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 12lead 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 KaplanMeier 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 postprocedure, 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 metaanalysis 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 netclinical 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

operatorsdiscretion, 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

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