`
`J CARDIOVASC SURG 2002;43:379-84
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`
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`The Dutch Randomised Endovascular Aneurysm
`Management (DREAM)trial
`Background, design and methods
`
`
`M. PRINSSEN, E. BUSKENS”’, J. D. BLANKENSTEIJN
`
`After the introduction of endovascular repair of abdom-
`inal aortic aneurysms (AAA), both benefits and draw-
`backs of this new technique have been reported. To
`assess whether the new technique is an adequate sub-
`stitute of conventional AAA repair, a randomised study
`is due. The Dutch Randomised Endovascular Aneurysm
`Management (DREAM) trial is a randomised multicen-
`ter trial enrolling patients eligible for elective treatment
`of infrarenal AAAs. In this study, the cost-effectiveness
`of endovascular aneurysm repair (EAR) is compared
`with that of conventional transabdominal surgery, in
`patients that are considered suitable for both types of
`treatment. The primary endpoint is combined opera-
`tive mortality and morbidity. Secondary endpoints and
`additional assessments include event free survival,
`quality of life, length of hospital stay and costs. It is
`expected that the DREAM-trial will lead to a safe and
`controlled introduction of a new technology. Also, the
`medical conumunity will obtain valid scientific evidence
`of the merits of endovascular AAA repair. Finally, poli-
`cy makers will be provided with accurate cost-effective-
`ness data for the Dutch healthcare system. The aim of
`the present paper is to describe the background, meth-
`ods and design of the DREAM-trial.
`KEY worps: Randomized controlled trials - Aortic aneu-
`rysm, abdominal, surgery - Blood vessel prosthesis implan-
`tation - Stents.
`
`B ased upon population screening programs, the
`prevalence of an abdominal aortic aneurysm
`(AAA) in men over 65 years is estimated to be 5-
`8%.+-6 As a result of the ageing of the population
`
`This work is being funded by research grants from the Dutch
`Health Insurance Council.
`
`Authors’ address: J. D. Blankensteijn, Chief, Division of Vascular
`Surgery, Department of Surgery, G04.232, University Medical Center,
`PO Box 85560, Utrecht 3508 GA, The Netherlands.
`E-mail: j.d-blankensteijn@chir.azu.nl
`
`
`
`From the Department of Vascular Surgery
`and *Julius Center for Health Sciences and Primary Care
`University Medical Center, Utrecht, The Netherlands
`
`and the improvement of diagnostic modalities the
`absolute number of individuals with an AAA
`increases as well as the proportion in whom its
`presence is known,’
`Aneurysms commonly remain symptomless until
`they rupture. The risk of rupture is low but increas-
`es exponentially with increasing diameter of the
`aneurysm.’ 9 In case of a rupture of an AAA mor-
`tality is high (85%).10 4! Prophylactic surgery, ‘e.,
`elective abdominal aneurysm repair has a 30-day
`mortality rate of about 7%.!2. 13 Based upon the
`results of the UK Small Aneurysm Trial it appears
`that ultrasonographic surveillance until the diame-
`ter of the aneurysms exceeds 5.5 cm, or grows
`more than 1.0 cm per year or until the aneurysm
`becomestenderis a safe alternative.4
`Since the introduction of endovascular repair of
`AAA (EAR) in 1991 by Parodi, many endovascular
`devices in various configurations have been devel-
`oped, Because the endovascular technique is less
`invasive, a significant decrease in short-term mor-
`tality and morbidity was expected and has indeed
`been demonstrated.15. 16 Also, EAR is expected to
`result in faster patient recovery and in a shorter
`hospital stay. This may also lead to a significant
`reduction in costs associated with AAA repair as
`compared to the conventional procedure.
`However, EAR is an expensive procedure and cer-
`tainly more costly than open repair. Several cost
`effectiveness studies have shown EAR to be more
`expensive, though still cost effective.’ The latter
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`PRINSSEN
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`THE DUTCH RANDOMISED ENDOVASCULAR ANEURYSM MANAGEMENT (DREAM) TRIAL
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`should be interpreted as though the extra costs are
`considered worthwhile in terms of improved out-
`come. |8
`However, presently long-term outcomes after
`EAR are unknown and as the mid-term results after
`EAR becomeavailable, concerns about the compli-
`cation rates and long term durability of endovascu-
`lar prostheses have been raised.19-22
`It is still not known whether EAR is equivalent
`to conventional repair, better or possibly even
`worse. The only evidence available at this
`moment is derived from observational studies
`based on selected patient populations. This is
`likely to have resulted in biased results. For
`instance,
`if only patients with a relatively simple
`aneurysm were included, the success of EAR
`could have been overestimated. On the other
`hand,
`in the initial stage of EAR only high risk
`patients were treated endovascularly, which may
`have affected the outcome of EAR adversely,33
`These issues cannot be solved adequately until a
`comparative study with random allocation to con-
`ventional or endovascular repair is conducted.
`The Dutch Randomised Endovascular Aneurysm
`Management (DREAM)trial is such a randomised
`multicenter study enrolling patients offered an
`elective treatment of an infrarenal AAA. In this
`paper the design, methods and aims of the
`DREAM-trial are described.
`
`Study design
`
`Gramgiving body
`The Dutch Health Insurance Council funded the
`current study. It was not until several hurdles were
`taken that evaluating EAR could be started. Many
`consider EAR as an experimental intervention. The
`latter was the principal reason for rejection of the
`study in several consecutive grant application
`rounds. Also, the variety of the devices available
`on the market and be allowed for application in
`the study was previously considered a methodolog-
`ical flaw, because of a suspected diluting effect.
`However, the aim of this study is to compare two
`Strategies to treat an AAA,i.e. the conventional ver
`sus the endovascular repair, rather than one partic-
`ular device versus another. Accordingly, the study
`should allow using all devices approved and avail-
`
`able on the market, as well as having various sur-
`geons perform both the EAR as the conventional
`procedure.
`Anothercriticism raised was that EAR should be
`considered a “moving” technology. Old devices are
`improved and new devices are released, which
`could mean that results may be out of date by the
`time the study is published. Although we recognise
`this is an important fact, waiting for the develop-
`ments to end is impossible, because of the ever-
`continuing technological advances and the tech-
`nique thus is introduced without any valid and sol-
`id evaluation. Note also that this phenomenon is
`inherent to any development and science, in partic-
`ular medicine, and can only be addressed using
`valid statistical methods.
`
`Organisational structure
`
`A surgeon and a radiologist of each center par-
`take in the trial steering committee (TSC). The TSC
`has final responsibility for the conduct and report-
`ing of the trial. The site and device selection com-
`mittee (SDSC) ballots potential participating centers
`and physicians, and oversees the application of the
`guidelines issued by the Endovascular Safety
`Committee of the Dutch Society for Vascular
`Surgery and the Dutch Society for Radiology. A
`data monitoring and ethics committee (DMEC) is
`installed to ensure the proper conduct of the trial.
`This committee assesses the ethical aspects and
`monitors the safety aspects of the trial, based upon
`reports of the TSC. The University Medical Center
`in Utrecht is the co-ordinating center of the
`DREAM-trial.
`.
`
`Participating centers andphysicians
`The study was approved by the Institutional
`Review Board. The participating centers and physi-
`cians are required to comply with the guidelines
`for endovascular AAA repair issued by the
`Endovascular Safety Committee of the Dutch
`Society for Vascular Surgery and the Dutch Society
`for Radiology. Specifically, surgeons and radiolo-
`gists are required to co-operate in the trial. They
`should have passed their ‘learning curve’ in endo-
`vascular AAA repair prior to full participation. This
`means that they are required to have performed at
`least 20 endovascular procedures, The scrub nurses
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`THE DUTCH RANDOMISED ENDOVASCULAR ANEURYSM MANAGEMENT (DREAM) TRIAL
`
`PRINSSEN
`
`and radiology technicians have to be trained spe-
`cifically for EAR. Physicians not yet meeting the cri-
`teria for participation have the opportunity to par-
`ticipate by doing the endovascular procedure
`under supervision of an experienced colleague.
`Furthermore,
`the participating centers are
`required to have a yearly volume ofat least 30
`conventional AAA repairs and 50 endovascular pro-
`cedures, such as PTA and stent placement.
`A subgroupof participating centers performs con-
`ventional repair only. These centers refer their
`patients to an endovascular center. In case of alloca-
`tion to conventional treatment, the patient is referred
`back to the initial center. This trial design preserves
`normal referral patterns as far as possible. Thus,
`hospitals not yet performing EAR or limited numbers
`of conventional AAA treatment, but otherwise meet-
`ing the criteria for participation, have the option to
`participate and treat their own patients allocated to
`conventional treatment. Another reason for choosing
`this design is that co-operation between centers is
`stimulated paving the way for referral of patients
`and subsequentinclusion.
`
`Devices
`
`Requirements for devices to be included in the
`DREAM trial are consistent with the European CE-
`mark and Preliminary Market Approval (PMA) or
`Investigational Device Exemption (IDE) of the
`United States Food and Drug Administration (FDA).
`With respect to EAR, any configuration is
`allowed including tube, bifurcated, and mono-iliac
`devices, extension cuffs, and suprarenal fixation,
`such to the discretion of the surgeon performing
`the procedure. Preservation of at least one hypo-
`gastric artery must be planned.
`
`Eligibility and exclusion criteria
`All patients with an AAA eligible for EAR as well
`as conventional open repair are considered for par-
`ticipation in the DREAM trial. Patients have to meet
`the entry criteria, which are listed in Table I.
`
`Patient recruitment, informed consent and regis-
`tration
`
`In the participating centers all elective patients
`with an AAA of at least 5.0-cm are evaluated for
`both treatments. The results of the UK small aneu-
`
`‘FABLE I—Jnelusion and exclusion criteria.
`
`Inclusion criteria
`— Non-symptomatic infrarenal AAA, for which an intervention is
`indicated
`-— Adequate infrarenal neck
`——- Other aorto-iliac anatomical configuration suitable for EAR
`according to the criteria of the device used
`— Patient having a life expectation of at least 2 years and cleared
`for transabdominal intervention
`— Signed informed consent
`
`Exclusion criteria
`— Ruptured AAA or symptomatic AAA, which requires emet-
`gency surgery
`— Maximum aneurysm diameter <5.0 cm
`— Juxiarenal or suprarenal AAA
`— Inflammatory AAA (more than wall thickening)
`— Infrarenal neck unsuitable for endovascularfixation or aorto-
`iliac configuration otherwise unsuitable for EAR
`— Bilateral retroperitoneal incision required for EAR
`— Inflammatory AAA (more than wall thickening)
`-— Sacrifice of both hypogastric arteries required
`— Anatomical variations,
`i.e. horseshce-kidney, arteries requiring
`reimplantation (accessory renal arteries or indispensable IMA)
`— Patient unsuitable for laparotomy (i.e. multiple abdominal sur-
`gical interventions)
`— Administration of contrast agent not possible: proved, severe
`systemic reaction to contrast agent
`— Active infection present
`-— Transplantation patients
`— Limited life expectation due to otherillness (<2 years}
`— Non-iatrogenic bleeding diathesis
`— Connective tissue disease
`
`rysm trial have shown that there is no benefit for
`surgical treatment until the aneurysm has reached a
`diameter of 5.5 cm ¥ In this study the line for inclu-
`sion was drawn at 5.0 and not at 5.5 cm. This lower
`limit was chosen because there is often a variation
`between the measurements and the work-up for the
`intervention will also take some time.
`To standardise the information given to the
`patient, prior to physician contact patients receive
`a general information brochure explaining the
`treatment options for an AAA and announcing the
`DREAM-trial. The attending physician informs a
`patient who meets the entry criteria. Patients will-
`ing to participate in the study are included after
`signing an informed consent form. The surgeon
`then contacts the randomisation center by tele-
`phone and the result of the randomisation is given
`immediately. Because it is expected many variables
`will be specific to the participating centers (i.e.
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`PRINSSEN
`
`THE DUTCH RANDOMISED ENDOVASCULAR ANEURYSM MANAGEMENT (DREAM) TRIAL
`
`type of device, experience of the team, etc.), ran-
`domisation is stratified by center.
`Finally, the grant giving body also demanded an
`anonymous registration of all patients being treated
`for an AAA in the participating centers to get an
`overview of the aneurysm surgery in the Nether-
`lands, On a general registration form the treatment
`allocated is registered. In case of exclusion for the
`trial the reason for exclusion is also mentioned.
`
`widely used to measure the impact of manydiffer-
`ent health interventions and the form is scored on
`8 dimensions, which encompass general heath,
`physical function, vitality, bodily pain, social! func-
`tion and mental health.26 The results obtained by
`means of the EQ5D will be used to estimate survi-
`val time adjusted for QoL.
`QoL during follow-up will be compared to the
`preoperative assessment using non-parametric tests
`for paired samples.
`
`Cost effectiveness
`
`
`
`
`
`sasteounbinsacegabtyssacrssanegeyensrsinnimencceLxscpaceastaered
`
`Sample size
`The required sample size was estimated to
`amount to 400 patients (200 in each arm of the
`trial). This estimate is based on the expectation of
`reducing the combined operative mortality and mor-
`bidity from 20% in open to 10% in endovascular sur-
`gery. To be able to detect this relative reduction in
`operative mortality and morbidity of 50% with a sta-
`tistical power of 80% (B=0.2) and a=5%, 196 patients
`are required in each arm ofthetrial. Taking into
`account a 10% of the patients refusing participation,
`almost 450 eligible patients are needed.
`The yearly volume of elective AAA repair in the
`participating centers is estimated between 500 and
`800. Considering some differences in inclusion per-
`centages for the endovascular treatment (30-50%)
`between the centers based on the use of different
`devices, 400 patients are expected to be random-
`ised within 3 years.
`
`The effectiveness of the endovascular AAA treat-
`ment versus that of the conventional repair will be
`determined in terms of operative mortality, early and
`late complications, overall mortality and quality of
`life. The latter also comprises an index measure, 1.2.,
`utility, of overall quality of life that can be used to
`adjust survival time. Short-term results encompass
`outcome measures reported within a 30 day- and 6-
`month time frame. Mid-term results refer to outcome
`measures up to 2 years after EAR and long-term
`results include all outcomes beyond 2 years.4 The
`long-term effectiveness of the endovascular prosthe-
`sis is not known yet. Because follow-upin this trial is
`limited it will not be possible to obtain long-term
`results of the effectiveness of EAR within the study.
`To approximate these results an arithmetic model,
`#.2., a Markov Monte Carlo simulation model, based
`on results of earlier studies will be used.
`In parallel with the clinical study the costs of the
`operation will be determined for both trial arms,
`including a detailed assessment of the costs of
`staffing, investigations, drugs and overheads, In
`addition the indirect costs due to losses in produc-
`tion of paid and unpaid labour will be estimated.
`To estimate the costs associated with long-term
`outcomes the above-mentioned model will again
`be used. Finally,
`the model will also be used to
`compare the balance between costs and effects
`across the armsofthetrial in terms of incremental
`costs perlife year gained and per quality adjusted
`life year (QALY) gained.
`
`
`
`sagpononeglgenstntutticores
`
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`
`
`
`Outcome measures
`
`Combined operative mortality and morbidity
`The primary outcome for the DREAM trial is the
`combined perioperative mortality and morbidity.
`All moderate and severe complications are inde-
`pendently assessed at 30 days and combined in
`one comprehensive outcome. Complications are
`defined conform the SVS/AAVSreporting standards,
`dividing the complications into two groups, “remo-
`te/systemic” and “local/vascular” 2425
`
`Quatity oflife
`Quality of life (QoL) is assessed throughout this
`trial with the Medical Outcomes Short Form 36 (SF-
`36) questionnaire, the EQSD and a short question-
`naire about sexual function. The SF-36 has been
`
`Continuous sequential analysis ofsafety
`EARis a evolving technique and in recent history
`we have witnessed several devices being with-
`drawn from the market because of some technical
`
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`THE DUTCH RANDOMISED ENDOVASCULAR ANEURYSM MANAGEMENT (DREAM) TRIAL
`
`PRINSSEN
`
`failures occurring.?7, % Failing devices obviously
`pose a risk to patients having undergone EAR. The
`actual hazard, the extent and type of complications
`associated however are unknown at present.
`Conversely,
`the conventional open repair has a
`long track record with known advantages and dis-
`advantages.29 It would appear that conducting a
`study such as the DREAM trial, which uses an
`experimental device, is acceptable only if the safety
`of the participants is guarded. Therefore,
`if at any
`time during follow-up a primary endpoint, f.e., seri-
`ous morbidity or mortality, an infection of the pros-
`thesis or AAA rupture occurs an independent
`blinded (survival) analysis will be carried out to
`compare the incidence of the above outcomes
`across the arms ofthe trial. This so-called continu-
`ous sequential analysis will enable the TSC to take
`adequate action as soon as the data show a consid-
`erable difference (OR<0.5 or OR>2) in incident
`adverse outcomes. The safety of potential partici-
`pants not yet randomised is thus safeguarded.
`
`Final analysis
`One month after inclusion of the last patient, the
`analysis of the operative mortality and morbidity
`data will be performed. One year after this last
`inclusion the majority of patients will have had a
`follow-up of 18-30 months. Based on these results
`a prediction will be made about the effectiveness
`of EAR in prevention of further expansion or rup-
`ture of the aneurysm.
`
`Conclusions
`
`The DREAM-trial will hopefully lead to safe and
`controlled introduction of a new technology and
`will provide the medical community with valid. sci-
`entific evidence on the merits of endovascular AAA
`repair, Also, policy makers will be provided with
`information on the cost-effectiveness of this new
`therapy for the Dutch Healthcare setting,
`In February 2001 the first patient has been
`included in the trial, so the first results of the
`DREAM-trial are anticipated in early 2004.
`
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