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medical management only and found a numerical but not statistically

signiﬁcant difference in mean 6MWT distances at 1 year (362 m for

catheter-directed therapies and 231 m for medical management).

Results from 1-year follow-up of the OPTALYSE study showed a baseline

6MWT distance of 327 to 352 m across the 4 study groups, with

increased 6MWT distance of approximately 26.7 meters from 30 to 90

days, and again from 90 days to 1 year.

A more recent study of 190

patients demonstrated that endovascular therapy (CDT or mechanical

thrombectomy) led to signiﬁcantly higher 6MWT distances at 3-6

months in intermediate–high and high-risk patients with PE than

those receiving medical therapy only (342 m vs 272 m, respectively).

The median 6MWT distance of 398.1 m at 6 months in this report

represents an increase of 218 m from 48 hours to 6 months, exceeding

the published results discussed above. The PEmb-QoL results in this

report also compare favorably to literature values, which are sparse for

catheter-directed therapy studies. Patients’ PEmb-QoL scores

improved following CDT in the OPTALYSE study by a mean of 3.1

points between each follow-up timepoint out to 1 year, although spe-

ciﬁc values were not provided.

For those patients who survive PE, many will face the long-term

sequelae of RPVO, which is one of the strongest predictors of a poor

long-term prognosis.

The incidence of RPVO following thrombolytic

or AC treatment is up to 60% of patients with PE

25–27

and is associated

with a higher risk of venous thromboembolism recurrence,

26,28,29

persistent RV dysfunction,

development of CTEPH,

26,29,30

and mor-

tality.

Interventional treatments, including thrombectomy, that can

Figure 5.

Six-minute walk test distance and Borg

dyspnea and fatigue scores pre- and

postwalk at 48 hours, 30 days, and 6

months postthrombectomy. (A) Increase in

median 6MWT distance over time. Box and

whisker with half-violin plot demonstrates

median 6MWT distance in meters (middle

bar) and IQR [Q1, Q3] as outer bounds of

boxes, with mean indicated as a light blue

dot and outliers indicated as black dots.

Trend over time analysis was performed

using a generalized linear mixed effects

model (P < .001). (B) Borg dyspnea score and

at follow-up visits. Median scores pre- and

post-6MWT at each follow-up visit are

shown. Box and whisker plot presents me-

dian Borg scores (middle bar) and IQR (Q1-

Q3) as outer bounds of boxes, with mean

indicated as a light blue dot and outliers

indicated as black dots. Trend over time

analysis was performed using a generalized

linear mixed effects model. Trend over time

for dyspnea pre-6MWT: P ¼ .004; post-

6MWT: P < .001. Trend over time for fa-

tigue pre-6MWT: P ¼ .064; post-6MWT: P <

.001. The sample sizes below each timepoint

represent all available data. 6MWT, 6-minute

walk test.

Figure 6.

Total PEmb-QoL score at 30 days and 6 months postthrombectomy. Box and whisker

with half-violin plot demonstrates median PEmb-QoL scores (middle bar) and IQR (Q1-

Q3) as outer bounds of boxes, with mean indicated as a light blue dot and outliers

indicated as black dots. Trend over time analysis was performed using a generalized

linear mixed effects model (P < .001). The sample sizes below each timepoint represent

all available data. PEmb-QoL, Pulmonary Embolism Quality of Life.

6 S. Khandhar et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101000

rapidly extract thrombus may reduce the likelihood of RPVO and its

consequences, including CTED and CTEPH. The FLASH study had a

reported CTED prevalence of 1.9% and CTEPH prevalence of 1.0% at 6

months, lower than previously published CTEPH prevalence ranges of

2% to 4%,

possibly owing to the removal of acute thrombi and pre-

vention of RPVO. It is important to note that since much of the FLASH

study occurred during the COVID-19 pandemic, some of the symptoms

related to longer-term consequences of PE may overlap with those of

COVID-19, potentially leading to overstated impact of PE on functional

outcomes.

The FLASH registry has certain limitations. As with most registries,

a detailed treatment protocol was not speciﬁed. As a result, proce -

dural details and laboratory testing were perfor med per local clinical

practice and not standardized, so procedural and outcome variability

may be higher compared with an investigational trial with formally

prescribed procedural requirements. The site-reported nature of

CTED, CTEPH, and echocardiographic assessmen ts and th e lack of

residual thrombus burden measurement postthrombectomy are also

limitati ons. In addition, because o f changes in protocol requirements

for some outcome measurements over the course of the study, as well

as an inability of many patients to have in-person follow-up visits

during the COVID-19 pandemic, certain evaluations that could not be

performed in a telehealth appointment, such as echocardiography

and 6MWT, were not collected at all follow-up visits, resulting in a

lower cohort population for these measurements. Finally, because

FLASH is a single-arm registry, deﬁnitive comparisons to outcomes of

other treatment options including other interventions or conservative

medical management cannot be made. Randomized controlled trials

(RCTs) are needed to directly compare such outcomes. The currently

enrolling PEERLESS RCT will compare acute and intermediate-term

(30-day) clinical outcomes in patients with PE treated with the Flow-

Triever System vs CDT. The HI-PEITHO RCT is also currently enrolling

to evaluate the beneﬁt of in tervention with the EKOS CDT system

(Boston Scientiﬁc) vs sta ndard medical management in preventing

acute adverse clinical outcomes. The STORM-PE RCT will evaluate

improvements in the surrogate measure of RV/LV ratio in patients with

PE treated with aspirati on thrombect omy using the In digo Aspiration

System (Penumbra, Inc) vs standard medical management. Finally, the

PE-TRACT RCT will evaluate improvements in longer-term clinical

outcomes in patients with PE treated with intervention vs standard

medical management.

Conclusions

Among a large and geographically diverse cohort of patients with

acute intermediate-and high-riskPE treatedwith the FlowTriever System,

all-cause mortality and prevalence of CTED and CTEPH were low at 6-

month follow-up. Furthermore, patient-reported health status was

markedly improved by multiple measures suggesting durable clinical

Central Illustration.

Summary of patient enrollment, follow-up metrics, and 6-month clinical and functional outcomes for the fully enrolled US cohort of the FLASH registry in pulmonary em-

bolism.

The FLASH registry enrolled 800 patients with acute pulmonary embolism across 50 US sites who were undergoing treatment with mechanical thrombectomy using the FlowTriever

System and followed them through 6 months postthrombectomy. Follow-up completion and mean duration of follow-up are reported, along with 6-month all-cause mortality. Clinical

and functional outcomes assessed from baseline through 6 months include echocardiographic measurements of RV size and function, dyspnea using the modiﬁed Medical Research

Council score, exercise capacity using the 6-minute walk test, quality of life using the PEmb-QoL score, and prevalence of chronic disease outcomes including CTEPH or CTED. CTED,

chronic thromboembolic disease; CTEPH, chronic thromboembolic pulmonary hypertension; FLASH, FlowTriever All-comer Registry for Patient Safety and Hemodynamics; PEmb-QoL,

Pulmonary Embolism Quality of Life; RV, right ventricular.

S. Khandhar et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101000 7

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beneﬁts that compare favorably against other studies using similar

measures. These data suggest that rapid extraction of thrombus may

prevent or reduce long-term sequelae in patients with PE, informing the

hypothesis for future studies directly comparing the clinical outcomes of

promptmechanicalthrombectomy relative to conservativetherapy for PE

management.

Acknowledgments

The authors acknowledge all FLASH principal investigators who

enrolled patients treated with mechanical thrombectomy in the US

cohort (Supplemental Table S3). The authors acknowledge medical

writing and editorial support from Linda Hansen, PhD, and Jessica

Parsons, PhD, and biostatistical support from Milan Bimali, PhD. The

FLASH registry was funded by Inari Medical.

Declaration of competing interest

Sameer Khandhar is a consultant for Inari Medical. Wi ssam Jaber is

a consultant for Inari Medical and Medtronic. Matthew Bunte is a

speaker and consultant for Inari Medical, Shockwave Medical, and

Abbott, and he reports research support from Inari Medical and

Janssen. Kenneth Cho is a speaker and consultant for Inari Medical.

Mitchell Weinberg is a consultant for Boston Scientiﬁc, Magneto

Thrombectomy Solutions, and Medtronic. Fakhir Elmasri is a speaker

for Inari Medical. David Zlotnick is a speaker for Abiomed and Inari

Medical, and a consultant and speaker for AngioDynamics. Daniel

Brancheau reports owning stock in Inari Medical. Mohann ad Bisharat

is a consultant for Inari Medical, Philips, CSI, Medtronic, and Cook

Medical. Jun Li is on the advisory board for Boston Scientiﬁc, Inari

Medical, and Medtronic, and she is a consultant for Abbott Vascular,

Endovascular Engineering, Inquis Medical, and Philips. Catalin Toma

is a consultant for Medtronic and Philips. Bushra Mina, Brian Stegman,

Jeffrey Pollak, Akhil Khosla, and Gerald Koenig have no relevant

disclosures.

Funding sources

Inari Medical sponsored the FLASH registry and was involved in

the design of the study, statistical analysis of the data, and editing

of the manuscript under the direction of the Principal Investigators.

Ethics statement and patient consent

This research was conducted in adherence to the relevant ethical

guidelines, and all patients provided informed consent.

Supplementary material

To access the supplementary material accompanying this article,

visit the online version of the Journal of the Society for Cardiovascular

Angiography & Interventions at 10.1016/j.jscai.2023.101000.

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Meta-analysis

Long-term Incidence of Myocardial Infarction and Death After CABG and

PCI for Isolated Left Anterior Descending Artery Disease: A Meta-analysis

of Randomized Controlled Trials

Megha Prasad, MD, MS

, Yousif Ahmad, MRCP, PhD

, James P. Howard, MB, BChir, PhD

Johanna Ben-Ami, MD

, Mahesh V. Madhavan, MD, MS

, Ajay J. Kirtane, MD, SM

Margaret McEntegart, MD

, Erin Flattery, MD

, Gregg W. Stone, MD

, Martin B. Leon, MD

Jeffrey W. Moses, MD

NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York;

Yale School of Medicine, Yale University, New Haven, Connecticut;

National Heart and Lung Institute, Imperial College London, London, United Kingdom;

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn

School of Medicine at Mount Sinai, New York, New York;

St. Francis Heart Center, Roslyn, New York

ABSTRACT

Background: To compare the long-term incidence of myocardial infarction (MI) and death in patients randomized to coronary artery bypass grafting (CABG)

vs percutaneous coronary intervention (PCI) for treatment of isolated left anterior descending (LAD) coronary artery disease.

Methods: We systematically identiﬁed all randomized controlled trials comparing PCI with stenting to CABG with a left internal mammary artery (LIMA) graft

in patients with isolated LAD disease who had at least 4 years of follow-up. The primary outcome of interest was MI. Secondary outcomes were all-cause

mortality and target vessel revascularization (TVR).

Results: Four trials were included in the current analysis, with a total of 573 patients randomized to CABG with a LIMA (n ¼ 285) vs PCI (n ¼ 288) and followed

for 4 to 10 years. At latest follow-up (weighted mean 8.3 years), there was no statistically signiﬁcant difference in the risk of MI between CABG and PCI

(relative risk [RR], 1.33; 95% CI, 0.62-2.83; P ¼ .46), nor was there a statistically signiﬁcant difference in mortality between the groups (RR, 1.04; 95% CI, 0.70-

1.65; P ¼ .84). There was a signiﬁcantly lower risk of TVR after CABG compared with PCI (RR, 0.27; 95% CI, 0.15-0.46; P < .001).

Conclusions: The current meta-analysis suggests that there is insufﬁcient evidence that CABG with a LIMA confers protection against MI or death compared

to PCI with a stent for isolated LAD disease. CABG was, however, associated with reduced rates of TVR.

Introduction

The optimal revascularization strategy for patients with isolated

disease of the left anterior descending (LAD) coronary artery is uncer-

tain in part due to the limited number of randomized controlled trials

(RCTs) comparing clinical outcomes with percutaneous coronary inter-

vention (PCI) and coronary artery bypass graft surgery (CABG) in pa-

tients with isolated LAD disease.

1,2

CABG has been suggested to be

associated with improved long-term survival compared with PCI in

patients with complex multivessel disease by preventing late myocar-

dial infarction (MI) arising not only from severe target lesions but also

from proximal nonobstructive vulnerable plaques.

1,3,4

In this regard, it

has been stated that the left internal mammary artery (LIMA) grafted to

the mid or distal LAD confers the greatest survival beneﬁts and pro-

tection against MI. Conversely, PCI has been described as having no

impact on proximal nonstented lesions and is thought to prevent late

MI only by focal treatment of ﬂow-limiting lesions.

Despite these considerations, PCI is commonly used to treat isolated

LAD disease due to its minimally invasive nature with low rates of early

morbidity and mortality. However, there is little data evaluating the long-

term differences in the occurrence of MI and death in patients with iso-

lated LAD disease treated with CABG vs PCI.

We therefore

DOI of original article: https://doi.org/10.1016/j.jscai.2023.100611.

Abbreviations: CABG, coronary artery bypass graft; LAD, left anterior descending artery; LIMA, left internal mammary artery; MI, myocardial infarction; MIDCAB, minimally invasive

direct coronary artery bypass; PCI, percutaneous coronary intervention.

Keywords: coronary artery bypass grafting; death; left anterior descending artery; myocardial infarction; percutaneous coronary intervention.

* Corresponding author: jm2456@cumc.columbia.edu (J.W. Moses).

https://doi.org/10.1016/j.jscai.2023.100636

Received 21 November 2022; Received in revised form 12 March 2023; Accepted 14 March 2023

Available online 19 May 2023

the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100636

hypothesized that CABG does not confer a long-term reduction in MI

and death when compared to PCI and performed a systematic

meta-analysis to evaluate the long-term differences in outcomes in pa-

tients undergoing CABG with a LIMA vs PCI with a stent for isolated LAD

disease.

Methods

Data sources and search strategies

An investigator and a senior librarian (M.P. and L.P.) indepen-

dently conducted a comprehensive search of eligible studies from

January 1, 2002 to June 4, 2022. Two additional investigators

(M.V.M. and J.B .) reviewed the eligi ble studies and ensured that they

met the inclusion criteria. The databases included Ovid MEDLINE

Epub Ahead of Print, Ovid MEDLINE I n-Process & Other Non-

Indexed Citation s, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane

Central Register of Controlled Trials, Ovid Cochrane Database of

Systematic Reviews, and Scopus. Addition al studies were retrieved

using reference lists of included articles, abstracts, and expert bi b-

liographies. We limited our search to publication s in the English

language and in humans.

Eligible studies met the following inclusion criteria: (1) RCTs of PCI

with a stent (bare metal stent [BMS] or drug-eluting stent) vs CABG with

a LIMA in patients with isolated LAD disease; (2) incidences of death

and MI were reported with TVR reporting being optional; (3) follow-up

duration of 4 years. Included studies were assessed using the

Cochrane Risk of Bias tool (Supplemental Figure S1).

Funnel plots to

assess publication bias were not included due to there being <10 trials

included in our meta-analysis.

Data extraction

Data extraction was performed by 2 independent investigators (M.P.

and J.B.) and conﬁrmed by a third independent investigator (J.W.M.).

Each study was independently summarized with variables including ﬁrst

author, year of publication, population characteristics,design, follow-up,

use of cardiopulmonary bypass, and clinical outcomes.

Outcomes of interest and deﬁnitions

To determine whether CABG confers a beneﬁt in preventing MI in

patients with isolated LAD disease, the primary outcome of interest was

MI (both Q wave and non-Q wave, procedural and nonprocedural) at

latest follow-up. Secondary outcomes included all-cause death and

target vessel revascularization (TVR) at latest follow-up.

Statistical methodology

Statistical analysis was conducted according to Cochrane collabo-

ration recommendations and quality of reporting of meta-analysis

guidelines.

Outcomes were analyzed on an intention-to-treat basis.

Random-effect meta-analyses were performed using the restricted

maximum likelihood estimator. As a sensitivity analysis, ﬁxed-effect

analyses were also performed using a Mantel–Haenszel model. All

outcomes were assessed as relative risks (RR) at the time of last

follow-up available for each trial. Heterogeneity was assessed using the

statistic, with <25% deﬁned as low heterogeneity, 25% to 50%

deﬁned as moderate heterogeneity, and >50% deﬁned as high het-

erogeneity.

Continuous data are expressed as mean  standard

deviation unless otherwise stated, and statistical signiﬁcance was set at

Figure 1.

CONSORT diagram. LAD, left anterior descending artery.

2 M. Prasad et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100636

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P < .05. All analyses were performed with the metafor package from R

version 4.2.1.

Results

Studies and patients

The search yielded 2239 relevant reports, 4 of which met all inclu-

sion criteria

8–11

(Figure 1). A total of 573 patients were randomized,

including 285 patients to CABG and 288 patients to PCI. All studies

were found to be of moderate-to-high or high quality by the Cochrane

bias tool. Details from each study are shown in Table 1. The study

population had a mean age of 62.0 years, and the majority of patients

were male. A LIMA was used in all patients in the CABG arm whereas a

stent was used in all patients in the PCI arm (mostly BMSs). The longest

follow-up from each study ranged from 4 to 10 years (weighted mean

average 8.3 years). The end points of death, MI, and TVR were available

from all 4 trials.

Risk of MI

As shown in the Central Illustration, MI during follow-up occurred in

39 patients, with 22 MIs after CABG and 17 after PCI. There was no

statistically signiﬁcant difference in the risk of MI between groups (RR,

1.33; 95% CI, 0.62-2.83; P ¼.46). There was low heterogeneity between

studies (I

¼ 19.0%).

Risk of all-cause mortality

As shown in Figure 2, all-cause mortality during follow-up occurred

in 81 patients, with 42 deaths in the CABG group and 39 deaths in the

PCI group. There was no statistically signiﬁcant difference in the risk of

all-cause mortality between groups (RR, 1.04; 95% CI, 0.70-1.55; P ¼

.84). There was no heterogeneity between studies (I

¼ 0%).

Risk of TVR

As shown in Figure 3, TVR during follow-up occurred in 73 patients,

including 14 patients after CABG and 59 patients after PCI. The risk of

TVR was signiﬁcant reduced after CABG compared with PCI (RR, 0.27;

95% CI, 0.15-0.46; P < .001). There was no heterogeneity between

studies (I

¼ 0%).

Fixed-effect analyses

Fixed-effect analyses were consistent with the random-effect ﬁnd-

ings for MI (RR, 1.41; 95% CI, 0.73-2.74), all-cause mortality (RR, 1.04;

95% CI, 0.70-1.55), and TVR (RR, 0.27; 95% CI, 0.15-0.46).

Discussion

The current meta-analysis examined the long-term clinical outcomes

of patients with isolated LAD disease who were randomized to either

CABG with a LIMA or PCI with a BMS or drug-eluting stent. At a longest

weighted mean follow-up of 8.3 years, no differences were found in the

long-term risks of MI or death between the 2 revascularization modal-

ities. PCI was, however, associated with an increased risk of TVR

compared with CABG. Our analysis is limited by wide conﬁdence in-

tervals and inability to ascertain timing of events, and thus, caution is

warranted in drawing strong conclusions from these ﬁndings.

The reported ﬁndings question whether the long-term rates of MI

(and death) are reduced by CABG compared with PCI, at least in

Central Illustration.

Risk of myocardial infarction. CABG, coronary artery bypass graft surgery; MI, myocardial infarction PCI, percutaneous coronary intervention; REML, restricted maximum likelihood.

Table 1. Description of the 4 studies included in the meta-analysis.

Reference, year Geography of

enrollment

Enrollment period Longest

follow-up, y

Total

enrolled

Age, y

(mean)

Male (%) LIMA

use (%)

Stent

use (%)

Stent

type

Blazek et al,

2013 Germany June 1997-June 2001 10 220 62.1 74.5 100 100 BMS

Drenth et al,

2004 The Netherlands March 1997-September 1999 4 102 60.5 76.5 100 100 BMS

Goy et al,

2008 Europe October 1994-March 1998 10 121 59.5 79.3 100 100 BMS

Blazek et al,

2015 Germany January 2003-October 2007 7 129 66.0 70.0 100 100 DES

BMS, bare meta stent; DES, drug-eluting stent; LIMA, left internal mammary artery.

M. Prasad et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100636 3

patients with isolated LAD disease. Several prior meta-analyses have

examined the outcomes of CABG and PCI in LAD disease (Table 2),

reaching varying conclusions. While an early meta-analysis suggested

that cardiac events and death were reduced with surgical manage-

ment of isolated LAD disease, more recent data has not shown a clear

reduction in MI with CABG in these patients.

8,10,14–16

In a

meta-analysis of RCTs, Kapoor et al

also noted no difference in MI

and death, with reduced TVR and improved angina relief in patients

undergoing CABG, but h ad shorter follow-up, included balloon an-

gioplasty studies, and did not include additional data present in thi s

meta-analysis. Several other previous meta -analyses with signiﬁcantly

shorter follow-up and variability in design from the present

meta-analysis have also shown similar rates of MI and death in patients

undergoing CABG or PCI for isolated LAD disease

2,12,13,15

Deo et al

observed no difference in mortality or MI with CABG vs PCI but found

an increased rate of TVR after PCI. Since the publication of these early

analyses, longer-term follow-up of the previous RCTs has b een re-

ported. Moreover, since many of these previous meta-analyses, there

have been additional data included with longer follow-up in our

analysis. Additionally, our study excludes balloon angioplasty studies

and focuses only on patients that received stents. We have thus

importantly noted that despite only including stent studies, there is

only a higher risk of TVR, but not MI. Another principal difference

between the present report and p rior me ta-analyses is the require-

ment for follow-up of at least 4 years in the prese nt study, providing a

long-term perspective on the outcomes of CABG and PCI for isolated

LAD disease.

It has been argued that CABG may reduce the risk of late MI

compared with PCI by bypassing severely diseased coronary segments

as well as nonobstructive vulnerable plaques, theoretically preventing

the clinical sequelae from plaque rupture and vessel occlusion, as most

infarctions arise from proximal or mid vessel atherosclerosis.

3,5,18,19

this regard, the bypass graft mimics the protection provided by native

collateralization.

1,19,20

While the rate of late MIs may be reduced after

CABG in patients with complex multivessel and left main disease

compared with PCI,

such patients have substantially more diffuse

atherosclerosis and greater myocardium at risk than those with

single-vessel LAD disease. Thus, the results of the present study apply

only to patients undergoing isolated LAD revascularization and not

multivessel or left main intervention.

Figure 3.

Risk of target vessel revascularization. CABG, coronary artery bypass graft surgery; CI, conﬁdence interval; MI, myocardial infarction PCI, percutaneous coronary intervention; REML,

restricted maximum likelihood.

Figure 2.

Risk of all-cause mortality. CABG, coronary artery bypass graft surgery; CI, conﬁdence interval; MI, myocardial infarction PCI, percutaneous coronary intervention; REML, restricted

maximum likelihood.

4 M. Prasad et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100636

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Prior meta-analyses have not distinguished between periproce-

dural and spontaneous MI and thus technically are not able to address

the underlying question of whether CABG is protective purely against

long-term MI.

20,22,23

While this is a limitation of our study as well, the

longer-term follow-up from the present report more heavily weights

the accrual of late MIs compared with early periprocedural events.

With follow-up between 4 and 10 years in the 4 component studies of

the present analysis, no signiﬁcant difference in long-term MI risk was

noted between CABG and PCI after treatment of isolated LAD dis-

ease. It is important to note however, that there is evidence of ﬂawed

data in one of the meta-analyses due to erroneous inclusion of the

same study with multiple articles describing various timepoints of

follow-up.

Concordant with the similar risk of MI we also observed a similar risk

of all-cause mortality with CABG and PCI. However, TVR was performed

in substantially fewer patients during follow-up after CABG compared

with PCI. These data may be useful to the heart team as they discuss the

risk vs beneﬁt proﬁles of each procedure in a patient with isolated LAD

disease.

Limitations

An inherent issue in all meta-analyses is that the aggregate results

are drawn from studies with inherent variability between patient pop-

ulations and treatments. By excluding observational studies, and only

including RCTs with isolated LAD disease, LIMA and stent treatment,

and long-term follow-up, we have attempted to limit potential con-

founding. However, RCTs enroll a highly selected group of patients and

may exclude higher-risk cohorts in whom equipoise between PCI and

CABG does not exist (eg, extremely diffuse disease favoring CABG, or

frailty or other comorbidities favoring PCI). Additionally, information

about lesion complexity that may affect the relative outcomes of CABG

vs. PCI was not routinely available, nor were we able to account for

differences in interventional or surgical technique and operator skill/

experience in our analysis. Follow-up time varied between studies, and

hazard ratios were not available, requiring a reliance on RRs at the

longest follow-up time available, which may have introduced some

imprecision. Additionally, it is important to consider that while we aimed

to understand long-term events, the analysis may have been inﬂuenced

by early events as the timing of events within each study was not able to

be ascertained. Lastly, our analysis is limited by wide conﬁdence in-

tervals for the outcomes studied, and thus caution is warranted in

drawing strong conclusions from these ﬁndings.

Conclusions

The present meta-analysis of RCTs of patients with isolated LAD

disease undergoing PCI with stenting (mostly BMS) or CABG with a

LIMA shows that there is insufﬁcient evidence to establish that CABG

confers protection against MI, as we note a similar risk of MI and all-

cause mortality with both procedures at long-term follow-up, with an

increased risk of TVR after PCI. These ﬁndings must be placed into

context given the signiﬁcant advances in stent technology, interven-

tional and surgical techniques, and operator skill since these trials were

conducted. Our ﬁndings suggest that in noncomplex patients with

single-vessel LAD disease in whom there is equipoise for revasculari-

zation between CABG and PCI, there is insufﬁcient evidence to suggest

that CABG is associated with reduced long-term risk of MI or death

when compared with PCI. Further studies examining the origin of MIs

after CABG and PCI (whether type I, II, IV, or V)

and whether arising

from the target lesion, target vessel, or nontarget vessel are needed to

further delineate the causes of MI after both procedures and to explore

the protective effects of CABG in patients with complex multivessel and

left main disease.

Acknowledgments

We would like to acknowledge librarian Larry Popko and graphic

designer Amy Mousley for their contributions to this manuscript.

Declaration of competing interest

Megha Prasad is a consultant for Abbott and Conavi and serves on a

speaker’s bureau for Philips. James Howard is funded by the British Heart

Foundation (FS/ICRF/22/26039). Ajay Kirtane reports institutional

funding to Columbia University and/or Cardiovascular Research Foun-

dation from Medtronic, Boston Scientiﬁc, Abbott Vascular, Amgen, CSI,

Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical,

Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck. In

addition to research grants, institutional funding includes fees paid to

Columbia University and/or Cardiovascular Research Foundation for

consulting and/or speaking engagements in which Ajay Kirtane

controlled the content. Ajay Kirtane reports consulting fees from IMDS,

and travel expenses/meals from Medtronic, Boston Scientiﬁc, Abbott

Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens,Zoll, and

Regeneron. Margaret McEntegart received consultant fees or honoraria

from Boston Scientiﬁc, Biosensors, Shockwave Medical, and Teleﬂex.

Gregg Stone discloses speaker honoraria from Medtronic, Pulnovo,

Table 2. Comparison of the present and prior meta-analyses of randomized trials of PCI vs CABG in isolated LAD disease.

Reference, year Follow-up

range

No. of

RCTs

No. of observational

studies

Total

enrolled

Stent

type(s)

Principal ﬁndings

Harskamp et al,

2014 6 mo to 5 y 2 2 941 DES Lower TVR rates with CABG but otherwise similar clinical

outcomes compared to DES

Raja et al,

2018 1 to 7.3 y 3 9 7710 DES Reduced TVR with CABG, but similar mortality, MI, and MACCE

compared to PCI with DES for proximal LAD disease

Kapoor et al,

2008 <5 y 9 0 1210 BMS/DES Similar survival in CABG and PCI groups, but signiﬁcantly

reduced angina and repeat revascularizations with CABG

Kinnaird et al,

2016 6 mo to 7 y 3 8 5044 DES Similar mortality, MI, and stroke rates to CABG at the expense of

increased TVR.

Boodhwani et al,

2005 6 mo to 5 y 8 9 13,319 PTCA/

BMS/ DES

Reduced MACE, mortality and MI and reduced angina with

surgery

Deo et al,

2014 <5y 7 5 >2000

patients

BMS/DES Similar survival with PCI and CABG, however higher rates of

angina recurrence and TVR with PCI

Prasad et al, 2023

(present study)

4 to 10 y 4 0 573 BMS/DES Similar long-term rates of MI and all-cause death after PCI and

CABG; reduced TVR with CABG.

BMS, bare metal stent; CABG, coronary artery bypass graft surgery; DES, drug-eluting stent; LAD, left anterior descending artery; LIMA, left internal mammary artery;

MACE, major adverse cardiac event; MACCE, major adverse cardiac and cerebrovascular events; MI, myocardial infarction;. PCI, percutaneous coronary intervention;

PTCA, percutaneous transluminal coronary angioplasty; RCT, randomized controlled trial; TVR, target vessel revascularization.

M. Prasad et al. / Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 100636 5

Infraredx, Abiomed, and Abbott. Gregg Stone serves as a consultant to

Valﬁx, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious,

Miracor, Neovasc, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo

Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, Adona

Medical, and Millennia Biopharma and holds equity/options from

Ancora, Cagent, Applied Therapeutics, Biostar family of funds, Spec-

traWave, Orchestra Biomed, Aria, Cardiac Success, Valﬁx, and Xenter.

Institutional disclosures: Gregg Stone’s employer, Mount Sinai Hospital,

receives research support from Abbott, Abiomed, Bioventrix, Cardio-

vascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular

Dynamics, Pulnovo, and V-wave. Gregg Stone’s daughteris an employee

at IQVIA.

Funding sources

This research did not receive any speciﬁc grant from funding

agencies in the public, commercial, or not-for-proﬁt sectors.

Ethics statement and patient consent

Ethical approval was not required because this was a meta-analysis

of existing clinical trials that were independently reviewed and

approved by respective committees.

Supplementary material

To access the supplementary material accompanying this article,

visit the online version of the Journal of the Society for Cardiovascular

Angiography & Interventions at 10.1016/j.jscai.2023.100636.

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