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Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
A Prospective Randomized Trial of Proximal A Prospective Randomized Trial of Proximal Microcirculatory Protection in Patients with Microcirculatory Protection in Patients with Acute Myocardial Infarction Undergoing Acute Myocardial Infarction Undergoing Primary PCIPrimary PCI
The PREPARE TrialThe PREPARE TrialPRPRoximal oximal EEmbolic mbolic PProtection in rotection in AAcute MI and cute MI and RResolution of ST-esolution of ST-EElevationlevation
Karel T. KochKarel T. Koch
Joost D.E. Haeck, Jan G.P. Tijssen, Luc Bilodeau*, René J. van der Schaaf, Joost D.E. Haeck, Jan G.P. Tijssen, Luc Bilodeau*, René J. van der Schaaf,
José P.S. Henriques, Allard van der Wal, Jan Baan Jr., Marije M. Vis, Jan J. Piek, José P.S. Henriques, Allard van der Wal, Jan Baan Jr., Marije M. Vis, Jan J. Piek, Mitchell W. KrucoffMitchell W. Krucoff††, Robbert J. de Winter., Robbert J. de Winter.
Academic Medical Center - University of Amsterdam, The NetherlandsAcademic Medical Center - University of Amsterdam, The Netherlands
*Institut de Cardiologie de Montréal, QC, *Institut de Cardiologie de Montréal, QC, CanadaCanada††Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USADuke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Within the past 12 months, I or my spouse/partner have had a financial Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial RelationshipAffiliation/Financial Relationship CompanyCompany
Grant/Research Support: Grant/Research Support:
Educational Grant Educational Grant St. Jude MedicalSt. Jude Medical
Disclosure statement of financial interestDisclosure statement of financial interest
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Inadequate myocardial reperfusion relates to prognosis, Inadequate myocardial reperfusion relates to prognosis, even in the presence of adequate epicardial flow.even in the presence of adequate epicardial flow.
Embolization of atherothrombotic material plays a crucial Embolization of atherothrombotic material plays a crucial role in microvascular obstruction and impaired role in microvascular obstruction and impaired myocardial perfusion.myocardial perfusion.
The ProxisThe Proxis™™ device is a combined system of device is a combined system of proximal proximal embolic protection embolic protection andand thrombus aspiration thrombus aspiration. The device . The device has been shown feasible and safe in primary PCIhas been shown feasible and safe in primary PCI**..
The The PREPAREPREPARE Trial was designed to evaluate primary PCI Trial was designed to evaluate primary PCI with the Proxis system compared to primary PCI alone.with the Proxis system compared to primary PCI alone.
*Koch KT et al. Rev Cardiovasc Med. 2007;8(3): 160-6*Koch KT et al. Rev Cardiovasc Med. 2007;8(3): 160-6
BackgroundBackground
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Full length flexible catheterFull length flexible catheter6F and 7F GC compatible6F and 7F GC compatible
Sealing balloon at the tipSealing balloon at the tip
COCO22 based inflation device based inflation device
Deployed proximal to target Deployed proximal to target lesion before crossinglesion before crossing
Inflation of balloon suspends Inflation of balloon suspends antegrade flow during lesion antegrade flow during lesion interventionintervention
Stagnated blood and emboli Stagnated blood and emboli liberated during intervention liberated during intervention are retrieved by gentle are retrieved by gentle aspirationaspiration
Proxis embolic protection systemProxis embolic protection system
ProxisProxis™™ embolic protection system (St. Jude Medical, St. Paul, MN, USA) embolic protection system (St. Jude Medical, St. Paul, MN, USA)
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
• PRPRoximal oximal EEmbolic mbolic PProtection in rotection in AAcute MI and cute MI and RResolution of ST-esolution of ST-EElevationlevation
• Investigator-initiated randomized trialInvestigator-initiated randomized trial
• Comparison of primary PCI with Proxis system Comparison of primary PCI with Proxis system versus primary PCI aloneversus primary PCI alone
• Open trial with blinded evaluation of end pointsOpen trial with blinded evaluation of end points
• Participation of 2 centersParticipation of 2 centers
• 140 patients in each study arm140 patients in each study arm
PREPARE TrialPREPARE Trial
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Inclusion criteriaInclusion criteria
• Consecutive STEMI patients Consecutive STEMI patients ≤ 6 h≤ 6 h
• ST-segment elevation ST-segment elevation ≥ 2 mm in ≥ 2 leads≥ 2 mm in ≥ 2 leads
• TIMI flow grade 0 to 1 at first angiogramTIMI flow grade 0 to 1 at first angiogram
• Coronary anatomy suitable for ProxisCoronary anatomy suitable for Proxis
• ECG suitable for ST-segment resolution ECG suitable for ST-segment resolution
evaluationevaluation
Exclusion criteriaExclusion criteria
• Recurrence of MI in same areaRecurrence of MI in same area
• Prior CABG or lyticsPrior CABG or lytics
Patient selectionPatient selection
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
UFH 70 U/kgUFH 70 U/kgASA 300 mgASA 300 mgClopidogrel 600 mgClopidogrel 600 mg
Continuous Continuous ST HolterST Holter
Coronary angiogramCoronary angiogram
STEMI ≤ 6 hSTEMI ≤ 6 h
Primary PCIPrimary PCIalonealone
Clinical follow up at 30 daysClinical follow up at 30 days
Primary PCIPrimary PCIwith Proxiswith Proxis
PREPARE TrialPREPARE Trial
Study flow chartStudy flow chart
RR24 h24 h
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Primary end pointPrimary end point • ST-segment elevation resolution (STR) over time*ST-segment elevation resolution (STR) over time*
Secondary end pointsSecondary end points• TIMI graded flow TIMI graded flow
• Myocardial blush gradeMyocardial blush grade
• Angiographic signs of distal embolizationAngiographic signs of distal embolization
• Composite of death, MI, TVR, and stroke at 30 daysComposite of death, MI, TVR, and stroke at 30 days
End pointsEnd points
*Duke Clinical Research Institute Core Lab*Duke Clinical Research Institute Core Lab
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Patient characteristicsPatient characteristics
AgeAge 62 ± 1162 ± 11 59 ± 1159 ± 11
MaleMale 80% 80% 80%80%
Family history CADFamily history CAD 35%35% 38%38%
HypercholesterolemiaHypercholesterolemia 21%21% 13%13%
Current smokingCurrent smoking 50% 50% 65%65%
HypertensionHypertension 31%31% 23%23%
DiabetesDiabetes 12%12% 6%6%
Previous MIPrevious MI 6%6% 9%9%
Multivessel diseaseMultivessel disease 33%33% 31%31%
Symptoms to balloon (min) Symptoms to balloon (min) 170 170 153 153
ProxisProxisn = 141n = 141
ControlControln = 143n = 143
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Infarct related arteryInfarct related artery
RCARCA 61%61% 60%60%
LADLAD 29%29% 29%29%
LCxLCx 10%10% 11%11%
Pre-PCI TIMI graded flowPre-PCI TIMI graded flow
00 90%90% 89%89%
11 9%9% 8%8%
22 1% 1% 4% 4%
Lesion characteristicsLesion characteristicsProxisProxisn = 141n = 141
ControlControln = 143n = 143
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Procedural characteristicsProcedural characteristics
*P<0.05; IQR interquartile range*P<0.05; IQR interquartile range
Procedural successProcedural success 100%100% 99%99%
Proxis placedProxis placed 94%94% ──
Predilatation and stentingPredilatation and stenting 87%87% 76%76%
Direct stenting Direct stenting 11% 11% 19%19%
Balloon angioplastyBalloon angioplasty 3% 3% 6% 6%
GP IIb/IIIa receptor antagonistsGP IIb/IIIa receptor antagonists 43% 43% 35%35%
Additional thrombus aspirationAdditional thrombus aspiration 6% 6% 6%6%
Pathology confirmed thrombusPathology confirmed thrombus 75% 75% ─ ─
Puncture to balloon (min)Puncture to balloon (min)
MedianMedian 17 17 14*14*
IQRIQR 13-23 13-23 10-1810-18
**
ProxisProxisn = 141n = 141
ControlControln = 143n = 143
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Complete (>70%) STR Complete (>70%) STR
(Fisher’s Exact Test)(Fisher’s Exact Test)
ProxisProxisn = 141n = 141
ControlControln = 143n = 143
P-valueP-value
*Primary endpoint*Primary endpoint
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
ImmediateImmediate 66%66% (85/129)(85/129) 50%50% (67/135)(67/135) 0.0090.009
Complete (>70%) STR Complete (>70%) STR
(Fisher’s Exact Test)(Fisher’s Exact Test)
ProxisProxisn = 141n = 141
ControlControln = 143n = 143
P-valueP-value
*Primary endpoint*Primary endpoint
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
ImmediateImmediate 66%66% (85/129)(85/129) 50%50% (67/135)(67/135) 0.0090.009
30 min30 min 75%75% (91/122)(91/122) 66%66% (86/130)(86/130) 0.170.17
60 min60 min 80%80% (101/126)(101/126) 72%72% (93/129)(93/129) 0.140.14
90 min90 min 81%81% (100/124)(100/124) 74%74% (97/131)(97/131) 0.230.23
120 min120 min 78%78% (98/126)(98/126) 76%76% (100/131)(100/131) 0.880.88
Complete (>70%) STR Complete (>70%) STR
(Fisher’s Exact Test)(Fisher’s Exact Test)
ProxisProxisn = 141n = 141
ControlControln = 143n = 143
P-valueP-value
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Complete STR over timeComplete STR over time
Last Last contrastcontrast
4040
5050
6060
7070
8080
9090
3030 6060 9090 120120
Time after last contrast, minTime after last contrast, min
Pa
tie
nts
wit
h c
om
ple
te S
TR
, %
Pa
tie
nts
wit
h c
om
ple
te S
TR
, %
ControlControl
ProxisProxis
P=0.009P=0.009
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
ImmediateImmediate 73 ± 2773 ± 27 63 ± 3263 ± 32 0.0090.009
30 min30 min 79 ± 2179 ± 21 75 ± 2375 ± 23 0.300.30
60 min60 min 82 ± 2082 ± 20 78 ± 2178 ± 21 0.270.27
90 min90 min 82 ± 1982 ± 19 80 ± 2180 ± 21 0.170.17
120 min120 min 82 ± 1982 ± 19 81 ± 2081 ± 20 0.480.48
Mean % STRMean % STRP-valueP-value**ProxisProxis
n = 141n = 141ControlControl
n = 143n = 143
Mean (SD); Mean (SD); **T-TestT-Test
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Angiographic parametersAngiographic parametersProxisProxisn = 141n = 141
ControlControln = 143n = 143
*Cochran-Armitage Test*Cochran-Armitage Test††Fisher’s Exact TestFisher’s Exact Test
Post-PCI TIMI graded flowPost-PCI TIMI graded flow33 93%93% 87%87%
22 7%7% 11%11% 0.060.06**
0-10-1 0%0% 2%2%
Myocardial blush gradeMyocardial blush grade 33 81%81% 83%83%
22 16%16% 11%11% 0.930.93**
0-10-1 4%4% 6%6%
Distal embolization Distal embolization (yes/no)(yes/no) 10%10% 14%14% 0.360.36††
P-valueP-value
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
DeathDeath 22 22
MIMI 22 33
TVRTVR 33 66
StrokeStroke 00 11
MACCEMACCE** 66 (4%)(4%) 1010 (7%)(7%)
no complications at Proxis landing zoneno complications at Proxis landing zone
Clinical events at 30 daysClinical events at 30 daysProxisProxisn = 141n = 141
ControlControln = 143n = 143
For descriptive purposes only; no statistical comparisons doneFor descriptive purposes only; no statistical comparisons done*ARC MACCE definition Circ. 2007; 115: 2344–2351*ARC MACCE definition Circ. 2007; 115: 2344–2351
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
The Proxis system is The Proxis system is feasiblefeasible and and safesafe in the setting of STEMI, in the setting of STEMI,
and effectively retrieves embolic debris in most patients.and effectively retrieves embolic debris in most patients.
In conclusionIn conclusion
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
The Proxis system is The Proxis system is feasiblefeasible and and safesafe in the setting of STEMI, in the setting of STEMI,
and effectively retrieves embolic debris in most patients.and effectively retrieves embolic debris in most patients.
Complete STR wasComplete STR was better better inin Proxis Proxis treated patientstreated patients compared compared
to control patients. The difference in STR immediately after PCI to control patients. The difference in STR immediately after PCI
was highly statistically significant (p=0.009).was highly statistically significant (p=0.009).
In conclusionIn conclusion
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
The Proxis system is The Proxis system is feasiblefeasible and and safesafe in the setting of STEMI, in the setting of STEMI,
and effectively retrieves embolic debris in most patients.and effectively retrieves embolic debris in most patients.
Complete STR wasComplete STR was better better inin Proxis Proxis treated patientstreated patients compared compared
to control patients. The difference in STR immediately after PCI to control patients. The difference in STR immediately after PCI
was highly statistically significant (p=0.009).was highly statistically significant (p=0.009).
The results of the PREPARE trial suggest that primary PCI with The results of the PREPARE trial suggest that primary PCI with
combined proximal embolic protection and aspiration leads tocombined proximal embolic protection and aspiration leads to
better immediate microvascular flowbetter immediate microvascular flow in STEMI patients. in STEMI patients.
In conclusionIn conclusion
Academic Medical Center Amsterdam
Interventional CardiologyKoch Koch TCTTCT 2008 2008
Thank you for your attentionThank you for your attention
[email protected]@amc.uva.nl
PREPARE TrialPREPARE TrialPRPRoximal oximal EEmbolic mbolic PProtection in rotection in AAcute MI and cute MI and RResolution of ST-esolution of ST-EElevationlevation