Surgery Common in Stented Patients But Newer Stents Appear to Reduce Potential Risks

For patients who have received a coronary stent, the need for cardiac or noncardiac surgery occurs relatively frequently and is associated with “considerable risk” of ischemic and bleeding events, according to the results of a new study.

The risk of ischemic events is inversely related to the time from PCI to surgery—longer duration from stenting to surgery was associated with fewer ischemic events—and influenced by the type of stent the patient received.

“As cardiologists, every day we encounter colleagues who ask us what to do—should they stop both antiplatelet drugs, should they just stop one, or should they continue with both—with patients in which a surgical procedure is needed,” lead investigator Francesco Saia, MD, of the University of Bologna (Italy), told TCTMD. “It’s an everyday issue, and it’s always difficult to decide what to do. It’s very important to stratify patients based on their risk of ischemic and bleeding events.”

Daniel Simon, MD, of University Hospitals Case Medical Center (Cleveland, OH), agreed that stented patients requiring surgery are encountered frequently in clinical practice and their care can be complicated. “It’s much more common than you think because these are not young populations that we take care of anymore,” Simon told TCTMD. “These are patients who are in their 70s and 80s and they need gall-bladder surgery, they require endoscopy, or they have hips that need to be done, among other things.”

The study was published December 8, 2015, in Circulation: Cardiovascular Quality and Outcomes.

Urgent Surgery, Thrombotic Risk Raise Odds of Adverse Events

Speaking with TCTMD, Saia said the major issue surrounding surgery is the use of dual antiplatelet therapy (DAPT) in the perioperative phase. Stopping DAPT for surgery lowers the risk of perioperative bleeding but increases the risk of stent thrombosis and ischemic events. At present, however, there is no clear consensus on how to manage stented patients who require nonelective surgery while on DAPT.  

“There is no standard decision, and that is part of the problem,” said Saia. “What we normally see is the surgeon wants to stop everything, sometimes without asking the cardiologist. As for the cardiologist, it’s the other way around. We just tend to say the patient can’t stop dual antiplatelet therapy.”

Using data from the Italian REAL registry, the researchers studied 39,362 consecutive patients who underwent coronary stenting between 2002 and 2011 and were followed for a median of 4.8 years. The cumulative incidence of surgery at 30 days, 6 months, 1 year, and 5 years was 3.6%, 9.4%, 14.3%, and 40.0%, respectively. Regarding cardiac operations alone, the incidence was 0.8%, 2.1%, 2.6%, and 4.0%, respectively. Noncardiac surgery was much more common, occurring in 1.3%, 5.1%, 9.1%, and 31.7% of patients at 30 days, 6 months, 1 year, and 5 years, respectively.

Overall, surgery was associated with an approximate 1.5-fold increased risk of cardiac death. Other predictors of the combined endpoint of cardiac death/MI included the need for urgent surgery and the patient’s baseline thrombotic risk. Those at intermediate risk of thrombosis had a 50% higher risk of cardiac death/MI while the risk increased more than two-fold among patients with high thrombotic risk, both of which were compared against patients at low risk.

Regarding bleeding, urgent surgery and noncardiac surgery were associated with three- and four-fold increased risks of serious bleeding, respectively.

The researchers also confirmed previous reports that showed the time of surgery relative to the PCI was inversely associated with ischemic risk. In examining the interplay between stent type and the timing of surgery, the found that the newer-generation DES “appear to be at least as safe as bare-metal stents at any time point and perhaps a little bit safer in the first 6 months,” said Saia.

 

The parity between newer-generation DES and BMS “is important because, in general, if a surgical procedure is planned, clinicians will implant a bare-metal stent because it’s thought to be safer if they use dual-antiplatelet therapy for a shorter period of time,” he continued. “Of course, our findings are retrospective and hypothesis-generating, but this observation that the newer drug-eluting stents may be safer than bare-metal stents may really change the paradigm of our attitude to bare-metal stents in these patients.”

When in the catheterization lab, Saia said he and his colleagues make a point to ask patients if they have a procedure planned in the next 6 or 12 months. Clinical guidelines recommend DAPT for 1 month after BMS but at least 6 to 12 months if a DES is selected. An upcoming surgical procedure in this first year could influence stent selection. Surgery, however, is not always planned.

Saia said it is important for physicians to realize how frequent surgery is for patients who have received a coronary stent. Historical estimates of the need for surgery in the first year post-PCI range from 5% to 10%, which is considerably lower than the 14.3% they observed in their analysis. Beyond 1 year, the number of patients needing surgery continues to grow.

“The major issue of dual antiplatelet therapy in surgery is within the first year, but even after one year there is still a remaining issue with antiplatelet medication,” said Saia. “We know that if the patient is taking only aspirin, there might also be a risk of interrupting aspirin [for surgery]. There might also be a risk of continuing aspirin.”

Newer Stents, Less DAPT

Simon, who was not involved in the analysis of the REAL data, noted the Resolute Integrity (Medtronic) stent currently has CE Mark approval to indicate the interruption or cessation of DAPT after 1 month following implantation. The Promus and Promus Plus stents (Boston Scientific), as well as the Xience Prime and Xience V (Abbott Vascular) stents, also gained CE Mark approval to update their label to 3 months of DAPT.

“I think that, in general, 6 weeks is sort of the magical zone where patients really do much better if you can continue DAPT to that time,” Simon told TCTMD. “If they have non-elective or semi-elective surgery that is medically indicated—for example, severe sciatica with muscle weakness requiring back surgery—on the basis of the CE Mark indication for interruption, we are now willing to say we can interrupt safely at 6 weeks to 3 months and it’s not such a big deal.”

He noted cardiac surgery can be a little trickier, particularly in STEMI patients, who might receive a stent for the infarct vessel but will then need to go for definitive coronary artery bypass graft surgery. In these settings, heart surgeons typically understand there are times when they have to operate while the patient is taking DAPT. In some high-risk settings, including high-risk anatomy or a reoperation, physicians might switch to cangrelor (Kengreal; The Medicines Company) and then restart DAPT after surgery, he noted.

---

Source: 
Saia F, Beatrice LM, Guastaroba P, et al. Risk of adverse cardiac and bleeding events following cardiac and noncardiac surgery in patients with coronary stent. Circ Cardiovasc Qual Outcomes. 2015;Epub ahead of print.

Related Stories:

• Study Suggests Noncardiac Surgery Can Be Safe as Early as 3 Months After PCI
• Study Challenges Guidelines Regarding for Noncardiac Surgery After PCI
• Noncardiac Surgery After Stent Placement Ups Risks for Complications