Bài giảng A decade of left main intervention: PCI vs CABG where are we now

The lecture presents the content LMCA interventionalists are called cowboy doctors; mai primary endpoint landmark analysisn compare 5 year; syntax left main subgroup; guideline recommendations for left main revascularisation; temporal trends of LM revascularization...

A Decade of Left Main Intervention :

PCI vs CABG Where are we now ?

Gim-Hooi Choo Cardiac Vascular Sentral KL (CVSKL)

12th July, 2019

• No conflicts pertaining to this

lecture

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• Left Main Stem Revascularisation: The Story A Decade Earlier

• After EXCEL and NOBLE in 2016 :

More Clarity or Confusion?

• Current Position of LMCA Revascularisation

Left Main : Why the Fuss ?

Andreas Gruentzig’s Log Book :

1 st Successful LMCA PCI :

3 rd PCI case [Nov 24 th 1977]

“Third PCI patient ever treated Forty-three year old man with severe angina pectoris since September, 1977 First angiogram (November 11) revealed severe stenosis of the main L.C.A .”

Note: The patient expired suddenly about 4 months after this procedure

Gruntzig A Lancet 1978;1:263

Yusuf S et al Lancet 1994; 344: 563-70

CABG was the ONLY option !

For 30 years, Surgeons RULED ! Left Main is a No Entry Zone for Interventionalists !

LMCA Interventionalists are called COWBOY Doctors

MAIN COMPARE, 5 Year

Propensity Match Patients (n=542)

Park DW, et al JACC 2010;56:117-24

DES vs CABG

Pre-2016 RCTs

Limitations :

First Generation of DES ; Low rate of IVUS/OCT use

Non inferiority trial

Relative small sample size

SYNTAX – LM : a subgroup

Large Non-Inferiority margin (6-7%)hinhanhykhoa.com

SYNTAX: Left Main Subgroup

De novo disease (n=1800)

Serruys PW et al NEJM 2009;360:961-72

Mohr FW et al Lancet 2013;381:629–38

[Death /MI /Stroke /Repeat Revascularization]

ITT population

Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates

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SYNTAX : Left Main Disease

5 year Outcomes [n=705]

Mohr FW et al Lancet 2013;381:629–38

MACCE to 5 Years by SYNTAX Score Tercile

Low to Intermediate Scores (0-32)

Serruys PW et al Lancet 2013;381:629–38

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MACCE to 5 Years by SYNTAX Score Tercile

High Scores ≥ 33

Serruys PW et al Lancet 2013;381:629–38

PCI vs CABG for Left Main Disease Meta-analysis of 4 RCTs, 1,611 Patients

1 Year MACCE

Capodanno et al, JACC 2011;58:1426-32

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PCI vs CABG for Left Main Disease

1 year MACCE

Capodanno et al, JACC 2011;58:1426-32

Fixed effects estimate

PCI vs CABG for Left Main Disease

Meta-analysis of 4 RCTs

1 year mortality

Capodanno et al, JACC 2011;58:1426-32

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Capodanno et al, JACC 2011;58:1426-32

Fixed effects estimate

PCI vs CABG for Left Main Disease

Meta-analysis of 4 RCTs

1 year MI

PCI vs CABG for Left Main Disease

1 year TVR

Capodanno et al, JACC 2011;58:1426-32

Fixed effects estimate

hinhanhykhoa.com

PCI vs CABG for Left Main Disease

Meta-analysis of 4 RCTs

1 year stroke

Capodanno et al, JACC 2011;58:1426-32

Fixed effects estimate

Guideline Recommendations for

Left Main Revascularisation

Levine G, et al J Am Coll Cardiol 2011;58:44-122; Windecker S, et al Eur Heart J 2014;35:2541-619

Temporal Trends of LM Revascularization

(IRIS LM Registry n=5,883), 2017

Medical Tx

CABG

PCI

Temporal Trends in Unprotected Left Main PCI

in the US (NCDR) 3,342,162 Patients 33,128 PCI

Valle et al, JAMA Cardiol 2019;4:100-109

Before 2016

N=705

N=201

N=600 N=105

Then in 2016, something important happened !

2016:

Trump became President of the USA

BAN EVERYTHING HUAWEI

In 2016 : Other Important things

happened in LMCA revascularisation

N=705

N=201

N=600 N=105

N=1905

N=1201

EXCEL

A Prospective, Randomized Trial Comparing Everolimus-Eluting Stents and Bypass Graft Surgery in Selected Patients with Left Main Coronary Artery Disease

Gregg W Stone

Joseph F Sabik, Patrick W Serruys, Charles A Simonton, Philippe Généreux, John Puskas, David

E Kandzari, Marie-Claude Morice, Nicholas Lembo, W Morris Brown, III, David P Taggart, Adrian Banning, Béla Merkely, Ferenc Horkay, Piet W Boonstra, Ad Johannes van Boven, Imre Ungi,

Gabor Bogáts, Samer Mansour, Nicolas Noiseux, Manel Sabaté, Jose Pomar, Mark Hickey,

Anthony Gershlick, Pawel Buszman, Andrzej Bochenek, Erick Schampaert, Pierre Pagé, Ovidiu

Dressler, Ioanna Kosmidou, Roxana Mehran, Stuart J Pocock, and Arie Pieter Kappetein, for the

EXCEL Trial Investigators

Stone GW, Sabik JF, Serruys PW, et al Everolimus-eluting stents or bypass surgery for left main coronary artery disease N Engl J Med 2016; DOI:10.1056;NEJMoa1610227

Follow-up: 1 month, 6 months, 1 year, annually through 5 years

Primary endpoint: Measured at a median 3-yr FU, minimum 2-yr FU

Study Design

2900 pts with unprotected left main disease

SYNTAX score ≤32 Consensus agreement of eligibility and equipoise by heart team

Yes (N=1900)

No (N=1000)

Enrollment registry

PCI (Xience EES)

Protocol Procedures

PCI recommendations

• Complete revascularisation of all ischemic territories with EES

• IVUS guidance strongly recommended

CABG recommendations

• Complete anatomic revascularization of all vessels ≥1.5 mm

in diameter with ≥50% DS

• Arterial grafts strongly recommended

Guideline-directed medical therapy for both groups

EXCEL : Primary Endpoint

Death, Stroke or MI at 3 Years

Gregg W.Stone, NEJM 2016;November 7

PCI (n=948)

CABG (n=957)

Diff [upper confidence limit] P NI HR [95%CI] P Sup

The pre-specified non-inferiority margins (deltas) were 4.2% for death, stroke or MI at 3 years, 2.0% for death,

stroke or MI at 30 days, and 8.4% for death, stroke, MI or ischemia-driven revascularization at 3 years

† Upper 97.5% confidence limit; ††Upper 95.0% confidence limit

EXCEL Primary Endpoint vs SYNTAX Score: Death, Stroke or MI at 3 Years

Primary Endpoint Landmark Analysis (post hoc)

From randomization to 30 days From 30 days to 3 years

PCI (n=948)

CABG (n=957) HR [95%CI]

P value

PCI (n=939)

CABG (n=947) HR [95%CI]

P value

Percutaneous coronary angioplasty versus coronary artery

bypass grafting in treatment of unprotected left main stenosis

Nordic–Baltic–British left main revascularisation study (NOBLE)

A prospective, randomised, open-label, non-inferiority trial

Evald Høj Christiansen

Timo Mäkikallio, Niels R Holm, Mitchell Lindsay, Mark S Spence, Andrejs Erglis, Ian B A Menown, Thor Trovik, Markku Eskola, Hannu Romppanen, Thomas Kellerth, Jan Ravkilde, Lisette O Jensen, Gintaras Kalinauskas, Rikard B A Linder, Markku Pentikainen, Anders Hervold, Adrian Banning, Azfar Zaman, Jamen Cotton, Erlend Eriksen, Sulev Margus,

Henrik T Sørensen, Per H Nielsen, Matti Niemelä, Kari Kervinen, Jens F Lassen, Michael Maeng, Keith Oldroyd, Geoff Berg, Simon J Walsh, Colm G Hanratty, Indulis Kumsars, Peteris Stradins, Terje K Steigen, Ole Fröbert, Alastair NJ

Graham, Petter C Endresen, Matthias Corbascio, Olli A Kajander, Uday Trivedi, Juha Hartikainen, Vesa Anttila, David Hildick–Smith, Leif Thuesen, and Evald H Christiansen

Makikallio T, Holm NR, Lindsay M, et al Percutaneous coronary angioplasting versus coronary bypass grafting in treatment of unprotected left main stenosis (NOBLE): A prospective randomized open-label non-inferiority study Lancet; 2016; DOI:10.1016/S0140-6736(16)32052-9

NOBLE Trial

7-year enrolment

Primary Endpoint Death, non-procedural MI, repeat

Revascularization and Stroke at 3 Years

Makikallio T et al Lancet 2016;388:2743–52

PCI did not show non-inferiority and CABG was superior to PCI

Results All-cause mortality

Results: Non-procedural myocardial

Results Total repeat revascularization

Results SYNTAX score subgroups

Updated Meta-analysis PCI vs CABG at 5 years

6 RCTs, n=4,686 pts,

Boudriot, LE MANS, PRECOMBAT, SYNTAX, NOBLE, EXCEL

Palmerini T et al Am Heart J 2017;190:54-63

LM Revascularisation : Are only these Endpoints Important?

CABG or PCI revascularisation

Two Very Different Procedures…

Different Cosmesis & Recovery

Potential

PCI (n=948)

CABG (n=957) RR [95%CI] P-value

- Sternal wound dehiscence 0.0% 2.0% 0.03 [0.00, 0.43] <0.001

- Infection requiring antibiotics 2.5% 13.6% 0.18 [0.12, 0.28] <0.001

- Prolonged intubation (>48 hours) 0.4% 2.9% 0.14 [0.05, 0.41] <0.001

Selection of Revascularisation Method is not

based on Anatomical Complexity Alone

• Risk Stratification : Surgical Risk includes

Evolving Standard of Care for

LM Revascularisation in 2019:

CABG

spontaneous MI higher with PCI during long-term FU – similar through 5 years

CABG

Evolving Standard of Care for

LM Revascularisation in 2019:

(including imaging, pharmacology) may be

considered an acceptable or even preferred

revascularization method for selected patients with LM disease

• As emerging evidence demonstrates equipoise between CABG & PCI, recommendation for

revascularisation derived from heart team

discussion, taking into account long-term and

short-term trade-offs of the procedures, specific patient’s circumstances and preferences

Thank You Very Much!

Cảm ơn nhiều

NOBLE: No increase in ST if first generation stents were excluded

No issue with expertise/experience of

Interventionalist or Surgeon