Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial

Adriaenssens, Tom; Dens, Joseph; Ughi, Giovanni Jacopo; Bennett, Johannes; Dubois, Christophe; Sinnaeve, Peter; Wiyono, Stefanus; Coosemans, Mark; Belmans, Ann; D'hooge, Jan; Vrolix, Mathias; Desmet, Walter

doi:10.4244/eijv10i4a77

Cited by 67 publications

(36 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In the mechanistic SEDUCE (Healing Responses After Treatment of Bare Metal Stent Restenosis With Implantation of an Everolimus-Eluting Xience V Stent Versus Use of a Paclitaxel-Eluting Balloon: Optical Coherence Tomography Study) randomized trial, 29 optical coherence tomography was used to assess the healing characteristics of patients with BMS-ISR allocated to EES or DEB (25 patients per arm). DEB were associated with better healing characteristics (strut coverage on optical 16 demonstrating that EES improved all late angiographic parameters.…”

Section: Alfonso Et Al Everolimus-eluting Stents For In-stent Restenosismentioning

confidence: 99%

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

Alfonso

Pérez-Vizcayno

Blanco³

et al. 2016

Circ: Cardiovascular Interventions

View full text Add to dashboard Cite

S tent implantation constitutes the default strategy during coronary interventions.1,2 Drug-eluting stents (DES) are widely used because of their unique ability to inhibit neointimal proliferation and reduce the restenosis risk.1,2 However, although rare, in-stent restenosis (ISR) still occurs after DES implantation. 3,4 Of concern, several studies have suggested that treatment Background-Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. Methods and Results-A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-ElutingBalloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at followup remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. Conclusions-This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EESprovide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940. Current address for A. of patients with DES-ISR is more challenging than treatment of patients with bare-metal stent (BMS) ISR. 5-9 Indeed, long-term clinical and angiographic results of patients treated for DES-ISR are significantly poorer than those seen in patients treated for BMS-ISR. [5][6][7][8][9] These findings have been demonstrated in patients with ISR treated with first-generation DES. 5,6 Recent studies suggest that drug-eluting balloons (DEB), another well-established therapy in this scenario, are also associated with poorer long-term clinical and ang...

show abstract

Section: Alfonso Et Al Everolimus-eluting Stents For In-stent Restenosismentioning

confidence: 99%

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

Alfonso

Pérez-Vizcayno

Blanco³

et al. 2016

Circ: Cardiovascular Interventions

View full text Add to dashboard Cite

show abstract

“…Its efficacy against other treatment strategies has been demonstrated in both randomised controlled trials [9] and in the real world setting [10]. Comparisons to date however have predominantly been between DEB, POBA and first generation DES [9], and individual studies comparing DEB to second generation DES have been relatively small in scale [11][12][13][14][15][16][17]. Herein we present the findings of our meta-analysis examining the efficacy of DEB in the treatment of ISR specifically in comparison to second generation DES.…”

Section: Introductionmentioning

confidence: 99%

Drug-eluting Balloon Versus Second Generation Drug Eluting Stents in the Treatment of In-stent Restenosis: A Systematic Review and Meta-analysis

Liou

Jepson

Cao

et al. 2016

Heart, Lung and Circulation

View full text Add to dashboard Cite

While equipoise has been demonstrated in selected clinical outcomes between DEB and second generation DES in the treatment of ISR, the suboptimal angiographic outcome at follow-up and the higher TLR and MACE rates associated with DEB observed in the RCT are concerning. The results of the present analysis should be regarded as preliminary, although the generalised adoption of DEB in the treatment of ISR currently cannot be recommended.

show abstract

“…In total, 2,173 patients are included in this analysis (31.4% from RCTs), 1,167 treated with a DES, and 1,006 treated with DCB. The sample size of the individual studies ranged from 50 to 628 patients . Three studies reported results on patients presenting with BMS‐ISR, four on patients with DES‐ISR and three other studies included a combined BMS/DES ISR population.…”

Section: Resultsmentioning

confidence: 99%

“…Last, one study that reported outcomes on patients treated with a sirolimus-eluting newer generation stent, was excluded because the scope of this meta-analysis was to compare DCB versus stents with the newer-limus substances (everolimus, zotarolimus, and biolimus). Ultimately, 10 studies were included in this systematic review and meta-analysis [20,21,24,25,[33][34][35][36][37][38]. The PRISMA Flow Diagram presents the selection of studies in Figure 1.…”

Section: R E Su Ltsmentioning

confidence: 99%

Second‐generation drug‐eluting stents versus drug‐coated balloons for the treatment of coronary in‐stent restenosis: A systematic review and meta‐analysis

Kokkinidis

Prouse

Avner

et al. 2017

Cathet Cardio Intervent

View full text Add to dashboard Cite

show abstract

Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial

Abstract: http://www.clinicaltrials.gov. Unique identifier: NCT 01065532.

Cited by 67 publications

References 33 publications

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

Drug-eluting Balloon Versus Second Generation Drug Eluting Stents in the Treatment of In-stent Restenosis: A Systematic Review and Meta-analysis

Second‐generation drug‐eluting stents versus drug‐coated balloons for the treatment of coronary in‐stent restenosis: A systematic review and meta‐analysis

Contact Info

Product

Resources

About