Disclosures Interventional Cardiology for the Non-Cardiologist: No - PDF document

◆ 10/13/17 Disclosures Interventional Cardiology for the Non-Cardiologist: No Conflicts of Interest New Innovations and New Guidelines Krishan.soni@ucsf.edu Krishan Soni, MD, MBA, FACC Assistant Professor of Medicine Division of Cardiology Interventional Cardiology for the Interventional Cardiology for the Non-Cardiologist Non-Cardiologist TOPICS ■ Major Society Guideline updates 2016-2017 ■ Anti Platelet Therapy ■ Updates on Bioresorbable Scaffolds ■ Clinical Trials Published ■ Updates on TAVR 2016-2017 (Transcatheter Aortic Valve Replacement) ■ Regulatory News and Events ◆ 1

◆ 10/13/17 Strength of Guideline Recommendations Acronyms ■ ACS : Acute Coronary Syndrome ■ BMS: Bare Metal Stent ■ CAD : Coronary Artery Disease ■ CABG: Coronary Artery Bypass Graft Surgery ■ DAPT : Dual Antiplatelet Therapy ■ DES: Drug Eluting Stent ■ PCI : Percutaneous Coronary Intervention ■ PPI: Proton Pump Inhibitor ■ SIHD : Stable Ischemic Heart Disease ■ TAVR : Transcatheter Aortic Valve Replacement Interventional Cardiology for the Antiplatelet Agents Non-Cardiologist Aspirin Clopidogrel Prasugrel Ticagrelor TOPICS (Plavix) (Effient) (Brilinta) Indication ACS ACS Post PCI ACS ■ Anti Platelet Therapy Post PCI Post PCI Post PCI Stroke Stroke ■ Updates on Bioresorbable Scaffolds PVD PVD Dose 325 mg 300-600 mg 60 mg 180 mg ■ Updates on TAVR Load 81 mg 75 mg 10 mg 90 mg Maintenance DAILY DAILY DAILY BID (Transcatheter Aortic Valve Replacement) 2 nd gen 2 nd gen Class NSAID CTPT thienopyridine thienopyridine (PRODRUG) (PRODRUG) Mechanism IRREVERSIBLE IRREVERSIBLE IRREVERSIBLE REVERSIBLE COX 1 P2Y12 P2Y12 P2Y12 Peak Effect 1-3 hours 6 hours 4 hours 2 hours CYP Metab NA 2C19 3A4 3A4/5 Hold prior to ?? 5 days 7 days 5 days Surgery ◆ 2

◆ 10/13/17 Aspirin Dosing in Patients with Coronary Artery Disease (CAD) ◆ Higher doses of aspirin are associated with bleeding and no increased anti-ischemic benefit ◆ When used with ticagrelor (Brilinta), aspirin doses of >100 mg are contraindicated Duration of Dual Antiplatelet Therapy According to US Guidelines, how long (DAPT) should patients be on Dual Antiplatelet Therapy (DAPT) after PCI with a Drug Duration of DAPT depends on: ■ Eluting Stent? ◆ Underlying condition ◆ Treatment provided A. 3 months B. 6 months C. 12 months D. It depends on the 0% 0% 0% 0% 0% indication for PCI E. Call a cardiology consult Stable Ischemic Heart Acute Coronary Syndromes Disease (SIHD) (ACS) ◆ 3

◆ 10/13/17 Duration of Dual Antiplatelet Therapy Duration of Dual Antiplatelet Therapy (DAPT) in Patients with ACS (DAPT) in Patients with SIHD Stable Ischemic Heart Acute Coronary Disease (SIHD) Syndromes (ACS) Stopping early at 3 months PCI with Bare PCI with Stopping 1 year Metal Drug early Stent Eluting at 6 months (BMS) Stent (DES) 1 MONTH 6 MONTHS When should DAPT therapy be The DAPT Score can guide risk / benefit continued for LONGER Duration? of longer therapy Risk of Ischemia Risk of Bleeding Score ≥ 2 Favorable benefit/risk For prolonged DAPT Score <2 NOT Favorable benefit/risk For prolonged DAPT ◆ 4

◆ 10/13/17 Which P2Y12 Agent should I What’s the update on triple therapy? recommend? For Medically ◆ For patients who require triple therapy: Ticagrelor Recommended Clopidogrel Managed ACS over (Brilinta) (Plavix) ◆ Use Coumadin (keep INR at low end of range) ◆ Use Clopidogrel For ACS with Ticagrelor Prasugrel Recommended Clopidogrel ◆ Use low dose aspirin PCI over (Brilinta) (Effient) (Plavix) ◆ Consider PPI Perioperative Management and Timing 65 yo man underwent PCI with a drug eluting stent of Non Cardiac Surgery to the LAD 2 months ago for stable angina. He now has severe knee osteoarthritis and is asking you when he can have surgery. How long after his stent should he wait? A. 1 month B. 3 months Wait at least 3 months and C. 6 months preferably 6 D. 12 months months after PCI with DES E. He should be managed 0% 0% 0% 0% 0% medically indefinitely Wait 30 days after PCI with BMS ◆ 5

◆ 10/13/17 Perioperative Management and Timing Perioperative Management and Timing of Non Cardiac Surgery of Non Cardiac Surgery ◆ How long before surgery should DAPT be stopped? ◆ CONTINUE ASPIRIN if possible! ◆ STOP Clopidogrel: 5 days prior to surgery ◆ STOP Ticagrelor: 5 days prior to surgery ◆ STOP Prasugrel: 7 days prior to surgery ◆ During perioperative period: Class IIb (Level C) ◆ Continue aspirin if possible Extrapolated from 2013 ACC/AHA STEMI Guidelines ◆ Restart P2Y12 as soon as possible Key Points Regarding DAPT (1/3) Key Points Regarding DAPT (2/3) Dose of Aspirin for all patients is 81 mg daily Choice of Agents: ■ ■ Duration of DAPT: ◆ Medical Management of ACS: Ticagrelor > Plavix ■ ◆ PCI in ACS: Ticagrelor or Prasugrel > Plavix ◆ ACS Patients: 1 YEAR for ALL (with/without stent) ◆ Do NOT USE Prasugrel if history of stroke or TIA ◆ SIHD (Stable Ischemic Heart Disease) Patients: ✦ Drug Eluting Stent (DES): 6 MONTHS ✦ Bare Metal Stent (BMS): 1 MONTH Triple Therapy: ■ Stopping Early: ◆ Short Duration ■ ◆ DAPT could be stopped 3 months after DES (drug ◆ Use clopidogrel/coumadin eluting stent) for high bleeding risk patients ◆ Target INR 2-2.5 Longer Therapy: ◆ Use PPI (Proton Pump Inhibitor) ■ ◆ Risk benefit between bleeding and ischemia ◆ DAPT score can be helpful ◆ 6

◆ 10/13/17 Key Points Regarding DAPT (3/3) Interventional Cardiology for the Non-Cardiologist Timing of Non-Cardiac Surgery: TOPICS ■ ◆ Ideally > 1 month after BMS , 6 months after DES ■ Anti Platelet Therapy ◆ Continue Aspirin if possible ◆ Hold : ■ Updates on Bioresorbable Scaffolds ✦ Clopidogrel 5 days prior to surgery ■ Updates on TAVR ✦ Ticagrelor 5 days prior to surgery (Transcatheter Aortic Valve Replacement) ✦ Prasugrel 7 days prior to surgery Bioresorbable Vascular Scaffold (BVS): Limitations of Current Metallic Stents ABSORB ■ NO Permanent Implant! ■ The standard of care for PCI for the last decade has been metallic stents ◆ Allows for restoration of vessel function (theoretical benefit) ◆ Bare Metal or Drug Eluting ◆ Maintain option for future surgery (CABG) ◆ Fewer permanent layers of metal in patients requiring treatment for stent restenosis (ISR) ABSORB GT1 (Abbott Vascular) ■ Metallic stents have disadvantages : Absorbable polymer, poly (L- lactide) (PLLA)with ◆ Risk of stent thrombosis 0.1-0.2%/yr everolimus drug coating ◆ Risk of repeat revascularization 2-3%/yr ◆ Permanent implant cannot be removed ◆ 7

◆ 10/13/17 A 52 yo M has ongoing CCS Class III stable angina ABSORB III Trial: BVS comparable to DES despite maximal medical therapy. Coronary angiography demonstrates a 90% focal RCA lesion. He is considering PCI and requests your opinion regarding a bioresorbable stent . What do you tell him? A. “It’s the latest and greatest, go for it” B. “The risks and benefits appear to 2008 patients with stable or unstable angina randomly ■ be similar to assigned in a 2:1 ratio to receive Absorb or an everolimus- current metallic eluting cobalt–chromium (Xience) stent stents.” 0% 0% 0% C. “Steer Clear, at Primary end point: target-lesion failure (cardiac death, ■ least for now!” target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year Follow up data shows higher stent ABSORB III Results thrombosis (March 2017) ◆ Target lesion failure non-inferior for ABSORB ◆ No difference in cardiac death at 1 (0.6% vs 0.1% p=0.29) ◆ Signal for increase in stent thrombosis at 1 year ◆ AIDA trial showed significantly higher stent thrombosis (1.5% vs 0.7%, p=0.13) ◆ 27 events vs 5! ◆ 8

◆ 10/13/17 The fate of ABSORB The fate of ABSORB Results from 2 year follow up of ABSORB shown at American College of Cardiology Meeting (3/2017): ◆ Target Lesion Failure: 11.0% vs 7.9% (significant) ◆ Target Vessel Myocardial Infarction: 7.3% vs 4.9% (p=0.04) Sales Halted September 2017 ◆ Stent Thrombosis: 1.9 vs 0.8% Key Points Regarding BVS Interventional Cardiology for the Non-Cardiologist Data through 2 years demonstrate a significantly TOPICS ■ higher risk of stent thrombosis with ABSORB ■ Anti Platelet Therapy bioresorbable vascular scaffold (BVS) ■ Updates on Bioresorbable Scaffolds FDA warning letter issued MARCH 2017 ■ ■ Updates on TAVR (Transcatheter Aortic Valve Replacement) ABSORB withdrawn from sale SEPTEMBER 2017 ■ Bioresorbable Vascular Scaffolds May Not be Ready for Primetime ◆ 9

◆ 10/13/17 An 82 yo lady presents to your office with severe Aortic Stenosis shortness of breath while walking from her bed to the bathroom. She appears frail. On exam, you hear a 3/6 mid systolic murmur. She has 1+ LE edema at ◆ Degree of Aortic the shins. Echo shows severe aortic stenosis with Stenosis is LVEF 35%. What do you recommend? determined by Echocardiography A. Surgical Aortic ◆ Symptoms are key! Valve Replacement B. Transcatheter Aortic Valve 0% 0% 0% 0% 0% Replacement C. Medical Therapy D. Hospice E. Ask my local cardiologist Aortic Stenosis – Progression of Disease Intervening on patients with severe symptomatic AS improves survival Valve replacement indicated for Stage C2 and D ◆ 10