Predictive Value of HAS-BLED and CHA2DS2-Vasc Scores After PCI

Predictive Value of HAS-BLED and CHA2DS2-Vasc Scores for Clinical Outcome After PCI

To assess the predictive value of two scoring systems, namely HAS-BLED and CHA2DS2-VASc scores, to be linked with bleeding events and recurrence of chest pain and other measures of clinical outcome of percutaneous coronary intervention. The investigators aim to provide evidence for local guidelines of optimum options suited to our population

Study Overview

• Status: Unknown
• Conditions: Percutaneous Coronary Intervention

Detailed Description

Dual-antiplatelet therapy (DAPT) with aspirin and an inhibitor of the platelet P2Y12 receptor is necessary to prevent stent-related thrombotic complications after percutaneous coronary intervention (PCI). (1) Although continuation of DAPT confers substantial and durable benefits that extend beyond the local stented segment, bleeding risk also increases with continued exposure to antiplatelet therapy. (2) Current guidelines give fixed duration of DAPT after coronary intervention but many patients still having early stent thrombosis despite this fixed policy, while others, on the contrary, suffer minor and major bleeding events. These clinical situations should raise the possibility of individualizing therapy. (5) The rationale of this study is to find a new method to tailor the optimal duration of DAPT for each patient by balancing long-term risks for both coronary thrombosis and major bleeding (MB).

The HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score has long been used to predict bleeding events in patients on anticoagulation therapy. (3) Also, the CHA2DS2-VASc (congestive heart failure, hypertension, ≥75 years, diabetes, stroke/transient ischemic attack or thromboembolism, vascular disease, elderly, sex) score is a well-established system for prediction of thrombo-embolic events in patients with atrial fibrillation. (4) The aim of the present study is to evaluate the predictive ability of these 2 scoring tools when applied to patients undergoing PCI.

• Study Type: Observational
• Enrollment (Anticipated): 173

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients who are scheduled for elective PCI (Percutaneous Coronary Intervention) and also those who undergo urgent primary PCI

Description

Inclusion Criteria:

• all patients undergoing PCI

Exclusion Criteria:

• Those who had undergone unexpected immediate CABG

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of bleeding events	number of bleeding events (epistaxis, bleeding gums, haematuria, GI bleeding, brain bleeding)	6 months after PCI
Rate of ischaemic events	number of ischaemic events (ACS, TIA, stroke, acute limb ischaemia, GI, ischaemia)	6 months after PCI

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Koene RJ, Win S, Naksuk N, Adatya SN, Rosenbaum AN, John R, Eckman PM. HAS-BLED and CHA(2)DS(2)-VASc scores as predictors of bleeding and thrombotic risk after continuous-flow ventricular assist device implantation. J Card Fail. 2014 Nov;20(11):800-7. doi: 10.1016/j.cardfail.2014.08.010. Epub 2014 Aug 23.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: August 3, 2019
• First Submitted That Met QC Criteria: August 3, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention
• Other Study ID Numbers: HAS-BLED-CHA2DS2-Vasc post-PCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No