LEFT MAIN CORONARY INTERVENTION

Mashhad university of medical science Falsoleiman H. MD

RISK ASSESSMENT

INTRODUCTION

Significant, defined as a >50% narrowing, left main coronary artery disease (LMCAD) is found in 5-7% of all patients who undergo coronary angiography.

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ANATOMY AND PATHOPHYSIOLOGY OF LMD

The LMCA arises from the superior portion of left aortic sinus just below the sinotubular junction .

Divided into 3 anatomical

regions:

-Ostium

-Midportion

-Distal portion

Average length = 10-15 mm Average diameter= 3-6 mm

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ANATOMY AND PATHOPHYSIOLOGY OF LMD

plaque burden in the LMS bifurcation is mor frequently diffuse rather than focal,

Involvement of proximal LAD artery in approximately 90% of cases

The LMCA differs from theother coronary arteries by itsrelatively greater elastic tissue content which can explain elastic recoil and highrestenosis rate following balloon angioplasty.

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The The segment of segment of the LMCA the LMCA

which which extends extends

beyond the beyond the aorta aorta

displays the displays the same same

layered layered architecture architecture

as that of as that of the other the other coronary coronary arteries.arteries.

In the LMS, bifurcation intimal atherosclerosis is accelerated primarily in areas of low shear stress in the lateral walls (i.e., opposite the flow divider – carina) close to the LAD and LCx bifurcation .

The bifurcation carina is frequently free of disease due to its being a high shear stress area.

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The LMCA is responsible for supplying: _>80% of the left ventricle in a Rt.dominant system _100% of the left ventricle in a Lt. dominant system

LMD is associated with MVD about 70% of the time,

LMD is associated with higher burden of advanced atherosclerosis as evidenced (higher prevalence of significant carotid stenosis and lower ABI).

unless it is unless it is protected protected

by by collateral collateral flow or a flow or a

patent patent bypass bypass

graft to graft to either the either the LAD or LAD or LCX.LCX.

Left main lesion is particular, because

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As a result, As a result, severe UPLMCA severe UPLMCA

disease will reduce disease will reduce flow to a largeflow to a large

portion of the portion of the myocardium, myocardium,

placing the patient placing the patient at high riskat high risk

for life-threatening for life-threatening events of LV events of LV

dysfunction anddysfunction and

arrhythmiasarrhythmias..

Patients with ULMCA disease treated medically have a 3-year mortality rate of 50%.

CABG has historically been regarded as the

gold standard treatment for Unprotected LMCA disease.

Important advances in percutaneous intervention techniques and stent technology, adjunctive pharmacotherapy and operator experience have led to increasing acceptance of PCI as a viable alternative to CABG for unprotected LMD.

Recent studies Recent studies have focused on have focused on the safety and the safety and efficacy of efficacy of stenting the stenting the LMCA to LMCA to determine determine whether it does whether it does provide a true provide a true alternative to alternative to CABG. So CABG. So should we stent should we stent the LM?the LM?

in patients with suitable anatomical conditions.in patients with suitable anatomical conditions.

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Percutaneous coronary intervention for ULM disease is usually “accepted” when:

1) bailout ULM PCI following complications during PCI; 2) ULM disease occurs in the setting of AMI; 3) protected LM by a functional coronary bypass graft; 4) patients are turned down for CABG; 5) patients refuse surgery.

Surveys of real-world practice have indicated that approximately 1/3 of patients with ULM lesions are treated by PCI .

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Does the ULM Need Revascularization?

Prior to formulation of a revascularization strategy for patients ULM lesion, it is important to determine whether the lesion is in actual need of revascularization (is it hemodynamically significant).

Therefore, in practice, a suspicious or borderline ULM lesion warrants further evaluation with IVUS, coronary CT, and/or functional assessment with FFR , before either suggesting the need for revascularization or dismissing the need altogether.

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Is There a Need for Risk Stratificationin ULM Revascularization?

Procedural risk stratification (for both PCI and CABG) serves several purposes:

In the short term, it provides clinician with supplementary information that can help guide treatment strategy,

procedural risk stratification enables patients to be more adequately informed about the risks/benefits of the alternative revascularization strategies available, allowing them to make an informed decision

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With the current state of evidence,

ad hoc ULM PCI should not be performed in the stable patient.

Available Methods of Risk Stratification for Patients With ULM Lesions

Risk models can be divided into those using: clinical-based variables, angiographic data, combination of both.

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SYNTAX score.

The SYNTAX Score hasproven to be a clinicallyuseful anatomical scoringsystem to aid in bothstratifying clinical outcomesand decision making for theoptimal revascularisationmodality in patients with ULMCA disease

low risk Score=<22Intermediate risk 23-32High risk score=>33

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The value of the SXscore in patients with ULM disease has been specifically assessed in over 3,000 patients with follow-up between 12m-4yin 4 separate studies:

the SYNTAX trial ( n=705) the CUSTOMIZE registry (n = 819) the MAIN COMPARE registry (n =1,580) the Rotterdam LM registry (n = 148)

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LMD _ _ SYNTAX trialFigure e3Figure e3

The PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicineThe PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicineLeft main coronary artery disease

Vasim Farooq, Patrick W. Serruys, Greg W. Stone, Renu Virmani, Alaide Chieffo, Jean Fajadet

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Clinical Outcomes (Composite of Death, Stroke, MI and RepeatRevascularization) Stratified by SYNTAX Score Tertile

LMD _ SYNTAX trial

3-Year Clinical Outcomes in Patients With Left Main Disease _ SYNTAX Trial

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SUMMARY

Overall MACCE in the PCI group was comparabe with CABG .

Similar overall safety outcome (death, CVA, MI) between CABG & PCI at 12 months.

PCI outcomes are excellent relative to CABG in LM isolated and LM+1VD

There was a higher rate of revascularization in the PCI group and higher rate of CVA in the CABG group.

Rate of symptomatic graft occlusion and stent thrombosis were similar.

CONCLUSION

For patients with LM disease:

Revascularization with PCI has compar-able safety and efficacy to CABG.

PCI is a resonable treatment alternative in this patients in particular when the Syntax score is low or intermediate.

combined risk scores

Clinical and angiographic risk models may be better suited to predict different outcomes.

In view of this, several combined clinical and angiographic risk scores have been Developed.

The most prominent combined risk scores include:

-Society of Thoracic Surgery (STS) Score, -clinical SYNTAX score(CSS), -combined EuroSCORE and SYNTAX.

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-Age-CrCl-LVEF

Clinical SYNTAX score (CSS):

The European Revascularisation guidelines regard use of the SYNTAX Score II as a class IIa indication (LOE; B). 

Functional SYNTAX Score: (a fractional flow reserve-derived SYNTAX Score) may improve

decision making in patients with ULMCA disease

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additive EuroSCORE

The EuroSCORE is an The EuroSCORE is an established risk score, utilising 17 clinical variables, within cardiothoracic surgical practice for predicting operative mortality. . The additive EuroSCORE assigns an individual score to 17 clinical variables (  Table 2 ), with a low EuroSCORE risk tertile ranging from 1-2, intermediate risk tertile from 3-5, and a high risk tertile of 6+.ertile of 6+.

EuroSCORE

  

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EuroSCORE is an effective method of identifying which patients, treated with PCI or CABG, are at high risk of mortality and/or MACCE.

EuroSCORE in isolation is probably of little use in determining selection of revascularization strategy,

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EuroSCORE + SYNTAX.

The EuroSCORE and SXscore are the most validated tools for risk assessing patients undergoing coronary revascularization and in particular those with ULM disease.

The combination of these 2 scores appears particularly attractive given the ability of the EuroSCORE to identify patients at high risk of adverse events irrespective of treatment modality and the ability of the SXscore to assist in establishing optimal revascularization strategy.

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Global risk Classification (GRC)

The Global Risk was shown to enhance substantially the identification of low-risk patients  compared to the SYNTAX Score alone.

The Global Risk demonstrated at least comparable clinical outcomes (all-cause death and MACCE) in low Global Risk patients with ULMCA disease undergoing CABG or PCI at 3 years, in the randomised and “All Comers” SYNTAX population .

The PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicineThe PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicineLeft main coronary artery disease

Vasim Farooq, Patrick W. Serruys, Greg W. Stone, Renu Virmani, Alaide Chieffo, Jean Fajadet

Proposed treatment algorythm for the management of LMS and 3VD

incorporating (additive Euroscore and anatomical Sxscore)

SYNTAX Study

The Relation-Ship Between EuroSCORE &SYNTAX Score in the ULM Population

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EDUCATIONAL CONTENT ENDORSED BY EAPCI,EDUCATIONAL CONTENT ENDORSED BY EAPCI,

A REGISTERED BRANCH OF THE EUROPEAN SOCIETY OF CARDIOLOGY

Table 4Table 4

The PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicineThe PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicine

Left main coronary artery diseaseVasim Farooq, Patrick W. Serruys, Greg W. Stone, Renu Virmani, Alaide Chieffo, Jean Fajadet

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EDUCATIONAL CONTENT ENDORSED BY EAPCI,EDUCATIONAL CONTENT ENDORSED BY EAPCI,

A REGISTERED BRANCH OF THE EUROPEAN SOCIETY OF CARDIOLOGY

The PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicineThe PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicine

Left main coronary artery diseaseVasim Farooq, Patrick W. Serruys, Greg W. Stone, Renu Virmani, Alaide Chieffo, Jean Fajadet

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ESC and EACTS GUIDELINES LM PCI 2011

Ostial and/or shaft lesion Class IIa

Distal LM lesion (isolated or with SVD)

Class IIb

LMD + MVD and SYNTAX Score <=32

Class IIb

LMD + MVD and SYNTAX Score >32

Class III

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The 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention

The PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicineThe PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicine

Left main coronary artery diseaseVasim Farooq, Patrick W. Serruys, Greg W. Stone, Renu Virmani, Alaide Chieffo, Jean Fajadet04/21/23 3535

Results of EXCEL trial, (the largest to directly compare the two treatments for LM CAD) could further clarify the issue. If PCI is proven as safe and effective as CABG for certain patients, it could mean that fewer LMD patients to be exposed to the risks of surgery.

The field of left main coronary artery disease continues to expand in terms of the evidence available for optimal patient evaluation and selection of treatment modalities.

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سسپا

CASE

64 years old femaleMild DOE + atypical chest

discomfortDM+ECG: NlEcho: LVEF=58%, no RWMAETT: Incomplete, non-dignosticSPECT: no perfusion defect

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Further analyses indicated that high EuroSCORE patients with ULMCA disease (regardless of the SXscore) appeared to gain at least a morbidity advantage (in terms of reduced MACCE) by undergoing surgical revascularisation compared to PCI.

Hypotheses to explain these latter findings were proposed, and concerned the observation that CABG potentially protects the entire treated coronary vessel from future cardiac events for the lifespan of the graft, compared to PCI which would treat the individual lesion.

One of the unexpected findings from the Global Risk was that higher risk subjects (high additive EuroSCORE ≥6) in all tertiles of the SYNTAX Score (low, intermediate or high), were shown to have a potential prognostic benefit from undergoing CABG compared to PCI, irrespective of the baseline SYNTAXScore, provided an acceptable threshold of operative risk was not exceeded (  Figure 21 ). For example in the 3VD cohort of the SYNTAX Trial, subjects with a low SYNTAX Score (<23) and a high EuroSCORE (≥6) had a doubling of 3 year mortality when undergoing PCI (15.9%) compared to CABG (8.2%).

The 2 scores have a somewhat complex relationship that is highlighted by the confusing results seen in the SYNTAX study, when patients in low, intermediate, and high Sxscore tertiles were further subdivided by a EuroSCORE above or below the median of 4 (Fig. 2).

The EuroSCORE was an independent predictor of MACCE for both revascularization strategies; therefore it would have been expected that outcomes in those with a high EuroSCORE were worse than those with a low EuroSCORE irrespective of the SXscore tertile.

However, as is clearly seen, in the low SXscore tertile the division by EuroSCORE identified those patients at highest risk of events from surgery and had little effect on PCI outcomes.

In the high SXscore tertile group the opposite was observed: whereas surgical outcomes in patients with a EuroSCORE above or below 4 were similar, PCI outcomes varied from 20% to 35%. The small number of patients in these subgroups may certainly have played its part in these observations, which therefore require further investigation with subsequent larger studies

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Hypotheses to explain these findings included the bypass graft would potentially ‘protect’ the entire treated coronary vessel from future cardiac events for the lifespan of the graft in high risk subjects, compared to PCI which would treat the individual lesion [6, 6]. Based on these observations, it was hypothesised by the investigators that low (or high) risk subjects were potentially concealed by high (or low) risk subjects in all tertiles of the SYNTAX Score. This hypothesis is what prompted the investigators to develop a more individualized approach to decision making between CABG and PCI, and subsequently lead to the development of the SYNTAX Score II [251, 252, 279, 280], as detailed below.

The SYNTAX SCORE II

Augmenting the anatomical SYNTAX score with clinical factors and the personalisation of decision making -

Since the anatomical SYNTAX Score was developed, limitations of this scoring system to aid decision-making between CABG and PCI became evident.

Namely, the lack of clinical variables and lack of a personalised approach to decision-making.

The SYNTAX Score II was designed to overcome these limitations.

Prospective validation of the SYNTAX Score II in EXCEL

Prospective validation of the SYNTAX Score II is currently occurring in the international multicenter EXCEL Trial (Evaluation of XIENCE PRIME™ or XIENCE V® Everolimus Eluting Stent System Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) Trial

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One of the unexpected findings from the Global Risk was that higher risk subjects (high additive EuroSCORE ≥6) in all tertiles of the SYNTAX Score (low, intermediate or high), were shown to have a potential prognostic benefit from undergoing CABG compared to PCI, irrespective of the baseline SYNTAXScore, provided an acceptable threshold of operative risk was not exceeded

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The New Risk Classification Score (NERS)

The NERS risk score consists of 54 variables (17 clinical, 4 procedural and 33 angiographic features).

Conversely, in the low-risk NERS group, outcomes were similar to the low SYNTAX Score group, suggesting at least from this study that anatomical variables alone may be sufficient to be predictive of clinical outcomes in the low-risk group.

When the NERS score was separated into 2 groups of risk (high and low) and clinical outcomes were assessed, the NERS score was able to identify a high-risk population forMACE, at 30 days and at over 5 years follow-up. Furthermore, the high-risk NERS group was demonstrated to be significantly more predictive of MACEcompared to the intermediate or high SYNTAX Score tertiles.

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Limitations of Risk Models

There are numerous other variables such as diabetic status and body mass index, which have been shown to influence clinical outcomes but have not been included in most risk models.

Importantly, the number of variables included inm the risk model must be sufficient, on one hand, to ensure the model adequately predicts risk, but, on the other hand, the

number must not be excessive to inhibit user uptake.

Furthermore, inclusion of numerous variables increases the chances of colinearity between independent variables resulting in redundant information being collected (33), whereas also increasing the chances of overfitting the model, thereby reducing the overall accuracy of the results (55). Overall, it must be acknowledged that all risk scores lack the sensitivity to accurately predict events in an individual patient who may have comorbidities not accounted for in the risk model. The purpose of risk scores therefore is to report the risk of the population being studied; in a good risk model the variables selected will account for interpatient variation in comorbidities.

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Conclusions

There is a clear need for adequate risk stratification in patients undergoing revascularization of the ULM. Although numerous different risk models are available for the assessment of these patients, each has been evaluated in a different patient population and has measured different outcome end points at varying follow-up time periods.

This heterogeneity identifies an important gap in the current evidence base. As a result, identification of a single best risk score for use as a day-to-day clinical tool is presently not possible.

Assessment of prospectively and carefully collected data from a large ULM population undergoing long-term follow-up is required to provide the substrate from which a useful risk stratification model can be developed that is capable of optimally discriminating

between PCI and CABG in patients with ULM disease requiring revascularization.

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The accuracy of risk models can also be improved with the inclusion of treatment-specific procedural factors, such as the number of stents implanted and the stenting technique employed in patients having PCI, and the cardiopulmonary bypass time and use of off-pump surgery in patients having CABG.

For example, Chen et al. (56) incorporated 4 procedural variables together with 17 clinical and 33 angiographic variables to produce a risk model that had a greater predictive accuracy than the SXscore alone in 337 patients with ULM disease treated with PCI. Despite the improved accuracy, it is important to remember that these variables cannot be reliably predicted prior to undertaking PCI or CABG, and therefore their inclusion unfortunately moves the ability to accurately calculate risk to a time point after the procedure has been completed.

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CON

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Finally, data indicate that overall ability of clinical orangiographic models to predict hard end points (such

as mortality) is superior to their ability to predict softer outcomes such as angiographic failure and repeat revascularization.

As shown in Table 8, this trend appears consistent with all risk models, with recent data from Garg et al. (52) indicating that combined scores such as the CSS are not exempt from this phenomenon.

STS Score.

The STS score is considered a combined risk mscore, although it only incorporates 2 angiographic variables (presence of ULM lesion and number of vessels diseased)

together with 40 clinical variables.

The STS risk model predicts the risk of operative mortality and morbidity after

adult cardiac surgery (49,50) such that it is used exclusively by cardiac surgeons; at present, no data exist regarding the utility of the STS score in patients undergoing PCI.

Previous data have indicated the STS score to be superior to the MCRS in patients having CABG (31), whereas comparisons between the EuroSCORE and STS score indicate only a slight improvement in mortality prediction with the STS score (51).

There appears to be little role of the STS score in the assessment of patients with ULM disease prior m to the selection of a strategy of surgical revascularization.

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These include the following: (1 the effect of specific lesion location on outcome - it is known that patients

with distal bifurcation left main disease have worse outcome; (2) the potential for subacute thrombosis of the left main coronary artery; (3) the impact of left ventricular function and patient comorbidities

irrespective of the degree and location of left main coronary artery stenosis; and

(4) the risk-benefit ratio of stenting versus coronary artery bypass graft surgery.

These issues are currently being addressed in two seminally important trials including the SYNTAX trial, which randomizes patients with left main and/or three-vessel disease to either coronary artery bypass graft surgery or a TAXUS drug-eluting stent.

This trial is in the final stages of patient recruitment and will have important implications for the field. The other trial is the COMBAT trial, which is focused exclusively on left main coronary artery stenosis and randomizes patients with left main coronary artery disease either to a Sirolimus-eluting stent (Cypher, Johnson and Johnson Cordis, USA) or to coronary artery bypass graft surgery.

The field of left main coronary artery disease continues to expand in terms of the evidence available for optimal patient evaluation and selection of treatment modalities.

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Percutaneous coronary intervention (PCI) with stenting has generally been restricted to such patients considered inoperable or at high risk for CABG, or with prior CABG and at least one patent graft to the left anterior descending or circumflex artery (so-called "protected" left main disease).

Graft patency is important in this setting in the event of acute or late closure after PCI. However, evidence is increasing to support the use of PCI with stenting in some cases

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, in a substudy of the SYNTAX trial utilising 3D- (QCA), Girasis et al demonstrated a large variation in the angulation parameters of the LMS (proximal and distal bifurcation angles with mean

pre-PCI end-diastolic values of 105.9 ± 21.7° and 95.6 ± 23.6° respectively).

In particular, systolic motion was shown to result in a reduction of the distal (-8.2°) and an enlargement of the proximal (+8.5°) bifurcation angle , and that subsequent PCI modified the distal bifurcation angle .

The incidence of MACCE at 12 months, however, did not differ across pre-PCI distal bifurcation angle values.

Final 5-year reporting of the SYNTAX Trial demonstrated a restricted post-procedural systolic-diastolic distal bifurcation angle range to be associated with a higher 5-year adverse event rates after LMCA bifurcation PCI .

Namely, patients with post-PCI systolic-diastolic range <10° had a significantly higher MACCE (50.8% vs. 22.7%, p < 0.001) and repeat revascularization (37.4% vs. 15.5%, p = 0.002).

In addition, post-PCI systolic-diastolic range <10° was shown to be an independent predictor of MACCE . Conversely, the pre-PCI bifurcation angle value was shown not to affect clinical outcomes.

. Confirmation of these findings are awaited from other randomised trials.

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 Table 4 and  Table 5 ) forms the basis of recommendations (  Table e3a and  Table e3b ) by the Heart Team in informing patients and guiding the approach to informed consent.

The presence of an ostial and/or shaft lesion is considered as a Class IIa indication for PCI, level of evidence B.

A distal isolated LM lesion, or being associated with single-vessel disease, is considered as a Class IIb indication.

Left main lesion associated with two-vessel or three-vessel disease and a low or intermediate SYNTAX Score is considered as a Class IIb indication.

Left main lesion associated with two-vessel or three-vessel disease and a high SYNTAX Score is considered as a Class III indication.

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Thank You

Kingsoft OfficeMake Presentation much more fun

In those patients in the low and intermediate SXscore

tertiles, the rates of MACCE between PCI and CABG are

comparable (Table 5), whereas in those patients in the highest SXscore tertile, outcomes are significantly worse in those receiving PCI.

Overall, these multiple studies indicate that the SXscore

has a role to play in both stratifying clinical outcomes and

assisting important revascularization decisions in those patients undergoing revascularization of ULM disease.

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The ongoing international multicentre randomised EXCEL (Evaluation of XIENCE Prime versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularisation) trial has recently completed recruitment of patients and outcomes of the study are now awaited.

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Risk stratification

A low to moderate SYNTAX Score (<33) in patients with ULMCA disease has been shown to have similar outcomes in terms of efficacy and safety in the SYNTAX trial at up to 5 years in patients undergoing surgical or percutaneous revascularisation. This has been validated in several registries at short and longer-term follow-up, and is now subject to the ongoing EXCEL trial

The outcomes of patients undergoing ULM PCI appears to be affected by a higher SYNTAX Score and its association with anatomical complexities and clinical comorbidity

Within the general population a higher SYNTAX Score has been associated with markers of systemic atherosclerosis (higher carotid intima-media thickness, ankle-brachial pressure index)

The “Functional SYNTAX Score” (a fractional flow reserve-derived SYNTAX Score) may improve decision making in patients with ULMCAdisease. Further study is on-going

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In all studies, irrespective of follow-up duration, a higher SXscore tertile has consistently been associated with the poorest outcomes, whereas several studies also identified the SXscore as an independent predictor of MACE in patients undergoing PCI

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EuroSCORE II

More recently the EuroSCORE II was developed to improve the risk predictions of the EuroSCORE I. The EuroSCORE II was developed on newer data to reflect more contemporary surgical practice given that cardiac surgical mortality has significantly reduced in the last 15 years despite older and sicker patients, and that the previous additive and logistic EuroSCORE models were suggested to be representative of outdated surgical practice.

The EuroSCORE II was shown to be better calibrated (actual mortality: 4.18%; predicted: 3.95%) compared to the original EuroSCORE model (actual: 3.9%; additive predicted: 5.8%; logistic predicted: 7.57%) whilst preserving discrimination (area under the receiver operating characteristic curve of 0.8095).

It should however be noted that regular revalidation of EuroSCORE II will need to be continued to identify calibration drift or clinical inconsistencies as seen in previous versions.

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Current evidence and guidelines would suggest that PCI with drug-eluting stents is a reasonable option in the short- to intermediate-term for patients with simple left main disease or for patients who are poor candidates for bypass surgery,” said David J. Cohen, MD, MSc, director of cardiovascular research, Saint Luke’s Mid America Heart Institute, Kansas City, Mo., and an Editorial Board member for Cardiology Today’s Intervention. “In general, most serious outcomes, including death and MI, appear quite comparable between the two strategies in these populations, although there is some evidence that PCI is less likely to result in stroke, whereas CABG is clearly associated with less need for repeat revascularization procedures.”