Dual source multi-slice CT angiography for non-invasive evaluation of coronary stent patency at 6 months comparing two abluminal coated drug eluting stents: Synergy* versus Nobori*.

Cardiovascular disease (CVD), of which coronary heart disease (CHD) is the most
common, is the major cause of death in adults in most European countries.1 By
the year 2000, CVD caused more than 4.35 million deaths annually in Europe (1.9
million in the European Union) and accounted for 43% of all deaths in men and
55% in women of all ages. One-year mortality in subgroups may be up to 20% per
year.2 Although CHD mortality is declining in the majority of European
countries, the actual number of patients with CHD has been increasing. This is
caused by several factors: aging of the populations, later onset of clinical
manifestation of the disease, and improved prognosis of individuals afflicted.
CVD is an important cause of disability and contributes substantially to the
escalating costs of healthcare.3 Treatment strategies consist of medical
therapy alone or, frequently in combination with surgical or percutaneous
revascularization.
Percutaneous coronary intervention (PCI) is a well-established treatment for
obstructive coronary artery disease both in emergency and elective settings.
The outcome of percutaneous revascularization is divers and depends on several
known and unknown factors. After percutaneous revascularization of a coronary
artery, a restenosis may occur due to intimal hyperplasia, leading to late
lumen loss, ultimately leading to angina pectoris, or even a (repeat)
myocardial infarction.
The initial treatment with balloon angioplasty alone was associated with
extremely high restenosis rates of up to 50%, in addition to high procedural
complications. The use of bare metal stent as scaffold to maintain coronary
patency dramatically improved the short term result of coronary interventions.
However, the medium and long term restenosis rates remained relatively high.
The endeavour to further increase the procedural and long term success rates
led to improvements in stent platform, the delivery system, and in early 2000*s
the emergence of drug eluting stents. The latter being mainly responsible for
considerable reduction in the rate of in-stent restenosis4, 5 To assess the
stent functionality, frequently a repeat angiography and intravascular
ultrasound (IVUS) analysis is performed to evaluate the result of PCI or
medical therapy and to assess progression of the coronary lesions. This is due
to the fact that up until now non-invasive testing, does not enable physician
to make sufficient reliable assumptions of the lumen patency.

To test the non-inferiority of the Synergy* abluminal coated everolimus eluting
stent with bio-absorbable polymer from Boston Scientific compared to the
Nobori* abluminal coated biolimus eluting stent with bio-absorbable polymer
from Terumo in the treatment of de novo coronary artery lesions.
The secondary objective of the study is to validate the accuracy of the
non-invasive angiography using a dual source 2x128 slice Computerized
Tomography versus Intra Vascular Ultra Sound techniques in evaluating coronary
stent patency of two new generation drug eluting stents with different
platforms and drugs at 6 months post implantation.

Single center, prospective open 1:1 randomized controlled trial.

Coronary intervention with stenting.

Participating patients will be asked to return to the hospital for one day at 6
months after the initial treatment, where they will receive a repeat coronary
angiography and a subsequent repeat coronary CT scan. Therefore the radiation
burden for the individual patient wille be somewhat higher than in patients not
participating in this study.