DAPT Mortality and Cancer: Focus on HIRA Database

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DAPT Mortality and Cancer: Focus on HIRA Database Korean Outcomes Registry Evaluating Antithrombotics (KOREA) Victor Serebruany, MD, PhD Owner, HeartDrug™ Research LLC; Johns Hopkins University; Busan, December 9, 2016

Why the Topic is So Hot ? Conflicting Results of Clinical Trials Conflicting FDA Reviews Extreme clinical importance

DAPT Trial Cancers

Confusion over DAPT results Before AHA After AHA

All New Solid Cancers After 7 Days in TRITON 0 2 4 6 8 10 12 14 16 months 0,000 0,005 0,010 0,015 0,020 Fraction of Subjects Number at risk rx=Clopidogrel 6795 6508 6439 6327 5773 5120 4773 4286 0 rx=Prasugrel 6813 6558 6463 6318 5725 5097 4729 4227 0 rx=Clopidogrel rx=Prasugrel The FDA Secondary Prasugrel Review, 2009

Meta-Analysis of Solid Cancers in the Thienopyridine Invasive Trials for Which the FDA Has Cancer Data

Hazard Ratio=2.5 (95% CI 1.4-4.6; p=0.002) Solid Cancers in APPRAISE Hazard Ratio=2.5 (95% CI 1.4-4.6; p=0.002)

Times to First Solid Cancer Events by Arm in TRACER FDA Secondary Vorapaxar Review, 2014

Times to First Solid Cancer Events by Arm in TRA2P FDA Secondary Vorapaxar Review, 2014

Follow-up Rates in Patients with and without GUSTO Moderate/Severe Bleeding Events in TRA2P FDA Secondary Vorapaxar Review, 2014

HIRA Database: The Health Insurance Review and Assessment (HIRA) service receives the claims of 97% of the population in South Korea; In 2010, the number of beneficiaries was 48,906,795 among the entire population (50,515,666) of the country; Accordingly, the HIRA database contains information on almost all insurance claims for the entire country, including prescribed medications, procedures, and outcomes.

POPULATION: HIRA post-PCI claims (June 2009 - July 2013) ; Age >18 years Inclusion: DAPT with aspirin and clopidogrel (517900ACH) for 1 year, and then either DAPT, or monotherapy with aspirin (N02BA01; B01AC06) for extra 18 months. Exclusions: History of PCI prior to 2009, Repeated PCI (2009-2013) over the follow-up, Not verifiable vital status, Unknown DAPT or ASA duration, Acute myocardial infarction (I21.X), Stroke (I63.X), Bleeding (H11.3, H.43.1,H45.0, I60.X, I62X, K22.6, K25-28.X, K28.7), Any cancer (C00.X–C96.X) occurring within one year since PCI.

Study Flow Chart:

Major Findings Outcome DAPT (n=32,539) DAPT-C (n=10,992) ASA P-value All Deaths Any Cancer 462 (1.42%) 1,433 (4.40%) 136 (1.24%) 455 (4.15%) 192 (1.28%) 606 (4.04%) 0.99 0.005

Impressions: HIRA/KOREA data reveal a mild excess of cancer risk, but no mortality benefit in Korean post-PCI patients treated with DAPT for an additional 18 months beyond conventional 12 months DAPT. These data challenge continuing DAPT for more than 1 year in East Asians. Future: cancer types and potential cancer association with bleeding and newer antiplatelet agents are warranted.