Comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction (COMFORTABLE AMI trial): rationale and design

Compared with bare metal stents (BMS), early generation drug-eluting stents (DES) reduce the risk of revascularisation in patients with ST-elevation myocardial infarction (STEMI) at the expense of an increased risk of very late stent thrombosis (ST). Durable polymer coatings for controlled drug release have been identified as a potential trigger for these late adverse events and this has led to the development of newer generation DES with durable and biodegradable polymer surface coatings with improved biocompatibility. In a recent all-comers trial, biolimus-eluting stents with a biodegradable polymer surface coating were found to reduce the risk of very late ST by 80% compared with sirolimus-eluting stents with durable polymer, which also translated into a lower risk of cardiac death and myocardial infarction (MI) beyond one year.

The SURTAVI model: proposal for a pragmatic risk stratification for patients with severe aortic stenosis

Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement (SAVR) for patients with symptomatic severe aortic stenosis (AS) and a high operative risk. Risk stratification plays a decisive role in the optimal selection of therapeutic strategies for AS patients. The accuracy of contemporary surgical risk algorithms for AS patients has spurred considerable debate especially in the higher risk patient population. Future trials will explore TAVI in patients at intermediate operative risk. During the design of the SURgical replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial, a novel concept of risk stratification was proposed based upon age in combination with a fixed number of predefined risk factors, which are relatively prevalent, easy to capture and with a reasonable impact on operative mortality. Retrospective application of this algorithm to a contemporary academic practice dealing with clinically significant AS patients allocates about one-fourth of these patients as being at intermediate operative risk. Further testing is required for validation of this new paradigm in risk stratification. Finally, the Heart Team, consisting of at least an interventional cardiologist and cardiothoracic surgeon, should have the decisive role in determining whether a patient could be treated with TAVI or SAVR.