Feature | April 07, 2014

Heparin More Effective Than Bivalirudin in Treating Patients During PCI

Study comparing two anti-clotting medications finds fewer repeat heart attacks with heparin

April 7, 2014 — In a comparison of two blood-thinning medications, heparin was associated with significantly fewer major cardiovascular events at 28 days than bivalirudin in patients receiving primary percutaneous coronary intervention (PCI) after a heart attack, according to research presented at the American College of Cardiology’s 63rd Annual Scientific Session.

The single-center, open label trial enrolled 1,829 patients with suspected heart attack who received a coronary angiography, an imaging test to see how blood flows through the heart. Patients were randomized to receive unfractionated heparin or bivalirudin — medications that block the body’s natural clot formation process and are routinely given during this procedure. Patients were followed for 28 days to examine the primary endpoint — a composite of all-cause death, stroke, repeat heart attack or unplanned repeat procedure. Data showed that patients taking bivalirudin had a significantly higher incidence of these outcomes at 8.7 percent compared with 5.7 percent of those in the heparin group. The largest difference between the groups was in the incidence of repeat heart attack caused by stent thrombosis, blocking of the stent with a new blood clot (3.4 percent in the bivalirudin group compared to 0.9 percent receiving heparin). There was no statistically significant difference in the primary safety outcome of major bleeding between groups (3.5 percent bivalirudin compared to 3.1 percent heparin).

“Both heparin and bivalirudin are used regularly worldwide in percutaneous coronary intervention, but there is still some debate about whether one drug has any advantage over the other,” said Adeel Shahzad, M.B.B.S., M.R.C.P., cardiologist at the Liverpool Heart and Chest Hospital and one of the lead investigators of the study. “We sought to evaluate the drugs by comparing outcomes in two well-matched groups of patients, and our study suggests that heparin may be a more effective agent.”

All patients who reported to the study site with a possible heart attack between February 2012 and November 2013 were assessed for inclusion in the study. Eligible patients were immediately randomized to one of the two study groups for emergency treatment. Percutaneous coronary intervention was performed in 82 percent of patients, with similar procedural success in both groups (97.5 percent in bivalirudin compared to 97.3 percent in heparin group). Because of the life-threatening nature of the situation at time of enrollment — and routine use of both trial medications — researchers obtained approval to get patients’ delayed consent. Of 1,829 treated patients, only four later refused or withdrew consent.

Patients received dual antiplatelet therapy — a combination of aspirin and another antiplatelet agent that together inhibit blood clotting — before their procedures as part of the routine practice at the study site. Those in the heparin group received a bolus dose of unfractionated heparin of 70 units/kg (1 kg = 2.2 lbs) pre-procedure, while bivalirudin was given as a bolus of 0.75mg/kg, followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure.

According to Shahzad, the routine use of heparin has the potential to reduce costs for health care providers, as the cost of bivalirudin can be much higher than heparin.

Although previous studies have compared bivalirudin to heparin, these studies have tested bivalirudin against a combination of heparin and another anti-clotting agent called a glycoprotein IIb/IIIa inhibitor. These studies have often shown a higher rate of bleeding in the heparin group, but Shahzad said it is difficult to know whether this was because patients were receiving two anti-clotting agents together.

Glycoprotein IIb/IIIa inhibitors were used for this study in special circumstances under current guidelines — for example, in patients with massive blood clots. Use of this medication was comparable in both groups (13.5 percent of bivalirudin patients compared to 15.5 percent of heparin), and there were no significant differences between the two treatment groups in terms of bleeding complications.

Interpretation of the study data may be limited due to single-center recruitment, the open label study design and predominantly Caucasian population. However, according to authors, this is both the largest ever single-center trial in cardiovascular medicine, as well as the first major trial to recruit 100 percent of all eligible patients, and study findings represent a true, unselected population of angioplasty patients.

Shahzad said that further research should be done to determine the best use of glycoprotein inhibitors.

Support for the study was provided by unrestricted grants from The Medicines Co., Parsippany, N.J., and AstraZeneca, Wilmington, Del.

For more information: www.cardiosource.org

Related Content

Sponsored Content | Videos | Cardiovascular Ultrasound| June 28, 2016
Interview with Rebecca Hahn, M.D., FASE, Columbia University Medical Center, New York, at the American Society of Ech
atrial fibrillation, stroke risk, aspirin vs blood thinners, JACC study
News | Antiplatelet and Anticoagulation Therapies| June 24, 2016
More than 1 in 3 atrial fibrillation (AF) patients at intermediate to high risk for stroke are treated with aspirin...
Zoll LifeVest wearable defibrillator, WEARIT-II Registry results, CardioStim EuroPace 2016
News | Defibrillator Monitors| June 21, 2016
Zoll Medical Corp. announced that patients experience a high one-year survival rate following use of the LifeVest...
Sponsored Content | Videos | Structural Heart Occluders| June 16, 2016
This is an animation of how a Gore Cardioform Septal Occluder is implanted for the transcatheter closure of ASDs or P
GE Healthcare, Getinge Group, Maquet, Discovery IGS 730 angiography system, Magnus operating table, integrated, hybrid OR

GE Healthcare's Discovery IGS 730 angiography system

Technology | Hybrid OR| June 13, 2016
GE Healthcare and Getinge Group announced the U.S. launch of a new, highly flexible angiography solution for surgery,...
Inventory management, cath lab inventory management, automated inventory management
Sponsored Content | Webinar | Inventory Management| June 10, 2016
Do you find products are stocked based on intuition rather than actual utilization based on clinical demand?
heart failure, muscle bleeding, British Cardiovascular Conference, MRI
News | Heart Failure| June 08, 2016
The amount a heart ‘bleeds’ following a heart attack can predict the severity of future heart failure, according to...
Biotronik, ORIENT trial results, EuroPCR 2016, Orsiro DES, hybrid drug-eluting stent
News | Stents Drug Eluting| June 03, 2016
Biotronik announced results establishing non-inferiority of the Orsiro hybrid drug-eluting stent (DES) to the Resolute...
News | Drug-Eluting Balloons| June 03, 2016
June 3, 2016 — Cardionovum GmbH recently announced the completion of enrollment of the RAPID trial.
Overlay Init