scholarly journals The long-term efficacy and safety of combining ablation and left atrial appendage closure: A systematic review and meta-analysis

Author(s):  
Feng Li ◽  
Jin-Yu Sun ◽  
Li-Da Wu ◽  
Jian-feng Hao ◽  
Ru-Xing Wang

Backgroud The long-term outcomes of this combined procedure remain elusive. This meta-analysis aimed to assess the long-term efficacy and safety of combined procedure. Methods PubMed, Embase, Cochrane Library, and Web of Science were systematically searched from the establishment of databases to 1 January 2021. Studies on the long-term (defined as a mean follow-up of approximately 12 months or longer) efficacy and safety outcomes of combined ablation and LAAC were included for meta-analysis. Results A total of 16 studies comprising 1,428 patients were included in the meta-analysis. The pooled long term freedom rate from atrial arrhythmia was 0.66 (95% confidence interval [CI], 0.59-0.71), long-term successful rate sealing of LAAC was 1.00 (95% CI, 1.00-1.00), and ischemic stroke/transient ischemic attack/systemic embolism during follow-up was 0.01 (95% CI, 0.00-0.02). Meanwhile, the rates of peri-procedural adverse events included phrenic nerve palsy, intracoronary air embolus, device embolization, peri-procedural death of 0.00 (95% CI, 0.00-0.00), procedure-related bleeding events of 0.03 (95% CI, 0.02-0.04), and pericardial effusion requiring or not requiring intervention of 0.00 (95% CI, 0.00-0.01). Moreover, the rates of long-term adverse events rate included device dislocation, intracranial bleeding, and pericardial effusion requiring or not requiring intervention, and all-cause mortality of 0.00 (95% CI, 0.00-0.00), device embolization of 0.01 (95% CI, 0.00-0.01), and other bleeding events of 0.01 (95% CI, 0.00-0.03). Conclusion This meta-analysis suggests that the strategy of combined atrial ablation and LAAC is effective and safe during long-term follow-up

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
B Lattuca ◽  
X Odorico ◽  
B.V Occean ◽  
L Cornillet ◽  
L Schmutz ◽  
...  

Abstract Background Recent trials have demonstrated that short-term efficacy and safety of ultrathin strut drug-eluting stents (DES) were non-inferior to contemporary stents but long-term benefit remains uncertain. Purpose The main objective of this meta-analysis was to evaluate efficacy and safety of ultrathin strut DES with an extended follow-up in comparison to 2nd and 3rd generations DES. Methods A double-blind review of randomized controlled trials (RCT) comparing ultrathin strut DES to contemporary DES was performed from MEDLINE and CENTRAL databases and from cardiological congresses. The primary efficacy endpoint was target vessel failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) and the primary safety endpoint was occurrence of stent thrombosis (ST). Short (1 year) and long term (≥2 years) effects were estimated separately. This analysis was pre-specified in PROSPERO (CRD42019142206). Results The meta-analysis included 13 RCT including 19,490 patients. In short term, we found TLF decrease with ultrathin strut DES (RR 0.85, CI [0.75–0.97], p=0.01), driven by lower TV-MI (RR 0.83, CI [0.66–1.03], p=0.1) and TLR (RR 0.77, CI [0.58–1.01], p=0.1) rates, and a non-significant downward trend in ST (RR 0.85 CI [0.64–1.14]). In long term, from the 5 trials with extended follow-up, there was no significant difference between ultrathin strut DES and thicker strut stents in rate of TLF at the longest available follow-up (RR 0.90, CI [0.76–1.06], p=0.2), despite a numerically reduction of TV-MI (RR 0.81, CI [0.61–1.08], p=0.05) and TLR (RR 0.85, CI [0.69–1.04], p=0.1) in favor of ultrathin strut stents. However, we observed a persistent numerically reduction in ST (RR 0.79, CI [0.61–1.02], p=0.01). Conclusion Ultrathin strut DES was associated with a lower target lesion failure rate at one year but not beyond 2-years follow-up. Nevertheless, the safety of the ultrathin strut stents was sustained over time with a numerically reduction of ST. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1780.1-1781
Author(s):  
E. Alexeeva ◽  
E. Krekhova ◽  
T. Dvoryakovskaya ◽  
K. Isaeva ◽  
A. Chomakhidze ◽  
...  

Background:Results from various phase 3 clinical studies have demonstrated the efficacy of canakinumab to treat patients with systemic juvenile idiopathic arthirtis (sJIA). However, limited information is available on the long-term efficacy and safety of this drug to treat children with sJIA.Objectives:To evaluate the long-term efficacy and safety of canakinumab in patients with sJIA treated at the National Medical Research Center of Children`s health, Moscow, Russia.Methods:This was a prospective, single-center study that included canakinumab (CAN)-naive patients diagnosed with sJIA following the International League of Associations for Rheumatology (ILAR) criteria and start receiving CAN treatment from 10/2012 to 03/2016. Patients included in this study also participated, for defined periods of time, in the clinical trialNCT02296424. Patients with active disease started treatment with canakinumab 4 mg/kg. A treat-to-target approach was used, canakinumab was discontinued in patients on clinical remission, either following theNCT02296424protocol or by investigator’s decision, and re-introduced in those patients who experienced a relapse afterwards. Disease characteristics and demographics were recorded at the time of diagnosis and initiation of treatment (study entry). Disease activity was evaluated periodically using the adaptedJIAACR core set measures, and percentages of patients with inactive disease and on clinical remission were calculated using the sJIA ACR criteria. Response to treatment was also evaluated by calculating modified ACR responses and JADAS-71 scores. Safety was assessed by collecting and classifying adverse events (AEs) at each visit.Results:Nineteen patients presenting with sJIA were included in this study, with a median age at treatment initiation of 9.6 (interquartile range, IQR 6.4-11.1) years and a median disease duration of 4.4 (IQR 1.2-7.0) years. Most patients (17/19) had been treated previously with one or more biologic agents for sJIA. As of 23 December of 2019, the median time of follow up was 55.5 (47-71.7) months, with all patients being followed for at least 3.5 years and 5 patients followed for more than 7 years. As it is shown in figure 1, most patients (16/19) were on clinical remission one year after starting therapy, and this effect was sustained at year 3.5 (17/19). ACR 90 responses were observed in 84.2% (16/19) patients at one year and 94.7% (18/19) patients at 3.5 years, whereas JADAS-71 scores decreased from 15 (14: 28.5) at baseline to 0 (0: 0) at one year with 4/19 patients maintained with JADAS-71 >0); at 3.5 years, only one patient had JADAS-71>0 (0.47, due to slight ESR increasing). Concerning the 5 patients with >7 years of follow up, three of them were in clinical remission for more than 3 years, including one who had discontinued therapy more than 2 years. Another patient had a relapse after attempting drug discontinuation, but recovered clinical remission after reintroducing canakinumab, and remained in this state for the last two years. The remaining patient has persistent low levels of disease activity during the last four years of follow up. AEs required hospitalization were reported in 36.8% (7/19) patients.Conclusion:Sustained clinical remission was observed in most patients with sJIA treated with canakinumab for up to 7 years, with no new or unexpected adverse events reported.Disclosure of Interests:Ekaterina Alexeeva Grant/research support from: Roche, Pfizer, Centocor, Novartis, Speakers bureau: Roche, Novartis, Pfizer., Elizaveta Krekhova: None declared, Tatyana Dvoryakovskaya: None declared, Ksenia Isaeva: None declared, Aleksandra Chomakhidze: None declared, Evgeniya Chistyakova: None declared, Olga Lomakina: None declared, Rina Denisova: None declared, Anna Mamutova: None declared, Anna Fetisova: None declared, Marina Gautier: None declared, Dariya Vankova: None declared, Meyri Shingarova: None declared, Ivan Kriulin: None declared, Alina Alshevskaya: None declared, Andrey Moskalev: None declared


Author(s):  
Houyong Zhu ◽  
Xiaoqun Xu ◽  
Xiaojiang Fang ◽  
Fei Ying ◽  
Liuguang Song ◽  
...  

Background Long‐term antithrombotic strategies for patients with chronic coronary syndrome with high‐risk factors represent an important treatment dilemma in clinical practice. Our aim was to conduct a network meta‐analysis to evaluate the efficacy and safety of long‐term antithrombotic strategies in patients with chronic coronary syndrome. Methods and Results Four randomized studies were included (n=75167; THEMIS [Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study], COMPASS [Cardiovascular Outcomes for People Using Anticoagulation Strategies], PEGASUS‐TIMI 54 [Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54], and DAPT [Dual Anti‐platelet Therapy]). The odds ratios (ORs) and 95% CIs) were calculated as the measure of effect size. The results of the network meta‐analysis showed that, compared with aspirin monotherapy, the ORs for trial‐defined major adverse cardiovascular and cerebrovascular events were 0.86; (95% CI, 0.80–0.93) for ticagrelor plus aspirin, 0.89 (95% CI, 0.78–1.02) for rivaroxaban monotherapy, 0.74 (95% CI, 0.64–0.85) for rivaroxaban plus aspirin, and 0.72 (95% CI, 0.60,–0.86) for thienopyridine plus aspirin. Compared with aspirin monotherapy, the ORs for trial‐defined major bleeding were 2.15 (95% CI, 1.78–2.59]) for ticagrelor plus aspirin, 1.51 (95% CI, 1.23–1.85) for rivaroxaban monotherapy, and 1.68 (95% CI, 1.37–2.05) for rivaroxaban plus aspirin. For death from any cause, the improvement effect of rivaroxaban plus aspirin was detected versus aspirin monotherapy (OR, 0.76; 95% CI, 0.65–0.90), ticagrelor plus aspirin (OR, 0.79; 95% CI, 0.66–0.95), rivaroxaban monotherapy (OR, 0.82; 95% CI, 0.69–0.97), and thienopyridine plus aspirin (OR, 0.58; 95% CI, 0.41–0.82) regimens. Conclusions All antithrombotic strategies combined with aspirin significantly reduced the incidence of major adverse cardiovascular and cerebrovascular events and increased the risk of major bleeding compared with aspirin monotherapy. Considering the outcomes of all ischemic and bleeding events and all‐cause mortality, rivaroxaban plus aspirin appears to be the preferred long‐term antithrombotic regimen for patients with chronic coronary syndrome and high‐risk factors.


2020 ◽  
Vol 9 (18) ◽  
Author(s):  
Lin Yang ◽  
Quan‐Yu Zhang ◽  
Xiao‐Zeng Wang ◽  
Xin Zhao ◽  
Xuan‐Ze Liu ◽  
...  

Background Acute penetrating aortic ulcers (PAUs) are reported to dynamically evolve into different clinical outcomes ranging from regression to aortic rupture, but no practice guidelines are available in China. Methods and Results All 109 patients with acute PAUs were monitored clinically. At 30 days follow‐up, 31 patients (28.44%) suffered from aortic‐related adverse events, a composite of aortic‐related mortality, aortic dissection, or an enlarged ulcer. In addition, 7 (6.42%) patients had clinically related adverse events, including all‐cause mortality, cerebral stroke, nonfatal myocardial infarction, acute heart failure alone or acute exacerbation of chronic heart failure, acute renal failure, arrhythmia, and bleeding events. In the present study, the intervention criteria for the Chinese PAU population included a PAU diameter of 12.5 mm and depth of 9.5 mm. The multivariate analysis showed that an ulcer diameter >12.5 mm (hazard ratio [HR], 3.846; 95% CI, 1.561–9.476; P =0.003) and an ulcer depth >9.5 mm (HR, 3.359; 95% CI, 1.505–7.494; P =0.003) were each independent predictors of aortic‐related events. Conclusions Patients with acute PAUs were at high risk for aortic‐related adverse events and clinically related adverse events within 30 days after onset. Patients with an ulcer diameter >12.5 mm or an ulcer depth >9.5 mm have a higher risk for disease progression, and early intervention may be recommended.


2019 ◽  
Vol 20 (6) ◽  
pp. 151-155
Author(s):  
Juan Tiraboschi ◽  
Natalia Lattour ◽  
Hernando Knobel ◽  
Pere Domingo ◽  
Esteve Ribera ◽  
...  

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