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Paclitaxel-eluting stent produced lower adverse events vs. saphenous vein graft

Brilakis ES. J Am Coll Cardiol Intv. 2010;3:742–750.

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Patients treated with a saphenous vein graft had higher comorbidities and a higher risk for adverse events vs. patients treated with a paclitaxel-eluting stent, study results indicated.

The U.S. researchers of the ARRIVE program compiled data on patients (n=7,492) who received at least one paclitaxel-eluting stent (Taxus Express, Boston Scientific), as well as patients who received a saphenous vein graft (SVG; n=474). Patients were enrolled at procedure start with no mandated inclusion/exclusion criteria, and all cardiac events were monitored with independent adjudication of endpoints.

After a 2-year follow-up, the SVG patients had more baseline comorbidities/complex disease than simple-use patients (n=2,698) who underwent native coronary intervention or other expanded-use patients (n=4,320 without SVG patients). SVG patients also had higher 2-year rates of mortality (10.9% vs. 4.2%), MI (5.3% vs. 2.2%) and Academic Research Consortium definite/probable stent thrombosis (4.7% vs. 1.4%; P<.001 for all) than the simple-use group. Additionally, SVG patients had higher 2-year adverse event rates, including higher mortality (10.9% vs. 7.5%; P=.008), than other expanded-use patients.

“These SVG patients had significantly more comorbidities and a higher risk of clinical events through 2-year follow-up than the subgroup of simple-use patients who would have been eligible for the TAXUS IV pivotal trial,” the researchers reported. “These results provide further support for a large, prospective, multicenter randomized controlled trial of drug-eluting stents in SVG lesions.” – by Brian Ellis

To me, 19.9% failure rate (defined as cardiac death, MI and target vessel revascularization) in patients with SVG stenting at 2 years is very high. This is because the underlying vein atherosclerosis is very friable and delicate and any procedure will result in poor outcome. I think it has little to do with whether it’s a bare metal stent or drug-eluting stent.

This study was just a registry in a sense, so it was open to all comers. I don’t know how much they cleaned it up. That’s why I don’t think anyone will pay much attention to the results and shouldn’t.

– Renu Virmani, MD
Cardiology Today Editorial Board

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