Author + information
- Published online March 20, 2017.
- Christian Spaulding, MD, PhD∗ ( and )
- Nicole Karam, MD, MPH
- Cardiology Department, European Hospital Georges Pompidou, INSERM U 970 and Sudden Death Expertise Center, Paris Descartes University, Paris, France
- ↵∗Address for correspondence:
Dr. Christian Spaulding, Cardiology Department, European Georges Pompidou, 20 rue Leblanc, Paris 75015, France.
- bioresorbable scaffolds
- drug-eluting stent(s)
- percutaneous coronary intervention
- stent thrombosis
For an interventional cardiologist who has lived through the eras of balloon angioplasty, bare-metal, and first-generation drug-eluting stents (DES), current percutaneous coronary intervention (PCI) technology, including DES, is worlds away from what we started and fought with. In recent clinical trials and registries, DES stent thrombosis rates are under 1%, and restenosis rates are <5% at 1-year follow-up (1). Can we do better?
Everolimus-eluting bioresorbable vascular scaffolds (BVS) were presented as the “magic bullet” for the treatment of coronary artery disease (2). Implantation of a disappearing stent could improve coronary vasomotion, and potentially reduce very late loss in the stented area. Moreover, coronary artery bypass surgery could be facilitated by the absence of metallic prostheses. Finally, lower stent thrombosis rates were expected: no stent, no thrombosis.…
Several recent trials have suggested that the BVS bullet may be missing the target. Randomized trials and registries have shown a 2-fold increase in stent thrombosis (3–6). In the recently published ABSORB II study (ABSORB II Randomized Controlled Trial), the primary endpoint was superiority of the Absorb BVS versus the Xience metallic stent (both Abbott Vascular, Santa Clara, California) in angiographic vasomotor reactivity after administration of intracoronary nitrate (7). There was no difference between groups. Late lumen loss was higher at 3 years in the BVS group, and an excess of definite or probable stent thrombosis and target vessel myocardial infarction was noted in the patients treated with BVS (3% in the Absorb group vs. 0% in the Xience group [p = 0.0331] and 7% vs. 1% [p = 0.0061], respectively).
In this issue of JACC: Cardiovascular Interventions, Geraci et al. (8) report 1-year outcomes in patients with “long lesions” treated with BVS. The numbers are impressive: the data come from the large GHOST-EU (Gauging Coronary Healing With Bioresorbable Scaffolding Platforms in Europe) registry, which included 1,722 lesions in 1,468 consecutive patients enrolled between November 2011 and September 2014 at 11 European centers. The lesions were divided into 3 groups according to continuous BVS length: 1) shorter than 30 mm (group A); 2) between 30 and 60 mm (group B); 3) longer than 60 mm (group C). Patients with lesions ≥60 mm had more comorbidities, more chronic total occlusions (37%), bifurcations lesions (40.3%), higher Syntax score (16.4 ± 7.8), and a higher number of scaffolds implanted per lesion (3.3 ± 0.9 mm). Target lesion failure at 1 year was significantly higher in group C (group A 4.8%, group B 4.5%, group C 14.3%; overall p = 0.001), with no significant differences between groups A and B. Finally, a numerically higher number of scaffold thrombosis were observed in group C when compared with shorter lesions (group A 2.1%, group B 1.1%, group C 3.8%; overall p = 0.29). Of note, stent thrombosis rates in groups A and B are similar to those previously published by the same group. Furthermore, the high rate of adverse outcomes occurred in the long-lesion group despite higher rates of post-dilation and intravascular imaging use.
What lessons can be learned from this study? First, percutaneous coronary intervention (PCI) for long lesions remains a challenge. Numerous studies have demonstrated that lesion or stent length is an independent predictor of adverse events (9–11). BVS do not seem to be the miracle solution to this everlasting problem. Second, this elegant substudy from the GHOST-EU registry adds another piece to the worrisome picture on outcomes after BVS implantation with high rates of repeat revascularization and, most of all, numerically higher rates of stent thrombosis.
Optimal BVS implantation technique including vessel preparation and use of intravascular imaging has been suggested as the Holy Grail to improve results. However, long procedures with the use of costly imaging devices are unlikely to speed the adoption of BVS in an era where cost restraints and improvement in efficiency have replaced patient and physician preference, especially if there is no clear benefit, or even worse, a higher rate of adverse outcomes.
Is the GHOST-EU registry adding another nail to the coffin of BVS? New PCI devices most often need several iterations to achieve optimal results. The first bare-metal stents were extremely difficult to implant; first-generation DES were plagued with late stent thrombosis, which virtually disappeared with progresses in polymer and strut thickness. Changes in BVS design will hopefully improve procedural and clinical outcomes. Until then, there are too many worrisome signals coming from randomized trials and large registries: the use of BVS should be restricted to highly selected patients and lesions.
↵∗ Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology.
Dr. Spaulding has received research grants from the French Ministry of Health; consulting fees from Abiomed, Zoll, Medtronic, and Medpass; speaker fees from AstraZeneca, Cordis, Servier, Lead-Up, Bayer, The Medicines Company, Eli Lilly, and WebMD; and research grants from the French Ministry of Health. Dr. Karam has reported that she has no relationships relevant to the contents of this paper to disclose.
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