Appendix
I.
Members of SAFE-PCI for Women Trial committees
a. Steering committee: Mitchell W. Krucoff MD (Chair), Sunil V. Rao
(Principal Investigator), Connie N. Hess MD, Britt Barham (Project
Leader), Kevin Anstrom PhD, Sanjit S. Jolly MD, Alice Jacobs MD,
L. Kristin Newby MD, C. Michael Gibson MD, David F. Kong MD,
Roxana Mehran MD, Ron Waksman MD, Ian C. Gilchrist MD
b. Data Safety Monitoring Board: Spencer King MD (Chair), Olivier F.
Bertrand MD PhD, Alexandra Lansky MD, Timothy Morgan PhD
c. Clinical Events Adjudication Committee: W. Schuyler Jones MD
(CEC Principal Investigator), Alexandra Shen MD, Prateeti
Khazanie MD, Thomas J. Povsic MD PhD, Chiara Melloni MD,
Pierluigi Tricoci MD, J. Matthew Brennan MD
II.
Partner Organizations
a. American College of Cardiology: Angelo Ponirakis, Kathleen Hewitt
MSN, John Messenger MD
b. National Cardiovascular Research Infrastructure: Robert A.
Harrington MD, Eric D. Peterson MD MPH, Brian J. McCourt
III.
Participating investigators –T. Patel, J. Jorgensen, E. Mazzaferri, M.
Martinelli, N. Patel, R. Caputo, P. Kaul, D. Westerhausen, S. Jones, C.
Pyne, P. Amsterdam, E. Moen, S. Mannino, A. Sonn, I. Arif, P. Best, T.
Mann, H. Malave, D. Abbott, F. Jaffer, K. Skelding, B. Ellis, R. Patel, S.
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Yakubov, D. Steinbgerg, L. Gruberg, J. Aji, N. Mejevoi, B. Stein, S.
Gandhi, N. El-Gharib/H. Dauerman, M. Vidovich, K.Tummalapalli, R.
Quesada, P. Patel, R. Yaryura, J. Tremmel, S. Guidera, G. Revtyak, G.
Ramaswamy, M. Ahmed, R. Nelson, M. East, G. Nseir, C. Barker/H.V.
Anderson, K. Gibbs, V. Iyer, J. Pap, D. Allen, D. Lewis, S. Maraboyina,
S. Martin, I. Gilchrist, M. White, P. Mason, C. Panetta, R. Shetty, D.
Sporn, D. Linert, J. Safirstein, R. Mazhari, C. Maniu
IV.
Definitions of the primary and secondary endpoints
a. Primary efficacy endpoint - Bleeding Academic Research
Consortium (BARC) Types 2, 3, or 5 bleeding or Vascular
complications requiring intervention
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Type 2 - Any overt, actionable sign of hemorrhage (e.g.,
more bleeding than would be expected for a clinical
circumstance; including bleeding found by imaging alone)
that does not fit the criteria for Types 3, 4, or 5, but does
meet at least one of the following criteria: 1) Requiring nonsurgical, medical intervention by a health care professional
2) Leading to hospitalization or increased level of care 3)
Prompting evaluation
ii. Type 3
1. Type 3a - Overt bleeding plus hemoglobin drop of 3 to
<5 g/dL (corrected for transfusion) provided
hemoglobin drop is related to bleed; Any transfusion
with overt bleeding
2. Type 3b - Overt bleeding plus hemoglobin drop ≥ 5
g/dL (corrected for transfusion) provided hemoglobin
drop is related to bleed; Cardiac tamponade; Bleeding
requiring surgical intervention for control (excluding
dental/nasal/skin/hemorrhoid); Bleeding requiring
intravenous vasoactive agents
3. Type 3c - Intracranial hemorrhage (does not include
microbleeds or hemorrhagic transformation; does
include intraspinal) confirmed by autopsy or imaging
or LP; Intra-ocular bleed compromising vision
iii. Type 5 - Fatal Bleeding
1. Type 5a - Probable fatal bleeding: no autopsy or
imaging confirmation, but clinically suspicious
2. Type 5b - Definite fatal bleeding: overt bleeding or
autopsy or imaging confirmation.
iv. Vascular complications defined as a composite of
arteriovenous fistula, or arterial pseudoaneurysm, or arterial
occlusion requiring intervention
Definitions of TIMI Major, TIMI Minor, ACUITY Major, and CathPCI
bleeding
a. TIMI major bleeding - Hemoglobin drop > 5 g/dL (with an identified
site of bleeding, not associated with CABG) or Intracranial
hemorrhage or cardiac tamponade.
b. Modified TIMI minor bleeding - Hemoglobin drop > 3 g/dL but <= 5
g/dL, with a known site (not associated with CABG) or
Spontaneous gross hematuria.
i.
V.
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VI.
c. Modified ACUITY bleeding - At least one of the following not
associated with CABG: Intracranial bleeding, retroperitoneal
bleeding, intraocular bleeding, access site hemorrhage requiring
surgical intervention, > 5 cm diameter hematoma at puncture site,
reduction in hemoglobin concentration of > 4 g/dL without an overt
source of bleeding, reduction in hemoglobin concentration of > 3
g/dL with an overt source of bleeding, re-operation for bleeding or
use of any blood product transfusion
d. Modified CATHPCI bleeding definition - Bleed is not associated
with CABG and at least one of the following: 1. Hemoglobin drop of
>=3 g/dL 2. Transfusion of whole blood or packed red blood cells 3.
Procedural intervention/surgery at the bleeding site to reverse/stop
or correct the bleeding (such as surgical closures/exploration of the
arteriotomy site, balloon angioplasty to seal an arterial tear,
endoscopy with cautery of a GI bleed).
Reasons for access site conversion (access site crossover)
a. Total randomized cohort
i. Conversion from radial access to femoral access other than
arterial spasm
1. Unable to gain arterial access (14 patients)
2. Arterial tortuosity limiting engagement of coronary
ostia (6 patients)
3. Poor catheter support (2 patients)
4. Referring physician requested bi-plane procedure
after pt was randomized, case was done femorally
5. Radial arterial loop, unable to advance the catheter
6. Allen and Barbeau test abnormal in cath lab.
7. Had both spasm in left radial and poor guide support
in right radial
8. Hx of lumpectomy & axillary node dissection on right
in the past
ii. Conversion from femoral to radial access
1. Femoral pulse too weak
2. Significant candida infection in groin
3. Unable to complete procedure
4. High grade stenosis (2 patients)
b. PCI cohort (subset of the total randomized cohort)
i. Conversion from radial to femoral access for reasons other
than arterial spasm
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VII.
1. Unable to gain arterial access (15 patients)
2. Arterial tortuosity limiting engagement of coronary
ostia (2 patients)
3. Poor guide catheter support
4. Referring physician requested bi-plane procedure
after pt was randomized, case was done femorally
5. Radial arterial loop, unable to advance the catheter
6. Allen and Barbeau test abnormal in cath lab.
7. Had both spasm in left radial and poor guide support
in right radial
8. Hx of lumpectomy & axillary node dissection on right
in the past
ii. Conversion from femoral to radial access
1. High grade stenosis
2. Weak pulse
3. Significant candida infection in groin
Primary efficacy endpoint results by actual treatment received
a. Total randomized cohort
i. Radial 0.6% vs. Femoral 1.6%, OR 0.36 (0.13-1.99), P=0.05
b. PCI cohort
i. Radial 0.9% vs. Femoral 3.1%, OR 0.29 (0.08-1.06), P=0.06
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