Elective PCI Doesn't Require Surgical Backup: C-PORT E

November 15, 2011

November 14, 2011 (Orlando, Florida) — Patients who had elective PCI at experienced US hospitals without on-site cardiac surgery fared no worse than those who had the same procedure at institutions with surgical backup, a new study shows.

The mortality rate after six weeks was almost the same for each group, at just under 1%, said Dr Thomas Aversano (Johns Hopkins Medical Institute, Baltimore, MD), who presented the findings of the Cardiovascular Patient Outcomes Research Team Elective (C-PORT E) study during a late-breaking clinical trial session here today at the American Heart Association (AHA) 2011 Scientific Sessions.

"The key finding is that the patient-related medical outcomes, at least the short-term safety outcomes, of elective angioplasty are the same, regardless of the hospital type," Aversano told heartwire . He added that his team will have data on how patients fared nine months after the procedure early next year. And he stressed: "The purpose of the trial was not to expand the number of centers doing angioplasty but to give healthcare policy makers--who can make rational decisions about access, quality, and cost of angioplasty care in their state--some information on which to base their decision."

The purpose of the trial was not to expand the number of centers doing angioplasty but to give healthcare policy makers some information.

The discussant of the findings, surgeon Dr Loren F Hiratzka (Bethesda North and Good Samaritan Hospitals, Cincinnati, OH), said the results are important, but it has to be borne in mind that very specific conditions were in place in this study. He and others warned that there could be "unintended consequences" of moving elective PCI out into the community. "The real central question is, 'Can these results be reproduced in general community practice?' " noted Hiratzka.

Speaking during the press briefing, Dr Robert Harrington (Duke Clinical Research Institute, Durham, NC) agreed: "The issue of unintended consequences is worth pausing on. In the angioplasty world, the American College of Cardiology (ACC)/AHA recommendations recommend 75 cases a year as the minimum volume. There are states in this country where the median volume for an interventional cardiologist is 50 cases a year. We need to ask ourselves, is that really what we want?

The real central question is, 'Can these results be reproduced in general community practice?'

"What we need to insist upon as we embark upon broadening the use of these procedures in the community is that all those steps [employed in C-PORT E] don't get forgotten in the zeal. This is an incredibly important topic that has both medical-care and policy implications attached to it."

Guidelines Committee Will Consider the Evidence

Asked by heartwire to comment on the C-PORT E data, Dr Alice Jacobs (Boston, MA)--who is the principal investigator of a very similar ongoing trial called MASSCOMM--said: "I think this is an important study. The practice across the country--absent data--is moving toward performing nonemergency PCI in hospitals without on-site surgery. Now we have the evidence."

"If you can show that you provide the same outcomes and do it in the fashion that C-PORT E is doing it--which is high-volume physicians, well-trained staff, specific criteria about things that you should tackle and you shouldn't tackle without on-site surgery--and if it appears to be safe, for which we'll wait for Dr Aversano's long-term outcomes and the MASSCOMM study, then I think the guidelines committees will consider the evidence."

She added that the new ACCF/AHA guidelines on PCI and CABG, released only last week, did update the recommendations on elective PCI without on-site surgery, which "is now class IIb from a class III recommendation, which means it's reasonable to consider it."

New studies such as C-PORT E will be considered on a case-by-case basis to see if they warrant updating the recommendations, she noted.

However, she too cautioned that many things need to be taken into consideration when looking at this issue. "It's not the focus on having on-site surgery available in 2011, because the emergency surgery rate is very low. What on-site surgery has represented in the past is a surrogate for volume and quality. If you have a patient with complex disease, it's taking that step back and calling the surgeons to the cath lab and getting that combined opinion, which is critically important."

Another issue that hasn't been addressed, she says, is, "How will we maintain the volume in tertiary sites to train our young interventionalists when the care moves into the community?"

C-PORT E Details

Aversano said one of the motivating factors for conducting the trial was that, as more and more centers have started to perform primary PCI for ST-elevation myocardial infarction (STEMI) without cardiac surgery backup, they have discovered that sustaining the volume of patients required to keep a program viable is difficult, so they have started to add elective PCIs.

In the C-PORT E trial, more than 18 500 patients were randomized on a 3:1 basis to PCI centers with cardiac-surgery capabilities or hospitals without surgical backup. The 60 institutions without surgery capabilities had to be able to perform at least 200 PCIs per year, although a "startup" figure of 100 was allowed in the first year, he noted, with a median of 150 annual procedures.

In a panel discussion that followed his presentation, he noted that some hospitals had been asked to leave the study because they had not performed enough procedures, but he did not yet have data on outcomes from those institutions.

The interventionalists in the study were required to perform more than 75 PCI cases per year, and all centers underwent a formally developed PCI program.

Mortality at six weeks was 0.93% in the surgical-backup group, compared with 0.91% in the no-surgical-backup group (p=0.94).

PCI success was >90% in both groups but lower in those randomized to hospitals without surgery on-site (success rate difference of 1.1% on a per patient basis). Emergency CABG was rare but occurred more frequently in those randomized to hospitals with surgery on-site compared with those with no surgical backup (0.2% vs 0.1%). The incidence of bleeding, vascular repair, stroke, and renal failure was similar in both groups.

Access vs Convenience; Should States Limit the Number of PCI Centers?

During a panel discussion following his presentation, Aversano was asked whether PCI centers had to be a certain distance from a tertiary centers as a study requirement. This was the case in some states, but not others, he said.

Dr Eric Peterson (Duke Clinical Research Institute, Durham, NC) wondered whether there should be a requirement that, if there is a program close by, "we would not institute another program," as his colleague Dr Manesh Patel (Duke Clinical Research Institute), observed that, "in some cities and places, there are 30 or 40 centers performing PCI that are not that far apart."

In some cities and places, there are 30 or 40 centers performing PCI that are not that far apart.

"Yes, I completely agree," noted Aversano. He added that one of the main reasons for doing this study was that "the colocation" requirement, whereby it is recommended that PCI centers are backed up by surgical facilities, "tends to spur on a kind of metastases of surgical programs just to back up angioplasty. So if there is evidence that we can separate them, it doesn't mean having more angioplasty programs, it means they don't have to be colocated necessarily."

Hiratzka, the surgeon, commented: "It clearly is an issue going forward. As a patient, is it better to take the 20-minute trip to a place that has surgery or a 10-minute trip to a place that does not, provided you can provide the same level of service for PCI in both?"

Aversano noted: "I want to dispel this 'convenience myth,' because it sort of irks me a little bit. There is an access issue, not just a convenience issue, especially for those in more rural areas. They are not 20 minutes away [from big tertiary centers], they are an hour or an hour and a half away. That's the big town, with doctors they don't know, at a great cost to their family when they have to come to visit them. There are a lot of factors that go into making that decision about where they want to go."

I want to dispel this 'convenience myth,' because it sort of irks me a little bit. There is an access issue, not just a convenience issue.

Jacobs agreed: "There are multiple motivations for moving care into community hospitals. A lot of it is not necessarily access to care but convenience of care, and that's important as well."

Peterson said another unintended outcome might derive from the volume question, "which might have the unexpected consequence of driving more procedures to be done, maybe in cases where the appropriateness is borderline, just in order to reach the volume targets."

Aversano agreed: "My hope in this study was to create information that would be used by regulators to inform those decisions. It's up to the policy makers to decide in the end."

Hiratzka declared no conflicts of interest.