Short and Long-term Results of PCI in no Touch Vein-graft.

NCT03999398 | Unknown

• 1 other identifier: OLL-242381
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention; Saphenous Vein; Coronary Artery Bypass

Keywords

Saphenous Vein; No-touch; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Rate of In-stent restenosis

  stenosis or occlusion of the stent implanted during the percutaneous coronary intervention procedurerevascularisation)

  after the percutaneous coronary intervention (until December the 01st 2020)

Secondary Outcomes (3)

• Rate of Major adverse cardiac event (MACE)

  after the percutaneous coronary intervention (until December the 01st 2020)

• Quality of life (RAND-36)

  after the percutaneous coronary intervention, through study completion, an average of 5 years

• QALY (quality-adjusted life-year)

  after the percutaneous coronary intervention, through study completion, an average of 5 years

Other Outcomes (1)

• Rate of Mortality

  after the percutaneous coronary intervention (until December the 01st 2020)

Study Arms (2)

No-touch

Participants that operated at the time of the coronary artery bypass grafting with a "no-touch" venous graft.

Procedure: Percutaneous coronary intervention (PCI)

Conventional

Participants that operated at the time of the coronary artery bypass grafting with a "conventional" venous graft.

Procedure: Percutaneous coronary intervention (PCI)

Interventions

Percutaneous coronary intervention (PCI) PROCEDURE

Participants are treated with a PCI and stent implantation in a venous graft (previously implanted during the CABG operation)

Also known as: Previously: coronary artery bypass grafting (CABG)

Conventional; No-touch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• percutaneous coronary intervention within 30 days from the primary operation

Sponsors & Collaborators

• Region Örebro County: lead
• Karlstad Central Hospital: collaborator

Study Sites (1)

Kärl-Thoraxkliniken; University Hospital of Örebro

Örebro, 70185, Sweden

Location

Related Publications (13)

• Souza D. A new no-touch preparation technique. Technical notes. Scand J Thorac Cardiovasc Surg. 1996;30(1):41-4. doi: 10.3109/14017439609107239. No abstract available.

  PMID: 8727856 BACKGROUND

• Souza DS, Dashwood MR, Tsui JC, Filbey D, Bodin L, Johansson B, Borowiec J. Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques. Ann Thorac Surg. 2002 Apr;73(4):1189-95. doi: 10.1016/s0003-4975(02)03425-2.

  PMID: 11996262 BACKGROUND

• Souza DS, Johansson B, Bojo L, Karlsson R, Geijer H, Filbey D, Bodin L, Arbeus M, Dashwood MR. Harvesting the saphenous vein with surrounding tissue for CABG provides long-term graft patency comparable to the left internal thoracic artery: results of a randomized longitudinal trial. J Thorac Cardiovasc Surg. 2006 Aug;132(2):373-8. doi: 10.1016/j.jtcvs.2006.04.002.

  PMID: 16872965 BACKGROUND

• Samano N, Bodin L, Karlsson J, Geijer H, Arbeus M, Souza D. Graft patency is associated with higher health-related quality of life after coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):388-394. doi: 10.1093/icvts/ivw372.

  PMID: 28040753 BACKGROUND

• Samano N, Geijer H, Liden M, Fremes S, Bodin L, Souza D. The no-touch saphenous vein for coronary artery bypass grafting maintains a patency, after 16 years, comparable to the left internal thoracic artery: A randomized trial. J Thorac Cardiovasc Surg. 2015 Oct;150(4):880-8. doi: 10.1016/j.jtcvs.2015.07.027. Epub 2015 Jul 15.

  PMID: 26282605 BACKGROUND

• Bourassa MG. Fate of venous grafts: the past, the present and the future. J Am Coll Cardiol. 1991 Apr;17(5):1081-3. doi: 10.1016/0735-1097(91)90835-w. No abstract available.

  PMID: 2007707 BACKGROUND

• Campeau L, Enjalbert M, Lesperance J, Bourassa MG, Kwiterovich P Jr, Wacholder S, Sniderman A. The relation of risk factors to the development of atherosclerosis in saphenous-vein bypass grafts and the progression of disease in the native circulation. A study 10 years after aortocoronary bypass surgery. N Engl J Med. 1984 Nov 22;311(21):1329-32. doi: 10.1056/NEJM198411223112101.

  PMID: 6333635 BACKGROUND

• Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.

  PMID: 8772748 BACKGROUND

• Hindnavis V, Cho SH, Goldberg S. Saphenous vein graft intervention: a review. J Invasive Cardiol. 2012 Feb;24(2):64-71.

  PMID: 22294536 BACKGROUND

• Goldman S, Zadina K, Moritz T, Ovitt T, Sethi G, Copeland JG, Thottapurathu L, Krasnicka B, Ellis N, Anderson RJ, Henderson W; VA Cooperative Study Group #207/297/364. Long-term patency of saphenous vein and left internal mammary artery grafts after coronary artery bypass surgery: results from a Department of Veterans Affairs Cooperative Study. J Am Coll Cardiol. 2004 Dec 7;44(11):2149-56. doi: 10.1016/j.jacc.2004.08.064.

  PMID: 15582312 BACKGROUND

• Lee MS, Park SJ, Kandzari DE, Kirtane AJ, Fearon WF, Brilakis ES, Vermeersch P, Kim YH, Waksman R, Mehilli J, Mauri L, Stone GW. Saphenous vein graft intervention. JACC Cardiovasc Interv. 2011 Aug;4(8):831-43. doi: 10.1016/j.jcin.2011.05.014.

  PMID: 21851895 BACKGROUND

• Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, Fusaro M, Laugwitz KL, Massberg S, Neumann FJ, Richardt G, Schomig A, Kastrati A; Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts? (ISAR-CABG) Investigators. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet. 2011 Sep 17;378(9796):1071-8. doi: 10.1016/S0140-6736(11)61255-5. Epub 2011 Aug 26.

  PMID: 21872918 BACKGROUND

• Stone GW, Goldberg S, O'Shaughnessy C, Midei M, Siegel RM, Cristea E, Dangas G, Lansky AJ, Mehran R. 5-year follow-up of polytetrafluoroethylene-covered stents compared with bare-metal stents in aortocoronary saphenous vein grafts the randomized BARRICADE (barrier approach to restenosis: restrict intima to curtail adverse events) trial. JACC Cardiovasc Interv. 2011 Mar;4(3):300-9. doi: 10.1016/j.jcin.2010.11.013.

  PMID: 21435608 BACKGROUND

Related Links

• link of the original (Swedish) project plan

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Gabriele Ferrari, MD

  Region Örebro län

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: October 1, 2017
• Primary Completion: January 1, 2022
• Study Completion: January 2, 2022
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication
• Access Criteria: All the individual data that can be shared according the Regional ethical review board rules. Those data will be share a specific upon request in order to contribute to other researchers own works (that want to compare their results with ours) or in case of meta-analysis.

Locations

SE (1)