Orlando, Fla.—The 30-day and one-year mortality rates are similar at hospitals with or without on-site cardiac surgery for STEMI patients undergoing primary PCI, based on results taken from the Mass-DAC registry presented Monday during the late-breaking clinical trials session at 2009 American Heart Association conference.
Despite the ACC/AHA guidelines recommending door-to-balloon times of 90 minutes or less, the majority of STEMI patients present to hospitals without primary PCI capability, explained lead researcher Ather Anis, a fellow from Boston University Medical Center. He added that in many states, including Massachusetts, the performance of PCI is not allowed in cardiac cath labs without cardiac surgery backup.
In 1997, the Massachusetts Department of Health approved a pilot program for primary PCI at hospitals without cardiac surgery onsite, in order to increase the number of STEMI patients with timely access to primary PCI.
In the study, researchers analyzed 3,018 patients who underwent primary PCI, including 977 treated at hospitals without surgical backup (non SOS), between January 2005 and September 2007, whose data was collected in the Massachusetts Data Analysis Center (Mass-DAC) registry.
The researchers wanted to determine whether patients fared better after having primary PCI at non SOS hospitals. They found the rate of death at 30 days and one year of follow up was no different following primary PCI at either type of facility (one year: 9.41 percent with SOS vs. 8.58 percent non SOS).
Also, they found that the non SOS hospitals had the capability of performing cardiac catheterization for diagnostic purposes, but without a cardiothoracic surgery program they would not routinely have done PCI.
In addition to all-cause mortality, the study had three additional primary endpoints, including recurrent MI, repeat revascularization and target vessel revascularization (TVR) at 30 days and one year.
Although there was no difference in TVR at 30 days and one year, researchers found more revascularizations of other coronary arteries in the non SOS group, which “could indicate more staged procedures in patients in the non SOS group with multivessel disease.”
Patients undergoing primary PCI at the non SOS hospitals had a “slightly higher incidence of recurrent heart attack at 30 days, for reasons that are unclear and will require further study,” Anis said. At one year, the recurrent MI rate was 6.66 percent at hospitals without SOS versus 5.06 percent at those with on-site cardiac surgery.
Also, there was a significant increase in the rate of repeat revascularization at 30 days and one year in the non SOS hospitals.
“Performing PCI at community hospitals without cardiac surgery onsite could increase the number of STEMI patients with timely access to this lifesaving procedure,” said Anis, who performs PCI at a hospital with SOS.
In his commentary on the trial, Robert A. Guyton, MD, chief of cardiothoracic surgery at Emory University in Atlanta, called this an “excellent analysis,” noting that “experienced operators can achieve results in non SOS hospitals that are equivalent to those in SOS hospitals.”
However, Guyton noted that this is not a study of the relative management of STEMI in PCI, adding that data were not collected on STEMI patients who did not have PCI, which he deemed “a problem.”
In examining the data from 58,821 STEMI patients enrolled in the National Registry of MI (NRMI) presenting to PCI hospitals from April 2004 to December 2006, Guyton pointed that 8.1 percent presented to non SOS hospitals. The national registry also shows that mortality was significantly higher in the non SOS hospitals (9.8 vs. 7 percent).
However, Guyton also noted that the NMRI, like the Mass-DAC registry, showed that among the STEMI patients undergoing PCI, outcomes were almost identical in non SOS and SOS hospitals.
Anis also noted that he and his colleagues are performing further analyses to assess the effects of operator volume and geographic area on clinical outcomes.
The study was funded through a contract with the Massachusetts Department of Public Health.