Most patients with advanced chronic kidney disease (CKD) and non-ST-elevation myocardial infarction (NSTEMI) fare better with coronary angiography with and without revascularization than with medical therapy, a large nationwide study suggests.
“Invasive management was associated with lower mortality, major adverse cardiovascular events (MACE), and need for revascularization, with a minimal increased risk of in-hospital, postprocedural acute kidney injury (AKI) requiring dialysis and major bleeding,” said lead researcher Ankur Kalra, MD, Cleveland Clinic, Cleveland, Ohio.
Also, similar post-discharge safety outcomes were seen at 6 months, he said in an online presentation of “key abstracts” released in advance of next month’s Transcatheter Cardiovascular Therapeutics (TCT) 2021 hybrid meeting.
Advanced CKD is an independent predictor of mortality and morbidity in patients with NSTEMI. In CKD, however, current guidelines lack evidence on the efficacy and safety of invasive vs medical management, he noted.
A rare randomized clinical trial in this high-risk population, ISCHEMIA-CKD, recently found no benefit and an increase in stroke with initial invasive management compared with optimal medical therapy.
Session co-moderator Ziad A. Ali, MD, DPhil, St. Francis Hospital & Heart Center, New York City, said the current study is “incredibly clinically impactful and answers a question that’s very difficult to answer because these patients aren’t randomized in randomized controlled trials and there’s a general avoidance, which we’ve now coined ‘renalism,’ like racism, where people don’t really want to touch these patients.”
He questioned, however, how the authors reconcile the results of ISCHEMIA-CKD, a “small but meaningful randomized controlled trial,” with their findings from a large dataset. “Perhaps this is all selection bias, even though the numbers are very large.”
Kalra replied that ISCHEMIA-CKD examined stable ischemic heart disease, whereas they looked at NSTEMI. “Even though it may fall under the same rubric, I truly believe it is a different set of patients — they are at a heightened risk for future cardiovascular events and have had an acute coronary event.”
For the study, ICD-10 coding data from 2016-2018 in the Nationwide Readmission Database was used to identify NSTEMI patients with CKD stages 3, 4, 5, and end-stage renal disease (ESRD). A total of 141,052 patients were available for in-hospital outcomes and 133,642 patients for post-discharge outcomes.
In-hospital and 6-month mortality – the study’s primary outcome – favored invasive management across all CKD stages and ESRD but did not achieve statistical significance for CKD stage 5. The number needed to treat (NNT) for CKD stages 3, 4, 5, and ESRD were 26, 56, 48, and 18, respectively.
Six-month MACE, including mortality, MI, stroke, and heart failure readmission, was significantly better in all groups with invasive management.
Table. Mortality and MACE: Invasive vs Medical Management
|Outcomes||CKD stages||Invasive (%)||Medical Mgmt (%)||Hazard Ratio with 95% CI||P value|
|In-hospital Mortality||CKD 3||3.8||7.7||0.47 (0.43 – 0.51)||< .001|
|CKD 4||6.3||8.1||0.79 (0.70 – 0.90)||< .001|
|CKD 5||5.8||7.9||0.72 (0.49 – 1.06)||.096|
|ESRD||6.8||12.5||0.51 (0.46 – 0.56)||< .001|
|6-month Mortality||CKD 3||1.9||3.1||0.58 (0.51 – 0.65)||< .001|
|CKD 4||2.2||3.6||0.61 (0.50 – 0.75)||< .001|
|CKD 5||1.4||2.8||0.49 (0.24 – 1.01)||.058|
|ESRD||3.4||4.6||0.73 (0.62 – 0.85)||< .001|
|6-month MACE||CKD 3||14.5||19.3||0.73 (0.70 – 0.77)||< .001|
|CKD 4||18.1||23.6||0.75 (0.70 – 0.81)||< .001|
|CKD 5||17.4||24.4||0.67 (0.54 – 0.84)||< .001|
|ESRD||16.5||20.0||0.80 (0.75 – 0.86)||< .001|
Kaplan-Meier curves for mortality showed similar benefits with an invasive strategy across CKD stages, again barring stage 5 disease.
With regard to in-hospital safety, stroke rates were not significantly different between the two treatment strategies across all groups.
Rates of AKI requiring dialysis, however, were lower with medical vs invasive management for CKD stage 3 (0.43% vs 0.6%; HR, 1.39; P = .016), stage 4 (1.2% vs 2.0%; HR 1.87; P < .001), and stage 5 (3.7% vs 4.3%; HR 1.17; P = .527). The number needed to harm (NNH) was 588 for CKD 3 and 125 for CKD 4.
Major bleeding, defined as requiring transfusion, was lower with medical management for all CKD stages but not for ESRD. The rates are as follows:
CKD stage 3: 2.5% vs 2.8% (HR, 1.11; P = .078; NNH = 333)
CKD stage 4: 2.9% vs 4.0% (HR, 1.42; P < .001; NNH = 91)
CKD stage 5: 2.2% vs 4.7% (HR, 2.17; P = .008; NNH = 40)
ESRD: 3.4% vs 3.3% (HR, 0.97; P = .709).
“The risk of AKI requiring dialysis and bleeding, as has been shown previously in other studies, was high but the number needed to harm was also high,” observed Kalra.
A separate analysis showed no difference in rates of AKI requiring dialysis among patients with CKD stages 3 and 4 who underwent angiography without revascularization and their peers who were medically managed.
Rates of the composite safety outcome of vascular complications, major bleeding, AKI, or stroke readmission at 6 months were not significantly different for invasive vs medical management for CKD stage 3 (both 3.3%), stage 4 (4.5% and 4.2%), stage 5 (3.9% vs 4.3%), and ESRD (2.3% vs 2.1%).
Besides the inherent limitations of observational studies and potential for selection bias, Kalra pointed out that the analysis relied on coding data for exact glomerular filtration rates and lacked information on contrast use, crystalloids before the procedure, and nephrotoxic medication use before or during admission. Out-of-hospital mortality was also not available in the database.
Co-moderator Allen Jeremias, MD, also with St. Francis Hospital & Heart Center, said one of the study’s strengths was that it included all comers, unlike randomized trials that typically exclude the highest risk patients.
“So, when we do these trials it’s very difficult to find the right balance, whereas this is a real-world analysis including everybody and I think the benefits are clearly demonstrated,” he said. “So I think I’m bullish on doing complex [percutaneous coronary intervention] PCI in this patient population.”
Kalra reports having no relevant financial relationships.
Transcatheter Cardiovascular Therapeutics (TCT) 2021; Presented October 20, 2021.