Endothelial dysfunction in patients with exaggerated blood pressure response during treadmill test

BACKGROUND: The diagnostic and prognostic importance of exaggerated blood pressure response to exercise is controversial. Endothelial dysfunction has been demonstrated in patients with atherosclerosis and risk factors for coronary artery disease, but there is a paucity of information on patients with exercise-induced hypertension. HYPOTHESIS: We designed the study to evaluate endothelial function in patients with exaggerated blood pressure response during exercise. METHODS: Exercise-induced hypertension was defined as systolic blood pressure > or = 210 mmHg in men and > or = 190 mmHg in women during the treadmill test. Using a high-resolution ultrasound technique, endothelial function of the brachial artery in patients with exercise-induced hypertension (n = 25) and control subjects (n = 25) was investigated. RESULTS: Endothelium-dependent vasodilation was impaired in patients with exercise-induced hypertension compared with controls (7.77 +/- 5.14 vs. 2.81 +/- 2.29%, p < 0.05). On univariate analysis, the extent of vasodilation correlated negatively with age (r = -0.43, p < 0.05) and delta systolic blood pressure (r = -0.39, p < 0.05). Even after adjustment for factors known to affect endothelial function, endothelium-dependent vasodilation was decreased in patients with exercise-induced hypertension (beta = 5.375, p = 0.02). CONCLUSION: Patients with exercise-induced hypertension have impaired endothelium-dependent vasodilation. This study also supports the concept that endothelial dysfunction may play an important role in exercise-induced hypertension.     

Effect of an eHealth intervention on older adults’ quality of life and health-related outcomes: a randomized clinical trial

BackgroundBy 2030, the number of US adults age ≥65 will exceed 70 million. Their quality of life has been declared a national priority by the US government.ObjectiveAssess effects of an eHealth intervention for older adults on quality of life, independence, and related outcomes.DesignMulti-site, 2-arm (1:1), non-blinded randomized clinical trial. Recruitment November 2013 to May 2015; data collection through November 2016.SettingThree Wisconsin communities (urban, suburban, and rural).ParticipantsPurposive community-based sample, 390 adults age ≥65 with health challenges. Exclusions: long-term care, inability to get out of bed/chair unassisted.InterventionAccess (vs. no access) to interactive website (ElderTree) designed to improve quality of life, social connection, and independence.MeasuresPrimary outcome: quality of life (PROMIS Global Health). Secondary: independence (Instrumental Activities of Daily Living); social support (MOS Social Support); depression (Patient Health Questionnaire-8); falls prevention (Falls Behavioral Scale). Moderation: healthcare use (Medical Services Utilization). Both groups completed all measures at baseline, 6, and 12 months.ResultsThree hundred ten participants (79%) completed the 12-month survey. There were no main effects of ElderTree over time. Moderation analyses indicated that among participants with high primary care use, ElderTree (vs. control) led to better trajectories for mental quality of life (OR=0.32, 95% CI 0.10–0.54, P=0.005), social support received (OR=0.17, 95% CI 0.05–0.29, P=0.007), social support provided (OR=0.29, 95% CI 0.13–0.45, P<0.001), and depression (OR= −0.20, 95% CI −0.39 to −0.01, P=0.034). Supplemental analyses suggested ElderTree may be more effective among people with multiple (vs. 0 or 1) chronic conditions.LimitationsOnce randomized, participants were not blind to the condition; self-reports may be subject to memory bias.ConclusionInterventions like ET may help improve quality of life and socio-emotional outcomes among older adults with more illness burden. Our next study focuses on this population.Trial RegistrationClinicalTrials.gov; registration ID number: {"type":"clinical-trial","attrs":{"text":"NCT02128789","term_id":"NCT02128789"}}NCT02128789Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-06888-1.Key Words: older adults, eHealth, telemedicine, quality of life, depression     

Comparing two-stent strategies for bifurcation coronary lesions: which vessel should be stented first, the main vessel or the side branch?

This study compared two-stent strategies for treatment of bifurcation lesions by stenting order, 'main across side first (A-family)' vs 'side branch first (S-family). The study population was patients from 16 centers in Korea who underwent drug eluting stent implantation with two-stent strategy (A-family:109, S-family:140 patients). The endpoints were cardiac death, myocardial infarction (MI), stent thrombosis (ST), and target lesion revascularization (TLR) during 3 years. During 440.8 person-years (median 20.2 months), there was 1 cardiac death, 4 MIs (including 2 STs), and 12 TLRs. Cumulative incidence of cardiac death, MI and ST was lower in A-family (0% in A-family vs 4.9% in S-family, P = 0.045). However, TLR rates were not different between the two groups (7.1% vs 6.2%, P = 0.682). Final kissing inflation (FKI) was a predictor of the hard-endpoint (hazard ratio 0.061; 95% CI 0.007-0.547, P = 0.013), but was not a predictor of TLR. The incidence of hard-endpoint of S-family with FKI was comparable to A-family, whereas S-family without FKI showed the poorest prognosis (1.1% vs 15.9%, retrospectively; P = 0.011). In conclusion, 'A-family' seems preferable to 'S-family' if both approaches are feasible. When two-stent strategy is used, every effort should be made to perform FKI, especially in 'S-family'.     

Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes

Patients still present with drug-eluting stent (DES) failure despite an angiographically successful implantation. The aim of the present study was to investigate the relation between the fractional flow reserve (FFR) measured after DES implantation and the clinical outcomes at 1 year. A total of 80 patients (mean age 62 years, 74% men, 99 DESs) underwent coronary pressure measurement at maximum hyperemia after successful DES implantation. The composite of major adverse cardiac events (MACE), including death, myocardial infarction, and ischemia-driven target vessel revascularization was evaluated at 1 year. The patients were divided into 2 groups (low-FFR group, FFR ≤0.90 and high-FFR group, FFR >0.90) according to the median FFR. The mean poststent percent diameter stenosis was 11 ± 5% in the low-FFR group and 12 ± 3% in the high-FFR group (p = 0.31). Left anterior descending coronary artery lesions were more frequent in the low-FFR group than in the high-FFR group (82% vs 55%, p = 0.02). The mean stent length was greater in the low-FFR group than in the high-FFR group (38 ± 18 vs 28 ± 13 mm, p = 0.01). Six cases (7.5%) of MACE occurred during the 1-year follow-up. The rate of MACE was 12.5% in the low-FFR group and 2.5% in the high-FFR group (p <0.01). Receiver operating characteristic curves revealed 0.90 as the best cutoff of FFR after DES implantation for the prediction of 1-year MACE. In conclusion, a poststent FFR of ≤0.90 correlated with a greater adverse event rate at 1 year.     

Efficacy and safety profiles of a new S(-)-amlodipine nicotinate formulation versus racemic amlodipine besylate in adult Korean patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, phase III, noninferiority clinical trial

BACKGROUND: "Chiral switching" from an existing racemate to a pure enantiomeric compound is a popular theme in drug development, especially when the enantiomer is found to have better efficacy and safety profiles. Amlodipine is a racemic mixture, composed of the S(-)-enantiomer, which is the pharmacologically active isomer, and the R(+)-enantiomer, which is 1000-fold less active. S(-)-amlodipine nicotinate, a chirally switched form of amlodipine nicotinate, has been developed and found to be bioequivalent to amlodipine besylate in Phase I clinical trials in Korea. OBJECTIVE: The aim of this study was to compare the efficacy and safety profiles of S(-)-amlodipine nicotinate with those of amlodipine besylate in adult Korean patients with mild to moderate hypertension (diastolic blood pressure [DBP] >or=90 mm Hg and or=90 and or=90 mm Hg). The primary end point was noninferiority of the difference in mean SiDBP from baseline to week 8 for S(-)-amlodipine nicotinate compared with amlodipine besylate. Secondary end points were as follows: (1) noninferiority of the difference in mean sitting systolic blood pressure (SiSBP) from baseline to week 8 between the study groups; and (2) SiDBP response rate (defined as the proportion of patients whose SiDBP was <90 mm Hg or whose SiDBP reduction was >or=10 mm Hg from baseline) after the 8-week treatment. Also, the incidence and severity of adverse events (AEs) and adverse drug reactions (ADRs) were reported. Severe AEs/ADRs were defined as those associated with any of the following: death; an event associated with a high risk of mortality; an event requiring hospitalization; or development of a permanent disability or congenital malformation. RESULTS: One hundred fifty-seven patients were assessed for inclusion in the study. Of these, 124 patients were randomly allocated to receive S(-)-amlodipine nicotinate (42 men, 21 women; mean [SD] age, 52.4 [10.3] years [range, 23-70 years]; weight, 67.7 [10.8] kg [range, 44-92 kg]) or amlodipine besylate (45 men, 16 women; mean [SD] age, 54.5 [10.0] years [range, 30-73]; weight, 68.9 [9.8] kg [range, 49-95 kg]). One hundred sixteen patients completed the study, but 11 patients (8.9%) were dropped from the per-protocol analysis due to violations; therefore, 105 patients were included in the modified intent-to-treat population analysis (S[-]-amlodipine nicotinate, 55 patients; amlodipine besylate, 50 patients). There were no significant between-group differences in the baseline characteristics. Baseline mean (SD) SiSBP and SiDBP were 142.6 (11.3) and 94.9 (4.8) mm Hg in the S(-)-amlodipine nicotinate group, and 141.8 (8.3) and 96.1 (4.9) mm Hg in the amlodipine besylate group. Mean (SD) changes in SiSBP were 17.6 (11.2) mm Hg in the S(-)-amlodipine nicotinate group and 18.6 (12.3) mm Hg in the amlodipine besylate group. The SiDBP response rates were 92.7% in the S(-)-amlodipine nicotinate group and 88.0% in the amlodipine besylate group. There were no significant between-group differences in the prevalence of AEs and ADRs. In the S(-)-amlodipine nicotinate group, 15 patients (23.8%) reported a total of 28 AEs, and 19 patients (31.1%) reported a total of 27 AEs in the amlodipine besylate group. Six patients (9.5%) in the S(-)-amlodipine nicotinate group and 7 patients (11.4%) in the amlodipine besylate group experienced a total of 19 ADRs (11 and 8, respectively). The most common ADRs were liver enzyme elevation (3/63 [4.8%]) in the S(-)-amlodipine nicotinate group and facial flushing (3/61 [4.9%]) in the amlodipine besylate group. No cases of severe AEs or ADRs were reported in either group. CONCLUSIONS: The reduction of SiDBP after 8 weeks of treatment with S(-)-amlodipine nicotinate was noninferior compared with that of racemic amlodipine besylate in these adult Korean patients with mild to moderate hypertension. The SiDBP response rate and the reduction of SiSBP after 8 weeks of treatment with S(-)-amlodipine nicotinate were not significantly different from those with racemic amlodipine besylate. Both treatments were generally well tolerated.     

Effects of a psychoeducational intervention for secondary prevention in Korean patients with coronary artery disease: A pilot study

This intervention study was designed to examine whether a 12‐week psychoeducational intervention influenced recurrent cardiac events, symptom experience and treatment adherence of patients with coronary artery disease. Fifty‐eight patients were randomized to either the intervention or the control group. Measures were taken at baseline, after intervention, and at 6‐month follow‐up. Recurrent cardiac events included revascularization, rehospitalization, emergency room visits and mortality. Symptom experiences were measured using the Seattle Angina Questionnaire‐Korean and Hospital Anxiety and Depression Scale. Treatment adherence included health behaviours, routine check‐up and medication adherence. At 6‐month follow‐up, the intervention group had significantly better physical functions and lower anxiety and depressive symptoms. Treatment adherence was also significantly higher in the intervention group than the control group. No significant difference was noticed in the incidence of recurrent cardiac events between the groups. A longer follow‐up study is needed to determine the long‐term effects on the prevention of recurrent cardiac events.