Long-term clinical outcome after implantation of the self-expandable STENTYS stent in a large, multicenter cohort

Abstract

Objective 

The objective of the study was to retrospectively evaluate the long-term clinical outcome after implantation of the self-expandable (SE) STENTYS stent in a large multicenter cohort.

Background 

Incomplete stent apposition is known to cause higher rates of myocardial infarction (MI) and stent thrombosis. Because of its self-expanding features, the SE STENTYS stent adapts to the vessel wall and is therefore expected to minimize malapposition and therefore the rates of MI and stent thrombosis.

Patients and methods 

Treatment with a total of 351 SE coronary stents was attempted in 314 patients of a cohort from three German institutions between 2011 and 2015. Technical success was achieved with 331/351 (94%) stents. Patients treated successfully with SE stents (n=298) were followed up using the primary outcome measure of target lesion failure (TLF), a combined endpoint of cardiac mortality, recurrent target vessel MI, acute stent thrombosis, and clinically driven target lesion revascularization. Follow-up was complete in 268/298 (90%) patients with a median follow-up period of 2.5 (interquartile range: 1.4–3.3) years.

Results 

TLF occurred in 54/298 (18%) patients. Event rates were 7.5% for cardiac mortality, 11.6% for target vessel MI, and 5.2% for clinically driven target lesion revascularization. Acute stent thrombosis occurred in 2/298 (0.7%). Overall, stent thrombosis had an incidence of 2.6% within the follow-up period. ST-elevation MI at baseline (P=0.02) and a dual antiplatelet therapy with clopidogrel for only 6 months (P=0.04) were the only clinical factors linked to the absence of TLF.

Conclusion 

Technical success of SE coronary stent implantation in an all-comer cohort of patients was high, although the rate of TLF and stent thrombosis during long-term follow-up was also relatively high.