scholarly journals Acute Mechanical Performance of Magmaris vs. DESolve Bioresorbable Scaffolds in a Real-World Scenario

2021 ◽  
Vol 8 ◽  
Author(s):  
Niklas F. Boeder ◽  
Oliver Dörr ◽  
Tim Koepp ◽  
Florian Blachutzik ◽  
Stephan Achenbach ◽  
...  
Keyword(s):  
Real World ◽  
Mechanical Performance ◽  
Eccentricity Index ◽  
Real World Setting ◽  
Vascular Scaffold ◽  
High Adverse Event ◽  
The Mean ◽  
Absorb Bvs ◽  
Event Rates ◽  
Minimal Area

Background: After the bioresorbable PLLA-based vascular scaffold (Absorb BVS) was taken from the market due to its high adverse event rates, a magnesium-based scaffold (Magmaris) was introduced.Objective: To compare the acute performance of the sirolimus-eluting magnesium alloy Magmaris scaffold with that of the novolimus-eluting PLLA-based DESolve scaffold in terms of appropriate scaffold deployment using optical coherence tomography (OCT).Methods and Results: Data from the final OCT pullback of 98 patients were included (19 Magmaris, 79 DESolve) and analyzed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. OCT showed a minimum lumen area for Magmaris vs. DESolve of 6.6 ± 1.6 vs. 6.0 ± 1.9 (p = 0.06). Scaffolds with residual area stenosis >20% were predominantly seen in the DESolve group (15.8 vs. 46.8%; p = 0.01). The mean eccentricity index did differ significantly (0.74 ± 0.06 vs. 0.63 ± 0.09; p < 0.001). No fractures were observed for Magmaris scaffolds, but 15.2% were documented for DESolve BRS (p < 0.001). Incomplete scaffold apposition area was significantly higher in the DESolve group (0.01 ± 0.02 vs. 1.05 ± 2.32 mm2; p < 0.001).Conclusion: This is the first study to compare the acute mechanical performance between Magmaris and DESolve in a real-world setting. The acute mechanical performance of Magmaris BRS seems to be superior to that of DESolve BRS, whereas OCT showed a good acute mechanical performance for both BRS in terms of generally accepted imaging criteria.

Baseline characteristics and clinical features of patients with heart failure with reduced ejection fraction: a European real-world, non-interventional registry study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
U Zeymer ◽  
L.H Lund ◽  
V Barrios ◽  
C Fonseca ◽  
A.L Clark ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Real World ◽  
Nyha Class ◽  
Funding Source ◽  
Class Iii ◽  
Reduced Ejection Fraction ◽  
Cardioverter Defibrillator ◽  
Real World Setting ◽  
The Mean

Abstract Background Heart failure (HF) is a major medical and economic burden that is often managed in office based practices. Recently, the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan (S/V) was introduced as novel therapeutic option into European guidelines for the management of HF. The ARIADNE registry aims to provide information on how outpatients with HF with reduced ejection fraction (HFrEF) are managed in Europe, in light of this novel treatment option. Methods ARIADNE was a prospective registry of patients with HFrEF treated by office-based cardiologists (OBC) or selected primary care physicians (recognized as HF specialists; PCP) in a real world setting. HFrEF patients were included prospectively, independently of whether treatment had been changed recently or not. 9069 patients were recruited from 687 centres in 17 European countries. Results The mean age of all patients was 68.1 years (S/V: 67.3 years, Non-S/V: 68.9 years). The majority of patients were in NYHA class II (61.3%), or NYHA class III (37.1%) overall, while more patients in the S/V group showed NYHA class III (S/V: 42.8%, Non-S/V: 30.9%). Mean LVEF was slightly lower in the S/V group than in the Non-S/V group (S/V: 32.7%, Non-S/V: 35.4%, overall 34.0%). The most frequently observed signs of HF were dyspnoea upon effort, followed by fatigue, palpitations on exertion at baseline. More patients tend to have more severe symptoms in the S/V groups (e.g. for dyspnoea on effort, Non-S/V: moderate 40.8%, severe 8.6%; S/V: moderate 46.4%, severe 14.1%). 44.0% of patients from the S/V group and 39.3% of non-S/V patients reported at least one hospitalization within 12 months prior to baseline, of which 73.3% in S/V and 69.9% in non-S/V patients were due to HF., At baseline, 44.7% of the patients used a CV device, of which most were implantable cardioverter defibrillator (ICD: Non-S/V 54.2%, S/V: 52.8%), implantable cardioverter defibrillator (CRT-ICD:Non-S/V 21.9%, S/V: 27.0%), and pacemaker (Non-S/V: 13.4%, S/V: 10.5%). The mean KCCQ overall summary score was 62.6 in the S/V group and 69.5 in the Non-S/V group at baseline. 83.9% of patients were treated with ARB or ACEi in Non-S/V group, (ACEi 57.3%, ARB 26.9%). The most frequently taken drug combinations in either group were ACEi/ ARB or S/V with β -blockers (Non-S/V 69.3%, S/V 67.3%). 40.2% in the Non-S/V group and 42.9% in S/V groups used a combination of ACEi/ARB or S/V, β-blocker and MRA. Conclusions The ARIADNE prospective registry provides insights and reflects variations in HF treatment practices in outpatients in Europe and the way S/V was introduced by OBCs and specialized PCPs in a real-world setting. In the observed population, S/V is more often prescribed to slightly younger patients with slightly lower LVEF, there was a greater observed percentage of S/V patients NYHA class III, with lower quality of life measurements and with more severe symptoms and recent hospitalizations for heart failure. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis Pharma AG

scholarly journals Real-World Clinical Outcomes Associated with Canagliflozin in Patients with Type 2 Diabetes Mellitus in Spain: The Real-Wecan Study

2020 ◽  
Vol 9 (7) ◽  
pp. 2275
Author(s):  
Juan J. Gorgojo-Martínez ◽  
Manuel A. Gargallo-Fernández ◽  
Alba Galdón Sanz-Pastor ◽  
Teresa Antón-Bravo ◽  
Miguel Brito-Sanfiel ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Real World ◽  
Primary Outcome ◽  
Baseline Hba1c ◽  
Real World Setting ◽  
Antihyperglycemic Therapy ◽  
The Mean ◽  
Hba1c Levels

The aims of this multicentric retrospective study were to assess in a real-world setting the effectiveness and safety of canagliflozin 100 mg/d (CANA100) as an add-on to the background antihyperglycemic therapy, and to evaluate the intensification of prior sodium–glucose co-transporter type 2 inhibitor (SGLT-2i) therapy by switching to canagliflozin 300 mg/d (CANA300) in patients with T2DM. One cohort of SGLT2i-naïve patients with T2DM who were initiated on CANA100 and a second cohort of patients with prior background SGLT-2i therapy who switched to CANA300 were included in the study. The primary outcome of the study was the mean change in HbA1c over the follow-up time. In total, 583 patients were included—279 in the cohort of CANA100 (HbA1c 8.05%, weight 94.9 kg) and 304 in the cohort of CANA300 (HbA1c 7.51%, weight 92.0 kg). Median follow-up periods in both cohorts were 9.1 and 15.4 months respectively. CANA100 was associated to significant reductions in HbA1c (−0.90%) and weight (−4.1 kg) at the end of the follow-up. In those patients with baseline HbA1c > 8% (mean 9.25%), CANA100 lowered HbA1c levels by 1.51%. In the second cohort, patients switching to CANA300 experienced a significant decrease in HbA1c (−0.35%) and weight (−2.1 kg). In those patients with baseline HbA1c > 8% (mean 8.94%), CANA300 lowered HbA1c levels by 1.12%. There were significant improvements in blood pressure in both cohorts. No unexpected adverse events were reported. In summary, CANA100 (as an add-on therapy) and CANA300 (switching from prior SGLT-2i therapy) significantly improved several cardiometabolic parameters in patients with T2DM.

scholarly journals CRT-300.05 Impact of Intravascular Imaging Methods for Optimal Scaffold Implantation Reducing Thrombosis After Absorb Bvs in a Real World Setting: Identification of Factors Related to Stent Failure

2018 ◽  
Vol 11 (4) ◽  
pp. S37
Author(s):  
Sergio G. Tarbine ◽  
Costantino R. Costantini ◽  
Costantino O. Costantini ◽  
Marcelo F. Santos ◽  
Daniel Anibal Zanuttini ◽  
...  
Keyword(s):  
Real World ◽  
Intravascular Imaging ◽  
Imaging Methods ◽  
Real World Setting ◽  
Absorb Bvs

scholarly journals IMPACT OF INTRAVASCULAR IMAGING METHODS FOR OPTIMAL SCAFFOLD IMPLANTATION REDUCING THROMBOSIS AFTER ABSORB BVS IN A REAL WORLD SETTING: IDENTIFICATION OF FACTORS RELATED TO STENT FAILURE

2018 ◽  
Vol 71 (11) ◽  
pp. A1070
Author(s):  
Sergio Tarbine ◽  
Costantino Costantini ◽  
Costantino Costantini ◽  
Rafael Macedo ◽  
Marcelo de Freitas Santos ◽  
...  
Keyword(s):  
Real World ◽  
Intravascular Imaging ◽  
Imaging Methods ◽  
Real World Setting ◽  
Absorb Bvs

scholarly journals POS0296 DOSING OF BDMARDS IN AXSPA AND PSA IN A REAL WORLD SETTING

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 373.1-373
Author(s):  
A. Regierer ◽  
A. Weiß ◽  
D. Poddubnyy ◽  
H. Kellner ◽  
F. Behrens ◽  
...  
Keyword(s):  
Real World ◽  
Standard Dose ◽  
Research Support ◽  
Biologic Dmards ◽  
Real World Setting ◽  
The Mean ◽  
Receive Treatment ◽  
Prospective Longitudinal ◽  
Higher Doses

Background:The treatment of patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) has been revolutionised by the introduction of biologic DMARDs targeting TNF, IL17, and IL23 inhibitors (i). In Germany, about 30-50% of axSpA and PsA patients receive treatment with bDMARDs. Although many patients benefit from these drugs, in some patients effectiveness of the standard dose may be insufficient and higher doses are used.Objectives:To describe dosing of TNFi and non-TNFi bDMARDs over a 2 year period in a real world cohort of patients with axSpA and PsA managed by rheumatologists.Methods:RABBIT-SpA is a prospective longitudinal cohort study including axSpA and PsA patients enrolled at the start of a new conventional treatment (including NSAID) or b/tsDMARD treatment. Description of dosing of TNFi (adalimumab bio-original (bo), adalimumab bio-similar (bs), etanercept bo, etanercept bs, golimumab, certolizumab) in comparison to nonTNFi-bDMARDs (secukinumab, ustekinumab, ixekizumab, guselkumab) in axSpA and PsA. Standard dosing was defined according to the current labels for axSpA and PsA.Results:1628 patients (axSpA: n=903, PsA: n=725) were included in this analysis. At inclusion mean age was 44 years in axSpA and 51 years in PsA. 44% of patients with axSpA and 58% of those with PsA were female. The mean disease duration of axSpA was 7.6 years, of PsA 6.4 years.Standard doses of TNFi were used during a 2 year period in > 90% of patients with axSpA and PsA (Figure 1). In contrast, standard doses of non-TNFi-bDMARDs were only used in 70-80% of patients. The percentage of documented higher doses in patients with axSpA ranged from 20-30% at different time points. In PsA, this percentage increased from 27% at baseline to 44% at 2 years. On the other hand, TNFi were used in lower doses than the label in up to 9% and 7 % of patients with axSpA and PsA, respectively, after 2 years.Figure 1.Percentages of patients with axSpA or PsA who received less than, equal to, or more than the approved doses of bDMARDs at baseline and at 5 follow-up visits.Conclusion:While TNFi are used in licensed doses in most patients, non-TNFi-bDMARDs were often used in higher doses, which corresponds to higher doses approved in other indications like psoriasis. The effectiveness of this treatment strategy in axSpA and PsA needs to be analysed further.Acknowledgements:RABBIT-SpA is supported by a joint, unconditional grant from AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris.We thank all participating patients and rheumatologists.Disclosure of Interests:Anne Regierer Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris., Anja Weiß Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris., Denis Poddubnyy: None declared, Herbert Kellner: None declared, Frank Behrens: None declared, Georg Schett: None declared, Juergen Braun: None declared, Joachim Sieper: None declared, Anja Strangfeld Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, UCB, and Viatris

LONG TERM CLINICAL OUTCOMES AFTER IMPLANTATION OF ABSORB BVS IN A REAL WORLD SETTING, WITH PRE DILATATION AND GUIDED BY INTRAVASCULAR IMAGING

2020 ◽  
Vol 75 (11) ◽  
pp. 1327
Author(s):  
Sergio Tarbine ◽  
Costantino R. Costantini ◽  
Costantino Ortiz Costantini ◽  
Marcelo Freitas ◽  
Marcos Denk ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Intravascular Imaging ◽  
Real World Setting ◽  
Absorb Bvs

scholarly journals Real-World Effectiveness of Damoctocog Alfa Pegol in the Subgroup of Adolescent Hemophilia A Patients Aged 12-18 Years in the ATHNdataset

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4241-4241
Author(s):  
Martin Chandler ◽  
Michael Recht ◽  
Chunla He ◽  
Thomas Moulton ◽  
Lena Charafi
Keyword(s):  
Real World ◽  
Hemophilia A ◽  
Demographic Data ◽  
Weekly Dose ◽  
Bleeding Events ◽  
Group 13 ◽  
Real World Setting ◽  
Moderate Disease ◽  
Adolescent Patients ◽  
The Mean

Abstract Background: The ATHNdataset is a HIPAA-compliant, de-identified database, sponsored by the American Thrombosis and Hemostasis Network. Over 40,000 people with a bleeding or clotting disorder followed at United States hemophilia treatment centers (HTC) have submitted health information, including 15,747 hemophilia A patients. Aims: To evaluate the effectiveness of damoctocog alfa pegol (BAY 94-9027/Jivi®) to treat hemophilia A adolescent patients aged between 12-18 years in a real-world setting. Methods: The ATHNdataset was queried for people with hemophilia A aged ≥12 years of age treated with damoctocog alfa pegol. From this dataset adolescent patients aged between 12-18 years, treated either prophylactically or on-demand were identified. Collected data included baseline demographic data, treatment history, comorbidities and bleeding rates. The data were captured via patient chart review and entered into the database. The database was queried for patient data between January 1, 2010 and October 31, 2020. Results: At the data cutoff, 16 patients aged between 12-18 years were being treated with damoctocog alfa pegol. In this group, 13 patients (81%) had severe hemophilia A and 3 patients (19%) had mild/moderate disease. The majority of patients were male - 14/16 (87.5%) with 2/16 (12.5%) being female and the mean age of patients was 15.9 years old (median = 15.8). Of the total, 4 patients (25%) had a history of inhibitors. Patients had an average of 1.2 years of therapy with damoctocog alfa pegol and most (56%) had over 12 months of treatment. All the patients included in this analysis had documented bleeding rates in the ATHN system (Table 1). Mean total annualized bleed rate (ABR) was 0.05. Mean joint ABR and spontaneous ABR were zero. In the subgroup of patients who were on prophylaxis with damoctocog alfa pegol (n = 13), the mean total ABR, joint ABR and spontaneous ABR were zero. The proportion of patients with zero total bleeds during the entire observational period was 15/16 (94%) in the overall cohort and 13/13 (100%) in adolescent patients who were on prophylaxis. The majority of patients who were on prophylaxis 9/13 (69%) were treated twice-weekly with the mean weekly dose of 77.2 IU/kg/wk. Conclusions: The data from this analysis show that damoctocog alfa pegol provides protection from bleeding events in adolescent patients aged 12-18 years in the real-world setting. Mean ABR was low in this patient population, with 94% of patients experiencing zero bleeds. This data should be interpreted with caution due to limitations in real-world studies. Figure 1 Figure 1. Disclosures Recht: American Thrombosis and Hemostasis Network: Current Employment; Oregon Health & Science University: Current Employment; Foundation for Women and Girls with Blood Disorders, Partners in Bleeding Disorders: Speakers Bureau; uniQure: Consultancy; Takeda: Consultancy; Sanofi: Consultancy; Pfizer: Consultancy; Octapharma: Consultancy; Novo Nordisk: Consultancy; Kedrion: Consultancy; Hema Biologics: Consultancy; Genentech: Consultancy; CSL Behring: Consultancy; Catalyst Biosciences: Consultancy. He: ATHN: Ended employment in the past 24 months. Moulton: Bayer: Current Employment. Charafi: Bayer: Current Employment.

scholarly journals Intravitreal conbercept for choroidal neovascularisation secondary to pathological myopia in a real‐world setting in China

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xin Nie ◽  
Yulong Wang ◽  
Hong Yi ◽  
Yanbin Qiao
Keyword(s):  
Visual Acuity ◽  
Adverse Events ◽  
Real World ◽  
Retinal Thickness ◽  
Central Retinal Thickness ◽  
Pathological Myopia ◽  
Corrected Visual Acuity ◽  
Real World Setting ◽  
The Mean ◽  
Best Corrected Visual Acuity

Abstract Background To evaluate the 12-month efficacy and safety of intravitreal conbercept for myopic choroidal neovascularization (CNV). Methods A retrospective, observational study. Thirty-four eyes of 34 pathologic myopic patients with CNV were treated with intravitreal conbercept (IVC) 0.5 mg with a follow up of 12 months. After the first injection, administration of conbercept followed a pro re nata (PRN) regimen. Outcomes included best corrected visual acuity (BCVA), central retinal thickness (CRT), CNV size, the total number of treatments, and adverse events. Results The mean patient age was 55.88 ± 16.17 years, and the mean eye spherical equivalent was − 8.72 ± 3.75 D. The mean number of IVC over 12 months was 2.12 ± 0.69. Overall, best-corrected visual acuity(BCVA)improved from 0.86 ± 0.33 logMAR at baseline to 0.44 ± 0.32 logMAR at month 12 (p < 0.001), mean improvement of vision was 4.12 ± 2.69 lines. Mean central retinal thickness reduced from 285.9 ± 104.6 µm at baseline to 192.1 ± 97.5 µm at month 12 (p < 0.001). Mean CNV size decreased from 0.52 ± 0.38 mm2 at baseline to 0.31 ± 0.19 mm2 at 12 months (p < 0.05). All the 34 eyes had reduced or stable size of CNV. Thirty-two eyes (94.12 %) showed the absence of CNV leakage at the end of the study period. No severe systemic or ocular adverse events were observed. Conclusions Intravitreal conbercept 0.5 mg was safe and effective for treatment of myopic CNV over 12 months in a real-world setting.

Real-World Evaluation of Dosing in Patients Converted From Insulin Glargine (Lantus) to Insulin Glargine (Basaglar)

2020 ◽  
Vol 54 (9) ◽  
pp. 846-851 ◽  
Author(s):  
Jamie M. Pitlick ◽  
Ginelle A. Bryant ◽  
Michael W. Daly ◽  
Carrie F. Koenigsfeld ◽  
Nicholas Lehman ◽  
...  
Keyword(s):  
Insulin Glargine ◽  
Real World ◽  
Basal Insulin ◽  
Insulin Dose ◽  
Health Care Environment ◽  
Real World Setting ◽  
Significant Difference ◽  
Acquisition Costs ◽  
The Mean ◽  
Glycemic Outcomes

Background: Basaglar, insulin glargine (BGlar; Eli Lilly, Indianapolis, IN), a follow-on biologic, was developed after the patent for Lantus, insulin glargine (LGlar; Sanofi-Aventis, Paris, France) expired. Objective: To compare the dosing and hemoglobin A1C (A1C)-lowering effects of BGlar compared with LGlar in a real-world setting. Methods: Adult patients, at 5 clinics, with type 1 (T1DM) or type 2 diabetes mellitus (T2DM) who were converted from LGlar to BGlar were included in this retrospective observational study. The primary outcome compared mean basal insulin dose (U/d) from the date of conversion to 6 months. Basal insulin and total daily insulin doses were also compared from baseline to 3- and 12-months postconversion, as also change in A1C, body weight, and estimated monthly acquisition costs of basal insulin. Results: Of the 225 patients included, 56% were male, and 81% had T2DM. The mean conversion dose (U/d) of LGlar was 46.3 ± 32.7. There was no significant difference in the mean BGlar dose (U/d) at 6 months (45.9 ± 33.5; P = 0.52), nor was there a statistical difference at 3 or 12 months. There were no significant differences in change in A1C at any time point. The estimated monthly acquisition cost of BGlar was significantly less than that for LGlar at conversion ($286 vs $341, P < 0.001) and 6 months ($290 vs $351, P < 0.001) respectively. Conclusion/Relevance: The results of this retrospective study suggest that BGlar resulted in similar glycemic outcomes compared with LGlar in a real-world setting and may be a preferable option in a value-based health care environment.

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