Here’s a great example of genuine medical progress: 10% of the first 50 patients who received balloon angioplasty from the developer of the procedure, Andreas Grüntzig, required emergency bypass surgery. By 2002 only 0.15% of PCI patients required emergency surgery, leading many to believe that surgical backup was no longer necessary.
Now a large new study provides strong evidence that PCI can in fact be performed safely and effectively at hospitals without surgical backup. In a presentation at the American College of Cardiology and published simultaneously in the New England Journal of Medicine. Thomas Aversano and colleagues in the Cardiovascular Patient Outcomes Research Team (C-PORT) report the results of a trial that randomized 18,867 patients to undergo PCI at hospitals with or without surgical backup.
- 6 week mortality was 0.9% at hospitals without surgical backup versus 1% at hospitals with surgical backup, which was well within the predefined margin of noninferiority of a 0.4% difference in risk (p=0.004).
- The 9-month composite rate of death, Q-wave MI, or target-vessel revascularization was 12.1% and 11.2%, which met the predefined margin of noninferiority of a 1.8% difference in risk (p=0.05).
The authors noted that high risk patients were excluded from the study, raising the possibility that the study population may differ from the general PCI population.
“The study shows that under certain circumstances, non-primary angioplasty can be performed safely and effectively at hospitals without on-site cardiac surgery,” said Aversano, in an ACC press release.
At an ACC press conference, Aversano discussed the potential impact of the study and warned against interpreting the study as an open invitation to implement PCI without surgical backup:
It doesn’t say you ought to go out and do this and expand it willy nilly, that was not the purpose of this project… These hospitals did not simply buy stents and start doing angioplasty. They went through a formal development program.