Safety of drug-coated stents.

Background: Drug-coated (i.e., drug-eluting) stents (DES) are frequently used nowadays in the treatment of coronary artery disease given their superior antirestenotic effect and clear benefits in terms of reduction of repeat revascularizations and major adverse cardiac events. However, a number of safety concerns have been raised on DES.

Objective: To appraise current data on the safety of DES.

Methods: A thorough PubMed search was done for pertinent clinical reports on DES safety with the following string (updated December 2007): (drug(*) OR sirolimus OR paclitaxel) AND eluting(*) AND stent(*) AND (safety OR complication(*) OR thrombos(*) OR infarction) NOT (editorial[pt] OR review[pt]).

Results/conclusion: A total of 1077 citations were retrieved and appraised. The most relevant threats to DES safety were bleeding, difficulties in balloon deflation and retrieval, endothelial dysfunction and vasospasm, hypersensitivity, infection, late acquired malapposition and aneurysm formation, late restenosis, peri-procedural myocardial infarction, plaque prolapse, stent dislodgement or embolization, stent fracture, and stent thrombosis (with ensuing risk of death, myocardial infarction or arrhythmia). Of these, the most important and debated safety issue is the potentially increased risk in late stent thrombosis, which might offset the antirestenotic benefits of DES especially in patients at higher risk of thrombosis or who cannot comply with the recommended dual antiplatelet regimen. Nonetheless, further clinical studies are warranted to clarify whether these safety threats should be a concern for the large target population of patients with coronary artery disease most likely to benefit from DES implantation.