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2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention (and Coronary Revascularization) • • • • PCI Revascularization Recommendations Pre-Procedural Considerations Procedural Considerations Post-Procedural Considerations 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Revascularization Recommendations 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 UPLM PCI to Improve Survival (ACS) COR IIaFor UA/NSTEMI if not a CABG candidate IIaFor STEMI when distal coronary flow is <TIMI grade 3 and PCI can be performed more rapidly and safely than CABG Single and Multivessel CAD PCI To Improve Survival (SIHD) Anatomic Scenario 2-3 Vessel CAD or 1 VD With Proximal LAD CAD 1 VD Without Proximal LAD CAD No anatomic or physiologic criteria for revascularization COR IIbUncertain benefit III: Harm III: Harm Clinical Scenario Survivors of sudden cardiac death with presumed ischemia-mediated VT COR I 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 IIa PCI to Improve Symptoms Clinical/Anatomic 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 No anatomic or physiologic criteria for revascularization I IIa IIa III: Harm Caveat COR CABG preferred over PCI for complex 3 VD and a good candidate for CABG IIa Cumulative 3-Year Incidence of MACE in Patients With 3-Vessel CAD in the SYNTAX trial Results For Each SYNTAX Tercile 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 ( 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 IIa IIb 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 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention PCI Revascularization Recommendations 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Pre-Procedural Considerations Pre-Procedural Considerations Recommendations Contrast-Induced AKI Assessment for risk of contrast-induced (CI) AKI COR I Adequate preparatory hydration I Minimization of volume of contrast media in patients with CKD I Administration of N-acetyl-L-cysteine for the prevention of CI-AKI Anaphylactoid Reactions Appropriate prophylaxis prior to repeat contrast administration in patients with prior evidence of an anaphylactoid reaction to contrast media Anaphylactoid prophylaxis for contrast reaction in patients with prior history of allergic reactions to shellfish or seafood Statins Administration of high-dose statin prior to PCI to reduce the risk of periprocedural MI Bleeding Risk Evaluation for risk of bleeding prior to PCI CKD Estimation of GFR and dosage adjustment of renally-cleared medications III: No Benefit I III: No Benefit IIa I I Contrast-Induced Acute Kidney Injury (AKI) Risk Reduction Recommendation COR Assessment for risk of contrast-induced AKI I Adequate preparatory hydration I Minimization of volume of contrast media in patients with CKD I Administration of N-acetyl-L-cysteine for the prevention of contrast-induced AKI III: No Benefit 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Procedural Considerations Vascular Access Recommendation Radial artery access to decrease access site complications COR IIa 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 Coronary Angiography in STEMI Indications COR 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 I I IIa Coronary angiography 3 to 24 hours after fibrinolysis Hemodynamically stable patients with evidence for successful fibrinolysis IIa Coronary angiography before hospital discharge Stable patients IIb 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 PCI in STEMI Indications COR 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 Primary PCI IIa IIb III: Harm 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 IIa IIa IIa IIb III: No Benefit Cardiogenic Shock Recommendation COR Immediate coronary angiography in patients with STEMI with severe heart failure or cardiogenic shock who are suitable candidates for revascularization I PCI for patients with acute MI who develop cardiogenic shock and are suitable candidates I Hemodynamic support device for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological therapy I 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 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 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 I 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 III - Harm I III - Harm 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 Aspirin in PCI Time Relative to PCI Recommendation COR Aspirin 81-325 mg before PCI if already on aspirin therapy I Nonenteric-coated aspirin 325 mg before PCI if not on aspirin therapy I PCI Aspirin administered at time of PCI I Post-PCI After PCI, aspirin continued indefinitely. I Pre-PCI After PCI, use of 81 mg/d of aspirin in preference to higher maintenance doses. IIa P2Y12 Inhibitors and DAPT Recommendation COR 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 I 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 I I I I IIa IIb III – Harm 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 STEMI treatment UA/NSTEMI SIHD Antithrombin Rx UFH Bivalirudin Enoxaparin Anti-Xa Inhibitors Fondaparinux COR I I IIa I IIa IIa IIa IIb I I IIb III - Harm GP IIb/IIIa Inhibitor Therapy Clopidogrel Pre-Treatment ? No Yes Clinical Setting COR STEMI UA/NSTEMI SIHD STEMI UA/NSTEMI SIHD IIa I IIa IIa IIa IIb Additional Recommendations COR 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 IIb III – No Benefit 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 Heparin-Induced Thrombocytopenia (HIT) Recommendation COR Bivalirudin or argatroban use during PCI for patients with HIT I 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 IIa SVG PCI Recommendation Embolic protection device use when technically feasible GP IIb/IIIa inhibitors PCI for chronic SVG occlusions COR I III - No Benefit III - Harm PCI in Specific Anatomic Situations Recommendation SVG CTO Bifurcation Lesions Aorto-Ostial Stenoses Calcified Lesions 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) COR I III – No Benefit III: Harm IIa 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 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 IVUS for the assessment of angiographically indeterminant left main CAD IIa DES use when PCI is indicated in patients with an aorto-ostial stenosis IIa Rotational atherectomy for fibrotic or heavily calcified lesions that might not be crossed by a balloon catheter or adequately dilated before stent implantation IIa Periprocedural MI Assessment Recommendation COR 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 Routine measurement of cardiac biomarkers in all patients after PCI IIb 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 I IIa III – No Benefit 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Post-Procedural Considerations P2Y12 Inhibitor Rx Post-Stent (P2Y12 Inhibitor = clopidogrel, prasugrel or ticagrelor) Recommendation COR 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 I I I IIa IIb PPI Therapy and DAPT Recommendations based on risk of GI bleeding Recommendation COR PPI use for patients with history of prior GI bleeding who require DAPT I PPI use for patients with increased risk of GI bleeding (advanced age, concomitant use of warfarin, steroids, NSAIDs, H pylori infection) who require DAPT. IIa 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 Restenosis Recommendation COR 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 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 I IIa IIb