JACC: Cardiovascular Interventions
Structural
Outcomes After Transfemoral Transcatheter Aortic Valve ReplacementA 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 and PARTNER Trial Investigators
Table 1
Table 1
Baseline Characteristics
| NRCA TF-TAVR (n = 1,023) | RCT TF-TAVR (n = 415) | p Value | |
|---|---|---|---|
| Age, yrs | 84.78 ± 7.72 | 83.57 ± 7.59 | 0.007 |
| Male | 579/1,023 (56.6) | 224/415 (54.0) | 0.36 |
| Society of Thoracic Surgeons score | 10.86 ± 3.73 | 11.58 ± 4.50 | 0.004 |
| Logistic EuroSCORE | 24.25 ± 15.11 | 28.14 ± 16.94 | <0.0001 |
| New York Heart Association functional class | |||
| III | 487/1,023 (47.6) | 187/415 (45.1) | 0.38 |
| IV | 494/1,023 (48.3) | 203/415 (48.9) | 0.83 |
| Coronary artery disease | 771/1,021 (75.5) | 300/415 (72.3) | 0.20 |
| Previous myocardial infarction | 234/1,013 (23.1) | 97/412 (23.5) | 0.86 |
| Previous CABG | 378/1,020 (37.1) | 154/415 (37.1) | 0.99 |
| Previous PCI | 387/1,021 (37.9) | 128/413 (31.0) | 0.01 |
| Previous balloon aortic valvuloplasty | 244/1,013 (24.1) | 58/415 (14.0) | <0.0001 |
| Cerebral vascular disease | 210/1,006 (20.9) | 104/398 (26.1) | 0.03 |
| Peripheral vascular disease | 276/1,008 (27.4) | 138/412 (33.5) | 0.02 |
| COPD | |||
| Any | 439/1,023 (42.9) | 182/415 (43.9) | 0.74 |
| Oxygen-dependent | 115/1,023 (11.2) | 63/415 (15.2) | 0.04 |
| Creatinine level >2 mg/dl, or 177 μmol/l | 150/1,020 (14.7) | 84/414 (20.3) | 0.010 |
| Major arrhythmia | 549/1,020 (53.8) | 202/415 (48.7) | 0.08 |
| Permanent pacemaker | 229/1,021 (22.4) | 83/415 (20.0) | 0.31 |
| Pulmonary hypertension | 393/1,021 (38.5) | 127/303 (41.9) | 0.28 |
| Frail condition | 132/1,021 (12.9) | 51/301 (16.9) | 0.08 |
| Aortic-valve area, cm2 | 0.66 ± 0.19 | 0.65 ± 0.19 | 0.44 |
| Aortic-valve mean gradient, mm Hg | 44.51 ± 14.46 | 43.68 ± 14.89 | 0.34 |
| Left ventricular ejection fraction, % | 52.5 ± 13.5 | 53.3 ± 12.8 | 0.45 |
| Moderate or severe mitral regurgitation | 188/973 (19.3) | 64/385 (16.6) | 0.25 |
Values are mean ± SD or n/N (%).
CABG = coronary artery bypass graft; COPD = chronic obstructive pulmonary disease; EuroSCORE = European System for Cardiac Operative Risk Evaluation; NRCA = Nonrandomized Continued Access registry; PCI = percutaneous coronary intervention; RCT = randomized controlled trial; TAVR = transcatheter aortic valve replacement; TF = transfemoral.
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