Noncardiac Surgery May Be Safe Earlier After PCI Than Previously Thought
Data from a large Danish registry appear reassuring for those headed for the operating room within months of a DES.
Despite guideline recommendations to avoid surgery for six months to a year after coronary artery stenting with a DES, the majority of patients are no more likely to die or suffer an MI than patients without heart disease as long as 30 days has passed. If a new Danish registry study is any indication, many physicians are clearly ignoring the guidelines anyway.
The researchers, led by Gro Egholm, MD, PhD (Aarhus University Hospital, Aarhus, Denmark), drew their cohort from all patients who underwent PCI in western Denmark between 2005 and 2012 and received a DES (first- or second-generation device). Of those, 4,303 required noncardiac surgery within a year and were compared with a control group of over 20,000 people undergoing similar surgical procedures, but who did not have ischemic heart disease.
Compared with controls, PCI patients had a greater risk of MI (OR 4.82; 95% CI 3.25-7.16) and cardiac death (OR 5.87; 95% CI: 3.60-9.58), but only when surgery was performed within 30 days after PCI. All-cause mortality, however, was not different at 30 days. From 2 months to 1 year after PCI, no differences in any of the outcomes were seen between patients and controls. In all, 34% of all surgeries were performed within the first 3 months after index PCI, 25% at > 3 to 6 months, 21% at > 6 to 9 months, and 20% at > 9 to 12 months.
A Common Problem
Current US guidelines issued earlier this year recommend delaying elective noncardiac surgery for 12 months after PCI with a DES, unless the risk associated with delay is considered larger than the risk of stent thrombosis. The European guidelines are less rigid, recommending a delay of 6 to 12 months after PCI in patients with stable CAD and 12 months in those with ACS.
“Our results suggest that surgery after DES-PCI might be performed earlier without increased risk,” Egholm and colleagues write in the December 20, 2016 issue of the Journal of the American College of Cardiology.
Interestingly, the researchers also showed an early hazard of surgery even in the controls without ischemic heart disease, suggesting that it may be more likely related to the type and urgency of surgery, rather than risks of a recent PCI alone.
In an accompanying editorial, Christian Spaulding, MD, PhD (European Hospital Georges Pompidou, Paris, France), and Marco G. Mennuni, MD (Humanitas Research Hospital, Milan, Italy), note that the problem of how to manage patients who need surgery within a year of PCI with DES is a common one that occurs in up to one-third of all patients. The decision, they add, is most often made on a case-by-case basis, with cardiologists, anesthesiologists, and surgeons all weighing in. According to Spaulding and Mennuni, the current study builds on data from the PARIS registry, showing that physician-guided interruption of DAPT for less than 14 days may be safe in terms of thrombotic events if surgery cannot be delayed long after PCI.
Weak Evidence to Support Delay
“I think this paper moves the needle towards being more liberal about sending patients for surgery in the first year after drug-eluting stents,” Harold L. Dauerman, MD (University of Vermont, Burlington, VT), who was not affiliated with the study, told TCTMD. He added that the guideline recommendations “are not necessarily fully supported by the data” and that evidence is weak and becoming weaker with regard to the need for delaying surgery beyond 30 days.
“We used to feel firmly that a bare metal stent made a difference compared to a drug-eluting stent in the timing of noncardiac surgery, but that also hasn’t been borne out in any of the last few registry studies,” he commented. “On a practical level, if you’re thinking that someone needs their gallbladder out in 2 to 3 months, there probably is no indication to put a bare-metal stent in, and there is probably no reason to delay that surgery 6 to 12 months.”
Dauerman said one of the most striking aspects of the Danish registry is how it reflects “that physicians are by necessity, or by intention, ignoring the guidelines anyway.” The fact that over 50% of the surgeries in the registry were performed within 6 months of DES placement suggests urgency rather than refusal to follow guidelines, he added.
“I think the guidelines probably need to change to be more reflective of the lack of firm data [demonstrating] that there is a hazard by going to the operating room in the first year,” Dauerman observed.
One of the strengths of the Danish registry study, he added, is that its comparison group was patients with nonischemic heart disease rather than patients with stents who were a year or two out from DES. “Patients who can wait two years for surgery are very different from patients who need surgery three weeks after their stent,” he said. Dauerman also noted that “the genius of this study is that it includes every patient in western Denmark,” with no exclusions. “So when we look at the event rates and the incidence of surgery at different time frames, it likely reflects what is really happening in a national population more than anything we’ve ever seen before.”
Egholm G, Kristensen SD, Thim T, et al. Risk associated with surgery within 12 months after coronary drug-eluting stent implantation. J Am Coll Cardiol. 2016; 68:2622-2632.
Spaulding C, Mennuni MG. Surgery after DES implantation. To operate or not to operate: is it still a question? J Am Coll Cardiol. 2016; 68:2633-2636.
- Egholm reports speaker honorarium from Bayer.
- Spaulding reports research grants from the French Ministry of Health; consulting fees from Abiomed, Medpass, Medtronic, and Zoll; and speaker fees from AstraZeneca, Bayer, Cordis, Eli Lilly, Lead-Up, The Medicines Company, Servier, and WebMD.
- Mennuni reports a training grant from the European Society of Cardiology and consulting fees from Boston Scientific.
- Dauerman reports consulting for and receiving research grants from Medtronic and Boston Scientific.