NEW YORK (Reuters Health) – Pooled data from four TAXUS trials show that at 5 years, target lesion revascularization rates are consistently lower when the paclitaxel-eluting stent (PES) rather than a bare metal stent (BMS) is used for percutaneous coronary intervention, according to a report in the May issue of JACC: Cardiovascular Interventions.

Dr. Gregg W. Stone, with Columbia University and Medical Center, New York, New York, and colleagues note that the paclitaxel-eluting Taxus stent has been used in more than 6 million coronary implants worldwide.

However, none of the clinical trials of the device were individually powered to provide estimates of low-frequency adverse events or of long-term safety and efficacy – “especially as regards the rate and influence of late stent thrombosis and whether the early gains with PES compared with BMS are diminished over time (late catch-up),” the authors explain.

For the current study, they combined patient-level data from four trials now that follow-up has been completed. The pooled study population included 1400 patients assigned to receive a PES and 1397 to receive a BMS.

“By multivariable analysis, treatment with PES rather than BMS was an independent predictor of a 47% reduction in target lesion revascularization at 5 years,” the investigators report. Specifically, the cumulative rates were 12.3% versus 21.0% (p<0.0001).

There was no significant difference between PES and BMS in cumulative 5-year rates of death (9.8% vs 9.1%; p=0.53) or MI (7.7% vs 6.6%; p=0.33), according to the report.

However, at 5 years, there was a statistically significant increase in stent thrombosis rates with PES (1.8%) compared with BMS (0.6%), based on the pre-specified protocol definition of stent thrombosis, the results indicate.

Also, between 1 and 5 years, there was a significant increase with PES versus BMS in MI (3.8% vs. 2.3%, p= 0.03), as well as a nonsignificant increase in cardiac death (3.5% vs. 2.5%, p=0.15), the authors found.

“Ongoing studies are being performed to determine whether the late safety profile of PES (and other drug-eluting stents) might be further improved with long-term administration of dual antiplatelet therapy,” Dr. Stone and colleagues comment.

J Am Coll Cardiol Intv 2011;4:530–542.