Comparison of the efficacy of everolimus-eluting stents versus drug-eluting balloons in patients with in-stent restenosis (from the RIBS IV and V randomized clinical trials)
Selected in The American Journal of Cardiology by D. Milasinovic
Alfonso F, Pérez-Vizcayno MJ, García Del Blanco B, García-Touchard A, Masotti M, López-Minguez JR, Iñiguez A, Zueco J, Velazquez M, Cequier A, Lázaro-García R, Martí V, Moris C, Urbano-Carrillo C, Bastante T, Rivero F, Cárdenas A, Gonzalo N, Jiménez-Quevedo P, Fernández C
Am J Cardiol. 2016 Feb 15;117(4):546-54
15 February 2016
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What is known
Recent angiographic follow-up studies showed that in-stent restenosis (ISR) remains a clinically relevant problem not only after implantation of bare-metal stents (BMS), but also in patients with drug-eluting stents (DES). Initial randomized studies on ISR treatment showed that drug-eluting balloons (DEB) were superior to traditional balloon angioplasty (BA) and non-inferior to 1st-generation DES in BMS-ISR and DES-ISR patients, with a purported benefit of delivering an antiproliferative drug while avoiding the risks of additional metallic layer.
This pooled, patient-level analysis of RIBS IV and V randomized trials assessed angiographic and clinical outcomes within one year of treatment with paclitaxel DEB (SeQuent Please) versus everolimus DES (Xience Prime) in a combined population of patients with BMS-ISR and DES-ISR.
- 249 patients with ISR (> 50% diameter stenosis on visual assessment) and angina or objective signs of ischemia were treated with DEB (95 BMS-ISR and 154 DES-ISR) and 249 with EES (94 BMS-ISR and 155 DES-ISR).
- Inclusion/exclusion criteria, as well as interventional protocol with mandatory predilation were identical in both trials and randomization was stratified according to restenosis length (≤ or > 10mm) and location (intrastent vs. edge).
- Acute gain was greater in patients treated with EES vs. DEB (1.47±0.5mm vs. 1.24±0.5mm, p<0.001).
- At median of 249 days, patients treated with EES had larger in-segment MLD compared to DEB (2.16±0.7 vs. 1.88±0.6, p<0.001) and smaller late loss (0.12±0.6 vs. 0.24±0.6, p=0.02), with corresponding lower binary restenosis rate (8.7% vs. 15.7%, p=0.02).
- At one year, treatment with EES compared to DEB was associated with lower rates of both target lesion (3.2% vs. 10.4%, p=0.001) and target vessel (6.0% vs. 12.4%, p=0.01) revascularization, while mortality (1.6% vs. 2.8%, p=0.36) and myocardial infarction (2.4% vs. 3.2%, p=0.59) rates were similar.
This study confirmed previous findings of superior acute angiographic results with stent implantation vs. balloon angioplasty for ISR, which together with smaller late loss resulted in the larger follow-up MLD and by extension lower rate of TLR in patients treated with everolimus DES vs. paclitaxel DEB. Moreover, the study informs clinical practice by showing superiority of DES over DEB irrespective of the setting (unstable vs. stable angina), patient characteristics (sex, age, presence of diabetes), underlying stent type (BMS-ISR vs. DES-ISR), vessel diameter (< or ≥ 3 mm), and lesion length (focal vs. diffuse) and location (intrastent vs. edge). However, beside the inability to assume a class effect of DEB and thus extrapolate the results of this study to different DEB types, there seem to be at least three questions that warrant further inquiry. First, the role of DEB in challenging anatomical subsets such as ISR involving a bifurcation lesion. Secondly, the issue of long-term outcomes. In both cases the capacity of DEB do deliver antiproliferative drug without adding another layer of metal onto the vessel wall may provide comparative benefit over metalic DES. Thirdly, since different contributing mechanisms (stent underexpansion, geographic miss, stent fracture, hypersensitivity reaction, drug resistance) and morphological patterns of ISR (homogeneous vs. heterogenous neointima on OCT) have been described, intravascular imaging assessment of stent geometry and in-stent tissue morphology may constitute the first step towards better understanding of the optimal interventional therapy for ISR in an individual patient.