News | May 18, 2015

Short-Acting Antiplatelet Drug Cilostazol Safely Helps Patients Stop DAPT Therapy Pre-Surgery

OUTSIDE START study finds bridge therapy effective even in high-risk patients

cilostazol, DAPT, bridge therapy, surgery, bleeding risk, SCAI

May 18, 2015 — Patients with a high-risk paclitaxel drug-eluting stent given the shorter-acting antiplatelet drug cilostazol prior to a surgical procedure safely transitioned off of dual antiplatelet therapy (DAPT) to reduce bleeding risk during their operation. These new findings from the OUTSIDE START study were presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions in San Diego.

DAPT, including aspirin plus an antiplatelet drug, is prescribed to patients for at least one year after receiving a drug-eluting stent to prevent blood clots from forming in the stent. About 5 to 10 percent of patients have a surgical procedure during the one-year period, requiring stopping DAPT to reduce the risk of bleeding complications. However, stopping DAPT places patients at high risk of having an adverse event, such as a blood clot, heart attack or death. Further, antiplatelet drugs often must be stopped five to seven days or more before an operation for antiplatelet activity to return to normal, which extends the amount of time patients are off of DAPT and increases the risk for an adverse cardiac event.

"Patients on DAPT can be a challenge to manage during surgery because there are significant risks of a stent clotting if DAPT is stopped, while there are also significant risks of bleeding if it is not stopped," said Charles Laham, M.D., FSCAI, interventional cardiologist at HFM Heart & Vascular Center in Manitowoc, Wisconsin, and the study’s principal investigator. "To manage these 'double jeopardy' risks, we evaluated bridge therapy, which allows the patient to transition off of DAPT for their surgical procedure using a short-acting antiplatelet drug."

For the study, patients stopped DAPT eight days prior to their operation. Seven days before their operation they began receiving the drug cilostazol (100 mg) twice per day or alternatively 50 mg if they were undergoing high-bleeding-risk surgery or were intolerant of the full dose. Lower-risk patients stopped cilostazol 24-30 hours prior to their surgical procedure and resumed DAPT 12-24 hours after surgery. Patients at higher risk of bleeding during surgery stopped cilostazol 54-60 hours before surgery and resumed DAPT 24-36 hours after surgery. Researchers considered patients "fully bridged" if they received at least 600 mg of cilostazol prior to surgery and resumed DAPT by at least 48 hours after surgery.

In total, 108 patients who had a drug-eluting stent (paclitaxel) had 183 operations with a cilostazol bridge from 2005 to 2012. Researchers measured rates of adverse events during bridging and within 30 days after surgery. In total, 171 patients who were fully bridged experienced no adverse events. Twelve patients in the study did not receive the full cilostazol bridge/DAPT resumption protocol, and of those, four (33 percent) experienced an adverse cardiac event.

"Even in high-risk patients, we found cilostazol bridging is effective without the risk of adverse events or bleeding within 30 days of an operation, provided the protocol timeline was followed," said Laham.

Researchers noted the current study involved only patients who had received higher thrombotic risk drug-eluting stents coated with the drug paclitaxel, but did not include patients with the newest generation of stents. Despite having similar successes with bridging of smaller numbers of other stent types in the main OUTSIDE patient study, larger studies should be conducted to confirm whether the bridge strategy is effective for larger numbers of patients with other types of drug-eluting and bare metal stents, as they are outside the scope of the current study.

Laham reported no relevant disclosures.

For more information:

Related Content

Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
CMS considers eliminating cardiac bundled payments.
Feature | Business| August 16, 2017 | Dave Fornell
August 16, 2017 — The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to reduce the number
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Four Blue Cross Blue Shield Companies Issue Positive Medical Policies on HeartFlow FFRct Analysis
News | FFR Catheters| August 09, 2017
HeartFlow Inc. announced that four Blue Cross Blue Shield companies have each issued a positive medical policy for the...
Ra Medical Systems Granted Broad Patent for DABRA Catheter
News | Peripheral Artery Disease (PAD)| August 09, 2017
August 9, 2017 — Ra Medical Systems announced that the United States Patent and Trademark Office (USPTO) has granted
Overlay Init