, open-label study in patients with dyslipidemia (total cholesterol ≥220 mg/dL and/or LDL-C ≥140 mg/dL) who were scheduled to undergo PCI for stable angina pectoris and had not received any lipid-lowering drugs within 1 year before enrollment. Patients were randomly allocated to receive atorvastatin 5 or 20 mg/d for 6 months. At baseline (the day after PCI), 18F-FDG uptake in the ascending aorta and femoral artery was determined using PET/CT imaging, and the mean target-to-background ratio (TBR) was calculated in individual plaques. The same regions were assessed by PET/CT after 6 months of treatment. Changes from baseline to follow-up in the lipid profile, serum malondialdehyde-modified LDL-C (MDA–LDL-C), and serum high-sensitivity C-reactive protein (hs-CRP) were also examined. Drug adherence, adverse events, and changes in medications were monitored at monthly outpatient visits. Of 32 patients initially screened, 2 were excluded due to newly diagnosed cancer; thus, 30 patients were randomly assigned to treatment, 15 in each group. Patients were predominantly male (18 [60%]), with a mean (SD) age of 54 (11) years, mean body weight of 65 (12) kg, and mean total cholesterol, HDL-C, and triglyceride concentrations of 240 (29), 48 (14), and 180 (102) mg/dL, respectively. After 6 months, the 20-mg group had significant reductions from baseline in mean (SD) TBR in the ascending aorta (from 1.15 [0.14] to 1.05 [0.12]; percent change, −7.9% [9.4%]; P = 0.007) and the femoral artery (from 1.12 [0.11] to 1.02 [0.11]; percent change, −9.9% [13.8%]; P = 0.012). The corresponding changes from baseline were not statistically significant in the 5-mg group. The differences in percent change in TBR in the 2 locations were not significant between groups. When data from the 2 groups were combined, the overall reduction in TBR from baseline to 6 months was significant in both the ascending aorta ( P = 0.003) and the femoral artery ( P = 0.021). The decreases in TBR in both arteries were significantly correlated with reductions in LDL-C (ascending aorta: r 2 = 0.230 [ P = 0.012]; femoral artery: r 2 = 0.338 [ P = 0.003]), MDA–LDL-C (ascending aorta: r 2 = 0.183 [ P = 0.028]; femoral artery: r 2 = 0.247 [ P = 0.010]), and hs-CRP (ascending aorta: r 2 = 0.132 [ P = 0.048]; femoral artery: r 2 = 0.271 [ P = 0.007]). One patient in the 5-mg group and 2 patients in the 20-mg group had ∼2-fold increases in serum aminotransferases on a single occasion; however, no specific musculoskeletal or hepatic adverse events were observed, and aminotransferase values decreased to within normal ranges without changes in the atorvastatin dose. Six months of treatment with atorvastatin 20 mg, but not 5 mg, was associated with a significant reduction in TBR in the ascending aorta and femoral artery in these Japanese adults with dyslipidemia undergoing PCI for stable angina pectoris. University Hospital Medical Information Network Clinical Trials Registry identifier: C000000371.

Transmyocardial laser revascularisation (TMLR) is used to treat patients with refractory angina due to severe coronary artery disease, not suitable for conventional revascularisation. We aimed in a randomised controlled trial to assess the effectiveness of TMLR compared with medical management. 188 patients with refractory angina were randomly assigned TMLR plus normal medication or medical management alone. At 3 months, 6 months, and 12 months after surgery (TMLR) or initial assessment (medical management) we assessed exercise capacity with the treadmill test and the 12 min walk. Mean treadmill exercise time, adjusted for baseline values, was 40 s (95% CI-15 to 94) longer in the TMLR group than in the medical-management group at 12 months (p=0·152). Mean 12 min walk distance was 33 m (-7 to 74) further in TMLR patients than medical-management patients (p=0·108) at 12 months. The differences were not significant or clinically important. Perioperative mortality was 5%. Survival at 12 months was 89% (83-96) in the TMLR group and 96% (92-100) in the medical-management group (p=0·14). Canadian Cardiovascular Society score for angina had decreased by at least two classes in 25% of TMLR and 4% of medical-management patients at 12 months (p<0·001). Our findings show that the adoption of TMLR cannot be advocated. Further research may be appropriate to assess any potential benefit for sicker patients.

ObjectiveTo evaluate the efficacy and safety of a combination therapy using Chinese medicine (CM) Shenzhu Guanxin Recipe (参术冠心方, SGR) and standard Western medicine treatment (SWMT) in patients with angina pectoris after percutaneous coronary intervention (PCI).MethodsDouble-blind randomized controlled trial was used in this experimental procedure. One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment (SGR) and control (placebo) groups. Outcome measures including angina pectoris score (APS), CM symptom score, and Seattle Angina Questionnaire (SAQ) score were evaluated in 1, 2, 3 and 12 months, and the death rate, restenosis and other emergency treatments were observed. The mixed-effects models were employed for the data analysis.ResultsIn the treatment group, a larger within-treatment effect size (d=1.74) was found, with a 76.7% reduction in APS from pretreatment to 12-month follow-up assessment compared with the control group (d=0.83, 53.8% symptom reduction); betweentreatment (BT) effect size was d=0.66. CM symptom scores included an 18.3% reduction in the treatment group (d=0.46), and a 16.1% decrease in the control group (d=0.31); d=0.62 for BT effect size. In regard to scores of SAQ, the BT effect size of cognition level of disease was larger in the treatment group (d=0.63), followed by the level of body limitation of activity (d=0.62), condition of angina pectoris attacks (d=0.55), satisfaction level of treatments (d=0.31), and steady state of angina pectoris (d=0.30). Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups, respectively. No significant difference in any cardiovascular event (including death toll, frequency of cardiovascular hospitalization or emergency room visits) was found between the two groups.ConclusionThe combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.

ObjectiveCompared with Shengmai Capsule (生脉胶囊, SM), the study was conducted to evaluate the efficacy and safety of Xuefu Zhuyu Capsule (血府逐瘀胶囊, XFZY) on the symptoms and signs and health-related quality of life (HR-QOL) in the unstable angina (UA) patients with blood-stasis syndrome (BSS) after percutaneous coronary intervention (PCI).MethodsA randomized, double-blinded, double-dummy, and placebo-controlled trial was applied. Ninety patients, diagnosed as UA and BSS after successful PCI, were enrolled and equally randomized into three groups, XFZY group, SM group, and placebo group, and administered with the corresponding medications respectively for four weeks. The clinical symptoms and signs (CSS), electrocardiography (ECG), and BSS scores were recorded and compared among groups during and after the treatment. Short-form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QOL in each group before and after the treatment. Safety indexes (blood routine and liver and kidney function tests) were also examined at the beginning and after the treatment.ResultsEighty-six patients completed the whole study. After the treatment, the total effective rates of the XFZY group in ameliorating CSS and ECG were 76.7% and 60.0%, respectively, which were obviously higher than those in SM (CSS: 53.3%; ECG: 36.7%) and the placebo (CSS: 43.3%; ECG: 30.0%) groups. After one week’s treatment, BSS scores slightly decreased in each group, but no signifificant differences were found among three groups (P>0.05). After four weeks’ treatment, BSS scores in the XFZY group decreased to a lower level compared with SM (P <0.05) and the placebo (P <0.01) groups. After the treatment, the effificacy of XFZY group in improving body pain (BP), general health (GH), vitality (VT), society functioning (SF), role emotional (RE), angina stability (AS), angina frequency (AF), and treatment satisfaction (TS) were better than those in the placebo group (P <0.05,P <0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, and TS were better improved than those in the SM group P <0.05). No obvious adverse reaction was found during and after the treatment except one case in the XFZY group reporting of stomach discomfort.ConclusionsCompared with SM Capsule treatment, a short-term treatment with XFZY Capsule exhibits better effificacy on CSS and BSS scores, and HR-QOL in UA patients with BSS after PCI. However, its long-term effificacy and safety still needs further investigation.

Effective therapy for patients suffering from refractory angina remains a major unmet need. Chronic angina, which is refractory to medical and interventional therapies, affects patients who are not suitable for revascularization, patients following successful revascularization, and patients with coronary microvascular dysfunction. Coronary sinus (CS) narrowing has been studied as a potential therapy for patients with angina. Pre-clinical and clinical data, including 2 randomized sham-controlled clinical trials and 2 large prospective multi-center registries, have confirmed the safety and effectiveness of CS narrowing in patients with refractory angina due to obstructive coronary artery disease (CAD). Preliminary pathophysiologic studies suggest that CS narrowing may also improve coronary microvascular function and alleviate microvascular angina. Here, we review the historical perspective, mechanism of action, and clinical applications of CS narrowing. In Conclusion: With the accumulation of new data, the time is ripe to revisit the therapeutic benefits seen in historical CS interventions and demonstrated in recent clinical research to reduce angina and ischemia and improve quality of life of patients with disabling refractory angina.