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

3. 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 GNL 2011

4. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Class of Recommendation (COR) and Level of Evidence (LOE) GNL 2011

6. Class of Recommendation (COR) CORBenefit/RiskKey Words (The procedure or treatment…) Class IBenefit >>>Risk Should be performed/administered Is recommended Is indicated Is useful/effective/beneficial Class IIaBenefit>>Risk Is reasonable Can be useful/effective/beneficial Is probably recommended or indicated Class IIbBenefit ≥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 GNL 2011

7. Comparative Effectiveness Class of Recommendation (COR) CORKey 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 GNL 2011

8. Level of Evidence (LOE) LOECriteria A 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 GNL 2011

9. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Revascularization Recommendations GNL 2011

10. Heart Team Approach to UPLM or Complex CAD GNL 2011

11. UPLM Revascularization to Improve Survival Revasc Method CORLOE CABGIB PCI 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 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 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 III: Harm  For SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG B GNL 2011

12. UPLM Revascularization to Improve Survival Revasc Method CORLOE CABGIB PCI 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 2%) B III: Harm  For SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG B 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 GNL 2011

13. Single and Multivessel (Stable) CAD Anatomy Revasc Method CORLOE 3 VD +/- Proximal LAD Disease *# CABGIB PCI IIb  Of uncertain benefit B 2 VD With Proximal LAD Disease # CABGIB PCI IIb  Of uncertain benefit B 2 VD Without Proximal LAD Disease # CABG IIa  With extensive ischemia B IIb  Of uncertain benefit without extensive ischemia C PCI IIb  Of uncertain benefit B 1 VD With Proximal LAD disease CABG IIa  With LIMA for long-term benefit B PCI IIb  Of uncertain benefit B 1 VD Without Proximal LAD disease CABGIII: HarmB PCIIII: HarmB *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) GNL 2011

14. Clinical Setting Revasc Method CORLOE No anatomic or physiologic criteria for revascularization CABGIII: HarmB PCIIII: HarmB LV DysfunctionCABG IIb  EF <35% without significant left main CAD B PCIInsufficient data Survivors of sudden cardiac death with presumed ischemia- mediated VT CABGIB PCIIC Single and Multivessel (Stable) CAD Revascularization to Improve Survival (slide 2 of 2) GNL 2011

15. Comparative Effectiveness Recommendations for Revascularization to Improve Survival GNL 2011

16. Cumulative 3-Year Incidence of MACE in Patients With 3-Vessel CAD in the SYNTAX trial Results For Each SYNTAX Tercile GNL 2011

17. One-Year Mortality Rates in Randomized Trials of Patients With Diabetes and Multivessel CAD, Comparing PCI With CABG GNL 2011

18. Revascularization to Improve Symptoms Clinical SettingCORLOE ≥1 significant stenoses amenable to revascularization and unacceptable angina despite GDMT I−CABG A I−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 C IIa−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 No anatomic or physiologic criteria for revascularization III: Harm−CABGC III: Harm−PCI GNL 2011

19. Hybrid Coronary Revascularization RecommendationCORLOE 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) IIaB Hybrid coronary revascularization as an alternative to multivessel PCI or CABG in an attempt to improve the overall risk/benefit ratio of the procedures IIbC GNL 2011

20. TMR Clinical SettingCORLOE Viable ischemic myocardium that is perfused by coronary arteries that are not amenable to grafting IIb – TMR as an adjunct to CABG B GNL 2011

21. 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 GNL 2011

22. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention PCI Revascularization Recommendations GNL 2011

23. 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 GNL 2011

24. UPLM PCI to Improve Survival (SIHD) Risk of PCI Complication Likelihood of Good Long-term Outcome CABG Mortality Risk CORLOE 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 2%) B III: Harm  For SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG B Low Hi Low GNL 2011

25. UPLM PCI to Improve Survival (ACS) CORLOE 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 GNL 2011

26. Single and Multivessel CAD PCI To Improve Survival (SIHD) Anatomic ScenarioCORLOE 2-3 Vessel CAD or 1 VD With Proximal LAD CAD IIb  Uncertain benefit B 1 VD Without Proximal LAD CADIII: HarmB No anatomic or physiologic criteria for revascularization III: HarmB Clinical ScenarioCORLOE Survivors of sudden cardiac death with presumed ischemia-mediated VT IC Multivessel CAD CaveatsCORLOE Reasonable to choose CABG over PCI for good CABG candidates with complex 3-vessel CAD IIaB Reasonable to choose CABG over PCI for multivessel CAD in patients with DM IIaB GNL 2011

27. PCI to Improve Symptoms Clinical/Anatomic SettingCORLOE ≥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 No anatomic or physiologic criteria for revascularization III: HarmC Caveat CORLOE CABG preferred over PCI for complex 3 VD and a good candidate for CABG IIa B GNL 2011

28. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Pre-Procedural Considerations GNL 2011

29. Pre-Procedural Considerations RecommendationsCORLOE Contrast-Induced AKI Assessment for risk of contrast-induced (CI) AKIIC Adequate preparatory hydrationIB Minimization of volume of contrast media in patients with CKDIB Administration of N-acetyl-L-cysteine for the prevention of CI-AKIIII: No Benefit A Anaphylactoid Reactions Appropriate prophylaxis prior to repeat contrast administration in patients with prior evidence of an anaphylactoid reaction to contrast media IB Anaphylactoid prophylaxis for contrast reaction in patients with prior history of allergic reactions to shellfish or seafood III: No Benefit C Statins Administration of high-dose statin prior to PCI to reduce the risk of periprocedural MI IIaA: statin naïve B: statin reload Bleeding Risk Evaluation for risk of bleeding prior to PCIIC CKD Estimation of GFR and dosage adjustment of renally-cleared medicationsIB GNL 2011

30. Contrast-Induced Acute Kidney Injury (AKI) Risk Reduction RecommendationCORLE Assessment for risk of contrast-induced AKIIC Adequate preparatory hydrationIB Minimization of volume of contrast media in patients with CKD IB Administration of N-acetyl-L-cysteine for the prevention of contrast-induced AKI III: No Benefit A GNL 2011

31. 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. GNL 2011

32. Radiation Safety RecommendationCORLOE 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 IC *e.g., total air kerma at the international reference point (Ka,r), air kerma air product (PKA), fluoroscopy time, number of cine images GNL 2011

33. 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

34. 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

35. PCI in Hospitals Without On-Site Surgical Backup RecommendationCORLOE Primary PCI in hospitals without onsite cardiac surgery (provided that appropriate planning for program development has been accomplished) IIaB 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) IIbB 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 – HarmC GNL 2011

36. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Procedural Considerations GNL 2011

37. Vascular Access RecommendationCORLOE Radial artery access to decrease access site complications IIaA GNL 2011

38. UA/NSTEMI: Choice of Strategy* RecommendationCORLOE An early invasive strategy** in patients who have refractory angina or hemodynamic or electrical instability (without serious comorbidities or contraindications to such procedures) IB An early invasive strategy** in initially stabilized patients (without serious comorbidities or contraindications to such procedures) who have an elevated risk for clinical events IA 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 IB A conservative strategy recommended (over an early invasive strategy) in women with low-risk features IB An early invasive strategy (within 12 to 24 hours of admission) chosen over a delayed invasive strategy for initially stabilized high-risk patients*** IIaB 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)*** IIbC 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) GNL 2011

39. 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 GNL 2011

40. Coronary Angiography in STEMI IndicationsCORLOE Immediate coronary angiography Candidate for primary PCIIA Severe heart failure or cardiogenic shock (if suitable revascularization candidate) IB Moderate to large area of myocardium at risk and evidence of failed fibrinolysis IIaB Coronary angiography 3 to 24 hours after fibrinolysis Hemodynamically stable patients with evidence for successful fibrinolysis IIaA Coronary angiography before hospital discharge Stable patientsIIbC 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 GNL 2011

41. PCI in STEMI* IndicationsCORLOE Primary PCI* STEMI symptoms within 12 hIA Severe heart failure or cardiogenic shockIB Contraindications to fibrinolytic therapy with ischemic symptoms <12 hIB Clinical and/or ECG evidence of ongoing ischemia between 12 and 24 h after symptom onset IIaB Asymptomatic patient presenting between 12 and 24 h after symptom onset and higher risk IIbC Noninfarct artery PCI at the time of primary PCI in patients without hemodynamic compromise III: HarmB Delayed or Elective PCI in Patients with STEMI (i.e. Non-Primary PCI) Clinical evidence for fibrinolytic failure or infarct artery reocclusionIIaB Patent infarct artery 3 to 24 h after fibrinolytic therapyIIaB Ischemia on noninvasive testingIIaB Hemodynamically significant stenosis in a patent infarct artery >24 hours after STEMI IIbB Totally occluded infarct artery >24 h after STEMI in a hemodyamically stable asymptomatic patient without evidence of severe ischemia III: No Benefit B *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

42. Cardiogenic Shock RecommendationCORLOE Immediate coronary angiography in patients with STEMI with severe heart failure or cardiogenic shock who are suitable candidates for revascularization IB PCI for patients with acute MI who develop cardiogenic shock and are suitable candidates IB Hemodynamic support device for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological therapy IB GNL 2011

43. 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 GNL 2011

44. Revascularization Before Noncardiac Surgery RecommendationCORLOE 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 IIaB Continuation of aspirin if possible and restarting of the P2Y 12 inhibitor as soon as possible in the immediate postoperative for patients with a DES who must undergo urgent surgical procedures IIaC Routine prophylactic coronary revascularization in patients with stable CAD before noncardiac surgery III – HarmB 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 P2Y 12 inhibitor will need to be discontinued III – HarmB GNL 2011

45. 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 RecommendationCORLOE 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 IC 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 IB PCI with coronary stenting in cases in which the patient is not likely to be able to tolerate and to comply with DAPT III - HarmB 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 - HarmB GNL 2011

46. 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 GNL 2011

47. Adjunctive Diagnostic Devices RecommendationCORLOE FFR to assess angiographic intermediate coronary lesions and to guide revascularization decisions in patients with SIHD IIaA IVUS for the assessment of angiographically indeterminate left main CAD IIaB IVUS after cardiac transplantationIIaB IVUS to determine the mechanism of stent restenosisIIaC IVUS for the assessment of non-left main angiographically intermediate stenoses IIbB IVUS for guidance of coronary stent implantationIIbB IVUS to determine the mechanism of stent thrombosisIIbC IVUS for routine lesion assessment when revascularization is not being contemplated III – No Benefit C Optical coherence tomographyNo Recommendations GNL 2011

48. DeviceRecommendationCORLOE Coronary Atherectomy Rotational atherectomy for fibrotic or heavily calcified lesions that might not be crossed by a balloon catheter or adequately dilated before stent implantation IIaC Rotational atherectomy performed routinely for de novo lesions or in-stent restenosis III – No Benefit A ThrombectomyAspiration thrombectomy for patients undergoing primary PCIIIaB Laser Angioplasty Laser angioplasty for fibrotic or moderately calcified lesions that cannot be crossed or dilated with conventional balloon angioplasty IIbC Laser angioplasty performed routinely during PCIIII – 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 IIbC Cutting balloon angioplasty performed routinely during PCIIII – No Benefit A Embolic Protection Devices Embolic protection devices (EPD) use during saphenous vein graft (SVG) PCI when technically feasible IB Hemodynamic Support Devices Elective insertion of an appropriate percutaneous hemodynamic support device as an adjunct to PCI in carefully selected high-risk patients IIbC Adjunctive Therapeutic Devices GNL 2011

49. Aspirin in PCI Time Relative to PCI RecommendationCORLOE Pre-PCIAspirin 81-325 mg before PCI if already on aspirin therapy IB Nonenteric-coated aspirin 325 mg before PCI if not on aspirin therapy IB PCI Aspirin administered at time of PCIIB Post-PCIAfter PCI, aspirin continued indefinitely.IA After PCI, use of 81 mg/d of aspirin in preference to higher maintenance doses. IIaB GNL 2011

50. P2Y 12 Inhibitors* and DAPT RecommendationCORLOE Administration of a loading dose** of a P2Y 12 receptor to patients undergoing PCI with stenting IA Patients counseling on the need for and risks of DAPT before placement of intracoronary stents, especially a DES IC P2Y 12 inhibitor therapy for at least 12 months in patients receiving a stent (BMS or DES) during PCI for ACS IB 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 IB 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) IB Earlier discontinuation (e.g., <12 months) of P2Y 12 inhibitor therapy after stent implantation if the risk of morbidity from bleeding outweighs the anticipated benefit afforded by a recommended duration of P2Y 12 inhibitor therapy IIaC Continuation of DAPT beyond 12 months in patients undergoing DES implantation IIbC Prasugrel administration in patients with a prior history of stroke or transient ischemic attack III – Harm B *P2Y 12 Inhibitors = clopidogrel, prasugrel, or ticagrelor **Clopidogrel loading dose of 600 mg recommended GNL 2011

51. Antiplatelet And Antithrombin Rx at the Time of PCI RecommendationCORLOE Oral Antiplatelet Rx AspirinIB P2Y 12 Inhibitor (clopidogrel*, prasugrel or ticagrelor) in patients treated with stent implantation IA GP IIb/IIIa Inhibitor Rx** No clopidogrel pre-treatmentSTEMI:IIaA UA/NSTEMIIA SIHDIIaB With clopidogrel pre-treatmentSTEMIIIaC UA/NSTEMIIIaB SIHDIIbB Antithrombin Rx UFHIC BivalirudinIB EnoxaparinIIbB Anti-Xa Inhibitors FondaparinuxIII - HarmC *Recommended loading dose for clopidogrel is 600 mg PO **Abciximab, double-bolus eptifibatide, or high-bolus dose tirofiban GNL 2011

52. GP IIb/IIIa Inhibitor Therapy* Clopidogrel Pre-Treatment ? Clinical SettingCORLOE No STEMIIIaA UA/NSTEMIIA SIHDIIaB Yes STEMIIIaC UA/NSTEMIIIaB SIHDIIbB Antithrombin Rx Additional RecommendationsCORLOE Administration of intracoronary (versus IV) abciximab administration in patients undergoing primary PCI with abciximab IIbB 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 GNL 2011

53. Dosing of Parental Anticoagulants During PCI DrugPatient has received prior anticoagulant therapyPatient has not received prior anticoagulant therapy UFHIV 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 EnoxaparinFor 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 BivalirudinFor 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 FondaparinuxFor 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 Argatroban200 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 GNL 2011

54. Heparin-Induced Thrombocytopenia (HIT) RecommendationCORLOE Bivalirudin or argatroban use during PCI for patients with HIT IB GNL 2011

55. No Reflow Pharmacological Therapy RecommendationCORLOE Administration of an intracoronary vasodilator (adenosine, calcium channel blocker, or nitroprusside) to treat PCI- related no-reflow that occurs during primary or elective PCI IIaB GNL 2011

56. SVG PCI RecommendationCORLOE Embolic protection device use when technically feasible IB GP IIb/IIIa inhibitorsIII - No Benefit B PCI for chronic SVG occlusionsIII - HarmC GNL 2011

57. PCI in Specific Anatomic Situations* RecommendationCORLOE PCI of a CTO in patients with appropriate clinical indications and suitable anatomy when performed by operators with appropriate expertise IIaB 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 IA 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 IIaB IVUS for the assessment of angiographically indeterminant left main CAD IIaB DES use when PCI is indicated in patients with an aorto-ostial stenosisIIaB 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 IIaC *SVG recommendations on separate slide GNL 2011

58. PCI in Specific Anatomic Situations RecommendationCORLOE SVGEmbolic protection device use in SVG PCI when technically feasibleIB GP IIb/IIIa inhibitors in SVG PCIIII – No Benefit B PCI for chronic SVG occlusionsIII: HarmC CTOPCI of a CTO in patients with appropriate clinical indications and suitable anatomy (when performed by operators with appropriate expertise) IIaB 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 IA 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 IIaB Aorto-Ostial Stenoses IVUS for the assessment of angiographically indeterminant left main CADIIaB DES use when PCI is indicated in patients with an aorto-ostial stenosisIIaB 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 IIaC GNL 2011

59. Periprocedural MI Assessment RecommendationCORLOE 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 IC Routine measurement of cardiac biomarkers in all patients after PCI IIbC GNL 2011

60. Vascular Closure Devices (VCD) RecommendationCORLOE Femoral angiogram pre-VCD to ensure anatomic suitability for deployment IC VCD for the purposes of achieving faster hemostasis and earlier ambulation (compared with the use of manual compression) IIaB Routine use of VCD for the purpose of decreasing vascular complications, including bleeding III – No Benefit B GNL 2011

61. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Post-Procedural Considerations GNL 2011

62. P2Y 12 Inhibitor Rx Post-Stent RecommendationCORLOE Post-Stent Implantation (BMS or DES) for ACS, P2Y 12 inhibitor Rx at least 12 months IB Post-DES for non–ACS, clopidogrel for at least 12 mo if patients are not at high risk of bleeding. IB Post-BMS for non-ACS, clopidogrel for a minimum of 1 mo and ideally up to 12 mo IB Counseling patients on the importance of compliance with DAPT and to not discontinue Rx before discussion with the relevant cardiologist IC Earlier discontinuation (e.g., <12 mo) of P2Y 12 inhibitor if the risk of morbidity from bleeding outweighs the anticipated benefit afforded by a recommended duration of P2Y 12 inhibitor therapy after stent implantation IIaC Continuation of P2Y 12 Rx beyond 12 mo in patients undergoing DES placement. IIbC (P2Y 12 Inhibitor = clopidogrel, prasugrel or ticagrelor) GNL 2011

63. Platelet Function Testing For Patients Undergoing PCI RecommendationCORLOE Platelet function testing in patients at high risk for poor clinical outcomes IIbC Routine clinical use of platelet function testing to screen clopidogrel-treated patients undergoing PCI III – No Benefit C Treatment with an alternate P2Y 12 inhibitor (e.g., prasugrel or ticagrelor) in clopidogrel-treated patients with high platelet reactivity IIbC GNL 2011

64. Genetic Testing For Patients Undergoing PCI Treated With Clopidogrel RecommendationCORLOE Genetic testing to identify whether a patient at high risk for poor clinical outcomes is predisposed to inadequate platelet inhibition with clopidogrel IIbC Routine clinical use of genetic testing to screen clopidogrel-treated patients undergoing PCI III – No Benefit C Treatment with an alternate P2Y 12 inhibitor (e.g., prasugrel or ticagrelor) in a patient identified by genetic testing as predisposed to inadequate platelet inhibition with clopidogrel IIbC GNL 2011

65. PPI Therapy and DAPT Recommendations based on risk of GI bleeding RecommendationCORLOE PPI use for patients with history of prior GI bleeding who require DAPT IC 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. IIaC 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

66. Stress Testing And Cardiac Rehabilitation RecommendationCORLOE Treadmill exercise testing in patients entering in to a formal cardiac rehabilitation program IIaC 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 IB GNL 2011

67. Restenosis* RecommendationCORLOE 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 IB Treatment of clinical restenosis after BMS with DES if anatomic factors are appropriate and the patient is able to comply with and tolerate DAPT IA IVUS to determine the mechanism of stent restenosisIIaC 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 IIbC *Intensified medical therapy and CABG are often also reasonable treatment strategies for restenosis GNL 2011

68. Secondary Prevention* RecommendationsCORLOE Lipid management with lifestyle modification and lipid-lowering pharmacotherapy Lifestyle modificationIB Statin therapyIA Statin therapy which lowers LDL to <100 mg/dL and achieves at least a 30% lowering of LDL IC Statin therapy which lowers LDL to <70 mg/dL in very high-risk patients IIaB Blood pressure control (with a blood pressure goal of <140/90 mm Hg) Lifestyle modificationIB PharmacotherapyIA Diabetes management (e.g., lifestyle modification and pharmacotherapy) coordinated with the patient’s primary care physician and/or endocrinologist IC Complete smoking cessationIA *Comprehensive secondary prevention recommendations in the ACCF/AHA Secondary Prevention and Risk Reduction 2011 Update GNL 2011

69. Quality and Performance Considerations RecommendationCORLOE 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 IC Participation by every PCI program in a regional or national PCI registry for the purpose of benchmarking its outcomes against current national norms IC Participation by all physicians that perform PCI in the American Board of Internal Medicine interventional cardiology board certification and maintenance of certification program IIaC * 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