JACC
Febnlary Igq8
4.~3A
The Impact of Time to Thrombolytlc Therapy on
Outcome In Patients With Acute Myocardial
Infarction ( A M i )
P, Chareonthaitnwee, RJ, Gibbons, RS, Roberts, TrF Chnstian, R. Bums,
S Yusut For the CORE Investigators; Ma]K~Clinic, Rochester, Minnesota,
USA; McMaMer Unit~erMy, Hami#on, O~tari~ Canada
Pno~ ~ t ~ m haNe suggested that the greatest t ~ f i t s of e<lfly thrombolysis may t~ o~zerv~ if administered within ~ holm of ~ y ~ t o m onset+ The
Ipu~<~ of ~ s i ~ t i o n
wi~ to exan~ne the impact of ~ m to ~rom.
bofy~ ~
on ~
AM! outcome velnaPles in CORE, ~n interr~ltional,
~ e g
tn~! of pofoxamer 188, Mortal~ (M) 4nd remf4rctmn fate (RR)
were meaI~red in 2,954 r ~
patients with AMI (.< 12 hogm' d~r~tmn)
recewed ~
ther4~. S ~ m ~ c l ~ umng T ~ e m ~ t a m , t .
lanai ~ (IS) and reldion~,mhde~
electron ~
(EF) measured
by ~mn~'al ~ a t o n e s mvOIved I,C~5 and 1,075 patmms, mspact~W, who
amalyzable ~ .
~ time to thrombalyttc therapy was ~gmfcantiy
asso~ated ~ IS, EF, M. ned RR:
Tume !o Theomtmlys+s
IS |%LV)
EFt%)
3 5 ~ M 1%)
E ~ t ~ t t M |%)
35-(t=-y RR t%l
19S t~ I~
051=.012
55
69
62
2"25:20
04S ¢ 0 1 4
70
S,2
32
2 4 1 1 19
048:013
77
10 1
4I
2~S ~ 2~
048¢015
t2a
155
09
0.014
0008
00001
<00001
0 0(~11
Coe~t~s~ns: 1} There are c~emonstrabM benefits el eadre~ relped~smn
therapy Onm~a~ m..-e,election fradmn, and ~ t t y .
2) +~baug~ rite effect of
tin.re to ff~ron~d~'sis On in~,~'t stze and eiection fracton ~spnmanly restricted
to therapy ~
w~thm 2 hours e! sym~om onseL me effect of time on
mo~alily is evident over all tm~e m~enrats. 3) Re~arctmn rate as htgl~r m
patients Ireated ~ earker t h ~
t~erapy.
Stenting: Carotid, Peripheral, Renal
(11), a n d R e s t e n o s i s
Diabetes
II
W e d n e s d a y , April 1, 1 9 9 8 , N o o n - 2 : 0 0 p.m.
Georgia World Congress Center, West Exhibit Hall Level
P r e s e n t a t i o n Hour:. N o o n - - 1 : 0 0 p.m.
~ -~--~
inRial
With the Corvita E n d o l u m i n a l
Graft in Peripheral Arteries
M Hemy, M Amo~. I. Henry. K. Tzvetanov. O. Tncodm. U CC.L.
Potyctz.,~/ue. Essay-tee-Nancy. France
Puq3Ose: To evaluate a self--expanding er~olummal vascular prostttes=s, the
Con.ta Endoluminal Graft (CEG). allewm~ percutaneous bypass gm~ng m
peni~erel artenes.
Method and Matenats: The CEG census of 2 ~ n ~ :
a ~t-expandab~ cyfindncal wire ~ ,
a h~ghly porous, elast¢ coating on ,nner surface of structure, m wh~-'h b~ood can coagulate, seahng the CEG to form
a new blood tight vessel wall. This flexible CEG can be compressed atria
8.-10F introducer sheat'-s a,qo~ng porcutaneeus entry, ts produced an vanous I~gths (3-30 cm). diameters (4 to 44 ram). cut to length by user, released
from t n ~ r
sheath at intended site by coa.=al ~
of a "tlof~ng"
catheter/slew pull back of the introducer sheath
ResuffS: 58 pts (M: 46, F: 12. mean age: 644 ± 9.7 ym [39-86]) with
occti.stve lesions (47)(sten.: 28, oocl.: 19), aneurysms (11), in lliac (35).
temo~opop. (23) arteries treated with CEG. Mean lesion length: iliac~ 58.3
± 24.3 mm (40-100), lemoropop.: 105.8 ± 7 ram. Mean % steno~s; 79
± 6.2. 65 stents easily placed percutaneously (10 pts had contralateral
approach). 6 lesions >12 cm treated ~ t h 2 overlapped slants. Immediate
technical success: 100%. Complications: 7 thromboses titian: 2, femoropoD:
5), 4 les~ons > 15 cm, requinng bypass (3), Fogarty (1). new angioptasty with
success (3). At 6 months, 3 reslenoses appeared outside the ~iu.; trebled
by now angioplast~,. Primary I~tency at 1 year: lliac: 95%, fern.pop.: 60% (p
< 0.00t). Secondary patency respectively: 100, 75% (p < 0.001).
Conclusion: The CEG seems an alternative to surgery to treat occlusive lesions and aneurysms, allowing true internal bypass by percutaneous
approach. Yet, treatment of long lesions leads to higher thrombosis rate.
~
Renal Arterial Stenting. A 7 Year Single C e n t e r
E x p e r i e n c e With a Serles of 206 Stented A r t e d e s
M Henry, M Amor, I. Henry, K. Tzvetanov, I. Masson, B. Mentre.
Polyclinique, Essey-les-Nanc~. France
Pu;pose: To evaluate the role of percutaneous stenting in the treatment of
renal 9ffenal lestons 9fter failure of previous 10alloonangtoplasty.
tv~thoclan<1M~tenats. 224 balloon e~panda¢~ steP~ (Palmaz: 164, AVE
60) placed in 206 renal aNanea of 181 patHmt~ tectal ~ :
140, non.
oatiol: 66) suffenng from HTN remtant to therapy (181), reflal dy~gnct~n
(41) with 9theromatou~ (197), tibremu~ut4r (7), "rakay4shu (2) ¢J~ses.
25 pts had t~laleral lesions, 3 a solitary kidney, Ind~-.atmns'. uf~a~factory
balloon a n g ~ p ~ resuits (173), mete.am (26), ~ s s e ~ n (7), Mean les~e
length; 11,9 .+- 4.3 rnm (5-.30), M ~ n 4tlmo~e %: 6 2 3 ± 6.4 (70-100) 14
very cal01i~ o ~ ! lemoni treate~ by Rofal01ator,
~uIP~." gmmed~el~ leche~l success;205/?06,3 major ¢omplc~t~s
(15%): 1 acu~_ m m m ~ i s cure¢l by fit~noly~, 1 aelanst perfom~on, 1
artenal rapture ( ¢ ~ t h after surgery), 6 montt~ el~poo~~
foaow.up m
el~
pts (175); rosteno~t# in I:~ pts (6.9%), Im~led by el new angmplaety.
C!,~cal results: systolic blood pmssm drop from (mmH0) 1"/8 ± 9 to 141
± 12 (p ~ 0,001) pant.slant, ~
~
preuum (.wVHg) mop from
106 ± 6 to B2 ± 10 (p .~ 0,01), ¢maumn (n~l) did nol ct~ange, n u n ~ of
dmg~patmnt; baseline*. 2,6, pos1-~mt; 1,;2(p < O,02-J,HTN; cured: 32/161
( ~ ) , iml~'Oved: 98/161 (61%), o~llanged: 30/161 (19%). Henal o~/sh~,~
tmn: Improved: 12/41 (30%), u~llanged; 27141 (1~%), ~ ;
~41 (4%),
At ? years, at! lesions: i~imary pstency: 76%, aecondary: ~ % , non osl~t
les~nS respectively 78, 100%, Ostlst leS~nS: BO elnd 93% (p:n.s.).
C o n c l ~ : Renal aflery stsnting is sale, effe¢tNe, may be an alternative
to Surgery. partlcutarty in o~tJal lesK~ng. Our expenen~e shows md~ction m
restenomS rote, compared to conventional angmptasty. All ostlal
~l~ouldbe slanted.
~
P e f ~ u t a n e o u s E n d o l u m l n a l Treatment o f
m l
A n o u l ~ / i m L A S i n g l e Centl~
F ~
With e ~ k ~ o s o f 3S A n o u w s m s
M. Henry, M. Arose, I. Henry, K. Tzvetanov, P. Khofer. Po/yc//mque,
~Na.c~,
France
Purpose: To evalume fea~l~lfly, efficacy at percutaneoustreatment of penpheralaneuq/smst0,~thcoveredstentsm most of the cases, CraggEndopm
System 1 (CES) and Corvita Endolummal Graft (CEG).
Meft/o~ and Ma~J/a/s: 33 pts (M: 28, F: 5, mean age: 65.4 ± 9.6 yrs
H7-83]) ~ l h 35 aneurysms treated w~h covered stems (CES: 10, CEG: 13,
non @ov~red stertts: 2, =i=~i graft: 1). ~
loCatlon: lenlorel
~'~.
12. poplrteal: 8, d~c:15. Mean leslon length.61.1 m m ± 21.3. Percutaneous
approach used m all cases, femoral antegracle (n = 19), lemofal retrograde
(n = 14), fern_ coqntralateral (n = 1). poptrteal (n = 1). Sten~ are ~tre~uced
tt~ougll 7-10F st~eattts. Multiple slenl~ used to cov~r all les~ns in 8 cases
Slants: from 6 to 12 mm in diameter, frem 30 to 120 mm in length.
Re~.d~: Sten~ ~
implanled in 34 cases, no leakage. In 1 long,
very tot'gJot~ femoropopliteal aneurysm, m ' q 3 o ~ e to cover rts low pint. the
dewce (CES) being too ng~d.No complicationobserved dunng the procedure.
3 of5 0 e v e k ~ non-+nfecllo~s fever/local pain with CES. 5 mremboses: 3
in a palm,teal a n e ~
t in a femoral aneu~s,m treated by bypass, 1 In an
thac aneu~am treated by Fogady techn=que. All othe~ slenis remaonpatent,
the aneuWSm completely exclucled o~er a mean follow-up of 13.3 ~ 10.4
and a max. folfow.-upof 46 rrm:~m. Primary palency at 42 months:
all Insane: T~=, ili~c ~teurysms: 100%, femoral aneurySm: 91%, poplttoat:
34%. Secondary patertcy: all lemons: 85%, iliac aneurysms: 100%, femoral:
91%. po~liteal- 56%.
Cor~usnon: Percutaneous endelummal treatment of p e n ~ r a l aneurysms
seems safe. effect~e, effanng t~gh technical success with good told+term results, except tot poptPeal lecalization. Long term result~ need to ba analyzed.
Thts method could be an altematwe to surgical bypass and may be the first
treatment to propose for this kind 01 disease.
~
P e r c u t a n e o u s Endoluminal Treatment of
A o r t a - A b d o m i n a l O c c l u s i v e Diseases
M. Henry, M. Amor. I. Henry, K. Tzvetanov, B. Mentre, D. Weill. UCCI..
Pofycl/nKTue, Essey4es.Nancg France
PurpOse:To evaluate the feasibility and efficacy of percutaneous endoluminal
treatment of aorta-abdominal occlusive diseases.
Methc~ and Materfafs: 28 pts (M: 25, P 3, mean age: 52.5 ± 113 ym)
were treated by Percutaneous Transluminal Angtoplasty' (PTA) tar aortaabdominal occluswe diseases. Lesions were located in the infremnal aorta
alone (stenoses: 12). or extended 1o lilac artenes (stanoses: 12, occlusions:
4). Mean % stenosiS: 80.4 ~_ 11.7. Mean lesion length: 33.5 ± 7.2 ram.
7 lesions were calcified, 9 ulcerated. 16 excentrated. Owing to Fontatrm's
clasmtication, 26 ~ were in stage It severe, 2 in stage III.
Resu/ts: Technical success in al: cases (100%). The 4 oo:lusions were
initially treated with tibnnolysis (3) or ultrasound mechanical thrombectomy
device (1). Stentts were implanted in 23 pts (Palmaz in 18 pts, Wallstent
in 2 and Optimecl in 3). A.B.I. increased from 0.63 :~ 0.15 to 0.97 ± 0.05.
No immediate complication. Max. follow-up: 9 years, mean follow-up: 26.4
E
D
N
E
:,~, S
O
A
y
P
0
S
E
R
454A
JACC
months, At 3 yrs, we report 2 rostonosos, 1 treated by PTA alone, 1 by PTA
and stent. All arteries remained patent,
Conclusion: PTA el infrarenat aorta. ,)cctt.lSlVOdlse~, ;os is sate and cOcolive Slant placement are necessary In most el the cases, Leng term results
ar~t o~collent This technique is an alternative to surgery
"o"' So.ported C..o,,d Ang,op,.,y (..CA) In
. . . . . . . . . . . . . .
Patients With Symptomatic Coronary Artery
Disease: Acute and Long Term Results
F/A, Shawl, A, Efstrotieu, F, Lapetlna, A, Dukevoic, T, Shahab, 8,B, Heft,
K,G, DO~lghnrty, Wa,~hingtorlAdventist H&~piIal. dikes# Prqrk. MD. USA
C~rolid endarteroctomy (CE) in tl~fl pro~onco el r~ymptomatte coronary artery
disease (SCAD) has boon associated with high molbidily and mortality Of
06 pie with SCAD who undnrwenl SSCA, 77 were conaiderod poor CE
candidates (g had scent MI, 27 had 8ovate LV dy~lunclien with Class III or
IV nngina pre~ent in 50), Twenty leHt wore ,g0 years, 0 l~nd eontralatorol
carotid o~oluslen, 20 had bilateral atano~is. 70%, 52 presented with TIA's or
eVA, 5 scent h~miplegla, and evolving stroke was prose~t In t, ~ C A was
undaftakon in g0 internal and 7 common carotid artenea with implanlatlca el
14t Palma~, stent~ with everlappieg sleet in 33% to Incroaae radial stronglh.
Pmeed~lr~l succo,~ we~ff100% (tl~(:;l~ldlnt155w!th combiner4 or at~god PTCA)
rodllclng the carotid Me.healSfrom 86 t 7% to 5 ~ 2% There were no deaths,
MI or meier strokes, hut, 3 pts l~r~dminer neurolofllc deficit which resolved
in 7 day& Moat (75%1 were discharged within 24 hetlrs, On fellow.up (g t
5 months), 6 p16 died teen combrava~c~dl~r) and 2 with known LV tl~mmbus
so(feed minor ~trekn In 71 p(s eligible for 6 monll~ anglograplric (4~ pts)
of uttr~se~,md (Tt pts) follow.up ~eveidcd, t asymptomatic ioslenotHs, wl~lch
wa~ ro.diltUed
Conchrsien: SSCA is associated with n high success tats, low recurrence
rat~ and infrequent complications,
L~8:~
-
Is Combined Parcutaneous Carotid Artery
Slanting and Coronary or Extra-Coronary Artery
Angloplasty a Safe Procedure?
JC. Laborde, J, Faiadet, B Cassagnoau, C Jordan, R Calms, T Joseph,
J P Laumnt, J Memo Unitd de Cmdlotoqie Infen.ent~onnelle, Chn~que
P&~ltr, TouletL~o, F~anct~
Background: To evaluate the risks and bnnohts el carotid orient stontmg m
comhtnation with coroner's, or oxtra-c"~renary angioplasty dunng the same
setting in patients at risk for ondartorectomy.
Mefhc~d.~ From 4/15/96 to 7,'20197, we pertormod combmed procedures
tn 22 pahonts ( t 8 males, mona ago 71 2 t 4 ? years, range: 62-78), considered at nsk fo~ su~tcal ondarlorectomy Assoclahon of caretid stontmg and
coronary ang~oplasty (balloon +stont: 5 pts, balloon angloplasty atone: 4 pls,
3therectomy + balloon 2mq~oplasty 1 pt) was performed in 10 pts, bilateral
camt~d stontmg ,~ 9 pts; carehd slenlmg ar(d ponphoral angloplasty (renal
stentmg: 1 pt; ihae stenhng: 1 pt; femoral angloplasty: 1 Dr) in 3 pie. Twelve
pts (55%'t had neurologlc symptoms incladtng transient ischomic attacks (8
pts) and recent stroke (4 pts). The remaining pts wore asymptomatic. Twenty
pts (91%4 had severe coronary associatod orion,/lesions. Moan diameter
stonosls of the carehd Ios~ons was ?9"0 frange: 65-95%). All pabonts wore
treated without downtlow carotid protection.
Results: Procedural success was achieved ~n 21/22 Dis (955%) Immediate comphcahons conmsfed ot 1 rumor stroke (45%,) At 30 days follow-up,
we obsewod one death t4,5",,) duo to cardiac arrest, non fatal cardiac events
m 2 pts (1 heart lailure, 1 ventncular tachycardia), 1 abdominal haemorrago,
no MI, no stroke. At follow-up, mean 5,7 t 4.1 months, we observed { 2
cardiac deaths, 2 PTCA for restonoms, no MI, no stroke
Conclusfons: Combination of carotid artery stentlng with controlatoral
carotid stoat implantahon or w~th coronary and extra-coronary angtoplasty
dunng the same setting appeared not to mcrease significantly the ask el
carotid stenting in high-risk pts lor surgery,
~ L a c k
of Benefit of Stentlng Compared to B a l l o o n
Angloplasty for Native Coronary Stenoses in
Diabetics
M.H. Ghatoun, GC. Timmls. T, Catlin, D, Aliabadi. R+D. Safian,
J.A. Goldstem, W.W O'Neill Wdliam Beaumont Hospital. Royal Oak,
Mich.gan. UqA
As suggested m recent teals of balloon angioplasty vs bypass surgew, diabetic patients may tare less well with angioplasty, Intracorenary stenting
reduces restenosis rates in pts undergoing elective angioplasty of native
coronary stenoses. However, whether stenting conlers such benefits in diabetics has not been established. Therefore, we retrospectively analyzed the
outcome over 9 months in diabetic patients undergoing balloon angioplasty
Fehnlary I ~81,I
alone (N = 154) or elective stonting (N ~ 87) of native coronary lesions, Endpoints el the study included target vessel rovascularizatlon (TVR) and major
clinical outcomes (MI, stroke and death), No differences w e e found between
groups with aspect to ago or gender. Acute success rotes between balloon
nnd stont groups were similar. Over 9 months, them w e e no ai~niflennt
difference between angioplasty end stent groups with regard to TVR roto~
(24% vs 28"/0, P = NS), MI (4,3% vs 3,8% P ~ NS), stake (P,~, vs 9.6%, P
==NS) or death (? R"/,,v~ .q,2%, P = NS), These data suggest that oomparod
with balloon nngioplaaty, elective intmooronaly stenting dens not provide
additional benefit in diabolic pts undergoing percutanoega rovascgl~nZ~tlon
el nntive ceronnry lesions, The moat elteCtlVe revaact!!rletolion strategy for
tl~nso pts has not boon dotetmmed
' ====
(111]I]~B4
~---'j The Effect of Dlel~tee and Revas©u!er!zetlon
+
-
-
~
Technique on Eerly Outcomes
G C Timmia, R T Collie, L Tomaka, W.W, O'Ned! WtlhamB~+umont
Hospffal, Revel/Oak, MI, US.4
Beeal.lse el the interaction at diabetes (DM) and mvasculalizattee technique
on eulcomea we interrogated our !nt~n/onhenal Outcomes Regtst~ Database
tel the following In,hospital events: death, IofalClion (b(3lh qMI and nqMl)
SllOkO, lllgellt 6lllglca! levascu!arl~aften, ca~iel~nl~ shock~ and reoo~Iuslon
a~ inlhteeced by DM status (beth type I and II) m~d by procedure (PTCA
vs sleet) There were 17',00g patients (pts) having procedures tree t,1,94
Ihreugh 3,31-97, 4,056 (29%) were diabetic (type Iaad It) but stmdar m a g e
gender and disease seventy There wore 62 and 104 doatbs m the OM v,s
non.DM pls (1 25%, vS 0.86%; p = 0.01 cJ). This was duo to an eKcess mo~akty
m PTCA pts with DM (1,22% vs 0.83% non, DM PTCA pts; p = 002.5) There
was no slgndleant mortalLty dlllemn¢o in sleeted DM vs non-DM pts tt 48%
vs 1 05%; p =, 0.3g) Roocclusions wore mere likely to complicate PTCA
regardless el the presence o! DM (1.68%, vs 0.49% with stoats; p = 0032) of
Its ab~enc~ (t 7~i% vs O~75% wtth stoats; p = O.OOt/ ConverserK MIs ¢~'re
more lreqnont with stents (2.33% vs 1.29%; p = 0.000) but wore equally
dlstnbuled beh~oon DM and non-DM pts regardless el procedure ~,~reover,
combining ~lt endpomts there was no stgmllcant difference per d~abot~cstatus
(p = 0.38) regaElloss ot procedure (stool: p = 027; PTCA: p = 0.48). No other
ondpetnt wos intktonced by DM status Iocludmg acute or delayed reoccluston
Conclusion: Hospital mortality is higher in OM pts alter PTCA but not alter
stealing. However, the combined endpoint was not influenced by diabetic
status bul rather by procedure mcluding polar differences in reoo=lusmn and
MI, These early outcemes unno~score the importance el adiunchve therapy
~1_8-8~
--
Predictors of Target Lesion Revascularization in
Diabetic Patients Treated With Palmaz-Schatz
Stents
A AbzzaLd, G.S Mmtz, B Otlaca. K M Kent, L F Sailer. A O Plchard.
H Wu, R Mehran, T Bucher, J J Popes, M B Leon Washmgton Hospital
Center, Washmgton, DC USA
To ovahtate the predicterS el target leslol~ ~eva~culartzatlon (TLR) m diabetics
treated w~th Palma=-Schatz stoats, t 51 native vessel lesions m 130 consecutwe pts were analysed using (lt pre and post-intervention mtravascular
ultrasound (IVUS: reterence and lesion ar(eeal, lumen, and plaque areas
and plaque burden (plaque/adenal area)} and t2) quanhtative angtography
{QCA: relorence diameter, mmimum htmen diameter (MLD), and diameter
stonosis (%DS)}. All pts were followed for at least 1 yr. Univanate predictors
included
N
h,:,oh~'lIher3py
QCA
R~lelelIce
Pest MLDt%)
IVUS
Rt!tetel~t~ lumer~areatan12)
Referenceplaquebulden
Postleslon lumenareatam ?)
Post MLD (am)
TLR
39
61 ~o
no TLR
112
44%
O001
2 95 t 0 F,8
268 '~ 049
3 10 t 0 66
294 : 066
e 05
003
7 50
52
6 70
2.55
9 57 t
47 :
7 53 t
2 76 t
000t
0066
0 02
0 002
.* 179
t 12
.* 174
t O28
3 48
12
2 57
0 52
p
Insulin-treated diabet,cs had a TLR rate of 3t°o (vs 19% for non-insulin
diabetics). Using multivariate logistic regression analysis, the mdependent
predictors of TLR were insulin therapy (Odds ratio = 0167. p = 0.048) and
IVUS final lumen area (Odds ratio = 0.034. p = 0.011).
We Conclude: Diabetic pts, especially those treated with insulin, have a
high rate of TLR 1 yr after stent placement (25% overall, 31% for insulintreated diabetics). However. even in these pts the IVUS final lumen CSA is
an important predictor of late events.