Barcelona, 29 August, 2017 – During the Late Breaking Science session at the European Society of Cardiology (ESC) Congress in Barcelona, Dr. Pim Tonino (interventional cardiologist, Heart center Catharina Hospital, Eindhoven, the Netherlands) presented study results comparing TiNO coated stents (OPTIMAXTM from Hexacath, Paris, France) versus EES (SYNERGYTM from Boston Scientific, Marlborough, USA) in ACS patients.
“The TIDES-ACS results show us that the OPTIMAX nitride-oxide coated stent is non-inferior in patients with acute coronary syndrome compared to one of the top drug-eluting stents (SYNERGY) used in current interventional cardiology,” explained Dr. Pim Tonino.
Conducted in 12 international sites, this study randomized 1491 ACS patients (2:1) to receive either TiNO-coated stents (989) or EES (502).
The primary endpoint was the rate of Major Adverse Cardiac Events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR) at 12 months.
The primary end point occurred in 6.3% of patients receiving TiNO-coated stents, versus 7.0% of those receiving EES (HR 1.12 [95% CI 0.73 – 1.72] p for non-inferiority <0.001, p for superiority=0.66).
Both cardiac death (0.5% versus 1.6%, respectively; p=0.04) and non-fatal MI (1.8% versus 4.6%, respectively; p=0.004) were observed less frequently with TiNO-coated stents. Ischemia-driven TLR was undertaken more frequently in the TiNO-coated stent arm (5.4% versus 3.4%, respectively; p=0.09).
“When you look at the individual components of the primary endpoint in this study, the OPTIMAX stent comes with a lower rate of cardiac death and myocardial infarction compared to SYNERGY, which is outbalanced by a higher rate of ischemia-driven target lesion revascularization for OPTIMAX. In other words, with the OPTIMAX stent hard clinical endpoints like myocardial infarction and cardiac death are less frequent in ACS patients than with SYNERGY, at the cost of a, probably less important, higher rate of repeat intervention,” announced Dr. Pim Tonino.
In conclusion, for patients presenting with ACS, cobalt-chromium-based TiNO-coated stents were non-inferior to platinum-chromium-based bioabsorbable polymer EES for the primary composite of safety and efficacy outcome at 12-month follow-up.
“TIDES-ACS trial is the first adequately powered head-to-head randomized comparison of contemporary bioactive stent technology with cutting-edge DES technology, in the setting of ACS. It provided sound evidence of non-inferiority of the former, compared with the latter, for the composite of hard safety and efficacy endpoints,” said the principal investigator of this study, Dr. Pasi Karjalainen (Heart Center, Satakunta Central Hospital, Pori, Finland).
“Based on this solid premise, we can advocate the use of TiNO-coated Bio Active Stent (BAS) as a worthwhile alternative to DES in ACS. It is our aspiration that stents based on this bioactive technology will be embraced by the upcoming Practice Guideline committees, as a viable and valid option for PCI in ACS patients,” he continued.
Hexacath is an independent French company founded in 1994 which develops, manufactures and distributes innovative vascular therapy products such as Bio-Active Stents (BAS), Bare Metal Stents (BMS) and various types of PTCA & PTA catheters for coronary and peripheral indications.
Since 1996, HEXACATH has headed an ambitious Research and Development program in collaboration with public laboratories and Key Opinion Leaders from various countries. The aim is to develop a range of advanced cardiovascular products that are superior to existing products giving clinicians the ability to improve the quality of life of their patients.
Over almost two decades, huge investment has been made to develop and establish a unique, patented coating technology based on Titanium-Nitride-Oxide culminating in today’s announcement.
For more information, please visit the website: www.hexacath.com