Drug-Eluting Balloon for In-Stent Restenosis - DARE

Contribution To Literature:

The DARE trial showed that PTCA with a DEB is noninferior to EES PCI at 6 months in patients with ISR (both DES and BMS).

Description:

The goal of this trial was to compare the efficacy of a drug-eluting stent (DES) versus a drug-eluting balloon (DEB) in the treatment of coronary in-stent restenosis (ISR).


Study Design

Patients with ISR (either due to DES or bare-metal stent [BMS]) were randomized in a 1:1 fashion to either percutaneous coronary intervention (PCI) with an everolimus-eluting stent (EES) (Xience) or use of a DEB (Sequent Please paclitaxel-eluting balloon).

Inclusion criteria:

  • ISR of any metallic stent (>50% stenosis either or within 5 mm of the edges of the stent)
  • Age >18 years
  • Total number of enrollees: 278
  • Duration of follow-up: 12 months
  • Mean patient age: 66 years
  • Percentage female: 22%
  • Percentage with diabetes: 32%

Exclusion criteria:

  • Reference vessel diameter (RVD) <2 or >4 mm
  • Unable to follow-up for angiography at 6 months
  •  Life expectancy <1 year
  • ST-segment elevation myocardial infarction (STEMI) presentation
  • Restenosis in a bioresorbable scaffold

Other salient features:

  • Target vessel: Left anterior descending 40%, right coronary artery: 50%, saphenous vein graft: 1%
  • Index stent: BMS: 44%
  • Focal ISR: 52%, proliferative: 8%
  • RVD: 2.58 mm

Principal Findings:

The primary outcome, difference in in-segment minimal lumen diameter between DEB and DES, was -0.03 mm, p for noninferiority < 0.001 (angiographic follow-up available for 79% of patients).

Secondary endpoints DEB vs. DES:

  • In-segment late lumen loss: 0.17 vs. 0.45 mm, p < 0.001
  • In-lesion late lumen loss: 0.09 vs. 0.21 mm, p = 0.055
  • In-lesion binary angiographic stenosis: 16.2% vs. 19.1%, p = 0.57
  • Target vessel MI: 1.4% vs. 0.7%, p = 0.54
  • Target vessel revascularization: 8.8% vs. 5.7%, p = 0.36

Interpretation:

The results of this trial indicate that percutaneous transluminal coronary angioplasty (PTCA) with a DEB is noninferior to EES PCI in patients with ISR (both DES and BMS). In-segment and in-lesion late lumen loss were, however, lower in the DEB arm, with no difference in clinical outcomes at 12 months. One limitation of this trial is that there was a high loss to follow-up (21%) for the primary endpoint at 6 months.

The late lumen loss noted in this trial (0.17 mm) is fairly consistent with earlier studies – 0.14 mm for BMS-ISR in the RIBS V trial, and 0.3 for DES-ISR in the RIBS IV trial, since the current trial included both stent types. DEBs seem to represent a reasonable treatment option for patients with ISR, particularly when avoidance of repeat DES PCI is desirable. Trials with other DEBs are ongoing. DEBs are currently not approved for coronary use in the United States.

References:

Baan J Jr, Claessen BE, Boerlage-van Dijk K, et al. A Randomized Comparison of Paclitaxel-eluting Balloon Versus Everolimus-eluting Stent for the Treatment of Any In-stent Restenosis: The DARE Trial. JACC Cardiovasc Interv 2017;Oct 30:[Epub ahead of print].

Presented by Dr. Jose P.S. Henriques at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2017), Denver, CO, October 30, 2017.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging, Chronic Angina

Keywords: Acute Coronary Syndrome, Angiography, Angioplasty, Balloon, Coronary, Constriction, Pathologic, Coronary Restenosis, Drug-Eluting Stents, Myocardial Infarction, Myocardial Revascularization, Paclitaxel, Percutaneous Coronary Intervention, Stents, TCT17, Transcatheter Cardiovascular Therapeutics


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