Transcript MISCELLANEOUS ISSUES IN 10 PCI

MISCELLANEOUS ISSUES IN PPCI
• CULPRIT VESSEL ONLY VS MULTIVESSEL PCI
DURING PPCI
• ADJUNCTIVE THROMBECTOMY/EMBOLIC
PROTECTION/ASPIRATION
• DES vs BMS
• 40-65% of the patients presenting with STEMI have
multivessel disease (MVD), which has been
associated with worse clinical outcome as
compared with single-vessel disease
• Multivessel intervention ?
Prognostic Impact of Staged Versus “One-Time”
Multivessel PCI in AMI .. Analysis From the HORIZONSAMI Trial [JACC aug 2011]
• Aim … to compare a one-time PPCI of the culprit and
nonculprit lesions vs PCI of only the culprit lesion and
staged nonculprit PCI at a later date
• HORIZONS-AMI trial … prosp open label multicentre
trial .. 668 of the 3,602 STEMI patients enrolled (18.5%)
underwent PCI of culprit and nonculprit lesions for
multivessel disease. Patients were categorized into a
single PCI strategy (n=275) vs staged PCI (n=393).
• The endpoints analyzed are the 1-year rates of MACEs
and its components, death,reinfarction, TVR for
ischemia and stroke.
Single versus staged PCI was a/w
• higher 1-year mortality (9.2% vs. 2.3%; p<0.0001)
• higher cardiac mortality (6.2% vs. 2.0%;P=0.005)
• higher definite/probable ST (5.7% vs. 2.3%;
p=0.02)
• trend toward greater MACE (18.1% vs. 13.4%;
p=0.08).
In patients undergoing truly elective multivessel
PCI also, mortality advantage was maintained.
Culprit Vessel PCI Versus Multivessel and Staged PCI
for STEMI Patients With MVD.. Hannan et al … jacc
2010
• STEMI with MVD….2003-2006
• subdivided into culprit vessel PCI and those who
underwent multivessel PCI during the index
procedure, during the index admission or staged
within 60 days of the index admission.
• Of the 4,024 pts in the study, 3,521 (87.5%)
underwent only culprit vessel revascularization at
the time of primary PCI and the remainder
underwent multivessel revascularization at the time
of primary PCI.
• 259 pts underwent staged PCI during the index
admission and 538 pts underwent staged PCI within
60 days of the index procedure.
For patients without hemodynamic compromise, culprit
vessel PCI during the index procedure was associated
with lower in-hospital mortality than multivessel PCI
during the index procedure (0.9% vs. 2.4%, p=0.04).
Patients undergoing staged multivessel PCI within 60
days after the index procedure had a significantly lower
12-month mortality rate than patients undergoing
culprit vessel PCI only (1.3% vs. 3.3%, p= 0.04).
Culprit Vessel Only Versus Multivessel and Staged PCI for
MVD in STEMI ….A Pairwise and Network Meta-Analysis
Vlaar et al. JACC Aug 2011
• 4 prospective and 14 retrospective studies involving
40,280 pts [STEMI pts with MVD who underwent PCI]
• Pairwise and network meta-analyses were performed on 3
PCI strategies
1) culprit PCI
2) multivessel PCI
3) staged PCI.
• The primary endpoint was short-term[1month] mortality
• Secondary endpoints were long term mortality,
reinfarction, any revascularization, major bleeding and
stroke
• Five studies compared all 3 PCI strategies;10 studies
compared culprit PCI versus MV-PCI ; 2 studies
compared culprit PCI versus staged PCI, and 1 study
compared MV-PCI versus staged PCI
Timing of staged procedures….majority …. during
hospitalization or within 1 month after index PCI
The staged PCI strategy was superior in comparison with
culprit PCI (odds ratio [OR]: 3.03, 95% CI: 1.41 to 6.51,
p=0.005) and MV-PCI (OR: 5.31, 95% CI: 2.31 to 12.21, p=
0.0001).
Mortality was lower in the culprit PCI strategy as compared
with MV-PCI (OR: 0.66, 95% CI: 0.48 to 0.89, p 0.007).
Current guidelines indicate that MV-PCI should not be
performed in hemodynamic stable STEMI patients.
Only for patients in cardiogenic shock, PCI may be
recommended for all critically stenosed large epicardial
coronary arteries. However, no randomized data have been
published indicating that MV-PCI is beneficial for
cardiogenic shock patients.
A deferred angioplasty strategy of nonculprit lesions
should remain the standard approach in patients with
STEMI undergoing primary PCI
MISCELLANEOUS ISSUES IN 10 PCI
• Culprit vessel only vs multivessel PCI during PPCI
• ADJUNCTIVE THROMBECTOMY/EMBOLIC
PROTECTION/ASPIRATION
• DES vs BMS
Thrombus Aspiration during Primary PCI in Acute MI Study
[TAPAS] … nejm 2008
single-center, prospective, randomized trial
Inclusion criteria
symptoms s/o a/c myocardial ischemia > 30 mts
onset of symptoms < 12 hours
STE> 0.1 mV in ≥ 2 leads
Exclusion criteria
Rescue PCI
Disease- life expectancy <6 months
• Before CAG,1071 pts randomised to thrombus
aspirn grp(535), conventional pci grp(536)..
• 10 end point : postprocedural myocardial blush
grade of 0 or 1
• 20 end points : postprocedural frequencies of TIMI
flow grade of 3, complete STR, the absence of
persistent ST-segment deviation, TVR,
reinfarction, death and the combination of MACE
by 30 days after randomization.
On the basis of the initial angiographic findings, 33
patients (approximately 6%) in each group did not
undergo PCI.
In the thrombus-aspiration group, aspiration and
direct stent implantation were performed in 295
patients (55.1%), balloon dilation was performed
before stent implantation in 153 patients (28.6%)
and conventional PCI was performed in 54 patients
(10.1%) in whom the operator judged the target
artery to be too small or too tortuous to permit use
of the aspiration catheter
• Aspiration before stenting results in improved
myocardial reperfusion
-documented by imprvt in the MBG
-increased STR
-reduced residual ST-seg deviation
• benefit - consistently present in all patients…..
irrespective of baseline clinical or angio
characteristics ( age, sex, IRA, preprocedural TIMI
flow or visible thrombus )
The EXPIRA (Thrombectomy With Export Catheter in
IRA during 10 pci) Prospective, Randomized Trial
• To evaluate the impact of a manual intracoronary
aspiration thrombectomy device, Export Medtronic as
adjunctive therapy [EM-PCI] on procedural outcomes,
MBG and 90-min STR 70% and on microvascular
obstruction(MVO) and Infarct Size assessed by CEMRI in patients with anterior STEMI.
Inclusion criteria
• first STEMI within 9 h from symptoms onset, IRA>
2.5 mm in diameter, thrombus score > 3, TIMI
grade<1 and age > 18 years.
Primary end points were the occurrence of myocardial
blush grade>2 and the rate of 90-min STr >70%.
RESULTS :
• Primary end points occurred more frequently in EMPCI (MBG>2: 88% vs 59%, p<0.0001; STr: 63% vs
39%, p=0.001)
• At 9 months, no differences were observed in terms
of cumulative MACE…..S-PCI had a higher incidence
of cardiac death (p=0.02) than did EM-PCI
CE-MRI results:
• No differences in the baseline EF, volumes and IS
were observed between the 2 groups.
• Postprocedural rate of MBG >2 and STr >70% was
higher in the EM-PCI group (89% vs. 59% and 84%
vs. 40% respectively; p 0.0001).
• In the acute phase, greater incidence and extent of
MVO was observed in the S-PCI group vs the EMPCI group (72.9% vs. 31.5%, p=0.0005; and 3.7+2.6 g
vs. 1.7 +1.9 g, p= 0.0003 respectively); no differences
were observed in IS.
• At 3 months, a reduction in final IS was detected in
the EM-PCI group (IS mass from 17+15g to11+ 8.7 g,
p=0.004; IS% from 14+12% to 9+4.5 %, p=0.001),
whereas no changes were observed in the S-PCI
group. MVO was not observed in either group at
follow-up.
Relation between Final Myocardial Blush Grade and
Cardiac Death and MACE at 2-years follow-up.
40
35
30
25
20
Cardiac death
15
MACE
10
5
0
MBG 3
Cardiac death (%) 0
MACE (%)
4.3
MBG 2
1.8
9.1
MBG 1
11.1
22.2
MBG 0
38
37.5
0.001
0.003
Relation between % STR and Cardiac Death / MACE
at 2-years follow-up
20
18
16
14
12
10
8
6
4
2
0
Cardiac death
MACE
ST resolution > 70%
Cardiac death (%)
MACE (%)
0.9
3.7
ST resolution < 70%
7.3
17.6
0.023
0.002
Pretreatment with manual thrombectomy
- results in a lower cardiac mortality and a lower
incidence of other MACEs at 2-year
Occurrence of cardiac death and MACE is significantly
related to final MBG and ST-segment resolution
The Angiojet thrombectomy system, used in the AIMI trial,
is a 4F catheter connected with a driving unit, which
generates high-velocity saline jets at the distal end of the
catheter. The resulting vortex fragments and aspirates
thrombus material in a collecting lumen
X AMINE ST trial
• Prosp randomised multicentric study
• X sizer thrombectomy + PCI [100pts] vs conventional
PCI[101 pts] in AMI <12 hrs & initial TIMI flow
grade 0 to 1
• The magnitude of STR 1 h after PCI was the primary
end point.
• Magnitude of STR was greater in the X-Sizer group
(7.5 vs 4.9 mm p=0.033) as is STR>50% (68% vs 53%;
p=0.037);distal embolization was reduced (2% vs 10%;
p=0.033);TIMI flow grade3 was obtained in 96% vs
89% (p=0.105). Myocardial blush grade 3 was similar
(30% vs. 31%; p=NS). Six-month clinical outcome was
comparable (death 6% vs 4% and MACCE 13% vs
13%)
So intracoronary thrombectomy with the X-Sizer
catheter during catheter-based treatment of AMI
improved myocardial reperfusion in patients
presenting with TIMI flow grade 0 to 1, as assessed
by a lower rate of distal embolization and a higher
rate of STR.
EMERALD: Enhanced Myocardial Efficacy and Removal by
Aspiration of Liberated Debris … jacc 2004
• To assess the safety and efficacy of GuardWire distal protection
device in AMI pts undergoing PPCI or rescue PCI.
Inclusion Criteria
• Patients with acute MI > 30 minutes and ≤ 6 hours in duration
• > 2 mm of ST-segment elevation MI in ≥ 2 contiguous leads or
left bundle branch block
• Absence of cardiogenic shock
• Reference vessel diameter 2.5-5.0 mm
• ≥ 3 cm of distal vessel available
Exclusion Criteria
• Multivessel intervention acutely required
• Multivessel disease requiring surgery within 30 days
• Upfront use of atherothrombectomy catheters
GuardWire temporary occlusion–aspiration system,
used in the EMERALD trial……0.014 in. guidewire
with a distal elastomeric occlusive balloon.
Balloon inflation is obtained through the EZ Flator.
After intervention, performed in the absence of
antegrade flow, liberated debris is aspirated through
the 5F monorail export catheter.
Primary end points
• Complete (≥ 70%) STR 30 mts after the last angio
• Infarct size as assessed by technetium-99m
sestamibi scintigraphy imaging at 5-14 days
Secondary Endpoints
• Myocardial blush score
• MACE defined as the combined endpoint of
death, new-onset severe HF, new-onset severe
hypotension, or readmission for LVF at 30-day
follow-up.
• 501 patients .. randomized to either PCI using
GuardWire (n = 252) or standard PCI (n=249)
Thus EMERALD trial failed to show a beneficial
effect from the use of distal embolic protection
devices in acute MI patients.
The FilterWire system : non-occlusive, filter-based
distal protection device[polyurethane porous
membrane filter] (pore size 110 mm) attached to a
nitinol loop at the distal end of a 0.014 in. guidewire
Randomized Comparison of Distal Protection Versus
Conventional Treatment in PPCI [DEDICATION trial]
626 patients with STEMI referred within 12 h
Random. to PCI performed with (n=312) or without
(n=314) distal protection.
10 end point was complete (>70%) STR.
Blood levels of trop-T and CK-MB were monitored
before and after the procedure, and LV wall motion
index (WMI) was performed before discharge.
• No significant difference in the occurrence of the
primary end point (76% vs. 72%, p=0.29), no
difference in maximum trop T (4.8 µg/l and 5.0 µg/l,
p=0.87) or maximum creatine kinase-MB (185 µg/l
and 184 µg/l,P=0.99), and no difference in median
WMI (1.70 vs. 1.70, p=0.35). The rate of MACCE 1
month after PCI was 5.4% with distal protection and
3.2% with conventional Rx (p 0.17).
• The routine use of distal protection by a filterwire
system during primary PCI does not seem to
improve microvascular perfusion, limit infarct size,
or reduce the occurrence of MACCE
• 2011 guidelines … Aspiration thrombectomy is
reasonable for patients undergoing primary PCI [IIa]
• JetStent Trial
• INFUSE-AMI Trial
• Systemic inhibition of GPIIb/IIIa receptors with
intravenous abciximab
MISCELLANEOUS ISSUES IN 10 PCI
• CULPRIT VESSEL ONLY VS MULTIVESSEL PCI DURING
PPCI
• ADJUNCTIVE THROMBECTOMY/EMBOLIC
PROTECTION/ASPIRATION
• DES VS BMS
DES in AMI (RCTs)
TYPHOON Trial: Study Design
712 patients with acute MI (prolonged chest pain with ST segment elevation) < 12 hours
since onset, culprit lesion in a native suitable for stenting
Randomized, 22% female, mean age 59 years, mean follow-up 1 year
follow
follow-up
71% received Glycoprotien llb/llla inhibitors, Door to balloon time=60 minutes
Cardiac catheterization/primary PCI
Cypher Stent Sirolimus-eluting
n=355
Bare-metal stent (any kind)
n=357
Concomitant Medications:
•Aspirin (≥100mg)
•Clopidogrel (300mg load and 75 mg/day for 6 months)
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Primary Endpoint: Target vessel failure at one year, defined as target vessel
revascularization, recurrent MI or cardiac death.
Secondary Endpoint: In
In-- hospital, 1, 6 & 12 months major adverse cardiac event
www. Clinical trial results.org
Presented
Presented at
at ACC
ACC 2006
2006
TYPHOON Trial
Single-blind, multicentered, prospective...2003-2005
Exclusion criteria : administration of fibrinolytics for the index
infarction, overt AHF, a previously documented LVEF of <30%,
previous MI and an estimated life expectancy of <12 months.
Primary endpoint – TVF(target vessel failure) at 12 mo
Angiographic follow-up on 174 pts at 8 mo
[Criteria for angiographic exclusion …. previous PCI of the
IRA, excessive tortuosity or calcification, ostial or multiple
lesions, massive thrombus in the IRA, bifurcation or LMCA
disease and severe multivessel disease requiring surgical
revascularization]
Target lesion with maximum length of 30 mm and located in a
native coronary artery with a reference-vessel diameter of
2.25-3.50 mm.
Typhoon … results @ 12 months
TYPHOON … Use of SES provided significant reduction in
TVR at 12 mo
4 year F/U of TYPHOON [jacc interv 2011 Jan]
Freedom from TLR at 4 years was signif better in the
SES group (92.4% vs. 85.1%; p = 0.002)
No signif diff in
1. freedom from cardiac death (97.6% and 95.9%; p = 0.37)
2. freedom from repeat myocardial infarction (94.8% and 95.6%; p = 0.85)
3. definite/probable stent thrombosis (SES: 4.4%, BMS: 4.8%, p = 0.83)
At 4 yrs, the all-cause death rate was 5.8% in the SES and 7.0% in the BMS group (p =
0.61).
PASSION
prospective, single-blind, RCT… Netherlands
primary end point … the first occurrence of MACE
20 end point …. occurrence of ST.
Failed to show a significant benefit with the use of PES vs
BMS
•Lack of angiographic follow-up may have contributed to
the findings
•No difference in ST between the groups
• only 12 mo data
PASSION 5 yr F/U … jacc interv 2011
• to elucidate a possible long-term benefit of DES over BMS
in STEMI in terms of MACE and to address the concern
of (very) late ST.
• At 5-year follow-up….The composite end point of
cardiac death, recurrent MI, or TLR was reached in 56
(18.6%) versus 66 (21.8%) patients in the PES and the
BMS groups, respectively (HR: 0.82, 95% CI:0.58 to 1.18;
p=0.28)
• Up to 5-years follow-up, no difference in the occurrence
of definite or probable ST was seen, although there might
be a higher incidence of (very) late ST using PES.
Passion f/u
SESAMI trial :
•Randomized single center study
•320 patients with acute STEMI- 12 month follow up
•SES vs BMS in 1:1 randomization
•The infarct-related vessel had to be a native coronary
artery with a visually estimated reference diameter
>2.5 and < 4.0 mm
•Primary endpoint – angiographic binary restenosis
(ABR) at 12 mo
[Binary Restenosis was defined as 50% reduction of the
initial lumen diameter in the target lesion inside or at
the proximal and distal 5 mm of the stent]
SESAMI
• At 1 Year
SES had a lower ABR than did BMS
Clinical endpoints (TLR, TVR, TVF and MACE) were
significantly better in the SES group
12-month ST rates were similar between groups
Typhoon & SESAMI trial showed a large absolute
difference in TLR in favor of SES, at 4.3% versus 11.2% (p
0.02) in SES and BMS,respectively. These differences,
however, were larger than those observed in PASSION
and HORIZONS-AMI.The larger differences in repeat
revascularization between the 2 stent groups in both
TYPHOON and SESAMI were mainly due to a much higher
incidence in the BMS groups.
Why this disparity ?
• could have been influenced by routine angiographic
follow-up within the first year after implantation .
• the stent platform of the DES used in PASSION TRIAL
was the exact same stent platform with which it was
compared.[cf. TYPHOON and SESAMI, in which a DES
was compared with a range of types BMS, possibly
resulting in less favorable outcome after the use of
BMS.
In current clinical practice guidelines, the use of DES
in acute STEMI is mentioned only as a method to
reduce restenosis.
Because there is no evidence for a reduction in the
occurrence of death, recurrent MI or ST, the
guidelines of the European Society of Cardiology or
the American College of Cardiology/American Heart
Association do not make a general recommendation
for the use of DES in the setting of STEMI.
THANK YOU
• TIMI thrombus grade 0, no cineangiographic
characteristics of thrombus are present; in TIMI
thrombus grade 1, possible thrombus is present,
with such angiography characteristics as reduced
contrast density, haziness, irregular lesion contour,
or a smooth convex "meniscus" at the site of total
occlusion suggestive but not diagnostic of
thrombus; in TIMI thrombus grade 2, there is
definite thrombus, with greatest dimensions ≤1/2
the vessel diameter; in TIMI thrombus grade 3,
there is definite thrombus but with greatest linear
dimension >1/2 but <2 vessel diameters; in TIMI
thrombus grade 4, there is definite thrombus, with
the largest dimension ≥2 vessel diameters; and in
TIMI thrombus grade 5, there is total occlusion.