• Cardiology Clinical Trials
• Valvular Disease
• Interventional Techniques & Devices

One–year data from the Placement of Aortic Transcatheter Valves Trial [PARTNER; NCT00530894] showed that survival rates were similar among high–risk patients with aortic stenosis (AS) who received either transcatheter aortic valve replacement (TAVR) or surgical replacement [Smith CR et al. N Engl J Med 2011; Vinall M. MD Conference Express: ACC 2011]. Susheel K. Kodali, MD, Columbia University Medical Center, New York, New York, USA, presented outcomes after 2 years of follow–up in the PARTNER trial [Kodali SK et al. N Engl J Med 2012].

Inclusion criteria were severe symptomatic AS; an echo–derived aortic–valve area (AVA) ≤0.8 cm² (or AVA index <0.5 cm²/m²) and a peak velocity ≥40 mm Hg (or peak jet velocity of >4.0 m/s); NYHA ≥II; and high surgical risk (ie, guideline–predicted risk of operative mortality ≥15%, as determined by site surgeon and cardiologist). The risk score threshold was an STS score ≥10 [http://riskcalc.sts.org/STSWebRiskCalc273/de.aspx].

The primary endpoint of the randomized, multicenter trial was all–cause mortality. Other endpoints included cardiovascular (CV) mortality, rehospitalization, strokes and transient ischemic attacks (TIAs), vascular and bleeding events, NYHA functional class, and echocardiographic measures of valve performance (including valve gradient/areas and postprocedural aortic regurgitation [AR]).

At 2 years, there were no significant differences in mortality from any cause between the TAVR group (33.9%; 95% CI, 28.9 to 39.0) and the SAVR group (35.0%; 95% CI, 29.8 to 40.2; p=0.78). CV mortality was also similar in the TAVR and SAVR groups (21.4% [95% CI, 16.8 to 26.0] and 20.5% [95% CI, 15.8 to 25.3], respectively; p=0.80).

The frequency of all neurological events (stroke or TIA) at 2 years was higher with TAVR than with surgical replacement (11.2% vs 6.5%; p=0.05). However, there was no significant difference in the number of overall strokes between the TAVR and SAVR groups (24 vs 20, respectively at 36 months; HR, 1.22; 95% CI, 0.67 to 2.23; p=0.52).

Moderate or severe paravalvular AR was more common after TAVR than after SAVR at both 1 and 2 years (7.0% vs 1.9% at 1 year; 6.9% vs 0.9% at 2 years; p<0.001 for both comparisons). The presence of paravalvular or any AR (mild, moderate, or severe vs none or trace) after TAVR was associated with increased late mortality (HR, 2.11; 95% CI, 1.43 to 3.10; p<0.001), underscoring the importance of close clinical follow–up and echocardiography in patients after TAVR.

Dr. Kodali concluded that TAVR should be considered an option for patients with severe symptomatic AS who are high risk for SAVR. He noted that TAVR remained equivalent to SAVR, with similar rates of all–cause and CV mortality, and that symptom improvement was similar in both groups. Although TAVR valve hemodynamics remained stable at 2 years, the more frequent late development of paravalvular and any significant AR following TAVR was associated with a doubling of late mortality.

Future research appears warranted to focus on further reducing periprocedural TAVR complications, including strokes, vascular events, and short– and long–term risk and prevention of paravalvular AR.

• © 2012 MD Conference Express®