State of DAPT The Short DAPT and Anticoagulation

State of DAPT The Short DAPT and Anticoagulation Debate February 24, 2020 Michael A. Kutcher, MD, FACC, FSCAI

Michael A. Kutcher, MD I have no relevant financial relationships

Michael A. Kutcher, MD, FACC, FSCAI Interventional Cardiology Wake Forest Baptist Medical Center Winston-Salem, North Carolina

Since this is Washington DC State of DAPT State of the Union

Objectives • Review triple versus double therapy in AF PCI • Review current guidelines of duration of DAPT after PCI stent procedures • Recent published studies on shortening DAPT • Propose DAPT strategies for the real world

DOUBLE VERSUS TRIPLE THERAPY IN PCI PATIENTS WITH ATRIAL FIBRILLATION

Summary of Major Triple vs Double Therapy Trials Wake Forest School of Medicine Capodanno D. Heart 2018; 104: 1976 -1983

Wake Forest School of Medicine

The North American Perspective – 2018 Update Pragmatic algorithm for the management of AF patients requiring OAC undergoing PCI Angiolillo DJ et al. Circulation 2018; 138: 527

2016 ACC/AHA AND 2017 ESC FOCUSED UPDATES ON DURATION OF DAPT AFTER PCI STENT

Timing of Non-Cardiac Surgery After PCI Levine GN et al. J Am Coll Cardiol 2016; 68: 1082 -115.

THE SPECTER OF NEWER GENERATION DRUG-ELUTING STENTS

BP-DES Platforms in Perspective Biomatrix Nobori SYNERGY Mi. Stent Orsiro Slendeiaa Bu. MA r Dynam. X Co. Cr. SES Co. Cr-NES 81µm 0. 0032” 80µm 0. 0031’’ 71µm 0. 0028” PEA PBMA/ PLGA PLLA Based/ PLGA 316 L-BES Pt. Cr-EES Co. Cr-SES Strut 120µm thickness 0. 0046” Polymer PLA Distribution / Abluminal 10µm thickness 125µm 0. 0047” 74µm 0. 0029” 64µm 0. 0025” 61µm 0. 0024” PLA PLGA PLLA/ Probio* Abluminal 20µm Abluminal Conformal 4µm 5µm / 15µm (Poly(ester) amide) Conformal 6 - Conformal 3. 5µm / 7 microns 3 -10µm 7. 5µm Conformal 9µm Slide Courtesy of Dean Kereiakes

RECENT PUBLISHED STUDIES ON EARLIER TRANSITION TO MONO ANTIPLATELET THERAPY AFTER PCI

Recent Shorter DAPT Publications PRECISE-DAPT Study • A meta-analysis of 14, 963 patients from 8 randomized trials where the PRECISE-DAPT score was applied in complex vs non -complex and long-DAPT versus short-DAPT DES patients. • Long-term DAPT in Non-HBR patients (< 25 score) reduced ischemic events in both complex and noncomplex PCI. Short term-DAPT in both groups reduced bleeding and ischemia risk only in the HBR (> 25 score) patients. Costa F et al. J Am Coll Cardiol 2019; 73: 741– 54.

Recent Shorter DAPT Publications SENIOR Study • A multi-center trial of 12, 604 patients > 75 years old were randomized to PCI with BMS or a platinum-chromium bioresorbable polymer everolimus-eluting stent (Pt. Cr-BP-EES) with 1 month DAPT for SIHD and 6 month DAPT for ACS. • A strategy of Pt. Cr-BP-EES and a short duration of DAPT were better than BMS and a similar duration of DAPT with respect to the occurrence of all-cause mortality, myocardial infarction, stroke, and ischemia-driven target lesion revascularization. Varenne O et al, Lancet 2018; 391: 41– 50.

Recent Shorter DAPT Publications STOPDAPT-2 Trial • A multi-center Japanese trial of 3, 045 patients who underwent PCI with implantation of a cobalt-chromium durable polymer (Co. Cr-DP-EES) were randomized to 1 month of DAPT followed by clopidogrel monotherapy or 12 months of DAPT with ASA and clopidogrel. • The 1 month strategy compared with 12 month strategy, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both non-inferiority and superiority. Watanabe H et al. JAMA. 2019; 321: 2414 -2427.

Recent Shorter DAPT Publications SMART-CHOICE Trial • A multi-center Korean open label trial of 2, 993 patients who underwent PCI with a variety of DP or BP DES were randomized to receive ASA and a P 2 Y 12 inhibitor for 3 months followed by P 2 Y 12 inhibitor monotherapy alone or DAPT for 12 months. • The 3 month DAPT strategy followed by monotherapy with P 2 Y 12 inhibitor was non-inferior to rates of major adverse events compared to the 12 month DAPT strategy. Hahn J-Y et al. JAMA. 2019; 321: 2428 -2437.

Recent Shorter DAPT Publications TWILIGHT Trial • A multi-center international trial of 9, 006 HBR patients who underwent PCI with variety of DES were followed by 3 months of DAPT with ASA and ticagrelor. • If, at three months, there were no bleeding or ischemic events, they were continued on ticagrelor and double blind randomized to either ASA or placebo. • At 1 year, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding compared to ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. Mehran R et al. N Engl J Med. 2019 Sep 26. doi: 10. 1056/NEJMoa 19084919.

Recent Shorter DAPT Publications ONYX ONE • A multi-center international randomized single-blind trial of 1, 996 HBR patients who underwent PCI with a DP-ZES or a polymer free umirolimus coated stent (PF-UCS) were given 1 month of DAPT with ASA and P 2 Y 12 agent followed single anti -platelet therapy thereafter, • At 1 year, DP-ZES was non-inferior to PF-UCS with regard to safety and effectiveness outcomes. Windecker S et al. N Engl J Med. 2020 Feb 12 doi :

PCI DAPT STRATEGIES IN THE REAL WORLD BEFORE NEW GUIDELINES ARE PUBLISHED

Real World PCI DAPT Strategies • Ongoing data for shorter duration of DAPT - 3 months – and even 1 month after implantation of second and third generation DES is intriguing and may very well justify a change in clinical practice. • The implementation of third generation thin strut and biodegradable polymer DES may provide further confirmation for the safety and efficacy of shortened duration of DAPT.

Real World PCI DAPT Strategies • There is merit to weigh risk/benefit of thrombotic versus bleeding events in determining the duration of DAPT. • Patient risk for stent thrombosis versus the increased bleeding risk and the duration of DAPT will vary with: – – – Patient clinical characteristics Acute versus stable presentation Complexity of coronary anatomy Type of DES Bleeding scores

Real World PCI DAPT Strategies • There is emerging data that a P 2 Y 12 agent may be a better choice than ASA for anti-platelet monotherapy after DAPT in DES. • If so, the type of P 2 Y 12 - clopidogrel or ticagrelor or prasugrel – long term duration and economics will be another issue.

Real World PCI DAPT Strategies • From a medical-legal standpoint, the duration of DAPT after DES should still generally follow the current ACC/AHA and ESC guidelines. • But, at this time, it may be appropriate to further shorten DAPT in certain risk/benefit cases. The rationale should be well documented and pertinent references cited.

Since this is Washington DC State of DAPT The PCI DAPT Guidelines need to be revised !!!

Thank You !!! Questions ? ?