jurnal makassar 1
DESCRIPTION
medical fuckTRANSCRIPT
Introduction
Contemporary techniques of primary percutaneous coronary intervention (pPCI)
enable therestoration of normal epicardial flow in the infarct-related artery in the
majority of patients, asevaluated by Thrombolysis in Myocardial Infarction (TIMI)
flow and the corrected TIMI framecount (cTFC) (1). However, vessel patency does
not always translate into microvascular reperfusion. Impaired microvascular
perfusion, measured by the TIMI myocardial perfusiongrade (TMPG), is
associated with increased infarct size and worse clinical outcomes (2). ST-segment
resolution (STR) has also been shown to correlate with microvascular reperfusion
after revascularization for ST-segment elevation myocardial infarction (STEMI)
(3, 4). Distalembolization of thrombotic material has been hypothesized as a
mechanism of microvascular obstruction and injury and provides the rationale
(Class IIa recommendation) for employing thrombus aspiration (TA) during pPCI
(5)
The results of previous studies of TA during pPCI for STEMI have been
conflicting, andcomparisons have been complicated by the variety of devices used.
Early randomized trials of rheolytic thrombectomy showed no benefit and a
possible increase in infarct size and major adverse cardiac events (MACE), while
prospective cohort studies and the recent multicenter randomized Thrombectomy
Before Direct Infarct Artery Stenting to Direct Stenting Alone inPatients with
Acute Myocardial Infarction (JETSTENT) trial in patients with high
gradethrombus burden reported improved surrogate and clinical outcomes (6, 7, 8,
9, 10, 11, 12, 13).Prospective cohort studies and randomized trials of manual TA
have fairly consistently reportedimproved STR, TIMI flow, cTFC, and TMBG, and
reductions in distal embolization and the no-reflow phenomenon (14, 15, 16, 17,
18, 19, 20). The more recent randomized Thrombectomywith Export Catheter in
Infarct Related Artery during Primary Percutaneous Coronary Intervention
(EXPIRA) and Thrombus Aspiration during Percutaneous Coronary Intervention
inAcute Myocardial Infarction Study (TAPAS) trials both reported improved
clinical outcomeswith manual TA, although neither was powered for these
endpoints, whereas the IntracoronaryAbciximab and Aspiration Thrombectomy in
Patients With Large Anterior Myocardial Infarction(The INFUSE-AMI) Trial
showed no improvement in reperfusion parameters, infarct size oncardiac magnetic
resonance imaging, or in 30-day MACE (18, 19, 20, 21). In this sub-analysis from
the Harmonizing Outcomes with Revascularization and Stentsin Acute Myocardial
Infarction (HORIZONS-AMI) Trial (22), we evaluated whether there might be an
association between the use of manual TA and changes in
angiographic,electrocardiographic and clinical outcomes of patients with STEMI
undergoing contemporary pPCI.
Materials and Methods
The HORIZONS-AMI study has been previously reported in detail (22). Briefly,
the studyrandomized 3602 patients with STEMI, presenting within 12 hours after
the onset of symptoms,who were undergoing pPCI, to receive bivalirudin alone
(n=1800) or heparin plus a glycoproteinIIb/IIIa inhibitor (n=1802). A second
randomization allocated patients to a paclitaxel-eluting or an otherwise identical
bare-metal stent.Manual thrombus aspiration with a catheter such as Export
(Medtronic, Minneapolis,MN), Diver CE (Invatec, Roncadelle, Italy), Pronto
(Vascular Solutions, Maple Grove, MN), or QuickCat (Spectranetics, Colorado
Springs, CO) was allowed by the protocol and was used atthe discretion of the
operator
The primary study endpoint was net adverse clinical events (NACE), which
includeddeath, re-infarction, ischemic target vessel revascularization (TVR),
stroke, or major bleeding.Other outcomes of interest were MACE (including death,
re-infarction, ischemic TVR, andstroke), components of MACE, major bleeding
not related to CABG, and definite or probablestent thrombosis according to ARC
criteria. Angiographically, reperfusion was assessed by thefinal TIMI flow in the
infarct artery and the TMPG (16, 18). STR was measured by continuousdigital 12-
lead Holter monitoring (3, 4, 23, 24).An independent clinical events committee
blinded to treatment assignments adjudicatedall primary end-point events by
reviewing original source documents and procedural angiograms.Angiographic and
ST-segment analysis were performed at a dedicated core laboratory with theuse of
validated methods by technicians who were unaware of the treatment assignments
andclinical outcomes (25). ST-segment elevation measurements were performed
manually, usingcalibrated/scaled magnifying glasses with a precision of 0.1 mm at
baseline, 60 minutes post- procedure, and at discharge. STR was calculated by the
angiographic core laboratory as the sumof the ST-segment elevation at the time
point of interest as a percentage of the sum of the ST-segment elevation at
baseline. Complete STR was considered STR ≥70%. Stent thrombosis wasdefined
as definite or probable, using the Academic Research Consortium classification
(26).
Statistical Analysis.
Categorical outcomes were compared using the chi-square or Fisher's exacttest.
Continuous variables were compared using the Wilcoxon rank-sum test. The
primary eventanalyses were performed with the use of time-to-event data (with
data censored at the time of a patient's withdrawal from the study or at the last
follow-up examination). The results of theseanalyses are shown using Kaplan-
Meier methods and were compared using the log-rank test. As a secondary
analysis, we performed a time-updated Cox proportional-hazards regression
withadjustment for TA vs. none, randomization to bivalirudin vs. heparin plus GPI,
age, gender,history of hypertension, diabetes, MI, creatinine clearance <60, Killip
Class 2-4 vs.1, anemia, baseline and final TIMI flow, baseline and final TMBG,
and symptom to first balloon inflationtime (hours), to adjust for baseline
imbalances between the two groups.
Results
Study Population.
The study flow chart is shown in Figure 1. Among 3340 patients treated with pPCI,
3298 (98.7%) had information concerning the use of manual TA. We excluded 63
patients(1.9%) in whom TA was used for bail-out indications (eg, slow or no
flow). The final study population included 3235 patients, 318 patients (9.8%) who
underwent pPCI with upfront use of TA and 2917 patients (90.2%) who underwent
PCI alone. The most commonly used TA deviceswere the Export and Diver CE
catheters (Figure 2).
Patient and Procedural Characteristics.
Baseline demographics are shown in Table I. Patientstreated with versus without
TA were younger and had a lower prevalence of hypertension, but ahigher
prevalence of smoking and prior PCI. Patients treated with TA had shorter
symptom-onsetto balloon time, a higher prevalence of single vessel disease,
angiographic evidence of thrombus,and baseline TIMI flow <3. Direct stenting and
post-stent dilatation were used more frequentlyin patients treated with TA (Table
II).
ST-segment Resolution.
At the end of the procedure, there was no difference between the twogroups in the
rates of final TIMI 3 flow and TMPG grade 2-3 (Table III). At 60 minutes post-
procedure, a similar proportion of patients treated with and without TA
hadcomplete STR (48.2% vs. 50.3%, p=0.51). However, significantly more
patients in the TA grouphad complete STR at discharge (71.8% vs. 64.6%,
p=0.02).
Clinical Outcomes.
At 30-day, 1-year, and 3-year follow-up, the TA and no TA groups hadsimilar
rates of MACE, NACE, death, MI, ischemic TVR, and stent thrombosis (Table
IV).There were more strokes and major bleeding events in the TA group at 30
days, but by 3 yearsthe difference was no longer apparent. The cumulative
incidence of definite or probable stentthrombosis was similar between the two
groups; however, late stent thrombosis occurredsignificantly more frequently in the
TA group.After multivariate adjustment, the use of manual TA was not associated
with anydifferences in long-term outcomes (Table V).
Discussion
In this sub-analysis of the HORIZONS-AMI trial we found that the quality of
reperfusion attained was similar between the two groups with no significant
differences in the rates of final TIMI 3 flow, TMPG 2-3, or complete STR at 60
minutes despite worse initial angiographic presentation among patients in the TA
group, who were more likely to have visible thrombus,TIMI 0/1 flow and TMPG
0/1 at baseline. Furthermore, there was a higher rate of complete STR in the TA
group at hospital discharge. With respect to clinical outcomes, there were
nosignificant differences in the rates of MACE, NACE, death, MI, ischemic TVR,
or stentthrombosis at 30 days, 1 year, or 3 years in patients treated with or without
TA. There was,however, a higher incidence of late stent thrombosis in patients
treated with TA, as well as anearly association with increased stroke and major
bleeding with TA which was no longer present at 3-year follow-up. Finally, after
adjusting for differences in the two groups, we found that theuse of manual TA
was not associated with rates of short- or long-term MACE.Unfortunately no
clinical benefit has been demonstrated from the use of distal protectiondevices (27,
28, 29, 30, 31). Analysis of the results of previous thrombectomy trials
iscomplicated by the variety of devices studied, which can be broadly categorized
into mechanicalthrombectomy (eg, Angiojet [Medrad, Warrendale, PA], X-sizer
[eV3, White Bear Lake, MN])and manual aspiration catheters (eg, Export, Diver
CE).Rheolytic thrombectomy using the Angiojet device had until recently been
reported inrandomized trials to be of no benefit and to possibly be associated with
increased infarct size,MACE, and reduced TIMI flow (6, 7). Prospective cohort
studies and registry data specifically in patients with high-grade thrombus burden
have reported improved angiographic and clinicaloutcomes (8, 9, 10, 32, 33). The
recently published JETSTENT multicenter randomized trial of rheolytic
thrombectomy and direct stenting versus direct stenting alone during pPCI with
highgrade thrombus burden reported improved STR, but no improvement in the
other primaryendpoints including infarct size (11). There was a significant
reduction in the secondary endpointof MACE at 1, 6, and 12 months (11).
Randomized trials of the X-sizer device demonstratedimproved STR, corrected
TIMI frame count (cTMC), and reduced distal embolization, butreported no
difference in TIMI 3 flow, TMBG, or MACE (12, 13).Randomized and
prospective cohort studies of manual TA, as used in this study, havereported
improvements in electrocardiographic and angiographic endpoints, including
STR,TIMI flow, cTFC, and TMPG (14, 15, 21, 16, 17, 18, 19, 20). In our study
there was noimprovement in post-procedural TIMI 3 flow and TMPG, or in 60-
minute complete STR withthe use of TA devices, while STR was significantly
improved in the TA group at discharge. This may indicate a delayed improvement
in microvascular reperfusion following TA in our study population. It should be
noted that the TA patients had more visible thrombus and a higher proportion of
TIMI 0/1 flow pre-procedure at baseline, from which they then achieved
similar rates of TIMI 3 flow as the no TA patients.While the majority of studies
report an improvement in surrogate markers with the use of manual TA, it remains
uncertain whether this translates into an improvement in clinicaloutcomes. One
early study suggesting a possible mortality benefit (34) was recently supported
bythe randomized EXPIRA and TAPAS trials (18, 19, 20). Both studies used the
Export catheter.Importantly, inclusion in EXPIRA required TIMI 0-1 flow and
high grade visible thrombus, andthe PCI strategy was direct stenting in both arms
of the trial. Manual TA was associated withimprovement in the co-primary
endpoints of TMPG and STR. Cardiac death, MACE and infarctsize on MRI were
also noted to be reduced, although the study was not powered to detect
theseendpoints (20). Similarly, in TAPAS, manual TA was associated with
improved TMPG, STR,cardiac death, and non-fatal MI, but again was not powered
for the clinical endpoints (18, 19).Although TAPAS was a large study, it was a
single center trial and, importantly, mandated pre-dilatation in the no TA group,
raising the issue of whether the benefits observed in the TA groupwere due to the
TA or to direct stenting (18, 19). A subsequent meta-analysis of 9
randomizedtrials, including TAPAS, concluded that manual thrombectomy was
associated with improved30-day mortality (35). A more comprehensive meta-
analysis of 30 randomized trials of alladjunctive devices used in STEMI also
reported that manual aspiration was associated withimproved mortality and
reduced MACE rates (36). Contrary to the results of TAPAS and themeta-analyses,
we did not observe any difference in MACE or mortality at 1 year with TA,
evenafter adjusting for many important covariatesAn important procedural
difference between the two groups in our study was a greater use of direct stenting
in the TA group than in the no TA group. As already discussed, there have been
concerns raised in prior TA trials, including TAPAS, that some of the benefit
observed may be due to direct stenting and not to the TA itself (18, 19, 36). There
is, however, some evidencethat the use of TA is an independent predictor of
improved angiographic outcomes even in thesetting of direct stenting (20, 37). In
our study, the use of direct stenting was more frequent in theTA group, but the net-
clinical effect of this difference in procedural approach would be difficultto assess
among a host of potential confounders. In the HORIZONS-AMI trial, median
ischemiatime of TA patients exceeded that of TAPAS by 14 minutes and the LAD
was less affected(33.4% as compared to 42.9%), differences that may reduce the
prognostic impact of TA.We reported an increased rate of stroke at 30 days and 1
year in the TA group. After adjusting for multiple covariates, patients treated with
manual TA still had a trend towards anincreased stroke rate at 1 year, but no such
difference was apparent at 3-year follow-up, and our finding should be regarded as
an association of clinical interest. This finding is partly consistentwith results from
the meta-analysis of randomized trials of thrombectomy and embolic
protectiondevices (36). That study demonstrated a trend towards increased stroke
following manual or mechanical thrombectomy. It is hypothesized that this could
be due to dislodgement andembolization of thrombus from the coronary ostium or
aspiration catheter.While there was no difference in the incidence of cumulative
definite or probable stentthrombosis between patients treated with or without TA,
we found a higher incidence of latestent thrombosis in the TA group at 1-year
follow-up. This clearly raises concern that TA, possibly due to endothelial
disruption and impaired endothelialization, may induce a higher incidence of late
stent thrombosis. Interestingly, we also observed a trend towards less sub-acute
stent thrombosis in our TA group, raising the possibility that the use of aspiration
catheters mayaffect the time of occurrence of stent thrombosis. Another important
consideration in our study isthat patients treated with manual TA were more likely
to have visible thrombus, and there isevidence in STEMI patients that large
thrombus burden is an independent predictor of infarct-related artery stent
thrombosis (38). However, at 3-year follow-up, the rate of late cumulativestent
thrombosis did no longer differ between the two groups, suggesting that slowing
down of vascular repair by TA may be a temporary phenomenon, but this
assumption should be regardedwith caution, due to many potential confounders
that cannot be corrected for.
Limitations
The use of manual TA was non-randomized and was left to the
operator’sdiscretion, potentially introducing confounding factors and bias into the
analysis, and as theanalysis was not pre-specified in the original study design, the
associations noted should beregarded as hypothesis generating.
Conclusions
In the HORIZONS-AMI trial, manual TA was associated with improved STR at
discharge,whereas final TIMI flow and TMPG were unaffected. There were similar
rates of NACE, death,cardiac death, re-infarction, ischemic TVR, major bleeding,
and MACE at 30 days, 1-year, and3-year follow-up. Further multicenter
randomized trials are required to clarify the safety andefficacy of routine TA in
patients with STEMI undergoing pPCI
References
1. Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ,
McCabeCH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count. a
quantitativemethod of assessing coronary artery flow. Circulation 1996;93:879-
888.
2. Stone GW, Peterson MA, Lansky AJ, Dangas G, Mehran R, Leon MB. Impact
of normalized myocardial perfusion after successful angioplasty in acute
myocardialinfarction. J Am Coll Cardiol 2002;39:591-597.
3. Santoro GM, Antoniucci D, Valenti R, Bolognese L, Buonamici P, Trapani M,
Boddi V,Fazzini PF. Rapid reduction of ST-segment elevation after successful
direct angioplastyin acute myocardial infarction. Am J Cardiol 1997;80:685-689.
4. Prasad A, Stone GW, Aymong E, Zimetbaum PJ, McLaughlin M, Mehran R,
Garcia E,Tcheng JE, Cox DA, Grines CL, Gersh BJ. Impact of ST-segment
resolution after primary angioplasty on outcomes after myocardial infarction in
elderly patients: ananalysis from the CADILLAC trial. Am Heart J 2004;147:669-
675.
5. 2009 Focused Updates: ACC/AHA guidelines for the management of patients
with ST-elevation myocardial infarction (updating the 2004 guideline and 2007
focused update)and ACC/AHA/SCAI guidelines on percutaneous coronary
intervention (updating the2005 guideline and 2007 focused update) a report of the
American College of CardiologyFoundation/American Heart Association Task
Force on Practice Guidelines. J Am CollCardiol 2009;54:2205-2241.
6. Ali A, Cox D, Dib N, Brodie B, Berman D, Gupta N, Browne K, Iwaoka R,
Azrin M,Stapleton D, Setum C, Popma J; AIMI Investigators. Rheolytic
thrombectomy with percutaneous coronary intervention for infarct size reduction in
acute myocardial infarction: 30-day results from a multicenter randomized study. J
Am Coll Cardiol2006;48:244-252.
7. Kaltoft A, Bøttcher M, Nielsen SS, Hansen HH, Terkelsen C, Maeng M,
Kristensen J,Thuesen L, Krusell LR, Kristensen SD, Andersen HR, Lassen JF,
Rasmussen K, RehlingM, Nielsen TT, Bøtker HE. Routine thrombectomy in
percutaneous coronary interventionfor acute ST-segment-elevation myocardial
infarction: a randomized, controlled trial.Circulation 2006;114:40-47.
8. De Rosa S, Cirillo P, De Luca G, Galasso G, Esposito G, Leosco D, Piscione
F,Chiariello M. Rheolytic thrombectomy during percutaneous coronary
interventionimproves long-term outcome in high-risk patients with acute
myocardial infarction. JInterv Cardiol 2007;20:292-298.
9. Sharma SK, Tamburrino F, Mares AM, Kini AS. Improved outcome with
AngioJetthrombectomy during primary stenting in acute myocardial infarction
patients with high-grade thrombus. J Invasive Cardiol 2006;18(suppl C):8C-11C.
10. Sianos G, Papafaklis MI, Vaina S, Daemen J, van Mieghem CA, Van Domburg
RT,Michalis LK, de Jaegere P, Serruys PW. Rheolytic thrombectomy in patients
with ST-elevation myocardial infarction and large thrombus burden: the
Thoraxcenter experience.J Invasive Cardiol 2006;18(suppl C):3C-7C.
11. Migliorini A, Stabile A, Rodriguez AE, Gandolfo C, Rodriguez Granillo AM,
Valenti R,Parodi G, Neumann FJ, Colombo A, Antoniucci D; JETSTENT Trial
Investigators.Comparison of AngioJet rheolytic thrombectomy before direct infarct
artery stenting withdirect stenting alone in patients with acute myocardial
infarction. The JETSTENT Trial. JAm Coll Cardiol 2010;56:1298-1306
12. Lefèvre T, Garcia E, Reimers B, Lang I, di Mario C, Colombo A, Neumann FJ,
ChavarriMV, Brunel P, Grube E, Thomas M, Glatt B, Ludwig J; X AMINE ST
Investigators. X-sizer for thrombectomy in acute myocardial infarction improves
ST-segment resolution:results of the X-sizer in AMI for negligible embolization
and optimal ST resolution (XAMINE ST) trial. J Am Coll Cardiol 2005;46:246-
252.
13. Beran G, Lang I, Schreiber W, Denk S, Stefenelli T, Syeda B, Maurer G,
Glogar D,Siostrzonek P. Intracoronary thrombectomy with the X-sizer catheter
system improvesepicardial flow and accelerates ST-segment resolution in patients
with acute coronarysyndrome: a prospective, randomized, controlled study.
Circulation 2002;105:2355-2360.
14. Kishi T, Yamada A, Okamatsu S, Sunagawa K. Percutaneous coronary
arterialthrombectomy for acute myocardial infarction reduces no-reflow
phenomenon and protects against left ventricular remodeling related to the
proximal left anterior descending and right coronary artery. Int Heart J
2007;48:287-302.
15. Ashraf T, Rasool SI, Saghir T, Rizvi SNH, Qamar N, Zaman KS, Ishaque M,
Kundi A.Aspiration of thrombus in ST segment elevation myocardial infarction. J
Pak Med Assoc2007;57:359-362.
16. Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M,
Garramone B,Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo
R, Crea F. Manualthrombus-aspiration improves myocardial reperfusion: the
randomized evaluation of theeffect of mechanical reduction of distal embolization
by thrombus-aspiration in primaryand rescue angioplasty (REMEDIA) trial. J Am
Coll Cardiol 2005;46:371-376.
17. Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia
J, OrricoP, de Biase A, Piccalò G, Bossi I, Klugmann S. Thrombus aspiration
before primary angioplasty improves myocardial reperfusion in acute myocardial
infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in
Myocardial Infarction) study. J AmColl Cardiol 2006;48:1552-1559.
18. Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel
AF,Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus
aspirationduring primary percutaneous coronary intervention. N Engl J Med
2008;358:557-567.
19. Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ,
van denHeuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F.
Cardiac deathand reinfarction after 1 year in the Thrombus Aspiration during
Percutaneous coronaryintervention in Acute myocardial infarction Study
(TAPAS): a 1-year follow-up study.Lancet 2008;371:1915-1920.
20. Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I,
FranconeM, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration
during primary percutaneous coronary intervention improves myocardial
reperfusion and reduces infarctsize: the EXPIRA (thrombectomy with export
catheter in infarct-related artery during primary percutaneous coronary
intervention) prospective, randomized trial. J Am CollCardiol 2009;53:309-315.
21. Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH,
OchalaA, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M,
Neunteufl T,Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM;
INFUSE-AMIInvestigators. Intracoronary abciximab and aspiration thrombectomy
in patients withlarge anterior myocardial infarction: the INFUSE-AMI randomized
trial. JAMA2012;307(17):1817-1826
22.Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D,
KornowskiR, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Kirtane AJ,
Parise H,Mehran R; HORIZONS-AMI Trial Investigators. Bivalirudin during
primary PCI inacute myocardial infarction. N Engl J Med 2008;358:2218-2230.
23. Schröder R, Wegscheider K, Schröder K, Dissmann R, Meyer-Sabellek W..
Extent of early ST segment elevation resolution: A strong predictor of outcome in
patients withacute myocardial infarction and a sensitive measure to compare
thrombolytic regimens. Asubstudy of the International Joint Efficacy Comparison
of Thrombolytics (INJECT)trial. J Am Coll Cardiol 1995;26:1657-1664.
24. de Lemos JA, Antman EM, Giugliano RP, McCabe CH, Murphy SA, Van de
Werf F,Gibson CM, Braunwald E. ST-segment resolution and infarct related artery
patency andflow after thrombolytic therapy. Am J Cardiol 2000;85:299-304.
25. Lansky A, Popma J. Qualitative and quantitative angiography. In: Topol EJ, ed.
Textbook of Interventional Cardiology. Philadelphia, PA: W.B. Saunders,
1999:725-747.
26. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG,
MorelMA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW,
SerruysPW; Academic Research Consortium. Clinical end points in coronary stent
trials: a casefor standardized definitions. Circulation 2007;115:2344-2351.
27 Dangas G, Stone GW, Weinberg MD, Webb J, Cox DA, Brodie BR, Krucoff
MW,Gibbons RJ, Lansky AJ, Mehran R; EMERALD Investigators. Contemporary
outcomesof rescue percutaneous coronary intervention for acute myocardial
infarction: comparisonwith primary angioplasty and the role of distal protection
devices (EMERALD trial). AmHeart J 2008;155:1090-1096.
28. Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Kløvgaard L,
Kaltoft A,Engstrøm T, Bøtker HE, Saunamäki K, Krusell LR, Jørgensen E, Hansen
HH,Christiansen EH, Ravkilde J, Køber L, Kofoed KF, Thuesen L. Randomized
comparisonof distal protection versus conventional treatment in primary
percutaneous coronaryintervention: the drug elution and distal protection in ST-
elevation myocardial infarction(DEDICATION) trial. J Am Coll Cardiol
2008;51:899-905.
29. Burzotta F, Testa L, Giannico F, Biondi-Zoccai GG, Trani C, Romagnoli E,
Mazzari M,Mongiardo R, Siviglia M, Niccoli G, De Vita M, Porto I, Schiavoni G,
Crea F.Adjunctive devices in primary or rescue PCI: a meta-analysis of
randomized trials. Int JCardiol 2008;123:313-321.
30. De Luca G, Suryapranata H, Stone GW, Antoniucci D, Neumann FJ, Chiariello
M.Adjunctive mechanical devices to prevent distal embolization in patients
undergoingmechanical revascularization for acute myocardial infarction: a meta-
analysis of randomized trials. Am Heart J 2007;153:343-353.
31. Stone GW, Webb J, Cox DA, Brodie BR, Qureshi M, Kalynych A, Turco M,
SchultheissHP, Dulas D, Rutherford BD, Antoniucci D, Krucoff MW, Gibbons RJ,
Jones D, LanskyAJ, Mehran R; Enhanced Myocardial Efficacy and Recovery by
Aspiration of LiberatedDebris (EMERALD) Investigators. Distal microcirculatory
protection during percutaneous coronary intervention in acute ST-segment
elevation myocardial infarction:a randomized controlled trial. JAMA
2005;293:1063-1072
32. Silva JA, Ramee SR, Cohen DJ, Carrozza JP, Popma JJ, Lansky AA, Dandreo
K, BaimDS, George BS, McCormick DJ, Setum CM, Kuntz RE. Rheolytic
thrombectomy during percutaneous revascularization for acute myocardial
infarction: experience with theAngioJet catheter. Am Heart J 2001;141:353-359.
33. Simonton CA 3rd, Brodie BR, Wilson H, Haber R, Kowalchuk G, Rinaldi M,
CedarholmJ, Humphrey A, Laurent S. AngioJet experience from the multi-center
STENT Registry. JInvasive Cardiol 2006;18(suppl C):C22-C23.
34. Nakatani D, Sato H, Sakata Y, Mizuno H, Shimizu M, Suna S, Nanto S,
Hirayama A, ItoH, Fujii K, Hori M. Effect of intracoronary thrombectomy on 30-
day mortality in patientswith acute myocardial infarction. Am J Cardiol
2007;100:1212-1217.
35. De Luca G, Dudek D, Sardella G, Marino P, Chevalier B, Zijlstra F.
Adjunctive manualthrombectomy improves myocardial perfusion and mortality in
patients undergoing primary percutaneous coronary intervention for ST-elevation
myocardial infarction: ameta-analysis of randomized trials. Eur Heart J
2008;29:3002-3010.
36. Bavry AA, Kumbhani DJ, Bhatt DL. Role of adjunctive thrombectomy and
embolic protection devices in acute myocardial infarction: a comprehensive meta-
analysis of randomized trials. Eur Heart J 2008;29:2989-3001.
37. Sardella G, Mancone M, Nguyen BL, De Luca L, Di Roma A, Colantonio R,
Petrolini A,Conti G, Fedele F. The effect of thrombectomy on myocardial blush in
primaryangioplasty: the Randomized Evaluation of Thrombus Aspiration by two
thrombectomydevices in acute Myocardial Infarction (RETAMI) trial. Catheter
Cardiovasc Interv2008;71:84-91
38. Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg
RT,Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of
drug-eluting stents in ST-segment elevation myocardial infarction: the importance
of thrombus burden. J Am Coll Cardiol 2007;50:573-583.