thumbs up/thumbs down – january 2002 rematch, madit-ii, and pricey technology clinical trial...
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Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Clinical trial commentary: REMATCH, MADIT-II, and pricey technology
Eric J Topol MDProvost and Chief Academic OfficerChairman, Department of Cardiovascular MedicineThe Cleveland Clinic FoundationCleveland, Ohio
Robert M Califf MDProfessor of MedicineAssociate Vice Chancellor for Clinical ResearchDirector, Duke Clinical Research InstituteDuke University Medical CenterDurham, North Carolina
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
New technology
Bx-Velocity StentSource: Cordis
HeartMate LVADSource: Thoratec
VENTAK PRIZM 2 ICDSource: Guidant
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Outline
REMATCH
LVADs as destination therapy
MADIT-II
ICDs for MI survivors with low EF
Crisis of technology costs
How will we pay for all this effective technology?
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
REMATCH
Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure
129 Class IV heart failure patients randomized to either HeartMate LVAD or medical therapy
Non-transplant candidates
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Time point LVAD (n=68)medical
therapy (n=61) p value
1 year 52% 25% 0.002
2 years 23% 8% 0.09
Kaplan-Meier estimates of survival at 1 and 2 years
REMATCH: survival
Rose EA, et al. NEJM 2001; 345:1435-43
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
REMATCH: quality of life
1-year quality of life assessment
LVAD group
Medical therapy group p value
Median NYHA functional class
II IV <0.001
SF-36 (physical function)
46 19 21 21 0.01
Minnesota Living with Heart Failure
41 22 58 21 0.11
Rose EA, et al. NEJM 2001; 345:1435-43
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
REMATCH: adverse events
Event
LVAD (n=67)
Medical therapy
(n=60)
Rate ratio (95% CI)
rate/patient-year
Sepsis 0.60 0.30 2.03(0.99-4.13)
Nonneurologic bleeding
0.56 0.06 9.47(2.30-38.90)
Suspected LVAD malfunction
0.75 N/A N/A
Rose EA, et al. NEJM 2001; 345:1435-43
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Cost-effectiveness
HeartMate® VE LVAD
Some estimates put it at >$160,000 per year of life saved.
If 100,000 patients eligible, that's $16 billion per year
Source: Thoratec
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Cost-effectiveness
HeartMate® VE LVAD
Formal cost-effectiveness has not yet been done
Cost-effectiveness may drive the interpretation of the devices usefulness
At $160,000 per year of life, it may not be covered, but would be at $60,000 per year of life
Source: Thoratec
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Interpretation
"What does it mean when you save a lot of lives, but in a short period of time, everyone is dead?"
Califf
REMATCH median improved survival is 250 daysMedian improved survival of many pharmacological therapies is <3 months but in a larger patient population
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Is it worth it?
In pharmacologic therapies, most patients live 10-12 years of life after the intervention
After REMATCH most were dead in 2 years
This is an early stage in the technology still, it will get better
"Maybe REMATCH is truly a segue into something that's going to be more
important for a more broadly applicable patient population in the years ahead.”
Topol
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
What do you do now?
"The genie's out of the bottle here, unfortunately. And this as well as the other device trials we're talking about today are really putting an inordinate stress on the system, on our ability to survive from a financial point of view."
Topol
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
End therapy
Jarvik 2000Source: Texas Heart Institute LionHeart LVAD
Source: Arrow International
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Who gets the device?
Will it be possible to deny this technology to an eligible patient?
The estimate of 100,000 patients may be low, especially if you go beyond the end-stage patient
"Now we have a technology that can do it, should we do it?"
Topol
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Califf: 2 thumbs up for REMATCH
"It raises a series of really interesting future questions."
Califf
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Topol: 2 thumbs up for REMATCH
"I think this is an enormously difficult trial for the medical community to absorb from a financial standpoint, from an ethical standpoint." Topol
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
MADIT-II
Multicenter Automatic Defibrillator Implantation Trial II
1232 post-MI patients with moderate LV dysfunction (EF 30%) randomized to ICD or medical therapy
Arrhythmia was not an inclusion criteria
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REMATCH, MADIT-II, and pricey technology
Mortality in MADIT-II
30% total reduction of mortality
0
5
10
15
20
25
ICD
Medical therapy
Perc
en
t m
ort
ality
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Potential patient population
MADIT-II entry criteria would lead to an additional 300,000 patients for ICDs, a $9 billion market
ICDs cost $25-35,000
The only thing holding back the numbers of implants are the numbers of electrophysiologists
Topol
VENTAK PRIZM 2 ICDSource: Guidant
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Obligatory ICDs
From databases, we could identify people who are post-MI with EF <30 – should we automatically bring them in to get ICDs?
At 6 lives saved for every 100 treated, are we ethically obligated to implant no matter what?
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Cheap ICDs for everyone?
"For some patients, a sophisticated ICD that could be used to treat comorbidities and monitor a variety of physiological functions may be indicated, whereas in others, an inexpensive ICD in the $10,000 to $15,000 range might be preferable."
ZipesDr Douglas ZipesSource: Indiana University School of Medicine
Zipes DP, Circulation 2001;103:1372-4
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
SCD-HeFT
2500 patients with either ischemic heart failure or dilated cardiomyopathy in proportions of roughly 50-50, EF 35%
Randomized to 3 arms: ICD, amiodarone, or placebo
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Estimated costs of new technology
02468
1012141618
LVAD(REMATCH)
ICD(MADIT-II)
Coated stents(RAVEL)
US
dollars
(in
billion
s)
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Money
"For us, [the medical community], to be able to live in this new world… we can't do it without more subsidy, and I don't know how that's going to happen."
Topol
Bx-Velocity StentSource: Cordis
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
A culture shift
We have a culture that is aggressively unaccepting of death
That culture demands a lot of financial support
`"Otherwise we need a culture shift and an acceptance of lesser survival, lesser
quality of life. That's not something that seems to be very acceptable."
Topol
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Life-saving stents
State-of-the-art stent implantaion
•Pre-procedural dual anti-platelet
• Intra-procedural IV GP IIb/IIIa inhibition
•Coated stents to reduce repeat procedures
This is a strategy that improves survival, not just reduces restenosis
Topol
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
A new crisis
The last medical cost crisis was about medical waste, this one will be about proven benefit that is very expensive
"I think it is going to be the cardiovascular devices that will force the issue
because of the epidemic proportions of the disease in the midst of an ageing population."
Califf
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Rationing
Vice President Dick CheneySource: GWU hospital
If Cheney can get his ICD, why can't everyone?
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Califf: final thoughts
"With these expensive technologies, how are we going to fairly allocate resources?
And obviously this is going to come to the forefront in the hospitals we all work in well before healthcare policy will have caught up to where it needs to be." Califf
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Topol: final thoughts
"I don't think that [delivering high-tech strategies to patients at large] is likely to be accomplished without some redesign of how medicine is supported by our government."
Topol
Thumbs up/Thumbs down – January 2002
REMATCH, MADIT-II, and pricey technology
Bx-Velocity StentSource: Cordis
HeartMate LVADSource: Thoratec
VENTAK PRIZM 2 ICDSource: Guidant