The Relationship Between Late Lumen Loss and Restenosis Among Various Drug-eluting Stents: a Systematic Review and Meta-regression Analysis of Randomized Clinical Trials

Aims: To relate late lumen loss (LLL) after drug-eluting stent (DES) implantation to angiographic (BAR) and target vessel revascularization (TVR) in randomized clinical trials of DES.

Methods And Results: We reviewed all clinical trials comparing different DES and having protocol-driven angiographic follow-up. We combined the data in a meta-regression analysis correlating LLL with BAR or TVR, with and without adjustment for diabetes mellitus, lesion length or reference vessel diameter. There were 15,846 patients in 29 trials (9 DES platforms) and 8697 had angiographic follow-up at a mean of 8 months. The mean age was 63 y, 28% were women and 33% had diabetes mellitus. Mean weighted in-segment LLL was 0.232mm (0.228-0.235mm), significantly higher in paclitaxel- and zotarolimus-eluting stents than in sirolimus-, everolimus- or biolimus-eluting stents. LLL was monotonically related to BAR (BAR=0.30×LLL+0.02, R(2)=0.53, P<0.0001) and TVR (TVR=0.20×LLL+0.02, R(2)=0.46, P<0.0001). Two thirds of patients with BAR had TVR. LLL remained significantly associated with BAR and TVR after multivariable adjustment. Reference vessel diameter and diabetes mellitus were inversely related to BAR.

Conclusions: LLL is a strong, monotonically related predictor of BAR and TVR. There is no evidence of threshold phenomenon in these relationships.