ABSTRACT
PURPOSE: Evaluate the safety of MynxGrip® for common femoral vein closure. METHODS AND MATERIALS: This is a multicenter, randomized, prospective study of 208 patients who were slated to undergo diagnostic/interventional procedures via femoral venous access. Patients were randomized 1:1 to receive venous hemostasis via MynxGrip® (nâ¯=â¯104) or manual compression (nâ¯=â¯104) utilizing 5, 6, and 7 Fr sheaths. Bilateral calf and thigh circumferences were measured serially. Patients were followed up through hospital discharge. There were no differences in the baseline characteristics between the two groups. RESULTS: There was no difference between the groups for venous thrombosis, (0%, pâ¯=â¯1). Overall, there was no significant change in access site calf (-0.18⯱â¯1.38â¯cm, pâ¯=â¯0.18) or thigh diameter (0.33⯱â¯2.86, pâ¯=â¯0.81). In both groups, none of the patients had major or minor vascular complications, access site infection, nerve injury, or access site bleeding requiring transfusion. The pre- to post-procedure hemoglobin drop was -0.51⯱â¯1.1 vs. -0.64⯱â¯1.3â¯g/dL, pâ¯=â¯0.59 in the manual compression group and MynxGrip® group, respectively. Time to hemostasis, was significantly lower in the MynxGrip® group compared to the manual compression group with 0.12⯱â¯0.89 vs. 7.6⯱â¯5.7â¯min, respectively (pâ¯<â¯0.001). CONCLUSIONS: The MynxGrip® extravascular sealant is safe and effective for femoral venous access site closure.
Subject(s)
Catheterization, Peripheral , Femoral Vein , Hemorrhage/prevention & control , Hemostatic Techniques/instrumentation , Vascular Closure Devices , Aged , Aged, 80 and over , Catheterization, Peripheral/adverse effects , Equipment Design , Female , Femoral Vein/diagnostic imaging , Hemorrhage/diagnosis , Hemorrhage/etiology , Hemostasis , Hemostatic Techniques/adverse effects , Humans , Male , Middle Aged , Pressure , Prospective Studies , Punctures , Time Factors , Treatment OutcomeABSTRACT
Ticagrelor, a potent platelet inhibitor, has primarily been studied in white patients. Platelet reactivity among black patients with acute coronary syndrome (ACS) on ticagrelor, however, is unknown. Our objective was to compare platelet reactivity in black versus white patients with ACS treated with ticagrelor. We conducted a prospective, pharmacodynamic study of 29 black patients with ACS treated with ticagrelor. Platelet reactivity was assessed at 1, 4, and 8 hours after a loading dose of ticagrelor 180 mg and at 30 days on a maintenance dose of ticagrelor 90 mg twice daily. Assays included light transmission aggregometry, VerifyNow P2Y12, and vasodilator-stimulated phosphoprotein. We provided comparison with a historical white cohort. Platelet reactivity among blacks with ACS on ticagrelor was similar to that in whites, except that blacks had lower values at 4 hours, 8 hours, and on maintenance therapy for light transmission aggregometry with 20 µmol/L adenosine diphosphate. Among blacks, high-on-treatment platelet reactivity for all 3 assays was uncommon at 1 hour and nonexistent at 4 hours, 8 hours, and while on maintenance therapy. Blacks preloaded with clopidogrel (n = 17) had significantly lower results of VerifyNow (64 ± 65 vs 198 ± 86, p <0.001) and vasodilator-stimulated phosphoprotein (12.8 ± 21.6 vs 58.9 ± 19.9, p <0.001) at 1 hour compared with those with no clopidogrel preload. In conclusion, among patients with ACS receiving ticagrelor, levels of platelet reactivity in blacks are similar to that in whites. This suggests that the cardiovascular benefits of ticagrelor observed in the platelet inhibition and patient outcomes (PLATO) trial are likely to be observed in blacks and whites.
Subject(s)
Acute Coronary Syndrome/drug therapy , Adenosine/analogs & derivatives , Black People , Blood Platelets/drug effects , Purinergic P2Y Receptor Antagonists/therapeutic use , White People , Adenosine/pharmacology , Adenosine/therapeutic use , Aged , Clopidogrel , Female , Humans , Male , Middle Aged , Platelet Aggregation Inhibitors/therapeutic use , Platelet Function Tests , Prospective Studies , Purinergic P2Y Receptor Antagonists/pharmacology , Ticagrelor , Ticlopidine/analogs & derivatives , Ticlopidine/therapeutic useABSTRACT
AIMS: We hypothesized that patients with a history of either alarming or nuisance bleeding events, compared to those with no history of bleeding, would have lower levels of on-treatment platelet reactivity (aspirin and a thienopyridine). METHODS AND RESULTS: In total, 42 patients with no bleeding, 34 with nuisance bleeding, and 14 with alarming bleeding underwent platelet reactivity testing 1 month to 1 year after PCI with light transmission aggregometry (LTA 5 and 20 µM adenosine disphosphate [ADP]), vasodilator stimulated phosphoprotein phosphorylation (VASP) and VerifyNow P2Y12. Clinical and demographic characteristics of the 3 groups were generally similar, except that patients with alarming bleeding were less likely to be Caucasian; only 6 patients (6.7%) were taking prasugrel. There was considerable overlap between no bleeding, nuisance bleeding and alarming bleeding groups with respect to on-treatment platelet reactivity. Furthermore, there was no difference in the median platelet reactivity values for all assays. Prevalence of high on-treatment platelet reactivity did not differ among the 3 groups; 32.6% of patients had high on-treatment platelet reactivity as measured by LTA with 5 µM ADP (P=.91); 40.0% as measured by VASP (P=.35); and 35.6% as measured by VerifyNow P2Y12 (P=.61). CONCLUSION: The use of platelet reactivity assays to identify patients on thienopyridine therapy at higher risk of bleeding is an unfounded strategy.
Subject(s)
Aspirin/adverse effects , Blood Platelets/drug effects , Hemorrhage/chemically induced , Percutaneous Coronary Intervention , Piperazines/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Purinergic P2Y Receptor Antagonists/adverse effects , Thiophenes/adverse effects , Ticlopidine/analogs & derivatives , Aged , Biomarkers/blood , Blood Platelets/metabolism , Cell Adhesion Molecules/blood , Chi-Square Distribution , Clopidogrel , Cross-Sectional Studies , Drug Therapy, Combination , Female , Humans , Male , Microfilament Proteins/blood , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Phosphoproteins/blood , Platelet Aggregation/drug effects , Platelet Function Tests , Prasugrel Hydrochloride , Predictive Value of Tests , Receptors, Purinergic P2Y12/blood , Receptors, Purinergic P2Y12/drug effects , Risk Factors , Severity of Illness Index , Ticlopidine/adverse effects , Time Factors , Treatment OutcomeABSTRACT
The National Adolescent Health and Development Strategy (2000) of Nepal considers adolescents a key target group for information and services. The extent to which sex education is being provided in schools has received little attention, however. At higher secondary level, students are supposed to be taught basic sex education using a chapter in a textbook called Health, Population and Environment. Little is known about how or how well this material is covered. In a study in 2002 among adolescents in eight schools in the Nawalparasi District in the Western Region of Nepal, we interviewed eight teachers responsible for teaching this subject. We also collected survey data from 451 students and held four focus group discussions with 26 of them. We found that adolescents in these schools did not appear to be getting the information they needed. Most of the teachers did not want to deal with sensitive topics and feared censure by their colleagues and society. Some lacked the skills to give such instruction. Many students also felt uncomfortable with the topics. The challenge is to strengthen sex education, make it more appropriate for the students and ensure that teachers are more comfortable and able to give instruction on the topic.
