Hybrid Percutaneous Coronary Intervention With Bioresorbable Vascular Scaffolds in Combination With Drug-Eluting Stents or Drug-Coated Balloons for Complex Coronary Lesions
State-of-the-Art Review
Central Illustration
Abstract
Bioresorbable vascular scaffolds (BVS) have become an attractive option in the percutaneous coronary intervention field due to the potential advantages associated with the complete resorption process that occurs within a few years. However, current-generation BVS have several limitations including thicker struts, reduced radial strength, and limited expansion capability when compared with drug-eluting stents (DES). As a result, complex coronary disease often contains BVS-inappropriate/unfavorable segments. This does not necessarily mean that BVS use must be completely avoided, and minimizing the length of permanent metallic caging may still be advantageous. Operators should fully understand the limitations of current BVS, and when to consider a hybrid strategy of BVS in combination with DES or drug-coated balloons.
Introduction
The long-term safety and efficacy of drug-eluting stents (DES) is well established, with each successive generation demonstrating marked improvements in design and a reduction in clinically important endpoints (1). Concerns remain however, even with newer-generation DES, regarding the continued late adverse events associated with the presence of a permanent rigid metallic cage (2). In this context, bioresorbable scaffolds may be attractive, with several potential advantages due to the complete resorption process that occurs within a few years (3,4). The possibility of restoring natural vessel function including vasomotor response and pulsatile motion (3–7) are features that may have a positive impact with long-term follow-up. Several randomized trials have demonstrated noninferiority of bioresorbable vascular scaffolds (BVS) to contemporary DES for short- and mid-term clinical outcomes in relatively simple lesion subsets, and real-world registries have reported acceptable results in more complex lesions (8–17). However, current-generation BVS have several limitations when compared with DES, including thicker and wider struts, less radial strength, and limited expansion capabilities (18–21), which must be fully appreciated when treating patients with complex lesions. A complex lesion may involve potentially BVS-unfavorable segments; however, containing such segments does not necessarily mean that BVS use must be completely avoided. On the contrary, minimizing the length of permanent metallic caging may be advantageous (Figure 1) (3,4,22). In such situations, a hybrid strategy using DES or drug-coated balloons (DCB) for the BVS-inappropriate/unfavorable segments can be considered. In this paper, we discuss a hybrid strategy for managing complex lesions unsuitable for pure scaffolding percutaneous coronary intervention (Central Illustration).
2 Representative Cases Involving LAD Long Lesions
The 2 representative cases involve left anterior descending coronary artery (LAD) long lesions including small diameter segments: (A) treated with only DES (full metal jacket), and (B) treated with a hybrid strategy with concomitant use of BVS and DES to reduce the length of permanent metallic caging. A (Base): Baseline angiogram revealing long diffuse disease from proximal to distal LAD. A (Final): Final angiogram demonstrating an excellent result after treatment with multiple DES (3.5 × 31 mm/3 × 38 mm/2.5 × 31 mm). B (Base): Baseline angiogram showing diffuse long disease from the proximal to distal LAD. B (Final): Final angiogram demonstrating an excellent result after treatment of hybrid strategy with multiple BVS (3.0 × 28 mm/3.0 × 28 mm/2.5 × 28 mm/2.5 × 28 mm) and DES use (2.25 × 18 mm/2.25 × 18 mm) for the distal segment with diameter unsuitable for BVS (vessel diameter <2.5 mm). BVS = bioresorbable vascular scaffolds; DES = drug-eluting stent.
BVS-Inappropriate/Unfavorable Segments
Red words (large and small vessels) are BVS-inappropriate segments; blue words (aorto-ostial, LMT, large diameter discrepancy, bifurcation SB) are BVS-unfavorable segments, and require careful consideration on whether to use BVS; green words are potential alternatives to BVS. BVS = bioresorbable vascular scaffolds(s); DCB = drug-coated balloon; DES = drug-eluting stent(s); LMT = left main trunk; RD = reference diameter; SB = side branch.
BVS, DES, and DCB Features for Consideration in Daily Practice
There are several types of bioresorbable scaffolds in development, and each scaffold has different mechanical and physical properties. In this report, we have focused on the Absorb BVS (Abbott Vascular, Santa Clara, California), which is most commonly used in clinical practice.
Currently available BVS diameters are 2.5 mm, 3.0 mm, and 3.5 mm, having a restricted application when compared with DES (2.25 to 5.0 mm) and DCB (2.0 to 4.0 mm). DES are widely used for nearly all coronary lesions from left main to small vessel disease. DCB have been used predominantly for in-stent restenosis and recently have also been considered for small vessel disease and bifurcation lesions (23). DCB are advantageous because they provide a treatment without adding a metallic/plastic layer; however, they provide no radial force in the acute phase. Therefore, DCB can generally be used where there is an adequate angiographic result after lesion preparation, such as ≤30% residual stenosis without major dissection (23,24). BVS uniquely enable temporary scaffolding and complete resorption, but on the other hand, are still inferior in acute performance when compared with DES. Current-generation DES have thinner and a smaller volume of struts, a lower crossing profile, and greater radial strength when compared with BVS (18). By contrast, due to larger struts, vessel wall coverage and strut volume in the lumen are much larger with BVS, which is especially pronounced if the scaffold is not fully expanded (25). Furthermore, BVS have a limited expansion capability (0.5 mm + scaffold size) when compared with DES (18,19,26).
Optimal Implantation Strategy: Ways to Minimize Risk
The use of an optimal implantation strategy should be considered mandatory, especially when treating complex lesions with current BVS. As previously published (27), a dedicated BVS implantation strategy consists of the following steps (Table 1): 1) careful lesion/patient selection and scaffold sizing; 2) adequate lesion preparation; 3) dedicated scaffold deployment; 4) high pressure post-dilation; and 5) post-implantation evaluation.
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Recently, the 3-year outcomes of the ABSORB II (ABSORB II Randomized Controlled Trial) trial have been reported (28). The trial failed to demonstrate its primary endpoint of superiority of vasomotor reactivity for BVS with respect to the metallic Xience stent (Abbott Vascular) at 3 years, and reported a numerically higher rate of very late scaffold thrombosis. The resorption process seems to take longer than initially expected. Furthermore, the study was conducted using a conventional strategy with small balloon pre-dilations and a low rate of post-dilation with relatively low pressure. Although further data are required to understand the impact of a dedicated implantation strategy on very late outcomes, stricter lesion selection and optimized implantation including the aforementioned 5 principles should be considered mandatory for implanting current-generation BVS.
There were no very late scaffold thrombosis events in patients on dual antiplatelet therapy for 3 years without interruption in the ABSORB II trial. Until a definitive answer is available, a prolongation of the usual period of dual antiplatelet therapy in patients with low bleeding risk and the avoidance of BVS implantation in patients with high bleeding risk should be considered.
How to Manage BVS-Inappropriate/Unfavorable Segments
Large lumen diameter
Large lumen diameter
Complex coronary lesions may encompass segments with large lumen diameters. BVS use should be avoided if the lumen diameter exceeds 4.0 mm, because the largest available BVS diameter is 3.5 mm with a corresponding maximum dilatable diameter of 4.0 mm (Figure 2). Using BVS in large vessels and leaving malapposed struts would be a risk of scaffold thrombosis (29,30), whereas overexpansion might cause scaffold fracture (18,19,26). Although bench tests have indicated that BVS can be dilated up to +1.0 mm over scaffold size, the threshold for fracture seems to decrease in the presence of plaque, and it is generally accepted that the maximum expansion capability in vivo is scaffold size +0.5 mm (18,19,26). If angiographically the reference diameter is unclear, the operator should not hesitate to use intravascular imaging. In a long lesion with a large lumen diameter in the proximal segment, BVS should normally first be implanted distally to proximally, followed by DES for the proximal segment with minimal overlap of DES and BVS struts. Post-dilation should be performed more carefully at the overlapping site in order to embed the outside scaffold struts into the wall, considering the concern regarding the potential occurrence of metallic stent strut malapposition after complete resorption of BVS.
Hybrid Strategy With BVS and DES for a Patient With Multivessel Disease Involving BVS-Unfavorable Segments
(A) Baseline angiogram of right coronary artery (RCA) demonstrating moderate stenosis at mid-part and total occlusion at distal-part; intravascular ultrasound after wire-crossing and pre-dilation, to confirm lumen/vessel diameter from the distal to proximal RCA, demonstrating BVS-unsuitable large lumen diameter (LD) (≥4.0 mm) at mid part (A′: LD 4.0 × 4.3 mm; A′′: 4.3 × 5.0 mm). (B) Baseline angiogram of left coronary artery (LCA) demonstrating diffuse disease from distal left main trunk (LMT) to mid-LAD. Intravascular imaging revealing large lumen diameter at proximal left main (B′: 3.9 × 4.5 mm). (C) Final angiogram of RCA demonstrating an excellent result after 2 × BVS (3.5 × 18 mm and 3.0 × 28 mm) for the distal RCA and DES (4.0 × 16 mm) for mid-RCA. (D) Final angiogram of LCA demonstrating an excellent result after continuous implantation of 1 DES (4.0 × 12 mm) from LMT to the proximal LAD and 2 BVS (3.5 × 28 mm and 3.0 × 28 mm) from proximal LAD to mid-LAD. (D′) Optical coherence tomography at overlapping of BVS and DES at proximal LAD showing well-embedded BVS struts covered by DES. Abbreviations as in Figure 1.
Small reference diameter
Complex disease commonly involves small diameter segments, especially at the distal part of a lesion. Considering that the smallest available BVS diameter is 2.5 mm, BVS must be avoided in segments with vessel diameter <2.5 mm. Due to the highly compliant delivery balloon of current BVS and the difference in structure from metallic stents, uneven balloon overexpansion can occur if oversized, which may lead to vessel injury (31). Even if the vessel is not injured, oversized BVS implantation (smallest 2.5 mm BVS for vessel <2.5 mm) results in increased vessel wall coverage and strut volume in the lumen (25), which increases thrombogenicity (32) and the potential for adverse events (33). However, angiographic assessment often underestimates true vessel diameter especially in diffuse disease (34), and sometimes a distal vessel can increase in size after pre-dilation of a proximal stenosis due to flow improvement. Operators should not hesitate to perform repeat intravascular imaging after pre-dilation and nitrate administration, in order to confirm actual diameter. When treating a small distal segment not ideal for BVS, DCB and/or DES are valid options (Figure 1B). If adequate results (generally residual stenosis ≤30% without major dissection) are obtained after pre-dilation (23,24), DCB use can be considered (35–38). If not, 2.25/2.5-mm DES should be the preferred option. Intravascular imaging is helpful in deciding whether a borderline segment is suitable for 2.5-mm BVS.
Large diameter discrepancy between proximal and distal landing sites
Lesions with large differences in diameter between proximal and distal landing sites are sometimes encountered, especially when crossing a large branch of a bifurcation (Figure 3A). In such situations, if undersized proximally, malapposition may occur around the proximal landing zone. By contrast, if oversized distally, vessel injury and/or increased vessel coverage may occur at the distal landing zone. Therefore, when a >0.5-mm diameter discrepancy exists between the proximal and distal landing zones, BVS use should be limited. DES use is an appropriate alternative due to the much higher expansion capability without fracture (18,39). A DES sized for the distal reference diameter can be implanted and post-dilated proximally with a large balloon (>0.5-mm stent size) to appose the proximal struts. However, the lesion is relatively long or another lesion exists adjacently, the segment could be divided and covered by 2 BVS of differing diameters. Intravascular imaging is useful for both determining exact measurements and to guide and optimize deployment.
Representative Cases Involving BVS-Unfavorable Segments
(A) A representative lesion with large diameter discrepancy between proximal and distal landing sites. Intravascular ultrasound revealed LD 3.6 × 4.0 mm and vessel diameter (VD) 5.1 × 5.3 mm around the proximal (Prox) landing zone, and LD 2.8 × 2.9 mm and VD 3.0 × 3.1 mm at the distal landing zone. A 3.5-mm BVS would be too large for the distal VD (3.0 × 3.1 mm), whereas, a 3.0-mm BVS would be too small for the proximal segment because the LD is 3.6 × 4.0 mm and larger than the corresponding maximum dilatable diameter of 3.5 mm. (B) A representative case involving an aorto-ostial lesion. Base: Baseline angiogram revealing long diffuse disease from ostium to distal right coronary artery. Final: Final angiogram demonstrating an excellent result after DES (3.5 × 23 mm) and multiple BVS (3.5 × 28 mm/3.0 × 28 mm/3.0 × 28 mm) continuously implanted from the ostium to distal segment. Abbreviations as in Figures 1 and 2.
Aorto-ostial lesions
Ostial lesions have been indicated to be associated with an increased rate of adverse events after BVS implantation (40,41). In aorto-ostial lesions, radial strength is important, and the consequence of protruding BVS struts into the aorta during the resorption process is currently unknown (27). Furthermore, the risk of longitudinal deformation during the procedure may be higher with BVS (42). Therefore DES should be recommended for aorto-ostial lesions (Figure 3B).
Severe calcification
Severe calcification is not necessarily a contraindication to BVS. However, due to the relative lack of radial strength, aggressive lesion preparation is mandatory before BVS implantation (43). Operators should have a low threshold for scoring/cutting balloons (44,45) or rotational atherectomy. If concerns remain after lesion preparation, BVS use should be avoided in the calcified segment.
Bifurcation lesions
Prior reports have indicated that BVS use for coronary bifurcation lesions are associated with acceptable outcomes (46–49). Although single bifurcation stenting with BVS is the most feasible strategy (47,48), some bifurcation lesions may require double stenting as intention to treat (39,46). In addition, even with a provisional strategy, additional side branch (SB) stenting is sometimes required after main branch (MB) stenting (50).
When SB stenting is required after MB BVS implantation, culotte stenting should be avoided, due to thickness of current BVS (39), and T-stenting and small protrusion is the preferred bailout strategy. However, protruding BVS struts from the SB into MB should probably be avoided with current BVS (46,51); therefore, BVS use for provisional SB stenting should be limited only when SB BVS can be implanted without protrusion into MB; which means that the bifurcation angle is approximately 90° (39). Even if the angle is appropriate, it is technically not easy to precisely position the scaffold ostially, and frequently the ostium is missed or there is excessive protrusion into the MB. Therefore, DES use is preferable in most cases requiring additional SB stenting after MB BVS implantation (Figure 4A).
2 Representative Cases of Bifurcation Lesions Treated With Hybrid Strategy
The 2 representative cases of bifurcation lesions treated with hybrid strategy are as follows: (A) BVS in main branch (MB) and DES in side branch (SB), and (B) DCB in SB. (A) 1.Base: Baseline angiogram showing LAD/diagonal true bifurcation lesion. 2.Post-SB DCB: Angiogram showing acceptable SB angiographic finding after SB pre-dilation followed by DCB (2.25 mm). 3.Post-MB BVS: Angiogram after MB BVS implantation (3.5 × 28 mm) showing SB compromise. 4.TAP: SB DES implantation (2.5 × 28 mm) with T-stenting and small protrusion technique (TAP) after confirming no recovery of SB compromise even with kissing balloon inflation. 5.Final: Final angiogram showing an excellent result. (B) Base: Baseline angiogram revealing LAD/diagonal true bifurcation lesion. Final: Final angiogram demonstrating an excellent result after DCB treatment (2.5 mm) for SB followed by MB BVS implantation (3.5 × 28 mm/3.5 × 28 mm). DCB = drug-coated balloon; other abbreviations as in Figures 1 and 2.
When performing elective 2-stenting using BVS in MB, the crush and culotte techniques using BVS in SB should be avoided due to the increased strut thickness. Clinical outcomes of bifurcation 2-stenting using BVS in MB seem acceptable when predominantly using the T-stenting technique with SB BVS and mini-crush with SB DES (46). BVS use in the SB can only be considered when the anatomy allows T-stenting (wide bifurcation angle) and the SB diameter is large enough for BVS (≥2.5 mm). A hybrid strategy (BVS in MB and DES in SB) should be considered for all other situations (39,52).
Alternatively, even for bifurcation lesions which seem to require a 2-stenting strategy at baseline, a hybrid strategy with DCB for SB can be considered if angiographically adequate results are obtained after SB pre-dilation (23,38) (Figure 4B).
In-stent restenosis
Recent reports have demonstrated acceptable clinical outcomes following BVS implantation for in-stent restenosis, and BVS could be an attractive option due to the avoidance of adding another permanent metallic layer (53–55). At the same time, we should keep in mind that current BVS have less radial strength, which means there might be some BVS-unfavorable in-stent restenosis lesions, including those involving stent fracture (56). Furthermore, optimal lesion preparation before scaffold implantation, and treatment of any previously underexpanded stents is mandatory.
Left main
To date, little clinical data have been available regarding BVS use for left main disease. However, the left main trunk frequently contains several unfavorable characteristics for BVS, including a large lumen diameter, aorto-ostial coverage, and large diameter discrepancy between proximal and distal landing sites when performing bifurcation crossover stenting. Therefore, BVS use in left main lesions should be carefully considered, and DES used if any uncertainties exist. When treating continuous left main to left anterior descending coronary artery (LAD) lesions, a hybrid strategy can be used. The left main DES and LAD BVS overlap should be in the proximal LAD and not involving the ostium in order to minimize the chance of recoil and inadvertent BVS strut protrusion in the left main (Figure 2).
Bail-out
There are numerous difficult situations that can arise post-BVS implantation, and DES use is an appropriate first-choice bail-out option. If scaffold fracture occurs and the fractured struts are protruding into the lumen, coverage with DES should be considered (42). In certain circumstances, acceptable expansion cannot be obtained, even with adequate lesion preparation and post-dilation. In these situations, DES with greater radial force can be used as bailout (57). If major edge dissections occur, additional BVS can be considered to cover the dissection; however, considering the larger crossing profile (18) and less radial strength of BVS, there should be a low threshold for using DES as a bail-out especially after long BVS implantation and/or urgent flow-limiting situations.
Conclusions
Due to the limitations of current-generation BVS, complex coronary lesions are often unsuitable for pure scaffolding percutaneous coronary intervention. Limiting the permanent metallic length implanted may still be beneficial for future advantages. Therefore, a hybrid BVS and DES or DCB strategy could be an appropriate alternative.
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Abbreviations and Acronyms
| BVS | bioresorbable vascular scaffold(s) |
| DCB | drug-coated balloon(s) |
| DES | drug-eluting stent(s) |
| LAD | left anterior descending coronary artery |
| MB | main branch |
| SB | side branch |
Footnotes
Dr. Latib serves on the advisory board for Medtronic; and has received speakers honoraria from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
