Download Cardiac patients undergoing non

Antithrombotic therapy: difficult clinical scenarios
Cardiac patients undergoing non-cardiac surgery.
Don Poldermans
Erasmus MC – Rotterdam The Netherlands
ESC Congress 2010 August 29th
500.000.000
inhabitants
40.000.000
surgical procedures annually
400.000
myocardial infarction (1.0%)
133.000
cardiovascular deaths (0.3%)
Perioperative myocardial infarction
Unstable plaque
Aspirin / Thienopyridines
Anticoagulant
Statin
Chronic beta-blocker
Flow limiting stenosis
Beta-blocker
Revascularization
Vulnerable plaques
Preoperative LAD
Vulnerable plaques
Preoperative RCA
Vulnerable plaques
Postoperative
Vulnerable plaques
After stenting
Commonly used antiplatelet agents around
non-cardiac surgery
• Aspirin
• Thienopyridines
• Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Perioperative Considerations
•
Should we initiate aspirin prior to surgery?
•
Weigh risks and benefits of stopping antiplatelet
therapy vs. risks & benefits of continuing therapy.
•
Who are the patients at high risk for having a
perioperative event after cessation of antiplatelet
therapy?
•
Who are the patients at high risk for bleeding?
To continue or discontinue aspirin in the perioperative period:
a randomized, controlled clinical trial: The ASINC study
•
Inclusion:
Patients undergoing elective, high- or intermediate-risk non-cardiac surgery
and having at least one cardiac risk factor.
•
Exclusion:
Warfarin or clopidogrel treatment and intracoronary stent.
•
Study design:
220 / 540 patients were assigned to receive either aspirin 75 mg or placebo.
Patients previously on aspirin were restarted on aspirin treatment
immediately thereafter.
Oscarsson, A. British Journal of Anaesthesia 2010 104(3):305-312
To continue or discontinue aspirin in the perioperative
period: a randomized, controlled clinical trial
Aspirin
(N=109)
Placebo
(N=111)
p-value
4 (3.7%)
10 (9%)
0.1
Myocardial infarction
2
7
Cardiovascular death
1
0
2 (1.8%)
10 (9%)
Troponin
MACE
0.02
Oscarsson, A. British Journal of Anaesthesia 2010 104(3):305-312
To continue or discontinue aspirin in the perioperative
period: a randomized, controlled clinical trial
•
In high-risk patients undergoing non-cardiac surgery, perioperative aspirin
reduced the risk of MACE without increasing bleeding complications.
•
However, the study was not powered to evaluate bleeding complications.
•
Since a vast majority of patients were taking aspirin before operation (90%), it is
impossible to be certain whether the effects seen were a consequence of
aspirin treatment or aspirin withdrawal in patients already on antiplatelet
therapy.
Oscarsson, A. British Journal of Anaesthesia 2010 104(3):305-312
Adverse thrombotic events after aspirin withdrawal
Coronary artery disease
Collet
Ferrari
Newby
Coronary artery stenting
Iakovou
CABG
Dacey
Mangano
Total
0.1
1
Risk estimate
Favors withdrawal
10
100
Favors control
Biondi-Zoccai, Eur Heart J 2006;27:2667-2674
1000
Perioperative aspirin induced complications
Orthopaedic surgery
Anekstein
Connelly and Panush
Ennis
Minor bleeding
>3 units transfusion
PEP trial
Local bleeding
Local bleeding + transfusion
Haematemesis or melaena
Haematemesis or melaena + transfusion
Fatal bleeding
0.1
Less
Burger, J Intern Med 2005;257:399-414
1
10
More bleeding
ESC recommendations on perioperative aspirin use
Recommendation
Continuation of aspirin in patients previously treated with
aspirin should be considered in the perioperative period
Discontinuation of aspirin therapy in patients previous e.g.
treated with aspirin should be considered only in those in
which haemostasis is difficult to control during surgery
IIa B
IIa B
The first stent
in a human being
28.03.1986
J. Puel
Toulouse
Outline
• Dual antiplatelet therapy as a standard of care after
contemporary PCI
• Outcome after intracoronary stenting and unplanned
non-cardiac surgery
• Recommendations for management according to
the new Guidelines
• How to anticipate complications according to the
new guidelines
Pathophysiology of acute perioperative stent thrombosis
• Discontinuation of aspirin / clopidogrel
• Rebound effect:
•
increased inflammatory prothrombotic state
•
increased platelet adhesion and aggregation
• Surgical intervention: increased prothrombotic state
• Incomplete endothelialized stents
• Stent thrombosis
• Myocardial infarction
• Death
Newsome et al. Anesth Analg 2008;107:570–90
Outcome after unplanned surgery
Bare metal stents
n
Reddy
Events
56
38% mortality or MI / 2 weeks after stenting
40
32% mortality / 2 weeks after stenting
AJC 2005
Kaluza
JACC 2000
Sharma
47
26% mortality / 3 weeks after stenting
Cathet Card Interven 2004
Wilson
JACC 2003
207
4% mortality or MI / 6 weeks after stenting
BMS and noncardiac surgery
Days between BMS and
surgery
# Pts
MACE
Bleeding
<30 days
248
26 (10.5%)
17 (6.9%)
31-90 days
260
10 (3.8%)
12 (4.6%)
91-180 days
165
5 (3.0%)
7 (4.2%)
181-365 days
226
6 (2.6%)
7 (3.1%)
TOTAL
899
47 (5.2%)
43 (4.8%)
Nuttall et al. Anesthesiology 2008;109: 583-5
Drug-eluting stents and non-cardiac surgery
Study
Patients (N)
Death
MI
Bleed
DES to Surgery
Antiplatelet
Management
Compton (2007)
38
0
0
0
260 days
(15<180 days)
Continued
ASA 94%
Clopidogrel 39%
Schouten (2007)
99
1
3
2
<2 yrs
(30 prematurely)
Stopped 39%
Conroy (2007)
22
0
3
1
Not stated
MI:7,18,22 months
Continued
ASA 100%
Clopidogrel 36%
Godet (2008)
96
1
12
0
14 months
Continued ASA 67%
Clopidogrel 37%
Rhee (2008)
141
5
7
-
228 days
Unclear
Risk: >7 days off
clopidogrel / Taxus
Brotman (2008)
114
0
2
1
236 days
(45<180 days)
Stopped both 77%
TOTALS
510
7 (1.4%)
27 (5.3%)
4
Erasmus MC databases
Methods
•
PCI database:
13.000 procedures
Noncardiac surgery (NCS): 78.000 procedures
•
Cross match of procedures between 2000 and 2007
•
1000 procedures followed by surgery
 550 NCS: - BMS 174 pt
- DES 376 pt
•
Outcome:
Major Adverse Cardiovascular Events
(MACE) within 30-days from NCS.
Erasmus MC databases
Results
PCI-BMS patients:
• 11 (6%) pt experienced a MACE
• Inverse relationship between
time-interval of PCI-BMS to
NCS and postoperative MACE
Erasmus MC databases
Results
PCI-DES patients:
• 48 (13%) pt experienced a MACE
• Inverse relationship between
time-interval of PCI-BMS to NCS
and postoperative MACE
Influence of antiplatelet therapy during non-cardiac surgery after stent placement
MACE
40%
Single antiplatelet
Dual antiplatelet
30%
20%
10%
0
<30dy
30dy-3mth 3-6mth
6-12mth
>12mth
Time-interval drug eluting stent placement to surgery
Erasmus MC databases
Conclusion
• PCI-BMS: - NCS at least 30 days after PCI
- preferably 90 days
• PCI-DES: - NCS at least 1 year after PCI
• In patients in whom NCS is planned, and prior PCI is
needed, BMS placement might be preferred
Perioperative antithrombotic therapy
Interruption
Continuation
Bleeding risk of total population
Risk of perioperative bleeding
• Rarely life threatening
• There are individual variations in the risk of bleeding
• No test available to determine the risk of bleeding
• Bleeding increases with 2 or more agents
• Certain procedures associated with increased risk
Lecompte et al. Can J Anesth 2006;53:S103-S112
Preoperative coronary revascularization
Time
Randomized
CARP (N = 510)
PCI 41 days
CABG 48 days
DECREASE V (N = 101)
PCI 29 days
CABG 32 days
Not randomized
CASS registry (N = 2617)
4.1 years
Godet et al. (N = 1158)
5 weeks
1 year
Posner et al. (N = 1372)
1
0.1
Revascularization
10
Medical treatment only
ESC recommendations on prophylactic coronary
revascularization in cardiac stable patients
Recommendation
Prophylactic myocardial revascularization prior to high-risk
surgery may be considered in patients with proven IHD.
IIb B
Prophylactic myocardial revascularization prior to
intermediate-risk surgery in patients with proven IHD is not
recommended.
III B
Prophylactic myocardial revascularization prior to low-risk
surgery patients with proven IHD is not recommended.
III C
III C
Anticipate complications
• What if urgent – semi-urgent surgery that cannot be delayed ?
Maintain dual antiplatelet therapy within the time frame
according to the PCI guidelines
Major bleeding
Stent thrombosis
• Continue aspirin – restart clopidogrel as soon as possible
Anticipate complications; role of prophylactic revascularization
Prophylactic myocardial revascularization prior to high-risk surgery
may be considered in patients with proven IHD.
IIb B
Prophylactic myocardial revascularization prior to intermediate-risk surgery
in patients with proven IHD is not recommended.
III B
Prophylactic myocardial revascularization prior to low-risk surgery
patients with proven IHD is not recommended.
III C
If non-cardiac surgery can be postponed safely, it is recommended
that patients be diagnosed and treated in line with
the Guidelines on unstable angina
IA
If PCI is indicated, the use of bare metal stents or
even balloon angioplasty is recommended.
IC
Conclusions
• Failure to comply with the PCI guidelines on dual antiplatelet
therapy in the setting of non-cardiac surgery exponentially
increases the risk for ischaemic – thrombotic complications
=> Respect the time frame
=> Balance risk – benefit
=> Continue aspirin – restart dual therapy promptly
• Except for unstable syndromes, prophylactic
revascularization is not routinely recommended
=> Bare metal stents recommended
Step 7b Extensive stress induced ischaemia
Individualized management
• benefit of the procedure
• predicted adverse outcome
• effect medication/ revascularization
IB
Cardiac stress test
Extensive
ischaemia
Balloon
angioplasty
Surgery > 2 weeks
aspirin
Bare metal stent
Drug eluting stent
Surgery > 6 weeks
Dual anti-platelet
therapy 6 wks – 3 mo
Surgery > 12 months
dual anti-platelet therapy
Surgery
CABG
Case 3
Peripheral arterial bypass surgery because of
critical limb ischaemia
Age: 64 years
Gender: male
Weight: 92 kg
Height: 1.72 m
Case 3
Complaints
Disabling intermittent claudication with critical limb ischaemia
Miller
History
•
Renal dysfunction
•
Transient ischemic attack
•
Hypertension controlled by medical therapy
•
Heart failure symptoms
• Angina
•
pectoris
Previous MI / CABG
Case 3
Risk factors
1. Myocardial infarction
2. Angina pectoris
3. Congestive heart failure
4. Diabetes mellitus
5. History of stroke/TIA
6. Renal dysfunction
Case 3
Medication
Aspirin:
100 mg once daily
Bisoprolol:
2.5 mg once daily
Fosinopril:
20 mg once daily
Fluvastatin XL:
80 mg once daily
Step 1
Urgent surgery
Yes
Patient or surgical specific factors dictate the strategy, and do not
allow further cardiac testing or treatment. The consultant provides
recommendations on perioperative medical management,
surveillance for cardiac events and continuation of chronic
cardiovascular medical therapy.
Yes
Treatment options should be discussed in a multidisciplinary team,
involving all perioperative care physicians as interventions might
have implication on anaesthesiological and surgical care.
Depending on the outcome of this discussion, patients can proceed
for coronary artery intervention, with the initiation of dual-anti
platelet therapy if the index surgical procedure can be delayed, or
directly for operation if delay is impossible with optimal medical
therapy.
Low
The consultant can identify risk factors and provide
recommendations on life style and medical therapy according to
the ESC guidelines for postoperative care to improve long-term
outcome.
No
Step 2
One of active or unstable cardiac conditions
(table XX)
No
Step 3
Determine the risk of the surgical procedure
(table XX)
Other than low
Step 4
Consider the functional capacity of the patient
In patients with coronary artery disease or risk factor(s), statin
therapy and a titrated low dose beta-blocker regimen can be
initiated prior to surgery as outlined in table xx.
>4 METs
< 4 METs
Step 5
Consider in patients with a moderate or less
functional capacity the risk of the surgical procedure
as outlined in table xx
Intermediate risk
surgery
High risk surgery
Step 6
Cardiac risk factors
Statin therapy and a titrated low dose beta-blocker regimen
appears appropriate prior to surgery.
In patients with systolic LV dysfunction ACE-inhibitors are
recommended prior to surgery.
In patients with one or more cardiac risk factors a preoperative
baseline ECG is recommended to monitor changes during the
perioperative period.
Statin therapy and a titrated low dose beta-blocker regimen are
recommended prior to surgery. In patients with systolic LV
dysfunction ACE-inhibitors are recommended prior to surgery.
<2
>3
Step 7
Consider non-invasive testing Non-invasive testing
can also be considered prior to any surgical
procedure for patient counselling, change of
perioperative management in relation to type of
surgery and anaesthesia technique.
Interpretation of non-invasive stress test results
Balloon angioplasty Surgery can be
performed > 2 weeks after
intervention with continuation of
aspirin treatment.
No/mild/
moderate
stress-induced
ischaemia
Extensive
stress-induced
ischaemia
Bare metal stent
Surgery can be performed > 6 weeks after
intervention. Dual anti-platelet therapy
should be continued for at least 6 weeks,
preferable up to 3 months.
Proceed with the planned surgical procedure, it is recommended to
initiate statin therapy and a titrated low dose beta-blocker
regimen.
An individualized perioperative management is recommended
considering the potential benefit of the proposed surgical
procedure compared with the predicted adverse outcome, and the
effect of medical therapy and/or coronary revascularization.
Drug eluting stent
Surgery can be performed within 12
months after intervention, during
this period dual anti-platelet therapy
is recommended
CABG
If applicable, discuss the continuation of chronic aspirin
therapy. Discontinuation of aspirin therapy should be
considered only in those patients in which haemostasis is
difficult to control during surgery.
Surgery
Perioperative cardiac events in patients
undergoing major vascular surgery
Odds Ratio (95% CI)
• Myocardial ischemia
• LV dysfunction
• Aortic stenosis
40 (5.3-292)
3.0 (1.3-6.9)
4.8 (1.4-16)
Echocardiography
40 Atropine 2 mg
30
20
10
13
11
8
10
Dobutamine
5
5
3
LAD
RCA
CX
Severity
Incidence 
Extent
Ischemic
threshold
0
1
2
3
4
5
Dobutamine stress echo
Dobutamine stress echo
Pat. Weg.
Perfusion
Metabolism
Post-lateral
Step 7b Extensive stress induced ischaemia
Individualized management
• benefit of the procedure
• predicted adverse outcome
• effect medication/ revascularization
IB
Cardiac stress test
Extensive
ischaemia
Balloon
angioplasty
Surgery > 2 weeks
aspirin
Bare metal stent
Drug eluting stent
Surgery > 6 weeks
Dual anti-platelet
therapy 6 wks – 3 mo
Surgery > 12 months
dual anti-platelet therapy
Surgery
CABG
Case 3
Successful PCI with a BMS.
Surgery performed after 3 months.
Initial dual antiplatelet therapy.
Anticipate complications
1.
Determine the type of stent(s): BMS or DES
2.
When were stent(s) implanted?
3.
Determine location of stent(s) in coronary circulation
4.
Is there a previous history of stent thrombosis?
5.
What antiplatelet regimen is being followed?
6.
Determine patient’s comorbidities, if any, to further ascertain level of risk
(ejection fraction, diabetes, renal insufficiency)
Summary: Surgery after stent placement
• Continue at least aspirin without interruption
• Continue clopidogrel until 5 days before surgery and resume
ASAP after surgery with a loading dose of 300 mg followed
by 75 mg daily (nasogastric tube)
• Delay elective surgery for at least 6 weeks after BMS
• If surgery planned in patient < 12-months of DES perform
surgery on dual anti-platelet therapy
Indications for preoperative coronary
revascularization
•
Similar to the non-surgical setting.
•
CABG and PCI have similar outcome.
• Anti-platelet
•
therapy should be continued.
Cardioprotective effect proven for left main disease.
Conclusion
• Lack of consensus and lot of controversy
since there is no RCT to guide management
• Patients require an individualized
custom tailored approach
• Need to balance the risk of bleeding and
thromboembolism in every patient
Case
• 69 year old female, presents for a preoperative evaluation for
a right hemicolectomy for colon adenocarcinoma.
• She has a history of Type 2 DM, hyperlipidemia.
• CAD with history of PCI about 2 months ago with coronary
artery stents.
• Her medication include :
clopidogrel, aspirin, metformin, atorvastatin and metoprolol.
What is the best next step in preparation for surgery?
1. Stop aspirin and clopidogrel about 7-days prior to surgery
2. Stop clopidogrel about 7-days before surgery but continue
aspirin
3. Determine more information about the patient’s coronary
artery stents
4. Stop aspirin and clopidogrel about 7-days prior to surgery and
bridge the patient with LMWH starting 2-days before surgery
What is the best next step in preparation for surgery?
1. Stop aspirin and clopidogrel about 7-days prior to surgery
2. Stop clopidogrel about 7-days before surgery but continue
aspirin
3. Determine more information about the patient’s coronary
artery stents
4. Stop aspirin and clopidogrel about 7-days prior to surgery and
bridge the patient with LMWH starting 2-days before surgery
The first thienopyridine use
• P. Barragan et al
Cathet Cardiovasc Diagn 1994
• Ticlopidine & subcutaneous heparin as an
alternative regimen following coronary stenting
Evidence from RCTs
CLASSICS – Bertrand et al, Circulation 2000
Clopidogrel
Clopidogrel
300mg loading 75mg loading &
& ASA 325mg
ASA 325mg
Ticlopidine
500mg & ASA
325mg
Safety
end point*
2.9%
6.3%
9.1%
Efficacy
end point**
1.2%
1.5%
0.9%
*Major bleeding – neutropenia – thrombocytopenia – early study drug discontinuation
** Cardiac death – myocardial infarction – target lesion revascularization
Outcome after unplanned surgery
Drug eluting stents
n
Vincenzi
103
39% cardiac complications
2 fold increase in complications in
recently implanted stents (<35 days)
192
13.3% adverse events for early surgery
0.6% late surgery*
Br J Anesth 2006
Schouten
JACC 2007
*Definition:
Event
Bare metal stent
(1 month),
Sirolimus eluting stent
(3 months)
Paclitaxel eluting stent
(6 months)
Pathophysiology of acute perioperative stent thrombosis
Newsome et al. Anesth Analg 2008;107:570–90
To continue or discontinue aspirin in the perioperative period:
a randomized, controlled clinical trial: The ASINC flowchart
Oscarsson, A. British Journal of Anaesthesia 2010 104(3):305-312
Perioperative myocardial infarction
plaque rupture
demand / supply mismatch
To continue or discontinue aspirin in the perioperative period:
a randomized, controlled clinical trial: The ASINC study
Aim of the study:
To assess the incidence of perioperative myocardial damage in patients with or
without low-dose aspirin treatment starting one week prior to surgery.
Hypothesis:
Low-dose aspirin reduces the incidence of myocardial damage and major adverse
cardiac events (MACEs, defined as acute myocardial infarction, severe arrhythmia,
cardiac arrest, or cardiovascular death) without increasing bleeding complications.
Oscarsson, A. British Journal of Anaesthesia 2010 104(3):305-312
To continue or discontinue aspirin in the perioperative
period: a randomized, controlled clinical trial
Aspirin
(N=109)
Placebo
(N=111)
71.8
72.6
Aspirin
97 (90%)
100 (90%)
Beta-blockers
68 (62%)
66 (59%)
ACE-inhibitors
41 (38%)
51 (46%)
Age
p-value
Study limitation:
The study was underpowered, as only 220 of the 540 planned patients were
enrolled, because of changing in recommendations of aspirin perioperative use.
Oscarsson, A. British Journal of Anaesthesia 2010 104(3):305-312
Perioperative aspirin induced complications
Vascular surgery
Lindblad
Reoperation for bleeding
McCollum
Reoperation for bleeding
All perioperative bleedings
0.1
Less
Burger, J Intern Med 2005;257:399-414
1
10
More bleeding
Aspirin and stroke after carotid surgery
Number event-free
120
ASA (n=117)
110
100
Placebo (n=115)
90
80
0
3
6
Time (months)
Lindblad, Stroke 1993;24:1125-1128
9
12
ESC staff: Keith McGregor, Veronica Dean, Catherine Després
Raffaele De Caterina
Available on www.escardio.org/guidelines
Step 1 Urgent surgery
IC
Urgent surgery
Yes
No
Step 2
Surgery
Patient or surgical specific factors dictate
the strategy, and do not allow further
cardiac testing or treatment. The
consultant provides recommendations
on perioperative medical management,
surveillance for cardiac events and
continuation of chronic cardiovascular
medical therapy.
IIa B
If applicable, discuss the continuation of chronic
aspirin therapy. Discontinuation of aspirin therapy
should be considered only in those patients in
which haemostasis is difficult to control during
surgery.
Aspirin
• Irreversibly inhibits
platelet cyclooxygenase
• Circulating platelet pool is
replaced q 7-10 days
• Therefore stop ASA 7-10
days before surgery
Cattaneo et al. Arterioscler Thromb Vasc Biol 2004;24:1980-1987/ Taggart et al. Ann Thorac Surg 1990:424-428
Thienopyridines
New P2Y12 receptor
antagonists: Cangrelor,
AZD6140 and Prasugrel
• Thienopyridine inhibits
adenosine diphosphate
(ADP) receptor-mediated
platelet activation and
aggregation
• Stop 7 days before
surgery but outcomes
data suggest 5-days may
be enough
Cattaneo. Arterioscler Thromb Vasc Biol 2004;24:1980 / Kapetanakis. Eur Heart J 2005;26:576
Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Reversibly inhibit platelet cyclooxygenase
• Inhibit renal prostaglandin synthesis & can induce renal
failure in combination with other drugs and hypotension
• Cyclooxygenase-2 Inhibitors (COX-2) eg. Celecoxib have
much less effect on platelet function
• In-vitro studies show no increased risk of bleeding with the
Cox-2 agents
• When is it appropriate to stop short acting NSAIDs?
Is 24-hours enough for short acting NSAIDs?
Goldenberg et al. Ann Intern Med 2005;142:506-509
The first bail out stent
12.06.1986 – U. Sigwart - Lausanne
The first stent thrombosis
25.04.1986 – U. Sigwart - Lausanne
The first landmark paper
Angiographic follow-up after placement of a self-expanding coronary-artery stent
Serruys et al, NEJM 1991
BACKGROUND. The placement of stents in coronary arteries after coronary angioplasty has been investigated as a way of treating
abrupt coronary-artery occlusion related to the angioplasty and of reducing the late intimal hyperplasia responsible for gradual restenosis of
the dilated lesion.
METHODS. From March 1986 to January 1988, we implanted 117 self-expanding, stainless-steel endovascular stents (Wallstent) in
the native coronary arteries (94 stents) or saphenous-vein bypass grafts (23 stents) of 105 patients. Angiograms were obtained immediately
before and after placement of the stent and at follow-up at least one month later (unless symptoms required angiography sooner). The
mortality after one year was 7.6 percent (8 patients). Follow-up angiograms (after a mean [+/- SD] of 5.7 +/- 4.4 months) were obtained in 95
patients with 105 stents and were analyzed quantitatively by a computer-assisted system of cardiovascular angiographic analysis. The 10
patients without follow-up angiograms included 4 who died.
RESULTS. Complete occlusion occurred in 27 stents in 25 patients (24 percent) ; 21 occlusions
were documented within the first 14 days after implantation. Overall, immediately after placement of the stent there was a significant
increase in the minimal luminal diameter and a significant decrease in the percentage of the diameter with stenosis (changing from a mean
[+/- SD] of 1.88 +/- 0.43 to 2.48 +/- 0.51 mm and from 37 +/- 12 to 21 +/- 10 percent, respectively; P less than 0.0001). Later, however, there
was a significant decrease in the minimal luminal diameter and a significant increase in the stenosis of the segment with the stent (1.68 +/1.78 mm and 48 +/- 34 percent at follow-up). Significant restenosis, as indicated by a reduction of 0.72 mm in the minimal luminal diameter
or by an increase in the percentage of stenosis to greater than or equal to 50 percent, occurred in 32 percent and 14 percent of patent
stents, respectively.
CONCLUSIONS. Early occlusion remains an important limitation of this coronary-artery stent.
Even when the early effects are beneficial, there are frequently late occlusions or restenosis.
The place of this form of treatment for coronary artery disease remains to be determined.
The first thienopyridine use
Intracoronary Stent Implantation Without Ultrasound Guidance and With
Replacement of Conventional Anticoagulation by Antiplatelet Therapy
30-Day Clinical Outcome of the French Multicenter Registry
Gaetan J. Karrillon, MD; Marie Claude Morice, MD; Edgar Benveniste, MD; Pierre Bunouf, MSC; Pierre Aubry,
MD; Simon Cattan, MD; Bernard Chevalier, MD; Philippe Commeau, MD; Alain Cribier, MD; Charles Eiferman,
MD; Gilles Grollier, MD; Yves Guerin, MD; Michel Henry, MD; Thierry Lefevre, MD; Bernard Livarek, MD; Yves
Louvard, MD; Jean Marco, MD; Serge Makowski, MD; Jean Pierre Monassier, MD; Jean Marc Pernes, MD;
Philippe Rioux, MD; Christian Spaulding, MD; Gilles Zemour, MD
Circulation 1996
N = 2,900 – stent thrombosis : 1.8%
Evidence from RCTs
stent thrombosis
Trial
No pts
ISAR*
(unless specified otherwise)
ASA &
thienopyridine
ASA &
warfarin
517
0.8%
5.4%
FANTASTIC°
473
0.4%
3.5%
Subacute
thrombosis
STARS**
1096
0.5%
2.7%
Angiographic
thrombosis
MATTIS°°
350
5.6%
11%
Composite end
point
*Schomig et al, NEJM 1996 - ° Bertrand et al, Circulation 1998
** Leon et al, NEJM 1998 - °° Urban et al, Circulation 1998
Characteristic
Evidence from RCTs
• 2658 pts with non-ST ACS
•
Primary end point :
Cardiovascular death
Myocardial infarction
Urgent TVR
Cumulative hazard for cardiovascular death and MI
PCI-CURE – Mehta et al, Lancet 2001
Evidence from RCTs
Current PCI guidelines – Eur Heart J 2005
Duration
Class of
recommendation
Bare metal stent
1 month
IA
Drug eluting stent
6-12 months
IC
After
NSTE-ACS
12 months
IB