Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and ...could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.
The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300–600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.
Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio OR 0·97, 95% CI 0·80–1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 11% of 941 patients in the ticagrelor group vs 71 8% of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12–2·11; p=0·0070).
Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.
ACTION Study Group and AstraZeneca.
Percutaneous pedicle screw fixations (PPSF) are increasingly used in spine surgery, minimizing morbidity through less muscle breakdown but at the cost of intraoperative fluoroscopic guidance that ...generates high radiation exposure. Few studies have been conducted to measure them accurately.
The objective of our study is to quantify, during a PPSF carried out in different experimented centers respecting current radiation protection recommendations, this irradiation at the level of the surgeon and the patient. We have prospectively included 100 FPVP procedures for which we have collected radiation doses from the main operator. For each procedure, the doses of whole-body radiation, lens and extremities were measured.
Our results show a mean whole body, extremity and lens exposure dose per procedure reaching 1.7±2.8μSv, 204.7±260.9μSv and 30.5±25.9μSv, respectively. According to these values, the exposure of the surgeon's extremities and lens will exceed the annual limit allowed by the International Commission on Radiological Protection (ICRP) after 2440 and 4840 procedures respectively.
Recent European guidelines will reduce the maximum annual exposure dose from 150 to 20mSv. The number of surgical procedures to not reach the eye threshold, according to our results, should not exceed 645 procedures per year. Pending the democratization of neuronavigation systems, the use of conventional fluoroscopy exposes the eyes in the first place. Therefore they must be protected by leaded glasses.
IV, case series.
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