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
References
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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: http://www.nice.org.uk/guidance/MTG1/chapter/1-Recommendations
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. http://dx.doi.org/10.1016/j.jacc.2012.09.020
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. http://dx.doi.org/10.4244/EIJV7SKA11
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