Correspondence: from balloons to stents and back again?

Br J Cardiol 2014;21:146 Leave a comment
Click any image to enlarge
First published online 24 October 2014

Correspondence from the world of cardiology

Dear Sirs,

Ischaemic heart disease (IHD) is a major cause of mortality and morbidity, and percutaneous coronary intervention (PCI) is a mainstay of treatment. The management of IHD has been revolutionised by major advancements in the field of coronary angioplasty, starting with the use of balloons for percutaneous transluminal coronary angioplasty (PTCA) in 1977 by Gruentzig.1 However, their use was limited by acute recoil (approximately 40%), vessel dissection and a high re-stenosis rate (50%). To treat the acute problems of recoil and dissection (with acute vessel closure) and reduce the rate of re-stenosis, coronary stents were introduced in 1986,2 and became the standard PCI technique in the ensuing decade. However, new problems emerged in the form of in-stent re-stenosis (ISR) as a result of injury, inflammation and neo-intimal hyperplasia caused by proliferation and migration of vascular smooth muscle cells, occurring within six to nine months post-procedure in 20–30% of cases.3,4 In addition, the endothelial injury and inflammation caused by stent implantation result in platelet activation and thrombosis.5,6 Drug-eluting stents (DES) evolved in order to reduce the incidence of re-stenosis and re-intervention, and showed a definite benefit over bare metal stents (BMS) (4–6% vs. 20–30% ISR).7 Unfortunately, problems still persist, with incomplete healing seen in DES at 180 days as compared with BMS,8 resulting in recommendations for prolonged dual antiplatelet therapy (DAPT), while stent thrombosis persists, with current generation stents showing rates of around 1% at 12 months with a significant mortality rate.9 Stents with biodegradable polymers (controlled release of drug followed by biodegradation of the polymer leaving bare metal only), polymer-free stents (drugs coated directly onto the metallic surface) and biodegradable scaffolds (complete resorption after a definite period of time, leaving the vessel virtually metal-free) have been developed to combat such problems, but re-stenosis and stent or scaffold thromboses still occur.10

Perhaps we need to re-visit the reason for stent implantation. The Benestent trial showed a very low bail-out rate for plain old balloon angioplasty (POBA) (5%), suggesting that the acute (in-lab) problems requiring stenting are minimal, such that the major reason for many implants is fear of re-stenosis and subsequent repeat revascularisation.11 Can re-stenosis be reduced without the use of a metallic cage? Drug-coated balloons (DCB) offer this possibility through the very uniform delivery of paclitaxel to the vessel wall. The current data support their use in ISR, including a National Institute for Health and Care Excellence (NICE) recommendation for use in BMS ISR.12 They have been associated with a low late loss in side branch ostia, small vessels and peripheral vessels.13-15 De novo PCI with a DCB-only strategy is now being performed and registry data show very promising results with low major adverse coronary events (MACE) and target lesion revascularisation (TLR).16 DCB-only treatment has recently been shown to result in a late lumen gain (for the first time in PCI).17 But long-term, randomised-controlled studies are lacking and the presence of elastic recoil or dissections can be a deterrent for some operators. The technology is promising and requires development, further study and a willingness to put aside the safety net we have become most comfortable with – the stent.

Conflict of interest

None declared.

Usha Rao, Cardiology SpR

Simon C Eccleshall, Consultant Cardiologist
([email protected])

Norfolk & Norwich Hospital, Colney Lane, Norwich, NR4 7UY


1. Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet 1978;311:263.

2. Sigwart U, Puel J, Mirkovitch V et al. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 1987;316:701–06.

3. Moliterno DJ. Healing Achilles—sirolimus versus paclitaxel. N Engl J Med 2005;353:724–6.

4. Arjomand H, Turi Z, McCormick D et al. Percutaneous coronary intervention: historical perspectives, current status, and future direction. Am Heart J 2003;146:787–96.

5. Gawaz M, Neumann FJ, Ott I et al. Platelet activation and coronary stent implantation. Effect of antithrombotic therapy. Circulation 1996;94:279–85.

6. Caramori PRA, Lima VC, Seidelin PH et al. Long-term endothelial dysfunction after coronary stenting. J Am Coll Cardiol 1999;34:1675–9.

7. Biondi-Zoccai GG, Agostoni P, Abbate A et al. Adjusted indirect comparison of intracoronary drug-eluting stents: evidence from a metaanalysis of randomized bare-metal-stent-controlled trials. Int J Cardiol 2005;100:119–23.

8. Tsimikas S. Drug-eluting stents and late adverse clinical outcomes: lessons learned, lessons awaited. J Am Coll Cardiol 2006;47:2112–15.

9. Iqbal J, Gunn J, Serruys PW. Coronary stents: historical development, current status and future directions. Br Med Bull 2013;106:193–211.

10. Iqbal J, Onuma Y, Ormiston J et al. Bioresorbable scaffolds: rationale, current status, challenges, and future. Eur Heart J 2014;35:765–76.

11. Serruys PW, De Jaeger P, Kiemenij F et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med 1994;331:489–95.

12. National Institute for Health and Care Excellence. SeQuent Please balloon catheter for in-stent coronary restenosis. NICE medical technologies guidance MTG1. London: NICE, 2010. Available from:

13. Latib A, Colombo A, Fausto Castriota F et al. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels. The BELLO (Balloon Elution and Late Loss Optimization) Study. J Am Coll Cardiol 2012;60:2473–80.

14. Mathey DG, Wendig I, Boxberger M, Bonaventura K, Kleber FX. Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial. EuroIntervention 2011;7(suppl K):K61–K65.

15. Tepe G, Zeller T, Albrecht T et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008;358:689–99.

16. Wöhrle J, Zadura M, Möbius-Winkler S et al. SeQuent Please world wide registry: clinical results of SeQuent Please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol 2012;60:1733–8.

17. Kleber FX, Shultz A, Clever YP et al. TCT-327 Late lumen enlargement – a potential new paradigm in vascular therapy. J Am Coll Cardiol 2013;62(suppl 1):B104.