Report Library
All Reports
2015 BioMedTracker / MedDeviceTracker Pre-ACC Report
March 06, 2015
The American College of Cardiology (ACC) 64th Annual Scientific Session will be held in San Diego, CA from March 14-16, 2015.
Major presentations will include Brilinta's (AZN) CV outcomes PEGASUS trial in prior heart attack patients. While top-line results already showed it met its primary endpoint, details will help gauge how much the drug could expand sales, which are currently moderate in the post-acute coronary syndrome (ACS) setting. In pulmonary arterial hypertension, Uptavi (Actelion) is the first oral prostacyclin agonist to show a morbidity/mortality benefit. Details from that study (GRIPHON) will likewise be important to determine potential usage.
The PCSK9 inhibitors have been a focus of recent CV conferences, and given they are likely to be approved this year, will continue to be of major interest, though much of the data being presented is incremental. Praluent (REGN, SNY) will have data from its monthly regimen in statin intolerant patients, though only in a poster. Repatha (AMGN) will have cardiovascular outcomes from controlled extension trials at a late-breaking session. If positive, it could reinforce confidence that the CV outcomes trials for the class will show a benefit, though that is widely expected. And both drugs will have more pooled safety analyses, which so far have not been showing any serious safety signals.
One potential wild card is Bendavia (Stealth), which targets mitochondria and has data from a Phase II trial on infarct size in a late- breaking session.
In the device space, the Sapien 3 (EW) TAVR device will have first data from its US IDE trial, though this is only single arm. CoreValve Evolut R (MDT) will have the first presentation of its 30-day CE Mark data. There is also a study comparing the Lotus Valve (BSX) to Sapien 3, both of which are on the market in Europe but not the US. Interestingly, there will also be an all-comer's trial of the earlier generation CoreValve (MDT) versus surgery that includes lower and intermediate risk patients. This could give a sense of what to expect from pivotal trials exploring expansion of TAVR use into intermediate risk groups.
Other interesting device presentations include first randomized results for the Triguard Cerebral Protection Device (Keystone), used in conjunction with TAVR valves, and first randomized results for Barostim (CVRx) in heart failure.
In this report we highlight details from these and a number of other selected presentations, in light of abstract results when they are posted (the higher profile studies do not generally list results).
Additionally, we have assembled a pre-meeting planner listing the sessions and posters to be presented at ACC. This can be found at the end of the report. To download the planner in Excel, please click the link under Support Material at the top of the page.
Please also see our special MedDeviceTracker report about TAVR/TAVI, as well as a European KOL interview on the topic.
For our disclosures, please read the BioMedTracker Research Standards.
Major presentations will include Brilinta's (AZN) CV outcomes PEGASUS trial in prior heart attack patients. While top-line results already showed it met its primary endpoint, details will help gauge how much the drug could expand sales, which are currently moderate in the post-acute coronary syndrome (ACS) setting. In pulmonary arterial hypertension, Uptavi (Actelion) is the first oral prostacyclin agonist to show a morbidity/mortality benefit. Details from that study (GRIPHON) will likewise be important to determine potential usage.
The PCSK9 inhibitors have been a focus of recent CV conferences, and given they are likely to be approved this year, will continue to be of major interest, though much of the data being presented is incremental. Praluent (REGN, SNY) will have data from its monthly regimen in statin intolerant patients, though only in a poster. Repatha (AMGN) will have cardiovascular outcomes from controlled extension trials at a late-breaking session. If positive, it could reinforce confidence that the CV outcomes trials for the class will show a benefit, though that is widely expected. And both drugs will have more pooled safety analyses, which so far have not been showing any serious safety signals.
One potential wild card is Bendavia (Stealth), which targets mitochondria and has data from a Phase II trial on infarct size in a late- breaking session.
In the device space, the Sapien 3 (EW) TAVR device will have first data from its US IDE trial, though this is only single arm. CoreValve Evolut R (MDT) will have the first presentation of its 30-day CE Mark data. There is also a study comparing the Lotus Valve (BSX) to Sapien 3, both of which are on the market in Europe but not the US. Interestingly, there will also be an all-comer's trial of the earlier generation CoreValve (MDT) versus surgery that includes lower and intermediate risk patients. This could give a sense of what to expect from pivotal trials exploring expansion of TAVR use into intermediate risk groups.
Other interesting device presentations include first randomized results for the Triguard Cerebral Protection Device (Keystone), used in conjunction with TAVR valves, and first randomized results for Barostim (CVRx) in heart failure.
In this report we highlight details from these and a number of other selected presentations, in light of abstract results when they are posted (the higher profile studies do not generally list results).
Additionally, we have assembled a pre-meeting planner listing the sessions and posters to be presented at ACC. This can be found at the end of the report. To download the planner in Excel, please click the link under Support Material at the top of the page.
Please also see our special MedDeviceTracker report about TAVR/TAVI, as well as a European KOL interview on the topic.
For our disclosures, please read the BioMedTracker Research Standards.
Disease Group Covered: |
Cardiovascular
Endocrine Metabolic |
Indications Covered: | Dysmenorrhea |
Additional Resources: