November 29th, 2009
Return to POBA?
Harlan M. Krumholz, MD, SM
We almost never do plain old balloon angioplasty in our place anymore. To many, that technique seems so last century. We have moved on to better procedures that have made restenosis a relatively rare occurrence.
We have even changed the name of the procedure. If an intern on rounds utters the word “angioplasty,” we quickly correct him or her, using the opportunity to teach the meaning of “percutaneous coronary intervention.” Angioplasty, we say, derives from Greek words meaning “molding of the vessel” — whereas PCI involves more than molding, often the implantation of a stent.
The problem with stenting is that we have exchanged a higher risk of restenosis, an annoying but generally non-life-threatening event, for a lower risk of stent thrombosis, an often abrupt, often catastrophic closure of the vessel that can result in AMI and death. The stent thrombosis risk can be mitigated with dual antiplatelet therapy — aspirin and a thienopyridine — but only if the patient can purchase the pills and take them.
During the last two weeks, experiences with several of my patients who received stents for the treatment of AMI had me reflecting on our progress. As their hospitalizations came to a close, it became clear that they could not afford clopidogrel and had few options. The price of the antiplatelet drugs, in addition to the other medications their care required, represented a heavy burden for these individuals. Pharmaceutical company assistance programs require at least a month and a lot of paperwork. And cost is not the only problem; some of my patients have developed contraindications to dual antiplatelet therapy during hospitalization, putting them in an especially difficult position.
I know that one of my patients, despite all pleading and efforts to make the pills affordable, will almost certainly not buy and take them. He is an undocumented resident who has lived in our area for 14 years. He occasionally finds work as a painter and has a loving family and many friends. He has a warm smile, even though he has just survived a devastating MI with many complications — including a retroperitoneal bleed requiring multiple transfusions — which only makes our discharge instructions more difficult to give.
Would he have been better off with a POBA and the risk of restenosis? If so, could we have known that in advance?
I worry that for some patients, we have set up a dangerous situation in our attempts to do good and provide the most advanced care.
“The downside” of stenting
Harlan, you raise an excellent concern about a potential “downside” of coronary stenting. In my experience – most of it spent at a large municipal hospital caring for indigent patients – the cost of clopidogrel (roughly $4 per day) is prohibitive; many of our patients simply can’t afford it. In addition, we commonly were asked to intervene on patients with cocaine-associated ACS. I was reluctant to implant a stent, with its obligate need for dual antiplatelet therapy, in known drug abusers (feeling that they were unlikely to afford or to take their clopidogrel reliably).
Apart from these issues, we have now trained a generation of interventional cardiologists with very limited experience in performing POBA; they are experienced only with stenting. With POBA, a post-procedural 25-30% residual stenosis, with some intraluminal haziness, is considered to be a good result; with stenting, it is thought to be unacceptable! In short, in my experience, it is difficult (nee, usually impossible) to convince a young interventionalist to declare the procedure “a success” when the post-procedural angiogram shows such a residual stenosis.
Harlan, I agree that in replacing POBA with stents we’ve traded an inconvenient complication (e.g., restenosis) for a more serious complication (e.g., acute thrombosis), with the latter more likely to occur when the patient doesn’t take dual antiplatelet therapy. Affordability and compliance are not trivial issues with clopidogrel. Rarely does the interventionalist question the patient about whether he or she can afford clopidogrel and is willing to take it for 12 months or longer. Unfortunately, once the stent’s been placed, “the cow is out of the barn.”
Initially stenting was used for the rare person who had acute closure following POBA. Now stenting is performed in >90% of PCIs in the US. Truthfully, I can’t remember the last time I referred a patient for PCI who received a POBA. Interestingly, when POBA was the only percutaneous revascularization available, the vast majority of patients with restenosis had an excellent short and long-term result with repeat POBA.
Of course, the alternative to a PCI rather than POBA first strategy would mean too often relying on the interventionalist’s “eyeball” assessment of whether the patient is a candidate for dual antiplatelet therapy or not. While the active drug abuser is an easy one, few cases are as clear cut as that, especially in an emergency. I’m not comfortable putting cardiologists by themselves in a position to make these judgments (not to mention the similar situation of choosing DES vs BMS, which is likely more common than PCI vs POBA). As a cynic, I don’t trust most of us and wish we had better standards for making these complex decisions.
“Great Expectations”
Carl points out that “Great Expectations” are placed on interventional cardiologists that are often unmet. We’re expected to intervene emergently, know best practices, be experlty skilled, apply treatment without “marketing bias” (POBA vs BMS vs DES; pharmacologic agents), assess the complication risk from the procedure and antiplatelet/antithrombotic therapy and — by the way — have insight into the patient’s medication preferences and affordability……in the midst of the patient’s acute MI. It’s amazing that in-hospital mortality is ~5% in these patients.
Maybe, we’ve to reassess POBA outcomes and more attentively analise stenting(BMS, or DES )benefits and risks? If in western countries dual antiplatelet therapy is considered expensive, what to say about my patients in Georgia, postsoviet country with a lot of problems?
Competing interests pertaining specifically to this post, comment, or both:
NONE