GNL 2011 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention (and Coronary...

GNL 2011

2011 ACCF/AHA/SCAI Guideline for

Percutaneous Coronary Intervention (and Coronary

Revascularization)

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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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Percutaneous Coronary Intervention

Class of Recommendation (COR) and Level of Evidence (LOE)

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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 CriteriaA •Multiple populations evaluated

•Data derived from multiple randomized clinical trials or meta-analyses

B •Limited populations evaluated•Data derived from a single randomized trial or nonrandomized studies

C •Very limited populations evaluated•Only consensus opinion of experts, case studies, or standard of care

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Revascularization Recommendations

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Heart Team Approach to UPLM or Complex CAD

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UPLM Revascularization to Improve SurvivalRevasc Method

COR LOE

CABG I BPCI IIaFor 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

IIaFor UA/NSTEMI if not a CABG candidate BIIaFor STEMI when distal coronary flow is <TIMI grade 3 and PCI can be performed more rapidly and safely than CABG

C

IIbFor 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

III: HarmFor SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG

B

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UPLM Revascularization to Improve Survival

Revasc Method

COR LOE

CABG I BPCI IIaFor 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

IIbFor 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%)

B

III: HarmFor SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG

B

IIaFor UA/NSTEMI if not a CABG candidate BIIaFor 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 (Stable) CAD

Anatomy Revasc Method

COR LOE

3 VD +/- Proximal LAD Disease*#

CABG I BPCI IIbOf uncertain benefit B

2 VD With Proximal LAD Disease#

CABG I BPCI IIbOf uncertain benefit B

2 VD Without Proximal LAD Disease#

CABG IIaWith extensive ischemia BIIbOf uncertain benefit without extensive

ischemiaC

PCI IIbOf uncertain benefit B1 VD With Proximal LAD disease

CABG IIaWith LIMA for long-term benefit BPCI IIbOf uncertain benefit B

1 VD Without Proximal LAD disease

CABG III: Harm B

PCI 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)

Revascularization to Improve Survival (slide 1 of 2)

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Clinical Setting Revasc Method

COR LOE

No anatomic or physiologic criteria for revascularization

CABG III: Harm BPCI III: Harm B

LV Dysfunction CABG IIbEF <35% without significant left main CAD

B

PCI Insufficient dataSurvivors of sudden cardiac death with presumed ischemia-mediated VT

CABG I BPCI I C

Single and Multivessel (Stable) CADRevascularization to Improve Survival (slide 2 of 2)

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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 SymptomsClinical Setting COR LOE

≥1 significant stenoses amenable to revascularization and unacceptable angina despite GDMT

I−CABG AI−PCI

≥1 significant stenoses and unacceptable angina in whom GDMT cannot be implemented because of medication contraindications, adverse effects, or patient preferences

IIa−CABG C

IIa−PCI

Previous CABG with ≥1 significant stenoses associated with ischemia and unacceptable angina despite GDMT

IIb-CABG CIIa−PCI C

Complex 3 VD (e.g., SYNTAX score >22) +/-involvement of the proximal LAD and a good candidate for CABG

IIa−CABG preferred over PCI

B


III: Harm−CABG C

III: Harm−PCI

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Hybrid Coronary Revascularization

Recommendation COR LOEHybrid 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)

IIa B

Hybrid coronary revascularization as an alternative to multivessel PCI or CABG in an attempt to improve the overall risk/benefit ratio of the procedures

IIb C

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TMR

Clinical Setting COR LOEViable 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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PCI Revascularization Recommendations

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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)

Low

Hi

Hi Hi

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UPLM PCI to Improve Survival (ACS)

COR LOE

IIaFor UA/NSTEMI if not a CABG candidate B

IIaFor 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 COR LOE2-3 Vessel CAD or 1 VD With Proximal LAD CAD IIbUncertain

benefitB

1 VD Without Proximal LAD CAD III: Harm BNo anatomic or physiologic criteria for revascularization

III: Harm B

Clinical Scenario COR LOESurvivors of sudden cardiac death with presumed ischemia-mediated VT

I C

Multivessel CAD Caveats COR LOEReasonable to choose CABG over PCI for good CABG candidates with complex 3-vessel CAD

IIa B

Reasonable to choose CABG over PCI for multivessel CAD in patients with DM

IIa B

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PCI to Improve SymptomsClinical/Anatomic Setting COR LOE

≥1 significant stenoses amenable to revascularization and unacceptable angina despite GDMT

I A

≥1 significant stenoses and unacceptable angina in whom GDMT cannot be implemented because of medication contraindications, adverse effects, or patient preferences

IIa C

Previous CABG with ≥1 significant stenoses associated with ischemia and unacceptable angina despite GDMT

IIa C


III: Harm C

Caveat COR LOECABG preferred over PCI for complex 3 VD and a good candidate for CABG

IIa B

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Pre-Procedural Considerations

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Pre-Procedural ConsiderationsRecommendations COR LOE

Contrast-Induced AKIAssessment for risk of contrast-induced (CI) 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 CI-AKI III: No Benefit

A

Anaphylactoid ReactionsAppropriate prophylaxis prior to repeat contrast administration in patients with prior evidence of an anaphylactoid reaction to contrast media

I B

Anaphylactoid prophylaxis for contrast reaction in patients with prior history of allergic reactions to shellfish or seafood

III: No Benefit

C

StatinsAdministration of high-dose statin prior to PCI to reduce the risk of periprocedural MI

IIa A: statin naïve

B: statin reloadBleeding Risk

Evaluation for risk of bleeding prior to PCI I CCKD

Estimation of GFR and dosage adjustment of renally-cleared medications 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

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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

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PCI in Hospitals Without On-Site Surgical Backup

Recommendation COR LOEPrimary PCI in hospitals without onsite cardiac surgery (provided that appropriate planning for program development has been accomplished)

IIa B

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)

IIb B

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

III – Harm C

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Procedural Considerations

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Vascular Access


Radial artery access to decrease access site complications

IIa A

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UA/NSTEMI: Choice of Strategy* Recommendation COR LOE

An early invasive strategy** in patients who have refractory angina or hemodynamic or electrical instability (without serious comorbidities or contraindications to such procedures)

I B

An early invasive strategy** in initially stabilized patients (without serious comorbidities or contraindications to such procedures) who have an elevated risk for clinical events

I A

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

I B

A conservative strategy recommended (over an early invasive strategy) in women with low-risk features

I B

An early invasive strategy (within 12 to 24 hours of admission) chosen over a delayed invasive strategy for initially stabilized high-risk patients***

IIa B

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)***

IIb C

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

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)

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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 STEMIIndications COR LOE

Immediate coronary angiographyCandidate for primary PCI I ASevere heart failure or cardiogenic shock (if suitable revascularization candidate)

I B

Moderate to large area of myocardium at risk and evidence of failed fibrinolysis

IIa B

Coronary angiography 3 to 24 hours after fibrinolysisHemodynamically stable patients with evidence for successful fibrinolysis

IIa A

Coronary angiography before hospital discharge

Stable patients IIb C

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

III: No Benefit

C

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PCI in STEMI*Indications COR LOE

Primary PCI*STEMI symptoms within 12 h I ASevere heart failure or cardiogenic shock I BContraindications to fibrinolytic therapy with ischemic symptoms <12 h I BClinical and/or ECG evidence of ongoing ischemia between 12 and 24 h after symptom onset

IIa B

Asymptomatic patient presenting between 12 and 24 h after symptom onset and higher risk

IIb C

Noninfarct artery PCI at the time of primary PCI in patients without hemodynamic compromise

III: Harm B

Delayed or Elective PCI in Patients with STEMI (i.e. Non-Primary PCI)Clinical evidence for fibrinolytic failure or infarct artery reocclusion IIa BPatent infarct artery 3 to 24 h after fibrinolytic therapy IIa BIschemia on noninvasive testing IIa BHemodynamically significant stenosis in a patent infarct artery >24 hours after STEMI

IIb B

Totally occluded infarct artery >24 h after STEMI in a hemodyamically stable asymptomatic patient without evidence of severe ischemia

III: No Benefit

B

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Cardiogenic Shock

Recommendation COR LOEImmediate 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

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Cardiogenic Shock

Early Shock, Diagnosed on Hospital Presentation

Delayed Onset Shock Echocardiogram to rule out

mechanical defects

Hemodynamic Support Device

Cardiac Catheterization and Coronary Angiography

Fibrinolytic therapy if all of the following are present:1. >90 minutes to PCI

2. <3 hours post MI onset? 3. No contraindications

Arrange prompt transfer to invasive capable center

1-2 vessel CAD Moderate 3-vessel CAD Severe 3-vessel CAD Left main CAD

PCI IRA PCI IRA

Staged Multivessel PCI Staged CABG

Immediate CABG

Cannot be performed

Arrange rapid transfer to invasive

capable center

Recommendations for Initial Reperfusion Therapy When Cardiogenic Shock Complicates STEMI

Dashed lines indicate that the procedure should be performed in patients with specific indications only

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Revascularization Before Noncardiac SurgeryRecommendation 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

IIa B

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

IIa C

Routine prophylactic coronary revascularization in patients with stable CAD before noncardiac surgery

III – Harm B

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

III – Harm B

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Coronary StentsRisk of restenosis needs to be weighted against the likelihood of the

patient to be able to tolerate and comply with (prolonged) DAPTRecommendation COR LOE

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 Elective PCI: A

UA/NSTEMI: C

STEMI: A

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

I C

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

I B

PCI with coronary stenting in cases in which the patient is not likely to be able to tolerate and to comply with DAPT

III - Harm B

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

III - Harm B

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Clinical Situations Associated With DES or BMS Selection Preference

DES Generally Preferred Over BMS

(efficacy considerations)

BMS Preferred Over DES (safety considerations)

Left main disease Small vessels In-stent restenosis Bifurcation lesions Long lesions Multiple lesions Saphenous vein graft lesions Diabetic patients

Patients unable to tolerate or comply with prolonged DAPT

Anticipated surgery requiring discontinuation of DAPT within 12 months

High risk of bleeding

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Adjunctive Diagnostic DevicesRecommendation COR LOE

FFR to assess angiographic intermediate coronary lesions and to guide revascularization decisions in patients with SIHD

IIa A

IVUS for the assessment of angiographically indeterminate left main CAD

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

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Device Recommendation COR LOECoronary Atherectomy

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

Rotational atherectomy performed routinely for de novo lesions or in-stent restenosis

III – No Benefit

A

Thrombectomy Aspiration thrombectomy for patients undergoing primary PCI IIa B

Laser Angioplasty

Laser angioplasty for fibrotic or moderately calcified lesions that cannot be crossed or dilated with conventional balloon angioplasty

IIb C

Laser angioplasty performed routinely during PCI III – No Benefit

A

Cutting Balloon Angioplasty

Cutting balloon angioplasty to avoid slippage-induced coronary artery trauma during PCI for in-stent restenosis or for ostial lesions in side branches

IIb C

Cutting balloon angioplasty performed routinely during PCI III – No Benefit

A

Embolic Protection Devices

Embolic protection devices (EPD) use during saphenous vein graft (SVG) PCI when technically feasible

I B

Hemodynamic Support Devices

Elective insertion of an appropriate percutaneous hemodynamic support device as an adjunct to PCI in carefully selected high-risk patients

IIb C

Adjunctive Therapeutic Devices

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Aspirin in PCITime

Relative to PCI


Pre-PCI 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

After PCI, use of 81 mg/d of aspirin in preference to higher maintenance doses.

IIa B

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P2Y12 Inhibitors* and DAPTRecommendation COR LOE

Administration of a loading dose** of a P2Y12 receptor to patients undergoing PCI with stenting

I A

Patients counseling on the need for and risks of DAPT before placement of intracoronary stents, especially a DES

I C

P2Y12 inhibitor therapy for at least 12 months in patients receiving a stent (BMS or DES) during PCI for ACS

I B

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

I B

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)

I B

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

IIa C

Continuation of DAPT beyond 12 months in patients undergoing DES implantation

IIb C

Prasugrel administration in patients with a prior history of stroke or transient ischemic attack

III – Harm

B

*P2Y12 Inhibitors = clopidogrel, prasugrel, or ticagrelor**Clopidogrel loading dose of 600 mg recommended GNL 2011

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Antiplatelet And Antithrombin Rx at the Time of PCIRecommendation COR LOE

Oral Antiplatelet RxAspirin I BP2Y12 Inhibitor (clopidogrel*, prasugrel or ticagrelor) in patients treated with stent implantation

I A

GP IIb/IIIa Inhibitor Rx**No clopidogrel pre-treatment STEMI: IIa A

UA/NSTEMI I ASIHD IIa B

With clopidogrel pre-treatment STEMI IIa CUA/NSTEMI IIa B

SIHD IIb BAntithrombin Rx

UFH I CBivalirudin I BEnoxaparin IIb B

Anti-Xa InhibitorsFondaparinux III - Harm C

*Recommended loading dose for clopidogrel is 600 mg PO **Abciximab, double-bolus eptifibatide, or high-bolus dose tirofiban

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GP IIb/IIIa Inhibitor Therapy*Clopidogrel

Pre-Treatment ?Clinical Setting COR LOE

NoSTEMI IIa A

UA/NSTEMI I ASIHD IIa B

Yes

STEMI IIa CUA/NSTEMI IIa B

SIHD IIb BAntithrombin Rx

Additional Recommendations COR LOEAdministration of intracoronary (versus IV) abciximab administration in patients undergoing primary PCI with abciximab

IIb B

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

III – No Benefit

B

*Recommendations apply for abciximab, double-bolus eptifibatide, or high-bolus dose tirofiban

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Dosing of Parental Anticoagulants During PCIDrug Patient has received prior anticoagulant therapy Patient has not received prior

anticoagulant therapyUFH 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

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;

0.5-0.75 mg/kg IV bolus

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

0.75 mg/kg bolus, 1.75 mg/kg per h IV infusion

Fondaparinux 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.

N/A

Argatroban 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

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Heparin-Induced Thrombocytopenia (HIT)


Bivalirudin or argatroban use during PCI for patients with HIT

I B

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No Reflow Pharmacological Therapy


Administration of an intracoronary vasodilator (adenosine, calcium channel blocker, or nitroprusside) to treat PCI-related no-reflow that occurs during primary or elective PCI

IIa B

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SVG PCI


Embolic protection device use when technically feasible

I B

GP IIb/IIIa inhibitors III - No Benefit

B

PCI for chronic SVG occlusions III - Harm C

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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

IIa 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 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

GNL 2011

PCI in Specific Anatomic SituationsRecommendation COR LOE

SVG Embolic protection device use in SVG PCI when technically feasible I BGP IIb/IIIa inhibitors in SVG PCI III – No

BenefitB

PCI for chronic SVG occlusions III: Harm CCTO PCI of a CTO in patients with appropriate clinical indications and suitable

anatomy (when performed by operators with appropriate expertise) IIa B

Bifurcation Lesions

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

Aorto-Ostial Stenoses

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

Calcified Lesions

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

GNL 2011

GNL 2011

Periprocedural MI Assessment

Recommendation COR LOEMeasurement 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

Routine measurement of cardiac biomarkers in all patients after PCI

IIb C

GNL 2011

GNL 2011

Vascular Closure Devices (VCD)Recommendation COR LOE

Femoral angiogram pre-VCD to ensure anatomic suitability for deployment

I C

VCD for the purposes of achieving faster hemostasis and earlier ambulation (compared with the use of manual compression)

IIa B

Routine use of VCD for the purpose of decreasing vascular complications, including bleeding

III – No Benefit

B

GNL 2011

GNL 2011



Post-Procedural Considerations

GNL 2011

GNL 2011

P2Y12 Inhibitor Rx Post-StentRecommendation COR LOE

Post-Stent Implantation (BMS or DES) for ACS, P2Y12 inhibitor Rx at least 12 months

I B

Post-DES for non–ACS, clopidogrel for at least 12 mo if patients are not at high risk of bleeding.

I B

Post-BMS for non-ACS, clopidogrel for a minimum of 1 mo and ideally up to 12 mo

I B

Counseling patients on the importance of compliance with DAPT and to not discontinue Rx before discussion with the relevant cardiologist

I C

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

IIa C

Continuation of P2Y12 Rx beyond 12 mo in patients undergoing DES placement.

IIb C

(P2Y12 Inhibitor = clopidogrel, prasugrel or ticagrelor)

GNL 2011

GNL 2011

Platelet Function Testing For Patients Undergoing PCI


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

Treatment with an alternate P2Y12 inhibitor (e.g., prasugrel or ticagrelor) in clopidogrel-treated patients with high platelet reactivity

IIb C

GNL 2011

GNL 2011

Genetic Testing For Patients Undergoing PCI Treated With Clopidogrel


Genetic testing to identify whether a patient at high risk for poor clinical outcomes is predisposed to inadequate platelet inhibition with clopidogrel

IIb C

Routine clinical use of genetic testing to screen clopidogrel-treated patients undergoing PCI

III – No Benefit

C

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

IIb C

GNL 2011

GNL 2011

PPI Therapy and DAPTRecommendations based on risk of GI bleeding


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

GNL 2011

Stress Testing And Cardiac Rehabilitation


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

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

I B

Treatment of clinical restenosis after BMS with DES if anatomic factors are appropriate and the patient is able to comply with and tolerate DAPT

I A

IVUS to determine the mechanism of stent restenosis IIa 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

IIb C

*Intensified medical therapy and CABG are often also reasonable treatment strategies for restenosis

GNL 2011

GNL 2011

Secondary Prevention*Recommendations COR LOE

Lipid management with lifestyle modification and lipid-lowering pharmacotherapy

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

I C

Statin therapy which lowers LDL to <70 mg/dL in very high-risk patients

IIa B

Blood pressure control (with a blood pressure goal of <140/90 mm Hg)

Lifestyle modification I B

Pharmacotherapy 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

*Comprehensive secondary prevention recommendations in the ACCF/AHA Secondary Prevention and Risk Reduction 2011 Update

GNL 2011

GNL 2011

Quality and Performance ConsiderationsRecommendation 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

I C

Participation by every PCI program in a regional or national PCI registry for the purpose of benchmarking its outcomes against current national norms

I C

Participation by all physicians that perform PCI in the American Board of Internal Medicine interventional cardiology board certification and maintenance of certification program

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

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GNL 2011 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention (and Coronary...

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