Gregg W. Stone, M.D., offered a preview Sept. 10 of some of the key, late-breaking clinical trials and trends in interventional cardiology that will be presented during the Transcatheter Therapeutics (TCT) 2009 Symposium Sept. 21-25 in San Francisco.
Dr. Stone is the immediate past chairman, Cardiovascular Research Foundation (CRF) and codirector of the medical research and education division, and director of Cardiovascular Research and Education at the Center for interventional vascular therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center. CRF is the sponsor of TCT.
He said one of the biggest trends in interventional cardiology is percutaneous structural heart repair. Dr. Stone said much of the interest at TCT 2009 will center on Edwards Lifesciences’ SAPIEN transcatheter aortic valve, which completed enrollment in its U.S. PARTNER trial last week. He said the valve is already approved for use in Europe, where it is having a major impact. Beyond percutaneous valves, other structural heart interventions covered at TCT will include devices for the prevention of stroke and the closure of septal shunts.
Other trends highlighted in sessions at TCT 2009 include medical therapy verses angioplasty, carotid and renal artery interventions, peripheral artery interventions, new heart failure therapies, percutaneous interventions to mediate hypertension, and treatment guidelines.
The results from many key clinical trials are released each year at TCT. This year Dr. Stone said CRF received about 100 applicants for its late-breaking trial sessions. He said 18 were chosen for presentation in the main arena. For a complete listing of the highlighted trials at TCT 2009 visit www.dicardiology.net/node/33798.
Dr. Stone said the information being released from these late breaking trials will have a major impact in the field of medicine. The primary areas being covered by these trials are stents on Wednesday, pharmacology on Thursday, and PCI tools and techniques on Friday.
In addition, he said there were several other very important trials the organizers decided to group into a four-hour presentation session, “Featured Clinical Trials: First report Investigations,” between 2 and 5:45 p.m. Thursday, Sept. 24, in room 131. For a complete listing of the 14 studies covered in this session visit www.dicardiology.net/node/33899.
New Data on Stents
Key stent trials include the SPIRIT IV head to head comparison of XIENCE everolimus-eluting stent verses the TAXUS paclitaxel-eluting stent, The trial does not include angiographic follow-up, which Dr. Stone said eliminates complications related to invasive imaging and gives and a more real-world comparison. He said he COMPARE trial will highlight the comparison between everolimus-eluting and paclitaxel-eluting stents.
Two-year follow-up data from the LEADERS trial will show the safety and efficacy of a biolimus A9 eluting stent using a biodegradeable polymer verses sirolimus-eluting stents with a durable polymer. One-year data presented last year showed noninferiority of the bioabsorbable polymer stent.
“If it is successful, it will be a major shift for drug eluting stents,” Dr. Stone said of bioabsorbable polymer technology.
Cardiologists have used DES off-label to treat in-stent restenosis for several years without any clinical data to back up this indication, Dr, Stone said. However, data from the ISAR-DESIRE 2 trial will deliver this data on paclitaxel-and sirolimus-eluting stents being used to treat sirolimus-eluting stent restenosis.
Data From Four Plavix Trials Highlighted
Pharmaceuticals are becoming very important in managing cardiac patients with or without PCI and will be a focus of clinical trial data presented on Thursday. Data from several studies of the most commonly prescribed anti-platelet drug Plavix (clopidogrel) will be highlighted.
“Adjunct pharmacology is just exploding and seems to be becoming as important as the interventions themselves,” Dr. Stone said.
Data from CURRENT-PCI OASIS 7 will compare high verse standard-dose clopidogrel and high verse low-dose aspirin in patients undergoing PCI for acute coronary syndromes. The data presented will include Plavix use in STEMI patients.
The PLATO INVASIVE trial data will examine ticagrelor verse clopidogrel in patients with acute coronary syndromes managed with PCI. Dr. Stone said part of the trial looked at what doses work best in patients.
There has been a lot of discussion over the past year since the release of studies showing proton pump inhibitors (PPIs) reduce the effectiveness of clopidogrel. Dr. Stone the definitive study on this effect is COGENT, and data from the study will be presented. It examines the effect of the PPI omeprazole in patients receiving aspirin and clopidogrel.
Plavix does not work in all patients, and data from the CHARISMA GENOMICS substudy takes a look at the genome response to the drug to help determine its effectiveness for primary and secondary prevention.
The cost-effectiveness of prasugrel verses clopidogrel will also be examined based on results from the TRITON-TIMI 38 economic substudy.
Advancing PCI Tools, Techniques
Dr. Stone will present data from the highly-anticipated PROSPECT study on Thursday, which uses a multimodality, intracoronary imaging study to identify vulnerable plaque. He said around 300 patients had their entire coronary tree examined with various intravascular imaging systems to try and determine which plaques were vulnerable and whether prophylactic will prevent STEMIs.
On Friday data will be presented on SYMPLICITY I one-year results following radio-frequency ablation of the renals to prevent refractory hypertension.
Dr. Stone said data from the HORIZONS AMI two-year follow-up will examine the use of heparin plus glycoprotein IIb/IIIa inhibitors verse bivalirudin, and the differences between paclitaxel-eluting stents as opposed to bare metal stents in STEMI patients. DES proved effective between in the first year, but there were concerns about late-stent thrombosis, which the 3,600-patient study will hopefully address, Dr. Stone said.
The results of using intra-aortic balloon pumps in high-risk patients undergoing PCI will be discussed in the presentation of BCIS-1 trial data on Friday.
Stenting bifurcated lesions is one of the more difficult interventions, and data from the NORDIC-BALTIC Bifurcation Study III will help outline the best strategy may be the use of a single stent, Dr, Stone said.
Using ultrasound guidance for better femoral arterial access will also be covered in data presented from the FAUST trial on Friday.
Dr. Stone said the current healthcare reforms pending in Washington will be the focus of the first part of the annual FDA Town Hall Meeting, from 8 to 8:40 a.m. Thursday, Sept. 24, in room 102.
“Many of us feel that while the debate is ongoing, physicians are the ones with the least amount of input,” Dr. Stone said. He said the town hall meeting will give cardiologists a chance to hear what is going on in Washington.
The transformation of healthcare and many of the reforms being considered are directly related to the expanded use of electronic medical records. Dr. Stone EMRs will also be addressed in sessions at the symposium.
New Symposium Location
TCT has been held in Washington, D.C. for the past 20 years, and this is the first time the event has been moved to another city. Dr. Stone said San Francisco was chosen to test the waters and see if it generated more interest. He said the response so far has been increased attendee registration over previous years.
“I think you are going to see a packed meeting this year in San Francisco,” Dr. Stone said.