A Prospective Noninterventional, Observational Study to Describe the Effectiveness and Safety of Trandolapril and Verapamil Single-Pill Combination in the Management of Patients with Hypertension and Type 2 Diabetes Mellitus: A Harvest TR Study.

Maintaining regular blood pressure control usually requires multidrug regimens rather than monotherapy. The objective of this study was to describe the effectiveness and safety of an angiotensin-converting enzyme inhibitor and a nondihydropyridine calcium channel blocker in a single-tablet combination in patients with hypertension, a heart rate higher than 70 beats/min, and type 2 diabetes mellitus (T2DM). This study was conducted in Turkey as a prospective, noninterventional, observational study. At 22 clinical sites, the data of 200 patients with hypertension were used for efficacy analysis; however, 262 patients received at least one dose of trandolapril/verapamil fixed-dose combination at two dose strengths. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, PR interval, glycated haemoglobin (HbA1c), and albumin/creatinine ratios were recorded during 8 weeks of treatment. With treatment, the mean (±SD) SBP that was recorded as 162.8 (±14.642) mm Hg at baseline was reduced to 131.7 ± 11.1 mm Hg at week 8 (p < 0.05). Similarly, the mean DBP was reduced from 93.76 ± 9.16 mm Hg to 77.6 ± 7.6 mm Hg (p < 0.001). Following 8 weeks of treatment, SBP and DBP values were reduced below 140 mm Hg and 90 mm Hg in most patients (81.5%), respectively. The mean heart rate as evaluated using electrocardiography measurements was reduced to 78.25 beats/min at week 8 as compared with baseline during trandolapril/verapamil single-pill combination treatment (p < 0.001). Treatment with trandolapril and verapamil was well tolerated over 8 weeks with no unexpected safety signals. In conclusion, the single-pill combination of trandolapril and verapamil was considered effective in reducing and controlling blood pressure in patients with hypertension and T2DM. There was a significant improvement in HbA1c and ACR levels in a smaller subgroup of the patient cohort. The trandolapril/verapamil combination was evaluated as being safe and well-tolerated following a treatment period of 8 weeks. This trial was registered with NCT02298556.

Coronary anatomy, anatomic variations and anomalies: a retrospective coronary angiography study.

INTRODUCTION: The incidence of coronary artery anomalies (CAAs) varies from 0.2% to 8.4%. Knowledge of such anatomical variations is important as coronary procedures are regularly performed these days. We aimed to find the coronary dominance pattern, intermediate artery (IMA) frequency and CAA incidence in our clinic, and compare them to those in the literature. METHODS: The medical reports of 5,548 patients who had undergone coronary angiography (CAG) between 2005 and 2009 were retrospectively investigated. Dominance pattern and presence of IMA and CAA were recorded. CAAs were described using two different classifications: Angelini and Khatami's classification, and a new modified classification that was derived from Angelini and Khatami's classification. Some procedural details and clinical features of the patients with CAA were also investigated. RESULTS: Coronary dominance pattern was: 81.6% right coronary artery, 12.2% circumflex artery and 6.2% co-dominant. IMA was present in 613 (11.0%) patients. The incidences of overall anomaly were 2.7% and 1.4%, according to the different classifications. Absent left main coronary artery, which was the most common anomaly in the present study, was found in 51 (0.9%) patients. Incidences of myocardial bridge, coronary arteriovenous fistulae and aneurysms were 1.1%, 0.2% and 0.3%, respectively. CONCLUSION: CAAs are generally asymptomatic, isolated lesions. Some may lead to anginal symptoms, myocardial infarction or sudden death. We found that CAA was associated with increased radiation and contrast exposure in patients who underwent CAG. This risk could be reduced if appropriate catheters were designed and training programmes on ostial cannulation were developed.

Effects of Paclitaxel and Carboplatin combination on mechanical myocardial and microvascular functions: a transthoracic Doppler echocardiography and two-dimensional strain imaging study.

AIM: Paclitaxel and carboplatin are frequently used chemotherapy drugs in the treatment of gynecologic malignancies. Little is known about their effects on left ventricular mechanical and coronary microvascular functions. METHODS: Thirty consecutive patients were prospectively enrolled. Patients underwent transthoracic echocardiography (TTE) before and after chemotherapy, to evaluate left ventricular mechanical functions and coronary flow reserve (CFR). A comprehensive TTE, tissue Doppler and two-dimensional (2D) strain imaging were performed and coronary flow velocity was measured at baseline and after dipyridamole infusion. CFR was calculated as the ratio of hyperemic to baseline diastolic peak flow velocities. Mitral annular velocities by tissue Doppler, peak strain, and systolic strain rate by velocity vector imaging (VVI) were measured. Baseline measurements were compared with healthy controls (n = 26). RESULTS: No patient developed heart failure (HF) symptoms, no significant change occurred in left ventricular ejection fraction or cardiac output and no significant difference was observed in CFR after chemotherapy. Baseline mean longitudinal peak strain and systolic stain rate were similar between patients and controls: -17.5 ± 2.6% versus -17.6 ± 2.2% (P = NS) and -1.04 ± 0.14/sec versus -1.05 ± 0.12/sec (P = NS). Peak strain and systolic strain rate decreased significantly after chemotherapy (from -17.5 ± 2.6% to -16.2 ± 2.5%, P < 0.02; and from -1.05 ± 0.12/sec to -0.96 ± 0.11/sec, P = 0.01, respectively). However, mean longitudinal velocity did not change significantly. CONCLUSION: Paclitaxel and carboplatin combination did not impair CFR; however, this chemotherapy combination could induce subtle impairment in myocardial mechanical function which can be detected by advanced deformation imaging techniques rather than by tissue Doppler imaging or conventional 2D and Doppler echocardiography.

Could plasma asymmetric dimethylarginine level be a novel predictor beyond the classic predictors of stent restenosis?

OBJECTIVE: The aim of this study was to investigate the factors associated with coronary stent restenosis and if there is an association between plasma asymmetric dimethylarginine (ADMA) levels and stent restenosis. METHODS: Ninety-one patients, who had a history of coronary bare metal stent implantation due to any cause in the last one year period, were admitted to this observational cross-sectional study. Coronary angiography was performed to all patients and quantitative angiography was used to determine the presence of stent restenosis. Laboratory parameters and angiographic features that contribute to stent restenosis were evaluated. Plasma ADMA levels were measured by using high performance liquid chromatography. Logistic regression analysis was used to determine the independent factors of stent restenosis. RESULTS: Angiographic restenosis was found in 35 patients (38.5%). Stent diameter (p=0.038) and left ventricular ejection fraction (p=0.023) were lower and stent implantation history due to acute coronary syndrome (p=0.029), plasma ADMA level (5.0±1.8x10-4 mmol/L vs. 3.9±1.0x10-4 mmol/L, p=0.001), C-reactive protein concentration (p=0.016), white blood cell count (p=0.044) and stent length (p=0.005) were higher in patients with restenosis. Plasma ADMA level (ß=0.536; OR: 1.710; CI: 1.022-2.861; p=0.041), C-reactive protein concentration (ß=0.062; OR: 1.064; CI: 1.003-1.129; p=0.041), stent diameter (ß=-3.047; OR: 0.048; CI: 0.007-0.313; p=0.002) and length (ß=0.165; OR: 1.179; CI: 1.036-1.343; p=0.013) were found to be the independent predictors of stent restenosis in logistic regression analysis. CONCLUSION: We conclude that plasma ADMA levels may be used as a novel marker for stent restenosis beyond the classic stent restenosis markers.

Use of alpha-lipoic acid in prevention of contrast-induced nephropathy in diabetic patients.

In this prospective study, we aimed to determine the protective antioxidant role of alpha-lipoic acid (ALA) on development of contrast-induced nephropathy (CIN) in diabetic patients undergoing coronary angiography. Seventy-eight diabetic patients undergoing coronary angiography were included. Thirty-nine patients were randomized to control group and 39 patients to ALA group. Both groups were hydrated on the day of angiography, and the ALA group had also received three doses of "Thioctacid 600 mg HR, MEDA Manufacturing GmbH" in pill form. Serum creatinine clearance, cystatin C, and urinary neutrophil gelatinase-associated lipocalin (NGAL) were studied before and after angiography. We defined CIN as either ≥25% or ≥0.5 mg/dL increase in serum creatinine at 48th hour after angiography. Baseline clinical characteristics were similar in both groups. Mehran risk score and creatinine clearance were comparable in control and therapy groups (5.59 ± 1.96 vs. 5.49 ± 1.73, p = 0.54 and 89 ± 21 vs. 96 ± 24, p = 0.13, respectively). The volumes of contrast media (median values of 80 mL vs. 75 mL) and hydration with saline (2862 ± 447 mL vs. 2637 ± 592 mL) were also similar (p > 0.05). The incidence of CIN was the same (8%) in both the groups. Alterations in serum creatinine, cystatin C, and urinary NGAL levels before and after the procedure were comparable between the ALA and control groups (group p-values were >0.05 in two-way repeated measures analysis of variance). We presented for the first time that ALA therapy added to hydration does not decrease the risk of CIN development in diabetic patients undergoing coronary angiography.

Renal transplant improves pulmonary hypertension in patients with end stage renal disease.

BACKGROUND: Pulmonary hypertension (PH) is present in a significant proportion of patients with end stage renal disease (ESRD) and is of prognostic importance. Data on the effect of renal transplant on PH is very limited. In this study, the aim was to examine the effect of renal transplant on systolic pulmonary artery pressure (SPAP) determined by Doppler echocardiography. METHODS: Analysis was performed on the records of 500 consecutive patients who underwent renal transplant at our center between the years 1999 to 2008. The prevalence of PH in the preoperative assessment period was established. Patients were diagnosed as having PH when measured SPAP values were > 35 mm Hg. RESULTS: Pulmonary hypertension was detected in 85 of the 500 (17%) patients under pre-transplant evaluation. At post-transplant follow up Doppler echocardiographic examination was performed on 50 of the 85 patients. After exclusion of 8 cases (1 due to massive pulmonary thromboemboli; 7 due to graft failure requiring dialysis therapy) analyses were performed on 42 patients who had undergone both pre- and post-transplant echocardiographic examination. Mean SPAP at pre-transplant evaluation was 45.9 ± 8.8 mm Hg and in 6 (14.3%) cases SPAP was above 50 mm Hg.Compared to pre-transplant values, a significant decrease was observed in mean SPAP values in an average of 53 months of postoperative follow up (41.8 ± 7.4 mm Hg vs. 45.9 ± 8.8 mm Hg, p < 0.0001). CONCLUSION: These findings indicate that patients with ESRD accompanied by PH may benefit from renal transplant. Further research is required for more concrete conclusions to be drawn on this subject.