The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design

Table 1 Patient demographics

	BMAC	Control	Total
Patients	34	14	48
Age (years)	72.5	65.7	69.5
	(42 - 93)	(52 - 85)	(42 - 93)
Male (n)	23	9	32
	(7.6%)	(64.3%)	(66.7%)
Diabetes Mellitus
Type 1	1	1	2
	(2.9%)	(7.1%)	(4.2%)
Type 2	17	5	22
	(50.0%)	(35.7%)	(45.8%)
Type 1 + Type 2	18	6	24
	(52.9%)	(42.9%)	(50.0%)
Renal insufficiency (Cr clearance< 40 mg/dL)	3	1	4
	(8.8%)	(7.1%)	(8.3%)
Cardiac disease
Angina	4	3	7
	(11.8%)	(21.4%)	(14.6%)
Myocardial infarction	11	2	13
	(32.4%)	(14.3%)	(27.1%)
Congestive heart failure	7	4	11
	(20.6%)	(28.6%)	(22.9%)
Other cardiac	20	11	31
	(58.8%)	(78.6%)	(64.6%)
Coronary revascularization
Coronary artery bypass	11	2	13
	(32.4%)	(14.3%)	(27.1%)
Coronary angioplasty	5	6	11
	(14.7%)	(42.9%)	(22.9%)
Rutherford class
Rutherford 4	11	7	18
	(32.4%)	(50.0%)	(37.5%)
Rutherford 5	23	7	30
	(67.6%)	(50.0%)	(62.5%)
Ankle brachial index (ABI)	0.46	0.396	0.44
	(0.13-1.23)	(0.17-0.74)	(0.13-1.23)
Previous amputation (contralateral)
Major amputation	7	1	8
	(20.6%)	(7.1%)	(16.7%)
Minor amputation	6	2	8
	(17.6%)	(14.3%)	(16.7%)
Previous lower extremity revascularization
Surgical bypass	23	8	31
	(67.6%)	(57.1%)	(64.6%)
Angioplasty	8	7	15
	(23.5%)	(50.0%)	(31.3%)
Stent	5	6	11
	(14.7%)	(42.9%)	(22.9%)
Atherectomy	2	4	6
	(5.9%)	(28.6%)	(12.5%)
Reason for no option status
Failed revascularization	18	6	24
	(52.9%)	(42.9%)	(50.0%)
Anatomic poor candidate	31	12	43
	(91.2%)	(85.7%)	(89.6%)
Medical high risk	5	1	6
	(14.7%)	(7.1%)	(12.5%)
Other	1	1	2
	(2.9%)	(7.1%)	(4.2%)
Medication
Cholesterol lowering agent	24	11	35
	(70.6%)	(78.6%)	(72.9%)
Beta blocker	15	5	20
	(44.1%)	(35.7%)	41.7%)
Antiplatelet agent	28	14	42
	(82.4%)	(100.0%)	(87.5%)

ISSN: 1479-5876