Clinical trial NCT03999398: Short and Long-term Results of PCI in no Touch Vein-graft.
Official title: Short and Long-term Results of PCI in no Touch Vein-graft:a Comparison With the Standard One.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Percutaneous Coronary Intervention
Saphenous Vein
Coronary Artery Bypass
Keywords: Saphenous Vein
No-touch
Percutaneous Coronary Intervention
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Karlstad Central Hospital
First posted: 2019-06-26
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the subjects that previously were operated with a coronary artery bypass grafting at the Cardiothoracic department of the University hospital of Orebro (from the 1992 until 30th June 2020) and that underwent a percutaneous coronary intervention in a venous graft between January the 1st, 2006 and June the 30th, 2020.

Brief summary: Coronary artery disease is one of the biggest health issue worldwide.The treatment, in a large part of the patients, implicates a so called bypass-operation, that consists in to connect new vascular conduits (grafts) beyond the narrowed coronary vessels to improve the blood supply to the heart. One of the graft that is commonly used is the saphenous vein from the leg. The disadvantage of the saphenous vein graft is the predisposition to early obstruction. The international literature shows the following grades of occlusion: 15% in the first year and 40% after 10 year.

At the Cardio-Thoracic Clinic of the University hospital of Örebro has been developed a new method to harvest the saphenous vein together with the surrounding fat-tissue. This technique, called no-touch technique, has the advantage to reduce the damages to the vein during the harvesting, showing a substantially reduced risk for future occlusion (5% after 18 months and 10% after 8,5 years).

The aim of the PhD project is to evaluate the results of the no-touch technique in compare to the conventional technique for the venous graft harvesting. The focus of the study is to analyse all the operated patients in our clinic who underwent a post-operative coronary angiography do to angina pectoris (heart pain). All the patients who received a stent during the post-operative angiography will be analysed in detail and one will compare the occlusion grade and the rate of major adverse cardiac events (MACE).

This study is the first and the only one in the world that will examine the long-term results of the no-touch technique in particular after the stenting of the venous graft.

Detailed description: The study is a observational retrospective with registered-based data. The register used is Swedeheart which is the national Swedish intervention-related quality register for cardiological interventions (such as percutaneous coronary intervention (PCI)) and cardiac surgical procedures that are performed every year in Sweden.

After the approval of the Regional ethical review board in Uppsala (Sweden), one could review all the subjects that received a PCI in a venous graft between January the 1st, 2006 and June the 30th, 2020 either at the Angiographic unit of the University Hospital of Orebro or at the Angiographic unit of the Hospital of Karlstad. All the participants has been previously operated at the Cardiothoracic department of the University hospital of Orebro with a coronary artery bypass grafting (CABG) procedure, with one type of vein graft (no-touch) or the other (standard) All the relevant data for the study that are missed in the quality register, are extrapolated by the clinical registers of the two hospital involved (Orebro and Karlstad).

Once finished the data extraction and review, the data will be statistically analysed in term of short and long term results; and an advanced comparison between the two different type of venous graft involved. This is to show if there is a significant difference between the two techniques also after a PCI procedure (already proven clinical different between the two technique in favour of the no-touch one by numerous studies).

Moreover an assessment of the patients´ quality of life in the two different studies will be performed with the use of Health related quality of life surveys (RAND-36); even a health economics analysis will be preformed (QALY).

Eligibility criteria: Inclusion Criteria:

* Participants previously operated with a coronary artery bypass grafting at the Cardiothoracic department of the University hospital of Orebro
* Participants that underwent a percutaneous coronary intervention in a venous graft

Exclusion Criteria:

* percutaneous coronary intervention within 30 days from the primary operation

Primary outcomes:
measure: Rate of In-stent restenosis
timeFrame: after the percutaneous coronary intervention (until December the 01st 2020)
Secondary outcomes:
measure: Rate of Major adverse cardiac event (MACE)
timeFrame: after the percutaneous coronary intervention (until December the 01st 2020)
measure: Quality of life (RAND-36)
timeFrame: after the percutaneous coronary intervention, through study completion, an average of 5 years
measure: QALY (quality-adjusted life-year)
timeFrame: after the percutaneous coronary intervention, through study completion, an average of 5 years
Other outcomes:
measure: Rate of Mortality
timeFrame: after the percutaneous coronary intervention (until December the 01st 2020)
Locations:
city: Örebro
country: Sweden
facility: Kärl-Thoraxkliniken; University Hospital of Örebro
Study officials:
affiliation: Region Örebro Län
name: Gabriele Ferrari, MD
role: PRINCIPAL_INVESTIGATOR
References:
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