P666Anti-platelet therapy in the primary prevention of cardiovascular disease in patients with chronic obstructive pulmonary disease: randomised controlled proof of concept trial (APPLE COPD-ICON 2)
The APPLE COPD-ICON2 trial is a prospective 2x2 factorial, double blinded proof of concept randomised controlled trial targeting patients with chronic obstructive pulmonary disease (COPD) at high risk of cardiovascular disease. The primary goal was to investigate if antiplatelet therapy (APT) will produce the predefined cut-off of platelet inhibition measured using the Multiplate test. We also assessed inflammatory biomarkers in serum. Patients were randomised to Aspirin plus placebo, ticagrelor plus placebo, Aspirin plus ticagrelor or placebo only for 6 months. The primary outcome is inhibition of arachidonic acid (ASPI-test, cut-off <40) and adenosine diphosphate (ADP-test, cut-off <46) induced platelet aggregation at 6 months based on intention to treat (ITT) and sensitivity per protocol (PP) analyses. Safety outcomes included rates of major/minor bleeding. Of 543 patients screened, 120 were recruited (mean age of 67.5 years). The ITT response rate to Aspirin was 48.3% (95%......Read more
274 Poster Session 1: Atrial fibrillation, anti-platelet therapy, anticoagulation and bleeding P666 Anti-platelet therapy in the primary prevention of cardiovascular disease in patients with chronic obstructive pulmonary disease: randomised controlled proof of concept trial (APPLE COPD-ICON 2) V. Kunadian, N. Wilson, D. Stocken, H. Ali, E. McColl, G. Burns, N. Howe, A. Fisher, A. De Soyza Newcastle University, Newcastle upon Tyne, United Kingdom Funding Acknowledgement: Astra Zeneca (Funder reference number ISSBRIL0303) The APPLE COPD-ICON2 trial is a prospective 2x2 factorial, double blinded proof of concept randomised controlled trial targeting patients with chronic obstructive pulmonary disease (COPD) at high risk of cardiovas- cular disease. The primary goal was to investigate if antiplatelet therapy (APT) will produce the predefined cut-off of platelet inhibition measured using the Multiplate test. We also assessed inflammatory biomarkers in serum. Patients were randomised to Aspirin plus placebo, ticagrelor plus placebo, Aspirin plus ticagrelor or placebo only for 6 months. The primary out- come is inhibition of arachidonic acid (ASPI-test, cut-off <40) and adeno- sine diphosphate (ADP-test, cut-off <46) induced platelet aggregation at 6 months based on intention to treat (ITT) and sensitivity per protocol (PP) analyses. Safety outcomes included rates of major/minor bleeding. Of 543 patients screened, 120 were recruited (mean age of 67.5 years). The ITT response rate to Aspirin was 48.3% (95% confidence interval [CI] 35.8–61.0%) according to ASPI-test and the response rate to ticagrelor was 41.4% (95% CI 29.3–54.6%) according to ADP-test. The PP ASPI- test response rate to Aspirin was 68.3% (95% CI 52.3–80.9%) and the PP ADP-test response rate to ticagrelor was 68.8% (95% CI 50.4–82.6%). There were no differences between the groups in the changes in Quality of Life using questionnaires (EQ5D 5L, St. George’s COPD-C), inflamma- tory markers, carotid intima media thickness and vascular stiffness from baseline to 6-months. There were 5 type 1 bleeds according to the BARC criteria recorded in this study; 2 in the placebo arm, 2 in the Aspirin arm, and 1 in the ticagrelor arm. The MRC Dyspnoea score, FEV1 and FVC was similar across the groups. Nearly one third of COPD patients did not have a platelet response to anti- platelet therapy with Aspirin and ticagrelor. These findings support the high pro-thrombotic milieu and the need for further research in COPD patients. Primary outcome measures Aspirin No Aspirin Ticagrelor No Ticagrelor ITT analysis set* n 60 60 58 62 Baseline No. of responders 1 6 4 1 % (95% CI) 1.7 (0.2, 11.3) 10 (4.5, 20.8) 6.9 (2.6, 17.3) 1.6 (0.2, 10.9) 6 months No. of responders 29 7 24 2 % (95% CI) 48.3 (35.8, 61) 11.7 (5.6, 22.8) 41.4 (29.3, 54.6) 3.2 (0.8, 12.3) PP analysis set** n 41 45 32 54 6 months No. of responders 28 7 22 2 % (95% CI) 68.3 (52.3, 80.9) 15.6 (7.5, 29.6) 68.8 (50.4, 82.6) 3.7 (0.9, 14.0) *Descriptive statistics for the primary outcome of response for the comparative groups at baseline and 6 months for the ITT analysis set and **PP analysis set. Note that response is ASPI response in the Aspirin and No Aspirin columns and ADP response in the ticagrelor and No ticagrelor columns. Primary outcome measure ESC Congress 2019 together with World Congress of Cardiology 31 August – 4 September 2019, Paris - France Downloaded from https://academic.oup.com/eurheartj/article/40/Supplement_1/ehz747.0272/5594255 by guest on 24 January 2023
274
Poster Session 1: Atrial fibrillation, anti-platelet therapy, anticoagulation and bleeding
P666
Anti-platelet therapy in the primary prevention of cardiovascular disease in patients with chronic
obstructive pulmonary disease: randomised controlled proof of concept trial (APPLE COPD-ICON 2)
V. Kunadian, N. Wilson, D. Stocken, H. Ali, E. McColl, G. Burns, N. Howe, A. Fisher, A. De Soyza
Newcastle University, Newcastle upon Tyne, United Kingdom
Funding Acknowledgement: Astra Zeneca (Funder reference number ISSBRIL0303)
35.8–61.0%) according to ASPI-test and the response rate to ticagrelor
was 41.4% (95% CI 29.3–54.6%) according to ADP-test. The PP ASPItest response rate to Aspirin was 68.3% (95% CI 52.3–80.9%) and the
PP ADP-test response rate to ticagrelor was 68.8% (95% CI 50.4–82.6%).
There were no differences between the groups in the changes in Quality
of Life using questionnaires (EQ5D 5L, St. George’s COPD-C), inflammatory markers, carotid intima media thickness and vascular stiffness from
baseline to 6-months. There were 5 type 1 bleeds according to the BARC
criteria recorded in this study; 2 in the placebo arm, 2 in the Aspirin arm,
and 1 in the ticagrelor arm. The MRC Dyspnoea score, FEV1 and FVC was
similar across the groups.
Nearly one third of COPD patients did not have a platelet response to antiplatelet therapy with Aspirin and ticagrelor. These findings support the high
pro-thrombotic milieu and the need for further research in COPD patients.
Primary outcome measures
ITT analysis set*
Baseline
6 months
PP analysis set**
6 months
n
No. of responders
% (95% CI)
No. of responders
% (95% CI)
n
No. of responders
% (95% CI)
Aspirin
No Aspirin
Ticagrelor
No Ticagrelor
60
1
1.7 (0.2, 11.3)
29
48.3 (35.8, 61)
41
28
68.3 (52.3, 80.9)
60
6
10 (4.5, 20.8)
7
11.7 (5.6, 22.8)
45
7
15.6 (7.5, 29.6)
58
4
6.9 (2.6, 17.3)
24
41.4 (29.3, 54.6)
32
22
68.8 (50.4, 82.6)
62
1
1.6 (0.2, 10.9)
2
3.2 (0.8, 12.3)
54
2
3.7 (0.9, 14.0)
*Descriptive statistics for the primary outcome of response for the comparative groups at baseline and 6 months for the ITT analysis
set and **PP analysis set. Note that response is ASPI response in the Aspirin and No Aspirin columns and ADP response in the
ticagrelor and No ticagrelor columns.
Primary outcome measure
ESC Congress 2019 together with World Congress of Cardiology
31 August – 4 September 2019, Paris - France
Downloaded from https://academic.oup.com/eurheartj/article/40/Supplement_1/ehz747.0272/5594255 by guest on 24 January 2023
The APPLE COPD-ICON2 trial is a prospective 2x2 factorial, double
blinded proof of concept randomised controlled trial targeting patients with
chronic obstructive pulmonary disease (COPD) at high risk of cardiovascular disease. The primary goal was to investigate if antiplatelet therapy
(APT) will produce the predefined cut-off of platelet inhibition measured
using the Multiplate test. We also assessed inflammatory biomarkers in
serum.
Patients were randomised to Aspirin plus placebo, ticagrelor plus placebo,
Aspirin plus ticagrelor or placebo only for 6 months. The primary outcome is inhibition of arachidonic acid (ASPI-test, cut-off <40) and adenosine diphosphate (ADP-test, cut-off <46) induced platelet aggregation at 6
months based on intention to treat (ITT) and sensitivity per protocol (PP)
analyses. Safety outcomes included rates of major/minor bleeding.
Of 543 patients screened, 120 were recruited (mean age of 67.5 years).
The ITT response rate to Aspirin was 48.3% (95% confidence interval [CI]
Kinetic impacts of two DBU-based ionic liquids in the three-component synthesis of 1H-pyrazolo[1,2-b]phthalazine-5,10-diones and the mechanism of the reaction were investigated by DFT calculations.
A disseminação do conhecimento científico pela Comissão de Direito Imobiliário e Urbanístico da Ordem dos Advogados do Brasil em Londrina é iniciativa da Doutora Ana Lucia Arruda dos Santos Silveira, que, em 2018, à época presidindo a Comissão, confiou a mim e a Professora e Doutora Adiloar Franco Zemuner a organização do primeiro volume da obra Estudos em Direito Imobiliário e em Direito Urbanístico. Nos anos seguintes o empreendimento foi mantido com o lançamento de outros dois volumes, graças ao comprometimento dos demais membros da comissão, que produziram artigos relevantes mesmo com o advento de uma pandemia. A firmação desses esforços agora se dá com o lançamento do quarto volume da obra, organizado pelos Doutores Renata Calheiros Zarelli e Gabriel Carmona Baptista. Os artigos foram criteriosamente escolhidos e reverberam não só a intensa e recente alteração legislativa, notadamente no campo do direito imobiliário, mas também uma perspectiva civil-constitucional aos temas escolhidos, exemplificados, respectivamente, pelo trato ao princípio da concentração dos atos na matrícula com o advento da Lei 14.382/2022 e o respeito à função social da cidade como limitação ao direito de construir. Mais uma vez, o conteúdo oferecido ao púbico é de excelente qualidade e contribuirá para a construção do conhecimento daquele operador do direito que se ocupa das questões ligadas ao direito imobiliário e urbanístico. Tudo a impor a recomendação de leitura da obra.
ALESSANDRO MARINELLI DE OLIVEIRA.
Doutorando em Filosofia Política. Mestre em Direito Negocial. Professor do
Departamento de Direito Privado da UEL. Advogado.
In this paper, the architecture of a versatile networking and control platform for Light-Emitting Diode (LED) lighting applications is presented, based on embedded wireless and wired networking technologies. All the possible power and control signals distribution topologies of the lighting fixtures are examined with particular focus on dynamic lighting applications with design metrics as the cost, the required wiring installation expenses and maintenance complexity. The proposed platform is optimized for applications where the grouping of LED-based lighting fictures clusters is essential, as well as their synchronization. With such an approach, the distributed control and synchronization of LED lighting fixtures' clusters is performed through a versatile network that uses the single wire Local Interconnect Network (LIN) bus. The proposed networking platform is presented in terms of its physical layer architecture, its data protocol configuration, and its functionality for smart ...