An effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial).

The combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) has been demonstrated to have comparable effectiveness or better to ATRA and chemotherapy (CHT) in non-high-risk acute promyelocytic leukemia (APL). However, the efficacy of ATRA-ATO compared to ATRA-ATO plus CHT in high-risk APL remains unknown. Here we performed a randomized multi-center non-inferiority phase III study to compare the efficacy of ATRA-ATO and ATRA-ATO plus CHT in newly diagnosed all-risk APL to address this question. Patients were assigned to receive ATRA-ATO for induction, consolidation, and maintenance or ATRA-ATO plus CHT for induction followed by three cycles of consolidation therapy, and maintenance therapy with ATRA-ATO. In the non-CHT group, hydroxyurea was used to control leukocytosis. A total of 128 patients were treated. The complete remission rate was 97% in both groups. The 2-year disease-free, event-free survival rates in the non-CHT group and CHT group in all-risk patients were 98% vs 97%, and 95% vs 92%, respectively (P = 0.62 and P = 0.39, respectively). And they were 94% vs 87%, and 85% vs 78% in the high-risk patients (P = 0.52 and P = 0.44, respectively). This study demonstrated that ATRA-ATO had the same efficacy as the ATRA-ATO plus CHT in the treatment of patients with all-risk APL.

[A randomized controlled trial of rapid artificial cardiac pacing in thoracic endovascular aortic repair].

OBJECTIVE: To compare the safety, efficacy and their impact on stent graft positioning between rapid artificial cardiac pacing induced hypotension and sodium nitroprusside induced hypotension during thoracic endovascular aortic repair (TEVAR). METHODS: From September 2007 to February 2009, a randomized controlled trial as approved by the Ethics Committee of our hospital was conducted in 197 patients undergoing elective thoracic endovascular aortic repair of thoracic aortic dissection (n = 175) or aneurysm (n = 22). The patients were randomized into sodium nitroprusside group (n = 98) and rapid artificial cardiac pacing group (n = 99). During the localization and deployment of stent graft, hypotension was induced by intravenous sodium nitroprusside or rapid artificial cardiac pacing. Hemodynamics, landing precision (deviation from planned placement site), duration of procedure, renal function, neurocognitive function, incidence of endoleaks and paraplegia/hemiplegia were compared. RESULTS: Rapid artificial cardiac pacing was conducted without technical difficulty in all 99 patients. The level of hypotension (mm Hg, 1 mm Hg = 0.133 kPa) was most pronounced in the rapid artificial cardiac pacing group (47 ± 5 vs 82 ± 7, P = 0.003. Once rapid pacing ceased, blood pressure recovered more quickly to the preparing levels in the rapid artificial cardiac pacing group [(9 ± 2) s vs (481 ± 107) s, P < 0.01]. And the duration of procedure was also shorter in the rapid artificial cardiac pacing group [(94 ± 16) min vs (103 ± 24) min, P < 0.01]. Moreover, precise positioning and deployment was observed in rapid artificial cardiac pacing group versus to the sodium nitroprusside group (P < 0.01). There was no difference in renal function and neurocognitive function before and after the procedure in both groups. There was no difference in the incidences of endoleaks and paraplegia/hemiplegia between different groups (P > 0.05). CONCLUSION: As compared with sodium nitroprusside, rapid artificial cardiac pacing is safer in thoracic endovascular aortic repair. It shortens the endovascular procedure and enables more precise positioning and deployment of stent graft.

Ticagrelor and the risk of infections during hospitalization in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention.

BACKGROUND AND AIMS: Although ticagrelor exerts an antibacterial activity, its effect on infections in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) is unclear. We aimed to assess whether ticagrelor and clopidogrel affect infections in these patients during hospitalization. METHODS: A total of 2116 consecutive patients with STEMI undergoing PCI were divided into the ticagrelor (n = 388) and clopidogrel (n = 1728) groups. The primary outcome was infection onset. Secondary outcomes were in-hospital all-cause death and major adverse cardiovascular and cerebrovascular events (MACCE). Propensity score analyses were conducted to test the robustness of the results. RESULTS: Infections developed in 327 (15.4%) patients. There was no significant difference in infection between both groups (ticagrelor vs. clopidogrel: 13.1% vs. 16.0%, p = 0.164). Patients in the ticagrelor group had lower rates of in-hospital all-cause death and MACCE than patients in the clopidogrel group. Multivariate logistic regression analysis determined that ticagrelor and clopidogrel had a similar preventive effect on infections during hospitalization (adjusted odds ratio [OR] = 1.20; 95% confidence interval [CI] = 0.80-1.78, p = 0.380). Compared to the patients treated with clopidogrel, patients treated with ticagrelor had a slightly lower risk of other outcomes, but no statistical difference. Propensity score analyses demonstrated similar results for infections and other outcomes. CONCLUSIONS: Compared with clopidogrel treatment, ticagrelor treatment did not significantly alter the risk of infections during hospitalization among STEMI patients undergoing PCI, but was associated with a slightly lower risk of in-hospital all-cause death and MACCE.

Changes of cerebrospinal fluid pressure after thoracic endovascular aortic repair.

BACKGROUND: Decreasing the intracranial pressure has been advocated as one of the major protective strategies to prevent spinal cord ischemia after endovascular aortic repair. However, the actual changes of cerebrospinal fluid (CSF) pressure and its relation with spinal cord ischemia have been poorly understood. We performed CSF pressure measurements and provisional CSF withdrawal after thoracic endovascular aortic repair, and compared the changes of CSF pressure in high risk patients and in patients with new onset paraplegia and paraparesis. METHODS: Four hundred and nineteen patients were evaluated for the risk of spinal cord ischemia after thoracic endovascular aortic repair. Patients with identified risk factors before the procedure constituted group H and received prophylactic sequential CSF pressure measurement and CSF withdrawal. Patients who actually developed spinal cord ischemia constituted group P and received rescue CSF pressure measurements and CSF withdrawal. RESULTS: Among the 419 patients evaluated, 17 were graded as high risk. Four patients actually developed spinal cord ischemia after endovascular repair. The incidence of spinal cord ischemia in this investigation was 0.9%. The patients who actually developed spinal cord ischemia had no identified risk factors and had elevated CSF pressure, ranging from 15.4 to 30.0 mmHg. Six of the 17 patients graded as high risk had elevated CSF pressure: >20 mmHg in two patients and >15 mmHg in four patients. Sequential CSF pressure measurements and provisional withdrawal successfully decrease CSF pressure and prevented symptomatic spinal cord ischemia in high-risk patients. However, these measurements could only successfully reverse the neurologic deficit in two of the patients who actually developed spinal cord ischemia. CONCLUSIONS: Cerebrospinal fluid pressure was elevated in patients with spinal cord ischemia after thoracic endovascular aortic repair. Sequential measurements of CSF pressure and provisional withdrawal of CSF decreased CSF pressure effectively in high risk patients and provided effective prevention of spinal cord ischemia. Risk factor identification and prophylactic measurements play the key role in prevention of spinal cord ischemia after thoracic endovascular aortic repair.