News | September 22, 2014

New Study Examines the Optimal Duration Time of Dual Antiplatelet Therapy in Patients With Second-generation Drug-eluting Stents

Results of SECURITY trial reported at TCT 2014; findings simultaneously published in the Journal of the American College of Cardiology

September 22, 2014 — According to a new study, patients receiving six months of dual antiplatelet therapy (DAPT) after receiving a second-generation drug-eluting stent (DES) appeared to have similar outcomes to patients who received DAPT for a full year. Findings were reported Sept. 15 at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Results of the trial were simultaneously published in the Journal of the American College of Cardiology.

The optimal required duration of DAPT in patients implanted with a second-generation DES is a subject of current controversy, with recent studies suggesting that the currently recommended standard of one year of DAPT may be longer than necessary. The SECURITY trial was a randomized, multicenter, multinational, investigator-driven study that aimed to address the need for prolonged use DAPT following the implantation of second-generation DES for patients without high-risk acute coronary syndromes.

SECURITY was designed to test the non-inferiority of six months of DAPT following second generation DES implantation to 12 months of DAPT. Patients with a diagnosis of stable or unstable angina or documented silent ischemia undergoing revascularization with at least one second-generation DES were eligible for the study. A total of 1,399 patients were randomized, 682 assigned to the six-month and 717 to the 12-month group.

After 12 months, the incidence of the primary endpoint (the composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, or bleeding academic consortium criteria (BARC) type 3 or 5 bleeding) was 4.5 percent in the six-month group compared to 3.7 percent in the 12-month group. After 24 months, both the six-month and 12-month groups showed similar incidences of cardiac death (0.9 percent vs. 0.8 percent, p=0.925), MI (3.1 percent vs. 2.6 percent, p=0.636), stroke (0.9 percent vs. 0.4 percent, p=0.636), stent thrombosis (0.4 percent vs. 0.4 percent, p=0.951) and BARC 3 or 5 bleeding (0.7 percent vs. 1.1 percent, p=0.496).

The rates of the 12-month secondary endpoint (composite of cardiac death, spontaneous MI, stroke, definite or probable stent thrombosis, or BARC type 2, 3 or 5 bleeding at 12 and 24 months) were also similar among the six-month DAPT and 12 month DAPT groups. At 12 months, the incidence of the secondary composite endpoint was 5.3 percent in the six-month group compared to 4 percent in the 12-month group. In the year that followed, both groups had lower incidences of secondary composite endpoints (1.5 percent and 2.2 percent, respectively).

A multivariable analysis found that patient age of 75 years or older, stent type used, mean number of stents implanted, mean stent length, and mean stent size as significant independent predictors of the primary endpoint.

“Six-months of DAPT appeared to be non-inferior to a 12-month regimen in patients undergoing PCI with a second generation DES regarding the primary composite endpoint of cardiac death, MI, stroke, definite or probable stent thrombosis, or BARC type 3 or 5 bleeding at 12 months of clinical follow-up,” said lead investigator Antonio Colombo, M.D. Colombo is the director, Cardiac Catheterization Laboratory of MO GVM Centro Cuore Columbus/San Raffaele Hospital in Milan, Italy.

“Additionally, the six-month DAPT group appeared to be non-inferior to the 12-month group regarding the incidence of the secondary composite endpoints defined by the study protocol,” he said.

The SECURITY trial was funded by grants from Medtronic and Terumo. Colombo reported being a minor shareholder of Direct Flow Inc. 

For more information: www.crf.org and www.tctconference.com

Related Content

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Heart Failure Market to Surpass $16 Billion by 2026
News | Heart Failure| September 19, 2017
The heart failure space across the seven key markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Overlay Init