TY - JOUR
T1 - Outcomes after transfemoral transcatheter aortic valve replacement a comparison of the randomized PARTNER (placement of aortic transcatheter valves) trial with the NRCA (nonrandomized continued access) registry
AU - Fearon, William F.
AU - Kodali, Susheel
AU - Doshi, Darshan
AU - Fischbein, Michael P.
AU - Yeung, Alan C.
AU - Murat Tuzcu, E.
AU - Rihal, Charanjit S.
AU - Babaliaros, Vasilis
AU - Zajarias, Alan
AU - Herrmann, Howard C.
AU - Brown, David L.
AU - Mack, Michael
AU - Teirstein, Paul S.
AU - Whisenant, Brian K.
AU - Makkar, Raj
AU - Kapadia, Samir
AU - Leon, Martin B.
N1 - Publisher Copyright:
© 2014 By The American College of Cardiology Foundation Published by Elsevier Inc.
PY - 2014
Y1 - 2014
N2 - OBJECTIVES This study sought to determine whether outcomes for transfemoral (TF) transcatheter aortic valve replacement (TAVR) differ between the randomized controlled trial (RCT) and the subsequent NRCA (Nonrandomized Continued Access) registry of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial. BACKGROUND The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) is noninferior to surgery in high-risk patients and superior to standard therapy for inoperable patients. METHODS The inclusion and exclusion criteria, data collection, monitoring, and core laboratories were the same for the RCT and NRCA registry. Baseline characteristics, procedural results, and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry. RESULTS In the RCT, 415 patients underwent TF-TAVR, whereas in the NRCA, 1,023 patients did. At 30 days, death, cardiac death, stroke, and transient ischemic attacks were not different in the NRCA registry than in the RCT. Major vascular complications (8.0% vs. 15.7%, p < 0.0001) and major bleeding (6.8% vs. 15.3%, p < 0.0001) were signifi- cantly lower in the NRCA registry. At 1 year, death rates were significantly lower in the NRCA cohort (19.0% vs. 25.3%, p = 0.009) and cardiac death tended to be lower (8.4% vs. 11.1%, p = 0.12). Stroke or transient ischemic attack (6.2% vs. 8.7%, p = 0.10) and stroke alone (5.0% vs. 7.1%, p = 0.13) also tended to be lower. CONCLUSIONS The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT.
AB - OBJECTIVES This study sought to determine whether outcomes for transfemoral (TF) transcatheter aortic valve replacement (TAVR) differ between the randomized controlled trial (RCT) and the subsequent NRCA (Nonrandomized Continued Access) registry of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial. BACKGROUND The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) is noninferior to surgery in high-risk patients and superior to standard therapy for inoperable patients. METHODS The inclusion and exclusion criteria, data collection, monitoring, and core laboratories were the same for the RCT and NRCA registry. Baseline characteristics, procedural results, and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry. RESULTS In the RCT, 415 patients underwent TF-TAVR, whereas in the NRCA, 1,023 patients did. At 30 days, death, cardiac death, stroke, and transient ischemic attacks were not different in the NRCA registry than in the RCT. Major vascular complications (8.0% vs. 15.7%, p < 0.0001) and major bleeding (6.8% vs. 15.3%, p < 0.0001) were signifi- cantly lower in the NRCA registry. At 1 year, death rates were significantly lower in the NRCA cohort (19.0% vs. 25.3%, p = 0.009) and cardiac death tended to be lower (8.4% vs. 11.1%, p = 0.12). Stroke or transient ischemic attack (6.2% vs. 8.7%, p = 0.10) and stroke alone (5.0% vs. 7.1%, p = 0.13) also tended to be lower. CONCLUSIONS The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT.
KW - Aortic stenosis
KW - Transcatheter aortic valve implantation
KW - Transcatheteraortic valve replacement
KW - Transfemoral
UR - http://www.scopus.com/inward/record.url?scp=84922540805&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2014.05.033
DO - 10.1016/j.jcin.2014.05.033
M3 - Article
C2 - 25459036
AN - SCOPUS:84922540805
SN - 1936-8798
VL - 7
SP - 1245
EP - 1251
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 11
ER -