Clinical trial NCT03538509: Percutaneous Coronary Intervention in Patients witH OrthotoPic hEart Transplantation: the PCI-HOPE a Multicenter Study.
Official title: Percutaneous Coronary Intervention in Patients witH OrthotoPic hEart Transplantation: the PCI-HOPE a Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplant Failure and Rejection
Coronary Artery Disease
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: Azienda Ospedaliera Universitaria Integrata Verona
name: University of Padova
name: University of Bologna
name: Hospital Clinic of Barcelona
name: University of Roma La Sapienza
First posted: 2018-05-29
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Evaluation incidence, prognostic factors and outcomes of percutaneous theraphy in patients with Transplant Coronary Artery Disease (TCAD)

Brief summary: This is a retrospective, multicenter, study including patients undergone to one or more percutaneous revascularization after OHT. The rate of restenosis, the kind of percutaneous revascularization, the feature of coronary disease and the medical therapy for positive vessel remodeling will be evaluated.

Detailed description: Actual standard of care. Orthotopic heart transplantation (OHT) represents the optimal solution for the cure of end-stage heart failure, but it is burdened by numerous comorbidity. The main cause of morbidity and mortality in these patients is related to Transplant coronary artery disease (TCAD), that affects at least fifth percent of transplanted at five years of transplantation. TCAD is a purely immunological phenomen, emphasized by non-immunological factors, favoring oxidative stress, like dyslipidemia, smoking, hypertension, diabetes.(1-3) Many anatomic-pathological studies showed cellular infiltration with predominance of T-cell, mainly in the neointima and in adventizia. TCAD often resulted without angor because of denervation of the heart after transplantation (4-6). The managment and the treatment of TCAD are somewhat complex, because of accelerated vasal infiltration. Furthermore in multivessel disease a surgery revascularisation presented an elevated surgery risk.

Limits and complications of actual standard of care. In the first era of angioplasty percutaneous therapy was considered like palliation in this kind of coronary lesions , but with the beginning of BMS and DES era the outcomes of these patients considerably improved. However TCAD's lesions showed a rate of restenosis greater than classic atherosclerotic plaques(7). There is also a disagreement of results between implantation of DES or BMS, because some studies showed a superiority of the DES group, others didn't show any significant difference(8-9).

Potential improvements of standard of care. In this retrospective study an interesting point of research would be point out if the risk of restenosis was reduced with a particular kind of medicated stent for local effect of polymers, currently used. The general pharmacological effect of sirolimus was known like inhibitor of cell-T proliferation and then it could reduce vessel cellular infiltration, acting as a local immunosuppressant(10-12).

For this argument evidence is discordant, although the problem is getting relevant due to the prolonged survival of these patients and the augmented number of transplantation. These patients are often young and have an elevated general risk for iatrogenic immunosuppressed state. Therefore with this retrospective study we propose to understand the physio-pathological mechanisms of TCAD and also what actual therapy results the best .

Eligibility criteria: Inclusion Criteria:

* All consecutive patients undergone percutaneous revascularization, both with symptomatic CAD and asymptomatic, with one or more coronary vessel disease, will be enrolled.

Exclusion Criteria:

1. Infective endocarditis;
2. Life expectancy less than 1 year for non-cardiovascular causes;
3. Recent cerebrovascular accident (\<6 months);
4. Inability to express informed consent;

Primary outcomes:
measure: Rate of restenosis
timeFrame: 18 years
Secondary outcomes:
measure: MACE
timeFrame: 18 years
measure: Rate of TCAD
timeFrame: 18 years
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Citta della Salute
Study officials:
References:
citation: Zimmer RJ, Lee MS. Transplant coronary artery disease. JACC Cardiovasc Interv. 2010 Apr;3(4):367-77. doi: 10.1016/j.jcin.2010.02.007.