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Dr.Ibrahim Al Rashdan


    

 

Mr. MS 59 year old Non diabetic. Recent NSTEMI Cardiac cath showed Left main LAD and LCX disease. He was referred for CABG. As he is managing a large family charity organization abroad he cannot afford to be off and thus declined CABG.


 With right radial approach.  Wiring, predilatation.  3 stents with final kissing, CMT technique.


ď‚— Procedure time less than 30 minutes. ď‚— Patient fully mobile and functional virtually same

day.


Experienced operators have developed a good eye and brain for selecting the right case for PCI procedures. The Syntax score which is an effort to replace the experienced eye has achieved its promise only partially. (inter-observer variability of scoring). We tend to study the anatomy in greater details understanding the capabilities of our current devices. The local surgical expertise, and patient related medical and social aspects should be accounted for.


STRENGTH 

Almost all-comers trial 71% of screened patient included. First use of anatomical variable SYNTAX SCORE. Randomized after heart team agreement.

WEAKNESSES 

First generation DES Taxus, with known prolonged non healing. Non inferiority trial with PE unmet.


All-Cause Death to 5 Years TAXUS (N=903)

Cumulative Event Rate (%)

CABG (N=897)

50

Before 1 year* 3.5% vs 4.4% P=0.37

1-2 years* 1.5% vs 1.9% P=0.53

2-3 years* 1.9% vs 2.6% P=0.32

3-4 years* 2.2% vs 3.2% P=0.22

4-5 years* 3.1% vs 2.3% P=0.34

P=0.10 25

0

13.9% 11.4% 0

12

24 36 Months Since Allocation

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

SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 11

48

60 ITT population


Repeat Revascularization to 5 Years TAXUS (N=903)

Cumulative Event Rate (%)

CABG (N=897)

50

Before 1 year* 5.9% vs 13.5% P<0.001

1-2 years* 3.7% vs 5.6% P=0.06

2-3 years* 2.5% vs 3.4% P=0.33

3-4 years* 1.6% vs 4.2% P=0.002

4-5 years* 1.9% vs 4.3% P=0.008

P<0.001 25.9% 25

0

13.7%

0

12

24 36 Months Since Allocation

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

SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 12

48

60 ITT population


Per Protocol Graft Occlusion or Stent Thrombosis to 5 Years (Per Patient Binary Rates)

Patients (%)

7

0

7

CABG

0.3

0.3

(3/870)

(3/868)

2.0 0

0.2 (2/896)

Acute ≤1d

7

PCI

1.4 0.2 (12/854)

0.9

0.8

(2/812)

(6/790)

0.6

0.5

0.4

0.4

(3/764)

(3/729)

0.9

0.7

(18/893)

(8/874)

(5/850)

(4/830)

(7/803)

(5/768)

2-30d

31-365d

366730d

7311095d

10961460d

14611825d

Subacute

Late

Very Late

Days Postprocedure

0

7

0

5.5 (32/581)

6.6 (47/708)

Total

5 year

Per protocol GO and ST: clinical presentation of ACS with angiographically confirmed occlusion within/adjacent to a previously successfully treated lesion/graft during follow-up and/or Q-wave MI in the treated vessel territory within 30 d of the index procedure. Numbers are per patient, 1PCI patient had an ST 1d and 6d post-procedure; therefore, counted in the ≤1d and 2-30d intervals but only once in the total.

SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 13


MACCE to 5 Years by SYNTAX Score Tercile Low Scores (0-22) CABG (N=275) TAXUS (N=299)

Overall

Cumulative Event Rate (%)

50

32.1%

P=0.43

25

28.6%

CABG

PCI

P value

Death

10.1%

8.9%

0.64

CVA

4.0%

1.8%

0.11

MI

4.2%

7.8%

0.11

14.9%

16.1%

0.81

16.9%

23.0%

0.06

Death, CVA or 0

MI 0

12

24

36

48

60

Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value

SYNTAX 5-year Outcomes • ESC 2012 • Mohr • August 2012 • Slide 14

Revasc .

Core lab-reported Data; ITT population


 

In the left main subset of Syntax. The only penalty to pay wit PCI is Target Vessel Revascularization. 11.2% higher in PCI compared to CABG (26.7%-15.5%). This is in exchange with higher stroke rates with CABG 4.3% compared to 1.5%in PCI. (2.8% absolute difference). TVR is a short lived procedure compared to a permanent CVA, thus correct weightage should be given to its impact on patients


STRENGTHS   

Only DM patients. NHLBI Funded. randomized

WEAKNESSES 

 

Only 5% of screened patient finally included. Therefore its representation of real world questionable. First generation DES Average syntax score 26


TRIAL SCREENING & ENROLLMENT 32,966 Patients were screened for eligibility 3,309 were eligible (10%) 1,409 did not consent

1,900 consented (57%)

953 Randomized to PCI/DES* 5 underwent CABG 3 withdrew prior to procedure 3 died prior to procedure 3 underwent neither PCI/DES or CABG

947 Randomized to CABG 18 underwent PCI/DES 26 withdrew prior to procedure 3 died prior to procedure 7 underwent neither PCI/DES or CABG

16 withdrew post-procedure 43 were lost to follow-up

36 withdrew post-procedure 51 were lost to follow-up

nd 947 included ITT analysis using all available follow-up time post-randomiz


PRIMARY OUTCOME – DEATH / STROKE / M PCI/DES CABG Logrank P=0.005

Death/Stroke/MI, %

30

PCI/DES

20

CABG 10

5-Year Event Rates: 26.6% vs. 18.7%

0 0

1

2

3

4

5

6

Years post-randomization PCI/DES N 953 219 40

848

788

625

416

CABG N 943

814

758

613

422


STROKE Severely Disabling Scale CABG

30

Stroke, %

PCI/DES

20

NIH > 4 55% Rankin >1 70%

27% 60%

CABG PCI/DES

Logrank P=0.034 10

5.2%

CABG PCI/DES

0

0

1

2

2.4% 3

Years post-randomization

4

5

PCI/DES N 953

891

833

673

460

241

CABG N 947

844

791

640

439

230


Repeat Revascularization, %

REPEAT REVASCULARIZATION PCI/DES CABG

30

Log rank P<0.0001 20

13% PCI/DES

10

5% CABG

0 0

1

2

3

4

5

6

7

8

9

10

11

12

Months post-procedure PCI/DES N944 CABG N911

887 858

856 836

818 825

792 806


 

 

These observations portrait the effect of the first generation DES on selected patients. The long term first generation DES had well documented late non healing, mostly related to the polymer in use. The first generation DES (Cypher and TAXUS) are not used any more. This has been addressed by the newer generation DES with better polymer profile, biodegradable polymer, or fully bioresorbable vascular scaffolds. The latest Bioresorbable Vascular Scafolds adds new dimension to PCI as a vehicle for vascular reperative therapy.


Case KHU PHR  62 year old Man  HTN, No DM  Known CAD recent NSTEMI, CCS III angina  Normal LV  3VD and diffuse LAD disease  CABG thought suboptimal by the surgeons due to

diffuse LAD disease


Severe Diffuse Calcific LAD stenosis, OM1, OM2 Om3 disease, Sever Dominant LCX disease


We used Rotablation based on Floro calcification


Final Angiographic results After 3 BVS in LAD

VRT in this LAD will render it suitable for future CABG if need arise


LCX and OM treated with DES

Direct Stenting of LCX 3.5 X 15 DES and stenting of OM1 with 2.5 X 23 mm DES after predilatation


Before

After 2 DES of LCX and OM


conclusion  PCI is advancing in its techniques and technologies.  Experienced operators can select the suitable cases

for PCI.  Some very complex lesions can be treated with simple strategies in PCI.  The Data of older generation Stents should be used with the knowledge of their shortcomings.  Within the selected cases there is no real penalties to pay for PCI vs. CABG except the higher TVR which can be offset by higher weightage of Stroke in CABG


Back to the first patient ď&#x201A;&#x2014; It is my honor to share with you, this wonderful gift I

received from the first patient shown in the presentation the manager of a large family charity organization. ď&#x201A;&#x2014; A poem hand written by the patient on the hospital prescription pad prior to his discharge,


SPIRIT IV: Stent Thrombosis Stent thrombosis (%) ARC Definite or Probable

XIENCE V (n=2458) TAXUS Express (n=1229)

HR [95%CI] = 0.27 [0.11, 0.67] p=0.003

1.06% Î&#x201D; 0.77%

0.29% Months

Number at risk XIENCE V

2458

2426

2412

2388

2376

TAXUS

1229

1195

1184

1174

1166

Stone GW. NEJM 2010;362:1663-74.


COMPARE 2° Endpoint Result

Stent Thrombosis (ARC definite or probable) Stent thrombosis (%)

5

Taxus Liberté (n=903) Xience V (n=897)

4

P = 0.002

(log-rank test)

RR = 0.26 (0.11-0.64)

3

2.6 %

2

1

0.7 %

0 0

30

60

90

120

150

180

210

240

270

300

Days Since Index Procedure

Kedhi et al. Lancet 2010 on-line

330 360


Stent Thrombosis in RESOLUTE All-Comers (ARC Def/Prob) Definite Stent Thrombosis

Cumulative Incidence of Events (%)

2.0

Cardiac death MI (according to ARC definition) Target-lesion revascularization

1.5

Probable Stent Thrombosis

Cardiac death MI (according to ARC definition)

Zotarolimus

P=0.05

1.0

0.5

0.0

Everolimus

0

10 20 30 Days since Initial Procedure Serruys PW et al. NEJM 2010; on-line.

270 360

SHA24/075001  

Presentation