Background Ticagrelor has a Class I recommendation for use following percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS). However, ticagrelor needs to be taken twice a day, as compared to clopidogrel. Its adverse effects, such as dyspnea or bleeding, are known to be more common than with clopidogrel. Dyspnea may tend to be uncomfortable and limit activity. Major bleeding often leads to hospitalization or transfusions, and frequent minor bleeding, which might not result in patients seeking medical care, can make ACS patients feel unhealthy. Thus, these characteristics may affect the health-related quality of life (HQOL). Methods In the PLEIO (comParison of ticagreLor and clopidogrEl on mIcrocirculation in patients with acute cOronary syndrome) trial, we randomized 120 participants to receive ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for at least 12 months. We carried out an HQOL assessment with the Short Form 36 Health Survey (SF-36) questionnaire on the day of discharge following PCI, as well as six months later. Results At discharge, the HQOL measures were similar in the ticagrelor and clopidogrel groups, both having a physical component summary (PCS) and a mental component summary (MCS) score. A six-month HQOL follow-up assessment showed that there were no differences between the two study groups in either the PCS or the MCS scores. In both groups, the PCS scores significantly increased over six months of treatment (both p < 0.01). However, the MCS score did not differ significantly. A baseline MCS score is an independent predictor of better physical and mental health status at six months. Conclusions Ticagrelor, as compared to clopidogrel, did not significantly reduce the HQOL during the six months following PCI in patients with ACS. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02618733.
Background This study investigated whether the microvascular dysfunction differed between culprit and non‐culprit vessels in patients with acute coronary syndrome who underwent percutaneous coronary intervention. Methods and Results In 115 prospectively recruited patients, after successful percutaneous coronary intervention, culprit and non‐culprit intracoronary hemodynamic measurements were performed and repeated at 6‐month follow‐up. 13 N‐ammonia positron emission tomography was performed at 6‐month follow‐up visit to determine absolute myocardial blood flow. The resistance values of each vessel were calculated using the coronary pressure data and the myocardial blood flow values obtained from 13 N‐ammonia positron emission tomography data. We compared the measurements between culprit and non‐culprit vessels and assessed changes in microvascular dysfunction during the study period. In 334 vessels (115 culprit and 219 non‐culprit), the culprit vessel group showed a lower fractional flow reserve and coronary flow reserve than the non‐culprit vessel group at baseline and 6‐month follow‐up, respectively. The value of index of microcirculatory resistance was different between the 2 groups in the baseline but not at 6‐month follow‐up. The microvascular resistance at rest and hyperemic microvascular resistance were not different between the 2 groups, but resistance to stenosis was higher in the culprit vessel group, under both resting and hyperemic status ( P =0.02 and P <0.01, respectively). In the culprit vessel analysis, the fractional flow reserve and index of microcirculatory resistance decreased whereas coronary flow reserve increased ( P <0.01 for all) at 6‐month follow‐up. However, there was no change in index of microcirculatory resistance, coronary flow reserve, and fractional flow reserve from baseline to 6‐month follow‐up in the non‐culprit vessel analysis. Conclusions The observed microvascular dysfunction in acute coronary syndrome is limited to the culprit vessel territory in the acute phase, which is relatively recovered in the chronic phase and there is no out‐of‐culprit territory involvement. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04169516.
In recent years, IT organizations are in the process of introducing IT Governance as the concept and measure of transparency, accountability and effectiveness of IT activities and control for managing governance processes. In this paper, the influential factors for IT organizations to adopt COBIT(The Control Objectives for Information and related Technology) which is a typical framework for effective IT Governance execution were classified and analyzed empirically into internal and external factors. Internal factorswere designed based on influential factors in the theory of innovation diffusion, and external factors were designed based on influential factors from outside certification which were absent in COBIT and expertise support from the outside. The result of this study showed that understandability, transition and effectiveness which were internal factors had no effect on COBIT introduction, and only expertise support among certification and expertise support which were external factors had significant effects. This result shows that there are lack of COBIT supports and introduction in internal IT organizations. It is expected that the result of this study will allow strategic approach of COBIT adoption in future by verifying influential factors of COBIT introduction within IT organizations.
Background East Asians treated with potent P2Y12 inhibitors (prasugrel or ticagrelor) are exposed to more potent platelet inhibitory response. Whether half-dose de-escalation strategy would be benefit for chronic antiplatelet strategy in East Asian patients with acute coronary syndrome (ACS) remain uncertain. Method In half-dose de-escalation strategy, 129 Korean ACS patients were assigned to receive standard-dose potent P2Y12 inhibitors (n=86, prasugrel [n=38], ticagrelor [n=48]), followed by half-dose reduction at 1 month for maintenance, and was compared to clopidogrel (n=43) as control. The primary safety outcome was any clinically significant bleeding according to BARC (Bleeding Academic Research Consortium) criteria at 12 months. The pharmacodynamic response is accessed by VerifyNow P2Y12 reaction unit (PRU) at 1 month and 3 months post PCI. Results Ticagrelor achieved significantly lower PRU (7 [4–32] vs. 11 [5–76] vs. 167 [97–212]) than prasugrel and clopidogrel, resulting OPR rate 0% vs. 21.6% vs. 58.5%, respectively at 1 month post PCI. Similar results were observed at 3 months (PRU 12 [6–43] in ticagrelor vs. 88 [58–148] in prasugrel vs. 169 [107–199] in clopidogrel), with OPR rate 7.1% vs. 51.5% vs. 65.9%, respectively. At 12 months, the incidence of BARC type-1 or -2 bleeding was significantly higher in potent P2Y12 inhibitors (37.5% in ticagrelor, 34.2% in prasugrel) than in clopidogrel (36.0 vs. 14.0%; HR, 2.86; 95% CI, 1.19–6.87; p=0.018). Conclusion In Korean ACS patients, pharmacodynamic response (OPR rate) with half-dose prasugrel appears comparable to that with clopidogrel, whereas ticagrelor still exhibit potent platelet inhibition either standard or half doses. De-escalation strategy with half-dose potent P2Y12 inhibitor was associated with higher incidence of clinically insignificant bleeding compared with clopidogrel. Optimal dose reduction strategies in potent P2Y12 inhibitors to balance safety and effectiveness remain uncertain, and require further studies. Pharmcodynamics to oral P2Y12 inhibitors Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): National Research Foundation of Korea
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