Biodegradable Orsiro stent proves non-inferior to Xience Prime drug-eluting stent for in-stent late lumen loss at nine months
21 May 2013, Paris, France: The Orsiro stent, which is a novel stent platform eluting sirolimus from a biodegradable polymer, demonstrated non-inferiority to the Xience Prime everolimus-eluting stent for the primary angiographic endpoint of in-stent late lumen loss at nine months in the results of an imaging substudy reported at EuroPCR 2013 today.
The BIOFLOW-II substudy used intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to quantitatively assess neointimal hyperplasia and stent apposition at nine months after treating patients with symptomatic coronary artery disease due to de novo stenotic lesions. Patients were randomly assigned to receive either the Orsiro (Biotronik) or the Xience Prime stent (Abbott Vascular). Images from baseline and the nine-month follow-up were analysed by independent and blinded core laboratories.
Results showed no difference in the angiographic endpoint of in-stent late lumen loss between the two stents at nine months (0.10+0.32mm with the Orsiro stent vs. 0.11 + 0.29mm with the Xience Prime stent, p non-inferiority=<0.0001). Rates of target lesion failure were also similar at nine months (4.8% vs. 5.3%, p=0.47).
The IVUS substudy showed somewhat less neointimal hyperplasia over nine months with the Orsiro stent (0.16) than the Xience stent (0.43, p=0.043) with 100% stent apposition. Similarly, neointimal area as assessed by OCT at nine months was somewhat less with the Orsiro stent (0.74+0.38mm2 ) than with the Xience stent (1.00+0.44mm2, p=0.024). The proportion of well-apposed struts was similar with the two stents and the proportion of covered struts was slightly higher with the Orsiro stent (98.3% vs. 97.5%, p=0.042).
Reporting the results, Stephan Windecker, Professor and Chief of Cardiology, Swiss Cardiovascular Center and Clinical Trials Unit Bern, Bern University Hospital, Switzerland, said, “The Orsiro sirolimus-eluting stent with a biodegradable polymer was non-inferior to the Xience Prime everolimus-eluting stent with a durable polymer for the primary angiographic endpoint of in-state late loss at nine months in this prospective, randomised trial.”
He added, “ We need to be careful in interpreting the results of a trial set up for an angiographic endpoint but we can speculate that neointimal hyperplasia may be somewhat less with the Orsiro stent platform. And an important additional finding is that this potentially improved efficacy is not compromised by a lower proportion of uncovered struts. In addition, clinical event rates were low and comparable with both stents.”
Looking to the future, he concluded, “These results will need to be extended to larger randomised trials including more complex patients and powered for clinical endpoints.”END
First results from DESolve Nx trial show low rate of late lumen loss with bioresorbable DESolve device
21 May 2013, Paris, France: The DESolve bioresorbable coronary scaffold system achieves good efficacy and safety with low rates of late lumen loss and major coronary adverse events at six months, show first results from the pivotal DESolve Nx trial reported at EuroPCR 2013 today.
DESolve (Elixir Medical Corporation) is the first bioresorbable PLLA-based polymer scaffold that releases novolimus, a major metabolite of sirolimus. “The degradation time is about one year,” explained the lead study author Alexandre Abizaid, Director of Interventional Cardiology at Institute Dante Pazzanese de Cardiologia, São Paulo, Brazil. He added, “One of the most attractive features, which we don’t see with most bioresorbable scaffolds, is that this device shows significant increase in vessel scaffold and luminal area at six months.”
The DESolve Nx trial treated target lesions in 126 patients with single de novo coronary artery lesions with the DESolve device. Results showed the primary endpoint of in-stent late lumen loss was 0.21mm (+0.34) at six months. Major adverse cardiac events occurred in 3.25% of patients, including one cardiac death. Acute recoil occurred in 6.6% of patients at six months.
Stents and vessels were assessed by IVUS in a subset of 40 patients. “There was a clearly significant increase in vessel area,” Abizaid reported. Mean vessel area increased by 16.8% at six months (p<0.001), while mean scaffold area increased by 15.7% (p<0.001) and mean lumen area by 9.0% (p<0.001). “We don’t usually see this improvement until two years,” he noted. Serial optical coherence tomography (OCT) analysis in 38 patients demonstrated a 16.9% increase in mean scaffold area (p<0.001) after six months. Nearly 99% of struts were covered by this time point.
Summing up the findings, Abizaid concluded, “The DESolve Nx trial was successful in demonstrating the safety and efficacy of the DESolve Scaffold. In terms of acute performance, there was a high rate of device deliverability and acute recoil was low. Efficacy results showed low late lumen loss at six months and safety was also good, with a low six-month MACE rate and high strut coverage.” He added, “What really impressed me was to see an increase in scaffold and lumen areas indicating early vessel restoration at six months. We saw results at six months that we see with most scaffolds at two to three years.”
Commenting on the study findings, Adnan Kastrati, Deputy Director of Cardiovascular Diseases at the German Heart Centre of the State of Bavaria, Munich, Germany, said, “Bioresorbable drug-eluting scaffolds are emerging as the dominant device of the future for percutaneous coronary interventions. The results shown today with the DESolve scaffold eluting novolimus make interventional cardiologists richer in treatment options. Different biopolymer resorption kinetics and antiproliferative drugs may better serve individualisation of PCI treatment to patients’ needs.”
But he cautioned, “The promising results shown with bioresorbable drug-eluting scaffolds so far need corroboration in larger patient cohorts followed for a longer period. Last, but not at least, available devices still need design improvement before offering their advantages to the majority of complex lesions we are currently treating.”END
Swedish registry questions superiority of bivalirudin over heparin in patients undergoing PCI for NSTE-ACS
21 May 2013, Paris, France: Results from a large observational study reported at EuroPCR 2013 today question whether bivalirudin is superior to heparin in the absence of GPIIb/IIIa blockade, showing similar 30-day mortality in patients with non-ST segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).
European and US NSTE-ACS guidelines currently recommend bivalirudin alone as an alternative to unfractionated heparin plus GP IIb/IIIa receptor inhibitors in patients undergoing an intended urgent or early invasive strategy.
Researchers compared 30-day mortality with heparin alone to that with bivalirudin alone in patients with NSTE-ACS undergoing PCI between 2005 and 2011 in the Swedish coronary angiography and angioplasty registry (SCAAR). The registry records all coronary angiographies and PCIs carried out in Sweden. Results were analysed for 31,351 patients treated with heparin alone and 10,186 given bivalirudin.
Oskar Angerås, Consultant Cardiology at Sahlgrenska University Hospital, Gothenburg, Sweden, reported that the adjusted odds ratio for 30-day mortality favoured heparin (1.53 for complete case analysis).
“One should be very careful when interpreting the results, however none of our models show that treatment with bivalirudin improves outcome. The results therefore question the superiority of bivalirudin to heparin in the absence of GP IIb/IIIa blockade in patients with NSTE-ACS undergoing PCI,” concluded Angerås. “The clinical implication is that if we use heparin alone, we can be assured that it’s enough. For those using bivalirudin, switching to heparin achieves similar outcomes and will reduce the cost of procedures.”
He said that a prospective, randomised trial comparing bivalirudin with heparin in this group of patients is warranted. He added that his group has started the registry-based randomised VALIDATE-SWEDEHEART trial comparing bivalirudin to heparin in patients pretreated with novel ADP-receptor blockers, with the aim of recruiting a total of 6,000 patients.
Commenting on the data, William Wijns, Chairman of PCR and Course Director of EuroPCR, said, “This new data comparing heparin with bivalirudin in NSTE-ACS patients undergoing PCI is very interesting and we await results from new trials looking at this further.”
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Post-approval TAVI registry shows high rates of device success at one year
21 May 2013, Paris, France: One-year results from SOURCE XT – one of the largest, post-approval transcatheter aortic valve implantation (TAVI) registries to-date – reported today at EuroPCR 2013 show good clinical outcomes in routine clinical practice, with high rates of device success for all access approaches, valve sizes and delivery systems.
The SOURCE XT Post-Approval Study followed up 2688 consecutively enrolled patients (mean age 81.5 years) undergoing TAVI with the Sapien XT heart valve at 93 centres in 17 countries between July 2010 and October 2011. Access was transfemoral, transapical, transaortic or transsubclavian. Events were adjudicated by an independent clinical event committee.
“Results for one-year outcomes showed a large treatment effect in terms of symptom relief and improved quality of life,” reported Stephan Windecker, Professor and Chief of Cardiology, Swiss Cardiovascular Center and Clinical Trials Unit Bern, Bern University Hospital, Switzerland. Patients showed sustained improvement in effective orifice area, with low rates of moderate or severe aortic regurgitation.
“One-year mortality and stroke rates were low in this elderly population,” Windecker said. The all-cause mortality rate was 19.5% and the stroke rate 6.3% overall. But he noted that one-year survival associated with all-cause mortality was higher in women (90.6%) than in men (87.6%; p=0.0075) and survival associated with cardiac mortality was also higher.
Windecker concluded, “SOURCE XT showed high rates of device success for all access approaches, valve sizes and delivery systems.”
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