Transcript PRIMARY PCI : Part 1

JOURNAL REVIEW
PRIMARY PCI : Part 1
Speaker: Dr Sandeep Mohanan
Senior Resident
Department of Cardiology
Government Medical College Calicut
TOPIC OVERVIEW
• COMPARISON OF PRIMARY PCI TO THROMBOLYSIS
• ASPIRATION THROMBECTOMY IN PRIMARY PCI
• DISTAL PROTECTION DEVICES IN PRIMARY PCI
• STENT USAGE IN PRIMARY PCI
PRIMARY PCI vs THROMBOLYSIS
• Efficacy
• Subgroups - Diabetics and Elderly
• Pre-hospital fibrinolysis(Pharmacoinvasive) : TRANSFER AMI, STREAM
• Facilitated PCI : CARESS in AMI, FINESSE-2, ASSENT-4
-- Inferior to PPCI
-- IIa B in AHA 2013
Efficacy of primary PCI vs thrombolysis
• Keeley et al. Primary angioplasty versus intravenous thrombolytic
therapy for acute myocardial infarction: a quantitative review of
23 randomised trials . :Lancet. 2003;361:13–20.
• 23 RCT trials ever since advent of PPCI for AMI till 2003.
• Well matched for heterogeneity and accepted as the reference for
recommendations in the AHA and ESC guidlines.
Keeley et al. Lancet 2003
Keeley et al. Lancet 2003
Keeley et al. Lancet 2003
Andersen HR et al. A comparison of coronary angioplasty with fibrinolytic
therapy in acute myocardial infarction. N Engl J Med. 2003;349:733– 42.
•
1572 patients with AMI—PPCI vs iv alteplase
•
-
RESULTS:
Primary end point was reached in 8.5% for PPCI vs 14.2% of the patients for TT (P=0.002)
(30 days)
The better outcome after angioplasty was driven primarily by a reduction in the rate of
reinfarction (1.6% vs. 6.3%, P<0.001);
No significant differences in the rate of death (6.6% vs 7.8%, P=0.35) or the rate of stroke
(1.1% vs 2%, P=0.15).
-
-
96% were transferred from referral hospitals to an invasive-treatment center within 2
hours.
• CONCLUSIONS:
A strategy for reperfusion involving the transfer of patients to an invasive-treatment center for
primary angioplasty is superior to fibrinolysis, provided that the transfer takes two hours
or less.
 Strong basis for present AHA/ESC guideline recommendation on timing of PPCI
DANAMI 2 study
(Danish trial in acute MI)- (AHJ2003, EHJ 2008, Circulation 2010)
High-risk ST elevation MI patients (>4 mm elevation), Sx < 12 hrs
5 PCI centers (n=443) and 22 referral hospitals (n=1,129), transfer criteria < 3 hrs
Lytic therapy
Front-loaded tPA 100
mg
Primary PCI
with transfer
Primary PCI
without transfer
(n=567)
(n=223)
(n=782)
Death / MI / Stroke at 30 Days
DANAMI-2: Primary Results
P=0.0003
16%
14%
Death / MI / Stroke (%)
P=0.048
P=0.002
16%
16%
14%
RRR
40%
RRR
45%
12%
Non-Transfer Sites
Transfer Sites
Combined
12%
12%
12%
9%
8%
8%
8%
8%
4%
4%
4%
0%
0%
0%
Lytic
Primary PCI
RRR
45%
Lytic
Primary PCI
7%
Lytic
Primary PCI
DANAMI-2: Primary outcomes
8%
Death
Recurrent MI
Stroke
P=0.35
P<0.0001
P=0.15
7.6%
8%
6.6%
8%
6.3%
6%
6%
6%
4%
4%
4%
2%
2%
1.6%
2.0%
2%
1.1%
0%
0%
Lytic
Primary PCI
0%
Lytic
Primary PCI
Lytic
Primary PCI
DANAMI conclusion
• Median D2B time was 114 mins.
• For such patients, the incidence of the composite
endpoint of death, recurrent MI, and stroke is
reduced compared with the administration of tPA
and heparin
DANAMI2 Long term follow up
DANAMI2 subgroup analysis (Circ 2010)
PPCI in DIABETICS
Timmer JR. Primary percutaneous coronary intervention compared with fibrinolysis for
myocardial infarction in diabetes mellitus: Arch Intern Med. 2007 Jul 9;167(13):1353-9.
• A pooled 19 trials comparing primary PCI with fibrinolysis for
treatment of STEMI.
RESULTS:
• Of 6315 patients, 877 (14%) had diabetes.
• 30 day mortality (9.4% vs 5.9%; P < .001) --higher in diabetes.
• Mortality was lower after PPCI compared to TT in both groups
-- with diabetes(OR- 0.49, 95% CI, 0.31-0.79; P = .004) and
-- without diabetes (OR- 0.69; 95% CI 0.54-0.86, P = .001),
PPCI in the Elderly
• GUSTO IIB trial was one of the first to report that PCI is superior to fibrinolysis.
• De Boer et al. JACC 2002 :
-- 87 patients , >75yrs PPCI vs SK.
 RR of the primary composite end point of death, reinfarction, or stroke at 30 days
of 4.3 (95% CI 1.2-20) for SK vs PCI.
• SENIOR PAMI -largest RCT for elderly undergoing PPCI vs TT by Grines et al(2005)
-- 481 patients >70 yrs
55% reduction in the combined end point of death, stroke, or reinfarction (P =
0.0093) associated with PCI. However, no advantage of one strategy over the
other was found among those older than 80 years.
•
Meta-analysis of 22 randomized trials comparing primary PCI with fibrinolysis,
de Boer et al. showed a mortality/stroke reduction favoring primary PCI in all
age strata.
1) de Boer, M. J. et al. for the Myocardial Infarction Study Group. Reperfusion therapy in elderly patients with acute myocardial infarction: a
randomized comparison of primary angioplasty and thrombolytic therapy. J. Am. Coll. Cardiol. 39, 1723-1728 (2002).
2) Grines, C. L. SENIOR PAMI: a prospective randomized trial of primary angioplasty and thrombolytic therapy in elderly patients with acute
myocardial infarction. Presented at the 17th Annual Transcatheter Cardiovascular Therapeutics Symposium, October 16-21, 2005.
3) de Boer, S. P et al. for the PCAT-2 Trialists Collaborators Group. Mortality and morbidity reduction by primary percutaneous coronary
intervention is independent of the patient's age. JACC Cardiovasc. Interv. 3, 324-331 (2010).
PPCI in the very elderly (>85yrs)
Omar Rana et al. Percutaneous Coronary Intervention in the Very Elderly (≥85 Years)
Trends and Outcomes. Br J Cardiol. 2013;20(1):27-31
• Single centre retrospective analysis.
• B/w 2006 and 2010, 294 patients PCI (mean age 88 ± 2 years, 56%
male)
• 62% underwent PPCI and 38% elective PCI
• 30-day mortality (5.6% vs. 3.4%, p=0.24) and
• 1 year mortality (20.0% vs. 14.0%, p=0.19)
• Male sex, previous PCI and shock – independent predictors
• PCI is a safe option for the very elderly with ACS. RCTs further
required.
Guideline statement on PPCI vs
Thrombolysis
AHA 2013 : I A
“ In the absence of contraindications,
fibrinolytic therapy should be given to
patients with STEMI and onset of ischemic
symptoms within the previous 12 hours when
it is anticipated that primary PCI cannot be
performed within 120 minutes of FMC”
THROMBECTOMY in PPCI
• Evidence on efficacy
• Thrombosuction devices
*Mechanical thrombectomy (Angiojet, Rescue, Xsizer)
* Manual aspiration thrombectomy (TVAC, Diver, Export, Pronto)
Early trials on Aspiration thrombectemy
Trial
N
Primary outcome
TA / MT
Result
1. AJC 2004
100
Early STR
Rheolytic MT
90% vs 72% (P=0.02)
2. JACC 2005 Jul
19;46(2):246-52.
X AMINE ST trial
201
RCT
STR after 1 hour
MT
(X-Sizer catheter
system)
STR>50% (68% vs. 53%; p =
0.037).
3. JACC2005 Jul
19;46(2):371-6
REMEDIA trial
100
RCT
Combined
MBG>/=2+ STR>70%
TA[ Diver CE
(Invatec)]
46% vs 24.5%, OR 2.6
(p = 0.025)
4. JACC 2006Oct
17;48(8):1552-9.
DEAR-MI trial
148
RCT
STR>70%, MBG=3
TA[Pronto extraction
catheter
(Vasc.solutions)]
STR>70: 68% versus 50% (p
< 0.05);
MBG-3 88% versus 44%
(p<0.0001)
5. JACC 2006.
Jul 18;48(2):244-52.
AIMI trial
480
RCT
Infarct size by SPECT
(30 day MACE)
Rheolytic MT
[5-F LF140 RT
catheter (Possis
Medical)] –no DP
-Infarct size larger for RT
(P=.03)
-MACE & mortality higher
for RT (P=0.01/ 0.02)
6. Circulation. 2006 Jul
4;114(1):40-7
215
RCT
Infarct size by SPECT
TA(Rescue catheter
(Boston Scientific)
Infarct size larger for
TA(15%vs 8%)P=0.006
TAPAS trial (NEJM 2008)
-Thrombus Aspiration during Percutaneous coronary intervention in AMI Study
• Single centre RCT
• 1071 patients: 535 Manual thrombus aspiration(6-French Export Aspiration
Catheter) + PCI vs 536 PCI
• Aspiration success by histopathological assessment
• Angiographic (myocardial blush score) and ECG STE resolution assessment
• The primary end point was a myocardial blush grade of 0 or 1 (defined as absent
or minimal myocardial reperfusion, respectively).
Results
• Histopathological examination confirmed successful aspiration in 72.9% of
patients.
• Predilatation was done in 207 of 502 (41·2%) of the patients randomly assigned
aspiration.
TAPAS primary endpoint
P < 0.001
Patients (%)
60
50
40
46
41
0/1
2
3
37
32
26
30
20
17
10
0
Thrombus aspiration
Conventional PCI
TAPAS- ST resolution
P < 0.001
57
60
< 30%
Patients (%)
50
40
30-70%
> 70%
44
38
31
30
20
18
13
10
0
Thrombus aspiration
Conventional PCI
TAPAS 30-day outcomes
P = 0.001
10
8.1
8
6
Death
3.9
4
2
5.7
Death/reinfarction
2.9
1.6
1.1
0
3
2
0 or 1
Myocardial blush grade
Conclusion: TA results in better reperfusion and clinical outcomes than conventional PCI
Pieter et al. Cardiac death and reinfarction after 1 year
in the TAPAS trial: a 1-year follow-up study.
(Lancet 2008)
• Cardiac death at 1 year was 3·6% (19 of 535 patients) in TA group
and 6·7% (36 of 536) in the conventional PCI group
( [HR] 1·93; 95% CI 1·11—3·37; p=0·020).
• 1-year cardiac death or non-fatal reinfarction occurred in 5·6% (30
of 535) in TA group and 9·9% (53 of 536) in conventional PCI group
(HR 1·81; 95% CI 1·16—2·84; p=0·009).
 Compared with conventional PCI, thrombus aspiration before
stenting of the infarcted artery seems to improve the 1-year
clinical outcome after PCI for ST-elevation myocardial infarction.
Ikari et al. Upfront thrombus aspiration in primary coronary intervention for patients
with ST-segment elevation acute myocardial infarction: :
VAMPIRE trial (JACC Cardiovasc interventions 2008)
• Performance of the TVAC(Nipro) during PPCI
 The study showed a trend toward improved myocardial
perfusion and lower clinical events in patients treated with
aspiration. Patients presenting late after STEMI appear to
benefit the most from thrombectomy.
Thrombectomy with export catheter in infarct-related artery during primary
percutaneous coronary intervention – a prospective, randomized trial.
EXPIRA trial -- JACC 2009
• Impact of TA on myocardial perfusion and
infarct size as by CE-MRI analysis
 Thrombectomy prevents thrombus embolization and
preserves microvascular integrity reducing infarct size, and it
therefore represents an useful adjunctive therapy in PPCI.
De Luca G et al. Adjunctive manual thrombectomy improves myocardial perfusion
and mortality in patients undergoing primary percutaneous coronary intervention for
ST-elevation myocardial infarction
: a meta-analysis of randomized trials. Eur Heart J.2008
• 9 RCTs with 2417 patients
• Adjunctive manual aspiration thrombectomy was associated with
significantly improved
- postprocedural TIMI 3 flow (87.1 vs. 81.2%, P < 0.0001),
- postprocedural MBG 3 (52.1 vs. 31.7%, P < 0.0001),
- less distal embolization (7.9 vs. 19.5%, P < 0.0001),
- significant benefits in terms of 30-day mortality (1.7 vs. 3.1%, P = 0.04).
Tamhane et al. Safety and efficacy of thrombectomy in patients undergoing
primary percutaneous coronary intervention for Acute ST elevation MI
:A
Meta-Analysis (BMC Cardiovascular Disorders 2010)
• 17 RCTs (3909 patients)
• Aspiration/Thrombectomy PCI vs conventional PCI
• No difference in risk of 30-day mortality (OR 0.84, 95% CI 0.54-1.29, P = 0.42)
• Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow
(OR 1.41, P = 0.007), MBG 3 (OR 2.42, P < 0.001), STR (OR 2.30, P < 0.001), and with
a higher risk of stroke (OR 2.88, 95% CI 1.06-7.85, P = 0.04).
•
Outcomes differed significantly between different device classes with a trend
towards lower mortality with manual aspiration thrombectomy (MAT) (OR 0.59,
95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards
higher mortality (OR 2.07, 95% CI 0.95-4.48, P = 0.07).
Angiojet rheolytic thrombectomy for PPCI
• VeGAS 1 & 2 trials (AJC 2002) :
- RT vs intracoronary UK
Encouraging results for Angiojet
• AIMI (JACC 2006):
 Negative results
Comparison of AngioJet Rheolytic Thrombectomy Before Direct
Infarct Artery Stenting With Direct Stenting Alone in Patients
With Acute Myocardial Infarction
: The
JETSTENT Trial (JACC 2010)
• Multicenter international RCT (December 2005 to September 2009)
• Coprimary endpoints : STR and Tc-SPECT infarct size
• Clinical endpoints: MACE at 1,6 and 12m
• 501 patients with angio evidence of thrombus (BMS)
Results:
• STR was 85.8% vs 78.8% (p = 0.043),
• 6m MACE was 11.2% vs 19.4% (p = 0.011).
• The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm,
and 75.0 ± 3.1% for the DS alone arm (p = 0.009).
The results of the study support the use of RT before infarct artery
stenting in patients with acute myocardial infarction and evidence of
coronary thrombus.
Major features of the 2 largest trials
on Angiojet RT
In light of the often superior thrombus extraction efficiency
with mechanical thrombectomy, what explains the
disappointing outcomes with mechanical devices in general?
• JACC 2010 editorial on the JETSTENT trial
•
-
Rheolytic MT:
Bulkier, complicated use, bigger learning curve,
requires favourable coronary anatomy,
longer procedure times,
propensity to initially impair distal microcirculation,
high incidence of symptomatic bradycardia and need for TPI.
• MAT: User friendly, quick and easier to learn.
Current guidelines on thrombectomy
AHA STEMI 2013:
ESC STEMI 2012:
Frobert et al. Thrombus Aspiration during ST-Segment
Elevation Myocardial Infarction
TASTE trial -(NEJM September 2013)
•
•
•
•
Prospective multicentre RCT from the Swedish registry(SCAAR)
7244 patients –PCI+TA vs conventional PCI
Primary endpoint—mortality at 30 days
Secondary endpoints – Stent thrombosis, hospitalization, reinfarction
Conclusion:
Routine thrombus aspiration before PCI as compared with PCI
alone did not reduce 30-day mortality among patients with
STEMI.
-There were no significant differences between the groups with respect to the rate
of stroke or neurologic complications at the time of discharge (P=0.87).
TASTE - Endpoints
P=0.63
P=0.09
--Rates of stent thrombosis were 0.2% and 0.5%, respectively (HR, 0.47 (0.20 to 1.02); P=0.06).
Consistency
of the
findings
among all
subgroups
A REVISION OF
CURRENT
GUIDELINES ??
Awaiting:
1) 1 year f/u
results
2) TOTAL trial in
the late stages
EMBOLIC PROTECTION DEVICES in PPCI
Guard wire occlusionaspiration system
Filter wire sytem
Proxis catheter system
Proven role of EPDs in SVGs and
carotid interventions
• Carotid : CABERNET
• SVG: BLAZE, BLAZE II, FIRE (Filter wire), SAFER
(Guard wire), PROXIMAL (Proxis)
Early trials with EPDs
- Balloon occlusion devices
Trial
N
Primary outcome
Particluars
Result
2. Am J Cardiol. 2003
-
TIMI flow, MBG,
30 day MACE
vs adjunctive
tirofiban
Benefit in all outcomes
42
Vs
101
-TIMI 3 flow
- Combined 30-day
MACE+ distal
thrombemb
events+ vasc
compli
-Radial vs Femoral
control at separate
periods
- Large IRAs + HBTF
-95% vs 79% (P=0.005)
74
(48 vs
26)
RCT
-TIMI flow
-
-Improved immediate TIMI
flow.
-Favourable 6 month
results
* Late stenosis at site of
balloon
Dec 1;92(11):1331-5
1. Catheter
Cardiovasc
Interv.2004
Apr;61(4):503-11.
3. Catheter
Cardiovasc
Interv. 2005
Jan;64(1):35-42.
-6 month
angiographic
results
- P <0.05 for 20 endpoints
Stone GW et al. Distal microcirculatory protection during percutaneous
coronary intervention in acute ST-segment elevation myocardial infarction:
a randomized controlled trial.
EMERALD trial (JAMA 2005 Mar 2;293(9):1063-72.)
•
•
.
Prospective RCT on 501 patients of STEMI for PCI
PCI with a balloon occlusion and aspiration distal microcirculatory protection system
(GUARD WIRE) vs angioplasty without distal protection.
OUTCOME MEASURES:
• STR 30 minutes after PCI by continuous Holter monitoring and
• Infarct size measured by technetium Tc 99m sestamibi imaging between days 5 and 14.
• Secondary end points included major adverse cardiac events.
RESULTS:
• Visible debris was retrieved from 73% (182/250).
• Complete STR 63.3% vs 61.9% , P = .78,
• Left ventricular infarct size was similar in both groups (12.0% vs 9.5% ; P = .15).
• MACE at 6m were 10.0% vs 11.0%, P = .66
The use of GuardWire device increased procedural time by 14 min on average and, due to the
CONCLUSIONS:
occlusive
nature
of the device,
such
an increase
almost
completely flow,
translated
into
a
Distal embolic
protection
did not
result
in improved
microvascular
greater
reperfusion
reperfusion
-----infarct
likely size,
additive
muscle loss
success, delay
reduced
or enhanced
event-free survival.
Muramatsu T et al.
Comparison of myocardial perfusion by distal protection before and after primary
stenting for acute myocardial infarction: angiographic and clinical results of a
randomized controlled trial.
: ASPARAGUS trial (Catheter Cardiovasc Interv 2007)
• Multicenter prospective RCT of 341 AMI
• +/- Guard wire system
Results:
• The rates of slow flow and no-reflow immediately after PCI were
5.3 and 11.4% in the GuardWire Plus and control groups,
respectively (P = 0.05).
Gick M at al. Randomized evaluation of the effects of FILTERBASED DISTAL PROTECTION on myocardial perfusion and infarct size after primary
percutaneous catheter intervention in myocardial infarction with and without STsegment elevation.
PROMISE trial Circulation. 2005
• First major trial on Filter devices
• 200 patients – RCT
• The primary end point was the maximal adenosine-induced Doppler
flow velocity in the recanalized infarct artery;
• The secondary end point was infarct size estimated by the volume of
delayed enhancement on nuclear MRI.
• Thirty-day mortality was 2% in filter-wire group and 3% in the control
group.
Cura FA et al. Protection of Distal Embolization in High-Risk Patients with
Acute ST-Segment Elevation Myocardial Infarction (PREMIAR).
: PREMIAR
trial (Am J Cardiol 2007)
• 140 patients with AMI
• +/- Filter device system
Results:
• Rate of STR 61% vs 60% (0.85)
• MBG 67 vs 70% (0.73)
• In-hospital LVEF 47% vs 45% (0.29)
• MACE at 6 m 14% vs 15% (0.8)
“The use of filter-based distal protection is safe and
effectively retrieves debris; however, such use does not translate
into an improvement of myocardial reperfusion, left ventricular
performance, or clinical outcomes.”
Role of adjunctive thrombectomy and embolic protection devices in
acute myocardial infarction: a comprehensive meta-analysis
of randomized trials
:European Heart Journal (2008)
• Primary objective was to assess clinical outcomes
• 30 trials -6415 patients
• Mean follow-up of 5.0 months,
•
Overall Mortality was 3.2% for the adjunctive device group vs. 3.7%
for PCI alone
(rr-0.87; 95% confidence interval, 0.67– 1.13).
• Thrombus aspiration- 2.7% vs 4.4% (0.018) [ NNT = 59 ]
• Mechanical thrombectomy - 5.3 vs 2.8% (0.05) [ NNH = 38 ]
• Embolic protection devices - 3.1% vs 3.4% (0.69) – Neutral effect
Role of Proximal embolic protection-aspiration system
(PROXIS)
• Proven role for SVG graft interventions in the
PROXIMAL trial
• PREPARE trial (JACC cardiovasc interv
2009, Heart 2010)
 284 patients , PROXIS system vs conventional PCI
-
STR at 60 min -- 80% vs 72% (0.14)
MACCE at 30 days and 6m (8% vs 10%) were
similar
No difference in finnal infarct size/ LVEF on CMR
-
 No definite benefit
Kelbæk H et al. Randomized Comparison of Distal Protection Versus
Conventional Treatment in Primary Percutaneous Coronary Intervention:
The Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction
: (DEDICATION) Trial. J Am Coll Cardiol. 2008
• 626 patients Filter wire system vs conventional
• 50% underwent DES implantation
• Endpoints --STR, MACCE at 30 days, WMI, Trop
I, CK-MB
• All endpoints were similar.
• (MACCE) 1 month –5.4% vs 3.2% (p = 0.17).
•
Routine use of a filterwire system during
primary PCI does not seem to improve
microvascular perfusion, limit infarct size, or
reduce the occurrence of MACCE.
Guideline statement on EPDs in STEMI
• ESC 2012: Routine use of distal protection devices is not
recommended. (III C)
Int J Cardiol 2013:Effect on MVO of DPDs after PPCI
• 126 patients , prospective RCT
• Evaluation of MVO by cMRI after PCI for STEMI
• MVO ratio was larger when DPDs were used.
• DPDs should not be used for PPCI.
STENT USAGE IN PPCI
• POBA vs Stent
• BMS vs DES
• Newer stent designs in PPCI
POBA vs Stent in PPCI
• No remaining dispute on the superiority of stenting
Trial
Publication
Favouring
Stenting
STENT
PAMI
Circulation 1999
√
FRESCO
JACC 1998
√
GRAMI
AJC 1998
√
PASTA
Catheter Cardiovasc interv 1999
√
STENTIM2 JACC 2000
√
CADILLAC
√
NEJM 2002
- However no conclusive mortality benefit in any study
Clinical Outcomes of Primary Stenting versus Balloon Angioplasty in
Patients with Myocardial Infarction
: A Meta-analysis of RCTs (Am J Med 2004)
• 1979-2002, 9 trials ---4433 patients.
• Stenting vs POBA
• Mortality:
30 days - 1.17 (95% confidenceinterval [CI]: 0.78 to 1.74)
6m - 1.07 (95% CI: 0.76 to 1.52)
12m - 1.09 (95% CI: 0.80 to 1.50)
• Reinfarction at 1, 6 and 12 m:
 0.52 (95% CI: 0.31 to 0.87), 0.67 (95% CI:0.45 to 1.00) & 0.67 (95% CI: 0.45 to 0.99)
• Target vessel revascularization
0.46 (0.34 to 0.61) at 30 days, 0.42 (0.35 to 0.51) at 6m & 0.48 (0.39 to 0.59) at 12 m
• No increased bleeding complications
===> No definite mortality benefit upto 1 year for Stenting vs POBA
Mehta RH et al. Comparison of coronary stenting versus conventional balloon
angioplasty on five-year mortality in patients with acute myocardial infarction
undergoing primary percutaneous coronary intervention.
:Am J Cardiol.2005
• To study the long term outcome of stenting vs POBA
• 2,087 patients enrolled from various PAMI trials
• 692 (33%) underwent stenting.
•
-
Absolute difference in mortality rates favoured stent usage
In-hospital (2.2% vs 3.3%),
1-year (3.3% vs 5.2%), and
5-year (10% vs 13%)
• Regression model identified significant 5 yr mortality reduction with stenting vs
POBA (HR 0.60, 95% confidence interval 0.42 to 0.85).
• The absolute reduction in mortality was greatest in the highest risk group.
ESC 2012 and AHA 2013 --- Primary stenting preferred to balloon angioplasty (Class I A)
BMS vs DES in PPCI
• PES versus BMS --- PASSION trial, NEJM 2006
• SES versus BMS --- TYPHOON trial , NEJM 2006
--- SESAMI trial , JACC 2007
• EES versus BMS --- EXAMINATION trial, LANCET 2012
• METAANALYSIS --- EHJ 2012
Laarman et al.Paclitaxel-Eluting versus Uncoated Stents
in Primary Percutaneous Coronary Intervention
: PASSION (NEJM 2006)
• 619 patients with STEMI, PES (TAXUS)vs BMS
• Primary end point-- composite of death from cardiac causes, recurrent
myocardial infarction, or target-lesion revascularization at 1 year
• Included LMCA, bifurcation and high thrombus burden lesions
p=0.12
Death, reinfarction, or TLR
(%)
15
10
12.6%
8.7%
5
0
Paclitaxel-eluting stent
Bare-metal stent
PASSION results (contd)
p=0.23
% Death/MI and TLR
10
p=0.39
8
6.5%
6
7.4%
6.2%
4.8%
4
2
0
Death/MI
Paclitaxel-eluting stent
TLR
Bare-metal stent
Stent thrombosis at 1 year – 1% in PES and DES
All individual endpoints revealed a trend for benefit with PES – statistically NS
Spaulding et al, Sirolimus-Eluting versus Uncoated Stents in
Acute Myocardial Infarction:
TYPHOON, NEJM 2006
• 712 STEMI at 48 centres, SES (CYPHER) vs BMS
• Primary EP – Target vessel failure (TVR, Reinfarction, death)
Target Vessel Failure at one year
20%
p=0.003
TVF
14.3%
10%
7.3%
0%
Cyper stent
Bare-metal stent
TYPHOON results(contd)
Rate of Target Lesion Revascularization (%)
p<0.0001
15%
12.6%
Rate of death - 2.3% and 2.2%, P = 1.00
Reinfarction - 1.1% and 1.4%, P = 1.00
10%
TLR
Stent thrombosis -3.4% and 3.6%,P = 1.00
5%
3.7%
0%
Cyper stent
Bare-metal stent
4 year follow up (JACC Cardiovasc 2011) – 580 patients
Freedom from TLR at 4 years 92.4% vs. 85.1%; p = 0.002;
Freedom from cardiac death (97.6% and 95.9%; p = 0.37)
Freedom from repeat myocardial infarction (94.8% and 95.6%; p = 0.85)
Definite/probable stent thrombosis-- SES: 4.4%, BMS: 4.8%, p = 0.83.
The all-cause death rate was 5.8% in the SES and 7.0% in the BMS group (p = 0.61).
Menichelli et al. Randomized trial of Sirolimus-Eluting Stent
Versus Bare-Metal Stent in Acute Myocardial Infarction
:SESAMI trial (JACC 2007)
• RCT of 320 STEMI , SES vs BMS
• Primary end point was binary restenosis (>50% stenosis) at 1yr
RESULTS:
• Binary restenosis was 9.3% vs. 21.3%,; p = 0.032),
• TLR 4.3% vs. 11.2%; p = 0.02,
• MACE 6.8% vs. 16.8%; p = 0.005,
• Definite stent thrombosis was 1.2% vs 0.6%
3 year f/u (JACC 2010) : Similar results
Sabate et al, Everolimus-eluting stent versus bare-metal stent in STsegment elevation myocardial infarction
EXAMINATION trial: Lancet. 2012
• Multicentre RCT 1504 patients EES vs BMS ....1 year
RESULTS
• The primary endpoint – 11.9% vs 14.2% (0.19)
• Rates of TLR was significantly lower in the EES group– 2% vs 5%
(0.007)
• Other endpoints were similar.
• Stent thrombosis rates EES 0.5% vs BMS 1.9% (0.019)
• Primary endpoints were significantly better for LAD-plasty
(9.5% vs 18.9%) --(Insights from EXAMINATION- AHJ Sept 2013)
Comparison of drug-eluting stents with bare metal stents in
patients with ST-segment elevation myocardial infarction
: A METAANALYSIS (EHJ 2012)
• 15 RCTs with 7867 patients  1st gen DES vs BMS in STEMI
• Stent thrombosis at 5 years was similar for DES and BMS
 RR- 1.08, 95% CI 0.82– 1.43].
• ST for 1st yr --RR of 0.80 (95% CI 0.58 –1.12)
• ST after 1st year 2.1(95% CI1.20 –3.69 )
• TVR was less for DES (RR 0.51, 95% CI 0.43–0.61) – benefit greater in 1st yr
• Other endpoints(30D,6m & 1yr) were similar for both
• NNT to prevent 1 TVR till 5 years = 15
• NNH to produce 1 ST till 5 years = 79
Guideline statements on DES vs BMS in
PPCI
AHA 2013
ESC 2012
M-Guard
• A novel Co-Cr stent wrapped with
ultra thin polymer mesh
• Excellent Deliverability and
Flexibility
• Built in embolic protection
• Plaque stabilization
• Rapid exchange deliverysystem
Stone et al. Prospective, Randomized, Multicenter Evaluation of a Polyethylene
Terephthalate Micronet Mesh-Covered Stent (MGuard) in STEMI
: The MASTER Trial (J Am Coll Cardiol 2012 Sep 28)
• Multicentre RCT -- 433 patients with STEMI
• The primary endpoint was the rate of complete (≥70%) STR measured
60 to 90 min post-procedure.
RESULTS:
• Complete STR was (57.8% vs. 44.7%;; p = 0.008).
• Superior rates of TIMI3 flow (91.7% vs. 82.9%, p = 0.006)
• MBG 2 or 3 (83.9% vs. 84.7%, p = 0.81).
• MACE at 30 days were similar
 Long term results awaited
MAGICAL trial - unpublished
-Data of 54 patients who underwent PPCI with M Guard stent
- Comparison with a matched cohort from TAPAS trial presented at
ESC interventional conference.
Closed vs Open cell stent for high-risk PCI in STEMI
:COCHISE study (AHJ 2013)
• Ongoing quest to tackle the no-reflow
phenomenon after PPCI.
• An attempt to assess the effect of free-cell
area.
• Coronary flow patterns by MBG and TFC
after PPCI between both stent designs
• RCT of 223 patients.
Significantly higher TFC, lower TIMI 3 flow
and lower MBG3 in open stent group.
Closed stent design has better
angiographic results following PPCI.
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