scholarly journals An abluminal biodegradable polymer sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients undergoing coronary revascularization: 3-year clinical outcomes of a randomized non-inferiority trial

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Haijun Zhang ◽  
Xiaoping Zhang ◽  
Yuxia Yin ◽  
Chao Zhou ◽  
Wei Deng ◽  
...  
Keyword(s):  
Absolute Risk ◽  
Coronary Revascularization ◽  
Group Versus ◽  
Target Lesion ◽  
Risk Difference ◽  
Durable Polymer ◽  
Safety Endpoint ◽  
Sirolimus Eluting Stent ◽  
Primary Safety Endpoint ◽  
Xience V Stent

AbstractThe Cordimax stent has proved non-inferior to the Cypher Select durable polymer sirolimus-eluting stent for the primary endpoint of angiographic in-stent late luminal loss and in-stent mean diameter stenosis at 9 months. The trial was designed to compare the efficacy and safety of the Cordimax stent with the Xience V stent in patients undergoing coronary revascularization. This randomized, multicenter trial enrolled 3697 patients treated with Cordimax stent (2460 patients) and Xience V stent (1237 patients). The primary efficacy endpoint was a target-lesion failure (TLF) at 1 year and the primary safety endpoint was a composite of death or myocardial infarction (MI) at 3 years. 3399 patients (91.9%) completed 3-year follow-up. At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI −1.0–1.5%, Pnon-inferiority < 0.0001). At 3 years, the primary safety endpoint occurred in 39 (1.6%) patients in the Cordimax group versus 19 (1.5%) patients in the Xience V group (0.05% absolute risk difference, 95% CI −0.8–0.9%, Pnon-inferiority < 0.0001). The incidence of target lesion revascularization was low in Cordimax group compared with Xience V group (3.6% versus 5.1%, P = 0.03). There were no differences between Cordimax and Xience V in terms of Cardiac death (0.3% versus 0.4%, P = 0.70), myocardial infarction (1.2% versus 0.9%, P = 0.37), and the stent thrombosis (0.4% versus 0.6%, P = 0.61). In conclusion, safety and efficacy outcomes of Cordimax stent were non-inferior to the Xience V stent 3 years after stent implantation.

scholarly journals Midterm Clinical Impacts of Biodegradable Polymer Everolimus-Eluting Stents Compared with Durable Polymer Everolimus-Eluting Stents: A 3-Year Propensity-Matched Study

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Hiroaki Matsuda ◽  
Ai Kagase ◽  
Takahiro Tokuda ◽  
Yusuke Ochiumi ◽  
Akira Murata ◽  
...  
Keyword(s):  
Biodegradable Polymer ◽  
Cumulative Incidence ◽  
Cardiac Death ◽  
Group Versus ◽  
Target Lesion ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Durable Polymer ◽  
The Individual ◽  
Few Data

Objectives. Our aim was to evaluate the safety and efficacy of biodegradable polymer everolimus-eluting stents (BP-EES) compared with durable polymer everolimus-eluting stents (DP-EES) in midterm. Background. There are few data about midterm clinical outcomes of BP-EES compared with DP-EES. Methods and Results. Between January 2016 and December 2017, 395 consecutive patients were treated with BP-EES and 391 consecutive patients were treated with DP-EES in Nagoya Heart Center. The primary endpoint was a 3-year cumulative incidence of target lesion failure (TLF) defined as cardiac death, target vessel myocardial infarction (MI), and clinical indicated target lesion revascularization (TLR). Moreover, clinical indicated target vessel revascularization (TVR) and definite stent thrombosis (ST) were also evaluated as the secondary endpoints. After propensity score matching, 327 patients were selected in each group. At 3 years, the cumulative incidence of TLF was 4.5% in the BP-EES group versus 6.5% in DP-EES (adjusted HR 0.67 (95% CI 0.33–1.30), log-rank P=0.23). Regarding the individual components of the TLF at 3 years, the cumulative incidence of target vessel MI was significantly lower in BP-EES than in DP-EES (0% versus 1.9%: adjusted HR 0.83 (95% CI 0.71–0.97), log-rank P=0.01), but there was no difference between BP-EES and DP-EES in the incidence of cardiac death and clinically indicated TLR. The cumulative 3-year incidence of definite ST was significantly lower in BP-EES than in DP-EES (0% versus 1.6%, log-rank P=0.02). Conclusions. There were no significant differences of TLF between BP-EES and DP-EES within 3 years. In this study, BP-EES seems to prevent definite ST and be safer than DP-EES in midterm.

scholarly journals Novel Supreme TM DES with Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation after DES implantation in Coronary Artery Disease: Results of the PIONEER III Randomized Clinical Trial

Circulation ◽  
2021 ◽  
Author(s):  
Alexandra J. Lansky ◽  
Dean J. Kereiakes ◽  
Andreas Baumbach ◽  
Stephan Windecker ◽  
Yasin Hussain ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Clinical Trial ◽  
Absolute Risk ◽  
Target Lesion ◽  
Base Layer ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Durable Polymer ◽  
Coronary Syndromes

Background: Accelerated endothelial healing after targeted antiproliferative drug delivery may limit the long-term inflammatory response of drug eluting stents (DES). The novel Supreme TM DES (Supreme) is designed to synchronize early drug delivery within 4-6 weeks of implantation, leaving behind a pro-healing permanent base layer. Whether the Supreme DES is safe and effective in the short term and can improve long term clinical outcomes is not known. Methods: In an international 2:1 randomized single-blind trial, we compared treatment with Supreme DES to durable polymer everolimus-eluting stents (DP-DES) in patients with acute and chronic coronary syndromes. The primary endpoint was target lesion failure (TLF) - a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (TLR). The trial was designed to demonstrate non-inferiority (margin of 3.58%) of the Supreme DES at 12 months compared to DP-DES (clinicaltrials.gov-NCT03168776). Results: From October 2017 to July 2019, a total of 1629 patients were randomly assigned (2:1) to the Supreme DES (N=1086) or DP-DES (N=543). At 12 months, TLF occurred in 57 of 1057 patients (5.4%) in the Supreme DES group and in 27 of 532 patients (5.1%) in the DP-DES group (Absolute Risk Difference 0.32%, 95%CI [-1.87%, 2.5%]; p non-inferiority =0.002]. There were no significant differences in rates of device success, clinically driven TLR or stent thrombosis at 12 months, and the safety composite of CV Death and TV MI was 3.5% vs 4.6%; HR [95.0% CI] 0.76 [0.46, 1.25] with Supreme DES compared to DP-DES, though rates of combined clinical and non-clinical driven TLR at 12 months were higher with Supreme DES. Conclusions: Among patients with acute and chronic coronary syndromes undergoing percutaneous coronary intervention, the Supreme DES proved to be non-inferior to the standard DP-DES. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT03168776

scholarly journals Five Years Sustained Clinical Safety and Efficacy of An Abluminal Biodegradable-Polymer Coated Sirolimus-Eluting Stent: A Randomized Controlled Trial

2021 ◽  
Author(s):  
mingkun cao ◽  
Yuxia Yin ◽  
Chao Zhou ◽  
Wei Deng ◽  
Jianying Ma ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Biodegradable Polymer ◽  
Controlled Trial ◽  
Target Lesion ◽  
Clinical Safety ◽  
Safety And Efficacy ◽  
Durable Polymer ◽  
Sirolimus Eluting Stent ◽  
Target Lesion Failure

Abstract Background Drug-eluting stent (DES) with durable polymers have been proven to cause late or very late adverse events. Biodegradable polymer-coated DES was developed to address the risk by avoiding persistent inflammatory irritation from persistent polymers. However, it is unknown whether the benefits of biodegradable polymer DES will occur over longer time. Methods The trial was a prospective, multicenter and randomized non-inferiority clinical trial done in China. Patients with indications for stent implantation were assigned into Cordimax and Xience V group in a 2:1 allocation. The composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularisation (CI-TLR) was the primary endpoint target lesion failure (TLF). The pre-specified endpoint at five years was major adverse cardiac event (MACE) which was defined as a composite of all-cause death, non-fatal myocardial infarction (MI), and CI-TLR. Results 3266 patients (88.3%) completed 5-year follow-up. No difference was observed for TLF between Cordimax (7.5%) and Xience V (8.3%) group (RR: 0.90, 95% CI: 0.70 to 1.15, P = 0.39). MACE occurred in 280 patients (11.4%) in Cordimax group and 162 patients (13.1%) in Xience V group (RR: 0.85, 95% CI: 0.69 to 1.05, P = 0.13). The incidence of definite or probable stent thrombosis did not differ in both groups (Cordimax 0.7%, Xience V 0.9%; RR: 0.78, 95% CI: 0.36 to 1.66; P = 0.51). Conclusion The biodegradable polymer Cordimax stent showed a comparable result to the durable polymer Xience V stent at 5 years, showing its long-term safety and efficacy performance. Trial registration: This study is registered with ClinicalTrials.gov, number NCT03185221 (14/06/2017).

scholarly journals Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer‐Generation Drug‐Eluting Stents

2021 ◽  
Author(s):  
Rayyan Hemetsberger ◽  
Mohammad Abdelghani ◽  
Ralph Toelg ◽  
Nader Mankerious ◽  
Abdelhakim Allali ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Target Vessel ◽  
Durable Polymer ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
Bioresorbable Polymer ◽  
Sirolimus Eluting Stent

Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare‐metal and first‐generation drug‐eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer‐generation drug‐eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable‐polymer sirolimus‐eluting stent or a durable‐polymer everolimus‐eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target‐lesion failure (TLF) (cardiac death, target‐vessel myocardial infarction, or target‐lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P =0.003) and stent thrombosis rates (2.1% versus 0.2%; P <0.0001), whereas target‐lesion revascularization was not different between the groups (5.0% versus 3.9%; P =0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89–2.08; P =0.148) but did for target‐vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03–2.68; P =0.037). TLF rates were similar between bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent (12.6% versus 15.4%, P =0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable‐polymer sirolimus‐eluting stent showed lower TLF (7.5% versus 10.3%, P =0.045). Conclusions With newer‐generation drug‐eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target‐vessel myocardial infarction was higher. The bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

Abatacept for Rheumatoid Arthritis: A Cochrane Systematic Review

2010 ◽  
Vol 37 (2) ◽  
pp. 234-245 ◽  
Author(s):  
LARA J. MAXWELL ◽  
JASVINDER A. SINGH
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Journal Club ◽  
Absolute Risk ◽  
Group Versus ◽  
Risk Difference ◽  
Cochrane Library ◽  
Control Group ◽  
Number Needed To Treat ◽  
American College Of Rheumatology

Objective.To perform a systematic review of efficacy and safety of abatacept in patients with rheumatoid arthritis (RA).Methods.We searched the Cochrane Library, MEDLINE, EMBASE, ACP Journal Club, and Biosis Previews for randomized controlled trials (RCT) comparing abatacept alone or in combination with disease modifying antirheumatic drugs (DMARD)/biologics to placebo or other DMARD/biologics in patients with RA. Two reviewers independently assessed search results, risk of bias, and extracted data.Results.Seven trials with 2908 patients were included. Compared with placebo, patients with RA treated with abatacept were 2.2 times more likely to achieve an American College of Rheumatology 50% response (ACR50) at one year (relative risk 2.21, 95% CI 1.73, 2.82) with a 21% (95% CI 16%, 27%) absolute risk difference between groups. The number needed to treat to achieve an ACR50 response was 5 (95% CI 4, 7). Significantly greater improvements in physical function, disease activity, pain, and radiographic progression were noted in abatacept-treated patients compared to placebo. Total adverse events (AE) were greater in the abatacept group (RR 1.05, 95% CI 1.01, 1.08). Other harm outcomes were not significant, with the exception of serious infections at 12 months, which were more common in the abatacept group versus control group (Peto odds ratio 1.91, 95% CI 1.07, 3.42). Serious AE were more numerous in the abatacept + etanercept group versus the placebo + etanercept group (RR 2.30, 95% CI 1.15, 4.62).Conclusion.Abatacept seems to be efficacious and safe in the treatment of RA. Abatacept should not be used in combination with other biologics to treat RA. Further longterm studies and postmarketing surveillance are required to assess for longer-term harms and sustained efficacy.

scholarly journals Endovascular renal sympathetic denervation to improve heart failure with reduced ejection fraction: the IMPROVE-HF-I study

2021 ◽  
Author(s):  
L. Feyz ◽  
R. Nannan Panday ◽  
M. Henneman ◽  
F. Verzijlbergen ◽  
A. A. Constantinescu ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Group Versus ◽  
Sympathetic Denervation ◽  
Renal Sympathetic Denervation ◽  
Reduced Ejection Fraction ◽  
Safety Endpoint ◽  
The Mean ◽  
Primary Safety Endpoint ◽  
Renal Sympathetic

Abstract Introduction The aim of the present study was to assess the safety and efficacy of renal sympathetic denervation (RDN) in patients with heart failure with reduced ejection fraction (HFrEF). Methods We randomly assigned 50 patients with a left ventricular ejection fraction (LVEF) ≤ 35% and NYHA class ≥ II, in a 1:1 ratio, to either RDN and optimal medical therapy (OMT) or OMT alone. The primary safety endpoint was the occurrence of a combined endpoint of cardiovascular death, rehospitalisation for heart failure, and acute kidney injury at 6 months. The primary efficacy endpoint was the change in iodine-123 meta-iodobenzylguanidine (123I‑MIBG) heart-to-mediastinum ratio (HMR) at 6 months. Results Mean age was 60 ± 9 years, 86% was male and mean LVEF was 33 ± 8%. At 6 months, the primary safety endpoint occurred in 8.3% vs 8.0% in the RDN and OMT groups, respectively (p = 0.97). At 6 months, the mean change in late HMR was −0.02 (95% CI: −0.08 to 0.12) in the RDN group, versus −0.02 (95% CI: −0.09 to 0.12) in the OMT group (p = 0.95) whereas the mean change in washout rate was 2.34 (95% CI: −6.35 to 1.67) in the RDN group versus −2.59 (95% CI: −1.61 to 6.79) in the OMT group (p-value 0.09). Conclusion RDN with the Vessix system in patients with HFrEF was safe, but did not result in significant changes in cardiac sympathetic nerve activity at 6 months as measured using 123I‑MIBG.

5-year outcomes in patients with acute coronary syndrome treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.F Iglesias ◽  
D Heg ◽  
M Roffi ◽  
D Tueller ◽  
O Muller ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndrome ◽  
Cardiac Death ◽  
Target Lesion ◽  
Funding Source ◽  
Target Vessel ◽  
Coronary Syndrome ◽  
Durable Polymer ◽  
Stable Cad

Abstract Background Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating. Purpose To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS. Methods We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years. Results Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES. Conclusion In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland

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