YEAR I . NUM. 02 Thursday 12th August, 2010 SOLACI DAILY República The Official Newspaper of SOLACI Congress

SOLACI – CACI 2010 Opening Ceremony

ith the attendance of a massive audience, SOLACI - CACI 2010 opening ceremony, was chair Wby Dr Oscar Mendiz, Congress President, who was accompanied by SOLACI President, Dr Darío Echeverri; CACI President, Dr Rubén Piraino; the Spanish Society of Cardiology President Dr Carlos Macaya; and Argentinean Society of Cardiology and Argentinean Federa- tion of Cardiology representatives. During the ceremony which was coordinated by the famous radio announcer Maria Isabel Sanchez, and after the Argentinean National Anthem was sang, Dr. Echeverry an Dr. Pirai- no addressed the audience. After that Dr Men- diz declared officially opened (Cont. Page 3)

SOLACI President Interview CACI President Interview

Dr. Darío Echeverri Dr. Rubén Piraino

- Dr. Echeverri, how do you assess your - Mr. Piraino, what can you tell us about first year as President of SOLACI? your year as head of the Argentine Colle- I think it has been a good year, although it has ge of Interventional Cardioangiologists not been easy. I received the Society with Infor- (CACI)? mation (Web), Education (ProEducar) and Con- The management objectives of this Board of Di- gress and Conference Offices, which had clear rectors are to continue to add to what previous administrative structures and goals, but in a administrations have achieved. If there is so- time characterized by great restrictions and mething remarkable about all previous CACI worldwide economic difficulties in sectors that Boards of Directors is that none of them has affected the health sector. aimed at starting their administrations from That is why a considerable part of my work as scratch, on the contrary, they have added new President of SOLACI has been focused on ra- things to what was already being done tionalizing money, promoting synergic action among the different Offices for the achievement - How does the CACI receive each join event of better results; fulfilling SOLACI’s Mission with SOLACI? Dr. Darío Echeverri and Vision; working on common (Cont. Page 3) SOLACI represents our most (Cont. Page 5) Dr. Rubén Piraino 02 . SOLACI DAILY . The Official Newspaper of SOLACI Congress . Thursday, August 12th, 2010 Thursday, August 12th, 2010 . The Official Newspaper of SOLACI Congress . SOLACI DAILY . 03

(Cont. of “SOLACI President Interview”) ty and not a Confederation, it is necessary to Not all LIMUS are the same SOLACY DAILY ...goals with the industry, such as increasing strengthen the joint activities carried out with Year One / Number Two cardiovascular interventions in Latin America, different local Societies in Latin America, the and in Diabetic population Thursday, 12th August, 2010 developing a supportive action program with United States, Europe and Asia. In response to the differences are even the population in need (SOL Program), streng- that sentiment, the Board of Directors I preside Director thening international relationships (TCT-CRF, has created a SOLACI’s International Commit- more accentuated Oscar Mendiz, MD EuroPCR and SCAI), attracting international tee, precisely to reinforce its relationships with Dr. Dayse Repsold Chief Editor members from Spain, Portugal, Puerto Rico and other international scientific societies. José Alvarez, MD the United States to our Society. By the end of n 1975, Rapamycin was first isolated from Content Coordinator this first year, after six months of hard work - Do you think Conferences are enough for a soil microorganism Streptomyces hygros- Flavia Cobas and after analyzing the survey’s results, I hope SOLACI to establish its presence in coun- copius, and was classified as an immunosu- Managing Editor to start executing an internal Strategic Plan ai- tries which are not seats of the Congress? Ippressive drug with anti-proliferative and anti- Eugenia Gesualdi, Edelman med at organizing the Society and directing its One of the greatest legacies left by Dr. Daniel inflammatory characteristics. Cypher, was the Justiniano Vila, Edelman efforts to achieving common interests for the Berrocal’s administration is SOLACI’s Conferen- first stent to utilize this drug, also known as Congress General Organizer benefit of its members in the short, medium ces. Precisely, they were aimed at meeting the Sirolimus, creating the concept of the Drug Elu- Alejandro Londero and long terms. continuous education and scientific knowledge ting Stent. Contact: [email protected] needs of members in countries where the Con- Many years after, a large number of DES was - You have been an active member of the gress was not held. Their results are highly suc- launched, on which the drug derived or is a Society for many years, what do you think cessful and well appraised by members. synthetic reproduction of Sirolimus. Today we (Cont. of “SOLACI – CACI 2010 Opening Ceremony”) about its development through time? Therefore, we are working to increase our pre- have an enormous amount of information and ...the XVI SOLACI Congress, XX CACI Congress SOLACI has given me the opportunity to grow, sence there by strengthening relationships with evidence-based clinical randomized controlled and XX Nurses and XXX Technicians Congress both personally and professionally. Its evolu- local societies, emphasizing the role of member studies directly comparing different pharmaco- Opening lecture was given by Prof Gregg Sto- tion has been a positive one. It has not only representatives, taking part in local congresses logical stents each other, which have clearly de- ne was co-director of Cardiovascular Research influenced me, but it has also allowed me to ge- and trying to increase and improve educational monstrated the differences between them. The Foundation and Director of one of the biggest nerate ideas and projects for the Society. It has activities (ProEducar), Registration and, hope- difference is even greater the more complex the and more famous Interventional Cardiologist been a very interesting exchange. fully in the future, clinical research project led disease to be treated, such as in small vessels meeting, the TCT and co-director of Inter- by SOLACI’s members. and diabetic patients. The relative performance ventional Cardiology at Columbia University - What are your views on the Congresses of the CYPHERTM stent versus others DES in in NYC, USA. During his presentation he ta- organized by SOLACI? Their development - What are your plans for SOLACI 2011 in patients with diabetes showed that SES reduces lks about “A Personalized Approach to the has been remarkable, what do you think Santiago de Chile? re-intervention rates in patients with diabetes Treatment of Acute Coronary Syndromes: Ba- about that? It is one of the Board of Directors’ greatest cha- mellitus as showed the results from the Meta- lancing Ischemia versus. Bleeding” he pointed These congresses have become the “body and llenges. Together with the Advisory Council we Analysis of 05 Randomized Trials comparing out how we can better approach each particu- soul” of the Society. Thanks to my predeces- fully trust in Santiago de Chile’s capacities and SES vs PES in Patients with Coronary Artery lar patient and how can decrease the risk of sors great efforts and to the creation of an the commitment of the Scientific and Organizing Disease and Diabetes Mellitus. bleeding what can bring fatal complications. Office exclusively devoted to the organiza- Committees led by Dr. Gaston Doussalliant. The Western Denmark Heart Registry evalua- After official presentation SOLACI 2010 at- tion of these congresses during Dr. Alexander ted safety and effectiveness of SES and ZES in tendees enjoyed listening tango songs by the Abizaid’s administration, today we can say that - Is there anything else you would like to 944 patients with diabetes mellitus treated with famous Tango singer Raul Lavie; one of the our Congress is very well positioned at the in- say to people attending the Congress in either ZES (N= 342) and SES (N= 602) and fo- most famous tango singer in activity how kin- ternational level and attracts the world’s main Buenos Aires? llowed for up to 27 months. The endpoints dea- dly accepted to share his voice with meeting opinion leaders, more than 2,000 assistants and On behalf of the Board of Directors and the th and late myocardial infarction (late MI: >30 attendees. the unconditional support of leading business Advisory Council I would like transmit all its days) were ascertained from national medical After enjoying the classical music from Buenos companies, showing its current importance at members a message of confidence in and opti- databases, while data on target lesion revascu- Aires, everybody enjoyed a cocktail offeredd the academic and scientific levels. mism for the results. We will continue working larization (TLR), in-stent restenosis (ISR), and at the exhibit. hard to make SOLACI a stronger and more solid definite stent thrombosis were obtained from - What is your opinion about the joint ses- society. Teamwork and active member partici- the Western Denmark Heart Registry and con- sions held with other Societies? pation will help fulfill our Vision. firmed by review of the angiograms. The re- Even though SOLACI is a members Socie- gistry concluded that diabetic patients treated with ZES stent had two-fold higher TLR and ISR than ZES treated patient without diabetes, whereas the SES group had similar TLR and ISR rates in patients with and without diabetes mellitus. In those with diabetes, ZES patients had a 3-fold and 6-fold increase in TLR and ISR respectively, compared with SES treatment. Based on Spirit IV and Compare there is parity between Xience V and Taxus Liberté in DM pa- tients. The latest trial comparing these two DES in diabetic population, presented at Euro PCR 2010, Spirit V Diabetic RCT, in 324 patients is not powered to analyze any clinical endpoint. As conclusion, in patients with Diabetes Me- llitus undergoing coronary stent implantation, CYPHER sirolimus-eluting stent (SES) are asso- ciated with superior efficacy and similar safe- ty compared to Taxus paclitaxel-eluting stent (PES) and with significantly lower risk of TLR and ISR compared to Endeavor zotarolimus- eluting stent (ZES). Xience V just showed parity with Taxus in diabetic population. 04 . SOLACI DAILY . The Official Newspaper of SOLACI Congress . Thursday, August 12th, 2010 Thursday, August 12th, 2010 . The Official Newspaper of SOLACI Congress . SOLACI DAILY . 05

(Cont. of “SOLACI President Interview”) the Argentine Society of Cardiology (SAC), in entity, but not autarchic. This means that it has the Congress Office, the Procedures, Devices ...they are the protagonists. Since this is a La- order to widely spread our practices in the field independence of criteria, but within the scope and Drugs Registration Office, and the Area of tin American congress, Latin Americans must of Clinical Cardiology. of the policy of the College, which is represen- Equipment, Rooms and Services have the leading role, by having the opportuni- ted by each Board of Directors. The success of a ty of expressing their ideas, showing their ex- -CACI has one of the few university pro- magazine lies in its content; therefore, we want - Is there anything else you would like to periences and being able to discuss their points grams in the world aimed at training specia- to stimulate it. And I allow myself to use these talk to us about? of view with other colleagues. In addition, their lists. What is your opinion on this matter? lines, to encourage all interventional cardiolo- I would like to congratulate the people working papers are presented in an important academic The Hemodynamics Specialist and General An- gists to send their papers to our magazine. on the initiative of having a Congress Newspa- environment, and could be published in one of giography University Program is jointly deve- per, which provides the opportunity of rea- the major Journals. loped by the CACI and the University of Buenos - What other project do you have in store ching a massive audience and I would also like Aires (UBA). It is a matter for great pride for our for the rest of the year? to let them know that we understand the effort - What is your opinion about interventions College because it is one of the first of its kind There are both new projects, and those already this implies. There is, however, an event that in Argentina, regarding the number of in the world and because of the excellence in in progress, to be continued through time. For has deeply touched us all. Therefore, I would procedures and their practice level? the academic level. example, the UBA-CACI Specialist University like to pay a special tribute to our late José One of the main policies that we are developing Program, the Specialist Degree granted by the Gabay, Vice-President of CACI, Treasurer of in this administration aims at increasing the - This year the CACI has relaunched its ma- National Ministry of Health, which in its reso- the SOLACI Congress, Editor of SOLACI’s Pro number of procedures in Argentina. We have gazine, what can you tell us about this? lution makes special emphasis on the fact that Educar, Deputy Chief of the Interventional Car- implemented a strong penetration policy in the The Magazine is the official dissemination ins- the CACI is the only authorized certification diology Service of the Italian Hospital of Bue- two societies of cardiology of our country, the trument of the Argentine College of Interven- entity.Among the new undertakings (which are nos Aires, and above all an exceptional human Argentine Federation of Cardiology (FAC) and tional Cardioangiologists. It is an autonomous already a reality )I would like to mention three: being and friend.

Transmission of Live Cases, an What do you think about SOLACI – CACI Exiting Educational Activity 2010?

After the welcome messages of Dr. Darío Echeverri, SOLACI’s President, and Dr. Rubén Piraíno, Dr. Silvia Makhoul (Clinical Cardiologist of CACI’s President, the transmission of live cases begun. This is the most interactive activity the Hospital Británico de and the one which offers the greatest educational content. Buenos Aires) “It is very important for the integration of cardiologic pathologies related to inter- ventionism.”

Dr. Juan M. Telayna (Interventional Cardio- logist) “By showing new develop- ments in the area, the aim is to share the knowledge with Clinical Cardiology”

Dr. Alejandro Hita (Chief of Cardiology of the Austral University Hospital) “It is focused on the fact that clinical and interven- tional cardiology are one thing.” n a first session, coordinated from the Pa- nal techniques”, according to what Dr. E. Souza iliac artery, after which it could be placed in cífico Conference Room by Dr. Hugo Lon- said. the correct position without further problems. dero, a case was presented about a patient Afterwards, in the second transmission of the This was an excellent example of complications Patricia Chombi Iwith tandem lesions in the anterior descending morning, with the participation of Dr. César that may arise, and how to treat them. (Nurse) artery, which involved the origin of a well de- Morís de la Tassa, from the Asturias Central Finally, two coronary cases: one with lesion in “It fosters personal growth veloping diagonal branch. A interesting dis- University Hospital, the audience could see the the ostium of the left main coronary artery, and and development which cussion was generated in the panel about the placement of an aortic valve in an 81-year-old, another case with severe and complex three- benefit the patient.” different treatment strategies to use for the symptomatic patient, with previous by-pass vessel lesions in a high surgical risk patient, set bifurcation lesions, a chapter of the speciality surgery. During the partial liberation of the the basis for the use of different imaging (in- which is still the source of thorough clinical valve, the valve moved from its annular posi- travascular ultrasound, tomography) and the- research with dedicated devices “that so far tion towards the ascending aorta, for which it rapeutic (cutting-balloon, Rotablator) devices, have not shown better results than conventio- was necessary to recapture the device in the and the discussion about their indications. 06 . SOLACI DAILY . The Official Newspaper of SOLACI Congress . Thursday, August 12th, 2010 Thursday, August 12th, 2010 . The Official Newspaper of SOLACI Congress . SOLACI DAILY . 07

José Manuel Gabay, M.D.: In Memoriam The Year in Coronary Heart Disease The last year in coronary heart disease has been very exciting on many fronts including accumula- tion of data on expanded subsets of patients, close identification of specific technological develop- ments and the introduction of new evolving concepts.

By David R. Holmes, Jr., M.D.

1. Pharmacogenomic testing has been the sour-

José Manuel Gabay, M.D.: 6/3/63 – 6/25/10 ce of great interest. This has resulted from information initially related to clopidogrel me- For all of us who knew José and have shared tabolism. As is well known, clopidogrel is a pro with him numerous activities in the last few drug which must be converted after gastrointes- years, his early and tragic death has been the tinal absorption to the active metabolite. This cause of grief and tremendous emptiness. A line of investigation was initially stimulated by deep reaching wound, that has left its mark the core issue of stent thrombosis which, while and that only time will be able to heal so that infrequent, is associated with major morbidity we can enjoy the memories of the good times and mortality. In an initial series of investiga- we spent together. tions, it was identified that there is genetic va- Among his responsibilities within the sco- riation in cytochrome metabolism which then pe of this congress, he had organized and affects the activity of clopidogrel. Accordingly, executed live cases; therefore, the question there are some patients, who on regular dose I made that fateful Friday afternoon (“Whe- clopidogrel (75 mg) do not receive the benefit of re is José?”), while we were watching the optimal antiplatelet effect. end of a World Cup match so as to start with There is increasing information on the pharma- the live case meeting organized in the Ita- cogenomics of this field which led to the FDA lian Hospital, does not make sense any more; boxed warning earlier this year. This, in turn, and it does not make any sense either to ask led to considerable confusion and controversy fate about why he had not stayed to share but there are major implications for the field. that activity with us. For all this and much This whole issue is being studied in several on- more, on behalf of the 2010 SOLACI-CACI going or planned clinical trials. David R. Holmes, Jr., M.D. Congress, I would like to say a prayer in his At present, pharmacogenomic testing can be memory and share with you a phrase that used to identify patients at risk of having su- on standard dose clopidogrel or who may be at high incidence of MACE rate in the PCI group the gauchos of the Argentine Pampas use boptimal response to clopidogrel administra- very high risk for an event, several strategies are compared with the coronary bypass graft surgi- to say goodbye to a friend: “See you soon, tion. This is complicated by the fact that there available including the use of alternative agents; cal group but this was driven by the higher need brother.” is no point of care testing and we do not have for example, prasugrel or ticagrelor, or increa- for target vessel revascularization in the PCI Oscar Mendiz, M.D. large scale data on devising patient care algo- sing the dose of clopidogrel to 150 mgm, or fina- group. There was a lower risk of stroke. One President SOLACI-CACI 2010 rithms based upon this data. In patients who lly adding a third drug such as cilostazol. of the more important findings from this stu- are nonresponders, either because of an event dy for both left main coronary artery disease as 2. Another area of great interest is that of the well as multivessel disease patients was the fact effective bleeding on early and intermediate that depending upon the SYNTAX Score, which outcome after PCI. This bleeding is usually vas- is a measurement of complexity of angiographic cular access bleeding and relates to the transfe- disease, patients could be categorized into 3 ter- moral access site. It is associated with increased ciles – low, medium and high. In the patients morbidity and even mortality. Whether this with low SYNTAX scores or even intermediate bleeding is a marker for co-morbid conditions SYNTAX scores, MACE rates were very simi- or whether it is the transfusion itself that has lar at both 1 and 2 years. It was not until the deleterious consequences remains unknown. group of patients with the most complex disea- Because most bleeding is related to vascu- se, namely the highest tercile that MACE rates lar access, there has been great enthusiasm increased in the PCI patients compared to coro- for transradial approaches. Although in the nary bypass graft surgical patients. Recently, United States, only approximately 2% of PCI in the past several months, an important initia- procedures are performed using radial access, tive has been undertaken and now published. elsewhere, worldwide in many countries, this That initiative is based upon the fact that the has become the dominant strategy favored by SYNTAX score was an angiographic score, but patients as well as physicians alike. While this there are other co-morbid conditions that relate approach can be somewhat more demanding to baseline clinical care characteristics. There with somewhat more radiation exposure, inter- have been recent publications dealing with the est in it grows. This remains a fertile field for additive value of clinical conditions to the SYN- investigation. TAX score and a series of papers have evaluated the EURO Score in combination with the SYN- 3. The application of PCI in patients with com- TAX Score. This combination of clinical, as well plex left main coronary artery and multivessel as angiographic factors, adds significantly addi- disease has been the focus of recent trials, par- tional information to the ability to discrimina- ticularly most recently the SYNTAX trial which te and identify patients who can be very well was published in 2009. Follow-up continues in treated by PCI vs. those who are better suited this group of patient. At one year, there was a for coronary bypass graft surgery. 08 . SOLACI DAILY . The Official Newspaper of SOLACI Congress . Thursday, August 12th, 2010 Thursday, August 12th, 2010 . The Official Newspaper of SOLACI Congress . SOLACI DAILY . 09 10 . SOLACI DAILY . The Official Newspaper of SOLACI Congress . Thursday, August 12th, 2010 Thursday, August 12th, 2010 . The Official Newspaper of SOLACI Congress . SOLACI DAILY . 11

UBA-CACI: 20 years of experience in trainning and recertifiying specialists

By Marcelo Ruda Vega, M.D. and from Europe (Spain, Bulgaria). There was an 90 Interventional Cardiologists will complete that include all of their Interventional Cardio- even distribution of students attending practical 4 Annual Update Programs obtaining recerti- angiologists. n Argentina there is a formal TRAINING training given in Hemodynamics Laboratories fication for the speciality. Their professional AND CERTIFICATION system in place sin- located in the City of Buenos Aires, in the Great practice places were uniformly distributed TECHNOLOGY IN EDUCATION ce 1990, jointly organized by the School Buenos Aires area and in the provinces, and the- throughout the country. Virtual reality simulators have reached a level Iof Medicine of the University of Buenos Aires re were 31 foreign students. The 8th graduating of technological excellence that makes them –UBA– and the Argentine College of Interven- class, June 2008-May 2011, is composed by 59 EDUCATIONAL PROJECT ORIGINALITY suitable for training in different diagnostic and tional Cardioangiologists –CACI–, which is the Argentine students and 7 students from Bolivia, The name of the Program, Hemodynamics, Ge- therapeutic techniques. The CACI’s new cen- 3-year Hemodynamics, General Angiography Brazil, Cuba, Ecuador, Peru and Venezuela. neral Angiography and Interventional Cardio- tral office has comfortable facilities which have and Interventional Cardiology Specialists Uni- angiology, is in itself a clear definition of the been especially designed for interventionists to versity Program. Also, in 2004 these institutions, UBA-CACI, scope intended for the course. Indeed, in 1989 work with two simulators: one for training in started an UPDATE AND RECERTIFICATION when we presented the project for the creation the use of the radial pathway and another one Part 1 - OBJECTIVES system called Update Program on Interventio- of the Program to the University of Buenos Ai- for peripheral, renal, carotid and coronary an- • Complete theoretical and practical training nal Cardioangiology, which lasts one year. If the res we believed it must include full knowledge gioplasty. This will enable professors to com- in cardiac catheterization in adults, diagnose to- Program is completed successfully, recertifica- of total body angiography and that therapeutic pare training abilities and skills among novel tal body angiography, including the coronary, tion is granted for 9 years. This is a one-year catheterizations must include from coronary, and expert specialists. We do not mean that we peripheral, splanchnic and cerebrovascular te- theoretical and practical course on therapeutic carotid, renal and peripheral angioplasties to can see the irreplaceable personalized practical rritories. catheterizations designed for Hemodynamics embolization of malformations or tumors. The education given by the expert in the Labora- • Complete theoretical and practical training and Angiography Specialists who have actively syllabus always included these topics and was tory, but learning times will be significantly re- in Interventional Cardiology, peripheral, renal worked with certification issued by the CACI focused on interpreting the scopes of the spe- duced. Another close application will be using and splanchnic interventions. (or equivalent certifications from abroad) per- ciality just as it is practiced in Argentina. The simulators as a complement of the professional • Guidance on pediatric diagnostic and in- forming diagnostic studies, and with experien- latest programs of major international TCT, PCR evaluation needed for granting certificates and terventional catheterization and Interventional ce in therapeutic procedures. or SOLACI congresses certify that the path cho- recertification. Neuroradiology. sen 20 years ago was the right one. Last but not least, these Educational Programs Part 2 - OBJECTIVES There is no other Medical Speciality in our coun- have been developed by CACI’s Education Com- RESULTS : after its seventh cycle, which ended • Fast update on therapeutic catheterizations try that has a structured Certification system mittee, in which I have worked with members in June 2008, the Program has been completed of the different vascular sectors through centers for young professionals who start with a Uni- of the permanent staff: Doctors Hugo F. Londe- by 186 specialists who practice their profession with wide experience in each territory. After versity Specialist Program and the voluntary ro, Alejandro Cherro, Ernesto Torresani, Gui- throughout the country, from Formosa to Tie- completing the Program, graduates are recertified Recertification of specialists which is granted llermo Migliaro, Guillermo Martino and Juan F. rra del Fuego, in every Province where there to perform catheterization procedures for 9 years, for nine years (revalidated at 5 years) through a Arellano. Also, the Chiefs of Service (Associate is a Hemodynamics Laboratory. Also, there are with a revalidation of background at 5 years. one-year Update Program. As far as we know, Directors) who are responsible for supervising graduates from Latin America (Bolivia, Colom- other countries don not have comprehensive practical activities and more than 300 invited bia, Chile, Costa Rica, Ecuador, Mexico, Peru) RESULTS: between July 2004 and June 2011, national Training and Recertification programs professors regularly giving theoretical classes.

Gene therapy: where are we and were are we going?

By J. Alberto Crottogini, MD, PhD* double-blind, placebo-controlled trials on lar- tients included in the AGENT trial. role to play in post-infarction heart failure. ger patient populations exhibited little, if any, The placebo effect is just one of the problems that In large mammals, we as well as others have schemic heart benefit. In the Euroinject Trial, in which 0.5 gene therapy research faces at present. Another shown that the transfer of genes coding for disease (IHD) mg of a plasmid encoding vascular endothelial one is the dose to be used. In an uncontrolled, mitogenic cytokines can not only promote remains the ma- growth factor (VEGF) was injected intramyo- open-label study on intramyocardial transfer of proliferation of resident myocyte precur- Ijor cause of morbi- cardially, no differences other than a better lo- a plasmid-VEGF developed by Bio Sidus (Bue- sors, but also induce the adult cardiomyoc- dity and mortality cal linear myocardial shortening were observed nos Aires, Argentina), we have observed that tes to reenter the cell cycle and advance to worldwide. For pa- between placebo- and VEGF treated groups at doses duplicating those employed in the NOR- mitosis. Such an approach to myocardial re- tients not amenable 3 months follow up. Neither did a fourfold hig- THERN trial are safe and improve symptoms, generation would insure physiologic electro- for conventional re- her dose of plasmid-VEGF, as used in the NOR- myocardial perfusion and stress ejection frac- mechanical connection between new and vascularization, and THERN trial, result in significantly different tion. However, the lack of a placebo group pre- resident cells, a fact not yet demonstrated remaining sympto- anginal symptoms, myocardial perfusion or cludes us from drawing firm conclusions. for stem cell implantation. Alberto Crottogini, MD matic despite optimal treadmill walking time either at 3 or 6 months Other crucial issues such as vector optimiza- In summary, gene therapy has a significant medical treatment, follow up. In the AGENT trial, in which intraco- tion, appropriate administration strategies, potential in IHD. The paucity of positive therapeutic angiogenesis has been proposed ronary adenovirus-mediated fibroblast growth treatment regime (single vs. repeated adminis- results in recent randomized trials, rather as an option. Gene transfer-mediated angio- factor 4 was employed, a non-significant ten- tration) and, most relevantly, the gene or com- than discouraging its use, should stimulate genesis consists of promoting the growth of dency for reduced anginal symptoms and myo- bination of genes to be used deserve further the research on basic scientific and technical capillaries and arterioles by intracoronary cardial ischemic burden was observed. investigation. The angiogenic process is the re- issues on which, at present, we have a frag- or intramyocardial injection of genes co- One of the main reasons for these discouraging sult of a complex cascade of events of which we mented knowledge. ding for angiogenic growth factors. results is the notable placebo effect observed know very little. Neither do we know which Early studies on animal models of IHD as in this kind of trials. Intriguingly, the placebo patient population would most probably bene- *Chairman, Dept. of Physiology, Favaloro University well as on small groups of patients yielded effect is much stronger in men than in women, fit from angiogenic gene therapy. promising results. However, randomized, as shown by the pooled analysis of the 532 pa- Last, but not least, gene therapy may have a 12 . SOLACI DAILY . The Official Newspaper of SOLACI Congress . Thursday, August 12th, 2010 Thursday, August 12th, 2010 . The Official Newspaper of SOLACI Congress . SOLACI DAILY . 13 14 . SOLACI DAILY . The Official Newspaper of SOLACI Congress . Thursday, August 12th, 2010 Thursday, August 12th, 2010 . The Official Newspaper of SOLACI Congress . SOLACI DAILY . 15

Complex SVG PCI in Acute Coronary Syndrome: Utilization of laser ablation and intragraft glycoprotein IIb/IIIa inhibitors via ClearWay therapeutic infusion catheter to improve procedural safety

By Rajesh M. Dave, MD, FACC, FSCAI* We describe a complex thrombotic saphenous vein graft (SVG) percutaneous coronary inter- aphenous vein graft (SVG) PCI is known vention (PCI) case resolved with the aid of laser to be associated with high risk of no re- atherectomy and ClearWay™ (Atrium Medical flow (8-15%) and periprocedural MI (up Corporation, Hudson, NH) local Abciximab Sto 28%). This is largely due to a very high in- delivery. The ClearWay therapeutic infusion cidence of atherothromboembolism that occurs catheter enables local drug delivery to reach during SVG PCI. Due to vein graft degenera- approximately a 500-fold greater drug con- tion, high atheroscelerotic burden with soft centration versus systemic delivery. While the plaque and thrombus is the norm. This sets the flow is occluded, the thrombus is contained and stage for distal embolization during SVG PCI, the drug is infused, maximizing the drug bioa- ultimately leading to poor outcome. vailability at the site and enabling an enhanced Several embolic protection devices have shown therapeutic effect. significant improvement in rates of distal embo- Figure 1 - Severe thrombotic stenosis of Figure 2 - Reduction in TIMI thrombus grade In summary, significant limitations still exist lization and improved procedural safety. Howe- sequential saphenous vein grafts (SVG). and lesion severity post ClearWay. with currently available approaches and further ver, these devices are not universally effective. refinement in thrombus management is needed In embolic protection device (EPD) trials, the patch catheter-delivering intragraft abciximab, concentration of glycoprotein IIb/IIIa inhibi- to improve safety and outcome of these com- major adverse cardiac events (MACE) rate still demonstrated statistically significant median tors can be achieved with ClearWay-directed plex procedures. As shown in this procedure, remains at 10%, which suggests persistent risk percentage diameter stenosis reduction (69% to delivery. This approach should add great value where neither a proximal nor distal protection of micro-embolic showers occurring despite 45%, p = .0001), and improvement and reduc- to complex SVG PCI. In our single-center ex- device was feasible, use of intra-graft Abcixi- EPDs, producing myocardial damage. tion in thrombus grade (68% to 34%, p = .0001). perience, we have seen very promising results mab followed by laser atherectomy allowed safe It is well known that glycoprotein IIb/IIIa in- In a similar study of SVG PCI, use of translumi- with use of intra-graft abciximab delivered completion of the PCI procedure. This may be hibitors reduce the overall MACE in acute co- nal extraction coronary (TEC) atherectomy and via the ClearWay catheter, in conjunction with explained with the achievement of higher drug ronary syndrome intervention. Published IV intra-graft abciximab demonstrated excellent EPD, mechanical thrombectomy or laser athe- concentrations at the site of thrombus due to abciximab trials in SVG intervention have not procedural safety with no evidence of emboli- rectomy. Together, this pharmaco-mechanical utilization of the ClearWay therapeutic infusion shown to reduce periprocedural events or im- zation or no reflow. approach has produced excellent acute proce- balloon catheter, potentially leading to impro- prove MACE. Conversely, a multi-center pilot Reduction in thrombus burden then reduces dural outcomes in very complex, diffusely di- ved efficacy. trial of SVG PCI (n = 58), performed using Dis- likelihood of distal embolization. High local seased thrombus containing vein graft PCI.

Are Dual Antiplatelet Requirements the Same for all Drug-eluting Stents? Long Term Safety Results of the Endeavor Zotarolimus-Eluting Stent May Permit Shorter Dual Antiplatelet Therapy Requirements

By Fausto Feres* cal Evaluation of Clopidogrel revascularization, and stent thromboses. Therapy Duration Following he routinary use of drug-eluting stents Percutaneous Treatment of Di- Summary (DES) as the primary treatment for obs- seased Coronary Vessels with The DATE and OPTIMIZE trials are the only tructive coronary artery diseases was the Endeavor Zotarolimus-Elu- two trials to test the use of DAPT for only Tcalled into question after a review in 2006 of ting Stent in Patients from the 3 months. Even with these trial results, each the long-term follow-up data from early DES “Real-World” Clinical Practi- patient’s specific clinical profile needs to be trials led to concerns about late stent thrombo- ce) study, a milticenter, non- considered when determining the appropria- sis. Subsequently, guidelines were published inferiority trial of 3200 patients te DAPT strategy. Patients with more complex recommending extending the duration of dual randomized (1:1) to received lesions, not tested in these trials may warrant antiplatelet therapy (DAPT) to 12 months, albeit 3 or 12 months of aspirin and a more conservative approach of prolonging without the support of clinical trial evidence. clopidogrel following percuta- DAPT to 6 or even 12 months. An important Recently reported late outcomes from the DATE neous coronary intervention outcome of OPTIMIZE, will be to determine (Optimal Duration of Dual Antiplatelet Therapy (PCI) (Figure). The primary en- if specific DES types warrant specific DAPT After Implantation of the Endeavor Stent) trial, dpoint is net adverse cardiac requirements. The safety of the Endeavor which evaluated the rate of death, myocardial and cerebral events (NACCE), a stent has been consistently reported, with a infarction (MI), and stent thrombosis in patients composite endpoint of death, MI, cerebral vas- 500mg at least 24 hours prior the procedure is low rate of stent thrombosis across the entire treated with the Endeavor zotarolimus-eluting cular accident (CVA), and major bleeding (accor- recommended. During the procedure, use of in- clinical program. While most of these trials stent, and DAPT for only 3 months, challenged ding to the modified REPLACE-2 and GUSTO travenous heparin is given to maintain an acti- were in patients with restricted inclusion cri- the guidelines, showing similar clinical results criteria) at 12 months post procedure. Follow-up vated clotting time >250 seconds (>200 seconds teria, the experience at our center with 100 or even better when you include bleeding in pa- for all patients is scheduled at 1, 3, 6, 12 and 18 if glycoprotein IIb/IIIa receptor inhibitors were “real-world’ patients enrolled in the E-Five tients with a short term therapy. The conclusions months and yearly up to 3 years. used). The use of glycoprotein IIb/IIIa and/or Registry, we reported no ST Events at 1 year. in this study point to the need for a larger, ran- bivalirudin is left upon operator´s discretion. The potential benefits of a shorter required domized trial. Medication Regimen Postprocedure medications include aspirin duration of DAPT use are multidimensional. If the patient is not already taking clopidogrel (100-200mg daily) indefinitely and a thieno- Patient compliance is a universal problem, es- OPTIMIZE Study Design prior to the procedure, a loading dose of 300 pyridine (clopidogrel (75mg daily) based on the pecially in patients requiring other surgical The Endeavor zotarolimus-eluting stent is cu- mg is recommended at least 24 hours pre-pro- randomization scheme. An independent clinical or dental procedures. In addition, prescribing rrently being evaluated in the OPTIMIZE cedure. Similarly, if the patient is not already events committee will classify (and adjudicate) thienopyridines can be cost prohibitive lea- (Prospective, Multicenter, Randomized Clini- taking daily aspirin, a loading dose of 300- all deaths, MI, target lesion – or target vessel ding to under treatment. 16 . SOLACI DAILY . The Official Newspaper of SOLACI Congress . Thursday, August 12th, 2010