Durham, NC - Two-year "real-world" follow-up of patients undergoing coronary stenting has shown that those treated with drug-eluting stents (DES) have lower target-vessel revascularization (TVR) rates than those treated with bare-metal stents, but the absolute benefit is less than observed in clinical trials [1].
"Our results from a community practice setting serve to support, although at a diminished levels, the TVR benefits reported for clinical trials of DES vs bare-metal stents but also suggest a higher risk of death for both types of stents than found in clinical trials," write lead author Dr Kevin Anstrom (Duke Clinical Research Institute, Durham, NC) and colleagues in the August 11/25, 2008 issue of the Archives of Internal Medicine. "Our two-year follow-up period extends well beyond the time horizon of most clinical trials, and our results demonstrate the sustainability of the reduction in TVR."
The long-term study followed patients, including those with multivessel disease and diabetes mellitus, from the Duke Databank for Cardiovascular Disease who underwent revascularization with DES or bare-metal stent from 2000 to 2005. At two years, there was no difference in the rates of death and MI between patients treated with bare-metal stent or DES, but there was a significant difference in the rate of TVR, favoring the DES, a benefit that included patients with diabetes mellitus.
Adjusted outcomes for bare-metal stents vs DES
Outcome
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Bare-metal stent, n=2817 (%)
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DES, n=604 (%)
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Difference (DES vs bare-metal stent)
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p
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Death
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8.6
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8.6
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0.1
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0.94
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Nonfatal MI
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4.8
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3.3
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-1.5
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0.02
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TVR
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16.3
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6.6
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-9.7
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<0.001
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Any revascularization
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20.1
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12.0
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-8.1
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<0.001
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Revascularization other than TVR
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8.3
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7.4
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-0.9
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0.34
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Death/TVR
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24.2
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14.6
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-9.5
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<0.001
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Death/MI
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12.9
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11.2
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-1.7
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0.16
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Death/MI/TVR
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25.6
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16.2
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-9.4
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<0.001
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To download table as a slide, click on slide logo above
The Duke investigators point out the death and MI findings agree with a pooled analysis by Dr Gregg Stone (Columbia University, New York) et al, a study that showed that the rates of death or MI did not differ significantly between the DES- and bare-metal-stent-treated patients in more than 5000 patients in nine randomized trials [2]. The group notes, however, that the risk of mortality at one year—6.4% for DES and 5.4% for bare-metal stent—was higher than observed in previous clinical trials.
The investigators also observed a benefit in patients treated for multivessel disease. "Although the current FDA-approved indication for DES is limited to discrete, de novo lesions in native vessels with reference vessel diameters of 2.5 to 3.5 mm, our results indicate that the target-vessel revascularization benefits associated with DES vs bare-metal stent occur in patients with one-, two-, and three-vessel coronary artery disease and are greater in patients with multivessel disease vs those with single-vessel disease," write Anstrom and colleagues.
Anstrom has received research and salary support from Alexion, AstraZeneca, Bristol-Myers Squibb, Lilly, Eyetech, Innocoll Pharmaceuticals, Medtronic, Medtronic Vascular, Pacific Therapeutics, Pfizer, and Proctor & Gamble.
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Sources
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Anstrom KJ, Kong DF, Shaw LK, et al. Long-term clinical outcomes following coronary stenting. Arch Intern Med 2008; 168:1647-1655.
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Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007; 356:998-1008.
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August 19, 2008 07:26 (EDT)
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This study does not negate the need for careful patient selection
To date my DES patients include:
1. known brain tumour which delayed bx
2. pt on study protocol for multiple myeloma that requires bone marrow bx and aspiration q3-6 months.
3. anemics
4. pt. with known bladder cancer with high risk of recurrence
5.those who obviously cannot afford clopedigrel
6. noncompliant patients with poor follow up
7. lung nodule patient facing bronch/bx
8. patient facing knee replacement
9. patient facing major abdominal surgery
I think we're getting better at stent selection now that the DES feeding frenzy is over and we've settled into the real world practical utilization of these entities, but it really bites when we have to delay services that could cost patient life years due to poor stent selection.
Melissa |
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August 25, 2008 12:59 (EDT)
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DES vs BMS
It would be educative to understand why the DES group had fewer nonfatal MI's( albeit insignificantly).We all know that ST is more in DES.
Also, what was that the nature of the need and methodsemployed to tackle TVR in both groups of patients.
And Mellisa comments, "To date my DES patients's include"....... should the word not be 'exclude.' |
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August 25, 2008 06:37 (EDT)
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Careful selection a must
Deepak,
Unfortunately no. These are actually patients who have had a DES by various implanters.
History, History, History.
Melissa |
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August 26, 2008 07:00 (EDT)
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The big question is..
If DES implants have more patent vessel(all data said the same thing), why don't they live longer than patients receiving BMS(less patient died) and the results of myocardial infarct attacks are marginal better or equal to bare metal stents? The data said one thing clear: DES has only TVR advantages but not MI or death rate. Something is very wrong here. |
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September 5, 2008 01:10 (EDT)
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apples and oranges
It is interesting to study the DES data in this regard: The "landmark" DES trials compared Cypher and Taxus to Velocity and Express II. In the past 5 years, who has implanted one of these bare metal stents? The answer is, of course, no one. The Endeavor and Spirit trials compared these stents to Taxus, with the goal that these new SDS platforms need only to achieve "noninferiority" to Taxus to gain FDA approval. Whant really needs to take place is a study of Xience(Promus) and Endeavor to the "best" BMS(probably Vision, based on TVR rates, but who's going to fund this one? Abbott? Medtronic? BSC? Cordis/ No way. They make much more by sugar coating stents and will continue to do so. BTW, how do you handle a DES ISR? It is admittedly difficult. My patients are getting Vision stents most often, and Xience/Promus for the rare occasion that I think a DES is the correct first line option. I've been saying this for years, but only recently has anyone agreed with me. Melissa, your "registry" is truly a real world experience. Patient selection is absolutely the key in DES utilization. I wonder if we are going to figure out that the only folks to really benefit from the DES "revolution" are our "friends" at Abbott, BSC, and Cordis. |
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September 6, 2008 06:44 (EDT)
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Good to hear from you William R.
William,
Good to hear from you. And, our practice mirrors your experience. My interventionalist utilizes Vision stents and very few DES (we're a primary pci hospital, so no non-STEMI's unless ongoing pain/ST changes).
And, I agree with you. Though not always the case, I do get so fatigued of randomized trials that are "randomized" with the deck stacked, yet everyone is smiling and nodding their heads as if this represents the norm.
Sometimes I think while I'm in press conferences that some of these trials would make a fantastic story for a John Grisham novel, only he'd have to switch to the NON-fiction shelf.
Melissa |
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