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ONGOING AND FUTURE ATHEROSCLEROSIS TRIALS

Chairpersons: Wolfgang Koenig (Munich, GER), Jean Claude Tardif (Montreal, CAN)
9.30 am – 12.30 pm / 2.00 pm – 3.30 pm
Residual risk still represents an important issue in patients with manifest cardiovascular
disease despite standard of care treatment. Thus, over 5 years post-ACS still 20% of
patients have experienced a recurrent event.
Several additional strategies have been reported this year or are presently being tested
in large clinical trials like aggressive lowering of LDL cholesterol by PCSK9 inhibition or
an RNA silencing mechanism, lowering of Lp(a) and finally triglycerides (TG) have seen
a revival and their lowering is presently being tested in several trials applying different
interventions like high-dose omega-3 and 6 or a SPARM (selective PPARα modulator).
But novel strategies are at the horizon.
The recently published FOURIER Study has shown a 20% decrease of a combined
endpoint consisting of cardiovascular death, MI and stroke in stable patients with
manifest atherosclerosis and an index event that had occurred 3 years before
randomization. These results fit very nicely in the cholesterol trialists estimation.
However, despite having reached on treatment LDL-C levels of 30 mg/dl there was a
significant number of patients with recurrent events, which is in line with 36% of patients
showing progression in the previously published GLAGOV IVUS Trial also with
evolocumab. Thus, there is room for other pathomechanisms and anti-inflammatory
treatment on top of standard of care might represent a further option. During ESC this
year results of the CANTOS trial in which 10,000 post MI patients were treated with an
interleukin-1β antagonist have been presented, showing a positive outcome with a
similar effect size on major cardiovascular endpoints as seen during potent LDL-C
lowering with a PCSK9 inhibitor. Thus, this implicates proof of the “inflammation
hypothesis” and a paradigm change in the treatment of patients with manifest
atherosclerosis. This may enable a personalized approach to treatment identifying those
with “residual cholesterol risk” versus those with “residual inflammatory risk”.
PCSK9 Trials
· PCSK9: From discovery to clinical evidence
Marianne Abi-Fadel (Beirut, LEB)
· FOURIER: enough evidence to justify widespread use? Did it fulfill its
expectations?
Marc Sabatine (Boston, USA)

Trials of agents targeting inflammation
· CANTOS: Anti-inflammatory treatment in the context of extreme low LDL
levels. Is there still room for improvement?
Paul Ridker (Boston, USA)
· Lessons from COLCOT and other ongoing and future anti-inflammatory
trials
Jean Claude Tardif (Montreal, CAN)
Further insights regarding into triglycerides as a target for intervention:
· Ongoing clinical trials: STRENGTH and PROMINENT
Aruna Pradhan (Boston, USA)
· Targeting triglycerides: Is angiopoietin-like 4 (ANGPLT 4) a new target?
Insights from genomic studies
Heribert Schunkert (Munich, GER)
· Would angiopoietin-like 3 (ANGPLT 3) be the better target?
Sotirios Tsimikas (Ionis Pharmaceutical, USA)
Gaining precision with cardiovascular clinical trials using genomics
Marie-Pierre Dubé (Montréal, CAN)
Percutaneous coronary intervention in stable angina (ORBITA Trial)
Darrel Francis (London, GBR)
Industry viewpoint: Don Black (Dalcore, CAN), Jay Edelberg (Sanofi, FRA), Narimon
Honarpour (Amgen, USA), David Kallend (The Medicine Company, USA), Tom Thuren
(Novartis, CHE),
Regulatory viewpoint: Pieter DeGraeff (EMA, NED), Jim Smith (FDA, USA)
Payers viewpoint: How much PCSK9 inhibition can the health care system afford?
Jakub P. Hlavka (Santa Monica, USA)
Patient viewpoint: Annemieke Lenselink (The Hague Area, NED), Marilyn Mann
(Patient advocate, USA)

12.30 pm – 1.00 pm
Key note lecture
“Can We Abolish Coronary Artery Disease?”
Eugene Braunwald (Boston, USA)
The Forum. Moderated discussion with the audience
Regulatory and reimbursment Challenges
Chairpersons: Wolfgang Koenig (Munich, GER), Jean Claude Tardif (Montreal, CAN)
Panelists: Marianne Abi-Fadel (Beirut, LEB), Don Black (Dalcore, CAN), Eugene
Braunwald (Boston, USA), Pieter DeGraeff (EMA, NED), Marie-Pierre Dubé (Montréal,
CAN), Jay Edelberg (Sanofi, FRA), Darrel Francis (London, GBR), Jakub P. Hlavka
(Santa Monica, USA), Narimon Honarpour (Amgen, USA), Larry Husten (CardioBrief,
USA), David Kallend (The Medicine Company, USA), Wolfgang Koenig (Munich, GER),
Annemieke Lenselink (The Hague Area, NED), Marilyn Mann (Patient advocate, USA),
Aruna Pradhan (Boston, USA), Paul Ridker (Boston, USA), Marc Sabatine (Boston,
USA), Heribert Schunkert (Munich, GER), Jim Smith (FDA, USA), Jean Claude Tardif
(Montreal, CAN), Tom Thuren (Novartis, CHE), Sotirios Tsimikas (Ionis Pharmaceutical,
USA),