TiNO-coated stent maintains edge over drug-eluting stent for ACS

The 3-year outcomes of the TIDES-ACS* trial continued to reflect favourable outcomes with the titanium-nitride-oxide (TiNO)-coated bioactive stent compared with a platinum-chromium-based biodegradable-polymer everolimus-eluting stent (EES) for patients with acute coronary syndrome (ACS).

“The TiNO-coated stent was noninferior to the EES for the primary composite endpoint of safety and efficacy outcomes at both 12 and 36 months,” said Dr Pasi Karjalainen from the Helsinki University Hospital, Helsinki, Finland, who presented the findings at TCT 2021. “[Moreover,] the TiNO-coated stent maintained superiority over EES for the coprimary endpoint of safety at 36 months.”

A total of 1,491 participants (mean age 62 years, 75 percent male) were randomized to receive either the TiNO-coated stent or the EES (n=989 and 502, respectively). The primary endpoint was MACE** (including cardiac death, MI, and target lesion revascularization [TLR]) at 12 months. Coprimary endpoint was cardiac death, MI, and major bleeding at 18 months. The study was done in five European countries including Belgium, Finland, Luxembourg, the Netherlands, and Spain. More than half of the participants came from the Netherlands. [TCT 2021, Innovation Theatre]

STEMI and NSTEMI*** were present in >45 percent of participants. Lesion lengths were similar, measuring about 15 mm in both arms. “We also had quite complex lesions (B2/C type) in >20 percent of cases. Thrombus was also present in culprit lesions in >30 percent of cases,” said Karjalainen. Stent diameter was comparable (3 mm on average) and so was total stent length (20 mm in both arms). The incidences of stent failures were low (0.3 percent for TiNO-coated stents and 1.0 percent for the EES).

At 3 years, MACE event rate was a bit lower numerically in the TiNO-coated stent vs the EES arm (10.1 percent vs 12.4 percent), but the difference was not statistically significant (hazard ratio [HR], 0.82; p=0.23). This mirrored the 1-year results (6.3 percent vs 7 percent; HR, 0.93; p=0.66) that have been recently published. [JACC Cardiovasc Interv 2020;13:1697-1705]

With regard to individual MACE components, compared with the EES arm, the TiNO-coated stent arm had significantly lower incidences of cardiac death (0.7 percent vs 3.6 percent; p<0.001) and MI (3.2 percent vs 5.8 percent; p=0.002) at 3 years. Again, these aligned with the results seen at 1 year (0.5 percent vs 1.6 percent; p=0.04 [cardiac death] and 1.8 percent vs 4.6 percent; p=0.004 [MI]).

There were comparable rates of ischaemia-driven TLR between the TiNO-coated stent and the EES arms, both at 3 years (6.9 percent vs 5.4 percent; p=0.26) and 1 year (5.4 percent vs 3.4 percent; p=0.09).

In terms of the coprimary endpoints, the TiNO-coated stent maintained superiority over the EES at 3 years (5.2 percent vs 10.1 percent; HR, 0.52; p=0.001). This was similarly seen at the 12 (3.0 percent vs 6.2 percent; HR, 0.65; p=0.005) and 18-month follow-up points (3.7 percent vs 7.8 percent; HR, 0.64; p=0.001).

TIDES-ACS was conducted after the BASE-ACS^# trial demonstrated noninferiority of the TiNO-coated stent vs the EES in patients with ACS. [EuroIntervention 2012;8:306-315] “After the BASE-ACS trial, the new device – the TiNO-coated stent – was introduced,” said Karjalainen.

The TiNO-coated stent is a cobalt-chromium alloy, with thinner strut thickness and thicker TiNO coating. “It has been demonstrated that this coating inhibits platelet aggregation, minimizes fibrin growth and thrombus formation, reduces inflammation, and promotes vascular healing at the site of the stent implant,” he continued.

The TiNO-coated stent is not a drug-eluting stent. It has a strut thickness of 75 µm. The EES is a third-generation drug-eluting stent with a strut thickness of 74–81 µm.