Five-year Angiographic Follow-up of the Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System.

The ABSORB First in Man (FIM) Clinical Investigation represented the first
clinical evaluation of the safety and performance of a drug-eluting
bioabsorbable stent. This stent demonstrated safety and efficacy in a total of
30 selected patients with single de novo coronary lesions. At 2-years there
were no deaths, TLR or stent thrombosis. Only 1 patient experienced a
non-Q-wave myocardial infarction. The angiographic in-stent late lumen loss at
6-months was similar to that reported with paclitaxel-eluting stents and the
minimum lumen diameter decreased only slightly (0.08mm) between 6-months and
2-years. To summarize the intravascular ultrasound (IVUS) findings, from
baseline to 6 months there was a loss of lumen area of 16.8% (p<0.001) which
was driven primarily by late stent recoil and accompanied by an increase in
plaque area. From 6 months to 2 years, these trends were reversed. Coincident
with absorption of the stent struts, lumen area had been regained by 10.9%
(p=0.03) and was accompanied by plaque regression with no significant change in
vessel area. Independent support for the IVUS analysis comes from optical
coherence tomography (OCT) data, which also indicated a reduction in minimum
lumen area from baseline to 6 months, followed by an increase from 6 months to
2 years (p=0.03). Of interest, vasomotion occurred at the stented site in
response to vasoactive agents suggesting normal endothelial function.
However, until now, there is no long-term (>2-years of follow-up) data present
on the healed coronary vessel with these imaging modalities.

The objectives of this study are to assess angiographic-, IVUS/IVUS-VH
imaging-, OCT imaging-, palpography and vasomotion parameters data 5-years
after single de novo native coronary stenting with the BVS everolimus-eluting
stent.

The trial is a single center, investigator driven, clinical study carried out
at the Thoraxcenter, Erasmus MC. Eligible patients are described in Section 4
(Study population). This patient group will be enrolled in the clinical study
for the evaluation of angiographic-, IVUS/IVUS-virtual histology (VH) imaging-,
OCT imaging-, palpography and vasomotion parameters.

The (control) angiography has the same risks as a PCI, namely vasospasm and
dissection as with all catheters that are introduced in a coronary artery (<1%)
and hematoma of the groin (catheter access site).