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Examining new frontiers in interventional cardiology
Examining new frontiers in interventional cardiology
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NOW IN ITS 8th year, the New Frontiers in Interventional Cardiology conference took place in Krakow, Poland, between 6-9 December 2007. The conference is under the patronage of the Working Group on Cardiovascular Intervention of the Polish Cardiac Surgery Society and the European Association for Percutaneous Cardiovascular Interventions and the course directors Dr Dariusz Dudek, Dr Jacek Legutko and Dr Krzysztof Zmudka. Once again, there was an impressive international faculty with Giancarlo Biamino, Carlo di Mario Thierry Le Fevre, Dierk Scheinert, and Sigmund Silber present amongst many others, including as usual a strong contingent from the USA, Germany and Hungary. The first day was dedicated to the 5th review course of interventional cardiology for central-eastern European countries and comprised of lectures looking at arteriosclerosis, the efficacy and safety of currently available drug-eluting stents (DES), state of the art complex coronary interventions, current and future perspectives in percutaneous treatment of structural heart disease, aortic as well as endovascular interventions for cardiologists. As ever the conference included some live case transmissions designed to give some insight into the management of patients with unsuitable angina and NSTEMI. Interestingly, it emerged that two DES in the same procedure were not reimbursed by the Polish health authorities which led to one DES and one bare metal stent (BMS) being commonly implanted, much to the surprise of the non-Polish interventional cardiologists present. Sigmund Silber was also surprised to learn that in France, the Xience V (due in January 2008 according to Thierry Le Fevre) had not got reimbursement approval yet and that in general, unlike in Germany, a CE mark was insufficient on its own to get a DES onto the French market.
Keynote speech The keynote speech was made by Thierry Le Fevre who assessed percutaneous aortic implantation. Le Fevre reminded the audience that many older patients and those with co-morbidities were unsuitable for traditional surgery. He reviewed the Edwards Sapien and Corevalve and their respective clinical results. Le Fevre was of the opinion that the main limitation of the retrograde approach was the learning curve of the operator and the team in managing difficulties and complications. He felt that when femoral access was contra-indicated the transapical approach was promising. He concluded that percutaneous aortic implantation would open up a new field in which more patients would have access to treatments, be it a percutaneous or conventional approach. Next, Gary Mintz from New York, presented a talk entitled: “What is the current value of IVUS, IVUS-VH and OCT before and during PCI?” He said that the greyscale IVUS provided the only solid reliable data and to ignore this, was in his opinion no longer scientific. Mintz felt at this stage it was not clear what VH would do to grayscale IVUS. However he postulated that preliminary data `suggested that VH could identify lesions at high risk in peri-procedural MI. ADAPT-DES would predict whether VH is a predictor of very late stent thrombosis. Finally, Mintz thought that OCT had the ability to replace greyscale IVUS in assessing lesions before and during PCI. However the data still needed to be accumulated. Mintz was followed by Neal Kleiman from Houston, USA, who discussed “Variable platelet response to aspirin and clopidogrel in patients with atherothrombotic disease diagnosis, clinical implications, management and future perspectives”. Kleiman suggested that interventional cardiologists looked at platelet aggregation to the detriment of other platelet characteristics. Platelets it should be remembered were not lifeless structures whose sole purpose was aggregation. He said studies have indicated that resistance to clopidogrel was linked with a chance of late stent thrombosis. Kleiman asked what it would take to make antiplatelet drug resistance and clinical data a clinical entity. One thing that would help he suggested, would be standard definitions and agreed upon laboratory measurement methods as well as large multicentre prospective studies that link standard, defined and measured antiplatelet resistance with meaningful clinical outcomes.
Optimising early and late outcomes Sigmind Silber discussed how to optimise early and late outcome after DES in a thought-provoking and at times controversial talk. After explaining that patient selection was key he reminded us that DES selection was important. He told the audience that of the 20 available on the market in Europe that have CE certification, eight were not supported by randomised clinical trial data. Silber cautioned against using such stents while being careful to point out that any of them could get good results in a randomised study, but it had to be proven before he recommended their use. He felt that CE certification, on its own, did not prove that a DES was effective or indeed safe. According to German Cardiological Society (DGK) guidelines he had been involved in, only Cypher, Taxus and Endeavor had high level of evidence supporting their use followed by Xience V/Promus and Yukon which demonstrated a medium level of evidence. All others had lower levels of recommendation in the DGK guidelines. He felt that it was important to preload patients with 600mg of clopidogrel if at all possible but that the optimal duration of dual anti-platelet therapy was unproven at this stage. Silber is not a great fan of metaanalyses and thinks they mingle various studies of different products and different qualities. Furthermore, he suggested that only 12% of randomised studies met the essential requirements of evidence-based medicine. He then criticised industry by saying that instead of many underpowered trials more adequately powered ones “were needed with a primary clinical endpoint followed by larger registries and longer follow-up”. Petr Widimsky from Prague then asked “What could be improved in PCI for STEMI?” He looked at issues such as availability, logistics (time, delay, reimbursement, networking and transport) and also felt that treatment should be tailored to each individual patient. Pim de Feyter asked if it was time for MSCT -guided PCI. According to Pim, MSCT provided information beyond angiographies, which may facilitate the procedure, save material contrast and time and also enhance the safety of the procedure. The retrograde strategy has been adapted in Europe with great diversity among centres. According to European multi-centre experience the retrograde approach has a high success rate was safe and can be regarded as a valid contributor to the armamentarium of the interventional cardiologist. Also on Saturday morning as flight problems prevented him from making the talk on Friday was Carlo di Mario. He looked at Pharmacoinvasive treatment of STEMI – during on new insights from CARESSE in AMI, FINESSE, the EUROTRANSFER Registry and HORIZONS AMI. Di Mario felt that for low risk patients with AMI, heparin and abciximab could be safely replaced by bivalirudine, with studies showing no appreciable difference in ischaemic events and a reduction in bleeding events. When no abciximab is used an adjustment in the antiplatelet treatment such as high dose clopidogrel pre PCI or prasugrel should be done to prevent stent thrombosis. Di Mario believed that Abciximab is likely to maintain a role in highly thrombotic lesions, if no reflow occurs, in complex lesions requiring multiple stents. Di Mario also asked if there was any role for facilitation when primary PCI is possible. He contended that the routine use of Abciximab or combination therapy does not lead to significant clinical benefits in patients at intermediate risk suitable for treatment with primary angioplasty. Furthermore, he believed that both treatments were associated with a small but significant increase in bleeding risk. Finally high-risk patients with a short interval after symptom inset and expected longer delays may benefit from early abciximab infusion.
Debate A highlight of the conference was the debate between Adnan Kastrati and Course Director, Dariusz Dudek, on how to choose the best DES. Kastrati argued that sirolimus was better than paclitaxel and Dariusz Dudek contended that they were equal. Kastrati said that with 8,500 patients randomised between paclitaxel and sirolimus-eluting stents, there are numerous sources of evidence from randomised stent versus stent trials. There is no significant heterogeneity across trials with respect to the treatment effect. Kastrati demonstrated from these randomised results that compared with paclitaxel, sirolimus are associated with a significant lower risk of intervention, a significantly lower risk of stent thrombosis and a trend toward a lower risk of myocardial infarction. Furthermore, there is no significant difference in the risk of death and that the difference in thrombotic risk becomes evident only after the first 9–12months from the procedure. Dudek countered by saying that to get the best estimate of the biological truth one has to look at all the pertinent data and find consistent patterns. He believed that a meta-analysis is only as good as the trials that go with it and the methodology used to aggregate the data. He then said that the patient level pooled analysis of the pivotal randomised trials showed that the Taxus stent is as safe (death, MI, stent thrombosis) and more effective (TLR) than BMS and is the most reliable data. He criticised the Schoemig 16 study meta analysis by saying that it looks at a limited collection of trials and its findings may be biased by four studies with a typically high occulostenotic reflex. Stettler network meta-analysis was also criticised. Dudek suggested that attempts to infer Cypher vs Taxus stent comparison using a possibly indirect and poorly accepted statistical method, which incorrectly assumed the same performance of BMS Bxvelocity Stent and the BMS Express Stent System. Dudek concluded that neither the Schoemig nor the Stettler findings were supported by either the pivotal trial patient level meta nor by the broader analysis of up to 35,000 patients studied in real world registries and randomised trials – which both show no difference in stent thrombosis, death, MI or TLR between the Taxus Stent and Cypher Stent. Dudek was followed by Maciej Lesiak from Poznan. He looked at who would be the optimal patient for left main disease with percutaneous treatment. He felt that the ideal patient would be a low-risk patient with good LV function and non-calcified lesion, anatomically suitable for stenting. He also said that patients who were not suitable for surgery included those with acute LM occlusion and/or stenosis were good PCI candidates. Other patients in this category included those with significant co-morbidities including COPD, CKD, neoplasm and others. Also included were those patients with MV, diffuse disease or anatomy that precludes satisfactory graft placement. Lesiak also contended that there were some patient categories where it was controversial which treatment pattern to use. This included preserved LV function with distal LM bifurcation. This years NFIC also included sessions on left main stenting and peripheral interventions for cardiologists as well as the long established nursing course. The Remarkable Career Achievement Award was given to Professor Lech Polanski from Zabrze in recognition for his services to Polish interventional cardiology. Attendance was up to 1,090 and the NFIC is now the major close of year event in the interventional cardiology field in Europe.
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