SAN DIEGO, CA — An antiplatelet agent used in the treatment of patients with peripheral artery disease (PAD) appeared to provide clinical protection for stented patients required to stop dual antiplatelet therapy (DAPT) because of emergency surgery, a new report has shown[1].

In their 8-year experience with off-label cilostazol use as a perioperative bridge therapy among paclitaxel-eluting stent (PES) patients stopping DAPT, investigators report there was not a single major adverse cardiac event (MACE) among 171 patients who were adequately bridged with cilostazol 100 mg twice daily and in whom DAPT was restarted within 48 hours of surgery.

"In the 171 patients who followed this regimen, there were zero events," said Dr Charles Laham (Holy Family Memorial Hospital, Manitowoc, WI). "Some patients couldn't tolerate it, and the dose [cilostazol] was reduced to 50 mg twice daily. And some patients were bridged for a shorter period, where we only had so many days before the surgery. Ideally, we found that if patient took more than 500 mg (cumulative), even on a modified protocol, they didn't have events."

Dr Matthew Price (Scripps Clinic, La Jolla, CA) called the use of cilostazol an "ingenious bridge" and questioned whether or not patients might have continued with the phosphodiesterase inhibitor-type-3 agent rather than resume DAPT following the surgery. The reason for continuing cilostazol in that setting would be that the highest risk of thrombotic events is directly after the procedure, he noted.

While SCAI session co-moderator Dr Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York) suggested the study could be designated a phase 2 trial, Laham was more cautious, saying he wasn't even sure it could be called that. Instead, he sees their experience as hypothesis generating for future trials and said he would like to see the bridging protocol tested in a randomized controlled clinical trial, given the lack of recommendations for how to manage DAPT-treated drug-eluting stent (DES) patients who require urgent surgery.

Treatment Protocol Varied Over Time

Speaking during the Society for Cardiac Angiography and Interventions (SCAI) 2015 Scientific Sessions, Laham said their experiences with cilostazol began in 2005. After early success in 28 urgent patients who needed to have their DAPT stopped for emergent surgery, they began to implement a program of cilostazol bridging in PES patients who needed to stop aspirin and clopidogrel for semiurgent surgery and even in those with a higher risk of bleeding.

Based on previously published data, Laham said patients who received the paclitaxel stent and stopped DAPT within the first year have a one-year MACE rate ranging from 10% to 25%. Given this higher risk for clinical events with PES, they bridged all patients who received a PES within 5 years with cilostazol if they needed to stop DAPT for surgery.

"This was actually a very high-risk group we looked at retrospectively," said Laham. "It wasn't intended as research, but we had developed a fair bit of experience, mostly between 2005 and 2008. In 2008, when the recommendations suggested indefinite [DAPT], we decided to extend bridging out to 5 years—any person having surgery, even elective surgery, was bridged."

In their center, the cilostazol-bridging protocol changed over time but was tailored to the patient's degree of ischemic and perioperative bleeding risks.

Aspirin and clopidogrel were stopped 8 days prior to the operation and cilostazol 100 mg twice daily started on day 7. For surgeries with a low or moderate risk of bleeding, cilostazol was stopped 24 to 30 hours before the surgery and DAPT restarted 12 to 24 hours postoperatively. For higher-risk procedures, such as epidurals, back surgery, urological surgery, or plastic surgery, cilostazol was stopped 54 to 60 hours before surgery and DAPT restarted 24 to 36 hours after the procedure.

Of the 183 patients included in their 8-year bridging experience, 12 were considered incompletely bridged, either because the surgeon stopped cilostazol after the patient reported a side effect from the antiplatelet agent or because the patient failed to resume DAPT after surgery. In these 12 patients, there were four clinical events, including a need for repeat PCI in one patient at 8 months. The other events included a patient death at 12.5 months, a need for repeat PCI at 28 months, and an MI at 40 months.

Included in the analysis were data on 55 patients who underwent surgery and stopped DAPT within the first year. For these at-risk patients, the one-year MACE rate was just 1.8% among those who were adequately bridged. For 132 at-risk patients who stopped DAPT within 30 months for an emergent surgery, there were no major bleeding events once they resumed aspirin and clopidogrel within 48 hours.

To heartwire from Medscape, SCAI past-president Dr Charles Chambers (Penn State Milton Hershey Medical Center, Hershey, PA), who was not affiliated with the analysis, said many surgeons these days will perform minor or standard procedures, such as a gall-bladder removal or a laparoscopic surgery, on DAPT and achieve excellent results. However, other surgeons might be more risk averse, especially in procedures where the potential for bleeding is higher. Clinicians conducting spinal surgery, neurosurgery, or even plastic procedures where surgeons do not want to negatively affect a new graft will suspend DAPT, or at the very least clopidogrel, noted Laham.

"Some of the surgeons don't want anything to do with [aspirin or clopidogrel]," Laham told heartwire . "And these are same ones who don't start the antiplatelet agents back up and don't tell you. The only way for this to work is to be calling the surgeon every day or drilling it into the patient, making sure they start their medication again."

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