The DESolve trial - stents that disappear but are not forgotten!
DESolve is a first-in-man trial, targeting single de-novo coronary artery lesions using a bio-resorbable biolimus-eluting scaffold polymer which completely dissolves over a 1–2 year period. The trial, taking place at three different sites in Europe and New Zealand, is tracking the long-term outcomes of this novel device in a small cohort of patients (n = 15). On Wednesday 16th May at EuroPCR 2012, Stefan Verheye presented performance and key endpoint data at six months.
The study demonstrated feasibility of delivery and deployment of the DESolve Coronary Scaffold System with the scaffold providing very excellent mechanical support to the vessel wall with low acute recoil (6.4%).
Imaging results demonstrated excellent neointimal hyperplasia suppression at six months with an in-scaffold late lumen loss of 0.19 ± 0.19 mm with no late recoil or scaffold shrinkage. Neointimal suppression was verified by IVUS, demonstrating a low percent volume obstruction of 7.2%. As observed by OCT, over 98% of the struts were covered by a thin layer of neointima (0.12 mm). Clinical event rates were low through six months with only one patient requiring revascularisation due to a stenosis located proximal to the implanted scaffold. The scaffold itself was widely patent.
Whilst the scaffold material is quite brittle and can break, the stent is being supplied in a wide range of sizes to ensure optimal apposition can be achieved and Stephan Verheye reflected: "I don't see a lot of negatives with this device". Unlike non-dissolving stents, once the scaffold has disappeared it cannot physically interfere with bypasss surgery or imaging. He continued: "A most important advantage of this technology is 'vascular restoration therapy' in that it brings back the vasoreactivity of the vessel to normal".
This is a novel technology and there is still much to discover as further clinical studies progress. The larger DESolve NX trial of over 100 patients, now underway, will provide more important clinical data and there is a need to establish its long-term safety and efficacy.
CT-derived computed fractional flow reserve and virtual coronary intervention
On Wednesday 16th May at EuroPCR 2012, Bon-Kwon Koo presented the next chapter in the fascinating story about CT-derived computed fractional flow reserve (FFRCT). Virtual coronary intervention can now be performed prior to embarking on an invasive procedure in patients.
Measurement of fractional flow reserve (FFR) during coronary angiography is regarded as the gold standard for identifying coronary artery lesions that cause ischemia and can improve clinical decision-making in revascularisation procedures. However, accurate FFR measurement is traditionally invasive and expensive, highlighting a need for cheaper and less-invasive approaches. Coronary CT angiography (CCTA) supplies accurate anatomical information but cannot provide functional information. FFRCT is a novel technology which provides a computer generated FFR measurement at any point within the coronary artery system using non-invasive CT technology.
Previously, in the DISCOVER FLOW study, FFRCT was shown to reduce the rate of false positives by 70% compared to CT angiography. The current study, 'A novel non-invasive technology for treatment planning using virtual coronary intervention and CT-derived computed fractional flow reserve (FFRCT)', evaluated the feasibility of treatment planning using 'virtual stenting' and FFRCT. From three centres in Seoul, Korea, and Riga, Latvia, 44 patients (48 vessels) with available CCTA and FFR after stenting were prospectively enrolled to the trial. FFRCT was assessed by core laboratory scientists who were blinded to patient, angiographic and FFR data. Virtual coronary intervention was performed using the information on the known stent size for each patient.
Before intervention, invasive FFR was 0.70 ± 0.14 and non-invasive FFRCT was 0.70 ± 0.15. FFR after stenting and FFRCT following virtual intervention were 0.90 ± 0.05 and 0.88 ± 0.05 respectively. The mean difference between post-intervention FFR and FFRCT was 0.02 and there was a positive correlation between the actual and virtual post-procedural measurements (R = 0.55, p < 0.01). The diagnostic accuracy of FFRCT to predict the residual ischemia (FFR ≤ 0.8) after stenting was 96% (sensitivity 100%, specificity 96%).
These results suggest that treatment planning using virtual stenting and FFRCT is feasible and can accurately predict the success of PCI in relieving myocardial ischemia. The technology may be of help in optimising treatment choices before an invasive procedure is performed. "You can plan a whole treatment strategy" was Bon-Kwon Koo's appraisal of the technology's implications.
The CLI-OPC study - the evidence base for optical coherence tomography grows
Coronary angiography is routinely used to guide decision-making in patients undergoing PCI. However, its luminological limitations are well established. Optical coherence tomography (OCT) is a high resolution imaging tool capable of viewing vessels from the inside, enabling a quantitative evaluation of the anatomy within vessels and providing important additional insights to guide treatment in these patients. However, there is currently little information available regarding its safety and efficacy in patients undergoing PCI.
On Wednesday 16th May at EuroPCR 2012, Francesco Prati, from San Giovanni Hospital in Rome, reported results from the CLI-OPC study, a multicentre, non-randomised, observational study of OCT in patients undergoing PCI with angiography in three Italian centres between 2009 and 2011. This study included 670 patients, 335 of whom received angiography plus OCT and 335 who received angiography alone.
OCT guidance plus angiography was associated with significant clinical benefits, including a reduction in the 1-year rate of cardiac death or MI. Patients receiving angiography and OCT demonstrated a 6.6% rate of cardiac death or MI at one year, compared with a rate of 13% in the group receiving angiography alone (p = 0.006).
Angiography plus OCT was not associated with any major complications in this study. Furthermore, OCT identified a number of further issues within the patients’ vessels, including edge dissection, malapposition, reference lumen narrowing, stent underexpansion and the presence of thrombi. These observations led to additional interventions in 35% of patients who received OCT.
This study is the first to appraise OCT guidance for PCI decision-making, and suggests that OCT can be safely performed to guide routine PCI. Furthermore, OCT improved clinical outcomes of patients by identifying additional procedural issues not recognised by angiography. Based on these findings, OCT is a technique with huge potential to improve patient outcomes in PCI. Indeed, Francesco Prati described this as ‘the unbelievable potential to improve efficacy in PCI by looking at vessels from the inside.’ Randomised controlled trials will now be required in order to move OCT from being predominantly a research-based tool to one used routinely in clinical practice.
Martin Leon wins the Ethica Award
The EuroPCR 2012 Ethica Award has been presented to Martin Leon from Columbia University, with colleagues from around the world paying tribute to his achievements. Each year the Board of EuroPCR bestows the Ethica Award upon one remarkable individual who has significantly contributed to the field of cardiovascular intervention as a teacher, scientist, care provider and a pioneer.
The first Ethica Award was presented in 2001 to Valentin Fuster and subsequent winners have been Bernard De Bruyne and Nico Pijls (2002), Alain Cribier and Philipp Bonhoeffer (2003), Martin Kaltenbach (2004), Seung-Jung Park (2005), Renu Virmani (2006), Julio Palmaz (2007), Frederich Mohr (2008), Bernard Meier (2009), Antonio Colombo (2010), Run-Lin Gao (2011).
Martin said that he was “honoured and moved to receive the most prestigious honour that an interventional cardiologist can receive”. He paid tribute to his many collaborators, describing this field of medicine as a “team sport” and saying that he was “fortunate to work with so many inspiring colleagues”. In the spirit of a true pioneer, he urged young colleagues to challenge themselves and stretch their creativity.
With a prestigious career spanning 30 years, Martin Leon’s pioneering work has saved the lives of many people across the globe. Among his many achievements, Martin played a key role in the development and approval of the transcatheter aortic valve alongside Alain Cribier. His contribution to medical research is extensively published through his work as principal investigator in over 50 clinical trials. These include ground breaking trials such as STRESS, STARS, Gamma-one, SIRIUS, ENDEAVOR, and the PARTNER trial that influenced clinical practice. He has also co-authored more than 1,500 publications.
Martin had a very personal motivation behind his commitment to interventional medicine and the improvement of patient outcomes. Following the loss of his mother in 1982 after cardiac bypass surgery, he pledged that he would devote the rest of his career to developing a less invasive treatment for coronary artery disease.
CV Innovation Pipeline: The 2012 Innovation Vintage
cvPipeline from MarketMonitors, Inc. tracks the competitive landscape in R&D for six sectors: drug-eluting stents, heart failure, heart valves, hypertension, atrial fibrillation and cardiac rhythm management, providing business executives, investors and industry analysts with a unified, daily view of the R&D landscape and the competitive status of cardiovascular medical devices in development – visit: www.cvPipeline.com.
The last few years have seen an explosion of new technologies with the potential for more safe and effective transcatheter aortic valve implantation (TAVI). These ‘enabling’ advances include visualisation and measurement technologies, devices for access and closure, embolic protection, and several other unique innovations. Most are at an early stage but it is encouraging to see so many – already over 40. An overview will be given by Hollis Call (CEO MarketMonitors, Inc.) at the Innovations session at EuroPCR 2012 on Thursday 17th May. A tremendous amount of new data abounds regarding TAVI procedures with the currently CE-marked prostheses, especially from smaller sites in Europe. cvPipeline is tracking all presentations in this area, including results presented at scientific sessions of cardiology societies and associations. The features/benefits and preclinical/clinical studies of next-generation technologies in development are all monitored, with almost 1,000 trials in total for heart valves for example.
Medtronic’s success with Symplicity (developed by Ardian) for renal denervation, has triggered the development of many new technologies whilst some existing ones have been repurposed. Ablation is popular but stimulation technologies and unique implants are now a focus. There are 22 technologies and over 75 trials planned or underway – a dramatic change from a few years ago when Ardian was the main contributor. Big companies and start-ups are getting in on the act and there will be more mergers and acquisitions with the involvement of new companies. MarketMonitors, Inc. has worked with the PCR-EAPCI Percutaneous Interventional Cardiovascular Medicine Textbook team to give a current snapshot of the landscape for innovation for several categories of technologies – look for the interventional innovation landscape chapter and annexes to several of the chapters. Looking to the future, percutaneous heart failure (HF) devices may be the next big thing and interesting new HF technologies will be presented during EuroPCR 2012. Attend next year and there will much more to tell you!