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PASSION: Drug-eluting stent as safe, effective as bare metal stent in angioplasty for acute MI
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American College of Cardiology 59th Annual Scientific Session
ATLANTA – Five-year data from the PASSION trial indicated no statistically significant difference in safety or efficacy between drug-eluting stents and bare metal stents in the setting of acute MI.
The results contrasted with the researchers’ hypothesis that the paclitaxel-eluting stent (Taxus/Express2, Boston Scientific) would perform significantly better for cardiac death, recurrent MI and target lesion revascularization. The results also failed to show a statistically significant difference between the two stent types in preventing late stent thrombosis.
The prospective, single blind study enrolled 619 patients with acute MI (mean age, 61 years; three-quarters men). Researchers randomly assigned each patient to either a paclitaxel-eluting stent or bare metal stent (Express2/Liberté, Boston Scientific). Nine patients were lost to follow-up.
At five years, researchers reported no statistically significant difference between the paclitaxel-eluting stent (18.3%) and bare metal stent (22%) for the primary composite endpoint of cardiac death, recurrent MI and target lesion revascularization (HR=0.81; 95% CI, 0.57-1.16). The researchers also found no statistically significant difference between the two stent groups for any of the major adverse cardiac events when examined individually.
The occurrence of both definite or probable stent thrombosis was comparable (3.9% with drug-eluting stent vs. 3.4% with bare metal stent), despite a twofold increase in the occurrence of definite stent thrombosis in the paclitaxel-eluting stent group (3.5% vs. 1.7%; P=.20). Follow-up also confirmed a small risk of very late stent thrombosis with the paclitaxel-eluting stent (2.9% vs. 0.8%; P=.06).
“The risk of stent thrombosis appears to persist for several years after stent implantation,” Maarten Vink, MD, of the Onze Lieve Vrouwe Gasthuis Hospital in Amsterdam, The Netherlands, said during a presentation. “We have to outweigh the possible advantage of drug-eluting stents in target lesion revascularization against the potential risk of very late stent thrombosis.”
The five-year data are in line with both the one-year and two-year PASSION data, which also found no statistically significant safety or efficacy differences between the two stents.
The researchers cautioned that these results cannot provide definitive answers on the use of drug-eluting stents in acute MI.
“It is a difficult choice to make, which stent to implant, especially when we see in our trial that at a higher cost with drug-eluting stents there is no difference at five years in major adverse coronary events,” Vink said at a press conference. “In the absence of clinical efficacy, there is no reason to implant the older drug-eluting stent based on our data.” – by Katie Kalvaitis
This is a great summary of a terribly important thing we have learned about this study with generation technology that we don’t use as much anymore. Does that mean it was unique to this specific stent, these findings? It is hard to be sure of that, as far as the ongoing debate about what to do in a specific patient at hand, what to use to treat that patient and how to measure the balance of safety and efficacy in the setting of acute MI, so there will be some great questions related to those important, critical issues.
– David R. Holmes Jr., MD
Cardiology Today Editorial Board member
For more information:
- Vink. LBCT V. Presented at: American College of Cardiology 59th Annual Scientific Sessions; March 13-16, 2010; Atlanta.
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