Unprotected Left Main Intervention How To Perform A Safe PCI Ian T. Meredith MBBS, PhD, FRACP, FACC, FCSANZ, FSCAI, FAPSIC Director of Monash HEART, Southern Health Professor of Cardiology and Medicine, Monash University, Melbourne, Australia

Ian T Meredith, MD, PhD Honoraria: Abbott Vascular Boston Scientific Corporation Medtronic, Inc.

“SAFE” PCI S Selection criteria, Scores, Syntax A Access, Adjunctive therapies, Angiographic angles, Approach F Finesse – techniques, tips and tricks E Evaluation - In real time, immediately post procedure (angiographic, IVUS/OCT and longer term

“SAFE” PCI S Selection criteria, Scores, Syntax A Access, Adjunctive therapies, Angiographic angles, Approach F Finesse – techniques, tips and tricks E Evaluation - In real time, immediately post procedure (angiographic, IVUS/OCT and longer term

Selection for “SAFE” L Main PCI Is the lesion functionally significant Is PCI the appropriate strategy? (Heart team forum, Evidence, Appropriateness criteria) What are the peri procedural MACE risks? (Syntax, NCDR, CIN, Bleeding Risk scores) What are the anatomic subtleties/complexities that may preclude a safe and successful procedure? (CTA, coronary angiography) Surgical Back up

Capodanno et al, JACC 2011;58:1426-32 PCI vs. CABG for Left Main Disease Meta-analysis of 4 RCTs, 1,611 Patients 1-Year Death PCI CABG OR (95%CI) p-Value LEMANS 1/52 4/53 0.24 (0.03-2.23) 0.21 SYNTAX left main 15/355 15/336 0.94 (0.45-1.96) 0.88 Boudriot et al. 2/100 5/101 0.39 (0.07-2.07) 0.27 PRECOMBAT 6/300 8/300 0.75 (0.26-2.17) 0.59 Fixed effects estimate 3.0% 4.1% 0.74 (0.43-1.28) 0.29 Random effects estimate 0.74 (0.43-1.28) 0.29 I2=0% OR (95%CI ) (24/807) (32/790) 0.01 0.1 1 10 100 Favors PCI Favors CABG Capodanno et al, JACC 2011;58:1426-32

Capodanno et al, JACC 2011;58:1426-32 PCI vs. CABG for Left Main Disease Meta-analysis of 4 RCTs, 1,611 Patients 1-Year MACCE PCI CABG OR (95%CI) p-Value LEMANS 16/52 13/53 1.37 (0.58-3.23) 0.48 SYNTAX left main 56/355 46/336 1.18 (0.77-1.80) 0.44 Boudriot et al. 19/100 14/101 1.46 (0.69-3.10) 0.33 PRECOMBAT 26/300 20/300 1.33 (0.73-2.44) 0.36 Fixed effects estiamate 14.5% 11.8% 1.28 (0.95-1.72) 0.11 Random effects estimate 1.28 (0.95-1.72) 0.11 I2=0% OR (95%CI ) (117/807) (93/790) 0.01 0.1 1 10 100 Favors PCI Favors CABG Capodanno et al, JACC 2011;58:1426-32

All-Cause Death to 4 Years Left Main Subset TAXUS (N=357) CABG (N=348) Before 1 year* 4.5% vs 4.2% P=0.88 1-2 years* 1.9% vs 1.5% P=0.68 2-3 years* 2.3% vs 1.8% P=0.67 3-4 years* 3.0% vs 4.3% P=0.39 25 50 P=0.94 Cumulative Event Rate (%) 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 52 2-Year_Randomized_20090820.doc Exhibits 21 SYNTAX 3-Year Report_Randomized_12JUL10.doc exhibits 21 (KM overall rate), 22 (year 2-3) SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 20 (KM rate on right sidea) and exhibit 22 (binary interval rate in white box) 11.4% 11.2% 12 48 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population 8

MACCE to 4 Years Left Main Subset TAXUS (N=357) CABG (N=348) Before 1 year* 13.7% vs 15.8% P=0.44 1-2 years* 7.5% vs 10.3% P=0.22 2-3 years* 5.2% vs 5.7% P=0.78 3-4 years* 6.4% vs 8.3% P=0.35 25 50 P=0.14 33.2% Cumulative Event Rate (%) 1 yr data From SYNTAX_CSR_randomized_Unblinded_2008Oct10.doc exhibit 52 2-Year_Randomized_20090820.doc Exhibits 21 SYNTAX 3-Year Report_Randomized_12JUL10.doc exhibits 21 (KM overall rate), 22 (year 2-3) SYNTAX 4-Year Report_Randomized_15JUN11.doc exhibits 20 (KM rate on right sidea) and exhibit 22 (binary interval rate in white box) 27.8% 12 48 24 36 Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value;*Binary rates ITT population 9

MACCE to 4 Years by SYNTAX Score Tercile Low Scores (0-22) TAXUS (N=118) CABG (N=104) CABG PCI P value Death 9.2% 7.1% 0.54 CVA 4.1% 1.8% 0.28 MI 3.1% 4.3% 0.64 Death, CVA or MI 14.2% 12.3% 0.60 Revasc. 16.8% 18.2% Left Main > Months Since Allocation Cumulative Event Rate (%) 12 24 50 25 48 36 > 28.4% P=0.60 < 4-Year_Randomized_SX0-22(Core)-LM(Site)_18JUL11.doc exhibit 1 26.0% > < Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

MACCE to 4 Years by SYNTAX Score Tercile High Scores (33) TAXUS (N=135) CABG (N=149) CABG PCI P value Death 10.5% 17.9% 0.06 CVA 4.9% 1.6% 0.14 MI 6.1% 10.9% 0.18 Death, CVA or MI 18.5% 23.1% 0.33 Revasc. 11.8% 31.3% <0.001 Left Main < 42.6% Months Since Allocation Cumulative Event Rate (%) 12 24 50 25 48 36 P<0.003 > < 4-Year_Randomized_SX 33+(Core)-3VD(Site)_18JUL11.doc exhibit 1 26.3% < < Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population

Vessel Distribution in LM Population According to Syntax Score Terciles LM Lesion Locations by SX Tertile 17SEP09.rtf \\Natfile06\depts\Clinical\Clinical Communications\Projects\IC\TAXUS\SYNTAX\Data Tables\LM and LM subgroups 35% 61% 4% 59% 29% 11% 66% 27% 7% Distal Nondistal Both 0-22 23-32 33+

Appropriateness Criteria for PCI JACC Vol. 53, No. 6, 2009

“SAFE” PCI L Main S Selection criteria, Scores, Syntax A Access, Adjunctive therapies, Angiographic angles, Approach F Finesse – techniques, tips and tricks E Evaluation - In real time, immediately post procedure (angiographic, IVUS/OCT and longer term

Access Site Selection – Radial vs Femoral

Adjunctive Therapy

Bleeding Risk Distribution of the Integer Risk Score and Consequent Probability of a Major Non–CABG-Related Bleed Within 30 Days JACC Vol. 55, No. 23, 2010 Mehran et al. 2561 June 8, 2010:2556–66

Angiographic Projections (General Principles) RAO Cau/ PA Cra or RAO Cra AP Caud/LAO Cra LAO/LAO Cau LAO Cra/RAO Cra Left Main stem RAO Caud/LAO Caud RAO Caud LAO/RAO or Lateral RAO Cra/LAO Cra Grossman 7th Edn

“SAFE” PCI L Main S Selection criteria, Scores, Syntax A Access, Adjunctive therapies, Angiographic angles, Approach F Finesse – techniques, tips and tricks E Evaluation - In real time, immediately post procedure (angiographic, IVUS/OCT and longer term

Left Main Techniques

Finesse

Finesse Use shallow AP Caudal and RAO AP Cranial Views Type of guide depends on position of L Main lesion but short tip & larger guides. With ostial and prox lesion engage and disengage by gentle rotation rather than advancing and retracting. Use IVUS to assess vessel size, lesion length, LAD and LCx ostial involvement and mal-apposition once stented. Use two wires if the adjacent ostium is compromised and crossover is necessary. USE an appropriately sized DES with good radial strength and side branch access if needed Avoid excessive aortic stent overhang

Tip 1 Not all left main lesions are actually left main lesions Particularly ostial lesions

Ostial Left Main

Tip 2 The Left Main Coronary is frequently much larger than you think

L Main Identifying Normal Ref Vessel

Tip 3 Ostial L Main Coronary lesions are often eccentric even when they appear concentric. Ostial lesions often distort and displace the true ostium. The degree of aortic plaque extension is a key factor in determining the suitability for stenting Stenting large ostial “lip” protruding into the L coronary Cusp will result in free stent overhang Eccentric plaques with minimal protrusion into the aorta are favourable targets for stenting Concentric ostial lesions with symmetrical aortic protrusion are the best and safest targets.

Eccentric Ostial L Main

Eccentric Ostial L Main Stent Protusion Distal LM L Cor Cusp

Concentric Ostial L Main Stenting

Tip 4 Distal L Main lesions invariably involve the ostium of LAD and or LCx. The extent of Ostial LAD and LCX determines the need for cross-over stenting or bifurcation stenting. Cross-over stenting rarely compromises the adjacent vessel if its ostium is disease free and > 3mm The choice of 2 stent bifurcation technique depends on anatomy

L Main-LAD Lesion Cross-over Stenting to LAD

Tip 5 Malapposition is very common in L Main stenting. Underestimate vessel size Reluctance to use large balloons Malapposition is difficult to avoid with L Main crossover or bifurcational techniques due to size mismatch. IVUS plays a pivotal role in detecting and resolving this problem

Most Useful Tip for L Main PCI DES are not a replacement for perfect technique

“SAFE” PCI L Main S Selection criteria, Scores, Syntax A Access, Adjunctive therapies, Angiographic angles, Approach F Finesse – techniques, tips and tricks E Evaluation - In real time, immediately post procedure (angiographic, IVUS/OCT and longer term

Selection for “SAFE” L Main PCI Is PCI the appropriate strategy? (Heart team forum, Appropriateness criteria) What are the peri procedural MACE risks? (Syntax NCDR Risk score) Step 3: What are the anatomical subtleties/complexities in angiography that preclude a safe and successful procedure? (CTA, coronary angiography) Step 4: What are the procedural strategies that will help in keeping the procedure simple, safe and elegant? Step 5: What are the post procedural risks for bleeding and contrast induced kidney injury?