Does one treatment fit for all kinds of restenosis?

Author: Dr. Nau – Hospital Universitario Punta de Europa, Algeciras, Cádiz.


The new generation of drug-eluting stents (DES) is currently a tool of great safety and efficacy in the treatment of coronary artery disease. However, multiple anatomical and clinical scenarios position drug-coated balloons (DCB) as a valid and expanding alternative. The treatment of restenotic lesions is the indication with the greatest scientific evidence; however, the literature is limited in alternative situations.

Clinical case

Male patient 65 years old, hypertensive, dyslipidemic, non-insulin-dependent type 2 diabetic, smoker (40 packs-years).
Other conditions:
– Chronic kidney disease grade 3a (GFR 52 ml/min),
– Paroxysmal atrial fibrillation, digestive bleeding episode in 2018 (gastric erosion),
– Ischemic heart disease,
– NSTEMI and PCI on LCx artery (3.0 x 40 mm stent) in 2018. Failed PCI to chronic total occlusion on LAD.
– Successful elective angioplasty to chronic total occlusion on mid LAD (stent 2.5 x 36 mm – 2.75 x 19 mm), PCI with stent 2.25/19 mm of first diagonal branch and POBA to second diagonal branch in 2019.

Treatment: ASA 100 mg, Apixaban 5 mg BID, omeprazole 20 mg, atorvastatin 80 mg, bisoprolol 5 mg, amlodipine 5 mg, valsartan 160 mg, HCTZ 12.5 mg.

May 2022: new episode of NSTEMI, without ECG changes, with a peak US troponin of 3799 ng/mL. Echocardiography showed moderate lateral and apical hypokinesia with good contractility of the rest of the segments, LVEF 58%. Pseudonormal mitral flow pattern.

Radial coronary catheterization was performed, showing
-LCx: subtotal restenosis in the middle third and distal thrombotic image, with preserved flow.
-Mild to moderate diffuse hyperplasia of stents implanted at the middle level and total occlusion (conventional balloon restenosis) of the 2nd diagonal branch obtaining collateral circulation of the distal LAD.

LAD was interrogated with pressure guidewire obtaining the result shown in the figure (Image 1).

Discussion. Issues to be addressed.

The LCx appears to be the culprit vessel, its treatment should be not very challenging. Should you use other imaging techniques to assess the lesion. If so, what would you change your plans?

Being a high-risk patient (ACS, chronic renal failure, DM), how would you balance the risk of treatment failure (ischemic) vs. haemorrhagic risk? Chads2Vasc 4, HASBLED 5, PRECISE DAPT 49

How would you technically approach the LAD – diagonal lesions?
-Regarding the LAD, is its treatment necessary?
-Diagonal branch … medical treatment vs PCI attempt?
-If PCI is planned, how would you manage the bifurcation?

Therapeutic procedure

The circumflex artery wasw deemed as the culprit vessel, both by angiography and OCT findings (severe restenosis, with image of neoatherosclerosis, possible rupture of intima vs. thrombus) (Image 2).

PCI was performed with semicompliant 3.0/20 mm balloon and cutting balloon 3.0/15 mm, finishing with Essential Pro DCB (paclitaxel) 3.0/30 mm for 60 seconds (Image 5).

The lesion in the LAD was physiologically significant, with a restenosis mechanism of stent under-expansion by OCT (Image 3, 4D).
A Fielder XT guidewire was successfully advanced on diagonal branch, while keeping the pressure guide wire in the LAD (4A). The main branch was predilated with a NC balloon 3.0/20 mm at 20 atm and the diagonal branch with a balloon 2.0/10 mm at 16 atm. (Image 4B). TIMI3 Flow was recovered in the diagonal branch, observing severe atheromatosis in its middle third. Cutting balloon 3.0/15 mm was used at bifurcation level at 14 atm.

Essential Pro DCBs (paclitaxel) 3.0/30 mm and 3.0/20 mm were used in LAD and 2.0/30 mm in diagonal branch with final kissing balloon.

After 7 months of clinical follow-up, patient remains asymptomatic for angina and dyspnea. Pharmacological stress test with images shows homogeneous and diffuse uptake of the radiotracer throughout the myocardium with no focal or segmental defects in the stress study, compatible with ischemic cardiomyopathy. (Image 6).

Treatment: clopidogrel 75 mg, Apixaban 5 mg BID, omeprazole 20 mg, atorvastatin 80 mg/ezetimibe 10 mg, bisoprolol 5 mg, amlodipine 5 mg, valsartan 160 mg, HCTZ 12.5 mg.
ASA was withdrawn one week after the procedure.


Patients with restenosis represent an increased risk subgroup, resulting from the failure of the most effective devices at present. As a consequence, alternatives are required: DCBs have become a valid tool, as acknowledged in revascularization guidelines with a grade I recommendation with evidence level A (1).

However, multiple variables in the restenosis process result in different scenarios that mayr affect the results of the therapy (2,3). We present our case with the use of DCBs in the following situations and make a call for discussion,
• Treatment of the culprit artery of ACS (4),
• High risk of bleeding. Time and/or need for double antiplatelet therapy (5,6,7),
• Mechanism of restenosis (neointimal hyperplasia vs neoatherosclerosis) (8),
• Stent failure secondary to mechanical issues. Lack of optimization in implantation.
• Use of DCBD in occlusions,
• Use of DCB in bifurcation lesions (9,10,11,12),
• Long-term success (11).


The systematic study in the literature, as well as the good results since the beginning of the use of DCBs, have allowed us to adopt this tool in our daily practice.

As a result, emphasis has been placed on certain points that highlight the evolution and optimization in the use of these techniques. Thus, plaque preparation, the complementarity of intracoronary imaging, the physiological certification of the result and the reduction in antiplatelet time position the technique in a place of greater efficiency at present.

The technological evolution of the balloons used in the reported case (Essential Pro, iVascular) is noteworthy, as they complement and make the final clinical result possible. The navigability to distal beds and secondary branches has been optimized.

A special mention should be made for bifurcations. Currently, DCBs do not differ from conventional balloons when passing through struts to the secondary branch, an innovative feature that increases practicality in daily interventional practice.

The benefit in the use of these devices is no longer a pending issue; however, we are still in the midst of discovering their optimization and searching for their reach. It should be noted that the technique does not seek to supplant the role of stents, but rather to show itself as a valid alternative to the limitations of metallic platforms in multiple anatomical scenarios or their failure.


1.Neumann, F. J., Sousa-Uva, M., Ahlsson, A., Alfonso, F., Banning, A. P., Benedetto, U., … & Jüni, P. (2019). 2018 ESC/EACTS guidelines on myocardial revascularization. European heart journal, 40(2), 87-165.

2. Shlofmitz, E., Iantorno, M., & Waksman, R. (2019). Restenosis of Drug-Eluting Stents: A New Classification System Based on Disease Mechanism to Guide Treatment and State-of-the-Art Review. Circulation: Cardiovascular Interventions, 12(8), e007023.

3. Alfonso F, Byrne RA, Rivero F, Kastrati A.Current treatment of in-stent restenosis. J Am Coll
Cardiol 2014;63:2659-73.

4. Scheller B, Ohlow MA, Ewen S, et al. Randomized comparison of bare metal or drug-eluting stent versus drug-coated balloon in non-STelevation myocardial infarction-PEPCAD NSTEMI. EuroIntervention 2020;15:1527–33.

5. Li SX, Chaudry HI, Lee J, et al. Patterns of inhospital mortality and bleeding complications following PCI for very elderly patients: insights from the Dartmouth Dynamic Registry. J Geriatr Cardiol 2018;15:131-6.

6. Palmerini T, Della Riva D, Benedetto U, et al. Three, six, or twelve months of dual antiplatelet therapy after DES implantation in patients with or without acute coronary syndromes: an individual patient data pairwise and network meta-analysis of six randomized trials and 11 473 patients. Eur Heart J 2017;38:1034-43.

Kleber F, Scheller B, Ong P, et al. Duration of dual antiplatelet therapy after drug-coated balloon implantation. J Am Coll Cardiol 2018;72 13 suppl:B309-10.

8. Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014. Eur Heart J 2015;36:3320-31.

Worthley S, Hendriks R, Worthley M, et al. Paclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-month results of the multicenter BIOLUX-I study. Cardiovasc Revasc Med 2015;16: 413-7.

10. Berland J, Lefèvre T, Brenot P, et al. DANUBIO- a new drug-eluting balloon for the treatment of side branches in bifurcation lesions: six-month angiographic follow-up results of the DEBSIDE trial. EuroIntervention 2015;11:868–76.

11. José Valencia , Fernando Torres-Mezcua, et al. Long-term effectiveness of the pharmacoactive balloon in the treatment of side branch bifurcation lesions. REC Interv Cardiol. 2023;5:7-13

12. Jeger RV, Farah A, Ohlow MA, et al. Drugcoated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet 2018;392:849-56.

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