Transcript 'The EUROpean Cardiac and Renal Remote Ischemic Pre

"The EUROpean Cardiac and Renal
Remote Ischemic Pre-conditioning
Study (EURO-CRIPS):
study design and methods."
Enrico Cerrato, MD
University of Turin, Turin, Italy
http://www.emounito.org
BACKGROUND:
BACKGROUND:
 P. A. McCullough, R. Wolyn, L. L. Rocher, R. N. Levin, and W.
W. O’Neill, “Acute renal failure after coronary intervention:
incidence, risk factors, and relationship to mortality,” American
Journal of Medicine, vol. 103, no. 5, pp. 368–375, 1997.
 E. M. Levy, C. M. Viscoli, and R. I. Horwitz, “The effect of acute
renal failure on mortality: a cohort analysis,” Journal of the
American Medical Association, vol. 275, no. 19, pp. 1489–
1494, 1996.
 Best PJ, Lennon R, Ting HH, Bell MR, Rihal CS, Holmes DR,
Berger PB., “The impact of renal insufficiency on clinical
outcomes in patients undergoing percutaneous coronary
interventions,” Journal of the American College of Cardiology,
2002; 39:1113– 1119.
 Brown JR, Malenka DJ, DeVries JT, Robb JF, Jayne JE,
Friedman BJ, Hettleman BD, Niles NW, Kaplan AV, Schoolwerth
AC, Thompson CA; Dartmouth Dynamic Registry Investigators,
“Transient and persistent renal dysfunction are predictors of
survival after percutaneous coronary intervention: insights from
the Dartmouth Dynamic Registry,” Catheterization and
Cardiovascular Interventions, 2008;72: 347–354
242 pts
Elective PCI
RIPC reduced:
 pain during the procedure
 electrocardiographic evidence
of ischaemia
 troponin release
 major adverse cardiac and
cerebral events at 6 months
Botker HE, Kharbanda R, Schmidt.
Prehospital remote perconditioning reduces infarct
size in patients with evolving myocardial infarction
undergoing primary percutaneous intervention.
Presented at Featured Clinical Studies session, 58th
Annual Scientific Sessions of American College of
Cardiology;
Orlando; March 29–31, 2009
The primary endpoint was myocardial salvage
assessed by nuclear scintigraphy (8h – 30d). The
study was completed after recruitment of 333
patients.
AIMS:
Conclusion:
255pts – 3 centers - NSTEMI
RIC by serial balloon inflations
and deflations during PCI.
- NNT 6 to avoid AKI
- Better 30-day clinical
outcome.p=0.05
AIMS:
The aim of the EURO-CRIPS Trial is to test whether in a real
world setting the use of a remote ischemic preconditioning
protocol vs. the current recommended gold standard therapy
for percutaneous myocardial revascularization in diabetic as in
non diabetic patients can reduce
the incidence of contrast induced nephropathy
and the amount of cardiac enzyme leakage during index
hospitalization.
Additionally, we will evaluate whether the pre-conditioned
patients will have a reduction of MACCE at 6 months.
METHODS: trial design
and eligibility criteria
METHODS: primary end point
METHODS: secondary end point
 Major adverse cerebro- and cardiovascular events (MACCE, defined as the
composite of death, nonfatal AMI, stroke and clinically-driven TVR) will be
adjudicated within 6 months
 Diabetes mellitus (DM) (defined as assuming anti-diabetic drugs, both oral or
insuline-therapy or a new diagnosis of DM defined as HbA1c level 6.5% (47
mmol/mol) or higher) was the only pre-specified subgroup of interest
METHODS: sample size
The study of Er et al. has shown an absolute reduction of AKI of 28% in patients at high
risk of AKI according to the score of Mehran. Incidence of AKI in patients with renal
clearance less than 60 ml/min/m2 is 18% in many contemporary registries and trials,
and considering a reduction of about one quarter clinically significant, using a two
tests queues for superiority, 555 patients per group will be necessary.
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Divisione di Cardiologia 1, A.O.U. Città della salute e della Scienza di Torino (Dr. C. Moretti)
Institut Cardiovasculaire Paris Sud, Hôpital Jacques Cartier, Paris, France (Dr. T. Levefre)
U.O. di Cardiologia, A.O. San Luigi Gonzaga, Orbassano (Dr. G. Carini)
U.O. di Cardiologia, A.O. Maria Vittoria, Torino (Dr. R. Belli)
U.O. di Cardiologia, Presidio Ospedaliero Misericordia, Grosseto (Dr U. Limbruno)
Department of Cardiology, Njeng Hospital, Pechino (Dr Chen)
U.O. di Cardiologia, A.O. s. Giovanni Bosco, Torino (Dr. F. Ugo)
U.O. Cardiologia, A.O. Morgagni, Forlì (Dr. F. Ottani)
U.O. di Cardiologia, A.O. Senese Siena (Dr R. Palazzuoli)
Cardiovascular Institute, Hospital Clinico San Carlos, Madrid, Spain (Dr. J. Escaned)
Istituto Humanitas, Cardiologia Interventistica (Dr.ssa Presbitero – Dr. Rossi)
DISCUSSION: future perspectives
Once proved its role in improving outcome of non urgent
percutaneous coronary revascularization procedures, it will be
of great interest the effort to extend RIPC to various different
clinical scenario of ischemia-reperfusion injury syndromes.
Due to its cheapness and no known adverse risks, RIPC
could even be administered at the emergency room in subjects
with suspected acute coronary syndrome.
If usefulness of RIPC in “hub” centers may translate in fewer
PCI complications with shorter hospital stay, we can’t exclude its
adoption also in “spoke” intensive care units as
“postconditioning” adjunctive therapy in patients undergone to
thrombolysis or in candidates to a conservative approach.
Grazie
Thank you for your attention
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