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Perspectives of Transcatheter Aortic Valve
Implantation in Asia: What are the next steps
and what are the limitations?
Paul Chiam
Cardiologist
Adjunct Associate Professor
National University of Singapore
Mount Elizabeth
Hospital Singapore
Patient with severe AS.
Rejected for surgery (extreme risk).
No other options.
Circulation 2002
Medtronic CoreValve
Edwards Sapien XT valve
(Self-expandable)
(Balloon-expandable)
Both achieved European CE mark 2007
PARTNER (Placement of Aortic
Transcatheter Valves) Study Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
Total = 1,057 patients
N = 699
High Risk
Inoperable
2 Parallel Trials:
Individually Powered
ASSESSMENT:
Yes
Transfemoral
Access
Transfemoral (TF)
1:1 Randomization
ASSESSMENT:
No
Transfemoral
Access
Transapical (TA)
1:1 Randomization
Yes
No
1:1 Randomization
N = 244
N = 248
N = 104
N = 103
N = 179
N = 179
TF TAVR
AVR
TA TAVR
AVR
TF TAVR
Standard
Therapy
VS
N = 358
VS
Primary Endpoint: All-Cause Mortality at 1 yr
(Non-inferiority)
Not In Study
VS
Primary Endpoint: All-Cause Mortality
Over Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortality
and Repeat Hospitalization (Superiority)
Cohort B (inoperable)
All cause mortality
Standard Rx
All-cause mortality (%)
TAVI
∆ at 1 yr = 20.0%
NNT = 5.0 pts
50.7%
30.7%
HR [95% CI] =
0.54 [0.38, 0.78]
P (log rank) < 0.0001
Months
Numbers at Risk
TAVI
Standard Rx
179
179
138
121
122
83
67
41
26
12
All-Cause Mortality (ITT)
Crossover Patients Censored at Crossover
Standard Rx (n = 179)
TAVR (n = 179)
93.6%
All-Cause Mortality (%)
80.9%
87.5%
68.0%
71.8%
50.8%
64.1%
53.9%
43.0%
30.7%
HR [95% CI] = 0.50 [0.39, 0.65]
p (log rank) < 0.0001
Months
* In an age and gender matched US population without comorbidities,
the mortality at 5 years is 40.5%.
Median Survival
11.1 Months
p (log rank) < 0.0001
29.7 Months
Months
PARTNER (Placement of Aortic
Transcatheter Valves) Study Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
Total = 1,057 patients
N = 699
High Risk
Inoperable
2 Parallel Trials:
Individually Powered
ASSESSMENT:
Yes
Transfemoral
Access
Transfemoral (TF)
1:1 Randomization
ASSESSMENT:
No
Transfemoral
Access
Transapical (TA)
1:1 Randomization
Yes
No
1:1 Randomization
N = 244
N = 248
N = 104
N = 103
N = 179
N = 179
TF TAVR
AVR
TA TAVR
AVR
TF TAVR
Standard
Therapy
VS
N = 358
VS
Primary Endpoint: All-Cause Mortality at 1 yr
(Non-inferiority)
Not In Study
VS
Primary Endpoint: All-Cause Mortality
Over Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortality
and Repeat Hospitalization (Superiority)
Cohort A –
High risk
0.5
Primary Endpoint:
All-Cause Mortality at 1 Year
HR [95% CI] =
0.93 [0.71, 1.22]
P (log rank) = 0.62
TAVR
AVR
0.4
26.8
0.3
0.2
24.2
0.1
0
0
6
No. at Risk
12
18
24
Months
TAVR
348
298
260
147
67
AVR
351
252
236
139
65
All-Cause Mortality (ITT)
HR [95% CI] =
0.93 [0.74, 1.15]
p (log rank) = 0.483
44.8%
44.2%
34.6%
26.8%
33.7%
24.3%
No. at Risk
TAVR
348
298
261
239
222
187
149
AVR
351
252
236
223
202
174
142
All-Cause Mortality or Strokes (ITT)
HR [95% CI] =
0.98 [0.79, 1.21]
p (log rank) = 0.839
47.1%
45.9%
36.9%
28.6%
36.1%
27.4%
No. at Risk
TAVR
348
287
250
228
211
176
139
AVR
351
246
230
217
197
169
139
NYHA Class Survivors (ITT)
p = NS
p = NS
p = 0.001
p = NS
17%
13%
15%
24%
p = NS
19%
15%
14%
Percent of Patients
35%
94%
IV
94%
III
II
I
No. at Risk
348 349
307 266
250 226
205 186
151 133
Baseline
30 Days
1 Year
2 Years
3 Years
Pivotal Trial Design
TCT 2013 LBCT
Extreme Risk Study | Iliofemoral Pivotal
1
Primary Endpoint: 1 Year All-cause Mortality
ACC 2014
Surgical
Transcatheter
19.1%
14.2%
4.5%
P = 0.04 for superiority
3.3%
14
2-year All-Cause Mortality
Δ = 6.5
Δ = 4.8
28.6%
18.9%
22.2%
14.1%
Log-rank P=0.04
Months Post-Procedure
No. at Risk
Transcatheter
391 378
354
334
219
Surgical
359 343
304
282
191
15
All Stroke
16
Echocardiographic Findings
TAVR had significantly better valve performance over SAVR at all follow-up visits (P<0.001)
17
NYHA Class
18
Conclusion
• We found that survival at 1 and 2 years was
superior in patients that underwent transcatheter
replacement with CoreValve
19
Transcatheter or Surgical Aortic Valve
Replacement in Intermediate Risk Patients
with Aortic Stenosis:
Final Results from the PARTNER 2A Trial
ACC 2016 | Chicago | April 2, 2016
The PARTNER 2A Trial
Study Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT by Heart Valve Team
Operable (STS ≥ 4%)
Randomized Patients
n = 2032
ASSESSMENT:
Transfemoral Access
Yes
No
Transfemoral (TF)
Transapical (TA) / TransAortic (TAo)
1:1 Randomization (n = 1550)
1:1 Randomization (n = 482)
TF TAVR
(n = 775)
VS.
Surgical AVR
(n = 775)
TA/TAo TAVR
(n = 236)
VS.
Primary Endpoint: All-Cause Mortality or Disabling Stroke at Two Years
Surgical AVR
(n = 246)
Primary Endpoint (ITT)
All-Cause Mortality or Disabling Stroke
All-Cause Mortality or Disabling Stroke (%)
1
50
Surgery
HR [95% CI] = 0.89 [0.73, 1.09]
p (log rank) = 0.253
TAVR
40
30
21.1%
20
16.4%
19.3%
8.0%
10
14.5%
6.1%
0
0
3
6
1021
1011
12
15
18
21
24
735
811
717
801
695
774
Months from Procedure
Number at risk:
Surgery
TAVR
9
838
918
812
901
783
870
770
842
747
825
All-Cause Mortality or Disabling Stroke (%)
TF Primary Endpoint (AT)
All-Cause Mortality or Disabling Stroke
1
50
TF Surgery
HR: 0.78 [95% CI: 0.61, 0.99]
p (log rank) = 0.04
TF TAVR
40
30
20.0%
20
15.8%
16.3%
7.5%
10
11.7%
4.5%
0
0
3
6
12
15
18
21
24
Months from Procedure
Number at risk:
TF Surgery 722
TF TAVR
762
9
636
624
600
591
573
565
555
537
717
708
685
663
652
644
634
612
The PARTNER 2A Trial
Conclusions
In intermediate-risk patients with symptomatic severe
aortic stenosis,
• TAVR using SAPIEN XT and surgery were similar
for the all-cause mortality or disabling stroke at 2 years.
• In the transfemoral subgroup (76% of patients), TAVR
reduced all-cause mortality or disabling stroke (p = 0.05).
Published online 1st April 2016
Edwards Sapien valve
Patient alive and well at 7.5 years – now 84 years old
NYHA class I-II; mean valve gradient 18 mmHg
