**12. References**

120 Coronary Interventions

Attempts at percutaneous revascularisation in saphenous vein graft lesions with balloon angioplasty were limited by a relatively low procedural success rate and a high incidence of

Stent implantation in patients with focal saphenous vein graft lesions improved procedural success and clinical outcome compared with balloon angioplasty. However, even with the use of stents treatment of saphenous vein graft lesions is associated with a high incidence of acute complications, principally distal embolisation and periprocedural myocardial infarction, because of the more friable atherosclerotic or thrombotic components of the saphenous vein graft lesions (Stankovic et al., 2003). Besides, the results of bare metal stents in saphenous vein grafts are less favourable than those in native vessels, with restenosis rates exceeding 30% (Savage et al., 1997; Silber et al., 2005). In fact some authors recommend carrying out percutaneous coronary intervention in native vessels whenever possible even when there is complete obstruction or to consider the possibility of new revascularisation surgery rather than percutaneous saphenous vein graft intervention (Lozano et al., 2005).

In an attempt to improve the outcome of intervention in stenotic vein grafts, several approaches and adjunctive pharmacological regimens have been studied, but with the exception of distal protection devices, none showed a clear benefit in reducing the incidence of distal embolisation, especially in complex lesions (Stankovic et al., 2003). However, despite the existence of successful proximal and distal filters and balloons, 30-day major adverse cardiac event rates still hover between 8% and 10%. A logical approach to assess a potential reduction in the incidence of no-reflow phenomenon and its deleterious consequences would be to conduct prospective, randomised, controlled trials assessing the combination of distal filter protection devices, glycoprotein IIb/IIIa inhibitors and pre-

Drug-eluting stents have been shown to reduce restenosis in many lesion types and clinical syndromes. However, there is a paucity of prospective data on drug-eluting stents in saphenous vein graft intervention (Brilakis et al., 2009). Most meta-analysis of randomised trials and observational studies comparing drug-eluting stents and bare metal stents in saphenous vein graft percutaneous intervention suggest that drug-eluting stent use in

Patients with previous coronary artery bypass graft surgery suffer from diffuse atherosclerosis of native coronary arteries as well as rapid saphenous vein graft degeneration, thus the benefit from drug-eluting stents could be largely diluted by acute coronary syndromes arising from other previously untreated coronary lesions (Lupi et al.,

In addition, it is well established that the long-term prognosis of patients with diseased saphenous vein grafts is mainly impacted by progression of disease in the nonintervened

Large, prospective, multicenter, randomised-controlled clinical trials that use a clinical rather than angiographic end point are needed to confirm the beneficial role of drug-eluting stents in saphenous vein graft lesions (Brilakis & Berger, 2008). Additionally, longer-term follow-up of at least 3 to 5 years is essential for randomised trials involving the use of drugeluting stents in saphenous vein grafts to address two potentially harmful events. First, the

treatment with intra-graft administration of vasodilators, particularly nicardipine.

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**1. Introduction** 

certain subgroups {Holmes et al, 2002}.

**2. Treatment of restenosis** 

**6** 

*UK* 

**Drug Eluting Balloon** 

*1Frimley Park Hospital NHS Trust,* 

*3Imperial College, London* 

*2East and North Hertfordshire NHS Trust,* 

S. Sharma1, N. Kukreja2 and D. A. Gorog2,3

Since the first percutaneous transluminal coronary angioplasty (PTCA) performed by Andreas Gruntzig in 1977 the technology has evolved significantly. Progress of PTCA has seen the development of many devices, some of which are still in use and many others that have fallen in disuse. The main limitation of the plain old balloon angioplasty (POBA) was the problem of elastic vascular recoil causing abrupt vessel closure and restenosis. The patho-mechanism of restenosis that occurs following balloon angioplasty involves negative vascular remodeling, elastic recoil and thrombosis at the site of injury {Moreno, 1999}. While the thrombus formation can be reduced by use of antiplatelet drugs, the restenosis threat remains. Early restenosis occurred in as many as 30% of angioplasty cases. This led to the development of the metal stent to exert radial force on the vessel wall and thus prevent elastic recoil. Although stents reduced restenosis, their use led to the realisation of a different and new challenge of in stent restenois (ISR). This occurs mainly due to neointima formation {Mach, 2000,Mudra et al, 1997, Hoffman et al, 1996, Kearney et al, 1997} that is principally composed of proliferating smooth muscle cells (SMC) and extra cellular matrix {Geary et al, 2003, Grewe et al, 1999}. By the late 1990s, it was acknowledged that although the incidence of ISR was lower than that of restenosis following balloon angioplasty {Serruys et al, 1991}, it occurred in 15–30% of patients, and possibly more frequently in

Over the years there have been intensive research efforts to identify possible pharmacotherapeutic regimens to prevent the neointimal restenotic process. Although most experimental studies and some small initial clinical studies showed promise, subsequent large randomized trials have been disappointing {Faxon, 1995, Bertrand et al, 1997, Boccuzzi et al, 1998, Serruys et al, 2000, Faxon, 2002}. Failure to achieve significant reduction in ISR with systemic drug therapy led to the exploration of the concept of local drug delivery. Local drug delivery (LDD), in theory, should achieve greater local drug concentration with lower overall dose compared to systemic therapy, to help achieve maximal tissue effects while minimizing undesired systemic toxicity. It also has the advantage of being able to utilize drugs with low systemic bioavailability or short half-life. Many devices have been

Vein Grafts. The Randomized BARRICADE (Barrier Approach to Restenosis: Restrict Intima to Curtail Adverse Events) Trial. *J Am Coll Cardiol Intv*, Vol. 4, No. 3, (March 2011), pp. 300-309.

