1. results from the Italian multicentre RAI Registry
Clinical outcome of bioresorbable vascular scaffolds in patients on dialysis treatment:
results from the Italian multicentre RAI Registry
Bernardo Cortese 1, Davide Piraino 2, Giuseppe Tarantini 3, Alessandro Colombo 4, Bruno Loi 5, Paolo Calabrò 6, Pietro Mazzarotto 7, Luciano Moretti 8,
Gabriele Tumminello 9, Francesco Pisano 10, Donatella Corrado 11, Giuseppe Steffenino 12
1Interventional Cardiology, A.O. Fatebenefratelli, Milan, Italy; 2Interventional Cardiology Unit, Policlinico “P.Giaccone” Palermo, Italy; 3Department of Cardiac, Thoracic and Vascular Sciences,
University of Padua Medical School, Padua, Italy; 4Interventional Cardiology, Ospedale Luigi Sacco, Milano, Italy; 5Cardiology Division, A.O. Brotzu, Cagliari, Italy; 6Interventional Cardiology, A.O.U. Federico II, Naples, Italy;
7Cardiology Division, Ospedale Maggiore, Lodi, Italy; 8Cardiology Division, Ospedale Mazzoni, Ascoli Piceno, Italy; 9Cardiology Division, Ospedale Cardinal Massaia, Asti, Italy;
10Interventional Cardiology, Ospedale Regionale Umberto Parini, Aosta, Italy; 11Fondazione Mario Negri Sud, Milan, Italy; 12USD Emodinamica, A.S.O. S.Croce e Carle, Cuneo, Italy
1520 patients enrolled
816 patients with normal renal function
(GFR > 90 ml/min)
704 patients with any stage of CDK
(GFR < 90 ml/min)
682 patients with mild-moderate CDK
(≥ 30 ml/min)
16 patients with severe CDK
(< 30ml/min)
6 patients on dialysis treatment
BACKGROUND
Chronic kidney disease (CKD) has a high prevalence in patients with coronary artery disease, ranging in about 20-45% of the cases. The outcome of CKD patients is impaired with increased mortality and a higher risk of major adverse cardiac event (MACE) after percutaneous coronary interventions (PCI), due to the complexity of the lesions, their high calcific burden, antiplatelet therapy resistance and higher platelet reactivity. The performance of bioresorbable vascular scaffolds (BVS) in patients with severe CDK is still unknown.
METHODS
The RAI Registry (ClinicalTrials.gov Identifier: NCT ) is an investigator-driven, multicentre, prospective registry including 1520 real-world patients treated with the BVS and consecutively enrolled at 25 sites in Italy.
RESULTS
Out of the 704 (46%) patients with any type of CKD enrolled, 16 patients had severe CKD (Class IV, glomerular filtration rate GFR, <30ml/min) and 6 were on dialysis treatment (Class V). Primary endpoint of this sub-study was target vessel failure (TVF) during available follow up. Mean age was 62.5 ±12 years, 12 (55%) patients were female and 10 (41%) had diabetes mellitus. Clinical indication for PCI was acute coronary syndrome in 64% of patients, including 28% of patients with ST-segment elevation myocardial infarction. After an average follow up of 7.7±5.3 months, the Class IV-V CDK population experienced one episode of TVF 18 months after BVS implantation. We did not register episodes of scaffold thrombosis or cardiac death.
CONCLUSIONS
The real-world RAI Registry shows that BVS implantation in patients with severe CDK is safe at a mid-term follow up.
Severe CKD (16 pz)
Dialysis Treatment (6 pz)
Procedural and Angiographic characteristics
MonoVessel PCI
93% (15 pz)
100% (6 pz)
Target Vessel
Left Anterior Descending artery
72% (16 pz)
Left Circumflex Artery
9% (2 pz)
Right Coronary Artery
4,5% (1pz)
Venous graft
Lesion Predilatation
Mandatory in all lesion with a semi-compliant balloon
Number of stents/lesion
1,5±0,7
Postdilatation after BVS implantation
50% (8 pz)
50% (3 pz)
Procedural Success
100% (22 pz)
TIMI flow grade 3 after procedure
In Hospital and Follow up Characteristics
In-Hospital events
Periprocedural-Myocardial Infarction
Death
Acute/Sub-acute scaffold thrombosis
Minor/major bleeding events
Follow up lenght
7,7 ± 5.3 months
Target Vessel Failure
1pz due to Target lesion revascularization (TLR)
Cardiac Death
Scaffold Thrombosis
Major adverse cardiac and cerebrovascular events
Figure 1: Population sample, according to CKD grade.
Severe CKD (16 pz)
Dialysis Treatment (6 pz)
Patient Characteristics
Mean Age
62.5 ±12 years
Female gender
55% (12 pz)
Diabetes Mellitus
31% (5 pz)
67% (4 pz)
Smoke
18% (3 pz)
16% (1 pz)
Hypertension
62% (10 pz)
83% (5 pz)
BMI
26,45±1,6
28,3±4,9
Clinical Presentation
Stable Angina
43% (7 pz)
32% (2 pz)
Acute Coronary Syndrome
56% (9 pz)
67%(4 pz)
-STEMI
Multivessel Disease (vessel >1)
56%(9 pz)
100%(6)
Previous MI FE
55±7%
48±12%
Table 2: Procedural,angiographic characteristics, in hospital and follow up events
Table 1: Demographic and clinical characteristics