If there was one theme presented at the recent American College of Cardiology (ACC) conference, it was ever increasing role of data of all kinds.
New therapies or devices initially focus on clinical data demonstrating key end points that are important for introducing the therapy to the market. An example of this type of data presented on the weekend was the 3-year survival data from the PARTNER trial
examining transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR). Approved for the surgically ineligible originally, and then for high-risk surgical patients last year, the Sapien transcatheter valve continues to demonstrate that TAVR is noninferior to SAVR. The positive clinical data presented at ACC and other conferences in the past 3 years has spurred been a strong initial uptake of the therapy in the US.
Moving beyond initial trials to prove the viability of a therapy are the data presented on next generations of therapies and devices. Again, the transcatheter heart valve space is a great example of this kind of data presented at ACC. Building on PARTNER, the PARTNER II trial
demonstrated that Edwards Lifesciences? next-generation Sapien XT valve was noninferior to the Sapien valve. While the Sapien XT did not demonstrate a lower rate of death or stroke than the original Sapien valve (it did at 30 days but it wasn?t statistically significant), it did show improved rates of vascular events at 30 days. One interesting note from the trial was the trend toward increased aortic and paravalvular leakage in the new Sapien XT valve. Regurgitation has become a key focus for physicians and new companies interested in transcatheter heart valves because it represents a serious complication. While this is bad news for Edwards Lifesciences, it's probably welcome news for Direct Flow Medical, which presented initial 6-month results from its DISCOVER
trial showing excellent scores for aortic regurgitation. Given that this smaller company is going to try to compete against some medtech giants in this space, this data will be key for the company. Interestingly, this company's TAVR device is unique in that it eschews a metal frame in favor of an inflatable valve.
Another type of data that played a key role at ACC was data that physicians provide to document their cases. The appropriate usage criteria for percutaneous coronary interventions (PCIs), which has been in the media spotlight, was the focus of multiple sessions. Physicians are increasingly being asked to provide data justifying their choice of procedures, and talks over the weekend indicated that physicians need to make sure that their coding and communication of findings is thorough and well documented. While some physicians will bemoan the increasing scrutiny of their practices, the speakers were adamant in trying to convince their colleagues that these guidelines were here to stay.
And this is not even speaking to the personal data collected by the RFID badges?so, overall, I guess we shouldn?t be surprised that the ?Clinical Trials? chapters in our cardiovascular reports are about three times longer than most other therapy areas.