Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft Percutaneous Coronary Intervention: Insights From DIVA Trial.


Journal

Circulation. Cardiovascular interventions
ISSN: 1941-7632
Titre abrégé: Circ Cardiovasc Interv
Pays: United States
ID NLM: 101499602

Informations de publication

Date de publication:
02 2020
Historique:
entrez: 6 2 2020
pubmed: 6 2 2020
medline: 1 9 2020
Statut: ppublish

Résumé

Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08]; In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.

Sections du résumé

BACKGROUND
Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization.
METHODS
We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up.
RESULTS
Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08];
CONCLUSIONS
In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.

Identifiants

pubmed: 32019343
doi: 10.1161/CIRCINTERVENTIONS.119.008494
pmc: PMC7053803
mid: NIHMS1563348
doi:

Banques de données

ClinicalTrials.gov
['NCT01121224']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, U.S. Gov't, Non-P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

e008494

Subventions

Organisme : CSRD VA
ID : I01 CX000440
Pays : United States
Organisme : CSRD VA
ID : I01 CX001549
Pays : United States

Commentaires et corrections

Type : CommentIn
Type : CommentIn

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Auteurs

Faisal Latif (F)

VA Medical Center, Oklahoma City (F.L.).
University of Oklahoma, Oklahoma City (F.L.).

Lauren Uyeda (L)

VA Cooperative Studies Program Coordinating Center, Mountain View, CA (L.U., R.E., M.-C.S.).

Robert Edson (R)

VA Cooperative Studies Program Coordinating Center, Mountain View, CA (L.U., R.E., M.-C.S.).

Deepak L Bhatt (DL)

VA Boston Healthcare System, MA (D.L., S.K., R.S.V).
Brigham and Women's Hospital Heart & Vascular Center, Boston, MA (D.L.B.).
Harvard Medical School, Boston, MA (D.L.B.).

Steven Goldman (S)

University of Arizona Sarver Heart Center, Tucson (S.G.).

David R Holmes (DR)

Mayo Clinic, Rochester, MN (D.R.H.).

Sunil V Rao (SV)

Durham VA Medical Center, NC (S.V.R.).

Kendrick Shunk (K)

San Francisco VA Medical Center, CA (K.S.).

Kul Aggarwal (K)

Harry S Truman VA Hospital, Columbia, MO (K.A.).
University of Missouri Healthcare, Columbia (K.A.).

Barry Uretsky (B)

Central Arkansas Veterans Health System, Little Rock (B.U.).
University of Arkansas for Medical Sciences, Little Rock (B.U.).

Islam Bolad (I)

Indiana University School of Medicine, Indianapolis (I.B.).
Roudebush VA Medical Center, Indianapolis, Indiana (I.B.).

Khaled Ziada (K)

University of Kentucky, Lexington (K.Z.).

Edward McFalls (E)

VA Medical Center, Minneapolis, MN (E.M.).
University of Minnesota, Minneapolis (E.M.).

Anand Irimpen (A)

Southeast Louisiana Veterans Health Care System, New Orleans (A.I.).
Tulane University Heart and Vascular Institute, New Orleans, LA (A.I.).

Huu Tam Truong (HT)

VA Loma Linda Medical Center, CA (H.T.T.).

Scott Kinlay (S)

VA Cooperative Studies Program Coordinating Center, Mountain View, CA (L.U., R.E., M.-C.S.).

Vasilios Papademetriou (V)

VA Medical center Washington DC (V.P.).
Georgetown University, Washington DC (V.P.).

Raghava S Velagaleti (RS)

VA Boston Healthcare System, MA (D.L., S.K., R.S.V).

Bavana V Rangan (BV)

Minneapolis Heart Institute Foundation, MN (B.V.R., E.S.B.).

Kreton Mavromatis (K)

Atlanta VA Healthcare System, GA (K.M.).
Emory University, Atlanta, GA (K.M.).

Mei-Chiung Shih (MC)

VA Cooperative Studies Program Coordinating Center, Mountain View, CA (L.U., R.E., M.-C.S.).

Subhash Banerjee (S)

Dallas VA Medical Center, TX (S.B.).
University of Texas Southwestern Medical Center, Dallas (S.B.).

Emmanouil S Brilakis (ES)

Minneapolis Heart Institute Foundation, MN (B.V.R., E.S.B.).
Minneapolis Heart Institute, MN (E.S.B.).
Abbott Northwestern Hospital, Minneapolis, MN (E.S.B.).

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Classifications MeSH