Comparison of Titanium-Nitride-Oxide coated Bio-Active-Stent (Optimax*) to the Drug (Everolimus) -Eluting Stent (Synergy*) in Acute Coronary Syndrome

Coronary artery disease (CAD) is the most frequent cause of death, accounting
for approximately 13% of all deaths. In western countries, the incidence of
ST-segment elevation myocardial infarction (STEMI) is around 77/100 000/year,
whereas in patients with non-ST-segment elevation acute coronary syndrome
(NSTE-ACS), the incidence is 132/100 000/year. Currently, PCI is the preferred
reperfusion strategy in patients with both acute STEMI and NSTE-ACS.
Although, DES delivering antiproliferative drugs from adurable polymer have
significantly reduced restenosis compared with BMS, with no apparent increase
in the risk of adverse events, durable polymers have been associated with a
hypersensitivity reaction, delayed healing, and incomplete endothelialization
that may contribute to an increased risk of late (30 days to 1 year) and very
late (beyond 1 year) stent thrombosis compared with BMS. A number of stent
technologies are being developed in an attempt to modify the proposed mediators
of late thrombotic events including bioabsorbable polymers, nonpolymeric stent
surfaces, and bioabsorbable stents. Synergy*-EES is a novel Promus-Element
stent platform that deliveres everolimus from an ultrathin bioabsorbable
polymer applied to the abluminal surface.
The safety of titanium-nitride-oxide-coated bioactive stents (Titan-2*-BAS) has
been established in several reports from real-life unselected populations.
Interestingly, prospective studies demonstrated an even *better* outcome with
Titan-2-BAS as compared with paclitaxel-eluting stents (Taxus) in high-risk
patients with complex coronary lesions, and in patients presenting with acute
myocardial infarction (MI). The recent BASE-ACS trial demonstrated that in
patients undergoing early PCI for acute coronary syndrome (ACS), the insertion
of Titan-2-BAS was non-inferior to Xience-V-EES concerning the occurrence of
the primary composite endpoint of MACE at 12 months follow-up. The relative
risk ratio of MACE for Titan-2-BAS was 1.07 (a 0.6-percentage-point absolute
risk difference) as compared with Xience-V-EES, a difference that met the chief
aim of the trial for non-inferiority of Titan-2-BAS in reducing MACE in this
patient category.On the other hand, stent coating with compounds like
titanium-nitride-oxide seem to decrease acute surface thrombogenicity, and
reduce in-stent restenosis when compared with conventional stainless steel
stents.
Optimax* stent is a novel, next generation BAS, in which a thicker layer of
titanium-nitride-oxide coating is inserted over the stent struts. The rationale
of this is to obtain more efficient and rapid vascular healing at the site of
the stent implantation.

The purpose of the trial is to compare the safety and effectiveness of
bio-active-stent (BAS; Optimax*) and everolimus-eluting stent (EES; Synergy*)
in patients presenting with acute coronary syndrome

A prospective, randomized and multicenter study of the BAS and EES in acute
coronary syndrome.

Clinical follow-up at 1, 6, 12 and 18 months and at 2, 3, 4 and 5 years.

Percutaneous Coronary Intervention for stent implantation.

This is a standard therapy. The risks for this standard care of MI patients are
related to the invasive procedure i.e. coronary angiography and stenting. These
include stroke, myocardial infarction, death, bleeding at the access site. This
overall risk for these events is < 0.5%.
With the novel stent designs, the risk of late complications e.g. stent
thrombosis and restenosis are supposed to be decreased