Optimal antiplatelet monotherapy during the chronic maintenance period in patients who undergo coronary stenting is unknown. We aimed to compare head to head the efficacy and safety of aspirin and ...clopidogrel monotherapy in this population.
We did an investigator-initiated, prospective, randomised, open-label, multicentre trial at 37 study sites in South Korea. We enrolled patients aged at least 20 years who maintained dual antiplatelet therapy without clinical events for 6–18 months after percutaneous coronary intervention with drug-eluting stents (DES). We excluded patients with any ischaemic and major bleeding complications. Patients were randomly assigned (1:1) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater, in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02044250.
Between March 26, 2014, and May 29, 2018, we enrolled 5530 patients. 5438 (98·3%) patients were randomly assigned to either the clopidogrel group (2710 49·8%) or to the aspirin group (2728 50·2%). Ascertainment of the primary endpoint was completed in 5338 (98·2%) patients. During 24-month follow-up, the primary outcome occurred in 152 (5·7%) patients in the clopidogrel group and 207 (7·7%) in the aspirin group (hazard ratio 0·73 95% CI 0·59–0·90; p=0·0035).
Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after percutaneous coronary intervention with DES significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater. In patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future adverse clinical events.
ChongKunDang, SamJin, HanMi, DaeWoong, and the South Korea Ministry of Health and Welfare.
Salt-sensitive hypertension (SSH) is characterized by impaired sodium excretion and subnormal vasodilatory response to salt loading. Sacubitril/valsartan (LCZ696) was hypothesized to increase ...natriuresis and diuresis and result in superior blood pressure control compared with valsartan in Asian patients with SSH. In this randomized, double-blind, crossover study, 72 patients with SSH received sacubitril/valsartan 400 mg and valsartan 320 mg once daily for 4 weeks each. SSH was diagnosed if the mean arterial pressure increased by ≥10% when patients switched from low (50 mmol/d) to high (320 mmol/d) sodium diet. The primary outcome was cumulative 6- and 24-hour sodium excretion after first dose administration. Compared with valsartan, sacubitril/valsartan was associated with a significant increase in natriuresis (adjusted treatment difference: 24.5 mmol/6 hours, 50.3 mmol/24 hours, both P<0.001) and diuresis (adjusted treatment difference: 291.2 mL/6 hours, P<0.001; 356.4 mL/24 hours, P=0.002) on day 1, but not on day 28, and greater reductions in office and ambulatory blood pressure on day 28. Despite morning dosing of both drugs, ambulatory blood pressure reductions were more pronounced at nighttime than at daytime or the 24-hour average. Compared with valsartan, sacubitril/valsartan significantly reduced N-terminal pro B-type natriuretic peptide levels on day 28 (adjusted treatment difference: -20%; P=0.001). Sacubitril/valsartan and valsartan were safe and well tolerated with no significant changes in body weight or serum sodium and potassium levels with either treatments. In conclusion, sacubitril/valsartan compared with valsartan was associated with short-term increases in natriuresis and diuresis, superior office and ambulatory blood pressure control, and significantly reduced N-terminal pro B-type natriuretic peptide levels in Asian patients with SSH.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01681576.
Background
The relationship between periodontitis and hypertension remains controversial. This study aimed to investigate the association of periodontitis, missing teeth, and oral hygiene behaviors ...with the incidence of hypertension.
Methods
A total of 104,349 participants were selected from the National Health Insurance System‐Health Screening (NHIS‐HEALS) cohort. Incident hypertension and periodontitis were diagnosed based on the patients’ clinical records and health examinations. A multivariable Cox proportional hazards regression analysis was performed after adjusting for socioeconomic factors, coexisting disease, and health behaviors.
Results
The mean age of the participants was 51.1 years (range, 40–79 years) at baseline, and 55.1% were men. A total of 52,855 incident hypertension cases were identified during the median follow‐up period of 9.6 years. Among the participants, periodontitis (hazard ratio HR: 1.02; 95% confidence interval 95% CI: 1.00–1.04), number of missing teeth (for ≥15 group, HR: 1.40; 95% CI: 1.29–1.52), dental scaling (HR: 0.93; 95% CI: 0.91–0.95), and toothbrushing frequency (for ≥3 group, HR: 0.85; 95% CI: 0.83–0.88) were significantly associated with incident hypertension after full adjustments for covariates. While periodontitis was significantly associated with incident hypertension (HR: 1.04; 95% CI: 1.02–1.06) in the middle‐aged group (40–64 years), the effect was insignificant in the older group (≥65 years).
Conclusions
Oral inflammation could contribute to the incidence of hypertension; thus, efforts to reduce oral inflammation should be encouraged. Future intervention studies are warranted to determine whether oral health care could be beneficial in the management of hypertension.
Abstract Knowledge of the status of real‐world home blood pressure (BP) measurements is crucial for establishing policies promoting hypertension treatment through home BP monitoring. However, only a ...few studies have investigated the status of home BP measurements in real‐world settings. This study investigated the practice of Korean patients in measuring BP at home. This study recruited participants aged ≥20 years who were taking antihypertensives and conducted a questionnaire‐based survey on home BP measurements. Of 701 participants recruited between August 2018 and April 2020, 673 were included in the analysis. Of these, 359 (53.3%) possessed home BP measurement devices. The devices used by 184 (51.3%) participants were validated, 110 (30.6%) were nonvalidated, and 65 (18.1%) had an unknown validation status. Only 18 patients (5.0%) with home BP devices were aware of the validation tests for home BP measurement devices. Of the 673 participants, 278 (41.3%) measured BP at home (77.4% of the patients owned home BP measurement devices). Among them, at least 74 (26.6%) performed proper measurements (at least once a month, at least twice a day or twice at a time, after at least 1 minute of rest, with at least a 1‐min interval between each measurement, and 30 min after drinking coffee, exercising, or smoking). In conclusion, our community‐based survey in the nonpresentive Korean population revealed a low rate of home BP measurement, a high rate of using nonvalidated devices, and a high rate of inappropriate measurements, suggesting that more efforts toward patient education regarding home BP measurements are needed.
Abstract
The authors evaluated the efficacy, safety, and characteristics of patients who respond well to standard dose triple combination therapy including chlorthalidone 25 mg with telmisartan 80 mg ...plus amlodipine 5 mg in hypertensive patients. This is a multicenter, double‐blind, active‐controlled, phase 3, randomized trial. Patients are randomized to triple combination (telmisartan 40 mg/amlodipine 5 mg/chlorthalidone 12.5 mg, TEL/AML/CHTD group) or dual combination (telmisartan 40 mg/amlodipine 5 mg, TEL/AML group) treatment and then dose up titration to TEL 80/AML5/CHTD25mg and TEL80/AML5, respectively. The primary endpoint is the change of mean sitting systolic blood pressure (MSSBP) at week 8. A Target BP achievement rate, a response rate, and the safety endpoints are also evaluated. Total 374 patients (mean age = 60.9 ± 10.7 years, male = 78.3%) were randomized to the study. The baseline MSSBPs/diastolic BPs were 149.9 ± 12.2/88.5 ± 10.4 mm Hg. After 8 weeks treatment, the change of MSSBPs at week 8 are −19.1 ± 14.9 mm Hg (TEL/AML/CHTD) and −11.4 ± 14.7 mm Hg (TEL/AML) (
p
< .0001). The achievement rates of target BP (53.8% vs. 37.8%,
p
= .0017) and responder rate (54.8% vs. 35.6%,
p
= .0001) at week 8 were significantly higher in TEL/AML/CHTD. There are no serious adverse event and no one discontinued medication due to adverse event. Among the TEL 80/AML5/CHTD25mg treatment group, patients of female or age ≥ 65 years old showed higher rate of target BP achievement than relatively young male. (61.4 vs. 46.8%,
p
= .042) Our study showed standard dose triple combination of telmisartan 80 mg/amlodipine 5 mg/chlorthalidone 25 mg is efficacious and safe in treatment of primary hypertension. Target BP achievement with triple therapy would be facilitated in female or old age.
The authors developed and validated a diagnostic algorithm using the optimal upper and lower cut‐off values of office and home BP at which ambulatory BP measurements need to be applied. Patients ...presenting with high BP (≥140/90 mm Hg) at the outpatient clinic were referred to measure office, home, and ambulatory BP. Office and home BP were divided into hypertension, intermediate (requiring diagnosis using ambulatory BP), and normotension zones. The upper and lower BP cut‐off levels of intermediate zone were determined corresponding to a level of 95% specificity and 95% sensitivity for detecting daytime ambulatory hypertension by using the receiver operator characteristic curve. A diagnostic algorithm using three methods, OBP‐ABP: office BP measurement and subsequent ambulatory BP measurements if office BP is intermediate zone; OBP‐HBP‐ABP: office BP, subsequent home BP measurement if office BP is within intermediate zone and subsequent ambulatory BP measurement if home BP is within intermediate zone; and HBP‐ABP: home BP measurement and subsequent ambulatory BP measurements if home BP is within intermediate zone, were developed and validated. In the development population (n = 256), the developed algorithm yielded better diagnostic accuracies than 75.8% (95%CI 70.1–80.9) for office BP alone and 76.2% (95%CI 70.5–81.3) for home BP alone as follows: 96.5% (95%CI: 93.4–98.4) for OBP‐ABP, 93.4% (95%CI: 89.6–96.1) for OBP‐HBP‐ABP, and 94.9% (95%CI: 91.5–97.3%) for HBP‐ABP. In the validation population (n = 399), the developed algorithm showed similarly improved diagnostic accuracy. The developed algorithm applying ambulatory BP measurement to the intermediate zone of office and home BP improves the diagnostic accuracy for hypertension.
Sodium intake reduction has been emphasized because sodium adversely impacts health, especially blood pressure (BP), and the cardiovascular (CV) disease risk. However, data obtained from several ...cohort studies have raised questions regarding the effects of high sodium intake on BP and the CV disease risk. In the present study, we systematically reviewed the literature to evaluate these associations. Studies showing negative associations between urine sodium and BP and CV outcomes relied on estimated 24-hour urine sodium from spot urine that is inappropriate for determining sodium intake at an individual level. Furthermore, controversy about the association between 24-hour urine sodium and BP may have been caused by different characteristics of study populations, such as age distribution, ethnicity, potassium intake and the inclusion of patients with hypertension, the different statistical methods and BP measurement methods. Regarding the association between sodium intake and the CV disease risk, studies showing negative or J- or U-shaped associations used a single baseline measurement of 24-hour urine sodium in their analyses. However, recent studies that employed average of subsequently measured 24-hour urine sodium showed positive, linear associations between sodium intake and CV outcomes, indicating that controversies are caused by the different sodium intake measurement methods and analytic designs. In conclusion, the study shows that positive associations exist between sodium intake and BP, CV outcomes, and mortality, and that the argument that reducing sodium intake is dangerous is invalid. Sodium intake reduction should be recommended to all, and not limited to patients with hypertension or CV disease.
Among the 146 patients enrolled in the Korean FH registry, 83 patients who had undergone appropriate LLT escalation and were followed-up for ≥ 6 months were analyzed for pathogenic variants (PVs). ...The achieved percentage of expected low-density lipoprotein-cholesterol (LDL-C) reduction (primary variable) and achievement rates of LDL-C < 70 mg/dL were assessed. The correlations between the treatment response and the characteristics of PVs, and the weighted 4 SNP-based score were evaluated. The primary variables were significantly lower in the PV-positive patients than in the PV-negative patients (p = 0.007). However, the type of PV did not significantly correlate with the primary variable. The achievement rates of LDL-C < 70 mg/dL was very low, regardless of the PV characteristics. Patients with a higher 4-SNP score showed a lower primary variable (R
= 0.045, p = 0.048). Among evolocumab users, PV-negative patients or those with only defective PVs revealed higher primary variable, whereas patients with at least one null PV showed lower primary variables. The adjusted response of patients with FH to LLT showed significant associations with PV positivity and 4-SNP score. These results may be helpful in managing FH patients with diverse genetic backgrounds.
Background: This study evaluated the association of body mass index (BMI) with adverse clinical outcomes during chronic maintenance antiplatelet monotherapy after percutaneous coronary intervention ...(PCI) with drug-eluting stents (DES).Methods and Results: Overall, 5,112 patients were stratified (in kg/m2) into underweight (BMI ≤18.4), normal weight (18.5–22.9), overweight (23.0–24.9), obesity (25.0–29.9) and severe obesity (≥30.0) categories with randomized antiplatelet monotherapy of aspirin 100 mg or clopidogrel 75 mg once daily for 24 months. The primary endpoint was the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome and major bleeding of Bleeding Academic Research Consortium type ≥3. Compared with normal weight, the risk of primary composite outcomes was higher in the underweight (hazard ratio HR 2.183 1.199–3.974), but lower in the obesity (HR 0.730 0.558–0.954) and severe obesity (HR 0.518 0.278–0.966) categories, which is partly driven by the difference in all-cause death. The risk of major bleeding was significantly higher in the underweight (HR 4.140 1.704–10.059) than in the normal weight category. A decrease in categorical BMI was independently associated with the increased risk of primary composite outcomes.Conclusions: Lower BMI is associated with a higher risk of primary composite outcomes, which is primarily related to the events of all-cause death or major bleeding during chronic maintenance antiplatelet monotherapy after PCI with DES.
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