Abstract 12022: Long-Term Clinical Outcomes of Everolimus-Eluting Stents versus Sirolimus-Eluting Stents: Systematic Review and a Meta-Analysis of 14 Randomized Control Trials, Focused on Stent Thrombosis

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
TOSHIAKI TOYOTA ◽  
Hiroki Shiomi ◽  
Takeshi Morimoto ◽  
Takeshi Kimura

Background: We sought to compare the long-term clinical outcomes between everolimus-eluting stent (EES) and sirolimus-eluting stents (SES) with a meta-analysis method. The long-term clinical outcomes, especially stent thrombosis (ST), after EES versus SES implantation has not been clearly defined among trials directly comparing the 2 types of stents. Methods: We searched PubMed, Cochrane database, and ClinicalTrials.gov. for trials comparing outcomes between EES (Xience V/Promus) and SES (Cypher select/Cypher select plus) in patients with native coronary artery disease using randomized controlled trial (RCT) design. We selected the article reporting the longest follow-up outcomes from each RCT. The outcome measure was all-cause death, myocardial infarction (MI), definite ST, and target-lesion revascularization (TLR). ST was further classified as those occurring early (<=30 days), late (30-365 days), or very late (<365 days). Results: We identified 14 RCT comparing EES and SES including 2 trials reporting the longest follow-up outcomes as a pooled analysis. We analyzed 13,434 randomly assigned patients with the weighted follow-up period of 2.1 years (Follow-up <=1-year: 7 trials, and 3191 patients; >1-year: 7 trials, and 10243 patients). EES as compared to SES was associated with significantly lower risks for overall ST, and early ST (pooled odds ratio (OR) 0.49, 95% confidence interval (CI) 0.30-0.81, P=0.01, and OR 0.42, 95% CI 0.18-0.99, P=0.046, respectively), while there was no significant difference in the risk for late ST and very late ST (OR 0.49, 95% CI 0.17-1.43, P=0.19, and OR 0.66, 95% CI 0.23-1.85, P=0.43, respectively). EES as compared to SES was also associated with significantly lower risks for TLR (OR 0.84, 95% CI 0.71-0.99, P=0.04). There was no significant difference in the risk for all-cause death, and MI between EES and SES. (OR 0.91, 95% CI 0.78-1.07, P=0.11, and OR 0.92, 95% CI 0.75-1.13, P=0.44, respectively). Conclusions: In the current meta-analysis of 14 RCT directly comparing EES with SES, implantation of EES as compared to SES implantation was associated with significantly lower risk for definite ST and TLR.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Kano ◽  
K Nasu ◽  
M Habara ◽  
T Shimura ◽  
M Yamamoto ◽  
...  

Abstract Background For recanalization of coronary chronic total occlusion (CTO) lesions, subintimal guidewire tracking in both antegrade and retrograde approaches are commonly used. Purpose This study aimed to assess the impact of subintimal tracking on long-term clinical outcomes after recanalization of CTO lesions. Methods Between January 2009 and December 2016, 474 CTO lesions (434patients) were successfully recanalized in our center. After guidewire crossing in a CTO lesion, those lesions were divided into intimal tracking group (84.6%, n=401) and subintimal tracking group (15.4%, n=73) according to intravascular ultrasound (IVUS) findings. Long-term clinical outcomes including death, target lesion revascularization (TLR), target vessel revascularization (TVR) were compared between the two groups. In addition, the rate of re-occlusion after successful revascularization was also evaluated. Results The median follow-up period was 4.7 years (interquartile range, 2.8–6.1). There was no significant difference of the rate of cardiac death between the two groups (intimal tracking vs. subintimal tracking: 7.0% vs. 4.1%; hazard ratio, 0.61; 95% confidence interval [CI], 0.19 to 2.00; p=0.41), TLR (14.3% vs. 16.2%; hazard ratio, 1.34; 95% CI, 0.71 to 2.53; p=0.37), and TVR (17.5% vs. 20.3%; hazard ratio, 1.27; 95% CI, 0.72 to 2.23; p=0.42). However, the rate of re-occlusion was significantly higher in the subintimal tracking group than intimal tracking group at 3-years re-occlusion (4.2% vs. 14.5%; log-rank test, p=0.002, Figure). In the multivariate COX regression, subintimal guidewire tracking was an independent predictor of re-occlusion after CTO recanalization (HR: 5.40; 95% CI: 2.11–13.80; p<0.001). Figure 1 Conclusions Subintimal guidewire tracking for recanalization of coronary CTO was associated with significantly higher incidence of target lesion re-occlusion during long-term follow-up period.


2021 ◽  
Vol 14 (7) ◽  
pp. 1081-1091
Author(s):  
Li Chen ◽  
◽  
Xiao Lin ◽  
Hao-Yu Li ◽  
Yi Du ◽  
...  

AIM: To update and investigate the clinical outcomes and complications between femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification cataract surgery (CPCS). METHODS: A Meta-analysis was performed using databases, including Pubmed, Embase, and the Cochrane library. At least one of the clinical outcomes and/or complications data in each included randomized controlled trials (RCT) was reported. The quality of the RCT was assessed with the Cochrane risk assessments tool. RESULTS: Overall, 25 RCTs including 3781 eyes were included. No statistically significant difference detected between FLACS and CPCS in terms of corrected distant visual acuity (CDVA), uncorrected distant visual acuity (UDVA), and central corneal thickness (CCT) at the long-term follow up, although FLACS showed better CDVA at 1wk postoperatively, and less increase in CCT at 1d and 1wk. FLACS had better postoperative endothelial cell count (ECC) at 1 and 4-6wk, while there was no significantly difference between FLACS and CPCS at 1d, 3 and 6mo [weighted mean difference (WMD): 51.54, 95% confidence interval (CI): -5.46 to 108.54, P=0.08; WMD: 48.52, 95%CI: -17.54 to 114.58, P=0.15; WMD: 12.17, 95%CI: -48.61 to 72.94, P=0.69, respectively]. Postoperative endothelial cell loss (ECL) of the FLACS was significantly lower than that of the CPCS at 1, 4-6wk, and 3mo (P=0.02, 0.008, 0.03, respectively). However, there was no significant difference between two groups at 6mo (WMD: -30.36, 95%CI: -78.84 to 18.12, P=0.22). No significant difference was discovered with respect to the macular edema [odds ratio (OR): 0.93, 95%CI: 0.42 to 2.05, P=0.85], capsular complication excluding posterior capsular tears (OR: 0.79, 95%CI: 0.42 to 1.50, P=0.47) and intraocular pressure change (OR: 0.82, 95%CI: 0.39 to 1.72, P=0.60). However, posterior capsular tears were more common in CPCS group (OR: 0.12, 95%CI: 0.01 to 0.98, P=0.05). The effective phacoemulsification times were significantly lower in the FLACS group compared to the CPCS group (WMD: -0.78, 95%CI: -1.23 to -0.34, P=0.0006). CONCLUSION: No statistically significant difference is discovered between FLACS and CPCS in clinical outcomes at the long-term follow up. However, higher rate of posterior capsular tears is detected in patients receiving CPCS.


2021 ◽  
Vol 8 ◽  
Author(s):  
Yawei Zheng ◽  
Jie Li ◽  
Lingzhun Wang ◽  
Peng Yu ◽  
Haibo Shi ◽  
...  

Background: At present, there are a variety of treatment strategies for percutaneous coronary intervention. The role of drug-coated balloon (DCB) in the treatment of side branch for de novo coronary bifurcated lesions (CBL) is unclear.Objective: To examine the effect of DCB in side branch protection for de novo CBL.Methods: Electronic databases, including Pubmed, Embase, the Web of science, Cochrance library, CNKI, CBM, WanFang Data and VIP were searched for studies that compared DCB with non-drug-coated balloon (NDCB) in side branch protection for de novo CBL from inception through July 7th, 2021. The primary outcome was target lesion revascularization (TLR). Secondary clinical outcomes included myocardial infarction (MI), cardiac death (CD). The angiographic outcomes included side branch late lumen loss (LLL), minimum lumen diameter (MLD), diameter stenosis (DS) and binary restenosis (BR). The target lesion failure (TLF) was also analyzed.Results: A total of 10 studies, including 5 randomized controlled trials and 5 non-randomized observational studies, with 934 patients were included. Meta-analysis results of angiographic outcomes suggested that DCB group had the less LLL, DS and BR and the higher MLD compared with NDCB group at follow-up (P &lt; 0.05). Meta-analysis results of clinical outcomes suggested that the significant difference in the TLR, MI and CD between DCB group and NDCB group has not been found yet (P &gt; 0.05). However, the MACE of DCB group was significantly less than that of NDCB group at 9-month follow-up [OR = 0.21, 95%CI (0.05, 0.84), P = 0.03] and 12-month follow-up [OR = 0.45, 95%CI (0.22, 0.90), P = 0.02]. In addition, there was no significant difference in TLF between DCB group and NDCB group (P &gt; 0.05).Conclusions: DCB had great effect in side branch protection for de novo CBL at short and medium-term follow-up with no reduction in the procedural success rate.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=267426, PROSPERO [Identifier: CRD42021267426].


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Jonghanne Park ◽  
Joo Myung Lee ◽  
Kyung Woo Park ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  

Background: Long term outcomes are imperative to confirm safety of drug-eluting stents. There have been two randomized controlled trials comparing everolimus-eluting stents (EES) and Resolute zotarolimus-eluting stents (ZES-R). To date, long-term clinical outcomes of these stents were limited to only one report which has recently reported 4-year comparisons of these stents. Therefore, more evidences are needed regarding long-term clinical outcomes of the second generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in “all-comer” cohorts up to 3-year follow-up. Methods: The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R. Target lesion failure and patient-related composite events were compared in crude and propensity score matched analyses. Results: Of 5054 patients, 3830 patients (75.8%) had off label indication (2217 with EES and 1613 with ZES-R). The stent-related outcome (189 [6.2%] vs. 127 [6.4%], p=0.812) and the patient-related outcome (420 [13.7%] vs. 250 [12.5%], p=0.581) did not differ between EES and ZES-R respectively at 3 year, which was corroborated by similar results from the propensity score-matched cohort (HR 0.92, 95% CI 0.70-1.20, p=0.523 and 0.85, 95% CI 0.70-1.02, p=0.081, for stent and patient related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs. 10 [0.5%], p=0.370) was also similar. The rate of stent thrombosis was very low and comparable between the two stents (3 [0.1%] vs. 1 [0.1%], p=0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440-5.354, p<0.001) and off label indication (adjusted HR 1.782, 95% CI 1.169-2.718, p=0.007) were the strongest predictors of target lesion failure. Conclusion: In this robust real world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 3-year follow-up. Overall incidences of target lesion failure and definite stent thrombosis, including very late stent thrombosis, were low, even in the patients with off label indications, suggesting excellent long term safety and sustained efficacy of both types of second generation drug-eluting stents.


2021 ◽  
Vol 10 (5) ◽  
pp. 995
Author(s):  
Marja Perhomaa ◽  
Tytti Pokka ◽  
Linda Korhonen ◽  
Antti Kyrö ◽  
Jaakko Niinimäki ◽  
...  

The preferred surgical fixation of forearm shaft fractures in children is Elastic Stable Intramedullary Nailing (ESIN). Due to known disadvantageous effects of metal implants, a new surgical method using biodegradable polylactide-co-glycolide (PLGA) intramedullary nails has been developed but its long-term outcomes are unclear. The aim of this study was to compare the long-term outcomes of Biodegradable Intramedullary Nailing (BIN) to ESIN and assess the biodegradation of the study implants via magnetic resonance imaging (MRI). The study population of the prospective, randomized trial consisted of paediatric patients whose forearm shaft fractures were treated with BIN (n = 19) or ESIN (n = 16). Forearm rotation at minimally four years’ follow-up was the main outcome. There was no clinically significant difference in the recovery of the patients treated with the BIN as compared to those treated with the ESIN. More than half of the implants (57.7%, n = 15/26) were completely degraded, and the rest were degraded almost completely. The PLGA intramedullary nails used in the treatment of forearm shaft fractures in this study resulted in good function and anatomy. No unexpected disadvantages were found in the degradation of the implants. However, two implant failures had occurred in three months postoperatively.


2019 ◽  
Vol 2019 ◽  
pp. 1-6 ◽  
Author(s):  
Joanna Wojtasik-Bakalarz ◽  
Zoltan Ruzsa ◽  
Tomasz Rakowski ◽  
Andreas Nyerges ◽  
Krzysztof Bartuś ◽  
...  

The most relevant comorbidities in patients with peripheral artery disease (PAD) are coronary artery disease (CAD) and diabetes mellitus (DM). However, data of long-term follow-up of patients with chronic total occlusion (CTO) are scarce. The aim of the study was to assess the impact of CAD and DM on long-term follow-up patients after superficial femoral artery (SFA) CTO retrograde recanalization. In this study, eighty-six patients with PAD with diagnosed CTO in the femoropopliteal region and at least one unsuccessful attempt of antegrade recanalization were enrolled in 2 clinical centers. Mean time of follow-up in all patients was 47.5 months (±40 months). Patients were divided into two groups depending on the presence of CAD (CAD group: n=45 vs. non-CAD group: n=41) and DM (DM group: n=50 vs. non-DM group: n=36). In long-term follow-up, major adverse peripheral events (MAPE) occurred in 66.6% of patients with CAD vs. 36.5% of patients without CAD and in 50% of patients with DM vs. 55% of non-DM subjects. There were no statistical differences in peripheral endpoints in both groups. However, there was a statistically significant difference in all-cause mortality: in the DM group, there were 6 deaths (12%) (P value = 0.038). To conclude, patients after retrograde recanalization, with coexisting CTO and DM, are at higher risk of death in long-term follow-up.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Xiaoran Yu ◽  
Ruogu Xu ◽  
Zhengchuan Zhang ◽  
Yang Yang ◽  
Feilong Deng

AbstractExtra-short implants, of which clinical outcomes remain controversial, are becoming a potential option rather than long implants with bone augmentation in atrophic partially or totally edentulous jaws. The aim of this study was to compare the clinical outcomes and complications between extra-short implants (≤ 6 mm) and longer implants (≥ 8 mm), with and without bone augmentation procedures. Electronic (via PubMed, Web of Science, EMBASE, Cochrane Library) and manual searches were performed for articles published prior to November 2020. Only randomized controlled trials (RCTs) comparing extra-short implants and longer implants in the same study reporting survival rate with an observation period at least 1 year were selected. Data extraction and methodological quality (AMSTAR-2) was assessed by 2 authors independently. A quantitative meta-analysis was performed to compare the survival rate, marginal bone loss (MBL), biological and prosthesis complication rate. Risk of bias was assessed with the Cochrane risk of bias tool 2 and the quality of evidence was determined with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. 21 RCTs were included, among which two were prior registered and 14 adhered to the CONSORT statement. No significant difference was found in the survival rate between extra-short and longer implant at 1- and 3-years follow-up (RR: 1.002, CI 0.981 to 1.024, P = 0.856 at 1 year; RR: 0.996, CI 0.968 to 1.025, P  = 0.772 at 3 years, moderate quality), while longer implants had significantly higher survival rate than extra-short implants (RR: 0.970, CI 0.944 to 0.997, P < 0.05) at 5 years. Interestingly, no significant difference was observed when bone augmentations were performed at 5 years (RR: 0.977, CI 0.945 to 1.010, P = 0.171 for reconstructed bone; RR: 0.955, CI 0.912 to 0.999, P < 0.05 for native bone). Both the MBL (from implant placement) (WMD: − 0.22, CI − 0.277 to − 0.164, P < 0.01, low quality) and biological complications rate (RR: 0.321, CI 0.243 to 0.422, P < 0.01, moderate quality) preferred extra-short implants. However, there was no significant difference in terms of MBL (from prosthesis restoration) (WMD: 0.016, CI − 0.036 to 0.068, P = 0.555, moderate quality) or prosthesis complications rate (RR: 1.308, CI 0.893 to 1.915, P = 0.168, moderate quality). The placement of extra-short implants could be an acceptable alternative to longer implants in atrophic posterior arch. Further high-quality RCTs with a long follow-up period are required to corroborate the present outcomes.Registration number The review protocol was registered with PROSPERO (CRD42020155342).


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Leah B Kosyakovsky ◽  
Federico Angriman ◽  
Emma Katz ◽  
Neill Adhikari ◽  
Lucas C Godoy ◽  
...  

Introduction: Sepsis results in dysregulated inflammation, coagulation, and metabolism, which may contribute to increased cardiovascular disease (CVD) risk. We conducted a systematic review and meta-analysis to determine the association between sepsis and subsequent long-term CVD events. Methods: MEDLINE, Embase, and the Cochrane Controlled Trials Register and Database of Systematic Reviews were searched from inception to May 2020 to identify observational studies of adult sepsis survivors (defined by diagnostic codes or consensus definitions) measuring long-term CV outcomes. The primary outcome was a composite of myocardial infarction, CV death, and stroke. Random-effects models estimated the pooled cumulative incidence and adjusted hazard ratios of CV events relative to hospital or population controls. Odds ratios were included as risk ratios assuming <10% incidence in non-septic controls, and risk ratios were taken as hazard ratios (HR) assuming no censoring. Outcomes were analyzed at maximum follow-up (primary analysis) and stratified by time (<1 year, 1-2 years, and >2 years) since sepsis. Results: Of 11,235 abstracts screened, 25 studies (22 cohort studies, 2 case-crossover studies, and 1 case-control) involving 1,949,793 sepsis survivors were included. The pooled cumulative incidence of CVD events was 9% (95% CI; 5-14%). Sepsis was associated with an increased risk (HR 1.59, 95% CI 1.37-1.86) of CVD events at maximum follow-up ( Figure ); between-study heterogeneity was substantial (I 2 =97.3%). There was no significant difference when comparing studies using population and hospital controls. Significantly elevated risk was observed up to 5 years following sepsis. Conclusions: Sepsis survivors experience an approximately 50% increased risk of CVD events, which may persist for years following the index episode. These results highlight a potential unmet need for early cardiac risk stratification and optimization in sepsis survivors.


2021 ◽  
Author(s):  
Kanthika Wasinpongwanich ◽  
Tanawin Nopsopon ◽  
Krit Pongpirul

Purpose Surgical treatment is mandatory in some patients with lumbar spine diseases. To obtain spine fusion, many operative techniques were developed with different fusion rates and clinical results. This study aimed to collect randomized controlled trial (RCT) data to compare fusion rate, clinical outcomes, complications among Transforaminal Lumbar Interbody Fusion (TLIF), and other techniques for lumbar spine diseases. Methods A systematic literature search of PubMed, Embase, Scopus, Web of Science, and CENTRAL databases was searched for studies up to 13 February 2020. The meta-analysis was done using a random-effects model. Pooled risk ratio (RR) or mean difference (MD) with a 95% confidence interval of fusion rate, clinical outcomes, and complication in TLIF and other techniques for lumbar diseases. Results The literature search identified 3,682 potential studies, 15 RCTs (915 patients) were met our inclusion criteria and were included in the meta-analysis. Compared to other techniques, TLIF had slightly lower fusion rate (RR=0.84 [95% CI 0.72, 0.97], p=0.02, I2=0.0%) at 1-year follow-up while there was no difference on fusion rate at 2-year follow up (RR=1.06 [95% CI 0.96, 1.18], p=0.27, I2=69.0%). The estimated risk ratio of total adverse events (RR=0.90 [95% CI 0.59, 1.38], p=0.63, I2=0.0%) and revision rate (RR=0.78 [95%CI 0.34, 1.79], p=0.56, I2=39.0%) showed no difference. TLIF had approximately half an hour more operative time than other techniques (MD=31.88 [95% CI 5.33, 58.44], p=0.02, I2=92.0%). There was no significant difference between TLIF and other techniques in terms of the blood loss, and clinical outcomes. Conclusions Besides fusion rate at 1-year follow-up and operative time, our study demonstrated similar outcomes of TLIF with other techniques for lumbar diseases in regard to fusion rate, clinical outcomes, and complications.


Sign in / Sign up

Export Citation Format

Share Document