Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03008772 |
| Other study ID # |
REWARDS-ISR |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2018 |
| Est. completion date |
January 2024 |
Study information
| Verified date |
October 2020 |
| Source |
Medstar Health Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
To define the long-term incidence and frequency of ISR follow DES implantation. Compare the
clinical presentation, treatment and intervention success among de novo coronary artery
stenosis and DES ISR.
Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR,
assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days,
6 months, 1 year, 3 years, and 5 years, if available.
Description:
Drug-eluting coronary stents (DES) significantly reduced the rate of neointimal hyperplasia
and in-stent restenosis (ISR) compared to bare metal stents (BMS) for the treatment of
coronary artery disease. In addition, the continued evolution in scaffold and polymer design
with concomitant improvements in antiplatelet therapy has improved the rates of late and very
late stent thrombosis. However, despite novel metal scaffold technology, increasing operator
experience, and improvement in adjunctive implantation techniques, the incidence of ISR in
durable-polymer DES remains a problem, with 1-year rates as high as 12 to 15%.
The outcomes associated with ISR highlight the fact that this is by no means a benign process
and studies report MI rates as high as 19.4% with one study demonstrating a total rate of
death or nonfatal MI of 3.5%. In addition, ISR presenting as acute coronary syndrome (ACS)
has an independent effect on major adverse cardiac events. The emergence of fully
bioresorbable vascular scaffolds (BVS) has provided an exciting alternative to combat the
long-term structural and functional effects on the coronary vessel seen with implantation of
a permanent metal scaffold, regardless of the drug coating. Initial studies have demonstrated
the non-inferiority of BVS compared to contemporary DES in regards to death, MI, and MACE. In
addition, intravascular imaging has confirmed complete resorbtion of the BVS by 3 years time.
The long-term benefits of such technology have yet to be fully assessed. However, based on
literature outlining the complicated course of ISR in short-term and that seen in the bare
metal stent era, it is projected that complete resorbtion of the vascular scaffold should
improve long-term outcomes of patients with ischemic heart disease.
Currently, the clinical presentation, incidence, and outcomes of ISR in contemporary DES are
not completely understood. The goal of this particular study is to retrospectively evaluate
the long-term impact of ISR over a 10-year period in current contemporary DES. The data can
be compared to de novo coronary artery lesions with similar characteristics and complexity to
highlight the significant differences in the clinical course of each disease. Ultimately, the
investigators will hopefully demonstrate the need for improvement in this arena, which the
BVS will potentially provide.
