PMID- 28807382
OWN - NLM
STAT- MEDLINE
DCOM- 20171030
LR  - 20221207
IS  - 1097-6809 (Electronic)
IS  - 0741-5214 (Linking)
VI  - 66
IP  - 5
DP  - 2017 Nov
TI  - Association between statin therapy and amputation-free survival in patients with 
      critical limb ischemia in the CRITISCH registry.
PG  - 1534-1542
LID - S0741-5214(17)31686-5 [pii]
LID - 10.1016/j.jvs.2017.05.115 [doi]
AB  - OBJECTIVE: Secondary prevention in patients with critical limb ischemia (CLI) is 
      crucial for the reduction of cardiovascular morbidity and mortality. Nonetheless, 
      current recommendations are extrapolated from other high-risk populations because 
      of the lack of CLI-dedicated trials. The aim of this explorative study was to 
      evaluate the association of statin therapy with the outcomes of CLI patients. 
      METHODS: The First-Line Treatments in Patients With Critical Limb Ischemia 
      (CRITISCH) registry is a prospective multicenter registry analyzing the 
      effectiveness of all available treatment strategies in 1200 CLI patients. For the 
      purposes of this analysis, patients were divided into two groups based on statin 
      administration. Treatment crossovers and nonadherent patients were excluded from 
      analysis. The primary composite end point of this study was the amputation-free 
      survival (AFS). Major adverse cardiovascular and cerebral events (MACCEs), time 
      to death, and time to major amputation were also analyzed. RESULTS: Statin 
      therapy was applied in 445 individuals (37%), 371 (31%) patients received no 
      statins, and 384 subjects were excluded from analysis (treatment crossovers). 
      Patients receiving statins were more likely to be younger (P < .001) and to have 
      a history of coronary heart disease (P < .001) or previous intervention at index 
      limb (P < .001). Patients receiving statin therapy had a lower hazard regarding 
      AFS (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.34-0.63; P < .001) 
      and death (HR, 0.40; 95% CI, 0.24-0.66; P < .001) as well as lower odds of MACCE 
      (odds ratio, 0.41; 95% CI, 0.23-0.69; P = .001). However, statin therapy was not 
      associated with reduced amputation rates (HR, 1.02; 95% CI, 0.67-1.56; P = .922). 
      Statin effect on AFS was consistent among diabetics (HR, 0.47; 95% CI, 0.31-0.70; 
      P < .001), patients with chronic kidney disease (HR, 0.53; 95% CI, 0.32-0.87; P = 
      .012), and patients older than 75 years (HR, 0.40; 95% CI, 0.26-0.60; P < .001). 
      Statin administration was also associated with an improved AFS in patients with 
      antiplatelet medication (HR, 0.64; 95% CI, 0.41-0.99; P = .049) and without 
      antiplatelet medication (HR, 0.26; 95% CI, 0.12-0.57; P = .001) and after both 
      endovascular therapy (HR, 0.51; 95% CI, 0.34-0.76; P = .001) and bypass 
      revascularization (HR, 0.38; 95% CI, 0.21-0.68; P = .001). CONCLUSIONS: Statin 
      therapy in CLI patients is associated with an increased AFS and lower rates of 
      mortality and MACCEs without improving, however, the salvage rates of the 
      affected limb.
CI  - Copyright (c) 2017 Society for Vascular Surgery. Published by Elsevier Inc. All 
      rights reserved.
FAU - Stavroulakis, Konstantinos
AU  - Stavroulakis K
AD  - Department of Vascular Surgery, St. Franziskus Hospital GmbH, Muenster, Germany; 
      Department of Vascular Surgery, University Clinic of Muenster, Muenster, Germany. 
      Electronic address: stavroulakis.konstantinos@yahoo.gr.
FAU - Borowski, Matthias
AU  - Borowski M
AD  - Institute of Biostatistics and Clinical Research, Westfalische 
      Wilhelms-Universitat Muenster, Muenster, Germany.
FAU - Torsello, Giovanni
AU  - Torsello G
AD  - Department of Vascular Surgery, St. Franziskus Hospital GmbH, Muenster, Germany; 
      Department of Vascular Surgery, University Clinic of Muenster, Muenster, Germany.
FAU - Bisdas, Theodosios
AU  - Bisdas T
AD  - Department of Vascular Surgery, St. Franziskus Hospital GmbH, Muenster, Germany; 
      Department of Vascular Surgery, University Clinic of Muenster, Muenster, Germany.
CN  - CRITISCH collaborators
LA  - eng
SI  - ClinicalTrials.gov/NCT01877252
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20170812
PL  - United States
TA  - J Vasc Surg
JT  - Journal of vascular surgery
JID - 8407742
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Platelet Aggregation Inhibitors)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - *Amputation, Surgical
MH  - Comorbidity
MH  - Critical Illness
MH  - Disease-Free Survival
MH  - Dyslipidemias/blood/diagnosis/*drug therapy/mortality
MH  - Endovascular Procedures
MH  - Female
MH  - Germany
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*therapeutic use
MH  - Ischemia/diagnosis/mortality/*therapy
MH  - Kaplan-Meier Estimate
MH  - Limb Salvage
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Odds Ratio
MH  - Peripheral Arterial Disease/diagnosis/mortality/*therapy
MH  - Platelet Aggregation Inhibitors/therapeutic use
MH  - Proportional Hazards Models
MH  - Protective Factors
MH  - Registries
MH  - Risk Assessment
MH  - Risk Factors
MH  - Secondary Prevention/*methods
MH  - Time Factors
MH  - Treatment Outcome
MH  - Vascular Grafting
FIR - Adili, Farzin
IR  - Adili F
FIR - Balzer, Kai
IR  - Balzer K
FIR - Billing, Arend
IR  - Billing A
FIR - Bockler, Dittmar
IR  - Bockler D
FIR - Brixner, Daniel
IR  - Brixner D
FIR - Debus, Sebastian E
IR  - Debus SE
FIR - Eckstein, Hans-Henning
IR  - Eckstein HH
FIR - Florek, Hans-Joachim
IR  - Florek HJ
FIR - Gkremoutis, Asimakis
IR  - Gkremoutis A
FIR - Grundmann, Reinhardt
IR  - Grundmann R
FIR - Hupp, Thomas
IR  - Hupp T
FIR - Keck, Tobias
IR  - Keck T
FIR - Gerss, Joachim
IR  - Gerss J
FIR - Klonek, Wojciech
IR  - Klonek W
FIR - Lang, Werner
IR  - Lang W
FIR - May, Bjorn
IR  - May B
FIR - Meyer, Alexander
IR  - Meyer A
FIR - Muhling, Bernhard
IR  - Muhling B
FIR - Oberhuber, Alexander
IR  - Oberhuber A
FIR - Reinecke, Holger
IR  - Reinecke H
FIR - Reinhold, Christian
IR  - Reinhold C
FIR - Ritter, Ralf-Gerhard
IR  - Ritter RG
FIR - Schelzig, Hubert
IR  - Schelzig H
FIR - Schlensack, Christian
IR  - Schlensack C
FIR - Schmitz-Rixen, Thomas
IR  - Schmitz-Rixen T
FIR - Schulte, Karl-Ludwig
IR  - Schulte KL
FIR - Spohn, Matthias
IR  - Spohn M
FIR - Steinbauer, Markus
IR  - Steinbauer M
FIR - Storck, Martin
IR  - Storck M
FIR - Trede, Matthias
IR  - Trede M
FIR - Uhl, Christian
IR  - Uhl C
FIR - Weis-Muller, Barbara
IR  - Weis-Muller B
FIR - Wenk, Heiner
IR  - Wenk H
FIR - Zeller, Thomas
IR  - Zeller T
FIR - Zhorzel, Sven
IR  - Zhorzel S
FIR - Zimmermann, Alexander
IR  - Zimmermann A
EDAT- 2017/08/16 06:00
MHDA- 2017/10/31 06:00
CRDT- 2017/08/16 06:00
PHST- 2017/01/02 00:00 [received]
PHST- 2017/05/15 00:00 [accepted]
PHST- 2017/08/16 06:00 [pubmed]
PHST- 2017/10/31 06:00 [medline]
PHST- 2017/08/16 06:00 [entrez]
AID - S0741-5214(17)31686-5 [pii]
AID - 10.1016/j.jvs.2017.05.115 [doi]
PST - ppublish
SO  - J Vasc Surg. 2017 Nov;66(5):1534-1542. doi: 10.1016/j.jvs.2017.05.115. Epub 2017 
      Aug 12.