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					Comparison of Coronary Artery Bypass
Surgery versus Percutaneous Coronary
Intervention With Drug-Eluting Stents in
 Patients with Chronic Kidney Disease

         Enrico Romagnoli

           Interventional Cardiology Unit
          Policlinico Casilino, Rome, Italy
              enromagnoli@gmail.com
     Background I

 The patient with Chronic Kidney Disease (CKD) and
  Coronary Artery Disease (CAD) represents special
  challenge for interventionalists and cardiologists in
  general.

 Indeed, CKD is associated to worse outcomes both with
  percutaneous and surgical coronary revascularization with
  an increased incidence of both in-hospital and long-term
  clinical events.
     Background II

 A post-hoc analysis of patients with CKD enrolled in the
  Arterial Revascularization Therapies Study (ARTS) trial
  comparing CABG versus PCI showed equivalent mortality
  and morbidity at 5 year, but the requirement for repeat
  procedures remained significantly higher after PCI
  treatment.

 More recently, the non-randomized ARTS II study
  demonstrated     a   comparable   need  for  repeat
  revascularization both with PCI and CABG in general
  population.
      Rationale of the study

 At present, available data on DES safety and efficacy in
  patients with CKD are limited to small single-center
  registries, therefore it is not known whether the improved
  outcomes in PCI with DES will be extended to patients
  with CKD disease.

 With this study we sought to compare the impact of DES
  introduction on clinical outcome of patients with CKD,
  when compared to CABG.
     Methods I: end-points
 We retrospectively identified all patients with Chronic
  kidney disease who underwent coronary revascularization
  at San Raffaele Hospital between 2002 and 2006.

 Primary end-point of the study was freedom from
  cerebrovascular accident, non fatal MI, or death.
  The Secondary end-point was the need for repeat
  revascularization by percutaneous or surgery.

 Additional clinical end-points were post-operative acute
  renal failure or contrast induced nephropathy, sepsis and
  bleeding complication rates.
 Methods II: patients selection

 For the purposes of this study, only patients who received
  DES stents were included in the percutaneous
  revascularization group.

 Patients who had a prior PCI or CABG, with valvular heart
  disease, congenital heart disease, obstructive or
  restrictive cardiomyopathy, and candidate for cardiac or
  renal transplantation were excluded.

 In general, patients who were thought not to be equal
  candidates for either CABG or PCI with DES (e.g. limited
  life expectancy, intolerance to aspirine or ticlopidine) were
  not included in the final analysis.
   Methods III: CKD definition

 Creatinine levels were measured the day before the time
  of the procedure, and renal function was assessed based
  on the CrCl using the Cockcroft-Gault formula*:
                       (140-age) x weight (Kg)
  CrCl (ml/min) =                                   (x 0.85 for females)
                    72 x serum creatinine (mg/dl)

 Renal impairment was defined as a calculated creatinine
  clearance <60 ml/min, the cut-off value proposed by the
  National Kidney Foundation’s Kidney Disease Outcome
  Quality Initiative Advisory Board to identify patients who
  have moderate renal impairment.
                           *Cockroft DW, Gault MH. Nephron. 1976;16:31– 41.
     Study period 2002-2006
PCI group         724 patients with CKD              CABG group
                    (<60 CrCl mil/min)
  407                                                       317
        26                                             10
                 36 patients with ESRD or dialysis
        12                                             137
                  149 patients with valvulopathy
        51                                             5
                 56 patients without LAD disease
        180                                            28
              208 patients with previous PCI or CABG


  138                                                       137
                   275 patients included
                    in the final analysis
   Study population characteristics
                                       Overall     PCI group CABG group      p
Male gender (%)                           72.8        70.5        75.2      0.42
Age (year)                                75±8        73±8        77±7     <0.01
Creatinine (mg/dl)                      1.4±0.5     1.5±0.5     1.3±0.5    <0.01
Creatinine Clearance (ml/min)          45.3±10.4   44.7±10.7   46.0±10.0    0.28
Previous MI (%)                           42.0        38.8        45.3      0.33
CAD family history (%)                    29.8        37.0        22.6      0.01
Hypertension (%)                          77.1        81.2        73.0      0.11
Hypercholesterolemia (%)                  53.3        59.0        47.4      0.07
Current smoker (%)                         8.0         9.4         6.6      0.51
Diabetes (%)                              33.0        33.1        32.8      1.00
Insulin treatment (%)                     10.9        11.5        10.2      0.85
Left ventricle ejection fraction (%)   49.2±11.7   48.9±11.2   49.4±12.1    0.70
Peripheral vascular disease (%)           32.6        37.2        27.7      0.10
Chronic lung disease (%)                  15.6        15.8        15.3      1.00
Neurological dysfunction (%)               4.4         3.6         5.1      0.57
Additive EuroSCORE                         7±3         7±3         7±3      0.56
Logistic EuroSCORE                       12±14       11±12       12±16      0.70
EuroSCORE >6                              52.5        53.2        51.8      0.90
    Study procedural characteristics
                                   Overall   PCI group CABG group     p
Diagnosis
Acute Myocardial infarction (%)      1.1        2.2        0.0       0.25
Unstable angina (%)                 30.8       28.1       33.6       0.36
Stable angina (%)                   73.2       72.7       73.7       0.89
Number of vessel disease (%)
        1                           15.6       23.7        7.3      <0.01
        2                           33.0       39.6       26.3       0.03
        3                           51.4       36.7       66.4      <0.01
   Left Main disease                17.4       10.8       24.1      <0.01
Number of stents implanted            -       3.0±1.8       -             -
Stented segment length (mm)           -      74.0±44.6      -          -
Number of conduits grafted            -          -       2.7±1.1       -
OPCAB (%)                             -          -        59.1         -
IABP use (%)                         8.3       10.1        6.6      0.38
Incomplete revascularization (%)    26.1       23.7       28.5      0.41
    Intended (%)                    17.4       18.7       16.1      0.63
    Unwilling (%)                    8.7        5.0       12.4      0.03
 Results: in-hospital outcome
                   primary end-points
  P=0.02          P=0.44       P=0.33         P=0.03          P= n.s.

        16.1%



                                     9.5%
 6.5%
                              5.8%
                                                  4.4%
                       3.6%
                1.4%
                                             0%              0%   0%

Death MI         Death           MI         TIA/Stroke       TVR/TLR
TIA/Stroke
                                                       PCI         CABG
  Results: in-hospital outcome
                  secondary end-points
P=<0.01    P=<0.01    P=0.027         P=0.99     P=0.02         P=0.01
   47.5%

              35.7%



                                                                      16.0%

8.0%                         10.2%                      9.5%
           7.2%
                      2.9%           2.2% 2.9%   0.7%          1.4%


 MAE       GFR         GFR           GFR>75% Sepsis  Major
           >25%        >50%          (dialysis)     bleeding
                                                        PCI            CABG
 Results: 1-year follow up
                   primary end-points
  P=0.73          P=0.99        P=0.98          P=0.07        P=<0.01

                                                             23.2%
        19.7%
17.4%

                              10.9%
                8.0%                  10.2%
                       7.3%
                                                      5.1%

                                               0.7%                  2.2%


Death MI         Death         Cum MI         TIA/Stroke repeat
TIA/Stroke                                           revascularization
                                 PCI            CABG
 Results: long term follow up
 primary end-points (median 38 months)
  P=0.86          P=0.98          P=0.97        P=0.21        P=<0.01


                                                             29.0%
        27.0%
25.4%

                15.2%
                        14.6%
                                11.6% 10.9%
                                                      5.8%           4.4%
                                               2.2%


Death MI          Death          Cum MI       TIA/Stroke repeat
TIA/Stroke                                           revascularization
                                   PCI          CABG
1-year outcome comparison
1-year outcome comparison
Correlation between renal failure and outcomes
Correlation between renal failure and outcomes
In hospital major adverse avent predictors

    0.01       0.1   1   5   10      15   Univariate analysis

Hypertension                 OR=2.8; 95%CI, 0.8-9.6, p=0.101


Diabetes                     OR=2.4; 95%CI, 1.1-5.3, p=0.024

Unstable angina              OR=1.96; 95%CI, 0.9-4.3, p=0.009


Left Main disease            OR=2.4; 95%CI, 1.0-5.6, p=0.047


CABG                         OR=2.4; 95%CI, 1.1-5.6, p=0.033

eGFR
decrease >25%                OR=5.4; 95%CI, 2.4-11.9, p=<0.01


    0.01       0.1   1   5   10      15
In hospital major adverse avent predictors

    0.01     0.1    1   5   10      15   Multivariate analysis




Diabetes                    OR=2.2; 95%CI, 1.0-5.1, p=0.056




Left Main disease           OR=2.7; 95%CI, 1.1-6.8, p=0.032




eGFR
decrease >25%               OR=4.9; 95%CI, 2.2-11.2, p=<0.01


    0.01     0.1    1   5   10      15
 One-year major adverse avent predictors

    0.01       0.1    1   5   10       15   Univariate analysis

Male gender                   OR=2.1; 95%CI, 0.9-4.7, p=0.074

Smoking history               OR=1.8; 95%CI, 0.9-3.4, p=0.071

Hypertension                  OR=1.9; 95%CI, 0.8-4.5, p=0.136

Diabetes                      OR=2.0; 95%CI, 1.1-3.7, p=0.035

Left main disease             OR=1.5; 95%CI, 0.7-3.3, p=0.275

Unstable angina               OR=2.2; 95%CI, 1.2-4.2, p=0.015

Emergency procedure
                               OR=3.3; 95%CI, 0.9-12.4, p=0.070
eGFR
decrease >25%                 OR=3.4; 95%CI, 1.7-6.6, p=<0.01

    0.01       0.1    1   5   10      15
 One-year major adverse avent predictors

    0.01      0.1   1   5   10      15   Multivariate analysis

Male gender                 OR=2.0; 95%CI, 0.9-4.7, p=0.093




Unstable angina              OR=1.9; 95%CI, 1.0-3.8, p=0.052




eGFR
decrease >25%               OR=2.9; 95%CI, 1.4-5.8, p=<0.01

    0.01      0.1   1   5   10      15
Discussion: DES impact on CKD

 This study confirms patients with CKD having a worse
  outcome with high rate of major adverse events,
  regardless of the revascularization strategy.

 At 1-year follow up, multivessel stenting with DES showed
  similar outcomes of death, MI or cerebrovascular events
  when compared to surgical revascularization.

 The higher rate of TVR at 1-year follow up in the PCI
  group suggests that use of DES does not prevent repeat
  revascularization when compared to CABG.
Discussion: CABG impact on CKD


 CABG treatment is associated with an increased risk of
  peri-procedural major adverse events, when compared to
  PCI.

 In particular, renal impairment and cerebrovascular event
  was 5 folds higher in the CABG group. At 1-year follow up
  the difference is still significant for cerebrovascular events.
Discussion: CKD impact on CKD


 At multivariate analysis the occurrence of post-procedural
  renal insufficiency is the strongest predictor of major
  adverse event (death, MI, or cerebrovascular events)

 There is a correlation between the grade of post-
  procedural renal impairment and the rate of adverse
  events, with the worst outcome in patients requiring
  dialysis treatment.
               Study limitations


 Retrospective design and limited sample size constitute
  the main limitations of this study.

 Only minority of patients were jointly evaluated by cardiac
  surgery and interventional cardiology consultants, then the
  choice of the revascularization strategy has been left to
  the patient-referring physician.
                   Conclusions

 This is the first study to compare clinical outcomes of DES
  versus CABG in patients with CKD.

 The use of DES does not seem to confer incremental
  benefits in death, MI or cerebrovascular events when
  compared to CABG, and does not offer comparable
  results in term of need for repeat revascularization.

 The lower rate of in hospital adverse events suggests that
  PCI with DES could be an acceptable and less invasive
  alternative to CABG in patients at high surgical risk.
    Main goals during the Master
As first author:

   Romagnoli E, Sangiorgi GM, Cosgrave J, et al. Drug eluting stenting the case for post-
    dilation. J Am Coll Cardiol Intv. 2008;1:22–31.

   Romagnoli E, Chieffo A, Ferrari A, et al. Randomized Comparison between Sirolimus
    (Cypher)/Sirolimus-analogous (Xience, Promus) vs. Paclitaxel (Taxus vs. Costar) Eluting
    Stents in Coronary Lesions: a Single Centre Experience. The ABSOLUTE Trial (submitted)

   Romagnoli E, Carminati M, Chessa M. Detachable coil use to treat residual shunt after PFO
    percutaneous closure (submitted)

As co-author:

   Rogacka R, Chieffo A, Michev I, et al. Dual antiplatelet therapy after percutaneous coronary
    intervention with stent implantation in patients taking chronic oral anticoagulation. J Am Coll
    Cardiol Intv. 2008;1:56–61.

   Sangiorgi G, Romagnoli E, Biondi-Zoccai GGL, et al. Percutaneous coronary implantation of
    sirolimus-eluting stents in unselected patients and lesions: clinical results and multiple
    outcome predictors (submitted).

   Butera G, Romagnoli E, Sangiorgi G, et al. Patent Foramen ovale percutaneous closure: the
    no-implannt approach. Expert Rev. Med Devices 2008;5 (in press)
Pz.          Cause              Age   LVEF%   Vessel disease   EuroSCORE      treatment
 1      Pulmonary embolism      82     55           2            11 (27.5%)      PCI

 2         Tumore osseo         72     59           3             7 (6.7%)       PCI

 3      Myocardial infarction   72     45           3           12 (30.4%)       PCI

 4      Myocardial infarction   87     25           3           17 (71.8%)       PCI

 5         Infarto renale       54     46           3             7 (7.3%)       PCI

 6          Heart failure       73     35         2 + LM         11 (22.9%)      PCI

 7       Acute renal failure    65     35           3            9 (11.6%)       PCI

 8     Death during new PCI     79     55           3             7 (9.6%)       PCI

 9          Heart failure       80     37         2 + LM        12 (27.4%)       PCI

10         Sudden death         75     53           3             6 (4.7%)       PCI

11         Sudden death         80     55           3            8 (10.2%)       PCI

12    Acute coronary syndrome   74     35           2             4 (3.5%)      CABG

13             Sepsi            81     55           3             6 (5.9%)      CABG

14       Acute renal failure    78     38         3 + LM         11 (23.7%)     CABG

15          Heart failure       74     40           3            9 (18.6%)      CABG

16       Infarto intestinale    81     50         3 + LM          8 (9.1%)      CABG

17             Stroke           72     60         3 + LM         4 (2.8%)       CABG

18         Sudden death         80     55           3            7 (6.0%)       CABG

19       Tumore polmonare       81     60         3 + LM        10 (17.3%)      CABG
Euroscore risk model evidences

• Predictor of late outcome after CABG
  (Toumpouls IK et al Eur J Cardiothorac Surg. 2004;
  Biancari F et al, Ann Thorac Surg. 2006)

• Predictor of prolonged lenght stay and specific
  postoperative complications such as renal failure and
  sepsis and/or endocarditis after CABG
  (Toumpoulis IK et al. Int J Cardiol 2005)

• Independent predictor of myocardial damage
  (Onorati F, Ann Thorac Surg. 2005)
• Selection criterium of off-pump CABG in high risk
  patients (Euroscore ≥10 and EF <30%)
  (Kunt AS et al, Curr Control Trials Cardiovasc Med. 2005)

• Predictor of in-hospital mortality after percutaneous
  coronary intervention (Romagnoli et al, Heart 2008)
Euroscore risk model
   The European System for Cardiac Operative Risk Evaluation is a
   method of calculating predicted operative mortality for patients
   undergoing cardiac surgery.

                                            Cardiac-related factors
Patient-related factors
                                            Unstable angina (score 2);
Age (score 1, per 5 years over 60 years);
                                            LV dysfunction
Sex (score 1, per female);
                                                    LVEF 30-50% (score 1);
Chronic pulmonary disease (score 1);                LVEF ≤29% (score 3);
Peripheral vascular disease (score 2);      Recent myocardial infarction (score 2);
Neurological dysfunction (score 2);         PAPS >60 mmHg (score 2);
Previous cardiac surgery (score 3);
                                            Operation related factors
Serum creatinine >200 mol/l (score 2);
Active endocarditis (score 3);              Emergency (score 2);
Critical pre-operative state (score 3);     Surgery on thoracic aorta (score 3);
                                            Post-infarct septal rupture (score 4);
For these and further slides on these
 topics please feel free to visit the
       metcardio.org website:

http://www.metcardio.org/slides.html

				
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