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OBSERVANT: 1-year outcomes comparable for TAVR, surgical AVR
In patients with severe aortic stenosis at low or intermediate surgical risk, 1-year risk for mortality and major adverse cardiac and cerebrovascular events was similar between transcatheter and surgical aortic valve replacement, according to new findings from the OBSERVANT study.
The observational, prospective, multicenter, cohort OBSERVANT study included 7,618 consecutive patients with aortic stenosis who underwent TAVR (n = 1,911) or surgical AVR (n = 5,707) at 93 Italian centers from December 2010 to June 2012. For this analysis, researchers evaluated a propensity-matched cohort of 1,300 patients, 650 patients per group, at low-to-intermediate surgical risk. Patients who underwent a related procedure or transaortic and/or transapical TAVR, had a porcelain aorta or hostile thorax or underwent CABG or PCI were excluded.
The primary endpoints was all-cause mortality and major adverse cardiac and cerebrovascular events (MACCE), including all-cause mortality, stroke, MI, PCI and CABG, at 1 year. Secondary endpoints included cerebrovascular accidents, acute MI, cardiac-related rehospitalizations and acute HF.
The 1-year all-cause mortality rate was 13.6% in the surgical AVR group vs. 13.8% in the TAVR group (HR = 0.99; 95% CI, 0.72-1.35). The two groups did not differ significantly with regard to MACCE (17.6% of patients in the surgical AVR group vs. 18.2% in the TAVR group; HR = 1.03; 95% CI, 0.78-1.36). Rates of stroke, acute MI, CABG and cardiac- or HF-related rehospitalization at 1 year also were not significantly different between the groups. Patients in the TAVR group were significantly more likely to receive a permanent pacemaker than those in the surgical AVR group (18.5% vs. 7.3%; P < .001).
“The results of this study on a large, propensity-matched cohort of real-world patients with severe [aortic stenosis] and at low or intermediate surgical risk suggest that [surgical AVR] and transfemoral TAVR have comparable rates of mortality, MACCE, and rehospitalization due to cardiac reasons at 1 year,” the researchers wrote. “Further studies are needed to identify patient characteristics other than high surgical risk scores that are associated with better long-term outcomes with TAVR than [surgical] AVR.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.