ESC-2015ESC-2015Univ.-Prof. Dr. Wilhelm Haverkamp

Stellvertretender Klinikdirektor

Charité - Universitätsmedizin Berlin

Medizinische Klinik mit Schwerpunkt Kardiologie

ALBATROSSALBATROSS

EPHESUSEPHESUS

EPHESUS, Therapiebeginn im Mittel 7 Tage nach Myokardinfarkt mit linksventrikulärer Dysfunktion (EF<40%) und Herzinsuffizienz Pitt et al., 2003

ALBATROSS StudyALBATROSS Study

• Aldosterone Lethal effects Blockade in Acute myocardial

infarction Treated with or without Reperfusion to

improve Outcome and Survival at Six months follow-up

ALBATROSS: DesignALBATROSS: Design

ALBATROSS: Primary endpointALBATROSS: Primary endpoint

ALBATROSS: DeathALBATROSS: Death

ALBATROSS: ConslusionsALBATROSS: Conslusions

CIRCUSCIRCUS

Does Does CCyclosporine yclosporine IImpmpRRove ove CClinical linical ooUUtcometcome

in in SST-elevation myocardial infarction T-elevation myocardial infarction patients ?patients ?

(the CIRCUS study)(the CIRCUS study)

• Michel OVIZE, MD, PhD Louis Pradel Hospital and

Claude Bernard University, Lyon, France

CIRCUS: DesignCIRCUS: Design

Secondary outcomes at 1 yearSecondary outcomes at 1 year

Cyclosporine(n=395)

Control(n=396)

Odds Ratio(95% CI)

P value

Death: all-cause 7.1 % 6.6 % 1.09[0.63 ; 1.90]

0.76

Death: cardiovascular

6.1 % 6.1 % 1.01[0.56 ; 1.81]

0.98

HF worsening or re-hospitalization for HF

22.8 % 22.7 % 1.01[0.72 ; 1.41]

0.97

Re-hospitalization for HF

10.6 % 10.4 % 1.03[0.65 ; 1.63]

0.65

ConclusionConclusion

• In anterior STEMI, cyclosporine did not reduce the risk of the composite primary outcome

– One out of four patients died or experienced heart failure despite receiving state-of-the-art medical care.

– Despite the results of CIRCUS, reperfusion injury is clinically important. The impact on clinical outcomes of recent encouraging phase II trials remains to be determined.

UNDER-ATPUNDER-ATPEAST-AFEAST-AF

PulmonalvenenisolationPulmonalvenenisolation

Verma et al, 2015

AF-Ablation: Persistierendes VHFAF-Ablation: Persistierendes VHF

Verma et al, 2015

UNmasking Dormant Electrical UNmasking Dormant Electrical ReconductionReconduction

by Adenosine TriPhosphateby Adenosine TriPhosphate

• Atsushi Kobori, Koichi Inoue, Kazuaki Kaitani, Yuko

Nakazawa, Toshiya Kurotobi, Itsuro Morishima,

Fumiharu Miura, Takeshi Morimoto, Takeshi Kimura,

and Satoshi Shizuta

BackgroundBackground

• Adenosine (triphosphate) has been reported to provoke dormant electrical conduction between the left atrium and Pulmonary Veins (PV) after an initially successful PV isolation (PVI).

• Adenosine triphosphate (ATP) guided PVI has been shown to improve the outcomes of AF ablation.

Hachiya H, et al. J Cardiovasc Electrophysiol. 2007;18(4):392.

Matsuo S, et al. J Cardiovasc Electrophysiol. 2007;18(7):704.

Kumagai K, et al. J Cardiovasc Electrophysiol. 2010;21(5):494.

Macle L, et al. Lancet 2015;386,9994:672.

AimAim

• The aim of this large-scale (>2,000) multicenter

prospective randomized controlled trial was to evaluate

the efficacy of ATP-guided PVI as compared with

conventional PVI in patients undergoing AF ablation.

EndpointEndpoint

Primary endpoint

•Recurrent atrial tachyarrhythmias* at 1-year with a

blanking period of 90 days post ablation.

Event-free Survival from the Event-free Survival from the Primary EndpointPrimary Endpoint

Fre

edom

fro

m A

tria

l Tac

hyar

rhyt

hmia

s (%

) 100

80

60

40

20

0

0 90 180 270 365 465 Days After First Ablation

ATP-Guided PVI

Conventionaal PVI

68.7%

67.1 %

Log-rank P=0.19Adjusted HR 0.89, 95% CI 0.74-1.09, P=0.25

Intervall 0d 90d 180d

270d

365d

450d

ATP-Guided PVI; N at risk

1112 1111

896 800 625

Conventional PVI; N at risk

1001 999 787 701 533

Clinical Follow-upClinical Follow-up

• Periodical visits: @ 3-, 6-, and 12-month (ECG, blood

samples etc.)

• 2-week ambulatory electrogram recording: @ hospital-

discharge, 6-month and 12-month

• 24-hour Holter monitoring : @ 6- and 12-month

• Additional symptom driven ECG-monitoring

LEADLESS 2LEADLESS 2

Reddy et al, 2015

Leadless PMLeadless PM

Reddy et al, 2015

Leadless PMLeadless PM

Reddy et al, 2015

Leadless IILeadless II

Reddy et al, 2015

LEADLESS II: Procedural characteristicsLEADLESS II: Procedural characteristics

Reddy et al, 2015

LEADLESS II: Serious adverse eventsLEADLESS II: Serious adverse events

Reddy et al, 2015

AEGEANAEGEAN

AEGEAN: Assessment of an Education AEGEAN: Assessment of an Education and Guidance and Guidance program for Eliquis program for Eliquis

Adherence in Non-valvular AFAdherence in Non-valvular AF

• Primary Objective:

– To assess the impact of an educational program on

implementation phase adherence in patients taking apixaban

for SPAF. Assessed at 24 weeks after initiation using an EMD,

Helping Hand®

• Secondary Objectives:

– To assess the impact of an educational program on persistence

at 24 weeks inpatients taking apixaban

AEGEAN: Discussant reviewAEGEAN: Discussant review

• Importance

– First large prospective RCT of an educational intervention on adherence and

persistence to NOACs

– High rate of adherence and persistence overall on apixaban

– No additional value of a proactive educational program on adherence in the first 6

months of treatment, in a selected trial population

• Limitations

– Patient selection, which may not fully represent real life patients

• Measuring adherence increases adherence [the patient is ‘aware’]

• Comorbidities and regular healthcare professional contact may influence

adherence and persistence

– Not powered for efficacy and safety endpoints

– Long term adherence and persistence (beyond 6 months) may decrease over time