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Characterizing Contemporary Interventional Cardiology: The DEScover Registry
April 2004
Can you describe the DEScover Registry?
The purpose of this registry is to characterize the use of drug-eluting stents in a real-world setting as well as the outcomes of patients treated with these stents. Most of the information we have about drug-eluting stents is from clinical trials, where people are pre-selected. However, we’re interested in the results of using drug-eluting stents in everyday, actual clinical practice.
To learn more about when and how drug-eluting stents are used, we’ve initiated the DEScover registry, which will record the outcomes of interventional procedures for 15,000 patients at over 200 cath labs. We will record all patients that undergo interventional procedures, not just those that get drug-eluting stents. The value in looking at patients who receive the stents, as well as those that don’t, is to try and find out what factors influence the selection process, and also to learn, for example, what proportion of patients receive drug-eluting stents. If we don’t record everyone, we won’t be able to learn the answers to these types of questions.
Thus, in order to make comparisons among various groups, the registry will record patients that get balloon angioplasty alone, patients that get bare metal stents and those that get drug-eluting stents.
We have solicited a broad cross-section of hospitals to participate in this project. Not just hospitals that are used to doing these studies, like university hospitals, but also community hospitals. The registry will include large and small hospitals, and there is a diversity of locations, both urban and non-urban. We are looking for insight into whether the type of hospital or its features in some way relates to either outcome or usage of drug-eluting stents.
We’re also going to include an opportunity for hospitals to analyze their performance and outcomes with those of other hospitals. This is a unique feature of this registry. Hospitals will be able to go online and compare their results with those of other hospitals. We have some preformed templates, so you will be able to query what your proportionate use of drug-eluting stents is at your 500-bed urban hospital, for example, and compare it with other urban and non-urban hospitals. Individual investigators, at their will, can make comparisons frequently during the course of the registry. As we enter the data and record it, then we’ll have access to the database to answer some larger questions.
What are some of those larger questions?
There are going to be patients that come into these hospitals that have already had drug-eluting stents, and they’ll be some that have had other stents. How are those patients treated? Somebody comes in that has already had a stent put in do they get a balloon, do they get radiation, do they get another drug-eluting stent? It’s a whole group of patients that we don’t know much about; where some stent of some kind has failed. The scope goes beyond the drug-eluting stent. The other reason I wanted to have a broader sampling is that you learn more about things by comparing them to something else. If we had planned to only enroll patients who receive drug-eluting stents, we wouldn’t be able to compare those patients to other patients who aren’t treated in that fashion.
Not only will we have in-hospital data, but the DEScover registry will also have follow-up information. That’s particularly unique to this registry. I’m unaware of any other registry of this size that will have in-hospital information as well as follow-up information. We will be querying patients at 1 month, 6 months and 12 months, and finding out what their clinical outcomes are in those time periods. There are some other registries that do follow up, but they’re smaller, and there are also some large registries that don’t do follow up, but there are none that are both. DEScover is very unique. Basically, we will be characterizing contemporary interventional cardiology at a broad cross-section of institutions, as it’s really performed. We will be able to learn the best way to do things and obtain insights that hopefully we can pass on as applicable lessons for better patient care.
Are you anticipating a lot of variances in DES usage?
I’m anticipating differences, but I’m not in any way biased as to how it might relate to the location or size of the hospital. It will be fun to find that out. We will characterize institutions in several ways, so we’ll know that information up front. The only thing that we’re sort of constraining is that we want to make sure that institutions have some kind of record of being able to provide complete, accurate, and timely information. If we go to places where they’ve never done anything like this and are unlikely to have the resources, then we’re not going to get good data, so we want to make sure that data are accurate and complete.
Any comment on how the recent approval of the Taxus paclitaxel-eluting stent will affect the registry?
The addition of the Taxus stent to the clinical sphere will be an advantage for our registry. We will enroll all consecutive patients having interventions in order to measure what really happens in clinical practice.
We will collect sufficient data to answer questions that relate to usage. With our follow-up information, we will gain some insight into long-term safety and effectiveness.
Can you tell us about the DEScover Registry investigator meeting which took place
in January?
The meeting was in Orlando, and was a one-day meeting. It was very successful. Over 230 sites were represented. We brought people up to date on the progress of DEScover, and we had a didactic presentation as to what is known about drug-eluting stents and what isn’t sort of a state of the science.
A key instrument of this registry is going to be the case report form. Since this is going to be a high-volume registry, we don’t want the form to be inordinately cumbersome or complicated. We want it to be as simple and as short as possible, yet still calling for the right information.
At the meeting, we separated everyone there into four working groups. These working groups actually walked through segments of the case report form online. We had the participants critique, develop and refine the case report forms. Then, we brought everyone back to a plenary session, each group having a leader, and went through the forms and the groups’ comments. Unlike most clinical trials, where clinical sites are just putting the patients in and don’t have a chance to participate in the trial design, in this case, everyone there had a chance to participate in molding the registry. The feedback from that was very positive. I think this will give all the sites a sense of ownership and investment in this project, rather than sort of being on the outside looking in.
When do you expect that data is going to be first available?
We hope to start to collect around May. Then the forms come in, and there’s a 1-month visit and a 6-month visit, and it takes time polling all this, then editing, cleaning and putting it together. Perhaps we could have something for TCT or the American Heart Association meeting. I hope to have some information to distribute this fall.
What is your experience with drug-eluting stents thus far?
Our experience with drug-eluting stents has been quite positive. We were an investigational site in the SIRIUS trial, which was for the Cordis sirolimus-eluting stent. We were also an investigational site in the TAXUS trial, which is Boston Scientific’s paclitaxel polymer stent. We put quite a few patients in SIRIUS, and had a sense that they were doing quite well, although half of them were placebo stents. But even then, we felt we were seeing something different. Some of the patients came back and we didn’t see any tissue at all.
Our total number of stents so far is well in excess of 1000, maybe as high as 1500 stents. The results have been extremely positive. We have seen probably no more than a handful of patients with restenosis, going back to early April 2003. Basically, a patient gets a drug-eluting stent from us if it’s not an acute myocardial infarction. We’re uncertain about that group at the moment, but everyone else pretty much gets a drug-eluting stent.
Why did you choose to get involved with the DEScover registry?
I’ve been involved with registries in interventional cardiology for a long time. I was the fourth or fifth person in the United States ever to do an angioplasty, and that was in 1978. Shortly after that, the National Heart, Lung and Blood Institute (NHLBI) initiated a registry. The data coordinating center for that has been at the University of Pittsburgh, in the school of epidemiology. I have a very close relationship with that registry. It has been active periodically, and is still active now.
There’s information you can get from randomized clinical trials, and there’s complementary information you can get from a registry. Both are valuable sources of information. I’ve worked with the NHLBI interventional registry for over 20 years. I was happy to become involved in what is a similar venture with the DEScover registry. It’s slightly different, but I felt comfortable I had the necessary skills and abilities to get the right information together and get it out. I enjoy the leadership role and I was happy to be invited to lead the DEScover registry.
What insights have you gained from the Dynamic registry at the University of Pittsburgh?
Well, for example, we’ve written several papers in the last few years where we looked at comparing patients in the pre-stent era balloon angioplasty alone to the post-stent era. We wanted to find out if the patients treated in the stent era were a different type of patient, and whether their outcome was different. The registry has data going back to before stents existed, so we can make these kinds of comparisons. What we see is older patients with much more complicated and advanced coronary disease being treated in the stent era. Looking at their outcomes at one year, the primary difference is that there are fewer repeat procedures. There’s less subsequent bypass procedures and there’s less subsequent repeat revascularizations. There’s no difference in patient mortality or in incidence of myocardial infarction after discharge. However, in the stent era, there are fewer infarctions in the hospital, and there’s less emergency bypass surgery. This is in routine clinical practice. We think that is the impact of the bare metal stent. I suspect the impact of the drug-eluting stent will be that it will further reduce the impact of repeat revascularization and will likely also be more applicable to a broader population of patients. Patients will increase in complexity, and I think that the likelihood of repeat surgery or angioplasty in the course of follow up will be less than with bare metal stents. I think that’s what we’ll see.
Selected recent references
Williams DO, Detre K, Yeh W, Bentivoglio L, Bourassa MG, Al-Bassam M, Block PC, Cohen H, Cowley M, Dorros G, Faxon D, Holmes DR, Holubkov R, Jacobs A, Kelsey S, King, III SB, Myler R, Slater J, Stanek V and Co-Investigators. Percutaneous coronary intervention in the current era compared to 1985-86: The NHLBI Registries. Circulation 2000:102: 2945-2951.
Jacobs AK, Johnston JM, Haviland A, Brooks MM, Kelsey SF, Holmes Jr. DR, Faxon DR, Williams DO, Detre KM: Improved outcomes for women undergoing contemporary percutaneous coronary intervention. Journal of the American College of Cardiology 2002;39(10):1608-1614.
Srinivas VS, Brooks MM, Detre KM, King, III SB, Jacobs AK, Johnston J, Williams DO: Contemporary percutaneous coronary intervention versus balloon angioplasty for multivessel coronary artery disease. A comparison of the National Heart, Lung, and Blood Institute Dynamic Registry and the Bypass Angioplasty Revascularization Investigation (BARI) Study. Circulation 2002;106:1627-1633.
Cohen HA, Williams DO, Holmes DR Jr., Selzer F, Kip KE, Johnston JM, Holubkov R, Kelsey SF, Detre KM. Impact of age on procedural and 1-year outcome in percutaneous transluminal coronary angioplasty: A report from the NHLBI Dynamic Registry. American Heart Journal 2003;146:513-519.
Holmes DR, Selzer F, Johnston JM, Kelsey SF, Holubkov R, Cohen HA, Williams DO, Detre KM: Modeling and risk prediction in the current ear of interventional cardiology. A report from the National Heart, Lung, and Blood Institute Dynamic Registry. Circulation 2003;107: 1871-1876.
David O. Williams, MD discloses he has received a research grant and is a consultant for Guidant Corporation, Cordis Corporation, and Boston Scientific Corporation.
Talking with Chief Research Nurse Elizabeth S. Haag, RN, BSN, About the DEScover Registry St. Francis Hospital, Roslyn, New York St. Francis Hospital is New York’s only specialty-designated cardiac center and performs more cardiac procedures than any other hospital in the Northeast. In 2003, we performed 12,108 cardiac catheterizations and 3,943 coronary angioplasties. There are 5 cath labs which treat approximately 55 patients per day. What is your role with the DEScover Registry? I will assume the responsibility of working alongside the Principal Investigator for the study, Richard A. Shlofmitz, MD, to initiate the study in our institution, proceed through all regulatory processes and coordinate the study with the Research and Cardiac Cath Lab Department staff to collect and submit all data. Did you or anyone at your facility have a chance to participate in the registry design meetings? One of our interventionalists, Thomas Pappas, MD, participated in the Investigator’s Meeting in Orlando, Florida. This was a unique opportunity to participate with several selected colleagues who each brought to the meeting their individual ideas for formulating the Registry protocol. This will enable this esteemed group of physicians to have their say into what information, variables, data and outcomes are to be measured in this registry. What is your experience with drug-eluting stents (DES) thus far? Our experiences have been very positive with DES. We have also participated in some of the early clinical trials associated with DES. The patient population in our institution is very familiar with this modality of treatment. Approximately 85% of all interventions include the use of a DES and our usage is approximately 1.6 stents per patient. How are data are being collected at your institution? Currently we are maintaining our own independent database of patients treated with DES as well as information obtained post cardiac catheterization/PTCA procedure via the Calysto System (Witt Biomedical, Melbourne, FL). Once we receive the registry protocol, we will send it through the review committees established at St. Francis Hospital. At this time, we are in the process of developing a streamlined method for obtaining the information about each DES case eligible for entry into this registry. How is the DEScover Registry different from other clinical trials in which you’ve participated? This is a landmark study which will provide extensive data on interventional procedures performed at leading institutions throughout the United States, with the largest patient enrollment available to date. The DEScover Registry will allow the interventionalists at St. Francis Hospital to participate in the largest research effort to identify and track trends and outcomes of DES in clinical real world practice at our institution, as well as having the opportunity to have access to information and data from other prestigious institutions throughout the United States. This will not only allow St. Francis to look at how we treat patients, our treatment outcomes, volume and use of DES, but will allow us to compare our data with other selected institutions. Lastly, this unique registry will allow access to data from the DEScover Registry database, which will allow physicians and staff to publish related findings. This valuable information will have the advantage of providing data to identify economical and clinical outcomes as well as patient satisfaction, and potentially quantify a patient’s improvement in quality of life.
Talking with Chief Research Nurse Elizabeth S. Haag, RN, BSN, About the DEScover Registry St. Francis Hospital, Roslyn, New York St. Francis Hospital is New York’s only specialty-designated cardiac center and performs more cardiac procedures than any other hospital in the Northeast. In 2003, we performed 12,108 cardiac catheterizations and 3,943 coronary angioplasties. There are 5 cath labs which treat approximately 55 patients per day. What is your role with the DEScover Registry? I will assume the responsibility of working alongside the Principal Investigator for the study, Richard A. Shlofmitz, MD, to initiate the study in our institution, proceed through all regulatory processes and coordinate the study with the Research and Cardiac Cath Lab Department staff to collect and submit all data. Did you or anyone at your facility have a chance to participate in the registry design meetings? One of our interventionalists, Thomas Pappas, MD, participated in the Investigator’s Meeting in Orlando, Florida. This was a unique opportunity to participate with several selected colleagues who each brought to the meeting their individual ideas for formulating the Registry protocol. This will enable this esteemed group of physicians to have their say into what information, variables, data and outcomes are to be measured in this registry. What is your experience with drug-eluting stents (DES) thus far? Our experiences have been very positive with DES. We have also participated in some of the early clinical trials associated with DES. The patient population in our institution is very familiar with this modality of treatment. Approximately 85% of all interventions include the use of a DES and our usage is approximately 1.6 stents per patient. How are data are being collected at your institution? Currently we are maintaining our own independent database of patients treated with DES as well as information obtained post cardiac catheterization/PTCA procedure via the Calysto System (Witt Biomedical, Melbourne, FL). Once we receive the registry protocol, we will send it through the review committees established at St. Francis Hospital. At this time, we are in the process of developing a streamlined method for obtaining the information about each DES case eligible for entry into this registry. How is the DEScover Registry different from other clinical trials in which you’ve participated? This is a landmark study which will provide extensive data on interventional procedures performed at leading institutions throughout the United States, with the largest patient enrollment available to date. The DEScover Registry will allow the interventionalists at St. Francis Hospital to participate in the largest research effort to identify and track trends and outcomes of DES in clinical real world practice at our institution, as well as having the opportunity to have access to information and data from other prestigious institutions throughout the United States. This will not only allow St. Francis to look at how we treat patients, our treatment outcomes, volume and use of DES, but will allow us to compare our data with other selected institutions. Lastly, this unique registry will allow access to data from the DEScover Registry database, which will allow physicians and staff to publish related findings. This valuable information will have the advantage of providing data to identify economical and clinical outcomes as well as patient satisfaction, and potentially quantify a patient’s improvement in quality of life.
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