Transcript 2011 Guideline for Percutaneous Coronary

2011 ACCF/AHA/SCAI Guideline
for Percutaneous Coronary
Intervention
(and Coronary Revascularization)
GNL 2011
GNL 2011
Slide Set Organization
• COR and LOE
• General Revascularization (CABG or PCI)
Recommendations
• PCI Revascularization Recommendations
• Pre-Procedural Considerations
• Procedural Considerations
• Post-Procedural Considerations
• Quality and Performance Considerations
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2011 ACCF/AHA/SCAI
Guideline for Percutaneous
Coronary Intervention
Class of Recommendation (COR)
and Level of Evidence (LOE)
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GNL 2011
Class of Recommendation (COR)
COR
Benefit/Risk
Key Words
(The procedure or treatment…)
Class I
Benefit >>>Risk
•Should be performed/administered
•Is recommended
•Is indicated
•Is useful/effective/beneficial
Class IIa
Benefit>>Risk
•Is reasonable
•Can be useful/effective/beneficial
•Is probably recommended or indicated
Class IIb
Benefit ≥Risk
•May/might be considered or be reasonable
•Usefulness/effectiveness is
unknown/unclear/uncertain or not well established
Class III – No
Benefit
•Not helpful
•No proven benefit
•Is not recommended/indicated
•Should not be performed/administered
•Is not useful/beneficial/effective
Class III –
Harm
•Harmful
•Excess cost without
benefit or harmful
•Potentially harmful
•Causes harm
•Should not be performed/administered
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Comparative Effectiveness
Class of Recommendation (COR)
COR
Key Phrasing
Class I
•Treatment/strategy A is recommended/indicated
in preference to treatment B
•Treatment A should be chosen over treatment B
Class IIa
•Treatment/strategy A is probably
recommended/indicated in preference to
treatment B
•It is reasonable to choose treatment A over
treatment B
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Level of Evidence (LOE)
LOE
A
B
C
Criteria
•Multiple populations evaluated
•Data derived from multiple randomized clinical
trials or meta-analyses
•Limited populations evaluated
•Data derived from a single randomized trial or
nonrandomized studies
•Very limited populations evaluated
•Only consensus opinion of experts, case studies, or
standard of care
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2011 ACCF/AHA/SCAI
Guideline for Percutaneous
Coronary Intervention
Revascularization
Recommendations
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Heart Team Approach to
UPLM or Complex CAD
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UPLM Revascularization to Improve Survival
Revasc
Method
CABG
PCI
COR
LOE
I
IIaFor SIHD when both of the following are present:
Anatomic conditions associated with a low risk of PCI procedural complications and
a high likelihood of good long-term outcome (e.g., a low SYNTAX score of ≤22, ostial
or trunk left main CAD)
Clinical characteristics that predict a significantly increased risk of adverse surgical
outcomes (e.g., STS-predicted risk of operative mortality ≥5%)
B
B
IIaFor UA/NSTEMI if not a CABG candidate
IIaFor STEMI when distal coronary flow is <TIMI grade 3 and PCI can be performed
more rapidly and safely than CABG
IIbFor SIHD when both of the following are present:
Anatomic conditions associated with a low to intermediate risk of PCI procedural
complications and an intermediate to high likelihood of good long-term outcome
(e.g., low-intermediate SYNTAX score of <33, bifurcation left main CAD)
Clinical characteristics that predict an increased risk of adverse surgical outcomes
(e.g., moderate-severe COPD, disability from prior stroke, or prior cardiac surgery;
STS-predicted operative mortality >2%)
B
C
III: HarmFor SIHD in patients (versus performing CABG) with unfavorable anatomy
for PCI and who are good candidates for CABG
B
B
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Revasc
Method
CABG
PCI
UPLM Revascularization
to Improve Survival
COR
LOE
I
IIaFor SIHD when low risk of PCI complications and high likelihood of good
long-term outcome (e.g., SYNTAX score of ≤22, ostial or trunk left main
CAD), and a signficantly increased CABG risk (e.g., STS-predicted risk of
operative mortality ≥5%)
B
B
IIbFor SIHD when low to intermediate risk of PCI complications and
intermediate to high likelihood of good long-term outcome (e.g., SYNTAX
score of <33, bifurcation left main CAD) and increased CABG risk (e.g.,
moderate-severe COPD, disability from prior stroke, prior cardiac surgery,
STS-predicted operative mortality >2%)
III: HarmFor SIHD in patients (versus performing CABG) with unfavorable
anatomy for PCI and who are good candidates for CABG
IIaFor UA/NSTEMI if not a CABG candidate
IIaFor STEMI when distal coronary flow is <TIMI grade 3 and PCI can be
performed more rapidly and safely than CABG
B
B
B
C
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Single and Multivessel (Stable) CAD
Revascularization to Improve Survival (slide 1 of 2)
Anatomy
Revasc
Method
3 VD +/- Proximal LAD CABG
Disease*#
PCI
2 VD With Proximal
CABG
LAD Disease#
PCI
2 VD Without
CABG
Proximal LAD Disease#
1 VD With Proximal
LAD disease
1 VD Without
Proximal LAD disease
PCI
CABG
PCI
CABG
PCI
COR
LOE
I
IIbOf uncertain benefit
I
IIbOf uncertain benefit
IIaWith extensive ischemia
IIbOf uncertain benefit without extensive
ischemia
IIbOf uncertain benefit
IIaWith LIMA for long-term benefit
IIbOf uncertain benefit
III: Harm
B
B
B
B
B
C
III: Harm
B
*Reasonable to choose CABG over PCI for good CABG candidates with
complex 3-vessel disease (e.g., SYNTAX score >22) (Class IIa; LOE:B)
#Reasonable to choose CABG over PCI for MVD in patients with DM (Class
IIa; LOE:B)
B
B
B
B
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Single and Multivessel (Stable) CAD
Revascularization to Improve Survival (slide 2 of 2)
Clinical Setting
No anatomic or
physiologic criteria
for revascularization
LV Dysfunction
Survivors of sudden
cardiac death with
presumed ischemiamediated VT
Revasc
Method
COR
LOE
CABG
PCI
III: Harm
III: Harm
B
B
CABG
IIbEF <35% without significant
left main CAD
Insufficient data
I
I
B
PCI
CABG
PCI
B
C
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Comparative Effectiveness
Recommendations for
Revascularization to Improve Survival
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Cumulative 3-Year Incidence of MACE in Patients
With 3-Vessel CAD in the SYNTAX trial
Results For Each SYNTAX Tercile
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One-Year Mortality Rates in Randomized Trials
of Patients With Diabetes and Multivessel CAD,
Comparing PCI With CABG
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Revascularization to Improve Symptoms
Clinical Setting
COR
≥1 significant stenoses amenable to
revascularization and unacceptable angina despite
GDMT
≥1 significant stenoses and unacceptable angina in
whom GDMT cannot be implemented because of
medication contraindications, adverse effects, or
patient preferences
Previous CABG with ≥1 significant stenoses
associated with ischemia and unacceptable angina
despite GDMT
Complex 3 VD (e.g., SYNTAX score >22) +/involvement of the proximal LAD and a good
candidate for CABG
I−CABG
No anatomic or physiologic criteria for
revascularization
LOE
A
I−PCI
IIa−CABG
C
IIa−PCI
IIb-CABG
C
IIa−PCI
C
IIa−CABG preferred
over PCI
B
III: Harm−CABG
C
III: Harm−PCI
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Hybrid Coronary Revascularization
Recommendation
Hybrid coronary revascularization in patients with
one or more of the following:
•limitations to traditional CABG, such as heavily
calcified proximal aorta or poor target vessels for
CABG (but amenable to PCI)
•lack of suitable graft conduits
•unfavorable LAD for PCI (i.e., excessive vessel
tortuosity or CTO)
Hybrid coronary revascularization as an alternative
to multivessel PCI or CABG in an attempt to improve
the overall risk/benefit ratio of the procedures
COR
LOE
IIa
B
IIb
C
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TMR
Clinical Setting
COR
LOE
Viable ischemic myocardium that is
perfused by coronary arteries that are
not amenable to grafting
IIb – TMR as an
adjunct to CABG
B
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Clinical Factors That May Influence The
Choice of Revascularization
•
•
•
•
•
•
Diabetes mellitus
Chronic kidney disease
Completeness of revascularization
LV systolic dysfunction
Previous CABG
Ability to comply with and tolerate DAPT
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2011 ACCF/AHA/SCAI
Guideline for Percutaneous
Coronary Intervention
PCI Revascularization
Recommendations
GNL 2011
UPLM PCI to Improve Survival in SIHD
Recommendations
• 3 complementary recommendations based on the
risk of PCI complication, likelihood of long-term
durability, and surgical risk
• Includes a new PCI class IIa recommendation
• SYNERGY score and STS score can be used to help
guide UPLM revascularization decisions
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UPLM PCI to Improve Survival (SIHD)
Hi
CABG Mortality Risk
Hi
Likelihood of Good
Long-term Outcome
Risk of PCI
Complication
Low
Hi
Low Low
COR
LOE
IIaFor SIHD when low risk of PCI complications and high
likelihood of good long-term outcome (e.g., SYNTAX score
of ≤22, ostial or trunk left main CAD), and a signficantly
increased CABG risk (e.g., STS-predicted risk of operative
mortality ≥5%)
B
IIbFor SIHD when low to intermediate risk of PCI
complications and intermediate to high likelihood of good
long-term outcome (e.g., SYNTAX score of <33, bifurcation
left main CAD) and increased CABG risk (e.g., moderatesevere COPD, disability from prior stroke, prior cardiac
surgery, STS-predicted operative mortality >2%)
III: HarmFor SIHD in patients (versus performing CABG)
with unfavorable anatomy for PCI and who are good
candidates for CABG
B
B
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UPLM PCI to Improve Survival (ACS)
COR
LOE
IIaFor UA/NSTEMI if not a CABG candidate
B
IIaFor STEMI when distal coronary flow is <TIMI
grade 3 and PCI can be performed more rapidly and
safely than CABG
C
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Single and Multivessel CAD PCI To Improve Survival
(SIHD)
Anatomic Scenario
2-3 Vessel CAD or 1 VD With Proximal LAD CAD
COR
IIbUncertain
benefit
III: Harm
III: Harm
LOE
B
Clinical Scenario
Survivors of sudden cardiac death with presumed
ischemia-mediated VT
COR
I
LOE
C
Multivessel CAD Caveats
Reasonable to choose CABG over PCI for good CABG
candidates with complex 3-vessel CAD
Reasonable to choose CABG over PCI for
multivessel CAD in patients with DM
COR
IIa
LOE
B
IIa
B
1 VD Without Proximal LAD CAD
No anatomic or physiologic criteria for
revascularization
B
B
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PCI to Improve Symptoms
Clinical/Anatomic Setting
COR
LOE
≥1 significant stenoses amenable to revascularization
and unacceptable angina despite GDMT
≥1 significant stenoses and unacceptable angina in
whom GDMT cannot be implemented because of
medication contraindications, adverse effects, or
patient preferences
Previous CABG with ≥1 significant stenoses associated
with ischemia and unacceptable angina despite GDMT
No anatomic or physiologic criteria for
revascularization
I
A
IIa
C
IIa
C
III: Harm
C
Caveat
COR
LOE
CABG preferred over PCI for complex 3 VD and a good
candidate for CABG
IIa
B
GNL 2011
2011 ACCF/AHA/SCAI
Guideline for Percutaneous
Coronary Intervention
Pre-Procedural Considerations
GNL 2011
Pre-Procedural Considerations
Recommendations
COR
LOE
I
C
Adequate preparatory hydration
I
B
Minimization of volume of contrast media in patients with CKD
I
B
III: No
Benefit
A
Contrast-Induced AKI
Assessment for risk of contrast-induced (CI) AKI
Administration of N-acetyl-L-cysteine for the prevention of CI-AKI
Anaphylactoid Reactions
Appropriate prophylaxis prior to repeat contrast administration in patients
I
with prior evidence of an anaphylactoid reaction to contrast media
Anaphylactoid prophylaxis for contrast reaction in patients with prior
III: No
history of allergic reactions to shellfish or seafood
Benefit
Statins
Administration of high-dose statin prior to PCI to reduce the risk of
IIa
periprocedural MI
Bleeding Risk
Evaluation for risk of bleeding prior to PCI
CKD
Estimation of GFR and dosage adjustment of renally-cleared medications
B
C
A: statin naïve
B: statin reload
I
C
I
B
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Contrast-Induced Acute Kidney Injury
(AKI) Risk Reduction
Recommendation
COR
LE
Assessment for risk of contrast-induced AKI
I
C
Adequate preparatory hydration
I
B
Minimization of volume of contrast media in
patients with CKD
I
B
Administration of N-acetyl-L-cysteine for the
prevention of contrast-induced AKI
III: No
Benefit
A
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Ethical Considerations
• Place the patient’s best interest first and foremost when making clinical
decisions (beneficence).
• Ensure that patients actively participate in decisions affecting their care
(autonomy).
• Consider how decisions regarding one patient may also affect other
patients and providers (justice).
• Plan and perform procedures and provide care with the intention of
improving the patient’s quality of life and/or decreasing the risk of
mortality, independent of reimbursement considerations and without
inappropriate bias or influence from industry, administrators, referring
physicians or other sources.
• Before performing procedures, obtain informed consent after giving an
explanation regarding details of the procedure, risks and benefits of both
the procedure and alternatives to the procedure.
• Plan and perform procedures according to standards of care and
recommended guidelines, and deviate from them when appropriate or
necessary to the care of individual patients.
• Seek advice, assistance or consultation from colleagues when such
consultation would benefit the patient.
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Radiation Safety
Recommendation
COR
LOE
Routine recording by cardiac catheterization
laboratories of relevant available patient
procedural radiation dose data*
and defining of the thresholds with
corresponding follow-up protocols for
patients who receive a high procedural
radiation dose
I
C
*e.g., total air kerma at the international reference point (Ka,r), air
kerma air product (PKA), fluoroscopy time, number of cine images
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Cath Lab Standards For Radiation Safety
• Specific procedures and policies are in place to minimize
patient (and operator) risk
• A radiation safety officer coordinates all radiation safety
issues and works conjointly with the medical or health
physicist
• Patient radiation exposure is reduced to as low as
reasonably achievable
• Patients at increased risk for high procedural radiation
exposure are identified
• Informed consent includes radiation safety information,
particularly in the high-risk patient
GNL 2011
Strategies to Reduce Radiation
Exposure to Patient and Operator
Precautions to Minimize Exposure to Patient and Operator
•Utilize radiation only when imaging is necessary to support clinical care
•Minimize use of cine
•Minimize use of steep angles of x-ray beam
•Minimize use of magnification modes
•Minimize frame rate of fluoroscopy and cine
•Keep the image receptor close to the patient
•Utilize collimation to the fullest extent possible
•Monitor radiation dose in real time to assess patient risk/benefit during the
procedure
Precautions to Specifically Minimize Exposure to Operator
•Use and maintain appropriate protective garments
•Maximize distance of operator from x-ray source and patient
•Keep above-table and below-table shields in optimal position at all times
•Keep all body parts out of the field of view at all times
Precautions to Specifically Minimize Exposure to Patient
•Keep table height as high as comfortably possible for the operator
•Vary the imaging beam angle to minimize exposure to any 1 skin area
•Keep patient’s extremities out of the beam
GNL 2011
PCI in Hospitals Without
On-Site Surgical Backup
Recommendation
Primary PCI in hospitals without onsite cardiac
surgery (provided that appropriate planning for
program development has been accomplished)
Elective PCI in hospitals without onsite cardiac
surgery (provided that appropriate planning for
program development has been accomplished, and
rigorous clinical and angiographic criteria are used
for proper patient selection)
Primary or elective PCI in hospitals without on-site
cardiac surgery capabilities without a proven plan
for rapid transport to a cardiac surgery operating
room in a nearby hospital or without appropriate
hemodynamic support capability for transfer
COR
LOE
IIa
B
IIb
B
III – Harm
C
GNL 2011
2011 ACCF/AHA/SCAI
Guideline for Percutaneous
Coronary Intervention
Procedural Considerations
GNL 2011
Vascular Access
Recommendation
Radial artery access to decrease access site
complications
COR
LOE
IIa
A
GNL 2011
UA/NSTEMI: Choice of Strategy*
Recommendation
An early invasive strategy** in patients who have refractory angina or hemodynamic
or electrical instability (without serious comorbidities or contraindications to such
procedures)
An early invasive strategy** in initially stabilized patients (without serious
comorbidities or contraindications to such procedures) who have an elevated risk for
clinical events
The selection of PCI or CABG as the means of revascularization in the patient with
ACS should generally be based on the same considerations as those without ACS
A conservative strategy recommended (over an early invasive strategy) in women
with low-risk features
An early invasive strategy (within 12 to 24 hours of admission) chosen over a delayed
invasive strategy for initially stabilized high-risk patients***
An initial conservative (i.e., a selectively invasive) strategy in initially stabilized
patients who have an elevated risk for clinical events (including troponin positive
patients)***
An early invasive strategy** in patients with extensive comorbidities in whom the
risks of revascularization and comorbid conditions are likely to outweigh the benefits
of revascularization, in patients with acute chest pain and a low likelihood of ACS, or
in patients who will not consent to revascularization regardless of the findings
COR LOE
I
B
I
A
I
B
I
B
IIa
B
IIb
C
III – No
Benefit
C
*UA/NSTEMI GL with additional and more comprehensive recommendations
**Early invasive strategy = diagnostic angiography with intent to perform revascularization
***Recs from the 2011 UA/NSTEMI focused update (not in PCI GL)
GNL 2011
General Considerations in Deciding Between an Early Invasive
Strategy and an Initial Conservative Strategy in UA/NSTEMI
Early Invasive Strategy
Generally Preferred
Initial Conservative Strategy
Generally Preferred or Reasonable
 Recurrent angina or ischemia at rest or
with low level activities despite intensive
medical therapy
 Elevated cardiac biomarkers (TnT or TnI)
 New or presumably new ST-depression
 Signs or symptoms of heart failure
 Hemodynamic instability
 High risk score (e.g., GRACE, TIMI)
 Sustained ventricular tachycardia
 PCI within 6 mo
 Prior CABG
 Diabetes mellitus
 Mild to moderate renal dysfunction
 Reduced LV function (LVEF <40%)
 Low risk score (e.g., GRACE, TIMI)
 Absence of high-risk features
 High risk for catheterization-related
complications
 Patient not a revascularization candidate
(with either PCI or CABG)
 Patient prefers conservative therapy
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Coronary Angiography in STEMI
Indications
COR
LOE
I
I
A
B
IIa
B
IIa
A
IIb
C
III: No
Benefit
C
Immediate coronary angiography
Candidate for primary PCI
Severe heart failure or cardiogenic shock (if suitable
revascularization candidate)
Moderate to large area of myocardium at risk and evidence of failed
fibrinolysis
Coronary angiography 3 to 24 hours after fibrinolysis
Hemodynamically stable patients with evidence for successful
fibrinolysis
Coronary angiography before hospital discharge
Stable patients
Coronary angiography at any time
Patients in whom the risks of revascularization are likely to
outweigh the benefits or the patient or designee does not want
invasive care
GNL 2011
PCI in STEMI*
Indications
COR
LOE
STEMI symptoms within 12 h
Severe heart failure or cardiogenic shock
Contraindications to fibrinolytic therapy with ischemic symptoms <12 h
Clinical and/or ECG evidence of ongoing ischemia between 12 and 24 h after
symptom onset
Asymptomatic patient presenting between 12 and 24 h after symptom onset
and higher risk
Noninfarct artery PCI at the time of primary PCI in patients without
hemodynamic compromise
I
I
I
IIa
A
B
B
B
IIb
C
III: Harm
B
IIa
IIa
IIa
IIb
B
B
B
B
III: No
Benefit
B
Primary PCI*
Delayed or Elective PCI in Patients with STEMI (i.e. Non-Primary PCI)
Clinical evidence for fibrinolytic failure or infarct artery reocclusion
Patent infarct artery 3 to 24 h after fibrinolytic therapy
Ischemia on noninvasive testing
Hemodynamically significant stenosis in a patent infarct artery >24 hours
after STEMI
Totally occluded infarct artery >24 h after STEMI in a hemodyamically stable
asymptomatic patient without evidence of severe ischemia
*Systems goal of performing primary PCI within 90 minutes of first medical
contact when the patient presents to a hospital with PCI capability (Class I, LOE:
B), and within 120 minutes when the patient presents to a hospital without PCI
capability (Class I, LOE: B).
GNL 2011
Cardiogenic Shock
Recommendation
COR
LOE
Immediate coronary angiography in patients
with STEMI with severe heart failure or
cardiogenic shock who are suitable candidates
for revascularization
I
B
PCI for patients with acute MI who develop
cardiogenic shock and are suitable candidates
I
B
Hemodynamic support device for patients with
cardiogenic shock after STEMI who do not
quickly stabilize with pharmacological therapy
I
B
GNL 2011
Recommendations for Initial Reperfusion Therapy
When Cardiogenic Shock Complicates STEMI
Cardiogenic
Shock
Delayed Onset Shock
Echocardiogram to rule out
mechanical defects
Early Shock, Diagnosed on
Hospital Presentation
Fibrinolytic therapy if all of the
following are present:
1. >90 minutes to PCI
2. <3 hours post MI onset?
3. No contraindications
Arrange rapid
transfer to invasive
capable center
Hemodynamic Support
Device
Arrange prompt transfer to
invasive capable center
Cardiac Catheterization and
Coronary Angiography
1-2 vessel CAD
Moderate 3-vessel CAD
PCI IRA
PCI IRA
Staged Multivessel PCI
Severe 3-vessel CAD
Left main CAD
Immediate CABG
Staged CABG
Cannot be performed
Dashed lines indicate that the procedure should be performed in
patients with specific indications only
GNL 2011
Revascularization Before Noncardiac Surgery
Recommendation
COR
LOE
A strategy of balloon angioplasty or BMS implantation
followed by 4 to 6 weeks of DAPT for patients who
require PCI and who are scheduled for elective
noncardiac surgery in the subsequent 12 months
Continuation of aspirin if possible and restarting of the
P2Y12 inhibitor as soon as possible in the immediate
postoperative for patients with a DES who must
undergo urgent surgical procedures
Routine prophylactic coronary revascularization in
patients with stable CAD before noncardiac surgery
Elective noncardiac surgery in the 4 to 6 weeks after
balloon angioplasty or BMS implantation or in the 12
months after DES implantation in patients in whom the
P2Y12 inhibitor will need to be discontinued
IIa
B
IIa
C
III – Harm
B
III – Harm
B
GNL 2011
Coronary Stents
Risk of restenosis needs to be weighted against the likelihood of the
patient to be able to tolerate and comply with (prolonged) DAPT
Recommendation
COR
LOE
Elective PCI: A
DES as an alternative to BMS to reduce the risk of restenosis in
cases in which the risk of restenosis is increased and the patient is
likely to be able to tolerate and comply with prolonged DAPT
I
Before implantation of a DES, interventional cardiologist discussion
with the patient regarding the need for and duration of DAPT and the
ability of the patient to comply with and tolerate DAPT
Use of balloon angioplasty or BMS (instead of DES) in patients with
high bleeding risk, inability to comply with 12 months of DAPT, or with
anticipated invasive or surgical procedures within the next 12 months
during which time DAPT may be
PCI with coronary stenting in cases in which the patient is not likely to
be able to tolerate and to comply with DAPT
DES implantation in cases in which the patient is not likely to be able
to tolerate and comply with prolonged DAPT, or this cannot be
determined prior to stent implantation
I
C
I
B
III - Harm
B
III - Harm
B
UA/NSTEMI: C
STEMI: A
GNL 2011
Clinical Situations Associated With DES
or BMS Selection Preference
DES Generally Preferred Over BMS BMS Preferred Over DES
(efficacy considerations)
(safety considerations)
 Left main disease
 Patients unable to
 Small vessels
tolerate or comply with
 In-stent restenosis
prolonged DAPT
 Bifurcation lesions
 Anticipated surgery
 Long lesions
requiring discontinuation
 Multiple lesions
of DAPT within 12 months
 Saphenous vein graft lesions
 High risk of bleeding
 Diabetic patients
GNL 2011
Adjunctive Diagnostic Devices
Recommendation
COR
LOE
FFR to assess angiographic intermediate coronary lesions
and to guide revascularization decisions in patients with
SIHD
IVUS for the assessment of angiographically indeterminate
left main CAD
IIa
A
IIa
B
IVUS after cardiac transplantation
IIa
B
IVUS to determine the mechanism of stent restenosis
IIa
C
IVUS for the assessment of non-left main angiographically
intermediate stenoses
IIb
B
IVUS for guidance of coronary stent implantation
IIb
B
IVUS to determine the mechanism of stent thrombosis
IIb
C
IVUS for routine lesion assessment when revascularization
is not being contemplated
III – No
Benefit
C
Optical coherence tomography
No Recommendations
GNL 2011
Adjunctive Therapeutic Devices
Device
Coronary
Atherectomy
Thrombectomy
Laser
Angioplasty
Cutting Balloon
Angioplasty
Embolic
Protection
Devices
Hemodynamic
Support
Devices
Recommendation
COR
LOE
Rotational atherectomy for fibrotic or heavily calcified lesions
that might not be crossed by a balloon catheter or adequately
dilated before stent implantation
Rotational atherectomy performed routinely for de novo
lesions or in-stent restenosis
Aspiration thrombectomy for patients undergoing primary PCI
IIa
C
III – No
Benefit
IIa
A
IIb
C
III – No
Benefit
IIb
A
III – No
Benefit
I
A
IIb
C
Laser angioplasty for fibrotic or moderately calcified lesions
that cannot be crossed or dilated with conventional balloon
angioplasty
Laser angioplasty performed routinely during PCI
Cutting balloon angioplasty to avoid slippage-induced coronary
artery trauma during PCI for in-stent restenosis or for ostial
lesions in side branches
Cutting balloon angioplasty performed routinely during PCI
Embolic protection devices (EPD) use during saphenous vein
graft (SVG) PCI when technically feasible
Elective insertion of an appropriate percutaneous
hemodynamic support device as an adjunct to PCI in carefully
selected high-risk patients
B
C
B
GNL 2011
Aspirin in PCI
Time
Relative
to PCI
Pre-PCI
Recommendation
COR LOE
Aspirin 81-325 mg before PCI if already on aspirin
therapy
I
B
Nonenteric-coated aspirin 325 mg before PCI if
not on aspirin therapy
I
B
PCI
Aspirin administered at time of PCI
I
B
Post-PCI
After PCI, aspirin continued indefinitely.
I
A
IIa
B
After PCI, use of 81 mg/d of aspirin in preference
to higher maintenance doses.
GNL 2011
P2Y12 Inhibitors* and DAPT
Recommendation
Administration of a loading dose** of a P2Y12 receptor to patients undergoing
PCI with stenting
Patients counseling on the need for and risks of DAPT before placement of
intracoronary stents, especially a DES
P2Y12 inhibitor therapy for at least 12 months in patients receiving a stent (BMS
or DES) during PCI for ACS
Clopidogrel for at least 12 months in patients treated with a DES for a non–ACS
indication, if patients are not at high risk of bleeding
Clopidogrel for a minimum of 1 month and ideally up to 12 months in patients
receiving a BMS for a non-ACS indication (unless the patient is at increased risk
of bleeding; then it should be given for a minimum of 2 weeks)
Earlier discontinuation (e.g., <12 months) of P2Y12 inhibitor therapy after stent
implantation if the risk of morbidity from bleeding outweighs the anticipated
benefit afforded by a recommended duration of P2Y12 inhibitor therapy
Continuation of DAPT beyond 12 months in patients undergoing DES
implantation
Prasugrel administration in patients with a prior history of stroke or transient
ischemic attack
COR LOE
I
A
I
C
I
B
I
B
I
B
IIa
C
IIb
C
III –
Harm
B
*P2Y12 Inhibitors = clopidogrel, prasugrel, or ticagrelor
**Clopidogrel loading dose of 600 mg recommended
GNL 2011
Antiplatelet And Antithrombin Rx at the Time of PCI
Recommendation
Oral Antiplatelet Rx
Aspirin
P2Y12 Inhibitor (clopidogrel*, prasugrel or ticagrelor) in
patients treated with stent implantation
GP IIb/IIIa Inhibitor Rx**
No clopidogrel pre-treatment
STEMI:
UA/NSTEMI
SIHD
With clopidogrel pre-treatment
STEMI
UA/NSTEMI
SIHD
Antithrombin Rx
UFH
Bivalirudin
Enoxaparin
Anti-Xa Inhibitors
Fondaparinux
COR
LOE
I
I
B
A
IIa
I
IIa
IIa
IIa
IIb
A
A
B
C
B
B
I
I
IIb
C
B
B
III - Harm
C
*Recommended loading dose for clopidogrel is 600 mg PO
**Abciximab, double-bolus eptifibatide, or high-bolus dose tirofiban
GNL 2011
GP IIb/IIIa Inhibitor Therapy*
Clopidogrel
Pre-Treatment ?
No
Yes
Clinical Setting
COR
LOE
STEMI
UA/NSTEMI
SIHD
STEMI
UA/NSTEMI
SIHD
IIa
I
IIa
IIa
IIa
IIb
A
A
B
C
B
B
COR
LOE
IIb
B
III – No
Benefit
B
Antithrombin Rx
Additional Recommendations
Administration of intracoronary (versus IV) abciximab
administration in patients undergoing primary PCI with
abciximab
Routine precatheterization laboratory (e.g., ambulance or
emergency room) administration of GP IIb/IIIa inhibitors as
part of a upstream strategy for patients with STEMI
undergoing PCI
*Recommendations apply for abciximab, double-bolus eptifibatide,
or high-bolus dose tirofiban
GNL 2011
Dosing of Parental Anticoagulants During PCI
Drug
UFH
Patient has received prior anticoagulant therapy
Patient has not received prior
anticoagulant therapy
IV GPI planned: additional UFH as needed (e.g., 2000 to
5000 U) to achieve an ACT of 200 to 250 s
IV GPI planned: 50 to 70 U/kg bolus to
achieve an ACT of 200 to 250 s
No IV GPI planned: additional UFH as needed (e.g., 2000 to
5000 U) to achieve an ACT of 250 to 300 for HemoTec, 300
to 350 s for Hemochron
No IV GPI planned: 70 to 100 U/kg
bolus to achieve target ACT of 250 to
300 s for HemoTec, 300 to 350 s for
Hemochron
0.5-0.75 mg/kg IV bolus
Enoxaparin
For prior treatment with enoxaparin , if the last
subcutaneous dose was administered 8 to 12 h earlier, or if
only 1 SC dose has been administered, an IV dose of 0.3
mg/kg of enoxaparin should be given;
If the last subcutaneous dose was administered within the
prior 8 h, no additional enoxaparin should be given
Bivalirudin
For patients who have received UFH, wait 30 min, then give
0.75 mg/kg IV bolus, then 1.75 mg/kg per hour IV infusion
For prior treatment with fondaparinux, administer
additional IV treatment with an anticoagulant possessing
anti-IIa activity, taking into account whether GPI receptor
antagonists have been administered.
0.75 mg/kg bolus, 1.75 mg/kg per h IV
infusion
N/A
200 µg/kg IV bolus then 15 µg/kg per min IV infusion (32)
350 µg/kg bolus then 15 µg/kg per
min IV infusion
Fondaparinux
Argatroban
GNL 2011
Heparin-Induced Thrombocytopenia
(HIT)
Recommendation
COR
LOE
Bivalirudin or argatroban use during PCI for
patients with HIT
I
B
GNL 2011
No Reflow Pharmacological Therapy
Recommendation
Administration of an intracoronary
vasodilator (adenosine, calcium channel
blocker, or nitroprusside) to treat PCIrelated no-reflow that occurs during
primary or elective PCI
COR
LOE
IIa
B
GNL 2011
SVG PCI
Recommendation
Embolic protection device use when
technically feasible
GP IIb/IIIa inhibitors
PCI for chronic SVG occlusions
COR
LOE
I
B
III - No
Benefit
B
III - Harm
C
GNL 2011
PCI in Specific Anatomic Situations*
Recommendation
COR
LOE
PCI of a CTO in patients with appropriate clinical indications and
suitable anatomy when performed by operators with appropriate
expertise
Provisional side branch stenting as the initial approach in patients
with bifurcation lesions when the side branch is not large and has only
mild or moderate focal disease at the ostium
Elective double stenting in patients with complex bifurcation
morphology involving a large side branch where the risk of side
branch occlusion is high and the likelihood of successful side branch
re-access is low
IVUS for the assessment of angiographically indeterminant left main
CAD
DES use when PCI is indicated in patients with an aorto-ostial stenosis
IIa
B
I
A
IIa
B
IIa
B
IIa
B
Rotational atherectomy is reasonable for fibrotic or heavily calcified
lesions that might not be crossed by a balloon catheter or adequately
dilated before stent implantation
IIa
C
*SVG recommendations on separate slide
GNL 2011
PCI in Specific Anatomic Situations
Recommendation
SVG
CTO
Bifurcation
Lesions
Aorto-Ostial
Stenoses
Calcified
Lesions
COR
LOE
I
III – No
Benefit
III: Harm
IIa
B
B
Provisional side branch stenting as the initial approach in patients with
bifurcation lesions when the side branch is not large and has only mild or
moderate focal disease at the ostium
I
A
Elective double stenting in patients with complex bifurcation
morphology involving a large side branch where the risk of side branch
occlusion is high and the likelihood of successful side branch re-access is
low
IIa
B
IVUS for the assessment of angiographically indeterminant left main CAD
IIa
B
DES use when PCI is indicated in patients with an aorto-ostial stenosis
IIa
B
Rotational atherectomy for fibrotic or heavily calcified lesions that might
not be crossed by a balloon catheter or adequately dilated before stent
implantation
IIa
C
Embolic protection device use in SVG PCI when technically feasible
GP IIb/IIIa inhibitors in SVG PCI
PCI for chronic SVG occlusions
PCI of a CTO in patients with appropriate clinical indications and suitable
anatomy (when performed by operators with appropriate expertise)
C
B
GNL 2011
Periprocedural MI Assessment
Recommendation
COR
LOE
Measurement of cardiac biomarkers in
patients with signs or symptoms suggestive
of MI during or after PCI, or in
asymptomatic patients with significant
persistent angiographic complications
I
C
IIb
C
Routine measurement of cardiac
biomarkers in all patients after PCI
GNL 2011
Vascular Closure Devices (VCD)
Recommendation
Femoral angiogram pre-VCD to ensure
anatomic suitability for deployment
VCD for the purposes of achieving faster
hemostasis and earlier ambulation
(compared with the use of manual
compression)
Routine use of VCD for the purpose of
decreasing vascular complications, including
bleeding
COR
LOE
I
C
IIa
B
III – No
Benefit
B
GNL 2011
2011 ACCF/AHA/SCAI
Guideline for Percutaneous
Coronary Intervention
Post-Procedural Considerations
GNL 2011
P2Y12 Inhibitor Rx Post-Stent
(P2Y12 Inhibitor = clopidogrel, prasugrel or ticagrelor)
Recommendation
COR
LOE
Post-Stent Implantation (BMS or DES) for ACS,
P2Y12 inhibitor Rx at least 12 months
Post-DES for non–ACS, clopidogrel for at least 12 mo if
patients are not at high risk of bleeding.
Post-BMS for non-ACS, clopidogrel for a minimum of 1 mo
and ideally up to 12 mo
Counseling patients on the importance of compliance with
DAPT and to not discontinue Rx before discussion with the
relevant cardiologist
Earlier discontinuation (e.g., <12 mo) of P2Y12 inhibitor if
the risk of morbidity from bleeding outweighs the
anticipated benefit afforded by a recommended duration of
P2Y12 inhibitor therapy after stent implantation
Continuation of P2Y12 Rx beyond 12 mo in patients
undergoing DES placement.
I
B
I
B
I
B
I
C
IIa
C
IIb
C
GNL 2011
Platelet Function Testing For Patients
Undergoing PCI
Recommendation
COR
LOE
Platelet function testing in patients at high risk for
poor clinical outcomes
IIb
C
Routine clinical use of platelet function testing to
screen clopidogrel-treated patients undergoing PCI
III – No
Benefit
C
IIb
C
Treatment with an alternate P2Y12 inhibitor (e.g.,
prasugrel or ticagrelor) in clopidogrel-treated
patients with high platelet reactivity
GNL 2011
Genetic Testing For Patients Undergoing
PCI Treated With Clopidogrel
Recommendation
Genetic testing to identify whether a patient at high
risk for poor clinical outcomes is predisposed to
inadequate platelet inhibition with clopidogrel
Routine clinical use of genetic testing to screen
clopidogrel-treated patients undergoing PCI
Treatment with an alternate P2Y12 inhibitor (e.g.,
prasugrel or ticagrelor) in a patient identified by
genetic testing as predisposed to inadequate platelet
inhibition with clopidogrel
COR
LOE
IIb
C
III – No
Benefit
C
IIb
C
GNL 2011
PPI Therapy and DAPT
Recommendations based on risk of GI bleeding
Recommendation
COR
LOE
PPI use for patients with history of prior GI bleeding
who require DAPT
I
C
PPI use for patients with increased risk of GI
bleeding (advanced age, concomitant use of
warfarin, steroids, NSAIDs, H pylori infection, etc.)
who require DAPT.
IIa
C
Routine use of a PPI for patients at low risk of GI
bleeding, who have much less potential to benefit
from prophylactic therapy
III: No
Benefit
C
GNL 2011
Stress Testing And
Cardiac Rehabilitation
Recommendation
COR
LOE
Treadmill exercise testing in patients entering in to a
formal cardiac rehabilitation program
IIa
C
Routine, periodic stress testing of asymptomatic
patients after PCI without specific clinical indications
III – No
Benefit
C
Recommendation to patients of medically
supervised exercise programs (cardiac rehabilitation)
after PCI, particularly for moderate- to high-risk
patients for whom supervised exercise training is
warranted
I
B
GNL 2011
Restenosis*
Recommendation
COR
LOE
Treatment of clinical restenosis after balloon angioplasty
with BMS or DES if anatomic factors are appropriate and
if the patient is able to comply with and tolerate DAPT
Treatment of clinical restenosis after BMS with DES if
anatomic factors are appropriate and the patient is able
to comply with and tolerate DAPT
IVUS to determine the mechanism of stent restenosis
I
B
I
A
IIa
C
IIb
C
Treatment of clinical restenosis after DES with repeat PCI
with balloon angioplasty, BMS, or DES with the same
drug or an alternative antiproliferative drug if anatomic
factors are appropriate and patient is able to comply
with and tolerate DAPT
*Intensified medical therapy and CABG are often also
reasonable treatment strategies for restenosis
GNL 2011
Secondary Prevention*
Recommendations
COR
LOE
Lifestyle modification
I
B
Statin therapy
I
A
Statin therapy which lowers LDL to
<100 mg/dL and achieves at least a
30% lowering of LDL
Statin therapy which lowers LDL to
<70 mg/dL in very high-risk patients
I
C
IIa
B
Blood pressure control
Lifestyle modification
(with a blood pressure goal
Pharmacotherapy
of <140/90 mm Hg)
I
B
I
A
Diabetes management (e.g., lifestyle modification and
pharmacotherapy) coordinated with the patient’s primary care
physician and/or endocrinologist
I
C
Complete smoking cessation
I
A
Lipid management with
lifestyle modification and
lipid-lowering
pharmacotherapy
*Comprehensive secondary prevention recommendations in the
ACCF/AHA Secondary Prevention and Risk Reduction 2011 Update
GNL 2011
Quality and Performance Considerations
Recommendation
COR
LOE
Operation by every PCI program of a quality
improvement program that routinely: a) reviews quality
and outcomes of the entire program; b) reviews results
of individual operators; c) includes risk adjustment; d)
provides peer review of difficult or complicated cases,
and; e) performs random case reviews
Participation by every PCI program in a regional or
national PCI registry for the purpose of benchmarking its
outcomes against current national norms
Participation by all physicians that perform PCI in the
American Board of Internal Medicine interventional
cardiology board certification and maintenance of
certification program
I
C
I
C
IIa
C
*Operator and institutional competency and volume
recommendations are included in the PCI GL and are currently
being re-evaluated by the ACCF/AHA/SCAI Clinical Competence
Statement on Cardiac Interventional Procedures Writing Group
GNL 2011