Long term follow up of patients treated with a polymer coated non drug-eluting stent in the COBRA-REDUCE trial.

Background: The use of a non-drug eluting coronary stent with a thromboresistant and pro-healing coating may result in long term advantages in comparison to FDA approved drug eluting stents (DES).

Methods: In the COBRA REDUCE trial, patients with an indication for OAC undergoing PCI were randomized to treatment with the COBRA-PzF stent followed by 14 days of DAPT or an FDA-approved new generation DES followed by 3- or 6-months of DAPT. In the subset of patients enrolled at the lead site, we collected additional long term follow up. The primary endpoints for the current analysis were a composite thromboembolic endpoint (all-cause death, myocardial infarction, definite or probable stent thrombosis, or ischaemic stroke) and ischemia driven target lesion revascularisation (ID-TLR) through to 4 years follow up.

Results: A total of 996 patients underwent randomization in the COBRA REDUCE trial. Of 140 patients randomized in Munich, 71 were randomized to the COBRA PzF stent and 69 to the control group. The primary composite ischemic endpoint occurred in 15/71 patients (21.8 %) in the COBRA PzF group and 15/69 patients (22.4 %) in the control group (hazard ratio [HR], 0.96; 95 % confidence interval [CI], 0.47-1.97, p value = 0.92). ID-TLR occurred in 7/71 patients (10.1 %) in the COBRA PzF group and 3/69 patients (4.5 %) in the control group (HR, 2.30; 95 % CI, 0.60-8.77, p value = 0.22). TLR occurred in 11/71 patients (15.8 %) in the COBRA PzF group and 3/69 patients (4.5 %) in the control group (HR, 3.76; 95 % CI, 1.06 to 13.32, p value = 0.04).

Conclusion: Through to 4 year follow up after PCI in patients with an indication for OAC, the COBRA PzF stent did not result in any advantages in comparison to FDA approved DES and was associated with an increased risk of TLR.