TCT-177: Diffuse Multi-vessel Coronary Artery Spasm by Intravenous Ergonovine Provocation Test is Not a Physiological Response by Ergonovine But One of the Type of Varinat Angina

KWWSFRQWHQWRQOLQHMDFFRUJFRQWHQWYROB0HHWLQJ$EVWUDFWV

3267(5

:('1(6'$<6(37(0%(530±30

7&7

7&7

'LIIXVH0XOWLYHVVHO&RURQDU\$UWHU\6SDVPE\,QWUDYHQRXV(UJRQRYLQH3URYRFDWLRQ7HVW LV1RWD3K\VLRORJLFDO5HVSRQVHE\(UJRQRYLQH%XW2QHRIWKH7\SHRI9DULQDW$QJLQD

$OFRKRO5HODWHG&LUUKRVLVLV$VVRFLDWHGZLWK6LJQL¿FDQWO\/HVV$QJLRJUDSKLFDOO\6HYHUH 'LVHDVHWKDQ1RQ$OFRKROLF5HODWHG&LUUKRVLV


6DQMD\3DWHO7RGG/.LHIHU7HUHQFH/LQ=LDG$$OL-HQQLIHU$7UHPPHO'DYLG3/HH$ODQ&
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¿QLWLRQRIGLIIXVHPXOWLYHVVHOYDVRVSDVP ZDV YDVRFRQVWULFWLRQ ! RI EDVHOLQH OXPLQDO GLDPHWHU WKH OHQJWK RI YDVRFRQVWULFWLRQ !FP RI HSLFDUGLDOFRURQDU\DUWHU\DQGYDVRFRQVWULFWLRQGHYHORSHGLQPRUHWKDQRQHPDMRUHSLFDUGLDODUWHU\ 5HVXOWV$WRWDOSDWLHQWVPDOH ZHUHHQUROOHG7KHUHZHUHSDWLHQWVDQGSDWLHQWVLQWKH QRVSDVPGLIIXVHPXOWLYHVVHOVSDVPDQGRWKHUVSDVPJURXSUHVSHFWLYHO\7KHPHGLDQDJHRISDWLHQWV ZDVDQG\HDUVS  7KHSURSRUWLRQRIWKHPDOHZDVDQGS  WKH FXUUHQW RU H[VPRNHU ZDV   DQG S  WKH DOFRKRO GULQNHU ZDV   DQG  UHVSHFWLYHO\S  7KH PHDQ YDOXH RI WULJO\FHULGH7*  “ “ DQG “S KLJKGHQVLW\OLSRSURWHLQ+'/ ““DQG“S UHVSHFWLYHO\0DMRU DGYHUVHFDUGLDFHYHQWV0$&( LQFOXGLQJP\RFDUGLDOLQIDUFWLRQQHHGIRUFRURQDU\UHYDVFXODUL]DWLRQ SURFHGXUHDQGGHDWKRFFXUUHGLQ  DQGSDWLHQWUHVSHFWLYHO\S  5HFXUUHQFHRI FKHVWSDLQZDVREVHUYHGLQ  DQGSDWLHQWV UHVSHFWLYHO\S   &RQFOXVLRQV'LIIXVHPXOWLYHVVHOVSDVPZDVPRUHIUHTXHQWO\LQGXFHGE\HUJRQRYLQHLQSDWLHQWVZLWK FDUGLRYDVFXODUULVNIDFWRUVVXFKDVPDOHFXUUHQWRUH[VPRNHUDOFRKROGULQNHUK\SHUWULJO\FHULGHPLD DQG ORZ +'/ $OWKRXJK WKH SURJQRVLV RI YDULDQW DQJLQD LV UHODWLYHO\ JRRG KRZHYHU WKH UDWH RI UHFXUUHQFHRIFKHVWSDLQWHQGVWREHKLJKHULQGLIIXVHPXOWLYHVVHOVSDVPRURWKHUVSDVPJURXSWKDQQR VSDVPJURXS7KHVHUHVXOWVVXJJHVWWKDWGLIIXVHPXOWLYHVVHOVSDVPVKRXOGEHFRQVLGHUHGDVDW\SHRI YDULDQWDQJLQDQRWDSK\VLRORJLFUHVSRQVHE\HUJRQRYLQHDQGVKRXOGEHWUHDWHGDQGIROORZHGXSZLWK VLPLODUPDQQHUOLNHSDWLHQWVZLWKSUHYLRXVO\NQRZQW\SLFDOW\SHRIYDULDQWDQJLQD

%DFNJURXQG 7KHUH LV FRQÀ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“ ZHUH LGHQWL¿HGDQGGLYLGHGLQWRDOFRKRORQO\UHODWHG(6/'Q  DOFRKROYLUDOUHODWHG(6/'Q  DQG QRQDOFRKROUHODWHG(6/'Q  'HPRJUDSKLFYDVFXODUULVNIDFWRUVDQG&$FKDUDFWHULVWLFVZHUH UHFRUGHG 5HVXOWV7KHUHZHUHQRVLJQL¿FDQWGLIIHUHQFHVLQDJHRUYDVFXODUULVNIDFWRUVEHWZHHQJURXSVKRZHYHU WKHDOFRKRORQO\DQGDOFRKROYLUDOJURXSVKDGVLJQL¿FDQWO\OHVVSUHYDOHQFHRIVHYHUH&$'GH¿QHG DV!VWHQRVLVLQDPDMRUHSLFDUGLDOYHVVHO YQRQDOFRKROJURXSS )LJXUH ,QDOOJURXSV SUHVHQFHRI!YDVFXODUULVNIDFWRUZDVDVVRFLDWHGZLWKVLJQL¿FDQW&$'SIRUDOO '6(ZDV SHUIRUPHGLQSDWLHQWV,QDOOJURXSV'6(KDGSRRUSUHGLFWLYHYDOXHIRUGLDJQRVLQJVLJQL¿FDQW &$'EXWZDVXVHIXOLQUXOLQJRXWSDWLHQWVZLWKRXWVLJQL¿FDQWGLVHDVHDOFRKRORQO\339139 DOFRKROYLUDO339139QRQDOFRKRO339139 

7&7 ,PSDFWRI6SRQWDQHRXV5HFDQDOL]DWLRQRI,QIDUFW5HODWHG$UWHU\RQ0LGWHUP&OLQLFDO 2XWFRPHVLQ'LDEHWLF$FXWH67VHJPHQW(OHYDWLRQ0\RFDUGLDO,QIDUFWLRQ3DWLHQWVLQ'UXJ HOXWLQJ6WHQW(UD 6XUHVKNXPDU5DPDVDP\0\XQJ+R-HRQJ
9DULDEOHV1

6SRQWDQHRXV5HFDQDOL]DWLRQ 65 Q 

7RWDOGHDWKV &DUGLDF'HDWKV $Q\0, 40, 1RQ40, 5HSHDW5HYDVFXODUL]DWLRQ 7/53&, 7953&, 7RWDO0$&(

        

1R6SRQWDQHRXV 5HFDQDOL]DWLRQ1R65  Q          

3YDOXH         

&RQFOXVLRQ 7KH SUHYDOHQFH RI 65 LQ ,5$ RI GLDEHWLF DFXWH 67(0, ZDV  'HVSLWH WKH ZRUVHEDVHOLQHFOLQLFDOFKDUDFWHULVWLFVSWVZLWKRXW65LQ,5$VKRZHGVLPLODUPLGWHUPFOLQLFDO RXWFRPHVH[FHSWWKHWUHQGWRZDUGKLJKHU795VXJJHVWLQJIDYRUDEOHLPSDFWRI'(6

&RQFOXVLRQ7KHUHZDVDVLJQL¿FDQWO\ORZHUSUHYDOHQFHRIVHYHUH&$'LQSDWLHQWVZLWKDOFRKROUHODWHG (6/' 2XU ¿QGLQJV WKHUHIRUH VXJJHVW WKDW LQYDVLYH &$ PD\ QRW EH QHFHVVDU\ LQ WKLV VXEJURXS SDUWLFXODUO\LQWKHDEVHQFHRIYDVFXODUULVNIDFWRUVDQGQHJDWLYH'6(

7&7 0XOWLFHQWHU)LUVW,Q0DQ7ULDOZLWKD1RYHO'UXJ(OXWLQJ%DOORRQLQ3DWLHQWV3UHVHQWLQJ ZLWK,Q6WHQW5HVWHQRVLV3(33(5 &KULVWRSK+HKUOHLQ*HUW5LFKDUGW0DUFXV:LHPHU+HQULN6FKQHLGHU&KULVWRSK1DEHU (OOHQ+RIIPDQQ8OULFK'LHW] 8QLYHUVLW\0HGLFDO&HQWHU)UHLEXUJL%U*HUPDQ\6HJHEHUJHU.OLQLNHQ%DG6HJHEHUJ *HUPDQ\+HU]'LDEHWHV=HQWUXP15:%DG2H\QKDXVHQ*HUPDQ\8QLYHUVLWlWVNOLQLNXP 5RVWRFN5RVWRFN*HUPDQ\(OLVDEHWK.UDQNHQKDXV(VVHQ*HUPDQ\.OLQLNXP%RJHQKDXVHQ 0XQLFK*HUPDQ\'HXWVFKH.OLQLNIU'LDJQRVWLN:LHVEDGHQ*HUPDQ\ 

%DFNJURXQG,QVWHQWUHVWHQRVLVFRQWLQXHVWREHDWKHUDSHXWLFFKDOOHQJH7KHSUHVHQWVWXG\DLPHGWR HYDOXDWHWKHVDIHW\DQGHI¿FDF\RIDQHZGUXJHOXWLQJEDOORRQWKH3DQWHUD/X[3DFOLWD[HO5HOHDVLQJ %DOORRQLQSDWLHQWVZLWKDVLQJOHLQVWHQWUHVWHQRWLFOHVLRQLQFRURQDU\DUWHULHV 0HWKRGV%HWZHHQ$XJXVWWKDQG)HEUXDU\WKSDWLHQWVSUHVHQWLQJZLWKLQVWHQW UHVWHQRVLVZHUHWUHDWHGZLWKWKH3DQWHUD/X[3DFOLWD[HO5HOHDVLQJ%DOORRQDW*HUPDQVLWHV3DWLHQWV ZLWKDVLQJOHUHVWHQRWLFOHVLRQLQDSUHYLRXVO\VWHQWHGDUHDRIDFRURQDU\DUWHU\LUUHOHYDQWZKHWKHUEDUH PHWDOVWHQWRUGUXJHOXWLQJVWHQWUHODWHG SUHVHQWLQJZLWKDWDUJHWUHIHUHQFHYHVVHOGLDPHWHURI PPDWDUJHWOHVLRQOHQJWKRIPPDQGDV\PSWRPDWLFWDUJHWOHVLRQZHUHHQUROOHGLQWKLV¿UVWLQ PDQWULDO7KHSULPDU\HQGSRLQWRIWKLVVWXG\ZDVDQJLRJUDSKLFODWHOXPHQORVVDWPRQWKIROORZXS $QJLRJUDSKLFGDWDSRLQWVZHUHHYDOXDWHGE\DQLQGHSHQGHQWFRURQDU\DQJLRJUDSK\FRUHODE 5HVXOWV7KLUW\VHYHQPHQ DQGHLJKWZRPHQ ZLWKDPHDQDJHRI“6'\HDUV SUHVHQWHGZLWKLQVWHQWUHVWHQRVLV7ZHQW\WKUHH EDUHPHWDOVWHQWVDQGWZHQW\RQH GUXJ HOXWLQJVWHQWVDQGRQHXQNQRZQVWHQWW\SHZHUHLPSODQWHG$OOSDWLHQWVXQGHUZHQWDDQGPRQWK FOLQLFDOH[DPLQDWLRQDQGDPRQWKDQJLRJUDSKLFIROORZXS7KHPDMRULW\RILQVWHQWUHVWHQRVLVZHUH FODVVL¿HGDV0HKUDQFODVV,,LQ1 SDWLHQWV IROORZHGE\FODVV,LQ1 SWV 'HYLFH VXFFHVVUDWHZDVGH¿QHGDVH[DFWGHSOR\PHQWRIWKHEDOORRQDVGRFXPHQWHGE\WZRGLIIHUHQW SURMHFWLRQVDVVHVVHGE\TXDQWLWDWLYHFRURQDU\DQJLRJUDSK\ &XPXODWLYH0$&(FRPSRVLWHRIFDUGLDF GHDWKQRQIDWDO0,FOLQLFDOO\GULYHQ7/5FOLQLFDOO\GULYHQ795 UDWHDWPRQWKVDQGDQJLRJUDSKLF LQGLFHVDWPRQWKVZLOOEHDYDLODEOHDWSUHVHQWDWLRQ &RQFOXVLRQ7UHDWPHQW RI LQVWHQW UHVWHQRVLV LQ FRURQDU\ DUWHULHV ZLWK WKH 3DQWHUD /X[ 3DFOLWD[HO 5HOHDVLQJ%DOORRQVKRZHGH[FHOOHQWDFXWHUHVXOWVZLWKDYHU\KLJKGHYLFHVXFFHVVUDWH

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

%

-$&&9RO6XSSO% _ 6HSWHPEHU _ 7&7$EVWUDFWV3267(5&$'2XWFRPHV