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PRevEntion of cardiac and Vascular pEriprocedural complications in patients undergoiNg coronary angiography or angioplasTy: IntraCoronary Adenosine administration.

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Presentation on theme: "PRevEntion of cardiac and Vascular pEriprocedural complications in patients undergoiNg coronary angiography or angioplasTy: IntraCoronary Adenosine administration."— Presentation transcript:

1 PRevEntion of cardiac and Vascular pEriprocedural complications in patients undergoiNg coronary angiography or angioplasTy: IntraCoronary Adenosine administration to prevent peRiprocedUral myonecrosiS in elective coronary angioplasty. A prospective double-blind randomized trial (PREVENT – ICARUS) trial. Giuseppe De Luca, MD, PhD Aggregate Professor of Cardiology Chief Interventional Cardiology Eastern Piedmont University Novara ClinicalTrials.gov NCT01148147

2 I, Giuseppe De Luca Do not have any conflict of interest

3 Distal embolization Side branch Loss Reperfusion injury Myocardial ischemia / coronary vasospasm PERIPROCEDURAL MYONECROSIS / INFARCTION PREVENT-ICARUS

4 Prevention of periprocedural Myonecrosis Glycoprotein IIb-IIIa Verapamil Nitroprussiate Nicorandil Adenosine Distal/proximal protection devices DRUGS PREVENT-ICARUS

5 Adenosine Receptor A 1 :Responsible for AV block Receptor A 2A : Microcirculation Vasodilatation Receptor A 2B : Broncospasm Receptor A 3 : Inhibiton of neutrophil degranulation PREVENT-ICARUS

6 Pharmacological effects of Adenosine Inhibition of platelet aggregation and thrombus formation Inhibition of activation and accumulation of neutrophils, and their adhesion to endothelial cells Reduction of calcium overloading and formation of Oxigen free radicals Vasodilatation of microcirculation Ischemic preconditioning PREVENT-ICARUS

7 Previous trials in elective patients Desmet et al: Pilot study ADELINE, 28 pts; adenosine ev -> Reduction in CK-MB Lee et al: Randomized trials with 62 pts; ic Bolus (50 μg) of adenosine before elective angioplasty -> significant reduction in myonecrosis (39% vs 13%) Limitation 1) Open label design 2) Small dimension 3) Low-dose intracoronary adenosine 4) No overall difference in periprocedural MI as defined by 3 times increase in CK-MB PREVENT-ICARUS

8 Aim of the Study To evaluate the adjunctive benefits of high- dose intracoronary adenosine administration as compared to placebo to prevent periprocedural myonecrosis in patients undergoing elective coronary angioplasty. PREVENT-ICARUS

9 METHODS PREVENT-ICARUS This is a single center, double blind randomized trial. Patients undergoing elective coronary angioplasty were randomly assigned (1:1) through sealed envelops to Placebo or Adenosine administrated intracoronary through the guiding catheter.

10 Exclusion criteria 1)Marked Bradycardia (< 40 bpm) 2)Previous allergy to adenosine 3)Inability to sign the informed consent 4)Asthma 5)Elevated cardiac enzymes (troponin I o CK-MB)

11 After knowing the treatment arm, a nurse not involved in the revascularization procedure prepared adenosine (diluted to 10 ml with 0.9% NaCl solution, at a concentration of 60 ug/ml) or placebo (10 ml 0.9% NaCl solution), both contained in a 10 cc syringe. Study drug (Adenosine) or placebo were administrated intracoronary through the guiding catheter at the dose of 120 ug (2 ml) (right coronary artery) and 180 ug (3 ml) (left coronary artery), respectively. In case of chronically occluded vessel, randomization was performed after initial dilatation, with al least antegrade TIMI 2 flow. Patients were clinically followed from hospital admission up to discharge. METHODS

12 Study Endpoints Primary study endpoint: Periprocedural increase in troponin I (> 3 times the upper normal limit). Secondary study endpoints: 1)Angiographic coronary flow, as evaluated by corrected TIMI frame count; 2) Increase in Troponin I > 10 times ULN; 3) Increase in CK-MB mass > 3 times ULN; 4) Cumulative in-hospital incidence of death, periprocedural MI, urgent target-vessel revascularization. Safety endpoint: Incidence of bradycardia and ventricular arrhythmias during study drug administration. PREVENT-ICARUS

13 According to an expected 15% absolute reduction (60% relative reduction) in the incidence of periprocedural myonecrosis with intracoronary adenosine as compared to placebo (from 25 to 10%), with an anticipated two sided test for differences in independent binomial proportions at the 5.0% and a statistical power of 80%, a total 112 patients per group were needed. In order to avoid any drop out, the enrolment was extended up to 130 patients per group. Study Hypothesis

14 260 patients undergoing elective angioplasty IC PLACEBO (N = 130) 0 h PCI 12 h 6 h 120-180 μg IC Adenosine (N = 130) Cardiac enzymes Study Flow Chart Hospital discharge Clinical outcome

15 VariableADENOSINE (N = 130)PLACEBO (N = 130)p value Baseline clinical and demographic characteristics Age (mean + SD)68 + 1169 + 100.89 Male Sex (%)71.578.50.2 Diabetes (%)32.331.80.93 Hypercolesterolemia (%)62.358.50.53 Smoking (%)21.131.50.07 Family hystory CAD (%)3030.80.89 Chronic Renal Failure (%)2015.40.33 Hypertension (%)76.975.40.77 Previous MI (%)29.531.50.72 Previous PCI (%)3025.40.41 Previous CABG (%)6.911.50.2 Previous CVA (%)9.210.10.82 Indication for angiography0.13 Stable angina (%)43.137.7 CMPD o Valvular heart disease (%) 6.914.6 ACS (%)5047.7 Patients’ characteristics

16 VariableADENOSINE (N = 130)PLACEBO (N = 130)p value Biochemistry Glyaceamia137 + 61131 + 520.45 Creatinin1.14 + 0.641.1 + 0.340.52 Platelet count216 + 62213 + 540.71 WBC7.32 + 1.727.78 + 5.320.35 Hb13.5 + 1.713.6 + 1.70.67 Therapy at admission Statines (%)66.263.80.7 ASA (%)73.879.20.31 Nitrates (%)48.556.20.21 Beta-blockers (%)66.9620.41 Ace-Inibitors (%)44.647.30.67 ARB (%)20.824.80.44 Diuretics (%)33.829.50.45 Ca-antagonists (%)27.125.40.75 Clopidogrel (%)37.733.10.44 Patients’ characteristics

17 VariableADENOSINE (N = 130)PLACEBO (N = 130)p value Target Vessel0.46 Left main (%)0.61.2 LAD (%)3730.3 LCx (%)30.927.3 RCA (%)27.934.5 AL (%)1.22.4 GRAFT (%)2.44.2 Multivessl disease (%)60.557.40.61 ≥ 2 treated lesions (%)25.620.20.3 Multivessel PCI (%)11.513.80.58 Type C Lesion (%)15.222.40.091 Lesion lenght (mm)18.6 + 10.518.1 + 11.40.67 % stenosis (mean + SD)85.8 + 11.889.1 + 9.310.005 Reference diameter (mm)3.05 + 0.783.21 + 1.440.24 Calcifications(%)2310.30.002 Bifurcation(%)15.620.60.25 Thrombus visible (%)30.60.21 Total Chronic occlusion (%)1.26.10.035 In-stent restenosis (%)7.39.10.55 Angiographic characteristics

18 VariableADENOSINE (N = 130)PLACEBO (N = 130)p value Preprocedural TIMI flow (%)0.038 TIMI 3 (%)95.290.9 TIMI 2 (%)31.2 TIMI 1 (%)01.8 TIMI 0 (%)1.86.1 GP IIb-IIIa Inhibitors (%)35.240.60.36 Clopidogrel loading dose > 4h (%)43.441.70.79 Stenting0.2 No (%)1.24.2 Direct (%)31.526.7 Predilatation (%)67.369.1 DES (%)52.851.30.79 Max balloon dilatation (atm)20.6 + 3.520.5 + 3.50.71 Postdilatation (%)77.675.80.7 n° stent / patients1.3 + 0.641.23 + 0.260.66 Multiple overlapping stent (%)14.513.30.75 Total stent lenght23.6 + 13.823.5 + 15.30.9 Maximum stent diameter3.11 + 0.553.16 + 0.580.42 Residual thrombus (%)00.61.0 Distal embolization (%)0.61.21.0 Loss of Side brach > 2 mm030.06 Procedural characteristics and results

19 VariableADENOSINE (N = 130)PLACEBO (N = 130)p value Postprocedural TIMI flow (%)0.18 TIMI 3 (%)99.497 TIMI 2 (%)01.8 TIMI 1 (%)00 TIMI 0 (%)0.61.2 IABP (%)00.61 Thrombectomy(%)00.61 Distal protection (%)01.20.5 Procedural success (%)99.4970.6 Adenosine (%)1000.6<0.00001 Procedural characteristics and results PREVENT-ICARUS

20 Troponin I > 3 times ULN (%) 67.7 70 p = 0.69 Adenosine Placebo Primary End-point PREVENT-ICARUS

21 54.6 43.1 p = 0.063 Adenosine Placebo Troponin I > 10 Times ULN (%) Secondary End-point PREVENT-ICARUS

22 12.3 10 p = 0.55 CK-MB mass > 3 times ULN (%) Adenosine Placebo Secondary End-point PREVENT-ICARUS

23 11.4 13 P = 0.21 cTFC (Frames) Adenosine Placebo Secondary End-point PREVENT-ICARUS

24 In-Hospital Death, PeriMI and uTVR(%) MorteuTVR 0.8 1.5 0 0 p = 1.0 13.1 10 MACE Adenosina Placebo Secondary End-point PREVENT-ICARUS p = 0.28 p = 0.44

25 Safety Profile 13 cases (10%) of transient (2-4 seconds) AV block, clinically irrilevant (p < 0.001 vs placebo). PREVENT-ICARUS

26 CONCLUSIONS Our randomized trial showed that preprocedural intracoronary administration of a single high-dose bolus of adenosine does not provide any benefit in terms of periprocedural myonecrosis in patients undergoing elective coronary angioplasty. PREVENT-ICARUS

27 However beautiful the strategy, you should occasionally look at the results (Winston Churcill)

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