ARC definition identified patients at high risk for bleeds

New research appears to validate a recently published consensus definition of high bleeding risk among patients on dual antiplatelet therapy (DAPT) following coronary revascularization.

One year ago, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) published the consensus document, designed to provide practical guidance to clinicians regarding the treatment of post-PCI patients with DAPT by identifying patients with a high and low risk for bleeds associated with prolonged treatment.

Until now, the clinical criteria for stratifying patient risk had not been validated in a real-world cohort.

In the study, published online in the Journal of the American College of Cardiology, the consortium definition was applied to a consecutive cohort of close to 10,000 patients who underwent coronary stent procedures between 2014 and 2017 at Mount Sinai Hospital, New York City.

Patients categorized as having a high bleeding risk using the ARC-HBR definition had an almost 3-fold greater likelihood of having a primary bleeding event 1 year after undergoing the stenting procedure, with 9.1% suffering an in-hospital or post-discharge bleed, compared to 3.2% of patients who did not meet the criteria for high bleeding risk (P<0.001).

A stepwise increase in bleeding risk corresponded to increasing individual patient bleeding risks.

Compared to patients without bleeding risk factors, patients who met the high bleeding risk (HBR) definition once had a 2.1-fold increased risk for bleeding, while those who met 4 of the definitions had a 12.3-fold increase in bleeding risk.

HBR patients also had significantly higher rates of MIs and death from all causes over the year following percutaneous coronary intervention (PCI).

“In this study, almost 1 in 2 patients (44.4%) undergoing PCI was at high bleeding risk according to the ARC-HBR criteria,” wrote researcher Davide Cao, MD, of New York City’s Icahn School of Medicine Mount Sinai, and colleagues.

The researchers noted that slightly fewer than 1 in 4 patients evaluated using the PRECISE-DAPT risk calculator were classified as high bleeding risk, and even fewer were classified as high bleeding risk in a study comparing antiplatelet therapies using the PARIS bleeding risk score.

“These discrepancies may be explained either by the inclusion of an unselected real-world group in our study or by the nature of the ARC-HRB definition itself, which is perhaps more sensitive, albeit less specific, than numerical risk scores in capturing this patient group,” the researchers wrote.

The ARC-HBR quantifies bleeding risk following PCI based on 20 major and minor risk factors, and high bleeding risk is defined as Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding risk of ≥4% at 1 year or a risk of an intracranial hemorrhage (ICH) of ≥1% at 1 year.

Patients were identified as having a high bleeding risk if they had at least 1 major or 2 minor risks based on the ARC criteria.

In the analysis of 9,623 patients, moderate or severe anemia was the most common major risk factor associated with high bleeding risk (33.2%) and age ≥75 years was the most frequent minor criterion and the most common risk factor overall (46.8%).

In an editorial published with the Cao et al study, Sunil Rao, MD and Zachary Wegermann, MD, of Duke University, Durham, North Carolina, wrote that a “targeted approach to identifying high bleeding risk patients has implications for both clinical care and evaluation of DAPT strategies for stents.”

They wrote that the study findings provide “more support that the ARC-HBR criteria clearly identify patients at high risk of bleeding and, importantly, demonstrate the importance of applying them in practice to make treatment decisions.”

They noted that PCI procedure-related bleeding risk can be reduced using strategies such as radical access.

“Transradical PCI clearly reduces bleeding compared with transfemeral PCI, especially in patients with high bleeding risk,” they wrote.

They noted that in the Mount Sinai cohort, radical access was used in just 14.4% of HBR patients, compared to 20.1% of non-HBR patients.

“This risk treatment paradox has been previously shown and highlights the disconnect that can exist between the identification of risk and the application of evidence-based strategies to reduce risk.”

They wrote that the study also raises questions about the optimal duration of DAPT following PCI. While guidelines recommend at least 6 months of DAPT after PCI for stable angina and 12 months after MI, studies involving newer generation drug-eluting stents suggest shorter courses may be associated with reduced bleeding events without a significant increase in stent thrombosis.

Given the finding that patients with ARC-HBR had a greater risk for MI and death, Rao and Wegermann wrote that in clinical practice “it may be useful to supplement ARC-HBR criteria with other risk scores such as the DAFT score to uncouple bleeding and ischemic risk and facilitate clinical decision making.”

“The clinician now has several strategies at his or her disposal to achieve the optimal balance between ischemic and bleeding risk in patients undergoing PCI, they concluded. “These include risk assessment tools like the ARC-HBR criteria and the DAPT score, procedural strategies like radial access and contemporary drug-eluting stents, and post-PCI pharmacological approaches like discontinuing aspirin in patients treated with oral anticoagulation or ticagrelor.”

  1. Using the ARC-HBR definition, patients with a high bleeding risk had an almost 3-fold greater likelihood of having a primary bleeding event 1 year after undergoing the stenting procedure, with 9.1% suffering an in-hospital or post-discharge bleed, compared to 3.2% of patients who did not meet the criteria for high bleeding risk (P<0.001).

  2. A stepwise increase in bleeding risk also corresponded to the number of times the ARC-HBR definition was met.

Salynn Boyles, Contributing Writer, BreakingMED™

Researcher Roxana Mehran reported receiving consulting fees or honoraria from Abbott Laboratories, Boston Scientific, Medscape, Siemens Medical Solutions, Philips (Spectranetics), PLx Pharma, Roivant Sciences Inc.,Volcano Corporation, Sanofi, Janssen, and Watermark Research Partners; has received research grants to her institution from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb, CSL Behring, Daiichi-Sankyo, Medtronic, Boston Scientific, Novartis, and OrbusNeich; has received institutional funding from and is on the Advisory Board of Spectranetics/Philips/Volcano Corporation; and has <1% equity in Claret Medical and Elixir Medical.

George Dangas has received consulting fees or honoraria from AstraZeneca, Biosensors, Boston Scientific, and Medtronic; is on the Advisory Board of Abbott Laboratories and Boston Scientific; has received research grants to the institution from Biotronik and Abbott Laboratories; and has equity (entirely divested) in Medtronic.

Usman Baber has received speaker honoraria from AstraZeneca and Boston Scientific; and has received honoraria from Amgen. Giulio Stefanini has received consulting fees or honoraria from B. Braun, Biosensors, Boston Scientific, and GADA; and the institution has received a research grant from Boston Scientific.

Dominick Angiolillo reported receiving consulting fees or honoraria from Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; has received payments for participation in review activities from CeloNova and St. Jude Medical; and has received research grants to his institution from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, and Renal Guard Solutions.

Davide Capodanno has received consulting fees or honoraria from Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Daiichi-Sankyo, and Sanofi.

Philip Urban has received consulting fees or honoraria from Biosensors-Europe; has participated in paid review activities (Clinical End Point Committee, Data Safety Monitoring Board) for Edward Lifesciences, Terumo, and Abbott Vascular; is a shareholder in and medical codirector of the Cardiovascular European Research Center (CERC), a contract research organization based in Massy, France; and is a shareholder in MedAlliance.

Marie-Caude Morice is the chief executive officer of CERC. Mitchell Krucoff has received consulting fees and research grants from Abbott Vascular, Biosensors, Boston Scientific, Cook Medical, Medtronic, and OrbusNeich. Samin Sharma has received consulting fees or honoraria from Abbott Vascular, Boston Scientific, Abiomed, and Cardiovascular System, Inc; and is on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular System, Inc.

Cat ID: 306

Topic ID: 74,306,730,306,192,925