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Dual antiplatelet therapy (DAPT) with a P2Y12 inhibitor + aspirin (ASA) decreases drug-eluting stent (DES) thrombosis. Annually 5%-10% of DES patients (pts) are advised DAPT interruption to reduce peri-operative (peri-op) bleeding. Premature DAPT stoppage especially early during the first year after (post) 1st generation (F-Gen) DES leads to high stent thrombosis (ST) rates of 10-20%. Of all DES, paclitaxel eluting DES have highest ST rates off DAPT with recent studies showing associated major adverse cardiac event (MACE) rates persist for at least 30 months post DES placement. There is no consensus as to the best bridging in DES patients taken off DAPT preoperatively. The feasibility of outpatient cilostazol bridging of DES off DAPT peri-op has not been formally tested. We report our 6 year experience with cilostazol bridging during peri-op DAPT stoppage mostly in F-Gen paclitaxel DES during periods of proven high ST/MACE risk.
From 2005 to 2010 we tested cilostazol bridging of DES in consecutive pts advised to stop both DAPT peri-op. 2 dosing regimen intervals were tailored to reduce risk and degree of expected peri-op bleeding. Initially DAPT was only advised for 6 months post DES and later extended to 1 year, thus early bridging was in urgent unavoidable surgeries during the high risk first 6-12 month post DES. When DAPT was later advised long-term due to late ST reports, peri-op cilostazol bridging was extended to all procedures up to 5 years post DES placement. MACE was felt related to bridging if it occurred while off DAPT peri-op or within 30 days post-op. We hereby report results for peri-op cilostazol bridging off DAPT from 2 weeks to 60 months post latest DES.
DAPT was stopped after last doses on 8th day pre-op and cilostazol 100mg po bid started on the 7th pre-op day: for low risk bleeding surgeries, cilostazol was stopped 24-30 hours (hrs) pre-op and DAPT resumption advised at 12-24 hrs post-op. For moderate-high bleeding risk surgeries (epidurals; back & urology surgery, coronary bypass) cilostazol was stopped 54-60 hrs pre-op after 1000 mg and DAPT resumed 24-36 hrs post-op. For those who didn’t tolerate cilostazol 100mg, dose was reduced to 50mg po bid. Pts were deemed adequately bridged if they took at least 600 mg of cilostazol pre-op and resumed DAPT within 48 hrs post-op.
A total of 95 pts with DES’s underwent 167 consecutive surgeries advising DAPT stoppage utilizing the cilostazol bridging and DAPT resumption protocols. 95% of patients had 1 or more high ST risk paclitaxel DES. Pts were adequately bridged during 157/167 surgeries with optimal dosing of 100mg bid (or 50mg if intolerant) and DAPT resumed within 48 hrs. None of the 157 fully bridged experienced peri or post-op MACE giving observed respective 100% compliant, and 94% intention to treat, success rates for cilostazol DES bridging. In the remaining 10 patients that were cilostazol intolerant, non-compliant and/or who failed DAPT resumption within 48 hrs post-op, 3 had MACE (Table) perioperatively or in the follow up period. Overall, a very low MACE rate of 2% (ie. 1/48 bridged surgeries) was observed with cilostazol off DAPT in the highest risk first 12 months post DES when compared to historical MACE rates of 10-20% with paclitaxel DES in the first year post DES when DAPT stopped prematurely without planned bridging. No significant bleeding other than nuisance bleeding occurred, none altering surgery success or requiring additional transfusions over that typical of surgery type.
Our study suggests that outpatient cilostazol peri-op bridging of DES off DAPT is feasible and results in low bleeding and low MACE rates as seen in patients with first generation DES when bridged off DAPT. Bridging success requires strict adherence to the cilostazol regimen and DAPT resumption schedules. As new generation DES have reported less ST risk & most surgeries don't stop both DAPT, the value of cilostazol bridging needs further confirmation in current generation DES and in those continuing ASA peri-op.