Randomized Comparison between Provisional and Routine Kissing Balloon Technique after Main Vessel Crossover Stenting for Coronary Bifurcation Lesions

(PROTECT-SB).

Masahiro Yamawaki, MD, PhD(1)

Masaki Fujita, MD, Shinya Sasaki, MD, Masanori Tsurugida, MD, MamoruNanasato,MD,PhD Motoharu Araki, MD, Hiroshi Ishimori, MD,PhDMasatsugu Nakano,MD,PhD Keisuke Hirano,MD, Yoshiaki Ito, MD,Hiroshi Oohira, MD, Reiko Tsukahara, MD,PhD and Toshiya Muramatsu, MD,

Saiseikai Yokohama City Eastern Hospital,YokohamaEdogawa Hospital,TokyoSaka General Hospital,ShiogamaFujimoto Hayasuzu Hospital, MiyakonojyoJapanese Red Cross Nagoya Daini HospitalNakagami Hospital, OkinawaGeneral Tokyo Hospital, Tokyo

Disclosure

MasahiroYamawaki

Noconflictofinterestforthistrial

Backgroud There is no guideline for ballooning and

stenting for side branch (SB)-stenosis after main vessel(MV)-stenting in 1 stent strategy#.

Residual ischemic burden and long-term outcome was not fully investigated in coronary bifurcation using 2nd generation DES.

#SongYBet.al,JACCCardiovasc Interve 2012

Purpose

To investigate ischemic burden 8 months after the different side branch(SB) strategies following 1-stenting using 2ndgeneration DES.

PROTECT-SB participating centers

Saiseikai YokohamaCityEasternHospitalMasahiroYamawaki

EdogawaHospitalMasakiFujita

SakaGeneralHospitalShinyaSasaki

FujimotoGeneralHospitalMasanoriTsurugida

Randomizationof120patients withde-novonon-leftmain(LM)coronarybifurcationlesions

Protocolviolation(n=7)-Elective2stentstrategy(n=2)-Baremetalstent(n=2)-Withdrawal(n=2)-LMTstenting(n=1)

ProvisionalFKIgroup(n=57)

RoutineFKIgroup(n=56)

CrossoverEESdeployment CrossoverEESdeployment

(1) SBTIMI0-2or

(2)SBresidualstenosis>50%or

(3)SBdissection

Conversiontodoublestent

YesNo

SBTIMI0-2 RoutineFKI

Provisional FKIFinish

Yes

(1)SBTIMI0-2or

(2)SBdissection

Yes No

No

Sidebranch(SB)TIMI-flowguided

(SBTIMI=3)

SBstenosisguided

(SBresidualstenosis

Longterm(3years)

Clinicalfollow-up(n=57)

Procedure

SPECT(n=47)Follow-upCAG(n=42)

SPECT(n=46)Follow-upCAG(n=47)

Clinicalfollow-upuntil(n=56)

Procedure

8 months

ProvisionalFKIgroup(n=57)

RoutineFKIgroup(n=56)

TIMI-flowguided(TIMI=3)

Stenosisguided(SBresidualstenosis

Method-3

Copyright American Heart Association, Inc. All rights reserved.

Frequency of target vessel ischemia (TVI) at 8 months, defined as regional SDS# 2

SDS* = SSS - SRS

Summed Difference Score (SDS)Summed Rest Score (SRS)Summed Stress Score (SSS)

Percent(%) myocardial ischemia= (100SDS * / 68)

# Hacker M , J Nucl Cardiol 2005

Primaryendpoint

10%myocardic ischemic

R. Hachamovitch et al. Circulation. 2003

Automated Quantitation of SPECT(Heart Score ViewR) at 8 months

Yoshinaga K,Circ J2010

PCI>medication

PCI