Wednesday, September 06, 2006

The Furor Grows: Stent with or Without Drug?

MedPageToday does a good job of balanced reporting on this issue. My feeling is that there are clear times when drug elluting stents are of value: when patients can take aspirin and clopidogrel (Plavix). If the patient is looking at surgery soon (knee replacement/hip replacement, etc.), then bare metal stents might be best.

We'll have to wait for more trials....

But it DOES appear clear that it is prudent to continue anti-platelet therapy after stenting for AT LEAST a year. I think our guys are continuing it indefinitely, if its tolerated.

--Wes

3 comments:

Kannan said...

I'd love to look at that meta-analysis. Have you come across any further details from that paper? In my experience, late in-stent thrombosis is not really a big problem, but then this could be biased: since this is such a catastrophic event, the patient might not make it to the hospital...

DrWes said...

Kannan-
Here's an excerpt on the issues from TheHeart.org:

The ongoing debate over the indications and safety of drug-eluting stents (DES) here at the World Congress of Cardiology 2006 has splintered in two separate but related issues: the first, whether DES are overused in certain patient subsets, and second, whether increased late stent thrombosis—as reported in several recent studies—is putting real-world patients at risk.
In a scheduled debate on day three of the meeting, Dr Salim Yusuf (McMaster University, Hamilton, ON) faced off against Dr Patrick Serruys (Erasmus University Hospital, Rotterdam, the Netherlands) on the question of whether DES improve cost efficacy and outcomes in stable chronic angina. Delivering the same impassioned arguments he'd offered earlier in the meeting, Yusuf suggested that eager interventionalists were succumbing to a "Tarzan" complex, needing to rescue their stable angina patients—and pad their bank accounts—despite no proven long-term benefits of doing so.

But Serruys, first showing historical data on angioplasty and bare-metal stents vs medical therapy and CABG, then the newer registry data pointing to at least equivalent outcomes with drug-eluting stents and CABG, argued that emerging evidence supports a potential benefit of DES. Chronic total occlusion patients in particular may experience reductions in hard clinical end points, including mortality, he said.

Serruys, however, steered largely clear of the topic Yusuf has been hammering at this meeting: inappropriate use of PCI/DES in stable patients who could be managed medically. Indeed, during their arguments, both men relied on trial data that looked at all-comers, and not specifically patients with chronic stable angina. Conspicuously, almost all of the studies cited by both debaters were, in the words of one observer, "so old as to be irrelevant."

What Serruys did acknowledge was the second issue: the signal of increased mortality and MI risk with drug-eluting stents over time, citing the data reported by Wenaweser and colleagues earlier this week. As reported by heartwire, Wenaweser's cohort analysis demonstrated an increased risk of late stent thrombosis in Taxus- and Cypher-treated patients in registries from Bern and Rotterdam.

"I was one of the ones, with the group in Bern, who has embraced [DES] technology, so we are in the position today, after putting in DES for three years in all-comers, to report what the industry and registries cannot report, and that is the fact that, yes, there is an incidence of 0.6% of late stent thrombosis per year," Serruys said.

Yusuf, for his part, repeatedly called for a reevaluation of how PCI and DES are employed in practice, calling them "inappropriately overused," leading to "inferior patient management at high costs."

"This is a humble plea to Patrick, to the ESC, and to most of you: let us work together," Yusuf said. "There is an inappropriate epidemic of PCI for stable CAD. This is not a debate; this is heartfelt and genuine. It's putting a huge drain on our resources; worse, it perverts cardiology. Our patients are misinformed, our trainees are misinformed, and there are distorted financial incentives."

The session moderator, speaking with heartwire after the debate, appeared to side with Yusuf.

"Many patients are getting procedures due to the fact that they are studied by interventional cardiologists who are willing to expand the arteries, but they are not so much concerned with outcomes over the long term," Dr Ramón Corbalán (Catholic University of Chile, Santiago) stated. "So every time they have a new device or drug, they want to use it, and I think a high proportion of patients are getting unnecessary procedures. If we were stricter about the use of these procedures, we would use these devices for patients who are symptomatic and have one- or two-vessel disease. If they have three-vessel disease, CABG is far better in terms of long-term prognosis and relief of symptoms."
You can read more about this here. (Registration required). In fact, the best review of the discussion I can find so far is at TheHeart.org as these data have yet to be peer-reviewed.

Jan said...

From the MedPageToday article:
Dr. Antman advised physicians to make sure that patients have completed a year of dual antiplatelet therapy. "If patients stopped the regimen short of a year, they should be restarted until they have accumulated 12 months of dual antiplatelet therapy."

This does not make much sense to me if the patient has completed at least 6 mos of dual therapy. What is probably more important is making sure that they don't stop ASA. Especially for elective procedures. I frequently had pt's being told to hold their anti-plt meds prior to EGD/colonoscopy etc. Raised this issue at a staff meeting and the GI docs now tell pts to talk with cardiology prior to holding their meds.

Cared for one patient who completed a year of dual tx, then he got lax with his ASA - missed about a week and had thrombosis of his RCA/PDA bifurcation (site of prior trouser stents), ended up with an IWMI.
So even a year of dual tx does not ensure SAT won't occur.

CardioNP