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

William F. Fearon, Susheel Kodali, Darshan Doshi, Michael P. Fischbein, Alan C. Yeung, E. Murat Tuzcu, Charanjit S. Rihal, Vasilis Babaliaros, Alan Zajarias, Howard C. Herrmann, David L. Brown, Michael Mack, Paul S. Teirstein, Brian K. Whisenant, Raj Makkar, Samir Kapadia, Martin B. Leon

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1245-1251
Number of pages7
JournalJACC: Cardiovascular Interventions
Volume7
Issue number11
DOIs
StatePublished - 2014

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Aortic Valve
Registries
Randomized Controlled Trials
Stroke
Transient Ischemic Attack
Transcatheter Aortic Valve Replacement
Blood Vessels
Hemorrhage
Mortality

Keywords

  • Aortic stenosis
  • Transcatheter aortic valve implantation
  • Transcatheteraortic valve replacement
  • Transfemoral

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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. / Fearon, William F.; Kodali, Susheel; Doshi, Darshan; Fischbein, Michael P.; Yeung, Alan C.; Murat Tuzcu, E.; Rihal, Charanjit S.; Babaliaros, Vasilis; Zajarias, Alan; Herrmann, Howard C.; Brown, David L.; Mack, Michael; Teirstein, Paul S.; Whisenant, Brian K.; Makkar, Raj; Kapadia, Samir; Leon, Martin B.

In: JACC: Cardiovascular Interventions, Vol. 7, No. 11, 2014, p. 1245-1251.

Research output: Contribution to journalArticle

Fearon, WF, Kodali, S, Doshi, D, Fischbein, MP, Yeung, AC, Murat Tuzcu, E, Rihal, CS, Babaliaros, V, Zajarias, A, Herrmann, HC, Brown, DL, Mack, M, Teirstein, PS, Whisenant, BK, Makkar, R, Kapadia, S & Leon, MB 2014, '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', JACC: Cardiovascular Interventions, vol. 7, no. 11, pp. 1245-1251. https://doi.org/10.1016/j.jcin.2014.05.033
Fearon, William F. ; Kodali, Susheel ; Doshi, Darshan ; Fischbein, Michael P. ; Yeung, Alan C. ; Murat Tuzcu, E. ; Rihal, Charanjit S. ; Babaliaros, Vasilis ; Zajarias, Alan ; Herrmann, Howard C. ; Brown, David L. ; Mack, Michael ; Teirstein, Paul S. ; Whisenant, Brian K. ; Makkar, Raj ; Kapadia, Samir ; Leon, Martin B. / 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. In: JACC: Cardiovascular Interventions. 2014 ; Vol. 7, No. 11. pp. 1245-1251.
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abstract = "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.",
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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.

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

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