Gregg Stone previews major trials, sessions at TCT
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| Gregg W. Stone, MD, director of cardiovascular research and education at New York-Presbyterian Hospital/Columbia University Medical Center in New York City. Source: Cardiovascular Research Foundation |
While the association has expanded its program considerably over the course of the five-day conference, the late breaking clinical trials, which were chosen from 100 applicants, usually “garner the most attention,” Stone noted.
On Wednesday, the late breaking clinical trials focus on drug-eluting stents (DES):
- SPIRIT IV: Prospective, randomized comparison of Abbott’s Xience V/Boston Scientific’s Promus everolimus-eluting stents versus Boston Scientific’s Taxus paclitaxel-eluting stent. Stone, who is the principal investigator of this trial, commented on this trial’s “notability” due to the patient enrollment of more than 4,000—“the largest completed head-to-head trial to date.” He added that it is powered to look at efficacy, as well as safety events; and that this trial has had no angiographic follow up, so it is “purely a real-world clinical trial of the two stents.”
- FAME: Two-year follow-up from a prospective randomized trial of FFR-guided versus angiography-guided PCI in patients with multivessel coronary artery disease. The presentation will include much data on quality of life and cost considerations.
- ISAR-DESIRE 2: Prospective, randomized trial of Taxus DES versus Cordis’ Cypher sirolimus-eluting stent for treatment of restenosis. “This trial will shed light on a method that physicians do all the time, but with relatively little data,” Stone said.
- SIRTAX-LATE: Five-year clinical and angiographic follow up from a prospective, randomized trial of the Taxus DES and Cypher DES. This trial seeks to address the controversial topic of late catch up after DES implantation, according to Stone.
- LEADERS: Two-year follow-up from a prospective randomized trial of BioMatrix Biolimus A9-eluting stent with a bioabsorbable polymer versus Cypher DES with a durable polymer. “With this long-term follow up, the hope with the bioabsorbable polymer is an enhanced safety profile,” he explained.
- COMPARE: Prospective randomized trial of the Xience V DES/Promus DES versus Taxus DES, which has an enrollment of several thousand patients, according to Stone, who added this patient population is more “real-world than SPIRIT IV, in which patients had very stable coronary disease.” He said that this trial will be very complementary to SPIRIT IV.
On Thursday, the late breaking clinical trials focus on the adjunctive pharmacology topics. Stone speculated that Thursday’s lineup is the “most anticipated presentations” of the conference.
- TRITON-TIMI 38 ECONOMIC Substudy: Cost effectiveness of Eli Lilly/Daiichi Sankyo’s Effient (prasugrel) versus Bristol-Myers Squibb/Sanofi Aventis’ Plavix (clopidogrel) from a prospective randomized trial of patients with acute coronary syndrome (ACS) undergoing PCI. “Now that prasugrel is approved in the U.S., this trial seeks to show whether it is a cost-effective agent, under it’s cost price point,” Stone explained.
- CURRENT-PCI OASIS 7, which was partially presented earlier this month at the 2009 ESC conference: Prospective, randomized, placebo-controlled trial of high- versus standard-dose Plavix and high- versus low-dose aspirin in patients undergoing PCI for ACS. Stone noted that the trial will include data on the STEMI cohort, which “has not previously been presented.”
- PROSPECT: Natural history study of atherosclerosis using multimodality intracoronary imaging to prospectively identify vulnerable plaque. Stone, who will make this presentation—the only nonrandomized trial of the late breakers—said it’s the “first large-scale study to use IUVS with virtual histology to image the entire coronary tree of 700 patients, and following them for three years to see if we can prospectively identify which patients are at risk for death, MI or sudden plaque progression.”
- COGENT: Prospective, randomized, placebo-controlled trial of AstraZeneca’s proton pump inhibitor (PPI) Prilosec (omeprazole) in patients receiving aspirin and Plavix. There have been a lot of questions about the interaction between PPI and Plavix. “While the non-randomized data from TRITON, presented at ESC, suggested that there might not be a significant interaction, COGENT’s large patient population will make it the definitive study on the topic,” Stone said.
- CHARISMA GENOMICS Substudy: Evaluation of the CYP2C19 polymorphism in a prospective, randomized, placebo-controlled trial of chronic Plavix use for primary and secondary prevention.
- PLATO INVASIVE, which also was partially presented earlier this month at the 2009 ESC conference: Prospective, randomized, placebo-controlled trial of AstraZeneca’s Brilinta (ticagrelor) versus Plavix in patients with ACS managed with an invasive strategy.
On Friday, Stone defined the late breaking clinical trials session as a potpourri of topics:
- SYMPLICITY 1: One-year results following sympathetic renal denervation in refractory hypertension. The device uses radiofrequency energy to ablate the renal vein, and previously only partial data has been presented. With this trial, the results will be revealed for all 100 patients, who have received treatment.
- DEBATER: Prospective, randomized trial of DES versus bare-metal stents with or without Eli Lilly/Centocor’s ReoPro (abciximab) in STEMI patients.
- BCIS-1: Prospective, randomized trial of intra-aortic balloon pump counterpulsation in high-risk patients undergoing PCI.
- FAUST: Prospective, randomized trial of ultrasound-guided versus standard femoral arterial access. This trial seeks to decrease vascular complications with ultrasound-guided femoral artery needle entry, Stone explained.
- NORDIC-BALTIC BIFURCATION Study III: Prospective, randomized trial of side-branch dilatation strategies in patients with coronary bifurcation lesions undergoing treatment with a single stent.
- HORIZONS-AMI: Two-year follow up from a prospective, randomized trial of heparin plus glycoprotein IIb/IIIa inhibitors versus The Medicines Company’s Angiomax (bivalirudin) and Taxus DES versus bare-metal stents in STEMI patients. “It will be important to see if the two-year benefit of bivalirudin sustains after two years, and whether DES continues to be safe and effective compared to bare-metal at two years,” Stone pointed out.
In addition to the late breaking trials, there were a group of 20-25 trials, which will not be presented during these sessions, but “were so important and impactful that they are being presented separately in a four-hour Featured Clinical Trials session, held Thursday afternoon” Stone noted. For example, one trial from that session will be BIO-FREEDOM, which evaluates Biolimus A9-eluting from a completely non-polymeric stent—a stainless steel stent in 75 patients.
Beyond DES, according to Stone, the most innovative aspect of interventional cardiology lies in percutaneous valve therapy, and the conference will present “a great deal of new evidence” on both mitral valve and aortic valve therapy this year, including a whole-day symposium on Monday and a four-hour session on Friday. “This area is absolutely overflowing with interest, and it has already had a great impact on European care,” he explained.
Finally, in a nod to the current healthcare reform debate, TCT09 will host two different public forums. The keynote speaker for these forums is Gail Wolensky, PhD, an economist, who was the administrator of the Health Care Financing Administration (now CMS) from 1990-1992, and served as deputy assistant to President George H. W. Bush for policy development, advising him on health and welfare issues from 1992-1993. Also, from 1997-2001, she chaired the Medicare Payment Advisory Commission.
During these sessions, Wolensky will interact with Jack Lewin, MD, CEO of the American College of Cardiology, representing the societies, Mike Mussallem, president of AdvaMed, representing industry, and Herbert Pardes, MD, president and CEO of New York Presbyterian Hospital in New York City, representing the provider perspective. They will each make a presentation, followed by a roundtable discussion. After that session concludes, a follow-up question-and-answer session will take place.
Also, there will be sessions on endovascular disease and cell therapies, in addition to a new session on EHRs. As Stone suggested, “You could spend a month at TCT next week.”