Percutaneous Coronary Intervention in Patients witH OrthotoPic hEart Transplantation: the PCI-HOPE a Multicenter Study. (PCI-HOPE)

Percutaneous Coronary Intervention in Patients witH OrthotoPic hEart Transplantation: the PCI-HOPE a Multicenter Study

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Heart Transplant Failure and Rejection
• Intervention / Treatment: Other: PCI and implantation drug eluting stent or bare metal stent

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 .

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Fabrizio D'Ascenzo, MD; Phone Number: 00390116336023; Email: fabrizio.dascenzo@gmail.com

Study Locations

• Italy
  • Turin, Italy, 10128
    • Recruiting
    • Città della Salute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Evaluation incidence, prognostic factors and outcomes of percutaneous theraphy in patients with Transplant Coronary Artery Disease (TCAD)

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of restenosis	observation rate of restenosis post-PCI	18 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Number of Cardiovascular events	18 years
Rate of TCAD	Number of CAD in transplant recipients	18 years

Collaborators and Investigators

• Sponsor: Fabrizio D'Ascenzo
• Collaborators: University of Zurich; University of Bologna; University of Roma La Sapienza; Azienda Ospedaliera Universitaria Integrata Verona; Hospital Clinic of Barcelona; University of Padova

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): May 25, 2018
• Study Completion (Anticipated): October 31, 2018

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: PCI-HOPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No