Appropriate use of bioresorbable vascular scaffolds in percutaneous coronary interventions: a recommendation from experienced users

Percutaneous coronary interventions (PCI) have become a reliable revascularisation option to treat ischaemic coronary artery disease (CAD) [1]. Drug-eluting stents (DES) are widely used as first choice devices in many procedures due to their established good medium to long term outcomes [2]. These permanent implants, however, do not have any residual function after vascular healing following the PCI. Beyond this initial healing period, metallic stents may induce new problems, resulting in an average rate of 2 % reinterventions per year [3]. To eliminate this potential late limitation of permanent metallic DES, bioresorbable coronary stents or ‘vascular scaffolds’ (BVS) have been developed. In a parallel publication in this journal an overview of the current clinical performance of these scaffolds is presented [4]. As these scaffolds are currently CE marked and commercially available in many countries and as clinical evidence is still limited, recommendations for their general usage are needed to allow successful clinical introduction.

Continuous technological innovation has contributed to the impressive improvement of medical care over the past decades. On the other hand, many new technologies failed to deliver on their promises and disappeared soon after introduction, such as coronary laser angioplasty and brachytherapy. Moreover, recently, several examples exist of new technologies that were introduced without appropriate recommendations and assessment. A recent example is the introduction of a metal-on-metal hip prosthesis, considered beneficial for younger patients, in which an unexpectedly high rate of device failure was present. Based on similar examples, the Dutch Society of Cardiology (NVVC) adopted policy documents for the introduction of new technologies [5]. Later, the Dutch Order of Medical Specialists in collaboration with ‘Zorginstituut Nederland’ composed a similar document for all medical specialists in the Netherlands [6]. Both documents provide important information on the introduction process for new devices. In these documents a preparation phase is described including a risk analysis and a multidisciplinary cooperation before advising on device introduction. Furthermore, post-introduction outcome registration and reporting are essential to assess for any unexpected adverse events. Also, due to the substantial increase in healthcare costs when CAD patients have to undergo PCI and taking into account that the number of PCIs has more than a doubled over the past 10 years in the Netherlands [7, 8], the cost-effectiveness of any new PCI technology remains an important issue. Regarding the need of adjunctive imaging and supporting techniques for optimal BVS placement, the cost-effectiveness of treating CAD with BVS has yet to be determined in an all-comer patient population.

Numerous reviews on the current status of bioresorbable vascular scaffolds (BVS) for PCI have been published. In this journal, we have updated these reviews with the latest data presented during the EuroPCR meeting in Paris from 20 to 23 May 2014. In short, the safety of BVS has once again been confirmed in a large group of patients for non-complex lesions for up to 2 years after scaffold implantation after initial good results for 5 years in smaller groups [9, 10]. Based on these results we think that the use of the Absorb BVS can be considered to be ‘appropriate’ for lesions that were included in the initial ABSORB Cohort A and B trial and the ABSORB Extend registry. The details of these ‘Absorb Extend-like lesions’ are summarised in Table 1. The first randomised study (ABSORB II trial) on whether the Absorb BVS offers an advantage over DES is currently ongoing. The results of the physiological study will be available in 2016. An interim analysis at 1 year of follow-up showed similar rates in a composite clinical endpoint based on death, myocardial infarction and coronary revascularisation [11].

For patients with more complex lesions, who were excluded from the initial BVS studies, some short-term data were reported during the last EuroPCR meeting. In addition, several medium-sized trials (100–300 patients) with outcome data for up to 12 months were also presented. Based on these data and the experience of the authors, the previous exclusion criteria for Absorb BVS use currently seem outdated. However, as the follow-up period for these more complex lesions as well as patient numbers are still limited, the level of recommendation made cannot exceed ‘probably appropriate’. With this limited evidence in mind, it is important for every operator and PCI centre to keep a registry of patients treated with BVS, including data on patient outcomes, as described in the NVVC guideline on the introduction of new technologies.

Within these real-world registries the number of patients with true complex lesions, such as two scaffold bifurcations, heavily calcified lesions with rotablator lesion preparation and chronic total occlusions, is limited. For these complex lesions no recommendations can be given as the number of patients is too small and the outcomes are still uncertain. Probably, the AIDA (Amsterdam Investigator-initiateD Absorb strategy All-comers) trial, a Dutch multicentre trial with over 2700 patients included, will provide more insights into the use of BVS in these more complex lesions.

Furthermore, two special subsets of lesions should be mentioned: arterial or venous grafts and in-stent restenosis. For both, the current Absorb BVS label (de novo lesions in native vessels) does not apply and at this moment the recommendation for these types of lesions has to be off-label, which should only be deviated from with a clear motivation.

A final—technical—limitation is the overexpansion capabilities of the Absorb BVS that is currently restricted to 0.5 mm. As the largest commercially available Absorb BVS is 3.5 mm at nominal pressure, vessels with a diameter above 4.0 mm (quantitatively measured by quantitative coronary arteriography, intravascular ultrasound (IVUS) and optical coherence tomography (OCT)) should not be targeted because of the greater risk of extensive malapposition (Table 2).

Every introduction of a new technology targets a specific subgroup of patients. With the introduction of DES with higher healthcare costs, initially, only patients with a high risk of early restenosis (diabetic patients, long lesions and small vessels) were selected. Solid clinical data and a price cut paved the way for DES use in the majority of patients undergoing PCI in the Netherlands. As bioresorbable therapy aims to improve patient outcomes after the first year of implantation, patient selection has to take into account other arguments. Although many classical predictors of early restenosis also apply for treatment failure beyond one year (j-Cypher Registry) i.e. diabetes mellitus, renal failure, dialysis and long lesions, some factors are less important for long-term target lesion revascularisation (TLR) such as bifurcation lesions with side branch stenting [12]. It is important to make a differentiation between factors mainly affecting late TLR and those also impacting on patient long-term (> 5 year) survival.

It is therefore essential to appropriately select patients in which BVS may yield the highest beneficial effect on long-time clinical outcome. The American National Cardiovascular Data Registry recently provided valuable information for patient selection [13]. Although a relatively complex model was used, some major points have been identified. Patients above > 80 years, patients with severe renal failure or on dialysis or patients who are in cardiogenic shock at the time of the procedure, have a limited life expectancy and therefore the overall potential long-term benefit of BVS therapy is very limited. Other patient-related conditions, such as diabetes mellitus, body mass index > 40, left ventricular ejection fraction < 40 %, cerebrovascular accident, peripheral artery disease and chronic obstructive pulmonary disease, have a negative impact on the patient’s life expectancy and should lower the upper age limit for patient selection. In Table 3 we provide a simplistic model that can be used for patient selection.

Lesion preparation is especially important, as the current Absorb BVS strut thickness is higher (150 µm) than that of conventionally used DES. Also, before inflation, the initial scaffold diameter is quite large (1.4 mm) which is related to the specific scaffold-related folding characteristics of the Absorb BVS. Therefore, highly calcified or tortuous lesions or lesions with a high degree of angulation can be quite challenging for BVS implantation. However, with extensive lesion pre-dilatation using increasing balloon sizes, even highly calcified lesions can be successfully treated with BVS, although special care has to be paid to a good implantation technique. In summary, the five golden ‘P’s for BVS implantation: Prepare the lesion, Properly size the vessel, Pay attention to the expansion limits of the BVS, Post-dilate the scaffold with a properly sized non-compliant balloon and Pay attention to the DAPT compliance of the patient.

To avoid BVS malapposition, also taking into consideration the current limited sizes in scaffold diameter and length, correct scaffold sizing based on reliable assessment of vessel dimensions is a second important issue. Invasive imaging modalities, such as IVUS and OCT, have been proven to be superior to angiography in providing accurate morphometry, including for estimating vessel diameter and lesion length. OCT is particularly suited to visualise the scaffold struts and their interaction with the vessel wall and can greatly improve the quality of BVS implantation [14]. Before implantation, OCT is indicated to predetermine lesion characteristics, such as lesion length and the amount of calcification, to estimate the optimal scaffold length and to identify the optimal proximal and distal landing zones. OCT after scaffold implantation can be invaluable to guide post-dilatation of the scaffold with properly sized non-compliant balloons to perfect strut apposition, taking into account the expansion limit of 0.5 mm for the Absorb BVS, especially in the initial experience of the operator.

Current guidelines for antiplatelet therapy post-PCI with DES advise dual antiplatelet therapy (DAPT) for 6–12 months for stable angina. For acute coronary syndrome patients, based on the European Society of Cardiology (ESC) non-STEMI and STEMI guidelines, a minimum of 12 months DAPT is advised, preferably with prasugrel or ticagrelor [15, 16]. Some new publications suggest that for second-generation DES, DAPT duration might be shortened [17]. However, most of these studies are retrospective analyses and only a limited number of patients have been analysed for shorter DAPT treatment. For the ABSORB BVS a minimum of 6 months DAPT was stated per protocol, and the majority of patients were on DAPT for 12 months. Based on the design where strut thickness of the ABSORB BVS is similar to first-generation DES, and regarding initial reports on the occurrence of early as well as late stent thrombosis, the best advice for the moment is to prescribe DAPT for 12 months for all patients with ABSORB BVS and to avoid implantation of the ABSORB BVS in patients with a strict indication for oral anticoagulation, as there are currently no data on shorter DAPT in patients on anticoagulants.

At the start of this new era in interventional cardiology, treating physicians should realise their responsibility for a careful introduction of the technology. This includes the preparation phase and a close follow-up phase for which both the NVVC and the Dutch Order of Medical Specialists have valuable guidelines.

Based on currently reported data and the experience of the authors with the Absorb BVS, some suggestions for the selection of patients and lesion characteristics for correct clinical indications as well as some useful implantation tips and tricks have been made.