Original title: A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent In-Stent Restenosis: The RIBS V Clinical Trial. Reference: Fernando Alfonso et al. J Am Coll Cardiol. 2014; Epub ahead of print.
Drug-eluting stents (DES) have proven to be superior in terms of restenosis than bare metal stents (BMS). BMS, however due to medical and economic reasons keep them widely used. Recently DEB´s proved to be superior to conventional balloons and comparable to first generation DES in the in-stent restenosis context. The relative effectiveness of the 2nd generation DES and DEB´s had not yet been tested to treat stent restenosis by BMS.
The RIBS V (Restenosis Intra – Stent Drug – Eluting Balloon versus Everolimus – Eluting Stent ) was a randomized, multicenter, prospective, open study comparing everolimus-eluting stent (Xience Prime, Abbott Vascular, Illinois, USA) with the eluting balloon paclitaxel (SeQuent Please, B. Braun Surgical, Melsungen , Germany) in patients with restenosis after BMS (> 50 % by angiography) that also present evidence of angina or myocardial ischemia. Patients with restenosis in small vessels ( 30 mm long), with the presence of thrombus or very early (before one month) were excluded.
The primary objective of the study was the minimum lumen diameter at 9 months by quantitative angiography. Between 2010 and 2012, 189 patients with restenosis after BMS (95 received DEB and 94 received XIENCE Prime) were included. 8% of the DEB branch eventually required the implantation of a stent due to suboptimal results or significant dissection. Patients receiving XIENCE, scored higher minimum lumen area, less residual stenosis and greater acute gain (all p < 0.01). Angiographic follow-up was achieved in 170 patients (92 % of eligible) to an average of 249 days observed minimal luminal diameter increased (2.36 ± 0.6 versus 2.01 ± 0.6 mm, p < 0.001) and a lower stenosis diameter (13 ± 17% versus 25 ± 20%; p<0.001) compared with the XIENCE DEB branch. Notwithstanding the foregoing, the late lumen loss, binary restenosis (4.7 % versus 9.5 %, P = 0.22) and target vessel revascularization (2% versus 6%, p = 0.32) was similar in both groups. These findings were consistent and uniform across patient subgroups and pre specified injuries.
Conclusion:
This randomized trial suggests that in patients with restenosis after BMS, both the standard balloon and everolimus-eluting stent have excellent results with a very low rate of clinical or angiographic recurrences. However, the everolimus-eluting stent showed superior angiographic results.
Editorial comment
Greater acute gain with XIENCE seems to explain the best long term angiographic result as the late lumen loss was low and similar in both groups. Angiographic superiority did not translate into clinical superiority while it is true that the study was not adequately powered to prove it.
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