Mounting evidence for safety and improved outcomes of drug-eluting stenting: but is it the stent?

Restenosis after coronary interventions was referred to as the “soft underbelly” of angioplasty by Richard Myler, MD, 30 years ago. However, restenosis was not demonstrated to be significantly related to a safety risk but was rather an “inconvenient truth,” which was reflected primarily by disruption of the patient’s schedule and increased costs. For the operator it provided an opportunity to perform rather easy angioplasty procedures with predictable results. Nonetheless, elimination of the “soft underbelly” was a dream for many, and after drug-eluting stents (DES) were shown to markedly reduce restenosis, Patrick Serruys, MD, PhD, declared that they were “a dream come true.” That dream seemed to be turning into a nightmare in 2006 when several reports pointed to the catastrophic complications of late stent thrombosis, which was more prevalent with DES than with bare metal stents (BMS).1 Despite the exaggerated benefit of DES seen in clinical trials, the reduction in restenosis in many lesion subsets was clear and a benefit not to be sacrificed lightly.2 The occurrence of late thrombosis, however, was also reported to be associated with an increased mortality rate for patients receiving DES. The Swedish Registry among others was sobering, and the use of DES plummeted from around 90% to close to 60% in the United States.3