scholarly journals Ten-Year Safety Data for Eurosilicone’s Round and Anatomical Silicone Gel Breast Implants

2019 ◽  
Vol 1 (2) ◽  
Author(s):  
Franck Duteille ◽  
Pierre Perrot ◽  
Marie-Hélène Bacheley ◽  
Erin Bell ◽  
Sharon Stewart
Keyword(s):  
Capsular Contracture ◽  
Safety Data ◽  
Cumulative Risk ◽  
Breast Implants ◽  
Complication Rates ◽  
Primary Reconstruction ◽  
Safety And Efficacy ◽  
Silicone Gel ◽  
Kaplan Meier

Abstract Background Although silicone breast implants have been available for over 60 years, their safety and efficacy continue to be assessed via long-term clinical and vigilance studies. Complications often associated with breast implant surgery include but are not limited to capsular contracture and rupture. Objective The authors investigate and evaluate the safety and performance of Eurosilicone’s (Eurosilicone S.A.S, Apt Cedex, France) Cristalline Paragel breast implants at least 10 years postimplantation. Methods Nine hundred and ninety-five of Eurosilicone’s textured mammary implants were implanted in 526 women undergoing primary (423 patients) and revision surgery (103 patients) at 17 centers throughout France. Complications were recorded at 3 months and annually thereafter for 10 years. Descriptive statistics were used and the Kaplan-Meier method was utilized to analyze key complications. Results Seventy-four women (98 implants) experienced capsular contracture across all cohorts. The Kaplan-Meier 10-year cumulative risk of capsular contracture (Baker Grade III/IV) per implant was 11.5% in the primary augmentation cohort and 25.2% in the primary reconstruction cohort. Sixteen implant ruptures were observed by surgeon examination giving a Kaplan-Meier risk of 3.8% per patient and 3.5% per implant. Surgical re-intervention (explantation/exchange) was reported 80 times resulting in a Kaplan-Meier cumulative risk of 13.3% and 31.6% for primary augmentation and primary reconstruction, respectively, per patient. Local complication rates including infection and seroma were low with risk rates of 0.6% and 0.2% by subject. Conclusions This multicenter clinical study demonstrates the long-term safety and efficacy profile through 10 years for Eurosilicone round and anatomical silicone gel breast implants. Level of Evidence: 3

scholarly journals Long-term outcomes of two-stage, immediate and delayed breast reconstruction with polyurethane-covered versus textured implants: protocol of a prospective, multicentre randomised controlled trial (TIPI trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e044219
Author(s):  
J X Harmeling ◽  
Kevin Peter Cinca ◽  
Eleni-Rosalina Andrinopoulou ◽  
Eveline M L Corten ◽  
M A Mureau
Keyword(s):  
Randomised Controlled Trial ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Capsular Contracture ◽  
Tissue Expander ◽  
Complication Rates ◽  
Two Stage ◽  
Randomised Controlled

IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

Long-Term Health Outcomes in Women With Silicone Gel Breast Implants

2015 ◽  
Vol 164 (3) ◽  
pp. 164 ◽  
Author(s):  
Ethan M. Balk ◽  
Amy Earley ◽  
Esther A. Avendano ◽  
Gowri Raman
Keyword(s):  
Health Outcomes ◽  
Breast Implants ◽  
Silicone Gel

scholarly journals Long term outcomes of acute and transient psychotic disorders: The missed opportunity of preventive interventions

2018 ◽  
Vol 52 ◽  
pp. 126-133 ◽  
Author(s):  
Grazia Rutigliano ◽  
Sergio Merlino ◽  
Amedeo Minichino ◽  
Rashmi Patel ◽  
Cathy Davies ◽  
...  
Keyword(s):  
High Risk ◽  
Psychotic Disorders ◽  
Cumulative Risk ◽  
Acute Onset ◽  
Kaplan Meier ◽  
Schizophrenia Spectrum ◽  
National Health Service Trust ◽  
Icd 10

AbstractBackground:Acute and transient psychotic disorders (ATPD) are characterized by an acute onset and a remitting course, and overlap with subgroups of the clinical high-risk state for psychosis. The long-term course and outcomes of ATPD are not completely clear.Methods:Electronic health record-based retrospective cohort study, including all patients who received a first index diagnosis of ATPD (F23, ICD-10) within the South London and Maudsley (SLaM) National Health Service Trust, between 1 st April 2006 and 15th June 2017. The primary outcome was risk of developing persistent psychotic disorders, defined as the development of any ICD-10 diagnoses of non-organic psychotic disorders. Cumulative risk of psychosis onset was estimated through Kaplan-Meier failure functions (non-competing risks) and Greenwood confidence intervals.Results:A total of 3074 patients receiving a first index diagnosis of ATPD (F23, ICD-10) within SLaM were included. The mean follow-up was 1495 days. After 8-year, 1883 cases (61.26%) retained the index diagnosis of ATPD; the remaining developed psychosis. The cumulative incidence (Kaplan-Meier failure function) of risk of developing any ICD-10 non-organic psychotic disorder was 16.10% at 1-year (95%CI 14.83–17.47%), 28.41% at 2-year (95%CI 26.80–30.09%), 33.96% at 3-year (95% CI 32.25–35.75%), 36.85% at 4-year (95%CI 35.07–38.69%), 40.99% at 5-year (95% CI 39.12–42.92%), 42.58% at 6-year (95%CI 40.67–44.55%), 44.65% at 7-year (95% CI 42.66–46.69%), and 46.25% at 8-year (95% CI 44.17–48.37%). The cumulative risk of schizophrenia-spectrum disorder at 8-year was 36.14% (95% CI 34.09–38.27%).Conclusions:Individuals with ATPD have a very high risk of developing persistent psychotic disorders and may benefit from early detection and preventive treatments to improve their outcomes.

The Evolution of Breast Implants

2002 ◽  
Vol 10 (5) ◽  
pp. 223-236 ◽  
Author(s):  
Walter Peters
Keyword(s):  
United States ◽  
Breast Augmentation ◽  
Capsular Contracture ◽  
Surface Texturing ◽  
Breast Implants ◽  
Early Years ◽  
Present Review ◽  
Thick Wall ◽  
The Past ◽  
Silicone Gel

The present review traces the evolution of breast implants over the past 50 years. During the early years (from 1951 to 1962), a number of different sponges were used for breast augmentation. The first of these was Ivalon, a polyvinyl alcohol sponge. Other sponges were introduced subsequently, including Etheron (a poly-ether sponge popularized by Dr Paule Regnault in Montreal) and Polystan (fabric tapes that were wound into a ball). Subsequently, polyethylene strips enclosed in a fabric or polyethylene casing were also used for breast augmentation. All of these materials had similar outcomes. Although the initial results were encouraging, within one year of augmentation, breasts became very firm and lost over 25% of their volume. This was due to capsular contracture, a process that would lead to the collapse of the sponge and would continue to plague plastic surgeons and their patients for the next 50 years. In 1963, Cronin and Gerow introduced the silicone gel ‘natural feel’ implant, which revolutionized breast augmentation surgery. Approximately 10 companies have manufactured many types of silicone gel breast implants over the years. They obtained their raw materials for gels and shells from a similar number of other companies that entered and left the market at intervals. Many of the suppliers and manufactures changed their names and ownership over the years, and most of the companies no longer exist. No formal process of United States Food and Drug Administration premarket testing was in effect until 1988. There have been three generations of gel implants and a number of other lesser variations. First-generation implants (1963 to 1972) had a thick gel and a thick wall. They have generally remained intact over the years. Second-generation implants (1973 to the mid-1980s) had a thin gel and a thin wall. They have tended to disrupt over time. Third-generation implants (mid-1980s to 1992) had a thick wall and a thick gel. Except for those made by Surgitek, these implants remain intact. The breast implant business was competitive and companies introduced changes such as softer gels; barrier low-bleed shells; greater or lesser shell thickness; surface texturing; different sizes, contours and shapes; and multiple lumens in search of better aesthetics. Ultimately, more than 240 styles and 8300 models of silicone gel breast implants were manufactured in the United States alone. Inflatable breast implants were introduced in Toulons, France in 1965 (the Simaplast implant). There have been three main eras of inflatable implants: seamed, high-temperature vulcanized and room temperature vulcanized implants. In 1973, spontaneous deflation rates of 76% to 88% over three years were reported for many types of inflatable implants. Because of this, most plastic surgeons abandoned their use. From 1963 until the moratorium on gel implants (January 6, 1992), about 95% of all breast implants inserted were silicone gel filled. Only 5% were saline filled. Since the moratorium, this ratio has been reversed and 95% of all implants have been saline-filled, with only 5% being gel filled. Polyurethane-coated (PU) silicone gel implants were introduced in 1968. Over the next 20 years, they were shown to reduce the prevalence of capsular contracture to 2% to 3%. Other forms of surface texturing (Biocell, Siltex, multistructured implant) also appear to reduce capsular contracture with gel implants, but the reduction has been much less dramatic than that seen with PU implants. Contoured (anatomical) shaping appears to have advantages in some patients with gel implants. No such advantage has been seen for texturing or shaping with saline-filled implants. The story of gel implants has culminated in the largest class action lawsuit in medical history, with US$4.2 billion being awarded to women with silicone gel implants. During the past decade, there has been a tremendous amount of research on the reaction of a woman's body to gel implants. A plethora of studies have demonstrated that silicone gel implants are not associated with the development of any medical diseases. Silicone gel-filled implants have therefore been approved for use under Health Canada's Special Access Program. Silicone gel-filled implants may now be used in certain patients in whom they would provide advantages over saline implants. Silicone gel implants have not been approved for unrestricted general use. The evolution of breast implants occupies the past half century. It has been a stormy course, with many exciting advances and many bitter disappointments. The universe of breast implants is large and the variation among the implants is substantial. The purpose of the present review is to trace the evolution of breast implants over the past 50 years.

scholarly journals P219 Long-term safety of filgotinib in patients with PsA: week 52 safety data from a Phase 2 open-label extension study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Laura Coates ◽  
Philip Mease ◽  
Dafna Gladman ◽  
Filip Van den Bosch ◽  
Anna Rychlewska-Hanczewska ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Safety Data ◽  
Janus Kinase ◽  
Controlled Study ◽  
Stock Ownership ◽  
Phase 2 ◽  
Open Label ◽  
Safety And Efficacy ◽  
Open Label Extension

Abstract Background Filgotinib (FIL) is an orally administered, selective janus kinase 1 (JAK1) inhibitor in development for psoriatic arthritis (PsA). Efficacy and safety of FIL in patients with active PsA were evaluated in a 16-week phase 2 study (EQUATOR, NCT03101670). After 16 weeks, patients could roll-over to an Open Label Extension (OLE) Study (EQUATOR2, NCT03320876) for the purpose of evaluating long-term safety and efficacy. The aim of this analysis was to assess safety and efficacy through 52 weeks of exposure to filgotinib. Methods Patients who completed the randomised, double-blind, placebo-controlled study were eligible for participation in the OLE, during which all patients received once daily (qd) open-label FIL 200mg. In this interim analysis of OLE, for the safety analysis, all data were included from the screening in the core study up to the data cut of 18 April 2019 in the OLE. For the efficacy analysis, all data until OLE Week 52 visit for each patient were included (observed case analysis). Results Of the 131 patients randomised and dosed in EQUATOR, 124 (95%) completed the study and 122 (93%) enrolled in EQUATOR2; 50% were female and mean age was 50. At this interim analysis, 106/122 (87%) remained in the OLE (premature discontinuations during OLE due to: 4 for safety, 11 withdrew consent, and 1 for other reasons). Cumulative patient years of exposure (PYE) on FIL were 160, median time on FIL was 66 weeks. Key safety data are summarised in Table 1. Key ≥Grade 2 treatment-emergent laboratory abnormalities seen with FIL arm (N = 128) compared with PBO (N = 66) were lymphocyte decrease 11.1% vs 4.5%, neutrophil decrease 5.5% vs 0%, ALT increase 1.6% vs 1.5% and creatinine increase 0.8% vs 0%, respectively. At week 52, 34% of the patients fulfilled criteria for minimal disease activity and 81%, 55%, and 33% of patients, respectively, achieved ACR20/50/70 responses. Conclusion FIL 200mg qd was generally well tolerated and the safety profile in PsA was comparable to that observed in the FIL rheumatoid arthritis studies. The data from this interim analysis suggest that further improvement of the patient condition can be expected beyond 16 weeks of treatment. Disclosures L. Coates: Other; Received support from Abbvie, Amgen, Celgene, Galapagos, Janssen, Lilly, Novartis, Pfizer, Prothena, Sun pharma, and UCB. P. Mease: Other; Received support from Abbvie, Amgen, BMS, Celgene, Galapagos, Genentech, Gilead, Janssen, Eli Lilly, Merck, Novartis, Pfizer, SUN, and UCB. D. Gladman: Other; Received support from Abbvie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, UCB, BMS, and Galapagos. F. Van den Bosch: Other; Received support from Abbvie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer, and UCB. A. Rychlewska-Hanczewska: Other; Received support from Galapagos and Gilead Sciences. C. Tasset: Corporate appointments; Employee of Galapagos NV. L. Meuleners: Corporate appointments; Employee of Galapagos NV. M. Trivedi: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Guo: Corporate appointments; Employee of Gilead Sciences, Inc... Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. R. Besuyen: Other; Employee of Galapagos NV. P. Helliwell: Other; Received support from Abbvie, Amgen, Celgene, Galapagos, Janssen, Novartis, Pfizer, and UCB.

Long-Term Health Outcomes in Women With Silicone Gel Breast Implants

2016 ◽  
Vol 165 (7) ◽  
pp. 527 ◽  
Author(s):  
Ethan M. Balk ◽  
Gowri Raman
Keyword(s):  
Health Outcomes ◽  
Breast Implants ◽  
Silicone Gel

scholarly journals Removal of fibroadenoma of the breast augmentation and breast implants. Analysis of the possibility of simultaneous and delayed execution of these operations

2021 ◽  
Vol 14 (2) ◽  
pp. 140-146
Author(s):  
Viktoriia Dzhuganova ◽  
Valery V. NOVOMLINSKY ◽  
Andrey Petrovich Sokolov ◽  
Pavel Alekseevich Lynov ◽  
Margarita Gennedievna Sokolova ◽  
...  
Keyword(s):  
Breast Augmentation ◽  
Capsular Contracture ◽  
Breast Implants ◽  
Needle Aspiration ◽  
Augmentation Mammoplasty ◽  
Simultaneous Treatment ◽  
Implant Placement ◽  
Simultaneous Operations ◽  
Cosmetic Effect

Introduction. Fibroadenomas (FA) are the most common benign breast neoplasms that are diagnosed in 25% of women. Dissatisfaction with the size of the breast and the desire to increase it occurs in 40%. For this reason, in the practice of a plastic surgeon, there are cases when the patient wants to remove fibroadenomas (FA) and increase the size of the breast. In this situation, there are two options for managing the patient- the simultaneous execution of two operations and the delayed one.Aim. To evaluate the possibility of simultaneous FA removal and augmentation mammoplasty, to analyze possible complications and methods of their correction.Materials and methods. We have analyzed the experience of simultaneous interventions of FA removal and augmentation mammoplasty on the example of 10 cases performed in the period from 2014-2019, as well as FA removal after implant placement-3 cases.Results. Performing a simultaneous operation has advantages due to the minimization of injuries (the ability to perform from a single access - submammary or periareolar), reducing psychological stress and better cosmetic effect. Two patients had postoperative complications in the form of capsular contracture, manifested in the asymmetry of the mammary glands, corrected by performing capsulotomy and forming a new submammary fold. When performing invasive diagnostic tests and surgical intervention in three patients after endoprosthesis augmentation mammoplasty, extreme caution was required due to the risk of violating the integrity of the implant. It was found that the incision of the posterior leaf of the MJ capsule with a large number of removed neoplasms in the postoperative period leads to the development of breast asymmetry. The fact of FA recurrence was also confirmed (2 patients), who subsequently underwent repeated surgical intervention.Conclusion. Performing simultaneous operations for benign breast tumors can be surely practiced by plastic surgeons, including as one of the options for simultaneous treatment of breast FA and augmentation mammoplasty. The occurrence of FA in the long-term period after breast augmentation surgery is associated with difficulties in diagnostics (mammography and fine needle aspiration biopsy under the control of ultrasound), as well as in the course of surgery itself, due to the presence of the implant and the risk of violation of its integrity.

scholarly journals Transscleral vs Endoscopic Cyclophotocoagulation: Safety and Efficacy When Combined with Phacoemulsification

2021 ◽  
Author(s):  
Abraham Nirappel ◽  
Emma Klug ◽  
Cameron Neeson ◽  
Mari Chachanidze ◽  
Nathan Hall ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Open Angle Glaucoma ◽  
Common Type ◽  
Complication Rates ◽  
Kaplan Meier ◽  
Surgical Failure ◽  
Transscleral Cyclophotocoagulation ◽  
The Mean

Abstract Precis: Phacoemulsification combined with MicroPulse transscleral cyclophotocoagulation appears to provide significantly greater long-term IOP reduction than phacoemulsification combined with endoscopic cyclophotocoagulation without compromising safety.Purpose: To compare the effectiveness and safety of phacoemulsification combined with endoscopic cyclophotocoagulation (phaco/ECP), phacoemulsification combined with MicroPulse transscleral cyclophotocoagulation (phaco/MP-TSCPC), and phacoemulsification alone (phaco) in the treatment of coexisting cataract and glaucoma. Methods: Retrospective cohort study of consecutive cases at Massachusetts Eye & Ear. The main outcome measures were the cumulative probabilities of failure between the phaco/ECP group, phaco/MP-TSCPC group, and the phaco alone group with failure defined as reaching NLP vision at any point postoperatively or the inability to maintain ≥20% IOP reduction from baseline with IOP between 5-18 mmHg. Additional outcome measures included changes in average IOP, number of glaucoma medications, and complication rates. Results: 64 eyes from 64 patients (25 phaco/ ECP, 20 phaco/ MPTSCPC, 19 phaco alone) were included in this study. The groups did not differ in age (mean 71.04 ± 6.7 years) or length of follow-up time. Primary open-angle glaucoma was the most common type of glaucoma in the phaco alone (42%) and phaco/ECP (48%) groups while mixed-mechanism glaucoma was the most common type in the phaco/MP-TSCPC group (40%). The mean IOP reductions at 1 year were 3.07 ± 5.3 mmHg from a baseline of 15.78 ± 4.7 in the phaco/ECP group, 6.0 ± 4.3 mmHg from a baseline of 18.37 ± 4.6 in the phaco/MP-TSCPC group and 1.0 ± 1.6 from a baseline of 14.30 ± 4.2 mmHg in the phaco alone group. Surgical failure was less likely in eyes in the phaco/MP-TSCPC and phaco/ECP groups compared to phaco alone based on the Kaplan-Meier survival criteria, with failure defined as the inability to maintain an IOP reduction of 20% or more with IOP between 5-18 mm Hg long term. There were no differences in complications among the three groups. Conclusions: Phaco/MP-TSCPC appears to provide for greater long-term IOP control than phaco alone and phaco/ECP. All three procedures had similar safety profiles.

scholarly journals Impact of malignancy on outcomes in European patients with atrial fibrillation: a report from the ESC-EHRA EURObservational Research Programme in Atrial Fibrillation General Long-Term Registry

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
V L Malavasi ◽  
M Vitolo ◽  
M Proietti ◽  
L Fauchier ◽  
F Marin ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Regression Analysis ◽  
Lower Risk ◽  
Cox Regression ◽  
Cumulative Risk ◽  
Research Programme ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
Prior Malignancy

Abstract Background Management of patients with atrial fibrillation (AF) and malignancy is a clinical challenge given the paucity of evidence supporting the appropriate clinical management. Purpose To evaluate the outcomes of patients with active or prior malignancy in a large contemporary cohort of European AF patients. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. We stratified the population into three categories (i) No Malignancy (NoM) (ii) Prior Malignancy (PriorM) and (iii) Active Malignancy (ActM). The primary outcome for this analysis was all-cause death among the three groups. The association between anticoagulant treatment, all-cause death and haemorrhagic events was also evaluated. Results Among the original 11 096 AF patients enrolled, 10 383 were included in this analysis (median age 71 years (interquartile range [IQR] 63–77, males 59.7%). Of these, 9 597 (92.4%) were NoM patients, 577 (5.6%) PriorM and 209 (2%) ActM. Patients with malignancy (prior or active) had a higher median age, median CHA2DS2-VASc and HAS-BLED scores, compared to patients without malignancy (p<0.001). Lack of anticoagulation (AC) prescription occurred more commonly in ActM (21.5%) as compared with the other groups (PriorM 10.1% vs NoM 12.8%, p<0.001). In case of AC treatment, patients with ActM were treated more frequently with heparins (ActM 8.1% vs PriorM 2.4% vs NoM 2%, p<0.001). After a median follow-up of 730 days [IQR 692–749], 982 (9.5%) patients died. Among all deaths, the proportion of cardiovascular death was different according to the three groups (40.0% in NoM, 26.0% in PrioM and 22.2% in ActM, p=0.002). For all cause-death, Kaplan-Meier analysis showed a progressively higher cumulative risk in the PriorM and ActM groups compared to NoM patients (Figure 1). On multivariable Cox regression analysis, adjusted for CHA2DS2-VASc score, use of AC, type of AF and chronic kidney disease, ActM group was independently associated with a higher risk for all cause death (hazard ratio [HR] 2.90, 95% confidence interval [CI] 2.23–3.76) while PriorM group was not. Among PriorM and NoM patients, multivariable adjusted Cox regression analysis found that the use of any AC was independently associated with a lower risk for all-cause death (HR 0.36, 95% CI 0.19–0.66; HR 0.66, 95% CI 0.54–0.81). No significant association between AC and all-cause death was found for ActM patients. Conclusions In a large contemporary cohort of European AF patients, active malignancy was found to be independently associated with all-cause death. Use of any AC was associated with a lower risk for all-cause death in patients with no malignancies and with prior malignancies, but with no significant association amongst patients with active malignancies. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): Since the start of EORP, the following companies have supported the programme: Abbott Vascular Int. (2011–2021), Amgen Cardiovascular (2009–2018), AstraZeneca (2014–2021), Bayer (2009–2018), Boehringer Ingelheim (2009–2019), Boston Scientific (2009–2012), The Bristol Myers Squibb and Pfizer Alliance (2011–2016), The Alliance Daiichi Sankyo Europe GmbH and Eli Lilly and Company (2011–2017), Edwards (2016–2019), Gedeon Richter Plc. (2014–2017), Menarini Int. Op. (2009–2012), MSD-Merck & Co. (2011–2014), Novartis Pharma AG (2014–2020), ResMed (2014–2016), Sanofi (2009–2011), SERVIER (2010–2021), and Vifor (2019–2022). Figure 1. Kaplan-Meier for all-cause death

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