The Drama of Drug-eluting Stent Thrombosis: Dr. Jekyll and Mr. Hyde

Long as the introduction of percutaneous coronary intervention (PCI), restenosis has always been the stumbling stone of this innovative therapeutic technology [1-3]. As such, the arrival of drug-eluting stents (DES) in scene has offered what initially seemed to be the long-waited solution to this troublesome sequel of everyday practice. Indeed, very early following FDA approval of first-generation DES in 2003, these devices have convincingly reshaped the landscape of interventional cardiology that the Healthcare Systems took a bold initiative of assigning impressively high reimbursements to account for their extraordinary cost. It was a short halcyon period during which interventional cardiologists were anxious of being deemed guilty if they did not offer their patients the so-called 'smart' stent whenever technically feasible. Then, with the fall of 2006, the winds began to shift with alarming reports raising concerns about disturbingly higher rates of very late (after one year) stent thrombosis associated with the use of DES as compared with bare-metal stents (BMS). The media flashed the red light particularly with some evidence suggesting that relative to other acute coronary syndrome events, DES thrombosis was associated with substantially higher mortality and morbidity. Albeit infrequent, almost all cases developed a myocardial infarction, and one-tenth to one-third of cases died [4]. Soon the FDA assigned an expert panel to review evidence available from an array of sources, and in December 2006, the panel expectedly announced that there was an evidence for a small - though insignificant - increase in stent thrombosis events following DES [5]. However, evidence was far from clear, and intuitively, further evidence was still needed especially given the rare nature of the event that made all the available reports statistically underpowered.