STEMI直接PCI时该不该处理
“非罪犯”病变？
广东省人民医院
陈纪言 杨峻青
• PCI患者完全重建优于不完全重建
不完全重建和死亡率
propensity-matched analysis of 6,511 pairs
95% CI
P Value
HR
Incomplete
1.16
1.06-1.27
0.001
One-Vessel
Incomplete
1.13
1.02-1.25
0.01
Multivessel
Incomplete
1.27
1.03-1.57
0.03
• STEMI患者完全重建也显优势
Meta-analysis of 19 trials: Multivessel PCI
Comparable to Culprit-Only Approach in
STEMI
Early outcomes (≤ 30 days)
2.0 ± 1.1 years follow-up
OR
95% CI
Repeat PCI
0.57
0.43-0.77
0.40-0.73
CABG
0.47
0.32-0.68
0.57-0.82
Stent
Thrombosis
1.28
0.62-2.61
MACE
0.60
0.50-0.72
OR
95% CI
Repeat PCI
0.56
0.32-0.98
CABG
0.54
MACE
0.68
Bangalore S, Am J Cardiol. 2011.
• 然而既往指南：直接PCI时只干预罪犯病变
指南2012：直接PCI
ESC2012 Guideline on STEMI
指南2013：直接PCI
ACCF/AHA 2013 Guideline on STEMI
APEX-AMI trial: complete intervention in
Primary PCI harms
Clinical Outcomes at 90 Days
Complete
Culprit
intervention Vessel PCI
P Value
Death
12.5%
5.6%
< 0.001
Death, CHF,
Shock
18.9%
13.1%
0.011
Toma M, Eur Heart J. 2010
• 除非心源性休克或严重心衰
Multivessel vs. Culprit-Only Primary PCI in
STEMI Patients with Shock, Cardiac Arrest
• 169 STEMI patients with resuscitated cardiac
arrest and cardiogenic shock and multivessel
disease.
– Six-month survival was improved with multivessel
PCI compared with culprit-only PCI (43.9% vs.
20.4%; P = 0.0017).
– The survival advantage was driven by a reduction
in the composite of recurrent cardiac arrest and
death from shock (50.0% vs. 68.0%; P = 0.024).
• 非罪犯血管：
– 延迟干预
– 狭窄程度、症状、功能学检查
欧洲指南2012：非梗塞支处理
ESC2012 STEMI
指南2013：非罪犯血管
ACCF/AHA 2013 Guideline on STEMI
指南2013：非罪犯血管
ACCF/AHA 2013 Guideline on STEMI
非罪犯血管：FFR可信
All Patients (n=101)
STEMI Patients (n=75)
NSTEMI
Patients (n=26)
Ntalianis A, JACC CI. 2010;3:1274
Acute Phase
1-month
Follow-up
P Value
0.77 ± 0.13
0.77 ± 0.13
NS
0.78 ± 0.10
0.76 ± 0.10
NS
0.77 ± 0.10
0.77 ± 0.20
NS
• 新证据支持直接PCI时完全重建
Propensity-Matched Mortality Rates by
Revascularization Strategy During Index
Procedure
Mortality
In-Hospital
24 Months
42 Months
Culprit
Multivessel
Vessel
at Time of
Alone at Primary PCI
Time of
(n = 458)
Primary PCI
(n = 458)
0.9%
2.4%
4.9%
7.2%
6.7%
10.4%
Hannan EL, JACC CI. 2010;3:22-31
P Value
0.04
0.07
0.08
• 新证据支持直接PCI时完全重建
– PRAMI研究
Preventive Angioplasty in Myocardial Infarction
N Engl J Med September 1st 2013;369. DOI: 10.1056/NEJMoa1305520
Acute STEMI
Exclusions
Previous CABG
Cardiogenic Shock
Left main stem >50%
Chronic total occlusion
Successful
Infarct-artery PCI
Multivessel Disease
(>50% stenosis in noninfarct-artery suitable for PCI)
Randomise
600
(target)
300
Preventive PCI
300
No Preventive PCI
Follow-up at 6 weeks and then annually
Trial stopped early
• On 24th Jan 2013, after 465 patients
• Recommendation of Data and Safety
Monitoring Committee
• Clear result
PRAMI
Freedom from
Primary Outcome (%)
Primary endpoint: Cardiac death, MI or refractory angina
Culprit PCI only
10
0
91%
80
60
40
HR 0.35 (95%CI 0.21-0.58)
P<0.001
20
0
0
No. at Risk
Preventive PCI
No Preventive PCI
77%
Complete revasc
6
12
18
24
30
36
118
96
89
74
67
50
Months
234
231
196
168
166
144
146
122
Wald DS et al. NEJM 2013
PRAMI
Median FU 2.3 Years
Complete
revasc
(N=234)
Culprit
PCI only
(N=231)
HR
(95%CI)
P value
Cardiac death, MI, or refractory
angina
21
53
0.35 (0.21-0.58)
<0.001
Cardiac death or MI
11
27
0.36 (0.18-0.73)
0.004
Cardiac death
4
10
0.34 (0.11-1.08)
0.07
Nonfatal MI
7
20
0.32 (0.13-0.75)
0.009
Refractory angina w/o CD or MI
12
30
0.35 (0.18-0.69)
0.002
Noncardiac death
8
6
1.10 (0.38-3.18)
0.86
Repeat revascularization
16
46
0.30 (0.17-0.56)
<0.001
Pre-specified outcomes
Secondary outcomes
Wald DS et al. NEJM 2013
• 新证据支持直接PCI时完全重建
– PRAMI研究
– CvLPRIT研究
CvLPRIT study
• 298 STEMI patients
• Randomised open-label study
• Compared treatment of IRA only (146 pts) with
complete revascularisation (150 pts) during index
admission for ST-elevation Myocardial Infarction
• Randomisation stratified for:
- site of infarct (Anterior vs. non-anterior)
- Symptom onset to balloon time (less than or greater
than 3hrs)
• 1o outcome: MACE – total mortality/recurrent MI/heart
failure and ischaemia-driven revascularisation at 12
months
Results 1: Percent MACE at 12 months
The primary endpoint composite of total mortality, recurrent MI, heart
failure and ischaemia-driven revascularisation at 12 months
IRA Only
Complete Revascularisation
26
MACE to 30 days
Variable
IRA only
(N=146)
Complete
Revascularisation
HR (95% CI)
P value
15 (10.0)
0.45 (0.24, 0.84)
0.009
2 (1.3)
2 (1.3)
4 (2.7)
7 (4.7)
0.32 (0.06, 1.60)
0.48 (0.09, 2.62)
0.43 (0.13, 1.39)
0.55 (0.22, 1.39)
0.14
0.39
0.14
0.2
4 (2.7)
2 (1.3)
5 (3.3)
8 (5.3)
0.38 (0.12, 1.20)
0.47 (0.09, 2.59)
0.47 (0.16, 1.38)
0.46 (0.20, 1.08)
0.09
0.38
0.16
0.07
2 (1.3)
2 (1.3)
4 (2.7)
0.27 (0.06, 1.32)
0.95 (0.13, 6.77)
0.55 (0.16, 1.87)
0.11
0.96
0.34
(N=150)
Time to First Event
MACE
31 (21.2)
All-cause mortality
6 (4.1)
Recurrent MI
4 (2.7)
Heart failure
9 (6.2)
Repeat
12 (8.2)
Revascularisation
Total number of events reported
All-cause mortality
10 (6.9)
Recurrent MI
4 (2.7)
Heart Failure
10 (6.9)
Repeat
16 (11.0)
Revascularisation
Adverse Events reported
CV mortality
7 (4.8)
Stroke
2 (1.4)
Major Bleed
7 (4.8)
Limitations of CvLPRIT
• Small study but significant outcome
• No FFR or IVUS of the N-IRA lesions
• Open study
ITT Population
Variable
IRA only
Complete
HR (95%
Revasculari
CI)
P
sation
All-cause mortality
14/146
6/150
0.41 (0.16,
or Recurrent MI
(9.6%)
(4.0%)
1.07)
All-cause mortality,
19/146
8/150
0.40 (0.18,
Recurrent MI or
(13.0%)
(4.7%)
0.92)
Heart Failure
0.060
0.025
• 新证据支持直接PCI时完全重建
– PRAMI研究
– CvLPRIT研究
– RCT荟萃分析
Meta-analysis of RCTs comparing
complete and culprit-only
revascularisation
• Search conducted in MEDLINE, EMBASE, PUBMED,
ISI Web of Science, conference abstracts.
• Only randomised controlled trials included
• 4 RCTs identified
• Total of 1,044 patients (478-culprit only,
687-complete revascularisation)
• Pooled OR using a Fixed-effects model
(Mantel-Haenszel)
• Analysis performed for MACE, Death (all-cause
and cardiac), repeat MI, repeat
revascularisation.
• Minimum follow-up 12 months (23 months PRAMI,
30 months Politi et al).
MACE
Study
%
All-cause Mortality
ID
OR (95% CI)
Weight
DiMario 2004
1.02 (0.04, 26.19)
1.79
Politi 2010
0.46 (0.19, 1.09)
36.05
Wald 2013
0.73 (0.34, 1.57)
37.77
Gershlick 2014
0.37 (0.11, 1.22)
24.39
Overall (I-squared = 0.0%, p = 0.745)
0.55 (0.33, 0.91)
100.00
.1
Favours Multi-vessel PCI
1
10
Favours Culprit-only PCI
Study
Repeat Revascularisation
%
ID
OR (95% CI)
Weight
DiMario 2004
0.38 (0.11, 1.31)
7.76
Politi 2010
0.24 (0.12, 0.49)
31.52
Wald 2013
0.30 (0.16, 0.54)
44.78
Gershlick 2014
0.46 (0.19, 1.11)
15.94
Overall (I-squared = 0.0%, p = 0.715)
0.31 (0.21, 0.46)
100.00
.1
Favours Multi-vessel PCI
1
10
Favours Culprit-only PCI
Study
Repeat Myocardial Infarction
%
ID
OR (95% CI)
Weight
DiMario 2004
0.31 (0.02, 5.20)
4.49
Politi 2010
0.53 (0.17, 1.64)
24.49
Wald 2013
0.33 (0.13, 0.79)
58.95
Gershlick 2014
0.48 (0.09, 2.66)
12.08
Overall (I-squared = 0.0%, p = 0.911)
0.39 (0.21, 0.73)
100.00
.1
Favours Multi-vessel PCI
1
10
Favours Culprit-only PCI
Cardiovascular Mortality
Study
%
ID
OR (95% CI)
Weight
DiMario 2004
1.02 (0.04, 26.19)
2.48
Politi 2010
0.36 (0.13, 1.03)
39.68
Wald 2013
0.38 (0.12, 1.24)
33.87
Gershlick 2014
0.27 (0.05, 1.31)
23.97
Overall (I-squared = 0.0%, p = 0.911)
0.36 (0.18, 0.71)
100.00
.1
Favours Multi-vessel PCI
1
10
Favours Culprit-only PCI
• 指南更新
欧洲重建指南2014
欧洲重建指南
2014：STEMI
• 实践
Management of Non-Culprit Lesions Identified at the time of Primary PCI
Immediate
PCI
Staged
PCI
50-70%
Medical
therapy
Immediate
PCI
Staged
PCI
70-90%
Medical
therapy
Immediate
PCI
Staged
PCI
>90%
Medical
therapy
Procedure time and radiation
Preventive
PCI
No Preventive
PCI
Increase
Procedure
time (minutes)
63
45
40%
Radiation
dose (Gycm2)
90
71
27%
• 理解指南
可以 ≠ 必须
• It remains to be determined how
clinicians can identify lesions that
should be revascularized beyond the
culprit lesion and whether complete
revascularization should be performed in
single- or multi-stage procedures.
• At present, multivessel PCI during STEMI
should be considered in patients with
cardiogenic shock in the presence of
multiple, critical stenoses or highly
unstable lesions (angiographic signs of
possible thrombus or lesion disruption),
and if there is persistent ischaemia
after PCI on the supposed culprit lesion.
ESC guideline 2014
小结
•
•
•
•
•
PCI完全重建显示获益
STEMI患者亦然
重建时机值得讨论
新的证据支持直接PCI时完全重建
应考虑患者耐受和治疗条件
谢谢！