Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft Percutaneous Coronary Intervention: Insights From DIVA Trial.
Aged
Angioplasty
/ adverse effects
Angioplasty, Balloon, Coronary
/ adverse effects
Coronary Artery Bypass
/ adverse effects
Coronary Thrombosis
/ etiology
Double-Blind Method
Female
Graft Occlusion, Vascular
/ diagnostic imaging
Humans
Male
Middle Aged
Myocardial Infarction
/ etiology
Prospective Studies
Risk Factors
Saphenous Vein
/ diagnostic imaging
Stents
Time Factors
Treatment Outcome
United States
Vascular Patency
angioplasty
dilatation
incidence
myocardial infarction
stents
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
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
e008494Subventions
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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