TAVI: reveal the truth, the whole truth, and nothing but the truth

Figures & data

Table 1.  Unpublished results related to the PARTNER trial (inoperable patients).

	Pivotal trial cohort b						Randomised continued access cohort b
	Pivotal trial published		Anatomically inoperable subgroup		Medically inoperable subgroup		Tavi	Control
	Tavi	Control	Tavi	Control	Tavi	Control
n	179	179	53	37	126	142	41	49
30-day mortality	5.0%	2.8%	1.9%	2.7%	6.3%	2.8%	9.8%	2.1%
1-year mortality	30.7%	50.7%	24.5%	52.4%	33.3%	50.3%	34.3%	21.6%

All data refer to Intention-to-Treat analyses.

Sources: Pivotal trial data: Leon et al.4; Anatomically and medically inoperable sub-groups: personal communication, Edwards Lifesciences S.A., Switzerland (August 10, 2011); Continued Access Study: FDA (July 20, 2011)8.

n, number of patients per sub-group; TAVI, trans-catheter aortic valve implantation; Control, ‘Standard Therapy’, including balloon aortic valvuloplasty in most patients, in combination with a medical supportive treatment.

Figure 1.  PARTNER trial timeline.

Table 2.  Selection of patient characteristics in the PARTNER trial (inoperable patients).

	TAVI (n = 179)	Standard therapy (n = 179)	p-value
STS score	11.2 ± 5.8	12.1 ± 6.1	0.14
Logistic EuroSCORE	26.4 ± 17.2	30.4 ± 19.1	0.04
Coronary artery disease, n (%)	121 (67.6)	133 (74.3)	0.20
Previous myocardial infarction, n/total (%)	33/177 (18.6)	47/178 (26.4)	0.10
COPD (any)	74 (41.3)	94 (52.5)	0.04
Creatinine > 2 mg/dL (177 μmol/l), n/total (%)	10/178 (5.6)	17/178 (9.6)	0.23
Atrial fibrillation, n/total (%)	28/85 (32.9)	39/80 (48.8)	0.04
Frailty, n/total (%)	21/116 (18.1)	33/118 (28.0)	0.09
Mean LVEF, %	53.9 ± 13.1	51.1 ± 14.3	0.06
All anatomic inoperable patients,* n (%)	53 (29.6)	37 (20.7)	0.05
Extensively calcified aorta, n (%)	34 (19.0)	20 (11.2)	0.05
Deleterious effects of chest-wall irradiation, n (%)	16 (8.9)	15 (8.4)	1.00
Chest-wall deformity, n (%)	15 (8.4)	9 (5.0)	0.29

Source: Leon et al.4; * data obtained from the study sponsor combining the patient characteristics ‘Extensively calcified aorta’, ‘Deleterious effects of chest-wall irradiation’, and ‘Chest-wall deformity’.

The estimated operative risk (EUROScore), chronic obstructive pulmonary disease (COPD), and atrial fibrillation were statistically significantly (p < 0.05) more prevalent in the control group. There were also more patients with a previous myocardial infarction (26.4 vs 18.6%, p = 0.10) and control patients had a lower left ventricular ejection fraction (LVEF) than TAVI patients (51.1% vs 53.9%, p = 0.06). Patients with ‘frailty’ were over-represented in the standard therapy arm. There were also less patients with an extensively calcified aorta (11.2 vs 19.0%, p = 0.05), i.e. those with a better outlook after a successful intervention, since they do not necessarily have severe medical co-morbid conditions.

Table 3.  PARTNER trial baseline characteristics.

	Cohort A	Cohort B
Medical characteristics
NYHA class III or IV, %	94.2	93.1
Coronary artery disease, %	75.9	71.0
Previous myocardial infarction, %	28.4	22.5
Previous CABG, %	43.4	41.5
Previous PCI, %	33.3	27.7
Previous Balloon aortic valvuloplasty	11.8	20.3
Cerebral vascular disease, %	28.4	27.5
Peripheral vascular disease, %	42.3	27.7
COPD, %: Any	43.2	46.9
COPD, %: Oxygen-dependent	8.2	23.5
Creatinine >2 mg/dL, %	9.1	7.6
Atrial fibrillation, %	41.8	40.9
Previous pacemaker, %	21.0	21.2
Pulmonary hypertension, %	39.4	43.1
Liver disease, %	2.3	3.4
Moderate or severe mitral regurg., %	20.6	22.6
Frailty, %	16.6	23.1
Anatomical characteristics
Extensively calcified aorta, %	0.9	15.1
Effects of chest-wall irradiation, %	0.9	8.7
Chest-wall deformity, %	0.2	6.7
Multiple previous interventions	NR	NR

Cohort A: high-risk operable patients; Cohort B: inoperable patients; NR, not reported.

Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607

 PubMed Web of Science ®Google Scholar

FDA. SAPIEN® THV Briefing Document – Advisory Committee Meeting. FDA, 2011. p 301. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM262935.pdf. [Last accessed 12 February 2013].

 Google Scholar