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Dual-therapy stent yields low revascularization, stent thrombosis rates at 1 year
A novel abluminal sirolimus-coated bioengineered appears to deliver excellent 1-year clinical results in an all-comers patient population, conferring high rates of initial procedural success, low revascularization rates and low stent thrombosis rates, according to findings from the REMEDEE registry.
In the multicenter, prospective, clinical outcomes postmarket registry, researchers evaluated 1,000 patients from nine European sites who underwent placement of the Combo stent (OrbusNeich Medical BV) as part of routine clinical care. The mean age of the patients was 65 years (range, 34-94 years), and 74% were men. A total of 18.4% of patients had diabetes, and 6.4% were on insulin treatment. Fifty-eight percent of the patient population was hypertensive, and 56% had dyslipidemia. PCI was indicated in this population for the following: urgent PCI for ACS (30.4%); STEMI (17.8%); non-ST segment ACS (8.3%); unstable angina (4.2%).
Combo stent, a bioengineered sirolimus-eluting stent consisting of a 100-µm thick strut of 316L stainless steel alloy abluminally coated with a biocompatible, biodegradable polymer containing sirolimus. After implantation with the device, patients were followed at 30 days, 180 days and 1 year by telephone call or during a scheduled outpatient appointment, according to the study background. Follow-up assessments monitored for MACE, including cardiac death, MI, hospitalization for angina and revascularization by PCI or CABG. The primary outcome was 1-year target lesion failure, defined as the composite of cardiac death, target vessel-related nonfatal MI or target lesion revascularization.
The researchers found that device success was achieved in 98.7% of patients. Overall, 0.9% of patients had stenosis of more than 20% after the procedure. TIMI flow grade < 3 was seen in 1.3% of patients. Stent delivery was unsuccessful in three patients (0.3%). In two cases, the target lesion could not be reached, with successful retrieval of the stent. One patient was not able to undergo stent placement due to the preoperative onset of severe dyspnea, leading to the cancellation of the procedure for safety reasons.
The rate of procedural success was 97.9%.
In the 98% of patients for whom 1-year follow-up data were collected, the primary endpoint of TLF was present in 5.7% of patients. Cardiac mortality was seen in 1.7% of patients, and target vessel MI was observed in 0.7% of patients. According to the researchers, 4.4% of patients underwent TLR (target lesion PCI and target vessel CABG), and 4.9% of patients underwent target vessel revascularization, PCI and CABG. Five patients had definite stent thrombosis, and one patient had probable stent thrombosis. Five of these six patients underwent PCI to treat ACS, and stent thrombosis occurred acutely or subacutely. There were no episodes of stent thrombosis between 9 days and 12 months after stent placement.
“In this multicenter, multinational, prospective postmarket registry, excellent clinical outcomes at 1-year follow-up after Combo stent placement are observed, including low stent thrombosis rates and no stent thrombosis beyond 9 days postprocedure,” the researchers wrote. “Randomized controlled trials with the novel Combo stent and registries are ongoing and may confirm the outstanding results found in this registry.” – by Jennifer Byrne
Disclosure: OrbusNeich supported this study through an unrestricted grant to Academic Medical Center, University of Amsterdam. Please see the full study for a list of the researchers’ relevant financial disclosures.