My Takeaways From TCT 2015
San Francisco, CA—Last week I was one of the roughly 11,000 people packing into TCT 2015 to watch live-case demonstrations and get breaking results from a host of major clinical trials. This year marked my fifteenth consecutive trip to the annual TCT meeting. That includes my first, to Washington, when the events of September 11, 2001, kept me from actually attending a session. Until now I’ve attended as a journalist at theheart.org, a position I made the difficult decision to leave last October.
I am coming home to cardiology after a whole year mostly spent thinking and writing about everything other than health and medicine. And I’ve returned with a brand-new mission—to serve as Editorial Director of the Cardiovascular Research Foundation, where I will be focusing my energies on TCTMD.com.
My new colleagues at TCTMD delved into many of these topics as part of their extensive coverage, including results from 16 simultaneously published trials, the most ever to come out of a TCT meeting. I used my time to check out as many different kinds of sessions as possible. Here are my thoughts on this year’s meeting.
A Return to the Coronaries
After several years of sessions crammed with transcatheter valve studies, TCT 2015 swung back to terrain that remains the most widely trodden by interventionalists: coronary stenting.
Topping the list were data on fully bioresorbable stents, including 1-year clinical results from the ABSORB III, the pivotal trial required to support US premarket approval of the Absorb BVS (Abbott Vascular), as well as 12-month angiographic findings from ABSORB China, 2-year results from ABSORB II, and first-in-human outcomes from BIOSOLVE-II. Both ABSORB III and ABSORB II showed the bioresorbable device to be noninferior to Xience, leaving interventionalists to speculate that any advantages to the “dissolving” stent may not emerge until several more years have passed.
Others, however, point out that the excellent outcomes for Xience in ABSORB III so far will be difficult to beat. Target lesion failure rates were just 6.1% and definite or probably stent thrombosis rates were a mere 0.7% at 1 year, compared to 7.8% and 1.5%, respectively, for the Absorb device (not a statistical difference for either endpoint).
Those numbers likely reflect the fact that operators have become expert at implanting Xience. In contrast, the absorbable device was typically being used by operators for the first time, with—in the minds of several panel discussants—suboptimal use of post-dilatation and IVUS. Whether unique advantages to the bioresorbable device emerge that are enough to justify what will inevitably be a pricier product remains to be seen. In the words of Daniel Simon, MD, of University Hospitals Case Medical Center (Cleveland, OH), at a TCT press conference: “This is very early on.”
These results, as well as those on bioabsorbable-polymer stents, spurred “big picture” discussions, including a debate over whether further innovation in the stent arena is money well spent. The upshot: session participants decided that even if a device is 80-90% “ideal,” there is still room for improvement.
Finally, radial PCI also added to its scorecard with DRAGON. The 1700-patient Chinese trial showed a radial approach to be noninferior to femoral for the composite primary endpoint of MACCE at 12 months and associated with fewer major bleeding complications at 7 days.
New Results and Reassurances For TAVR, SAVR
On the valve front, many interventional cardiologists are already eyeing the next frontier: mitral valve therapies. Each day at TCT 2015 featured debates, didactic sessions, and live case presentations dedicated to approved and emerging technologies for the treatment of mitral regurgitation.
For aortic valve disease, TCT 2015 saw results for first-in-human devices, positive longer term data for the CoreValve extreme- risk cohort, and 1-year data for the latest-generation Sapien 3 valve in the PARTNER II trial. As well, investigators reported positive results from the PARTNER II registries on valve-in-valve cases using the Sapien XT device. These coincided with an announcement from the US FDA that the device’s indications for use have been expanded to include this indication in the setting of a failed surgical bioprosthesis.
Finally, the issue of reduced leaflet mobility potentially linked to clot formation on both transcatheter and surgical devices, seen in several recent CT studies, also spent some time in the limelight. Leaflet thickening was the topic of a keynote lecture, a session on TAVR “controversies,” and a special press conference. In the latter, Raj R. Makkar, MD, of Cedars-Sinai Heart Institute (Los Angeles, CA), stressed that “findings related to neurologic events were preliminary and inconclusive” and that “more investigation needs to be done in terms of really understanding the impact of these interesting imaging findings.” He also urged researchers conducting future valve studies, especially those in lower risk patients, to include analyses of different blood-thinning medications and regimens.
Late Hint of Hope for PFO
One additional late-breaking trial that deserves mention is the late follow-up of RESPECT. PFO closure for cryptogenic stroke is a topic I’ve covered closely in the past, fascinated by the absolute absence of equipoise (and consequent slow enrollment), squabbles over best patient selection, high crossover/drop-out rates, and troubling conflicts of interest among investigators. The three major trials in this space—CLOSURE I, the PC Trial, and RESPECT—all missed their primary endpoints while a final trial, REDUCE, is still limping to the finish line.
At TCT 2015, John D. Carroll, MD, of the University of Colorado (Denver, CO), presented 5.5-year follow-up from RESPECT showing a 54% relative risk reduction in cryptogenic stroke among device-treated patients in the intention-to-treat group (Of note, the primary end point for the original trial was a composite of recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death.). In the extended follow-up, the reduction in recurrent cryptogenic stroke was even greater in device-in-place patients, patients under age 60, and patients with large shunts and atrial septal aneurysm at baseline.
Sticklers for clinical trial design will no doubt find fault with how this prespecified late-term analysis of RESPECT was conducted. Indeed, attendees of TCT 2015 had mixed feelings as to whether these data would be sufficient to sway US regulators. Yet out of 9 cardiologists who spoke at a press conference (with nary a neurologist among them), all said they’d opt for PFO closure if they suffered a stroke of unknown cause.
Other Topics of Interest
In the past, most of my time at TCT meetings has been spent hunting for hard news in the late-breaking sessions or tapping out stories in the subterranean press room. This time I had the luxury of checking out sessions that weren’t immediately newsworthy per se, but featured topics I’m going to keep my eye on in the months and years to come.
Several sessions focused on acute stroke interventions, asking whether interventionalists who are already comfortable with delicate catheter-based operations are best positioned to help broaden access to this technology. Many speakers pointed out that the STEMI centers could serve as the model for acute stroke care, with neurosurgeon Leo Nelson Hopkins, MD, of the University of Buffalo (Buffalo, NY), going so far as to suggest that interventional cardiologists who treat STEMI patients “already have the right mindset” and are “willing to get up at night.” Stephen Ramee, MD, of Ochsner Medical Center (New Orleans, LA), pointed out that the “turf wars and politics” are the biggest barriers to wider adoption, a sentiment echoed by others.
I stopped by a number of sessions rehashing the bivalirudin vs heparin in AMI debate, only to be told by HEAT-PPCI lead investigator Rod H. Stables, MD, of Liverpool Heart and Chest Hospital (Liverpool, England), when I bumped into him in the corridor, that the bivalirudin/heparin story is “old news.” What still needs to be teased out in these patients—regardless of the anticoagulant used—is the timing of ischemic and bleeding events, particularly since both tend to happen in the same patient, Stables noted. That key point is frequently misunderstood or understated in trial interpretation, he added.
Another hypothesis set forth at TCT 2015, by Harvey White, MD, of Auckland City Hospital (Auckland, New Zealand), is whether the bivalirudin/heparin feud has clarified a role for IV cangrelor. Roughly 1 out of 7 patients being rushed for STEMI care vomits during transfer, Dr. White observed, potentially losing oral antiplatelet drug protection. An “ideal marriage”—albeit a costly one—might be to protect against ischemic events using cangelor and reduce bleeding events with bivalirudin.
Finally, a big-picture theme broached in a smattering of TCT 2015 sessions was the digitization and democratization of medical data. In a keynote lecture, Eric J. Topol, MD, of Scripps Translational Science Institute (La Jolla, CA), raced through a dazzling array of technologies and tests that are increasingly placing patients at the center of their own health decision-making. His talk and its implications, as John A. Spertus, MD, MPH, of St. Luke’s Mid America Heart Institute (Kansas City, MO), put it, left the audience feeling as if they’d been drinking from a fire hose. Elsewhere, Dr. Spertus himself laid out the rationale for putting quality of life and other patient-related outcomes front and center in clinical trials, an idea he believes the FDA is slowing coming around to considering. The COURAGE trial, Dr. Spertus pointed out, serves as a classic example of a trial where patient-reported outcomes lost out to “harder” outcomes.
On a Personal Note
Whenever I could, I headed out into the San Francisco sun to warm up or chat with old associates and colleagues. I was struck by the number of people stepping out for a smoke, including a prominent interventionalist who, minutes later, turned up to speak at the morning press conference. When I saw him he was hunched around the side of the building, sucking on a cigarette as if this was his sole source of oxygen. It occurred to me that for all the ways the best minds in the business have slimmed down stent struts, shrunken sheaths, and decided upon the best DAPT duration, no one has figured out how to convince even the people who already know better how to look after their own arteries. It’s a sobering thought, one that compels me to put forward a suggestion for next year’s TCT meeting. Let’s power down the escalators and use them as stairs.
Thank you to everyone who welcomed me back warmly to interventional cardiology. I’m looking forward to giving you a richer experience at TCTMD, hearing your feedback, and telling your stories. You can find me at swood@crf. org or on twitter @shelleywood2.