Patient Characteristics, Procedural Details, and Outcomes of Contemporary Percutaneous Coronary Intervention in Real-World Practice: Insights from Nationwide Thai PCI Registry.

Background: Percutaneous coronary intervention (PCI) practice and outcomes vary substantially in different parts of the world. The contemporary data of PCI in Asia are limited and only available from developed Asian countries. Objectives: To explore the pattern of practice and results of PCI procedures in Thailand as well as a temporal change of PCI practice over time compared with the registry from other countries. Methods: Thai PCI Registry is a prospective nationwide registry that was an initiative of the Cardiac Intervention Association of Thailand (CIAT). All cardiac catheterization laboratories in Thailand were invited to participate during 2018-2019, and consecutive PCI patients were enrolled and followed up for 1 year. Patient baseline characteristics, procedural details, equipment and medication use, outcomes, and complications were recorded. Results: Among the 39 hospitals participated, there were 22,741 patients included in this registry. Their mean age (standard deviation) was 64.2 (11.7) years and about 70% were males. The most common presentation was acute coronary syndrome (57%) with a high proportion of ST-elevation myocardial infarction (28%). Nearly two-thirds of patients had multivessel disease and significant left main stenosis was reported in 11%. The transradial approach was used in 44.2%. The procedural success rate was very high (95.2%) despite the high complexity of the lesions (56.9% type C lesion). The incidence of procedural complications was 5.3% and in-hospital mortality was 2.8%. Conclusion: Thai PCI Registry provides further insights into the current practice and outcomes of PCI in Southeast Asia. The success rate was very high, and the complications were very low despite the high complexity of the treated lesions.

Dose-dependent effect of impaired renal function on all-cause mortality in patients following percutaneous coronary intervention.

OBJECTIVE: To determine the risk prediction of various degrees of impaired renal function on all-cause mortality in patients following percutaneous coronary intervention (PCI). BACKGROUND: Patients with chronic kidney disease (CKD) are at high risk of all-cause mortality after PCI. However, there are less data of various degrees of impaired renal function to predict those risks. METHODS: This was a subgroup analysis of nationwide PCI registry of 22 045 patients. Patients were classified into six CKD stages according to preprocedure estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2 ): I (≥90), II (60-89), III (30-59), IV (15-29), or V (<15) without or with dialysis. Baseline clinical and angiographic characteristics were compared among patients in each stage. One-year all-cause mortality was reported with risk prediction based on CKD stages and other risk factors. RESULTS: Patients with CKD stage I-V without and with on dialysis were found in 26.9%, 40.8%, 23.2%, 3.9%, 1.5%, and 3.7%, respectively. PCI procedural success and complication rates ranged from 94.0% to 96.2% and 2.8% to 6.1%, respectively. One-year overall survival among CKD stages I-V was 96.3%, 93.1%, 84.4%, 65.2%, 68.0%, and 69.4%, respectively (p < .001 by log-rank test). After adjusting covariables, the hazard ratios of all-cause mortality for CKD stages II-V as compared to stage I by multivariate Cox regression analysis were 1.5, 2.6, 5.3, 5.9, and 7.0, respectively, (p < .001). CONCLUSION: Among patients undergoing PCI, lower preprocedure eGFR is associated in a dose-dependent effect with decreased 1-year survival. This finding may be useful for risk classification and to guide decision-making.

Non-compliance with digoxin in patients with heart failure and/or atrial fibrillation: a systematic review and meta-analysis of observational studies.

BACKGROUND: Digoxin is highly potent and efficacious for treatment of heart failure (HF) and/or atrial fibrillation (AF) yet compliance is often poor. AIMS: To examine prevalence rates of non-compliance with digoxin; variations between clinical settings, types of non-compliance and methods of detection; and potential factors influencing non-compliance with digoxin. METHODS: This was a systematic review and meta-analysis of prospective observational studies of non-compliance with digoxin in patients with HF and/or AF, published in English. The studies were identified through these bibliographic databases: MEDLINE, EMBASE, CINAHL, IPA and Cochrane CENTRAL. Subgroup analysis examined the influence of clinical settings, types of non-compliance and methods of detection. RESULTS: Ten studies met the inclusion criteria, comprising 1841 patients with HF and/or AF. The corresponding prevalence rates of non-compliance for outpatients, after hospital discharge and inpatients were 43.1% (interquartile range [IQR] 29-48%), 25% (95% confidence interval [CI] 12-37%) and 4.5%, respectively. In patients with HF and AF co-morbidities, the prevalence rate of non-compliance with digoxin was 38.7% (IQR 27-46%); the corresponding prevalence rates of overdosing and underdosing were 33.04% (IQR 22-49%) and 33.8% (95% CI 25-42%), respectively. Rates varied depending on the methods of detecting non-compliance. Regularity of prescribed dose, diuretic use, coronary artery bypass, implantable cardioverter-defibrillator, number of office visits and pill boxes demonstrated strong associations with non-compliance with digoxin. CONCLUSIONS: Non-compliance with digoxin is prevalent among patients with HF and/or AF. A better understanding of the factors influencing compliance and improved intervention strategies are necessary to increase digoxin compliance.

Bioequivalence evaluation of two formulations of doxazosin tablet in healthy thai male volunteers.

The bioequivalence of two doxazosin 2 mg tablets was determined in 24 healthy Thai male volunteers after one single dose in a randomized cross-over study with a one week washout period. The study was conducted at Faculty of Pharmaceutical Sciences and Health Sciences Research Institute, Naresuan University, Phitsanulok, Thailand. Reference (Cardura, Heinrich Mack Nachf. GmbH & Co. GK, Illertissen, Germany) and test (Dozozin-2, Umeda Co., Ltd., Bangkok Thailand) were administered to volunteers after overnight fasting. Blood samples were collected at specified time intervals and plasma was separated. The validated HPLC method with fluorescence detection was used for quantification of doxazosin in plasma samples. The pharmacokinetic parameters, T(max), C(max), AUC(t), AUC(infinity), T(1/2), lambda(z), Cl and V(d), were determined from plasma concentration time profile of both formulations by using non-compartment analysis. The calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two brands. The analysis of variance (ANOVA) using log-transformed C(max), AUC(t), and AUC(infinity) did not show any significant difference between two formulations. The point estimates and 90% confidence intervals for C(max), AUC(t) and AUC(infinity) were within the acceptance range (0.80-1.25), satisfying the bioequivalence criteria of the Thailand Food and Drug Administration Guidelines. These results indicate that Dozozin-2 is bioequivalent to Cardura and, thus, may be prescribed interchangeably.