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J Am Coll Cardiol. 2014 Jul 15;64(2):158-68. doi: 10.1016/j.jacc.2013.08.1666.

Comprehensive analysis of mortality among patients undergoing TAVR: results of the PARTNER trial.

Author information

1
Cleveland Clinic, Cleveland, Ohio; PARTNER Publication Office, New York, New York, and Cleveland, Ohio. Electronic address: svenssl@ccf.org.
2
Cleveland Clinic, Cleveland, Ohio; PARTNER Publication Office, New York, New York, and Cleveland, Ohio.
3
Cleveland Clinic, Westin, Florida.
4
PARTNER Publication Office, New York, New York, and Cleveland, Ohio; Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
5
Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
6
Baylor Health Care System, Dallas, Texas.
7
Stanford University Medical School, Stanford, California.
8
Cleveland Clinic, Cleveland, Ohio.
9
University of British Columbia and St. Paul's Hospital, Vancouver, British Columbia, Canada.
10
Cedars-Sinai Medical Center, Los Angeles, California.
11
Emory University School of Medicine, Atlanta, Georgia.
12
Medstar Washington Hospital Center, Washington, DC.
13
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
14
Edwards Lifesciences, Irvine, California.

Abstract

BACKGROUND:

Patients with severe aortic stenosis (AS) who were deemed too high risk or inoperable for conventional aortic valve replacement (AVR) in the PARTNER (Placement of Aortic Transcatheter Valves) trial were randomized to transcatheter aortic valve replacement (TAVR) versus AVR (PARTNER-A arm) or standard therapy (PARTNER-B arm).

OBJECTIVES:

This study compared when and how deaths occurred after TAVR versus surgical AVR or standard therapy.

METHODS:

The PARTNER-A arm included 244 transfemoral (TF) and 104 transapical (TA) TAVR patients, and 351 AVR patients; the PARTNER-B arm included 179 TF-TAVR patients and 179 standard therapy patients. Deaths were categorized as cardiovascular, noncardiovascular, or uncategorizable, and were characterized by multiphase hazard modelling.

RESULTS:

In the PARTNER-A arm, the risk of death peaked after randomization in the TA-TAVR and AVR groups, falling to low levels commensurate with the U.S. population within 3 months. Early risk was less in TF-TAVR patients, resulting in initial superior survival; between 12 and 18 months, risk increased, such that within 2 years, TF-TAVR and AVR patients had similar survival rates. Cardiovascular, noncardiovascular, and uncategorizable deaths for TF-TAVR were 37%, 43%, and 20%, respectively, versus 22%, 41%, and 37%, respectively, for TA-TAVR and 33%, 43%, and 24%, respectively, for AVR. In the PARTNER-B arm, risk with standard therapy was 60% per year; TF-TAVR reduced risk to 20% per year, resulting in 0.5 years of life added within 2.5 years.

CONCLUSIONS:

In inoperable AS patients, TAVR substantially reduced the risk of cardiovascular death. In high-risk patients, TA-TAVR and AVR were associated with elevated peri-procedural risk more than with TF-TAVR, although cardiovascular death was higher after TF-TAVR. Therefore, TF-TAVR should be considered the standard of care for severely symptomatic inoperable patients or those at high risk of noncardiovascular mortality after conventional surgery. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

KEYWORDS:

TAVR; aortic stenosis; causes of death

PMID:
25011720
DOI:
10.1016/j.jacc.2013.08.1666
[Indexed for MEDLINE]
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