The clinical research that emerged from last week’s Transcatheter Cardiovascular Therapeutics (TCT) symposium validated the words of early 20th Century journalist Claude M. Bristol and the clinical practice of contemporary interventional cardiologists. The biggest message from TCT 2010 might be that interventionalists are taking the proper steps and using the proper tools to treat their patients and stock their inventory shelves. The conference also revealed some exciting new technologies that may soon be appearing at a cath lab near you.
The Xience V stent (Abbott) showed superiority in the randomized SPIRIT IV at two years, except in diabetics, which nearly mirrors the trend from the trial’s one-year data. However, SPIRIT IV Principal Investigator Dr. Gregg W. Stone told Cardiovascular Business News that while Taxus performed “well, Xience just did that much better.” These data, along with the results of the all-comers COMPARE trial, affirmed the current market dominance of the everolimus-eluting stent platform
However, in two separate trials, Xience failed to show statistically significant improvement in Xience over Cypher—the ISAR-TEST 4 trial, which wasn’t appropriately powered to assess stent differences, and the EXCELLENT trial, which found that Xience/Promus was non-inferior to Cypher.
Bivalirudin (Angiomax, The Medicines Company), which has continued to increase its presence in the cath lab, also showed positive results, particularly with the increase survival rates compared with the use of heparin plus a glycoprotein IIb/IIIa inhibitor in STEMI patients undergoing primary PCI, based on the three-year results of HORIZONS-AMI. Further justifying its use, a separate study found that use of bivalirudin as adjunctive therapy in PCI patients decreased incidence of bleeding, as well as reduced length of stay and costs.
The much-anticipated PARTNER trial dominated the news from the conference, as it showed that transcatheter aortic valve implantation could be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery, if it gains FDA approval. However, PARTNER Principal Investigator Dr. Martin B. Leon told Cardiovascular Business News that more long-term studies are now required to assess the durability of the devices, but those U.S. interventionalists who have been looking to utilize the technology like their European colleagues may now have a more likely possibility.
Finally, a new polymer-free drug-eluting stent showed a strong safety profile in the preliminary BioFreedom trial. The hope is that these polymer-free stents could reduce late events, but larger and longer trials are needed.
Watch for our continued coverage of TCT over the next couple weeks.
On these topics, or any others, please feel free to contact me.