First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: impact on longitudinal geographic miss during stenting

Lu, Huangling; Ijsselmuiden, Alexander; Grundeken, Maik J.; Nassif, Martina; Vries, Arie G. de; Weevers, Auke; Scholte, Martijn; Spaargaren, René; Wykrzykowska, Joanna J.; Tijssen, Jan G.P.; Winter, Robbert J. de; Koch, Karel T.

doi:10.4244/eijy15m05_07

Cited by 13 publications

(7 citation statements)

References 8 publications

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“…Of note, in the present study we included both the first generation of SES with the traditional Stentys release system and the more recent balloon‐delivered Xposition Stentys. As previously reported, these peculiar release systems did not appear to represent a substantial limitation to the use of these devices and they did not appear to relate to a higher rate of early definite ST and early adverse events in the SES group.…”

Section: Discussionsupporting

confidence: 68%

Self‐expandable sirolimus‐eluting stents compared to second‐generation drug‐eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS‐2 registries

Montefusco

D’Ascenzo

Gili

et al. 2018

Cathet Cardio Intervent

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Objectives: To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM).Background: SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed.Methods: Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points.Results: Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation.Conclusion: SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting. K E Y W O R D Spercutaneous coronary intervention, second-generation drug-eluting stent, self-expandable stent, unprotected left main

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Section: Discussionsupporting

confidence: 68%

Self‐expandable sirolimus‐eluting stents compared to second‐generation drug‐eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS‐2 registries

Montefusco

D’Ascenzo

Gili

et al. 2018

Cathet Cardio Intervent

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“…The latest Stentys Xposition S with balloon delivery system has radioopaque stent end markers to enhance precise placement of the stent. We concur with the SETUP study that postdilatation is still necessary as we also discovered significant immediate stent strut malapposition post stent deployment [4]. Despite repeated OCT guided balloon postdilatations, residual minor strut malapposition remained and hopefully, the nitinol based stent with self-expanding nature would conform to the vessel wall over time.…”

supporting

confidence: 85%

“…SETUP study authors suggested that Stentys Xposition S would be suitable and appropriate for cases with potential risk of stent malpositioning and mis-sizing [4]. Our case complicated with the LM-LAD anatomy, bifurcation and ectasia vessel factors with large and unpredictable diameter differences, rendering it highly susceptible to stent malpositioning and mis-sizing risks.…”

mentioning

confidence: 93%

First-in-man unprotected left main stenting with Stentys Xposition S self-apposing sirolimus eluting stent and optical coherence tomography guidance: The emerging panacea for left main intervention

Yew

Kang

2015

International Journal of Cardiology

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“…Also, optimal positioning was challenging with the older generation STENTYS stent because of shortening of the stent at deployment due to retracting an outer sheath which releases the stent from the distal edge. A novel balloon delivery system for the STENTYS SES, (the STENTYS Xposition), was therefore developed to improve accurate stent positioning[ 21 ].…”

Section: Limitations Of the Studymentioning

confidence: 99%

Comparison between the STENTYS self-apposing bare metal and paclitaxel-eluting coronary stents for the treatment of saphenous vein grafts (ADEPT trial)

et al. 2017

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AimsTo describe the safety and performance of STENTYS self-expandable bare metal stents (BMS) versus paclitaxel-eluting stents (PES) in saphenous vein grafts (SVGs).Methods and ResultsA randomised controlled trial was performed in four hospitals in three European countries between December 2011 and December 2013. Patients with de novo lesions (>50% stenosis) in an SVG with a diameter between 2.5–6 mm were included. Primary endpoint was late lumen loss at 6 months. Secondary endpoints included procedural success and the occurrence of major adverse cardiac events (MACE) at 12 months. A total of 57 patients were randomised to STENTYS self-apposing BMS (n = 27) or PES (n = 30). Procedural success was obtained in 89.5%. No significant differences in late lumen loss were found between BMS and PES at 6 months (0.53 mm vs 0.47; p = 0.86). MACE rates at 12 months were comparable in both groups (BMS 22.2% vs. PES 26.7%; p = 0.70).ConclusionsTreatment of SVGs with STENTYS self-expandable stents is safe and effective. No significant differences were found in late lumen loss and MACE between BMS and PES.

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First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: impact on longitudinal geographic miss during stenting

Cited by 13 publications

References 8 publications

Self‐expandable sirolimus‐eluting stents compared to second‐generation drug‐eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS‐2 registries

Self‐expandable sirolimus‐eluting stents compared to second‐generation drug‐eluting stents for the treatment of the left main: A propensity score analysis from the SPARTA and the FAILS‐2 registries

First-in-man unprotected left main stenting with Stentys Xposition S self-apposing sirolimus eluting stent and optical coherence tomography guidance: The emerging panacea for left main intervention

Comparison between the STENTYS self-apposing bare metal and paclitaxel-eluting coronary stents for the treatment of saphenous vein grafts (ADEPT trial)

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