Like most people, I am intrigued by novelty and my interest is piqued by research that addresses pressing clinical needs and gaps in our knowledge. The findings soon to be presented in the ACC.12 late-breaking clinical trials in Chicago offer much to anticipate, but I also wonder, is newer necessarily better?
Saturday through Tuesday we will be sharing results from what could be some pivotal trials for advancing cardiovascular care. Saturday’s presentation includes the TIMI 50 trial. The study takes vorapaxar (Merck)—which ACC Chair Patrick T. O’Gara, MD, said has been proven to be beneficial in the treatment in an acute setting—and nudged it into the realm of chronic ischemic heart disease.
This seems to be a logical extension, but biology is not exactly linear. In TRACER, vorapaxar added to standard therapy failed to significantly improve outcomes for patients with acute coronary syndromes (ACS) and increased the risk of major bleeding. The disappointing results were released at American Heart Association’s 2011 conference in Orlando, Fla.
Sunday’s Host-ASSURE trial fits a similar mode. It takes the drug cilostazol (Pletal, Otsuka Pharmaceutical), which is frequently used in South Korea to prevent stent thrombosis, in combination with aspirin and compares it with doubling the dose of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) in combination with aspirin in patients after they undergo PCI.
Monday’s headliner for many is the release of the two-year results of the PARTNER Cohort A trial. One-year results unveiled in November 2011 at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco found that patients who underwent transcatheter aortic valve replacement (TAVR) procedures fared better compared with those undergoing surgical aortic valve replacements (SAVR). At the same time, there were differences in the rates of procedure-related complications and valve performance at one-year with some end points favoring TAVR and others SAVR.
I am looking forward to hearing the results of the CORONARY trial, which compares the risks and benefits of off-pump and on-pump CABG based on data from nearly 5,000 patients. A recently published review of 86 clinical trials comparing the two techniques favored the on-pump approach and concluded that an assessment of the harms and benefits was sorely needed.
Another intriguing study has borrowed a strategy from oncology: the use of monoclonal antibodies in the targeted treatment of diseases. While this may be at its early stages in cardiology, biologicals such as the monoclonal antibody drug trastuzumab (Herceptin) have been credited with improving survival, in this case, of some breast cancer patients.
Researchers know that not all results support their hypotheses, though. In another recently published paper in the Journal of the American College of Cardiology, the authors hypothesized that the changes in the design and coating of everolimus-eluting stents compared with older-generation sirolimus-eluting stents would translate into better treatment of drug-eluting stent in-stent restenosis. But they were wrong. The two stents, despite one being newer, had comparable results.
We may look back at ACC.12 and realize it captured a turning point in patient care. But it may take time to know what amid the new is truly better.
Be sure to follow our conference coverage, including the late-breaking clinical trials starting Saturday, and feel free to share your thoughts with us during the conference.
Candace Stuart, editor