Stent, balloon and hybrid in de novo PCI: could the whole be greater than the sum of its parts?

Andreas Grüntzig, an ardent angiologist crafted an indeflatable sausage-shaped dual-lumen balloon-catheter, designed its delivery to the heart, launched minimally invasive coronary intervention and taught by beaming live demonstration. Subsequent advances are just incremental tweaks and tinkers around this fully formed framework from 1978. The near-immediate or instant feedback learning process by which the heart responds to any new invasive procedural variation facilitates each new change; be it drug-eluting stent, drug-coated balloon, or both in different combinations and permutations. Now with Grüntzig’s balloon armed with an antiproliferative drug, it could dominate the field once more, as he originally envisaged.

Introduction

The use of drug-coated balloon (DCB) in de novo coronary artery disease has seeped through into routine practice in recent years.¹ Largely unnoticed by the mainstream community, ignored by multi-national device companies and rarely discussed at international meetings. Its development actually parallels that of first-generation drug-eluting stent (DES) from the early 2000s; pioneered, propagated and instructed by expert German operators.^2,3 Its efficacy is proven for in-stent re-stenosis (ISR),⁴ small vessel disease,^5,6 high-risk bleeder,⁷ and where stenting might be avoided, such as in Takayasu arteritis.⁸ It has been safely trialled in ST-elevation myocardial infarction (STEMI),^9,10 side-branch involving left main,^11–13 multi-vessel,¹⁴ large-vessel¹⁵ and calcified^16,17 disease. Simply put, the whole spectrum of ischaemic heart disease is amenable to DCB, notwithstanding ectatic or aneurysmal coronary lesion that is too large to stent.^18,19

DCB practice

Searching with the terms “DCB”, “coronary” and “de novo” in Google Scholar brings up publications reaching 100 per month in 2022, compared with 140 for DES. Although the current drive for DCB is mainly in Far Eastern and Nordic countries. However, the evidence-base and strut/polymer/drug technology for DES have matured and its price has been driven down by competition. DCB costs two to three times more than DES. With the realisation that the bulk of coronary interventions could be completed with DCB, it is conceivable that big players will soon enter the foray. Cordis Corporation, which implanted the first DES in 1999 and launched it in 2003, has just reportedly acquired a DCB being studied for de novo use for nearly £1 billion. Its first-generation DES was hamstrung by thick stent strut, polymer allergy, stent thrombosis and excess mortality after two years.²⁰ It might lead again, using the same antiproliferative drug, this time delivered not with stent, but by balloon. Hence, leaving nothing behind, that is, no stent, no stent thrombosis.

In 2022 alone, over one million DCB-only or 20–25% of coronary interventions were undertaken in China. In the UK, DCB use was 8.1%, mainly for ISR but with a small de novo component, according to the British Cardiovascular Intervention Society (BCIS) national audit data from 2021/2022. If 70% of coronary cases are done with DCB in the UK, it would be an estimated £30 million market per annum in the next five to 10 years (see below for DCB vs. DES split). The DCB journey is akin to that of radial approach adoption, which is presently the dominant vascular access by diktat following a 25-year journey from fringe to the forefront. Each technique has its own performance bias. With radial access, the mortality benefit in acute coronary syndrome is only apparent in the above 70% high-volume operators.^21,22 DCB is similar, and its quarter-century voyage reaches its zenith by 2028, as coronary intervention did in 2003, when the author started his training.²³

The beginning

Percutaneous coronary transluminal angioplasty or plain-old balloon angioplasty (POBA) was first reported in The Lancet by Andreas Grüntzig (1939–85), a visionary German angiologist.²⁴ He improved on Charles Dotter’s technique performing peripheral angioplasty with his patented double-lumen balloon-catheter. He forged his sausage-shaped balloon with polyvinyl chloride (PVC) plastic after consulting with Heinrich Hopff, a retired German organic chemist in Zurich.²⁵ He designed a system with pressured-and-contrasted balloon indeflation, blood pressure transducing and radiographic-dye injection for visualisation to perform coronary angioplasty. This was with low-resolution cine-fluoroscopy without the replay button. He first tested his balloon on dogs, followed by patients undergoing coronary artery bypass grafting (CABG). It was a theatrical performance then, as it is today, when he imparted his technique broadcasted to a live audience starting on 7–10 August 1978; four such meetings took place in Zurich while he was there.^25–27

POBA has an instant feedback for success or failure, with 10% abrupt vessel closure (AVC), which Grüntzig had a tough time explaining to seniors at his institution, who were less than sympathetic, culminating with him leaving Zurich for Atlanta in 1980; entering the US as a national treasure.²³ He was offered a professorship and unlimited funding at Emory University, courtesy of a 100 million dollar grant from Coca Cola, which is headquartered at Atlanta.²⁷ Grüntzig’s Lancet series describes five patients. One was a 44-year-old man with an undilatable calcified circumflex artery. Another man, Dölf Bachmann who was 38, coincidentally the same age as Grüntzig at the time, was symptom free from his proximal left anterior descending (LAD) POBA for 23 years. He was also Grüntzig’s first coronary patient treated on 16 September 1977.²³ At 61 years of age, he had angina again with borderline pressure-wire fractional flow reserve of 0.84 and he had a bare-metal stent placed, which failed within two months. This was balloon dilated. He was well for another 14 years until 75 years old when he had a DES for recurrent ISR. One could speculate that he would have had fewer repeat procedures if Bernhard Meier, Grüntzig’s protégé had access to DCB. He detailed this man’s clinical course in his Andreas Grüntzig Lecture at the 35^th European Society of Cardiology (ESC) Congress in London on 30 August 2015. Early adopters of POBA had a 6–10% failure rate necessitating emergency CABG.^25,28,29 There was a learning curve in case selection and skilful lesion preparation. For instance, Geoffrey Hartzler’s institutional failure rate was under 1% after a decade’s practice, from 10%.²⁸

Stent issues

DES is recommended by guidelines for STEMI.⁴ The CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) study, which was conducted over 20 years ago, seemingly confirmed the superiority of stenting.³⁰ But this was on the basis of planned target-vessel revascularisation at six months, which was not clinically driven. Nevertheless, experience gained over the last two decades has uncovered some downsides to stenting in STEMI. These include no reflow from distal embolisation, causing microvascular obstruction that extends infarct size, as with side-branch occlusion.^31,32 In the mid-LAD, which is replete with side branches, the septal and diagonal branches are vulnerable to occlude with stent optimisation from plaque or thrombotic shift. Conversely, stent mal-apposition could result from stent under-sizing from vasoconstriction during STEMI.³³

With stenting in general, beyond nine months there is a continuous risk of ISR, from 5–15% within the year to a year-on-year rise to 25–30% in three to five years; this curve continues to climb, even with third-generation DES.^20,34–37 The ideal stenting rate is probably around 30%, according to Bernhard Meier, as per law of diminishing return for POBA and bare-metal stent.³⁶ Conjecturally, the same ratio holds true for DCB and DES. Target-vessel failure might partly be driven by vascular endothelial dysfunction that is exacerbated by the stent.³⁸ There is also renewed interest in the coronary microvasculature.³⁹ It plays a central role in coronary blood flow autoregulation, which explains the disconnect between epicardial coronary artery disease, symptoms and mortality in patients with stable disease,^40,41 chronic kidney disease (CKD),⁴² and heart failure;⁴³ where DES imparts salutary and no lasting benefit, nor does it impact survival in the unselected population.⁴⁴

In another Andreas Grüntzig Lecture at the 42^nd ESC Congress on 27 August 2022 in Barcelona, Javier Escaned cautioned that a third of daily coronary interventional practice now deals with stent failures. These are mainly caused by the metallic stent strut and neo-atheroma. Neither thinner strut nor abluminal biodegradable polymer coating offers durable outcomes, and the search for a bioresorbable stent remains elusive. Abbott’s Scaffold, a short-lived experiment with a bioresorbable poly-L-lactide strut, instead gave rise to the imaging-guided stenting approach. This involves extensive stenting for more complete plaque coverage, possibly contributing to further stent failures, as stenting length of over 40 mm is a potent predictor.^34,45

Plaque stabilisation?

The shortcomings of DES might be avoided by DCB. The large SCAAR (Swedish Coronary Angiography and Angioplasty Registry)⁴⁶ and other^47,48 research registries in the mode of post-marketing surveillance have demonstrated long-term efficacy and safety of DCB in all-comers, including STEMI. What is remarkable is that the target-vessel failure curve flattens after three years, reminiscent of a ‘cure’. This is also observed in some randomised-controlled trials (RCTs) comparing DES and DCB.^5,49 Not unlike that of POBA, in the author’s 20-year practice, only an 89-year-old woman re-presented for surveillance of her aortic stenosis. She had POBA 30 years prior in 1993 and has been angina free since. Perhaps this is because, without a stent-caged artery, POBA or DCB preserves vascular endothelial function,^50,51 regresses atherosclerotic plaque,⁵² and, in an animal experiment, stabilises vulnerable plaque.⁵³ The latter is being examined in the DEBuT-LRP (Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques) study (NCT04765956).

Abrupt vessel closure

There is undoubtedly a learning curve with DCB harking back to the POBA era.^24,28 It is clear that AVC is mostly thrombotic,⁵⁴ and rarely is due to occlusive dissection.⁵⁵ The former is uncommon with modern antiplatelet drugs pretreatment, while the latter requires stenting, and could be anticipated with practice, such that it becomes less frequent than acute stent thrombosis.^1,55 Otherwise, ambulatory DCB practice would not be feasible.⁵⁶ Pressure-wire guided DCB,⁵⁷ and controlled plaque-modification,⁸ provide added confidence. Although the fear of AVC without stenting is real, be that as it may, advanced chronic-total occlusion (CTO) operators are quite content to leave a dissected vessel unstented as an investment procedure (Invest CTO PCI Trial: NCT04774913). On the other hand, stent thrombosis occurs in 0.8% (one in 125) and 1% of cases within 30 days and one year, respectively, according to the BCIS national audit data. There are patient and procedural factors. Technically, stent under expansion and mal-apposition are probably less common with current practice, with the increased awareness for these, and the plethora of imaging and calcium modification devices we have in our armamentarium. However, the reverse might be happening. Stent oversizing, aggressive post-dilatation or stenting into a diseased segment causes stent-edge dissection (SED) in up to 20% of cases, detectable with optical coherence tomography (OCT), which carries a 5% mortality within three months.⁵⁸ This is because the resulting flap of tissue beyond the distal stent edge goes against the blood flow, extending the dissection, impeding blood circulation and precipitating subacute stent thrombosis (figure 1).

POBA without stenting could be achieved in over 95% of STEMI cases in RCTs.^10,30–32 In the DANAMI-DEFER (Deferred versus Conventional Stent Implantation in Patients with ST-segment Elevation Myocardial Infarction) study,³¹ deferring stenting for three days (612 stenting and 603 defer), AVC in the second half of study occurred in one (<1%) case versus 11 (1.5%) cases indicating a learnable process. Echocardiographic left ventricular ejection fraction was significantly better in the defer group (60% vs. 57%, p=0.042). In the Super-MIMI (Minimalist Immediate Mechanical Intervention) study,³² there was 1.2% AVC when stenting was delayed to one week, these cases did not receive a glycoprotein IIb/IIIa inhibitor. In the more up-to-date EROSION III (Effective Anti-Thrombotic Therapy Without Stenting: Intravascular Optical Coherence Tomography Based Management in Plaque Erosion) study,⁵⁹ patients with plaque erosion on OCT had medical treatment in nearly 60% of cases, suggesting that stenting is optional in STEMI. No AVC occurred, despite a 20% rate of glycoprotein IIb/IIIa inhibitor use, compared with a third in the DANAMI-DEFER study, but this study included a direct-acting third-generation P2Y₁₂ inhibitor. STEMI AVC is, therefore, as predictable as in other settings.^1,56,57 Importantly, intravascular imaging with OCT has highlighted the diverse aetiologies of STEMI; plaque rupture, plaque erosion, calcium protrusion and a whole host of MINOCA (Myocardial Infarction with Non-Obstructive Coronary Artery) presentations, where stenting is not advisable, such as in spontaneous coronary artery dissection (SCAD) with spreading intramural haematoma, bridging segment, thrombotic or embolic occlusion, epicardial and microvascular vasospasm, etc. STEMI intervention, hence, could be tailored and individualised. The STEMI guidelines written in 2018 will need to be updated.⁴

Hybrid provisional stenting strategy

Stent use was mostly off-label. The instruction for use (IFU) of DES dictated one stent for a straightforward lesion. In which case, ISR, metal allergy, CTO, STEMI, long lesion requiring two-stent overlap, vein graft, left main, bifurcation, ostial and three-vessel disease were all treated at the operator’s discretion. In spite of this, it drove technical innovation and refinement. The best attended sessions at meetings are case reviews on unforeseen challenges and get-out-of-trouble solutions, apparently worked out on the hoof. The heart is a highly-sensitive life-sustaining organ reacting with immediacy to any invasive procedure. This allows the instant feedback learning process. Any complication arises self-evidently and if not prompt, would be within a short time span. For example, the double-barrel or simultaneous-kissing stenting for bifurcation lesion went out of favour swiftly because of early stent failure.⁶⁰ Instead, crush stenting remains in use.⁶¹ Lim and Dzavik’s crucial description of balloon crush of side-branch stent in 2004⁶² allows for a stepwise approach, giving rise to double-kiss (DK) crush stenting, which is the standard for two-stent strategy.⁶³ In Europe, single-stent technique is favoured and, with DCB, it could be hybrid provisional stenting for complex bifurcation disease as illustrated in figure 2.

The hybrid provisional stenting strategy limits stenting and allows underfilled and diseased vessel to remodel, as demonstrated by Carlo Di Mario in a CTO case report.⁶⁴ It is being appraised in bifurcation RCTs.^65,66 Any two-stent technique creates stiff-and-thick multi-layered struts, mal-apposition and flow turbulence in the neo-carina, as nidus for stent failure. In contrast, one-stent layer allows conformation to the artery lumen minimising ISR. Further, T-stenting the side branch first guarantees its access after main-branch stent trapping, the sliver of uncovered ostium is then treated with DCB. This technique is quick, it enables easier future re-intervention and it is 5-French compatible, as well as suitable for the unstable patient who tolerates myocardial ischaemia poorly.

Conclusion

It is a good idea to heed many stent manufacturers’ advice to restrict to one non-overlapping DES if stenting is planned, in a straight segment, well-prepared and compliant if calcified, avoiding any bifurcation unless it involves the left main coronary artery. The rest is complemented with DCB, refraining from the spurious or purist argument of using either DES or DCB. Use of DES with DCB at once simplifies and hastens coronary intervention. DCB might be the primary focus for STEMI in the future, as its varied underlying mechanisms are considered. AVC is uncommon with newer antiplatelet drugs, and is both preventable and predictable with practice. DES delays, rather than prevents, target-vessel failure; from POBA that occurs within three to five months to three to five years and continues to fail in due course. With DCB the plaque appears to stabilise with plateauing event rate. Finally, DCB-alone strategy carries no systematic penalty. For the stent enthusiasts, it could be regarded as a defer-stent technique, even if it fails it results in limited stenting in a larger remodelled vessel, but stent deferment tends to be a long-term investment.

Key messages

• Drug-coated balloon reduces coronary restenosis from plain-old-balloon-angioplasty, matching that of drug-eluting stent in de novo small vessel disease
• It has been evaluated in the whole range of coronary artery disease and its use is increasing, especially in the Far East
• It causes luminal enlargement due to positive vascular remodelling, preserves endothelial function, potentially stabilises the plaque and speculatively improves cardiac function. Although its procedural outcome, as with stenting, depends critically on lesion modification, i.e. ‘failure to prepare is preparing to fail’
• Abrupt vessel closure after drug-coated balloon is preventable, predictable and is no more frequent than with stent thrombosis
• When drug-coated balloon is used with drug-eluting stent it limits stenting and simplifies complex coronary artery anatomy

Conflicts of interest

None declared.

Funding

None.

Patient consent

The patients have kindly given their informed consent for their cases to be shared for learned communication.

Acknowledgements

The author trained at the Toronto General Hospital (2003–2005) under Vladimir Dzavik. This started with the severe acute respiratory syndrome (SARS CoV-1) outbreak, albeit at the tail end. Procedures were performed with personal protection equipment as was the case with SARS CoV-2 or COVID-19 in the UK. Over the course of his fellowship, the prevailing philosophy of procedural success there, as was elsewhere, was defined by stenting. Brachytherapy was employed for repeated bare-metal stent ISR and the first-generation DES use started to pick up. Reports of late-acquired stent mal-apposition and thrombosis emerged with post-marketing surveillance after two years, resulting in National Institute for Health and Care Excellence (NICE) guidelines in 2008, which also took into account the costs; restricting second-generation DES to small vessel <3.0 mm in diameter and lesion >15 mm in length. Under this circumstance, the author’s use of DES was <30% and the rest were bare-metal stent and POBA plus thrombectomy in STEMI. The author’s first use of DCB was a DIOR in a 65-year-old man with CKD and right coronary artery ISR on 10 December 2009. It failed within six weeks. The second case was for a de novo ostial obtuse marginal branch lesion in a 59-year-old man with stable angina on 11 January 2010 and he remains well beyond 12 years. The author attended Jim Nolan’s Transradial Masterclass in Manchester on 20–21 November 2014. Simon Eccleshall presented an interesting de novo DCB case in the evening angiographic review session. The author asked him which product he used. Alex Grimster (former head of physiology) put it on the shelves within six weeks. The author participated in Simon Eccleshall’s DCB meeting in Birmingham on 4 September 2015 and the next one on 29 September 2016 sharing his early DCB experience. In the following meeting on 28 September 2017, the author presented his LAD STEMI series and postulated on the stented LAD’s impact on cardiac function. The author thanks the clinical seniors; Stephen Brecker, Rajan Sharma and Manav Sohal for their insightful and progressive leadership; also expresses gratitude to Mary Keal (Matron), Dinesh Sajnani (Head of Radiology), the patients treated by the author including the left main bifurcation case described in this manuscript, Klio Konstantinou and EnHui Yong (trainees) who assisted in the procedure, as illustrated in this report, and all the cardiology staff who selflessly looked after these patients. Finally, this article is the author’s personal viewpoint written from his own experience, interpretation of literature and through interactions with and listening to talks given by experts in the field; Bruno Scheller, Franz Kleber, Klaus Bonaventura, Simon Eccleshall, Sandeep Basavarajaiah, Bernardo Cortese and Tuomas Rissanen.

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