February 5, 2020

DIVA Trial Analyzes Stent-Only Versus Adjunctive Balloon Angioplasty Approach for Saphenous Vein Graft PCI

February 5, 2020—Faisal Latif, MD, et al published findings from the DIVA trial online in Circulation: Cardiovascular Interventions. The DIVA trial evaluated a stent-only versus adjunctive balloon angioplasty approach for saphenous vein graft (SVG) percutaneous coronary intervention (PCI).

According to the investigators, the background of the study is that direct stenting without predilation or postdilation has been advocated for SVG PCI to decrease the incidence of distal embolization, periprocedural myocardial infarction (MI), and target lesion revascularization (TLR).

The investigators performed a post hoc analysis of patients enrolled in the DIVA prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. The study's primary endpoint was the 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel MI, or target vessel revascularization). Secondary endpoints included all-cause death, stent thrombosis, MI, and TLR during follow-up.

In Circulation: Cardiovascular Interventions, the investigators reported that of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only PCI. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% vs 19%; hazard ratio [HR], 1.34; 95% confidence interval [CI], 0.86–2.08; P = .19).

They found that during long-term follow-up (median of 2.7 years), the following were lower in the stent-only group versus the balloon-stent group:

  • Incidence of definite stent thrombosis (1% vs 5%; HR, 9.2; 95% CI, 1.23–68.92; P = .0085)
  • Composite of definite or probable stent thrombosis (5% vs 11%; HR, 2.52; 95% CI, 1.23–5.18; P = .009)
  • Target vessel MI (8% vs 14%; HR, 1.92; 95% CI, 1.08–3.4; P = .023)

Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and more than one target SVG lesions were associated with increased target vessel failure during the entire follow-up, while preintervention thrombolysis in MI 3 flow was protective.

In patients undergoing PCI of de novo SVG 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 MI, concluded the investigators in Circulation: Cardiovascular Interventions.


February 6, 2020

Aria CV’s Pulmonary Hypertension System Granted FDA Breakthrough Device Designation

February 5, 2020

JenaValve Technology Closes $50 Million Financing Equity Round