CathPCI Model Fails to Capture Excess Bleeding Risk With PCI Plus TAVR
If a PCI is done together with a TAVR, “it probably should be excluded” from public PCI outcome reporting, one expert says.
Combining PCI and TAVR significantly increases the risk of bleeding compared with a coronary intervention alone, and that excess hazard is not captured well by the CathPCI risk model, data from a large New York City hospital show.
The rate of bleeding was about six times higher among patients who underwent both PCI and TAVR than among those who underwent PCI alone (43.4% vs 6.7%; P < 0.001), investigators led by Aakriti Gupta, MD (Columbia University Irving Medical Center, New York, NY), report.
The CathPCI risk model was better able to discriminate bleeding risk after PCI alone than after a combined procedure (C-statistic 0.72 vs 0.56), the investigators write in a research letter published recently online ahead of print in Circulation: Cardiovascular Interventions.
There are implications touching on patient care, quality improvement, and policies around the public reporting of PCI outcomes, Gupta told TCTMD.
More-precise information about bleeding risk would allow patients to be better informed heading into the procedure, she said, and “accurate bleeding risk stratification would support more-efficient use of bleeding avoidance strategies by operators to improve the safety of PCI in this group that is also receiving TAVR.”
Moreover, “better risk stratification for these patients who are undergoing combined PCI and TAVR would enable provision of more-accurate risk-adjusted bleeding outcomes feedback to TAVR-capable sites,” she said.
PCI outcomes are publicly reported without regard to concomitant TAVR, Gupta noted, so improving how outcomes are presented for patients undergoing a combined procedure “would minimize the risk that hospitals that disproportionately perform a high volume of TAVR be unduly penalized for the inherent high risk of bleeding when combined with PCI.”
Commenting on the findings for TCTMD, Alan Yeung, MD (Stanford University, CA), said it’s clear these combined PCI/TAVR procedures cannot be reported to PCI databases using the current criteria. “If the PCI is done in a setting together with a TAVR, it probably should be excluded” from public reporting of PCI outcomes, he said, citing the difficulty in risk-adjusting for concomitant TAVR.
These procedures should probably be reported to TAVR databases, with a subcategory for patients who also received a coronary intervention, he said.
Combined Procedures Infrequent, but Riskier
For the study, the investigators looked at data submitted to the National Cardiovascular Data Registry (NCDR) CathPCI registry on 6,678 patients from their institution who underwent PCI between 2015 and 2017. During that span, 76 patients underwent PCI and TAVR together, representing 1.1% of PCIs and 6.5% of TAVRs.
Patients who had combined procedures, compared with PCI alone, were more frequently older than 70 and female, and had a lower median body mass index. Certain comorbidities were less common in the PCI+TAVR group, such as prior MI, PAD, and diabetes, but heart failure and cerebrovascular disease were seen at higher rates.
Combined procedures less frequently involved use of intraprocedural bivalirudin and glycoprotein IIb/IIIa inhibitors (no cases), as well as ticagrelor, but there was no difference in use of clopidogrel. Radial access was more frequently used for PCI alone (27.8% vs 2.6%; P < 0.001).
Bleeding was defined according to the CathPCI definition as:
- Bleeding within 72 hours of PCI
- Hemorrhagic stroke or tamponade
- Post-PCI transfusion if hemoglobin was greater than 8 g/dL before the procedure
- Absolute hemoglobin decrease of at least 3 g/dL if hemoglobin was 16 g/dL or less before the procedure
According to this definition, bleeding occurred in 7.1% of patients undergoing PCI with or without TAVR, with a much higher rate seen in those who had a combined procedure. Access-site bleeding also was more common in the PCI+TAVR group (19.7% vs 1.9%; P < 0.001).
On multivariable analysis, concomitant TAVR during PCI was independently associated with bleeding (OR 9.6; 95% CI 5.9-15.7).
This makes sense, Gupta said, because patients undergoing TAVR are usually older and have more comorbidities than those in the general PCI population, and the procedure requires larger-bore access through the femoral artery. All of those factors increase bleeding risk.
Considering the poor performance of the CathPCI model for identifying bleeding risk in the growing population of patients undergoing both PCI and TAVR, new models are needed, Gupta said, noting that larger cohorts will be necessary to develop them.
In the meantime, “it’s important to consider not including these patients in public reporting or in the financial penalization for these outcomes,” she said. “This is just a uniquely different cohort that may either merit models that are uniquely built for them or [exclusion] from public reporting.”
Yeung said additional research also is needed comparing bleeding risks between patients undergoing PCI plus TAVR and those undergoing TAVR alone, which was not explored in this study. Adding PCI to TAVR might not increase bleeding risk much over TAVR alone, he explained, because much of the bleeding associated with valve replacement stems from the large-bore sheath it requires.
Note: Several co-authors are faculty members of the Cardiovascular Research Foundation, the publisher of TCTMD.
Gupta A, Liao M, Smyth E, et al. Bleeding outcomes in patients undergoing combined percutaneous coronary interventions + transcatheter aortic valve replacement: time for an adjustment to the CathPCI bleeding model? Circ Cardiovasc Interv. 2020;Epub ahead of print.
- Gupta reports receiving support from a US National Institutes of Health training grant; receiving payment from the Arnold & Porter Law Firm for work related to the Sanofi clopidogrel litigation, and from the Ben C. Martin Law Firm for work related to an inferior vena cava filter litigation; receiving consulting fees from Edwards Lifesciences; and holding equity in the healthcare telecardiology start-up Heartbeat Health.