2015 MedDeviceTracker Post-EuroPCR Report

EuroPCR was held this year from May 17-20 in Paris, France.

The presentations provided new and updated results from ongoing trials in the growing areas of the cardiovascular space. This cardiology report highlights results from trials of both approved and investigational devices in transcatheter aortic valve replacement (TAVR/TAVI), cerebral protection, coronary stents with biodegradable polymers and scaffolds, drug-eluting balloons, and optical coherence tomography (OCT). The content includes analysis of data presented at EuroPCR 2015 as well as data from previous relevant studies and data presentations. *For presentations and abstracts not mentioned in this report but included in the MDT database, see the EuroPCR 2015 Event List on page 31.

The bullets below provide highlights from these and other presentations.

Transcatheter Valve Replacement (TAVR/TAVI and TMVR/TMVI)

• Strong clinical outcomes from CE Mark study of Sapien 3 in high risk and intermediate patients, with the presenter for the intermediate risk group suggesting it could challenge surgical replacement as the gold standard in the elderly.
• Evolut R, Lotus, and Direct Flow also had good clinical outcomes data, though not all of the datasets were large enough to draw conclusions.
  • Lotus, while demonstrating the lowest rates of paravalvular leak, still had high rates of permanent pacemaker placement, despite inclusion of the 25 mm valve.
  • We note some numerical differences in the outcomes data compared to Sapien 3, but the studies are too small and populations too different to know if they are real.
• Remaining issues for TAVI and implications for moving to younger, lower risk patients, from a panel discussion.
• Studies on leaflet thickening somewhat reassuring, but small, so more data is needed.
• First-in-man data for Biovalve is mixed; more work is needed.
• Updated data for TriGuard embolic protection device without major new findings, except difference from control on cognitive measures no longer as apparent. More details were presented on differences in findings for Sapien 3 and CoreValve.

Coronary Stents

• In the battle between stents with biodegradable polymers, Orsiro meets non-inferiority with Nobori in large independent study (SORT OUT VII).
  • A significant reduction in stent thrombosis may allay some concerns raised by the BIOSCIENCE study where the stent was compared to Xience, though of course there is still a question whether the degrading polymer gives Orsiro any clear advantage over modern durable polymer stents.
• Elixir touts early "golden tube" seen with DESolve in update from CE Mark study.

Drug-Eluting Balloons (DEB)

• IN.PACT Admiral has encouraging data in longer peripheral arterial lesions, comparable to results in shorter plaques. 2-year data for the shorter plaques expected in the fall.

Intra-Coronary Imaging

• Tentative preliminary data presented for Ilumien OCT.
  • On usefulness of information, Ilumien OCT resulted in a large number of decision changes after FFR and angiography. Suggestion of lower MACE, but data are quite tentative, driven by a small group with both pre- and post-PCI changes.
  • Propensity-matched comparison with IVUS found similar stent expansion, though slightly higher in-segment % diameter stenosis.