Feature | November 02, 2012

Low Clopidogrel Responsiveness Predicts Stent Thrombosis, Heart Attack

One-year results of ADAPT-DES presented at TCT 2012

ADAPT-DES study TCT, 2012, Plavix, stent

November 2, 2012 — Patients who receive a drug-eluting stent (DES) and demonstrate low levels of platelet inhibition are more likely to have blood clots form on the stent and suffer a possible heart attack; conversely, patients with higher levels of platelet inhibition are at greater risk for bleeding complications. This is according to one-year results of the ADAPT-DES study, presented the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

At last year’s TCT meeting, ADAPT-DES researchers demonstrated a strong relationship between platelet hyporesponsiveness to clopidogrel and subsequent stent thrombosis (clot formation) up to 30 days after stent implantation. Now after one year of follow-up, the ADAPT-DES team is reporting the overall treatment implications of platelet hyporesponsiveness on patient outcomes.

In this large multicenter registry, 8,583 patients undergoing a percutaneous coronary intervention (PCI) with at least one drug-eluting stent were enrolled at 11 sites between January 2008 and September 2010. Researchers assessed platelet reactivity with the VerifyNow Aspirin, P2Y12 and IIb/IIIa tests. Patients were followed for one year to determine the relationship between platelet hyporesponsiveness and subsequent events. At one year, stent thrombosis occurred in 70 patients (0.84 percent), heart attack in 224 (2.7 percent), major bleeding in 531 (6.2 percent) and death in 161 (1.9 percent).

The number of platelet reactivity units (PRU) was measured by the VerifyNow P2Y12 test. Clopidogrel hyporesponsiveness was defined by a PRU of greater than 208 and was present in 42.7 percent of patients. Clopidogrel hyporesponsiveness was significantly associated with stent thrombosis (1.3 percent vs. 0.5 percent) and heart attack (3.9 percent vs. 2.7 percent), but was also found to protect against major bleeding (5.6 percent vs. 6.7 percent). Clopidogrel hyporesponsiveness was also associated with one-year mortality (2.4 percent vs. 1.5 percent). However, because clopidogrel hyporesponsiveness is also associated with other patient risk factors and baseline characteristics, multivariable modeling was also performed, which demonstrated no independent association between clopidogrel hyporesponsiveness and mortality.

“Results from the ADAPT-DES registry suggest that clopidogrel hyporesponsiveness after implantation of a drug-eluting stent is an independent predictor of one-year stent thrombosis and heart attack, but it is also protective against major bleeding, both of which impact mortality,” said lead investigator Gregg W. Stone, M.D., professor of medicine at Columbia University College of Physicians and Surgeons, and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.

“Clopidogrel hyporesponsiveness was not found to be an independent predictor of one-year mortality. Therefore, overcoming clopidogrel hyporesponsiveness with more potent antiplatelet agents is unlikely to improve survival unless the beneficial effect of reducing stent thrombosis and heart attack can be separated from the likely increase in bleeding that results from greater platelet inhibition,” said Stone.

He added, “Hyporesponsiveness to aspirin was unrelated to stent thrombosis, heart attack or death, but may be related to bleeding. This questions the utility of aspirin in patients treated with drug-eluting stents.”

The ADAPT-DES trial was sponsored by the Cardiovascular Research Foundation with research support from Boston Scientific, Abbott Vascular, Medtronic, Cordis, Biosensors, The Medicines Company, Daiichi Sankyo, Eli Lilly, Volcano and Accumetrics. Stone reported consulting fees from Abbott Vascular, Boston Scientific, Medtronic, The Medicines Company, Daiichi Sankyo, Eli Lilly, Astra Zeneca and Volcano.

For more information: www.crf.org

Related Content

electronic health records, EHR, warfarin therapy management, University of Missouri Health Care, blood thinner
News | Antiplatelet and Anticoagulation Therapies| January 17, 2017
Warfarin is a commonly prescribed blood thinner used to prevent harmful blood clots. However, the drug requires...
ICDs, implantable cardioverter defibrillators, survival rate, elderly patients, JACC study
News | Implantable Cardioverter Defibrillators (ICD)| January 17, 2017
Of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving sudden cardiac...
University of Utah, Frank Sachse, heart failure, LVAD implantation, left ventricular assist device, biomarker, t-system

Two patients may seem equally sick based upon clinical measures, but differences in their heart physiology could predict who has the potential to recover from heart failure. A study carried out by scientists at the University of Utah finds that patients whose hearts have flattened t-tubules have a decreased chance of showing signs of recovery after implanting a mechanical heart pump. Ordinarily, t-tubules in the heart are long, thin, and rounded. Image courtesy of Frank Sachse.

News | Cardiac Diagnostics| January 17, 2017
Investigators at the University of Utah have identified distinct differences in the hearts of advanced heart failure...
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
St. Jude Medical, Amplatzer Amulet LAA Occluder, observational study, TCT 2016
News | Left Atrial Appendage (LAA) Occluders| November 03, 2016
St. Jude Medical Inc. presented favorable results from the largest observational study to date of the company’s...
Medtronic, CoreValve Evolut R TAVR system, U.S. IDE Study, TCT 2016
News | Heart Valve Technology| November 03, 2016
Medtronic plc unveiled new clinical data showing that patients treated with the self-expanding CoreValve Evolut R...
congenital heart patients, cardiac cath lab, anesthesia sedation practices, joint document, SCAI, SPA, CCAS
News | Congenital Heart| November 03, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Pediatric Anesthesia (SPA) and the...
open-heart surgery, PCI, percutaneous coronary intervention, NOBLE trial, left main coronary artery disease, LMCAD, TCT 2016
News | Cardiovascular Surgery| November 03, 2016
Coronary artery bypass (CABG) surgery is the standard treatment for revascularization in patients with left main...
SENTINEL trial, transcatheter embolic protection, TCEP, TAVR, stroke, TCT 2016
News | Embolic Protection Devices| November 03, 2016
An international study has found that transcatheter cerebral embolic protection (TCEP) is safe, provides effective...
News | Drug-Eluting Balloons| November 03, 2016
The Spectranetics Corp. announced that it has submitted to the U.S. Food & Drug Administration (FDA) its Pre-Market...
Overlay Init