HORIZONS AMI, which studied 3,602 STEMI patients who underwent primary PCI after two years, continued to find a statistically significant superiority for initial treatment with bivalirudin alone compared with heparin plus GPIIb/IIIa inhibitors, and for drug-eluting stents over bare-metal stents. The study was presented during the late-breaking clinical trials at the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco on Sept. 25.
“The results at two years are more impressive than both the initial 30-day and the one year results that we reported at TCT last year," said principal investigator Gregg W. Stone, MD, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center in New York City.
"The data show that use of bivalirudin alone, as opposed to a combination of heparin and GP IIb/IIIa inhibitors, can save lives," Stone said.
After two years, treatment with bivalirudin (AngioMax from Medicines Company) alone, compared with heparin plus GPIIB/IIIa inhibitors, resulted in:
- A 36 percent reduction in major bleeding and a 25 percent reduction in reinfarction, with comparable rates of stent thrombosis, target vessel revascularization (TVR) and stroke.
- A 41 percent reduction in cardiac mortality and a 25 percent reduction in all-cause mortality, the latter representing 15 lives saved per 1,000 patients treated.
In addition, at two years, the implantation of a Boston Scientific Taxus Express paclitaxel-eluting stent compared with a Boston Scientific Taxus bare-metal stent (BMS) resulted in:
- Significant 42 percent and 34 percent reductions in ischemic target lesion revascularization (TLR) and TVR respectively, with no evidence of late catch-up.
- Comparable rates of all-cause and cardiac mortality, reinfarction and stent thrombosis, with no safety concerns apparent.
Interestingly, the stent thrombosis rates between BMS and DES flattened to 4.1 percent for each stent type to two years. Co-investigator Roxana Mehran, MD, also from Columbia, who co-presented the trial at TCT, noted that prior to HORIZONS, BMS had not been studied beyond nine months to one year in the STEMI population, adding that this was a “very interesting finding.”
Also, TLR, TVR and mortality were reduced between one and two years in patients treated with Taxus compared with BMS, observations that should be considered hypothesis generating given their borderline significance and possible influence of routine angiographic follow-up.
However, Mehran noted that the study is the first time that the safety of DES has been evaluated beyond a year in a large randomized trial.
“Yet, the message of this study is not to stop personalizing treatment, and not to use DES in every patient. That is not what we are here to say,” Mehran explained. “For STEMI patients, reperfusion matters first, then choosing pharmacotherapy that reduces ischemic complications, as well as bleeding complications. Finally, for device therapy for PCI, patient history needs to be considered, especially in the patient’s ability to take dual-antiplatelet therapy and lesion complications.”