MASS COMM: On-site Surgical Back-up Not Necessary for Elective PCI
SAN FRANCISCO, CA—Patients undergoing non-emergency percutaneous coronary intervention (PCI) experience similar outcomes whether they are treated at hospitals that possess on-site cardiac surgery capabilities or do not offer such services. Results of the MASS COMM trial were presented March 11, 2013, at the American College of Cardiology/i2 Scientific Session and published simultaneously online in the New England Journal of Medicine.
Researchers led by Alice K. Jacobs, MD, of the Boston University School of Medicine (Boston, MA), looked at 3,691 patients who presented for elective PCI at hospitals in Massachusetts without on-site surgery capabilities between July 7, 2006, and September 29, 2011. The patients were randomized in a 3:1 fashion to undergo PCI at the initial hospital (n = 2,774) or be transferred to another with on-site surgical back-up (n = 917).
At 30 days, the primary safety endpoint of MACE (death, MI, repeat coronary revascularization, or stroke) was equivalent between the 2 groups, meeting the criteria for noninferiority. All of the component endpoints were similar, as well.
Table 1. Thirty-Day Outcomes
|
|
No On-Site Surgery |
On-Site Surgery |
P Value |
|
MACE |
9.5% |
9.4% |
< 0.001a |
|
Death |
0.7% |
0.3% |
0.39 |
|
MI |
6.5% |
6.5% |
1.00 |
|
Repeat Coronary Revascularization |
2.7% |
3.5% |
0.25 |
|
Stroke |
0.4% |
0.1% |
0.21 |
aP for noninferiority.
The primary effectiveness endpoint of 12-month MACE was also equivalent between groups, achieving nonferiority for PCI without compared to with on-site surgery (table 2).
Table 2. One-Year Outcomes
|
|
No On-Site Surgery |
On-Site Surgery |
P Value |
|
MACE |
17.3% |
17.8% |
< 0.001a |
|
Death |
2.3% |
2.4% |
0.89 |
|
MI |
8.6% |
7.8% |
0.55 |
|
Repeat Coronary Revascularization |
8.5% |
9.9% |
0.24 |
|
Stroke |
1.0% |
0.8% |
0.83 |
aP for noninferiority.
Emergency CABG as well as emergency or urgent PCI at 30 days were similar between groups, as was ischemia-driven TVR at 30 days and 1 year. Stent thrombosis was equivalent at 30 days, but showed a trend for lower incidence at hospitals without on-site surgery at 1 year (1.1% vs. 2.1%; P = 0.07).
Adjustment for between-hospital variation in MACE incidence did not alter the overall results, which remained consistent on the as-treated analysis.
In 376 patients randomly selected for angiographic review, there were no differences between the 2 groups in terms of procedural success or complete revascularization. Results were the same on the as-treated analysis.
“These data now add to the growing body of evidence . . . which showed favorable outcomes among patients undergoing elective or nonemergency PCI at hospitals without on-site cardiac surgery,” the authors write in the NEJM paper.
Expansion of PCI, but Some Drawbacks
There are a number of reasons, they add, to support expansion of non-emergency PCI to hospitals without on-site surgery. These include wider patient choice in hospitals and additional support for active primary PCI programs due to added volume of procedures at centers without on-site surgical back-up.
However, without a cardiac surgical team on-site, the widely supported “heart team approach” is not possible, which could represent a drawback in terms of discussing revascularization strategies for patients with complex multivessel disease, as is recommended by PCI guidelines.
Nevertheless, “These data suggest that performance of PCI at hospitals without on-site cardiac surgery but with established programs and requisite hospital and operator procedural volume, may be considered an acceptable option for patients presenting to such hospitals for care,” Dr. Jacobs said.
She added that it is important to consider what the study did and did not address. “MASS COMM really didn’t compare all PCI at hospitals without on-site surgery to hospitals with on-site surgery,” she said. “It really evaluated a transfer strategy so that if you present [for elective PCI] to a hospital without on-site cardiac surgery, it’s safe and effective to have your procedure there.”
Strict Requirements Necessary
Panel member Christopher P. Cannon, MD, of Brigham and Women’s Hospital (Boston, MA), observed that “the translation of this study is really if you’re going to do this, you have to dedicate and create a high-level program at the community hospital.”
Dr. Jacobs agreed, noting that there were extensive criteria for participating in the study.
“You have to have a program with strict requirements, and you have to ascertain that people have met those requirements,” commented panel co-chair Neal S. Kleiman, MD, of Methodist DeBakey Heart and Vascular Center (Houston, TX). “It’s not just a case of ordering some stents and guiding catheters.”
Panel member James B. McClurken, MD, of Temple University School of Medicine (Philadelphia, PA), gave an example of the steps required to assure quality care in such a program. “Having lived through this in Pennsylvania in a demonstration project at Temple, we mandated stress test drills for the hospitals without surgery on site without knowledge of the receiving hospital in the middle of the day when the OR was full,” he said.
Study Details
Hospitals without on-site cardiac surgery were required to have performed a minimum of 300 diagnostic cardiac cath procedures per year and to have an ongoing program to support primary PCI. All operators were required to have performed a minimum of 75 PCI procedures per year.
Source:
Jacobs AK, Normand SLT, Masaro JM, et al. Nonemergency PCI at hospitals with or without on-site cardiac surgery. N Engl J Med. 2013;Epub ahead of print.
Disclosures:
- The study was funded by Massachusetts Hospitals without on-site cardiac surgery.
- Dr. Jacobs reports no relevant conflicts of interest.
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