NEW YORK (Reuters Health) – There is no solid evidence that drug-eluting stents (compared to bare-metal stents) increase the risk for stent thrombosis, death or myocardial infarction in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).
In fact, in a systematic review and meta-analysis of relevant research, use of a drug-eluting stent (DES) “was associated with a significant improvement in the rate of repeat revascularization,” Dr. Khaled M. Ziada, Director of the Cardiac Catheterization Laboratories, Gill Heart Institute, University of Kentucky in Lexington, told Reuters Health.
In a report online January 5 in the American Journal of Cardiology, Dr. Ziada and colleagues note that studies have suggested an early benefit of DES over BMS in decreasing adverse cardiac events in primary PCI; however, there are concerns regarding the increased risk of late and very late stent thrombosis after DES use. Yet, individual trials may have been underpowered to detect significant differences.
They, therefore, conducted a meta-analysis of eight randomized clinical trials and five observational studies comparing DES to BMS in 10,459 patients who underwent primary PCI for STEMI and were followed for three years or longer.
In the total DES-treated population, paclitaxel-eluting stents were used in 3,880 patients, sirolimus-eluting stents in 1,405, and a smaller number of patients received second-generation DES.
Among the controlled trials, receipt of a DES compared with a BMS was associated with a “robust decrease” in target lesion and target vessel revascularization (odds ratio, 0.48 and 0.53, respectively) that was sustained long-term.
Major adverse cardiac outcomes were also less likely with DES (odds ratio 0.69) and there was no increase in the incidence of stent thrombosis (odds ratio 1.02).
The meta-analysis of randomized controlled trials shows that DES is as safe as BMS in primary PCI and is not associated with increased mortality over 3 or more years, the investigators say. In fact, they found a nonstatistically significant 12% decrease in the risk of death in DES-treated patients.
“This is an important and reassuring finding given previous concerns regarding the potential harm with DES use in PPCI. The large sample and low heterogeneity of the studies further support the robustness of this conclusion,” they write.
As for the observational studies, fewer provided data on target lesion and vessel revascularization rates, but the trend “remained in favor” of DES, the researchers report. They did see a “small but statistically significant” increase in stent thrombosis with DES (odds ratio 1.62) three or more years after placement, but without evidence of MI.
“Although the patient registries show a small increase in risk of stent thrombosis with DES use, we believe this is due to the difference between the types of patients included in randomized trials versus those included in registries. Even in registries, there was no evidence of increased risk of death or MI,” Dr. Ziada told Reuters Health.
“As for standardization, I think that (DES) is appropriate in patients with relatively simple medical histories and when there are no major co-morbidities,” Dr. Ziada said.
“Additionally, one has to be somewhat confident that dual antiplatelet therapy is accessible and will not be interrupted. If these conditions are not met, bare metal stents are effective and safe, although repeat procedures are more likely,” he said.
SOURCE:
Am J Cardiol. 2012. Published online January 5, 2012.
