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Drug-eluting and Bare-metal Stents Have Similar Long-Term Safety Profile: Presented at SCAI

By Crystal Phend

CHICAGO, I.L. -- May 12, 2006 -- Long-term safety and outcomes with bare-metal and drug-eluting stents appears to be similar, according to a study presented here at the Society for Cardiovascular Angiography and Interventions 29^th Annual Scientific Sessions (SCAI).

"The clinical benefit of drug-eluting stents appears to be independent of a higher clinical risk profile seen in contemporary STEMI [ST elevation myocardial infarction] patients," said presenting author Timothy Shapiro, MD, director, cardiac catheterization laboratory, Lankenau Medical Research Center, Wynnewood, Pennsylvania.

Dr. Shapiro and colleagues analyzed data on stent use for percutaneous coronary intervention (PCI) in the National Heart Lung and Blood Institute Dynamic Registry.

They looked at 373 STEMI patients treated with PCI utilizing bare metal stents (BMS) and 221 who received drug-eluting stents (DES). Demographics were similar between groups, although those in the DES group had more comorbidities.

Those who received BMS were significantly more likely to have received them for an ST segment elevation myocardial infarction (MI) and to have received thrombolytic therapy (84.3% vs. 72.4% and 33.8% vs. 26.2%, respectively).

Drug eluting stents were most commonly sirolimus-eluting stents (65%) while 35% were paclitaxel-eluting stents, Dr. Shapiro said during his presentation on May 11^th.

Reflecting a shift in pharmacotherapy use, BMS patients were significantly more likely to have received unfractionated heparin (94.9% vs. 84.6%) and glycoprotein IIb/IIIa inhibitors than did DES patients (65% versus 57%), but significantly less likely to have received clopidogrel (65% vs. 87%). At discharge, ACE inhibitors and statins were significantly more likely to be given to DES patients than to BMS patients.

Both groups had a 99% rate of successful stent placement. Persistent flow reductions were more common in the DES arm.

Rates of in-hospital major adverse event were similar between groups. Death occurred in 3.2% of patients with BMS and 1.8% with DES. Nonfatal MI occurred in 1.9% of BMS patients and 1.4% of DES patients. Coronary bypass surgery occurred in 0.5% of the BMS group and 0% of the DES group.

None of the cumulative 1-year events were significantly different between groups, including death (5.65% BMS vs. 5.83% DES), PCI (10.4% BMS vs. 9.61% DES) and MI (4.7% BMS vs. 6.8% DES).

The researchers concluded that the use of DES has a similar short and 1-year clinical efficacy compared with BMS in this non-randomized, real-world population.


[Presentation title: Percutaneous Coronary Intervention in Acute ST Elevation Myocardial Infarction With Drug Eluting Stents: Findings From the National Heart Lung and Blood Institute Dynamic PCI Registry. Abstract O-5]

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