Original Title: Drug-eluting balloon versus second-generation drug-eluting stent for the treatment of restenotic lesions involving coronary bifurcations. Reference: Toru Naganuma et al. EuroIntervention 2016;11:989-995
Courtesy of del Dr. Santiago F. Coroleu.
PCI involving in-stent restenosis (ISR), especially in coronary bifurcations, is associated with high rates of recurrent restenosis and the need for new revascularization. Although drug eluting balloons (DEB) have been accepted as an effective and safe treatment for bare metal stent ISR, to the point of being added to the ESC Guidelines as a class II recommendation for such cases, its use for IRS in the context of coronary bifurcations has not yet been shown. The strategies commonly used at present to treat these lesions include the use of drub eluting balloons (DEB or cutting balloon), third generation DES implantation, and atherectomy (laser or rotational). From these alternatives, DEBs seem attractive seeing that it could prevent neointimal growth without adding new layers of metal to the vessel.
The study retrospectively assessed all bifurcation restenosis patients treated with the IN.PACT Falcon (Medtronic®) DEB or with any second generation DES (Xience Prime, Xience V, Promus Element, Endeavor Resolute) between February 2007 and August 2012 in four high volume centers in Milan, Italy.
All cases required predilation with non-compliant balloons, all DES implantation cases required post dilation and, when two stents were implanted, patients required final kissing balloon. As follow up treatment, aspirin was prescribed indefinitely, plus 12 days of clopidogrel for the DES group, 90 days for the BMS + DEB group, and 30 days for the DEB group.
It is worth noticing that the DEB group had patients with higher EuroScore (4.2±3.8 vs. 2.8±2.1, p=0.004), more severe kidney disease (27.4 vs. 11.8, p=0.012), more prior strokes (6.8 vs. 1.2, p=0.063) and higher prior stent in stent rates (25.6% vs. 15.6%, p=0.074).
The study assessed 167 bifurcation ISRs in 158 patients (DEB n=73, DES n=85) over a median follow up of 701 days, and did not find significant differences in terms of MACE between the two groups (DEB 32.1% vs. DES 27.6%; p=0.593), cardiac death (DEB 5.0% vs. DES 2.6%; p=0.369), target vessel revascularization (DEB 23.7% vs. DES 21.8%; p=0.884), target vessel revascularization per patient (DEB 16.6% vs. DES 17.6%; p=0.875) and target vessel revascularization for bifurcation (DEB 19.1% vs. DES 16.6%; p=0.861).
16 cases (20.5%) in the DEB group, were treated with the hybrid strategy (DEB and stent). Procedural success was 94.9% and 98.9%, respectively (p=0.130). There were no cases of infarction or in stent thrombosis over the two year follow up.
When assessing prior stent-in-stent vs. first restenosis in the DEB group, there was a great difference in terms of MACE (65.6% stent-in-stent vs. 16.4% first restenosis; p<0.001), which confirms patients presenting prior stent-in-stent restenosis have worse evolution. After multivariable analysis, they found the independent predictors of MACE were prior stent-in-stent (HR: 2.16; CI 95%: 1.11 to 4.20; p=0.023) and “real bifurcations” according to the Medina classification (HR: 2.98; CI 95%: 1.45 a 6.14; p=0.001).
Conclusion
Drug eluting balloons are a feasible option to treat bifurcations in-stent restenosis, especially in cases o with no prior stent-in-stent procedures.
Editorial Comment
Against:
-Retrospective study, observational, with operators deciding treatment strategies on a case by case basis.
-Relatively small sample, which does not allow to draw conclusions on subgroups presenting in the population.
-Extremely heterogeneous lesion characteristics (kind of stent presenting restenosis, strategy of the prior PCI, Medina classification of restenosis, kind of second generation stent, etc.).
For:
-Given the scarce information available in the literature, and the specificity of such coronary lesion, the present study serves mainly as a generator of hypotheses for subsequent studies.
-The use of DEBs seems an interesting therapeutic choice, especially because it prevents adding more layers of metal to an already complex lesion, it reduces DAPT time, minimizes struts of prior stents, allows homogeneous drug distribution to the vessel wall and allows more respect and conservation of the vessel anatomy.
Courtesy of del Dr. Santiago F. Coroleu.
Santiago del Estero Institute of Cardiology, Argentina.
