ESC guideline may help risk stratify patients with non ST-elevation ACS undergoing PCI
Click Here to Manage Email Alerts
Key takeaways:
- The 2020 ESC guidelines identified patients undergoing PCI at low-, moderate- and high-risk for MACE.
- Patients deemed high-risk experienced significant bleeding risk vs. moderate- and low-risk patients.
The 2020 European Society of Cardiology guidelines for the management of non ST-elevation ACS may help clinicians determine the thrombotic risk categories of patients being considered for PCI, a speaker reported.
In addition, patients undergoing PCI identified as high risk by the guidelines experienced significantly greater bleeding risk at 1 year compared with moderate- and low-risk patients, according to a presentation at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
Image: Adobe Stock
“We see an inherent need to provide individualized cardiology care using precision medicine principles adjusted on patient-unique risk factors,” George Dangas, MD, PhD, MSCAI, MACC, professor of cardiology and vascular surgery at the Icahn School of Medicine at Mount Sinai, said in a press release. “With this study, we are working to find the best way to provide the right blood thinner therapy to the right patient. Evaluating these criteria offers an important step toward the creation of a more personalized tool to identify high-risk patients who would benefit from a long-term treatment with more than one blood thinner.”
Criteria were proposed in the 2020 ESC guidelines for the management of NSTEACS to help identify patients at increased thrombotic risk who may benefit from a second antithrombotic agent, according to the presentation. Therefore, Dangas and colleagues conducted the present study to assess the criteria for the identification of patients at increased thrombotic risk.
For this study, the researchers included 11,787 consecutive patients with acute or chronic coronary syndrome who underwent PCI at Mount Sinai Hospital from 2012 to 2019.
Using the 2020 ESC guidelines, patients were designated as low-, medium- and high-thrombotic risk.
High-risk patients had one or more clinical features including diabetes, prior MI, peripheral artery disease, chronic kidney disease, age less than 45 years and multivessel CAD and one or more angiographic features including three or more stents and/or lesions, a total stent length more than 60 mm, left main PCI, chronic total occlusion and bifurcation with 2 stents.
Moderate-risk patients had one or more of the aforementioned clinical features except for age less than 45 years and multivessel CAD.
Low-risk patients were those who did not meet the high-risk and moderate-risk criteria.
The primary endpoint was a composite of 1-year MACE, including all-cause death, MI and stroke. Secondary endpoints included the individual components of the primary endpoint and major bleeding.
Overall, 22.4% of the cohort was identified as low risk, 44.8% of patients were moderate risk and 32.7% were high risk.
Among high-risk patients, multivessel CAD was the most common risk factor, followed by stent length more than 60 mm, diabetes and chronic kidney disease.
Among moderate-risk patients, diabetes was the most common risk factor, followed by chronic kidney disease, prior MI and PAD.
At 1 year, the primary endpoint of MACE occurred in 5.4% of high-risk patients, 4.1% of moderate-risk patients and 1.6% of low-risk patients (log-rank P < .001).
The rate of 1-year all-cause death was 2.7% among high-risk patients, 2.3% among moderate-risk patients among 0.6% of low-risk patients (log-rank P < .001).
Patients identified as moderate and high risk as defined by the 2020 ESC guidelines experienced greater risk for MACE, all-cause death and MI compared with low-risk patients (P for all < .001).
The risk for stroke was not significantly different among moderate- (P = .41) and high-risk patients (P = .324) compared with low-risk patients.
Compared with low-risk patients, risk for major bleeding was greater among high-risk patients (P < .001) but not among moderate-risk patients (P = .115).
Using Harrell’s C-index, Dangas reported that the 2020 ESC guidelines demonstrated a predictive value of:
- 0.6 for death, MI or stroke;
- 0.61 for all-cause death;
- 0.59 for MI;
- 0.55 for stroke;
- 0.59 for target vessel revascularization; and
- 0.55 for major bleeding.
Dangas added that because data regarding DAPT duration or adherence in this cohort were not available, the researchers could draw no conclusion on the utility of the 2020 ESC guidelines to inform appropriate DAPT duration.
“Stratification of patients undergoing PCI, as far as MACE or all-cause mortality, were somewhat limited by a few criteria,” Dangas said during a press conference. “We couldn't trace ... systemic inflammatory disease and all that, by the way our database is structured, and I think that's customary when you do research of validating other models and database that may have someone differences than others. We do not have any way to assess the compliance or adherence history on the dual antiplatelet therapy, which also seems to be an important criterion that they didn't have.”
Reference:
- Long term use of blood thinners shows promise in reducing complications for patients following a heart attack. https://www.eurekalert.org/news-releases/989833. Published on May 19, 2023. Accessed on May 19, 2023.
Perspective
Back to Top
The Europeans have always been very forward-thinking in terms of their treatment for cardiology. In juxtaposition a little bit of the American College of Cardiology/American Heart Association, that we can go a little bit longer in terms of DAPT for those at higher risk. We're looking at patient factors for this. One variable to consider with this study would be it did not look at any of the procedural factors, and I think that plays a big role in this. If you look at the STOPDAPT studies in Japan, they had 100% IVUS use and one to two stent thromboses. Even if they're higher risk, should we be thinking not so much in terms of the antiplatelets, but should we be thinking more about better PCI?
There are some meta-analyses that showed that if you do use longer-term clopidogrel, you have a mortality risk. We do not entirely understand the biologic theories behind that. We're thinking it's due to cancer and some platelet issues with microvascular permeability. But if you look at the DAPT trials, it is not insignificant when you start to think about the trade-offs between overall mortality and some of the bleeding and ischemic risks.
I think that this is a noble effort at trying to characterize the patient-level risk in terms of who needs longer-term antiplatelet therapy. The patients at the very highest risk still had a very high all-cause mortality with MIs and strokes and very high clinical event rates at 1 year.
In terms of the predictive value of which event they might have, it wasn't as clear. The limitations of this included only looking at 1 year after PCI; only looking at a patient-level data set; there were no data in terms of the very high bleeding risk in terms who are on anticoagulation to begin with; and there really were no data on procedural characteristics.
Perspective
Back to Top
Karim M. Al-Azizi, MD, FACC, FSCAI, FESC
Dangas and colleagues are to be congratulated on looking at all their PCI volume from 2012 to 2019 and trying to stratify those patients. The way I look at these curves, is they almost mimic what we would consider a SYNTAX trial, and they did include some degree of anatomical complexity grading, yet they also added the comorbidity aspect, which is key, but will change. What we need to think about is as we move forward, is it really worth looking into and applying a lot of previous PCI practices? We know, for example, that intravascular imaging does improve outcomes overall based on every study that we have looked at, primarily outside the U.S.
Should we add this to the mix when we perform PCI? How does that change? We have drug-eluting balloons that are coming onto the market. They're currently going through regulatory procedures and studies, but how will that affect the duration of DAPT and the safety of these interventions? This study reinforces that for patients who carry comorbidities and have advanced anatomical complexity, regardless of what we do, they have higher risk for events. They may be the ones that will benefit from certain therapies, and prolonging their therapies to minimize those events in general.
Collapse
Dangas G, et al. Late-Breaking Presentation X. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 18-20, 2023; Phoenix.
Click Here to Manage Email Alerts