Percutaneous treatment of severe aortic stenosis, complex CAD superior vs. surgery
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Key takeaways:
- Percutaneous intervention bested surgical treatment of severe aortic stenosis and complex CAD.
- The trial was halted due to early differences in outcomes.
- The results contradict current guideline recommendations.
A percutaneous approach to treatment of severe aortic stenosis and complex CAD was superior to surgical valve replacement and CABG, a speaker reported.
The results of the TCW trial comparing fractional flow reserve-guided PCI and transcatheter aortic valve replacement with surgical AVR and CABG for the treatment of severe aortic stenosis and concomitant complex CAD were presented at EuroPCR.
“Patients with severe aortic stenosis present frequently with concomitant coronary obstructive disease. ... The actual guidelines recommend to combine surgical AVR and CABG in these patients, but as you know, surgical AVR and CABG is associated with higher mortality than isolated surgical AVR or CABG,” Elvin Kedhi, MD, PhD, professor of medicine at McGill University and director of the interventional cardiology division at McGill University Health Centre, Royal Victoria Hospital in Montreal, said during a press conference. “TAVI has proven noninferior or superior to surgical AVR in patients with intermediate or low surgical risk and PCI is considered equivalent to CABG in patients with lower intermediated syntax score.
“FFR is at the present the gold standard technique to detect ischemia and guide revascularization, even in patients with aortic stenosis,” Kedhi said. “Therefore, we performed a randomized clinical trial comparing FFR-guided PCI and TAVI vs. CABG and surgical AVR in patients with severe aortic stenosis and concomitant complex coronary artery disease.”
For the TCW trial, the researchers enrolled 172 patients aged at least 70 years with severe aortic stenosis and complex CAD and randomly assigned them to either FFR-guided PCI and TAVR or CABG and surgical AVR (mean age, 76.5 years; 68.6% men).
The primary endpoint was a composite of all-cause mortality, MI, disabling stroke, unscheduled clinically driven target vessel revascularization, valve reintervention and major bleeding.
The TCW trial was halted early due to a data safety analysis that indicated a significant difference between the two groups at only 50% enrollment.
Risk for the primary endpoint at 12 months was lower in the FFR-guided PCI and TAVR arm compared with CABG and surgical AVR (4.4% vs. 22.9%; HR = 0.17; 95% CI, 0.06-0.51; P for noninferiority < .001; P for superiority < .001), which was primarily driven by lower all-cause mortality (0% vs. 9.74%; P = .002) and life-threatening or disabling bleeding (2.21% vs. 12.1%; P = .01) in the PCI and TAVR arm.
Moreover, the incidence of all-cause mortality and stroke was more than 10-fold higher in the CABG and surgical AVR arm compared with FFR-guided PCI and TAVR (1.1% vs. 12.5%; HR = 0.08; 95% CI, 0.06-0.66; P = .003), according to the presentation.
Major adverse CV events, defined as CV mortality, any stroke, MI and unscheduled coronary or valve reintervention, at 12 months was also lower in the PCI/TAVR group (4.4% vs. 22.9%; HR = 0.17; 95% CI, 0.06-0.51), the researchers found.
“The TCW trial is the first prospective randomized international trial in patients aged more than 70 years with severe aortic stenosis and concomitant complex CAD. It showed that a percutaneous approach by means of FFR-guided PCI and TAVR as compared to a surgical approach by means of surgical AVR and CABG resulted in a significant reduction of the trial primary endpoint of [major adverse CV events], all-cause mortality and stroke,” Kedhi said during the presentation.
“These results bring importance in this field, and they showed, differently from what is stated in the actual guidelines, a percutaneous approach might be better than surgery for this category of patients; however, longer follow-up data as well as larger dedicated randomized trials are still needed to corroborate these results,” he said.
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Kedhi E, et al. Late-breaking trials: TAVI head-to-head. Presented at: EuroPCR; May 14-17, 2024; Paris.
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