4
EuroPCR
Promising results for biodegradable polymers and bioresorbable scaffolds
More than a third of the hotline studies and late-breaking trials presented at EuroPCR (21–24 May, Paris, France) focused on drug-eluting stents with biodegradable polymers or on bioresorbable scaffolds, with all of the studies indicating good results for the respective devices
A
t the late-breaking trial session, Stephan Windecker (Department of Cardiology, Swiss Cardio- vascular Center Bern, Switzerland) pre- sented the preliminary results from the BIOFLOW-II (Safety and clinical perfor- mance of the drug-eluting Orsiro stent in the treatment of subjects with single de novo coronary artery lesions-II) study. He reported that, in the study, patients (440 overall) with stable coronary artery disease were randomised in a 2:1 fashion to receive a sirolimus-eluting stent with a biodegradable polymer (298; Orsiro, Biotronik) or an everolimus-eluting stent with a durable polymer (154; Xience Prime, Abbott Vascular). Patients were followed-up at one month, six months, and nine months.
At nine months, there was no signifi-
cant difference in the primary end- point—the rate of in-stent late lumen loss between the groups was 0.1±0.32mm for Orsiro vs. 0.11±0.29 for Xience Prime (p<0.0001 for non-inferiority). Also, angiographic follow-up at nine months showed no significant differ- ences between the stents in terms of late lumen loss, minimum length description, diameter stenosis, and binary stenosis (for both in stent and in segment for all variables). Furthermore, no significant differences were found in the rate of target lesion failure between groups and there were no cases of definite or prob- able stent thrombosis in either group. Therefore, Windecker concluded that the trial showed that: “The Orsiro sirolimus- eluting stent with a biodegradable poylmer was non-inferior to the Xience Prime everolimus-eluting stent with a durable polymer.”
According to the results of another study of the Orsiro stent (HATTRICK- OCT), assessment with optical coherence tomography (OCT) showed that the stent was associated with more complete strut coverage at three months than a zotaroli- mus-eluting stent with a durable polymer (Resolute Integrity, Medtronic) in patients with acute coronary syndromes. Speaking in a hotline session, study pre- senter Tuomas Kiviniemi (Turku Univer-
sity Hospital, Finland) also reported that there were no significant differences in vasodilator response between those who had received the Orsiro stent and those who had received the Resolute stent (22 patients in each group). He added: “Fur- ther large scale clinical studies address- ing shorter dual antiplatelet drug therapy with these newer generation drug-eluting stents are needed.”
Another sirolimus-eluting stent with a biodegradable polymer—Buma (Sino Medical)—was also found to have better strut coverage than a durable polymer (this time, everolimus-eluting) stent. Lead author Jingbo Hou (The Second Affiliated Hospital of Harbin, Medical University, China) told delegates: “Buma has a significantly better strut coverage compared with Xience V [Abbott Vas- cular] at 12 months (99.2% vs. 98.2%, respectively; p<0.001).” She added that the results suggested that the Buma stent may be associated with earlier endothe- lial healing than the Xience V stent. Hou concluded: “The better coverage and possible earlier endothelial healing of Buma suggested that the patients [with a Buma stent] may require a shorter dura- tion of dual antiplatelet therapy and have a better long-term benefit compared to Xience V.”
EVOLVE
Ian Meredith (MonashHeart, Clayton, Victoria, Australia) presented two-year clinical outcomes from a study compar- ing an everolimus-eluting stent with a biodegradable polymer (Synergy, Boston Scientific) with an everolimus-eluting stent with a durable polymer (Promus Element, Boston Scientific) in patients with de novo coronary lesions. Six-month data from the EVOLVE study have already been reported (in the Journal of the American Journal of Car- diology) and showed that both doses (full dose and half dose) of the Synergy stent investigated in EVOLVE were non-infe- rior to the Promus Element stent in terms of the primary angiographic endpoint of in-stent late lumen loss at six months. In this follow-up study, at two years,
August 2013
Orsiro
no significant differences were found in the rate of target lesion failure, cardiac death or myocardial infarction between patients who received the Synergy stent (94 full dose; 99 half dose) and those who received the Promus Ele- ment stent (98). Also, no incidence of stent thrombosis was reported for either stent. However, the Synergy stent was associated with a trend towards lower rates of revascularisation compared with the Promus Element stent. Meredith commented: “These results support the safety and efficacy of the novel ablu- minal bioresorbable polymer Synergy everolimus-eluting stent for the treatment of patients with de novo coronary artery disease.”
Real-world data for Absorb The use of the bioresorbable vascular scaffold (Absorb; Abbott Vascular) in real-world clinical settings was the focus of three registries presented during hotline sessions at EuroPCR. Robert-jan van Geuns (Thoraxcenter, ErasmusMC, Rotterdam, The Netherlands) pre- sented data from BVS Expand, which is a single-centre registry. He explained that the objective of the registry was to evaluate “the long-term safety and performance of the bioresorbable vas- cular scaffold coronary stent in routine clinical practice. Its objective is to measure the incidence of major adverse cardiac event in patients with non-ST-segment eleva- tion myocardial infarction, stable or unstable angina, or silent ischaemia.” Van Geuns reported that
Absorb Robert-Jan Van Geuns
following a strict implantation protocol, the first real-world experience with the scaffold (for ≥130 procedures) was “very positive”. He added that at 30 days, only one adverse event had been reported and that at the current follow-up point (median follow-up of 127 days), a low rate of major adverse cardiac events was observed. Van Geuns told Cardiovascu- lar News: “BVS-EXPAND showed that the acute outcome of the bioresorbable vascular scaffold in much more complex patients is excellent.” The POLAR ACS registry (a multi- centre Polish registry) found that the use of the scaffold was safe in patients with acute coronary syndromes. Presenter Dariusz Dudek (Jagiellonian University Medical College, Krakow, Poland) said: “Clinical device and clinical procedure success was achieved in 100% of cases with only 1.6% in-hospital major adverse cardiac events.” Petr Widimsky (Cardiocenter, Kralovske Vinohrady, Third Faculty of Medicine, Charles University Prague, Czech Republic) presented results from the Prague-19 study, which involved patients with acute ST-elevation myo- cardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) with the scaffold. He said: “With the currently available size spectrum and expiration times, the bi- oresorbable vascular scaffold can be used in 25–33% of STEMI patients. Availabil- ity of the 4mm size would substantially increase this proportion.” He added that long-term follow-up would “further elucidate the future role of bioresorbable scaf- folds in STEMI”.
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