Stent liberador de sirolimus vs everolimus en bifurcaciones
Mid-term Results ofJapanese Registry Study in Comparisonbetween Everolimus-eluting Stent andSirolimus-eluting Stent for the BifurcationLesion (J – REVERSE)Yoshinobu Murasato1, Yoshihisa Kinoshita2, Toshiro Shinke3,Masahiro Yamawaki4, Yoshihiro Takeda5, Kenichi Fujii6,Shin-ichiro Yamada7, Yoshihisa Shimada8,Takehiro Yamashita9, Kazuhiko Yumoto10, Masaya Arikawa11,Yoritaka Otsuka12 and Masaki Tanabe13On behalf of J-REVERSE investigators1. New Yukuhashi Hospital, 2. Toyohashi Heart Center, 3. Kobe University, 4. Saiseikai Yokohama EasternHospital, 5. Rinku General Medical Center, 6. Hyogo Medical University, 7. Himeji Cardiovascular Center,8. Shiroyama Hospital, 9. Hokkaido Ono Hospital, 10. Yokohama Rosai Hospital, 11. Oita medical Center,12. Fukuoka Wajiro Hospital, 13. Second Okamoto HospitalMay 23, 2013, Paris
Disclosure• Financial study supportAbbott Vascular, Cordis, Orbus Neich, Kaneka• Registered in Clinical Trials Government(NCT01266239)
Proximal stent deformation induced bykissing balloon (KB) inflationabcdeabcdeMurasato Y, European Bifurcation Club 2010KB inflation caused oval-shape dilation with theeccentricity value of 0.75 and 30% enlargement wasobtained compared to the distal site.Guérin P. Circ Cardiovasc Interv, 2010, 3, 120
Impact of symmetricityOtake H, JACC Intrv, 2009, 2,459KBTAsymmetrical stent expansion leads to uneven intimalgrowth and frequent thrombus attachment withuncovered struts after SES deployment.SEI: stent eccentricity indexNUS: neointima unevenness scoreKBT induces more asymmetrical stent expansion.What are its effects on neointimalialization after2nd generation DES deployment?
Purpose of the studyStudy-1To compare acute phase and mid-term outcome ofprovisional stenting between EES and SES deploymentunder the IVUS guidance.Study-2To investigate whether asymmetrical expansion in thebifurcation lesion leads to more disturbance ofneointimalization.EndpointsStudy-1Major adverse cardiac events (MACE) during 9-mo F/U periodDeath, Myocardial infarction, Target lesion revascularization(TLR), Target vessel revascularization (TVR), Stent thrombosisStudy-2OCT abnormal findings (unevenness of intimal growth,uncovered struts, thrombus attachment)
Complications: Acute phase0510Total MI SBdissectionSBocclusionSB stenting MV or SVTIMI≤1EESSES051015Total MI SBdissectionSBocclusionSB stenting MV or SVTIMI≤1KBTNon-KBT(%)(%)**** P<0.05 vs. non-KBT
9mo F/U: Major Adverse Cardiac Events (MACE)051015Prox MV Dist MVEESSES051015Prox MV Dist MVKBTNon-KBT01020304050SB01020304050SBP<0.05Restenosis in the Bifurcation(%) (%)One case of stent thrombosis (ST)occurred in the non-target lesion.05101520MI Death ST Non-TVR05101520MI Death ST Non-TVR
MACE: TLR0246810ns(%)EES NKBT EES KBTSES KBTSES NKBTFocal 13 casesDiffuse 2 casesLocation of TLRType of restenosisMV edge restenosisKBT 5/6, NKBT 0/7(P<0.05)
0102030405060pre post F/U0102030405060pre post F/UMB proxMB distSB-0.1-0.0500.050.10.150.20.25MV prox MV dist SBKBTnon-KBT(2) Late lossQCA: KBT vs. Non-KBTKBT Non-KBT(1) % Diameter stenosis(%)(%) (mm)※†:p<0.05 vs. pre PCI:p<0.05 vs. post PCI‡:p<0.05 vs. non-KBT※※※※※※†††‡‡‡※※※※※※††
QCU: KBT vs. Non-KBT11.522.53pre final11.522.53pre final12345678pre final12345678pre final406080pre final406080pre finalProx MVDist MVMLD MLA %ASKBTNon-KBT(mm) (mm2) (%)※†:p<0.05 vs. pre PCI:p<0.05 vs. non-KBT※※ ※※※※※※※※※※††
Impact of asymmetricity on neointimalization0.7 0.8 0.9 1.01.21.41.61.82.02.22.42.6AvgSEI0.7 0.8 0.9 1.00510152025AvgSEI0.7 0.8 0.9 1.00246810AvgSEInoofuncoveredstruts0.7 0.8 0.9 1.00.00.10.20.30.4AvgSEIAverageNITAverageNUSFrequencyofuncoveredstrutnumberofuncoveredstrutAverageNITAvg SEI Avg SEIAvg SEI Avg SEINo significant relations were found betweenSEI and disturbance in neointimalization in thisinterim report.
Conclusion• The EES deployment under the IVUS-guidance in thecoronary bifurcation lesion brought a favorable TLR ratecompared to the SES.• Although the KBT induced more SB dissection requiringstenting and asymmetrical stent expansion in theproximal MV, it maintained lower levels of SB stenosisand larger proximal MV lumen during the 9-month F/Uperiod without any increase in MACE.• Asymmetrical stent expansion induced by KBT did notresult in more disturbance in neointimalization, whichmight be influenced by the improvement inmalapposition or overstretch in the proximal MV.