Five-year data from the PASSION trial reveal that there is no statistically significant difference in the safety and efficacy of bare-metal and drug-eluting stents in acute heart attack-a finding that contrasted with the investigators' original hypothesis.
The trial examined data from 619 patients with acute heart attack who between March 2003 and December 2004 were randomized to receive either Taxus Express2-a paclitaxel-eluting stent-or the Express2 or Liberté bare-metal stents. All three were manufactured by Boston Scientific.
Results showed that there wasn't a statistically significant difference between the drug-eluting and bare-metal stents for the primary composite endpoint of cardiac death, recurrent heart attack and target lesion revascularization. Furthermore, there was no statistically significant difference between the two stent types in preventing very late stent thrombosis-a primary concern of drug-eluting stent use. The data were presented this week at the American College of Cardiology's annual scientific session in Atlanta.
"I think we can conclude from the trial that the use of drug-eluting stents in primary angioplasty is safe through several years after implantation," Maarten Vink, one of the study's researchers, says in a statement. While he acknowledged that the study provides valuable insight, he cautions that because the PASSION trial is the first large, randomized, controlled study to report five-year data, its findings cannot provide definitive answers on the use of drug-eluting stents in acute heart attack.
- check out the release (.pdf)