Dataset Information

Point-of-care platelet function testing predicts bleeding in patients exposed to clopidogrel undergoing coronary artery bypass grafting: Verify pre-op TIMI 45--a pilot study.

ABSTRACT:

Background

Guidelines recommend delaying coronary artery bypass grafting (CABG) for 5 days after discontinuing clopidogrel. However, platelet function may recover quicker in certain individuals.

Hypothesis

We hypothesized that perioperative measurement of platelet function with a point-of-care P2Y12 inhibitor assay could predict bleeding during CABG in patients exposed to clopidogrel.

Methods

Verify Pre-Op TIMI 45 was a prospective pilot study of 39 patients on clopidogrel who subsequently underwent CABG. Preoperative on-treatment platelet reactivity was assessed with VerifyNow P2Y12 Reaction Units (PRU), with higher PRU indicating more reactive platelets. Outcomes were stratified by PRU quartiles, as well as prespecified cutpoints for the lowest quartile (PRU 173), a cutpoint for major bleeding determined by the Youden index using receiver operator curve analysis (PRU 207), and clopidogrel resistance (PRU 230).

Results

Patients in higher PRU quartiles experienced smaller decreases in hemoglobin and hematocrit (P?ConclusionsIn this pilot study, we found that point-of-care platelet function assessment could predict bleeding in patients recently exposed to clopidogrel undergoing CABG.

SUBMITTER: Reed GW

PROVIDER: S-EPMC6711068 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Publications

Point-of-care platelet function testing predicts bleeding in patients exposed to clopidogrel undergoing coronary artery bypass grafting: Verify pre-op TIMI 45--a pilot study.

Reed Grant W GW Kumar Amit A Guo Jianping J Aranki Sary S Shekar Prem P Agnihotri Arvind A Maree Andrew O AO McLean Dalton S DS Rosenfield Kenneth K Cannon Christopher P CP

Clinical cardiology 20150205 2

<h4>Background</h4>Guidelines recommend delaying coronary artery bypass grafting (CABG) for 5 days after discontinuing clopidogrel. However, platelet function may recover quicker in certain individuals.<h4>Hypothesis</h4>We hypothesized that perioperative measurement of platelet function with a point-of-care P2Y12 inhibitor assay could predict bleeding during CABG in patients exposed to clopidogrel.<h4>Methods</h4>Verify Pre-Op TIMI 45 was a prospective pilot study of 39 patients on clopidogrel ...[more]

PMID: 25655085

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Project description:BackgroundProlonged or excessive bleeding after cardiac surgery can lead to a broad spectrum of secondary complications. One of the underlying causes is incomplete wound drainage, with subsequent accumulation of blood and clots in the pericardium. We developed the continuous postoperative pericardial flushing (CPPF) therapy to improve wound drainage and reduce postoperative blood loss and bleeding-related complications after cardiac surgery. This study compared CPPF to standard care in patients after coronary artery bypass grafting (CABG).MethodsThis is a single center, open label, randomized trial that enrolled patients at the Amsterdam UMC, location AMC, Amsterdam, the Netherlands. The study was registered at the 'Netherlands Trial Register', study identifier NTR5200 [1]. Adults undergoing CABG were randomly assigned to receive CPPF therapy or standard care, participants and investigators were not masked to group assignment. The primary end point was postoperative blood loss in the first 12-hours after surgery.FindingsBetween the January 15, 2014 and the March 13, 2017, 169 patients were enrolled and assigned to CPPF therapy (study group; n = 83) or standard care (control group; n = 86). CPPF reduced postoperative blood loss when compared to standard care (median differences -385 ml, reduction 76% p=≤0.001), with the remark that these results are overestimated due to a measurement error in part of the study group. None of patients in the study group required reoperation for non-surgical bleeding versus 3 (4%, 95% CI -0.4% to 7.0%) in the control group. None of the patients in the study group suffered from cardiac tamponade, versus 3 (4%, 95% CI -0,4% to 7.0%) in the control group. The incremental cost-effectiveness ratio was €116.513 (95% bootstrap CI €-882.068 to €+897.278).InterpretationThe use of CPPF therapy after CABG seems to reduce bleeding and bleeding related complications. With comparable costs and no improvement in Qualty of Life (QoL), cost consideration for the implementation of CPPF is not relevant. None of the patients in the study group required re-interventions for non-surgical bleeding or acute cardiac tamponade, which underlines the proof of concept of this novel therapy.FundingThis study was funded by ZonMw, the Netherlands organization for health research and development (project 837001405).

Project description:ObjectiveControversy persists surrounding the perceived bleeding risk associated with perioperative clopidogrel use in patients undergoing lower extremity bypass (LEB). The purpose of this study was to examine the LEB bleeding risk and clinical sequelae associated with clopidogrel.MethodsAll LEBs in the Vascular Quality Initiative (VQI) from 2008 to 2014 were studied. The exposure was perioperative clopidogrel. Primary outcomes were blood transfusion, estimated blood loss ≥500 mL, and reoperation for bleeding. Secondary outcomes included mean operative time, major cardiac events, respiratory complications, infectious complications, and in-hospital mortality. Univariate and multivariable analyses were used to analyze patients on the basis of clopidogrel use and its association with outcomes. Nonparametric test for trend and Mantel-Haenszel methods were used to analyze association of clopidogrel use with blood transfusion and secondary outcomes.ResultsAmong the LEB cohort (N = 9179), 28% (n = 2544) were taking clopidogrel and 72% (n = 6635) were not. Patients taking clopidogrel were more likely to have coronary disease, prior coronary intervention, abnormal findings on stress test, and aspirin use (P < .001 for all). Patients taking clopidogrel were more likely to receive blood transfusion (38% vs 24%; P < .001) and to have estimated blood loss ≥500 mL (21% vs 12%; P < .001). Reoperation for bleeding rates were similar (0.9% vs 1.1%; P = .9). Clopidogrel use was also associated with increased mean operative times (244 minutes vs 232 minutes; P < .001) as well as with cardiac complications (8.8% vs 6.5%; P = .001), respiratory complications (2.5% vs 1.6%; P = .007), and in-hospital mortality (1.3% vs 0.8%; P = .03). Multivariable analysis demonstrated that clopidogrel was associated with increased risk of 1- or 2-unit blood transfusion (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.5-2.1; P < .001) and >2-unit blood transfusion (OR, 2.0; 95% CI, 1.7-2.5; P < .001). Major cardiac events (OR, 1.2; 95% CI, 1.0-1.5; P = .05) and respiratory complications (OR, 1.4; 95% CI, 1.0-2.0; P = .03) were also independently associated with clopidogrel use. Weighted Mantel-Haenszel ORs controlling for blood transfusion amount revealed no remaining effect of clopidogrel on major cardiac events (OR, 1.1; P = .4) or respiratory complications (OR, 1.0; P = .8).ConclusionsPerioperative clopidogrel use in LEB surgery is associated with increased blood loss and blood transfusion. Associated clinical sequelae include increased cardiac and pulmonary complications. Accordingly, surgeons should consider discontinuation of perioperative clopidogrel when it is clinically appropriate unless it is strongly indicated at the time of LEB.

Dataset Information

Point-of-care platelet function testing predicts bleeding in patients exposed to clopidogrel undergoing coronary artery bypass grafting: Verify pre-op TIMI 45--a pilot study.

Background

Hypothesis

Methods

Results

Publications

Point-of-care platelet function testing predicts bleeding in patients exposed to clopidogrel undergoing coronary artery bypass grafting: Verify pre-op TIMI 45--a pilot study.

Similar Datasets

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