Which Intraprocedural Thrombotic Events Impact Clinical Outcomes After Percutaneous Coronary Intervention in Acute Coronary Syndromes?

JACC: CARDIOVASCULAR INTERVENTIONS

VOL.

ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER

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ISSN 1936-8798/$36.00 http://dx.doi.org/10.1016/j.jcin.2015.10.049

Which Intraprocedural Thrombotic Events Impact Clinical Outcomes After Percutaneous Coronary Intervention in Acute Coronary Syndromes? A Pooled Analysis of the HORIZONS-AMI and ACUITY Trials Jeffrey D. Wessler, MD, MPHIL,a Philippe Généreux, MD,a,b,c Roxana Mehran, MD,b,d Girma Minalu Ayele, PHD,b Sorin J. Brener, MD,b,e Margaret McEntegart, MD, PHD,f Ori Ben-Yehuda, MD,a,b Gregg W. Stone, MD,a,b Ajay J. Kirtane, MD, SMa,b

ABSTRACT OBJECTIVES This study sought to determine the extent to which individual components of intraprocedural thrombotic events (IPTEs) are associated with adverse events. BACKGROUND IPTEs occurring during percutaneous coronary intervention (PCI) are associated with adverse inhospital and late outcomes in patients with acute coronary syndromes. METHODS A total of 6,591 patients who underwent PCI for non–ST-segment elevation acute coronary syndromes/ ST-segment elevation myocardial infarction in the ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) and HORIZONS-AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction) trials underwent detailed frame-by-frame core laboratory angiographic analysis to assess for IPTEs. The associations of IPTE components with death, major bleeding, and major adverse cardiac events at 30 days were assessed using univariable analyses and multivariable models. RESULTS The overall incidence of IPTEs was 7.7%, with a greater incidence in ST-segment elevation myocardial infarction patients (12.2%) compared with non–ST-segment elevation acute coronary syndromes patients (3.5%). Specific components of IPTEs included no-reflow/slow reflow in 58.0%, new/worsened thrombus in 35.3%, distal embolization in 34.9%, abrupt closure in 19.8%, and intraprocedural stent thrombosis (IPST) in 9.5% of patients. Each IPTE component was independently associated with 30-day death, major bleeding, and MACE in multivariable models, with the strongest association observed for IPST (MACE hazard ratio: 7.51 [95% confidence interval: 4.36 to 12.94]). CONCLUSIONS The occurrence of IPTEs is not infrequent among high-risk acute coronary syndromes patients undergoing PCI, and each IPTE component was associated with subsequent adverse events. Although IPST represented <10% of IPTE events overall, it was the component with the strongest association with adverse events. (J Am Coll Cardiol Intv 2016;-:-–-) © 2016 by the American College of Cardiology Foundation.

From aNewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; bCardiovascular Research Foundation, New York, New York; cHôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada; dIcahn School of Medicine at Mount Sinai, New York, New York; eNew York Methodist Hospital, Brooklyn, New York; and the fGolden Jubilee National Hospital, Glasgow, Scotland. Dr. Mehran has received institutional research grant support from The Medicines Company, Bristol-Myers Squibb/Sanofi Pharmaceuticals, Eli Lilly and Company, Daiichi-Sankyo, Regado Biosciences, and STENTYS; is a consultant for Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, CSL Behring, Janssen Pharmaceuticals, Maya Medical, and Merck & Co.; is on the Advisory Board of Covidien, Janssen Pharmaceuticals, Merck, Sanofi, Endothelix Inc.; and has equity in and is a shareholder in Endothelix Inc. Dr. Kirtane has received institutional research grants to Columbia University from Boston Scientific, Medtronic, Abbott Vascular, Abiomed, St. Jude Medical, Vascular Dynamics, and Eli Lilly. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received September 14, 2015; accepted October 24, 2015.

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Clinical Impact of IPTE Post-PCI in ACS

T

ABBREVIATIONS AND ACRONYMS CI = confidence interval GPI = glycoprotein IIb/IIIa

he occurrence of intraprocedural

to either heparin plus glycoprotein IIb/IIIa inhibitor

thrombotic events (IPTEs) has been

(GPI), bivalirudin plus GPI, or bivalirudin alone. All

demonstrated to be a powerful and

patients underwent angiography within 72 h followed

independent predictor of both early and late

by PCI, surgical revascularization, or medical therapy

adverse clinical outcomes in patients under-

at

going percutaneous coronary intervention

HORIZONS-AMI trial, 3,602 patients undergoing pri-

(PCI) (1–6). In analyses conducted with pa-

mary PCI for STEMI were randomized to bivalirudin

tients experiencing both non–ST-segment

plus GPI versus heparin plus GPI; patients were sub-

elevation

syndromes

sequently randomized to a paclitaxel-eluting stent

thrombotic event

(NSTEACS) and ST-segment elevation acute

compared with an identical bare metal stent. The

MACE = major adverse

coronary syndromes, IPTE was indepen-

present analysis included the 6,591 patients who un-

cardiovascular event(s)

dently associated with ischemia and bleeding

derwent stent implantation in these 2 trials.

NSTEACS = non–ST-segment

(5,7). Compared with patients experiencing

Detailed frame-by-frame angiographic analyses

elevation acute coronary

ST-segment elevation myocardial infarction

were performed in PCI patients at an independent

(STEMI), those with NSTEACS had a reduced

angiographic core laboratory (Cardiovascular Re-

incidence of IPTEs compared with those

search Foundation, New York, New York) by tech-

with NSTEACS, but in both groups of pa-

nicians blinded to treatment randomization and

tients, IPTEs were associated with major

clinical outcomes. Standard definitions were used for

adverse cardiac events ([MACE], all-cause

lesion morphology, thrombus, and Thrombolysis In

death, myocardial infarction, target vessel

Myocardial Infarction (TIMI) flow grades (19–22).

revascularization, or stroke), major bleeding,

Each angiographic film underwent quantitative and

inhibitor

HR = hazard ratio IPST = intraprocedural stent thrombosis

IPTE = intraprocedural

syndrome

PCI = percutaneous coronary intervention

STEMI = ST-segment elevation myocardial infarction

TIMI = Thrombolysis In Myocardial Infarction

acute

coronary

and mortality (5,7).

the

treating

physician’s

discretion.

In

the

qualitative assessment of pre- and post-procedural

Although IPTEs overall are clinically challenging

images

as

well

as

independent

assessment

of

and are prognostically important, the extent to which

each cine angiographic frame for intraprocedural

individual components of IPTEs are associated with

complications.

adverse events is unknown. Several smaller studies

IPTE was defined as the development of a

have demonstrated worse clinical outcomes with

new or increasing thrombus, abrupt vessel closure,

various

intra-

no-reflow/slow flow, distal embolization, or IPST

procedural stent thrombosis (IPST), distal emboliza-

(defined as new or increased thrombus within the

tion, and no-reflow/slow flow (2,4,8–14); however, no

deployed stent during PCI) occurring any time during

study has assessed the relative importance of various

the procedure and not present at baseline. Each event

IPTE components on the subsequent development of

was assessed relative to the angiographic appearance

clinical outcomes. This is, in part, due to the large

of the previous frame, such that interval growth of a

sample size necessary to conduct such analyses and

baseline thrombus or interval resolution followed by

because systematic objective assessments of IPTEs

recurrence were both considered an IPTE. The clinical

require frame-by-frame assessments of a large cohort

outcomes in each trial, including MACE, major

of patients undergoing PCI. In this study, we sought

bleeding, and mortality, were evaluated at 30 days

to further characterize the extent to which individual

and adjudicated by an independent clinical events

components of IPTEs, including new or worsened

committee blinded to treatment randomization.

complications

of

PCI

including

thrombus, abrupt closure, no-reflow/slow flow, distal

Continuous variables were compared using the

embolization, and IPST, were associated with adverse

Kruskal-Wallis test and are expressed as medians

events using pooled core laboratory–adjudicated data

with interquartile ranges. Categorical variables were

from the ACUITY (Acute Catheterization and Urgent

compared using the chi-square or Fisher exact test, as

Intervention Triage StrategY) and HORIZONS-AMI

appropriate, and are expressed as proportions. A

(Harmonizing Outcomes with RevascularIZatiON and

separate multivariate Cox regression model of 30-day

Stents in Acute Myocardial Infarction) trials.

outcomes was constructed for each IPTE component. Candidate

METHODS

covariates

included

those

previously

identified as independent predictors of outcomes within these datasets (age, sex, history of diabetes,

The ACUITY and HORIZONS-AMI study designs, pro-

history of hypertension, hyperlipidemia, current

tocols, and results have been previously described in

smoking, previous myocardial infarction, baseline

detail (15–18). Briefly, ACUITY was a large, multi-

hematocrit, baseline white blood cell count) as well as

center, prospective trial of 13,819 patients with

other baseline demographic characteristics and pre-

moderate- to high-risk NSTEACS randomly assigned

and post-PCI characteristics selected using stepwise

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Clinical Impact of IPTE Post-PCI in ACS

selection with p < 0.05 for entry into the models. The analyses were similar when trial was included in the

T A B L E 1 Patient, Pre-PCI, and Procedural Characteristics by IPTEs

IPTEs (n ¼ 507)

model as a random effect. Final models were refitted after elimination of nonsignificant covariates to avoid overfitting due to missing covariates.

No IPTEs (n ¼ 6,084)

p Value

Demographic characteristics Age, yrs

61 (53–71)

61 (52–70)

0.46

Male

76.5 (388/507)

73.3 (4,459/6,084)

0.12

RESULTS

Diabetes mellitus

16.4 (83/507)

24.8 (1,506/6,068)

<0.0001

5.5 (28/507)

6.9 (416/6,068)

0.27

Frame-by-frame core laboratory angiographic anal-

Current cigarette smoker

41.4 (209/505)

38.9 (2,362/6,073)

0.28

ysis was completed for 6,591 patients in the combined

Hypertension (on medication)

54.0 (274/507)

61.7 (3,743/6,069)

0.0009

cohort, including 3,428 patients with NSTEACS from

Previous myocardial infarction

15.2 (77/506)

23.2 (1,393/5,993)

<0.0001

Previous PCI

14.3 (72/505)

30.5 (1,849/6,067)

<0.0001

Insulin-dependent

the ACUITY trial and 3,163 patients with STEMI from the HORIZONS-AMI trial. The overall incidence of

Previous CABG

8.5 (43/507)

12.9 (781/6,075)

0.003

Medications

IPTEs was 7.7%, with a greater incidence among

Previous aspirin use

98.8 (500/506)

98.7 (5,995/6,076)

1.00

STEMI patients (12.2%) compared with NSTEACS

Previous thienopyridine use†

8.48 (43/507)

17.95 (1,092/6,083)

<0.0001

patients (3.5%). Patients experiencing IPTEs had a

Previous heparin use

41.6 (211/507)

40.7 (2,478/6,084)

lower prevalence of diabetes, hypertension, previous

Previous low molecular weight heparin use

24.0 (29/121)

Randomized to bivalirudin ( GPI)

58.4 (296/507)

59.3 (3,606/6,084)

0.71

Randomized to bivalirudin alone

51.3 (260/507)

40.6 (2,469/6,084)

<0.0001

myocardial infarction, previous PCI, and previous coronary artery bypass grafting but were more likely

21.3 (704/3,305)

0.71 0.50

to have had elevated baseline cardiac biomarkers

Randomized to heparin

41.6 (211/507)

40.7 (2,478/6,084)

0.71

(Table 1). Previous use of thienopyridines was more

Randomized to GPI

48.7 (247/507)

59.4 (3,615/6,084)

<0.0001

frequent among patients without IPTEs, and patients

Laboratory

with IPTEs more likely to have been randomized to

Baseline CrCl, ml/min

88.1 (65.1–116.2)

90.6 (68.9–116.0)

bivalirudin rather than to heparin and GPI.

Biomarker positive

83.0 (93/112)

56.3 (1,726/3,064)

Compared with patients without IPTEs, patients with IPTEs had significantly higher 30-day rates of

0.26 <0.0001

Procedural characteristics Lesions*

4 (3–6)

4.00 (2–6)

0.12 <0.0001

TIMI grade 0/1 (pre-PCI)

68.2 (345/506)

35.5 (2,152/6,064)

MACE (12.7% vs. 6.5%, hazard ratio [HR]: 2.09, 95%

TIMI grade 2 (pre-PCI)

14.6 (74/506)

12.4 (751/6,064)

confidence interval [CI]: 1.60 to 2.72; p < 0.0001) and

TIMI grade 3 (pre-PCI)

17.2 (87/506)

52.1 (3,161/6,064)

<0.0001

death (4.0% vs. 1.2%, HR: 3.35, 95% CI: 2.04 to 5.50;

Vessel treated 42.8 (216/505)

42.3 (2,575/6,081)

0.85 <0.0001

p < 0.0001) (Table 2). Patients experiencing IPTEs additionally had significantly increased 30-day rates of definite or probable stent thrombosis (4.2% vs. 1.7%, HR: 2.49, 95% CI: 1.56 to 3.98; p < 0.0001) and

noncoronary

artery

bypass

grafting

major

Left anterior descending coronary artery

0.14

Left circumflex artery

17.2 (87/505)

27.2 (1,655/6,081)

Right coronary artery

44.6 (225/505)

42.3 (2,571/6,081)

Saphenous vein graft

1.6 (8/505)

0.4 (23/6,064)

0.002

Left main coronary artery

0.2 (1/505)

1.2 (73/6,081)

0.04

0.33

bleeding (10.6% vs. 5.3%, HR: 2.06, 95% CI: 1.54 to 2.75; p < 0.0001) compared with patients without IPTEs. Target vessel revascularization was modestly increased in patients with IPTEs compared with those without IPTEs (3.8% vs. 2.2%, HR: 1.84, 95% CI: 1.14 to

Values are median (interquartile range) or % (number of observations/total number of patients). *By core laboratory evaluation. †For ACUITY: thienopyridine taken pre-hospitalization within past 7 days; for HORIZONS-AMI, thienopyridine taken at home before arriving at the enrolling hospital. CABG ¼ coronary artery bypass grafting; CrCl ¼ creatinine clearance; GPI ¼ glycoprotein IIb/IIIa inhibitor; IPTE ¼ intraprocedural thrombotic event; PCI ¼ percutaneous coronary intervention; TIMI ¼ Thrombosis In Myocardial Infarction.

2.98; p ¼ 0.01). COMPONENTS OF IPTEs. The frequencies of the

various components (not mutually exclusive) of

Each IPTE component was strongly associated with

IPTEs are shown in Figure 1. Among patients with

subsequent 30-day MACE, as depicted in Figure 2.

IPTEs, no-reflow/slow reflow was present in 58%,

Moreover, each IPTE component was independently

new/worsened thrombus in 35.3%, distal emboliza-

associated with 30-day MACE, major bleeding, and

tion in 34.9%, abrupt closure in 19.8%, and IPST in

death in multivariable models, as shown in Table 3.

9.5% of patients. Of all IPTEs, 93.4% occurred in a

Although IPST was the least frequently occurring

main branch, whereas 17.4% occurred in a side

component of IPTEs, the strongest association be-

branch. More events occurred after stent placement

tween an IPTE component and adverse outcomes was

(68.0%) compared with before stent placement

observed for IPST (HR: 7.51, 95% CI: 4.36 to 12.94 for

(51.2%). Of note, there was significant overlap among

MACE; HR: 4.47, 95% CI: 2.44 to 8.20 for major

IPTEs in individual patients, with 57% having only 1

bleeding; and HR: 7.47, 95% CI: 3.21 to 17.39 for death)

IPTE, 23% having 2 IPTEs, and 20% having >2 IPTEs.

(Table 3, Figure 2E).

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Complications of PCI including IPTEs result in

T A B L E 2 HRs for 30-Day Events According to Presence of IPTE

30-Day Events

increased procedural complexity that can increase

IPTE

No IPTE

HR (95% CI)

p Value

the risk of subsequent adverse outcomes. In previous

Major adverse cardiac events*

12.7 (64)

6.5 (387)

2.09 (1.60–2.72)

<0.0001

analyses of patients undergoing PCI for NSTEACS and

Death

4.0 (20)

1.2 (73)

3.35 (2.04–5.50)

<0.0001

Reinfarction

8.6 (43)

4.6 (277)

1.93 (1.40–2.67)

<0.0001

10.6 (53)

5.3 (318)

2.06 (1.54–2.75)

<0.0001

Target vessel revascularization

3.8 (19)

2.2 (129)

1.84 (1.14–2.98)

0.01

Definite/probable stent thrombosis

4.2 (21)

1.7 (104)

2.49 (1.56–3.98)

<0.0001

Non-CABG major bleeding†

STEMI, IPTEs were strongly associated with the occurrence of 30-day MACE, major bleeding, and death (5–7,13). Previous studies assessed several components of IPTEs including no-reflow, distal embolism, and IPST—demonstrating worse clinical out-

Values are % (n) unless otherwise indicated. *All-cause death, myocardial infarction, target vessel revascularization, or stroke. †Excluding hematoma ¼ 5 cm. CI ¼ confidence interval; HR ¼ hazard ratio; other abbreviations as in Table 1.

comes with these individual events (2,4–6,8,9,11–13); however, no previous study has assessed the associations of multiple IPTE components at once in a large cohort. The ability to characterize the effects of IPTE

DISCUSSION

components has the potential to add significant value

This analysis, using pooled data from the ACUITY

the relationship between IPTEs and adverse out-

and HORIZONS-AMI trials, is the first assessment

comes. Component analyses offer insight into the

to the understanding of the mechanism underlying

of the effect of individual components of IPTEs

most significant mediators of clinically significant

on clinical outcomes, using frame-by-frame core

outcomes. In this study, IPST yielded the highest risk

laboratory angiographic analyses of 6,591 patients

of 30-day clinical outcomes, with HRs approximately

undergoing PCI for NSTEACS and STEMI. The

3-fold higher than those of the other individual

principal findings of this analysis are the following:

components. As IPST is increasingly recognized as an

1) IPTEs occurred in 1 of every 13 patients under-

important complication of PCI, this finding may have

going PCI for high-risk acute coronary syndromes;

important implications for future studies of various

2) although multiple IPTEs frequently occurred in

interventions

an individual patient, each individual component of

PHOENIX (Cangrelor versus Standard Therapy to

an IPTE was independently and strongly associated

Achieve Optimal Management of Platelet Inhibition)

during

PCI.

In

the

CHAMPION-

with adverse outcomes; and 3) the IPTE component

trial, for example, the rate of IPST was significantly

with the strongest association with adverse events

lower in the cangrelor group than in the control group

was IPST.

(0.6% vs. 1.0%, odds ratio: 0.65, 95% CI: 0.42 to 0.99; p ¼ 0.04), which may explain in part the improved outcomes seen in this group (6). Each of the other components of IPTE, including

F I G U R E 1 Frequency of Individual Intraprocedural Thrombotic Event Components

new/worsened thrombus, abrupt closure, no-reflow/ slow flow, and distal embolization were also highly predictive of MACE, major bleeding, and death at 30 days. Thus, therapeutic strategies targeted at preventing and minimizing these events have the potential for a significant clinical impact. Therapeutic

interventions

addressing

the

no-

reflow component have been studied extensively. Isaaz et al. (23) performed immediate angioplasty with very small balloons followed by maximal antithrombotic therapy in 93 patients with STEMI and an initial TIMI grade 0 flow, resulting in immediate and sustained recanalization in the majority of patients. Several studies have additionally examined the effects of pharmacological therapy on the resolution and outcomes of no-reflow. Treatment with systemic nicardipine, nitroprusside, and verapamil was equally effective in restoring normal flow IPST ¼ intraprocedural stent thrombosis; IPTE ¼ intraprocedural thrombotic events.

(TIMI flow grade increased from 1.62 to 2.78, p < 0.0001) in 347 patients (24), and intracoronary

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F I G U R E 2 Time-to-Event Curves for MACE According to Individual IPTE Components

(A) New or worsened thrombus. (B) Abrupt closure. (C) Slow reflow or no-reflow. (D) Distal embolization. (E) IPST. CI ¼ confidence interval; HR ¼ hazard ratio; MACE ¼ major adverse cardiac event(s); other abbreviations as in Figure 1.

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T A B L E 3 Adjusted HRs for IPTE and Its Components With 30-Day Outcomes*†

MACE‡ IPTE Component

Major Bleeding

HR (95% CI)

IPTE any New/worsened thrombus

Death

p Value

HR (95% CI)

p Value

HR (95% CI)

2.65 (1.98–3.53)

<0.0001

1.86 (1.38–2.51)

<0.0001

2.47 (1.48–4.13)

p Value

0.001

2.76 (1.78–4.26)

<0.0001

2.17 (1.41–3.35)

0.0004

3.47 (1.81–6.65)

<0.0001

Abrupt closure

3.42 (2.27–5.16)

<0.0001

2.90 (1.93–4.37)

<0.0001

3.36 (1.67–6.77)

0.001

No-reflow/slow flow

2.95 (2.08–4.18)

<0.0001

1.95 (1.33–2.87)

0.0007

3.07 (1.68–5.62)

<0.0001

Distal embolization

2.60 (1.69–4.00)

0.0049

2.59 (1.28–5.23)

0.008

7.47 (3.21–17.39)

<0.0001

IPST

7.51 (4.36–12.94)

<0.0001

1.90 (1.21–2.97)

<0.0001

4.47 (2.44–8.20)

<0.0001

*Adjusted for age, sex, history of diabetes, history of hypertension, hyperlipidemia, current smoking, previous myocardial infarction, baseline hematocrit, baseline white blood cell count, Thrombolysis In Myocardial Infarction flow grade 0/1, and participant in HORIZONS-AMI trial. †Each row represents a separate multivariate Cox regression model. ‡All-cause death, myocardial infarction, target vessel revascularization, or stroke. IPST ¼ intraprocedural stent thrombosis; MACE ¼ major adverse cardiac event(s); other abbreviations as in Tables 1 and 2.

administration of verapamil significantly improved

clinical outcomes cannot be excluded, particularly

flow (TIMI 3) in 201 patients undergoing primary PCI

because our study did not assess the determinants of

for STEMI (25). Despite these studies demonstrating

individual IPTE components. Additionally, because

effective restoration of flow by both pharmacological

this study used pooled data from 2 different cohorts

and mechanical interventions, no studies have

of patients with NSTEACS and STEMI, the specific

shown a beneficial effect in terms of clinical out-

effects of the IPTE component on each population

comes (26).

were not assessed. Although core laboratory angio-

In patients experiencing new/worsened thrombus

graphic analyses were performed prospectively by

or IPST, both pharmacological and mechanical stra-

technicians blinded to treatment randomization and

tegies have also been studied. Antiplatelet and

clinical outcomes, further validation of the findings is

antithrombotic therapies are frequently used for

warranted. Finally, we found that patients with a

bailout treatment of residual thrombus during PCI;

significant risk factor burden (diabetes, hypertension,

however, this likely contributes to the increased risk

coronary disease) experienced fewer IPTEs, a finding

of major bleeding observed in patients with new/

that might be explained by better baseline medical

worsened thrombus or IPST. In a recent analysis of

therapy or heightened practitioner awareness in

the ACUITY trial, bailout GPI therapy was used 4

these patients with greater baseline risk.

times more frequently in patients experiencing IPTEs compared with those without IPTEs (7).

CONCLUSIONS

Although bailout thrombectomy is often pursued during primary PCI with residual thrombus burden,

The results of the present study demonstrate the

in

with

significant positive association of IPTEs and their

STEMI, randomization to thrombectomy with PCI

individual components (all IPTEs, new/worsened

flow

thrombus, abrupt closure, no-reflow/slow flow, distal

compared with patients undergoing PCI alone (27).

embolization, and IPST) on adverse outcomes. IPST

Similar to the no-reflow component, the optimal

demonstrated the strongest association with adverse

treatment strategy for new/worsened thrombus or

events. The objective assessment of individual

IPST remains elusive.

components of IPTEs may contribute to future ther-

a

failed

multicenter to

study

demonstrate

of

141

patients

improvements

in

STUDY LIMITATIONS. First, patients with IPTEs had

differing baseline characteristics compared with

apeutic strategies aimed at minimizing adverse clinical outcomes.

those without IPTEs, with more frequent randomization to bivalirudin alone. These variances in base-

REPRINT REQUESTS AND CORRESPONDENCE: Dr.

line

Ajay J. Kirtane, Center for Interventional Vascular

characteristics

and

treatments

may

have

contributed to or influenced the various effects of

Therapy,

IPTE components on clinical outcomes, even though

New York-Presbyterian Hospital, 161 Fort Washington

Columbia

University

Medical

Center/

an attempt to adjust for them was made. Similarly,

Avenue, 6th Floor, New York, New York 10032. E-mail:

the role of unmeasured confounders as predictors of

[email protected].

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PERSPECTIVES WHAT IS KNOWN? IPTEs that occur during PCI are

WHAT IS NEXT? Further studies will focus on validation

associated with adverse outcomes in patients with ACS.

of these findings followed by therapeutic strategies aimed at minimizing the occurrence of these events and

WHAT IS NEW? This study demonstrates that IPTEs are

subsequent adverse outcomes.

not infrequent (occurring in 1 of every 13 patients undergoing PCI for high-risk ACS) and that IPST is the IPTE component with the strongest association with adverse clinical outcomes.

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KEY WORDS acute coronary syndrome(s), intraprocedural thrombotic event(s), percutaneous coronary intervention

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