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