Feature | April 08, 2011| Dave Fornell

Biocompatible Polymer Reduces Lesion Failure, Thrombosis Compared to Endeavor

April 9, 2011 - The Resolute zotarolimus-eluting stent using a new biocompatible polymer achieved a lower rate of restenosis and in-stent thrombosis compared to the Endeavor stent at 12 months in a U.S. trial. Data from the RESOLUTE U.S. trial was presented this week at the American College of Cardiology (ACC) Scientific Session in New Orleans.

Out of 1,112 patients who received the Resolute stent, only two cases of stent thrombosis were reported.

“This is one of the lowest stent thrombosis rates we have ever seen in a drug-eluting stent trial,” said Martin Leon, M.D., associate director of the Center for Interventional Vascular Therapy and professor of medicine at Columbia University/New York Presbyterian Hospital.

The Resolute stent’s rate of target lesion failure (TLF) at 12 months was 3.7 percent, compared with 6.5 percent for the historical control patients who received the Endeavor stent.

I think Resolute would be the preferred choice,” Leon said, based on the one-year data. “But, we don’t have the long-term follow-up as we do with the Endeavor. However, I feel most patients would be getting the Resolute stent."

The trial met its primary endpoint of non-inferiority to the historical control, the U.S. Food and Drug Administration (FDA)-approved Endeavor stent. It is the first U.S. study to observe the effect of drug elution characteristics on clinical outcomes. Both the Endeavor and Resolute stents are designed with the same cobalt chromium platform and use the same drug (zotarolimus), but the Resolute uses a new biocompatible polymer that allows for an extended drug release across approximately six months (compared to a 14-day release with Endeavor). This extended release is hypothesized to better prevent vessel renarrowing while still maintaining low stent thrombosis rates.

“The Resolute drug-eluting stent was shown in this study to deliver strong efficacy without a trade-off in safety through one year of patient follow-up,” Leon said. “The clinical results achieved with this new device show the important role that biocompatible polymers play in the design of drug-eluting stents.”

Study Details

Enrolling 1,402 patients across 116 U.S. investigational centers between August 2008 and December 2009, the research team conducted four analyses. The main study included 1,112 patients who received Resolute stents that were 2.5-3.5 mm in diameter. The primary endpoint for this group was 12-month target lesion failure (TLF – which combines the composite of cardiac death, target-vessel heart attack and clinically-driven target lesion revascularization). Clinical follow-up was performed at 30 days, six months, nine months and 12 months; it will continue at 18 months and annually thereafter through five years post-procedure.

The researchers compared the data from this main study group with historical data pulled from clinical trials of the Endeavor stent. In order to make accurate comparisons, the team used similar inclusion characteristics, data collection methodologies, endpoint definitions and statistical analyses. They used propensity score method to adjust for baseline covariates.

After conducting this analysis, the research team found that the Resolute stent’s rate of TLF at 12 months was 3.7 percent, compared with 6.5 percent for the historical control patients who received the Endeavor stent, meeting the study’s pre-set margin of non-inferiority (rate difference equals -2.8 percent, upper one-sided 95 percent confidence interval -1.3 percent, p

After looking at the individual components of the primary endpoint, the team found that the Resolute stent also had lower rates of target lesion revascularization, cardiac death and target-vessel heart attack, at 2 percent, 0.4 percent and 1.3 percent, respectively (compared to 4 percent, 0.8 percent and 2.4 percent for Endeavor).

Evaluation of the entire 1,402-person study group (which included patients with one or two lesions who received stents ranging from 2.25 mm to 4 mm) also showed strong outcomes for the Resolute stent, including a 4.7 percent rate of target-lesion failure and a 0.1 percent of definite or probable stent thrombosis. The overall population included 34 percent diabetic patients, the highest to date in any of the Resolute trials.

“The outcomes achieved in the diabetic group are better than expected and we can postulate that the Resolute’s prolonged drug elution profile may contribute to these favorable outcomes in this high-risk group,” Leon said.

Although the study was not a randomized trial, the researchers noted that the propensity score method did allow the team to adequately estimate the effect of changing one of the stent’s three components.

The study was funded by Medtronic. Leon serves on the scientific advisory board for Medtronic.

This study was published online this week in the Journal of the American College of Cardiology (JACC) and will appear in the April 26, 2011, print edition.

Related Content

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...
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...
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...
Medtronic, Resolute Integrity DES, drug-eluting stent, BIO-RESORT study, TCT 2016
News | Stents Drug Eluting| November 02, 2016
Investigators recently unveiled clinical data from the independent BIO-RESORT study, representing the first all-comers...
Medtronic, Harmony TPV, transcatheter pulmonary valve, clinical study results, TCT 2016
News | Heart Valve Technology| November 02, 2016
Medtronic plc recently announced new clinical data for the Harmony Transcatheter Pulmonary Valve (TPV) from its early...
Medtronic, Drug-Filled Stent, DFS, RevElution trial, first clinical data, TCT 2016, Stephen Worthley
News | Stents Drug Eluting| November 01, 2016
November 1, 2016 — Medtronic plc unveiled the first clinical outcomes of its novel...
Overlay Init