Massachusetts Data Show Similar STEMI PCI Outcomes in Hospitals With or Without Surgery

Reed Miller

November 16, 2009

November 16, 2009 (Orlando, Florida) — Registry data show that hospitals without surgery on-site achieve similar results to surgery-on-site (SOS) hospitals in primary coronary intervention of patients with ST-elevated MI (STEMI).

The results from 3018 patients treated for STEMI in Massachusetts hospitals from 2005 to 2007 in the Massachusetts Data Analysis Center (MASS-DAC) database were presented by Dr Ather Anis (Boston University Medical Center, MA) on November 16 during a late-breaking clinical-trials session here at the American Heart Association 2009 Scientific Sessions.

The study compared the outcomes of patients treated at SOS and non-SOS hospitals with propensity-score matching accounting for demographic, clinical, and angiographic variables. There was no difference between the patients treated at the non-SOS and SOS according to outcomes for death and MI either at 30 days or one year.

The only significantly different outcome was that the non-SOS centers had a higher rate of repeat revascularization within one year. Anis said the investigators believe the non-SOS centers were more likely to treat patients with planned staged PCI procedures following the initial treatment for STEMI.

Commenting on the study, surgeon Dr Robert Guyton (Emory School of Medicine, Atlanta, GA) said called the Massachusetts registry study an "excellent analysis of outcomes" and that it confirms that "experienced PCI operators can achieve results in non-SOS hospitals that are equivalent to those in SOS hospitals in the patients they choose for PCI. However, this is not a study of the relative management of STEMI in PCI-empowered hospitals with or without surgery on-site, because data were not collected in STEMI patients who did not have PCI.

"What patients in Massachusetts want to know is, 'What is my outcome if I am taken with STEMI to a hospital without surgery on-site vs my outcome if I am taken to a hospital with surgery on-site?' "

He noted that a retrospective study from 58 821 STEMI patients in the National Registry of Myocardial Infarction (NRMI) registry comparing PCI in SOS and non-SOS hospitals was recently published in Circulation: CV Quality and Outcomes [1]. That study found that STEMI patients treated with PCI at non-SOS hospitals have substantially higher mortality, are less likely to receive guideline-recommended medications within 24 hours, and are less likely to undergo acute reperfusion therapy; however, the difference in outcomes is almost attenuated after adjustment for hospital and treatment variables; and there was no difference in mortality among patients undergoing primary PCI. As reported in heartwire , a similar comparison of non-SOS- and SOS-center outcomes in NSTEMI patients in NRMI found that non-SOS centers' PCI outcomes appeared to be comparable to SOS centers when differences in medical therapy and other quality measures were adjusted for.

Is It Time to Bring PCI for STEMI to the Masses?

Dr Ken Rosenfield (Massachusetts General Hospital, Boston) told heartwire that the MASS-DAC study highlights the characteristics a non-SOS center must have to be a high-quality PCI center.

The first is appropriate selection of patients, he explained. In the trial at the non-SOS hospitals, "there is a definite population that was siphoned off and deemed to be too high risk, too ill, or in some other way unsuitable to be done at the local facility."

The second key component is ensuring that PCI operators are well-trained and can maintain their skills. "Massachusetts is a highly regulated environment and very academically oriented. The operators in the state of Massachusetts represent a very top-notch group. Even the most private of them are extraordinarily well-trained and are all board certified in interventional cardiology, and they all do a reasonable volume of cases and they do them, importantly, with tertiary centers which they are affiliated.

"So on an ongoing basis, they're getting continuing mentoring and continuing mentoring at a high level, and that makes a difference; it makes them better at case selection and makes them perform better when they're in the case."

Anis pointed out that in many states, PCI in hospitals without surgical backup is restricted. Current professional guidelines classify PCI with no on-site cardiac surgery as not recommended. But "there is more and more evidence on this topic that seems to be gaining more steam now. We hope that once this is published, it will add to the evidence that is out there that it is something for the ACC/AHA guidelines committee to review and assess whether it's time to change the recommendations."

We didn't want to just let people do community angioplasty in the state. There was a great perception that that would have very negative effects . . . much more far-reaching than a bad outcome here and there.

Since 1997, Massachusetts has authorized a number of centers without surgery on-site to perform PCI in STEMI patients, Rosenfield said, and so far Massachusetts has resisted the pressure to allow PCI to spread widely.

Currently, the Massachusetts Department of Health is overseeing the MASS-COMM study, a prospective, multicenter, nested, randomized controlled two-arm trial of PCI performed at non-SOS hospitals vs PCI performed at SOS hospitals. The trial is planning for 4800 eligible subjects who will be "randomized on the table" in a 3:1 ratio at the non-SOS hospitals for PCI to be performed at that non-SOS hospital or for the patient to be referred to an SOS center.

Rosenfield explained that cardiologists in Massachusetts elected to launch MASS-COMM "because we didn't want to let the cat out of the bag. We didn't want to just let people do community angioplasty in the state. There was a great perception that that would have very negative effects in the state that are much more far-reaching than a bad outcome here and there. There are implications of migration of angioplasty to the community without control, without oversight; and equally important, it's the effect it would have on medical education. All of the people that we're training to do angioplasty would no longer have access to many cases, and at the end of the day we'd be sending people out who were poorly trained without any oversight, and they'd never have to come back to a tertiary facility for quality assurance [QA]. They'd be responsible for their own QA, and that's a problem. You need to have a certain amount of oversight in these programs."


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