Randomized study assessing the effectiveness and safety of a novel scoring balloon for percutaneous coronary intervention: the Wedge NC trial

Introduction

With the increasing aged population and accompanying comorbidities, particularly diabetes mellitus and renal insufficiency, dilatation-resistant fibro-calcific lesions have become a common procedural challenge during percutaneous coronary intervention (PCI) (1,2). To ensure successful stent delivery and optimal PCI outcomes, these lesions must be adequately prepared (3-5). In addition to conventional non-compliant balloons, cutting balloons, rotational atherectomy, and the newly emerging intravascular lithotripsy, scoring coronary angioplasty catheters are routinely used devices for this complex lesion anatomy due to their efficient expansion capabilities (6,7).

On the other hand, as the concept of “intervention without implantation” is increasingly accepted, adequate lesion preparation with less residual stenosis and without a blood flow-limited dissection for drug-coated balloons (DCB) application is on demand (8,9). Scoring angioplasty catheters, utilizing the integral wire outside the balloon for scoring during inflation, could induce high focal stresses longitudinally along the luminal surface of the lesion at low inflation pressure, thereby reducing the occurrence of severe dissection (10,11).

The Wedge NC scoring balloon dilatation catheter (BrosMed Medical Co., Ltd., Guangdong, China) is one such device, equipped with a nickel-titanium scoring wire on the exterior of the balloon for inducing the desired intimal disruption. Given that it is newly designed and lacks practical application data, we conducted a non-inferior randomized trial to assess the effectiveness and safety of this scoring balloon dilatation catheter compared to the ScoreFlex coronary dilatation catheter (OrbusNeich Medical, B.V., Hoevelaken, The Netherlands) for treating stenotic coronary artery lesions during PCI. We present this article in accordance with the CONSORT reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1457/rc).

Methods

Study overview

The Wedge NC Scoring Balloon Dilatation Catheter trial (Wedge NC trial, NCT06214247) is a prospective, paralleled, multicenter, and open-label randomized controlled trial conducted at nine centers in China. From August 27, 2021 to February 28, 2022, 201 patients were screened, with two of them failing to meet inclusion criteria and one withdrawing the written consent, resulting in 198 successfully enrolled participants (Figure 1). The participants were randomized when the angiographic coronary artery stenosis was suitable for PCI, and were distributed equally to two groups, with 99 patients for each group. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The research proposal was approved by the ethics committee at each respective investigating center (leading center: The Second Affiliated Hospital, School of Medicine, Zhejiang University; approval number: A2021001203). All participating institutions were informed and agreed to the study, and all patients provided written informed consent.

Figure 1 Study flowchart.

Patient population

Adult patients (age ≥18 years) intended for PCI were assessed for study enrollment, and were suitable for inclusion if they had: (I) coronary artery disease (CAD) with objective evidence of myocardial ischemia or coronary artery stenosis suitable for PCI confirmed by invasive coronary angiography; (II) de novo or in-stent restenosis (ISR) lesions in native coronary arteries; (III) visual diameter of the lesions between 2.0 to 4.0 mm and length limited to ≤30 mm; (IV) only one target lesion in one coronary artery when multiple lesions existed simultaneously. Tandem lesions (defined as multiple nidi) were regarded as one if they could be covered by one single stent. Patients were excluded if they had: (I) bleeding diathesis or contraindications to anti-platelet and anti-coagulant therapy; (II) contrast sensitivity that were unable to be adequately premedicated; (III) severe renal failure; (IV) decompensated congestive heart failure or cardiogenic shock; (V) life expectancy <1 year; (VI) a known or suspected pregnancy; (VII) completely occlusive coronary lesions; (VIII) unprotected left main disease; (IX) prior surgical bypass grafts lesions. Detailed inclusion and exclusion criteria are available on ClinicalTrials.gov under the registration number NCT06214247.

Device description

The Wedge NC scoring balloon dilatation catheter (BrosMed Medical Co., Ltd., Guangdong, China) is a rapid-exchange coronary dilatation device. It features an external nickel-titanium wire on the balloon, which can exert a focused force angioplasty effect when the balloon is inflated (Figure 2). The proximal shaft of the catheter is constructed from a PTFE-coated stainless-steel tube that adheres to an inner round Luer taper. This smoothly transits to the distal part through a welding process. The proximal shaft is marked with two 3–5 mm indicators, denoting the relative position to the end of a brachial or femoral guiding catheter. The distal part of the catheter comprises an outer tube, balloon, and inner tube welded by laser. The lumen at the catheter tip is compatible with a standard 0.014-inch guidewire. The guidewire enters from the tip and advances coaxially out of the Rx port, thus enabling coaxial guidance and rapid exchange of the catheter using a single standard guidewire. Two radiopaque marker bands, indicating the dilating section, are located on the inner tube of the balloon. The balloon diameters range from 2.0 to 4.0 mm, crossing profiles from 0.035 to 0.052 inch, and lengths from 8 to 25 mm. The balloon is made of a non-compliant material with a rated burst pressure of 22 atm.

Figure 2 Schematic design of the Wedge NC scoring balloon catheter.

Study procedure

PCI was routinely performed using standard techniques, either via the femoral or radial approach, employing 6 or 7 Fr guiding catheters. Patients who had not been pre-treated with dual antiplatelet drugs were administered a loading dose of aspirin 300 mg and either clopidogrel 300 mg or ticagrelor 180 mg prior to the invasive procedure. Unfractionated heparin, at a dosage of 70–100 U/kg, was intravenously administered before the procedure, with subsequent boluses given to maintain the activated clotting time between 250 to 350 seconds. The utilization of GP IIb/IIIa inhibitors was left to the operator’s discretion. In all cases, lesion predilation was performed using either a Wedge NC scoring balloon or a ScoreFlex scoring balloon, which were slightly undersized based on conventional angiographic criteria. In cases where balloon expansion was incomplete with visible indentation, an inflation pressure nearing the rated burst pressure was applied. The subsequent PCI procedure adhered to the standard protocol.

Follow-up

Clinical events were assessed within 24 hours post procedure, three days post procedure or during hospitalization and at 30-day follow-up.

Study endpoints and definitions

The primary endpoint of the study was procedure success, defined as the residual stenosis of the target lesion ≤30% immediately after PCI procedure, without complications [limited to death, myocardial infarction (MI), or emergent coronary artery bypass grafting during postoperative hospitalization]. The secondary endpoints included device procedural success and balloon slippage, and angiographic minimal lumen diameter (MLD), percent diameter stenosis (%DS), acute lumen gain (ALG) measured by quantitative coronary analysis (QCA), as well as cardiac death, target vessel MI (TV-MI), and target lesion revascularization (TLR) at 30-day follow-up. Device procedural success was defined as fulfilling the followings: (I) successful delivery, inflation, deflation, and withdrawal of the study balloons; (II) absence of vessel perforation, flow-limited dissection (grade C or higher) or reduction in Thrombolysis in Myocardial Infarction (TIMI) grade from baseline. Cardiac death was defined as any death caused by cardiac or unknown factors. TLR was defined as any repeat revascularization within the treated segment. TV-MI was defined as evidence of myocardial injury within the vessel according to the Fourth Universal Definition of Myocardial Infarction (12). Balloon slippage was defined as an unanticipated balloon movement forward or backward ≥3 mm during inflation at the lesion site. Coronary lesion calcification was graded in accordance with the angiographic classification system established by Mintz et al. (13). Specifically, calcification was identified as distinct radiopaque areas within the target lesion. It was classified as severe when radiopaque areas were observed in the absence of cardiac motion prior to contrast injection, typically compromising both sides of the arterial lumen. QCA was measured by two experienced observers from an independent angiographic core laboratory (Jetmed Imaging Core Lab, Beijing, China). An independent, blinded Clinical Events Committee adjudicates all events.

Statistical analysis

The overall sample size for the Wedge NC trial was calculated based on the primary endpoint, procedure success. In alignment with the clinical practice and existing evidence (14), assuming the procedure success rate of 97% for the both arms and a noninferiority margin of ≤7%, a noninferiority sample size of 198 patients was calculated to provide a power of 80% at an α level of 0.025. Considering an expected attrition rate of 5%, we designed the trial to include 198 patients, with 99 patients in each arm. Randomization was performed using a web-based randomization programmer by an independent organization (S-Soft), and stratified by participating centers and diabetes mellitus. The primary endpoint of procedure success at the patient level was analyzed in both the intention-to-treat (ITT) population and per-protocol set (PPS). The ITT population consisted of all randomized subjects in their designed groups, irrespective of device utilization crossovers. The PPS consisted of subjects who received only the study device and did not experience any pre-specified protocol deviations. Continuous variables were presented as means with standard deviations and were compared using a 2-sided unpaired t-test or a Mann-Whitney U test. Categorical variables were presented as counts with percentages and were compared using a Chi-squared test or Fisher exact test when appropriate. A 2-sided P value <0.05 was considered statistically significant for all studied variables. All statistical analyses were performed using R version 4.2.3 (R Foundation for Statistical Computing, Vienna, Austria).

Results

Patient characteristics

A total of 201 consecutive patients were screened at nine study centers between August 2021 and February 2022. After excluding patients with at least 1 exclusion criterion, 198 patients were eventually included and randomly allocated to the Wedge group (n=99) or the ScoreFlex group (n=99). Overall, the ITT population included 198 patients, and the PPS included 98 patients in the Wedge group and 97 patients in the ScoreFlex group (Figure 1).

Baseline and angiographic characteristics

Patients in the two groups were well matched in baseline clinical characteristics. The mean age was 63.80±10.60 years in the Wedge group and 64.10±10.93 years in the ScoreFlex group (P=0.43) (Table 1). Of the total patients, 26.8% were females. Nearly 40% of patients were smokers and more than a quarter of the patients had diabetes (29.8%). There were no differences in the clinical presentations between the two groups.

Table 2 describes angiographic and procedural characteristics. Nearly a half of target lesions were located in LAD and only one lesion was located in the left main coronary artery of a Wedge group patient. There were 58 and 61 patients with multivessel disease in the Wedge group and ScoreFlex group, respectively (P=0.77). While owing to the study design, only one target lesion per patient was included in our trial. Nearly 10% of lesions involved moderate/severe calcification as well as moderate/severe tortuosity (P>0.99, P=0.82, respectively). More than 97% of lesions had preprocedural TIMI flow grade 3. QCA revealed no differences in baseline parameters. Mean vessel size and MLD were similar between the two groups. The average %DS before procedure was 68.46±11.51 in the Wedge group and 69.19±12.45 in the ScoreFlex group (P=0.67).

Procedural and clinical outcomes

During predilation procedure, the number of inflations, the maximal diameter during predilation and the balloon-to-vessel ratio were similar between the two groups, while patients in the Wedge group received larger balloons and more frequently maximal pressure dilatation compared to those in the ScoreFlex group (2.52±0.32 vs. 2.38±0.26 mm, P=0.002; 11.00±3.04 vs. 10.2±3.06 atm, P=0.042, respectively). Interestingly, immediately after the balloon inflation, MLD in the Wedge group was significantly larger than that of the ScoreFlex group (1.71±0.39 vs. 1.56±0.36 mm, P=0.02), resulting in a lower %DS and a higher ALG (36.04±11.43 vs. 41.14±10.63, P=0.004; 0.82±0.39 vs. 0.69±0.37 mm, P=0.02, respectively) (Table 2 and Figure 3). All patients in the Wedge group had post balloon inflation TIMI grade 3, while 2 patients in the ScoreFlex group failed to achieve TIMI grade 3 (100% vs. 98.0%, P=0.50).

Figure 3 Cumulative frequency distribution curves of (A) MLD and (B) %DS before the procedure and post balloon dilation. %DS, percent diameter stenosis; MLD, minimal lumen diameter.

Procedural outcomes are shown in Table 3. Procedure success, the primary endpoint of the trial, was 98 (99.0%) in both groups (P>0.99), with one patient developing periprocedural MI in the Wedge group and one patient having a residual stenosis ≥30% in the ScoreFlex group. In the ITT analysis, the mean difference between the Wedge and ScoreFlex was 0 (95% confidence interval: −2.79% to 2.79%, 1-sided P<0.001 with both Wald method and minimum risk weights method) (Figure 4). In the PPS analysis, the mean difference between the two group was −1.02% (−3.01% to 0.97%, 1-sided P<0.001 with Wald method; −3.85% to 1.81%, 1-sided P<0.001 with minimum risk weights method). Consequently, noninferiority of the Wedge NC Scoring Balloon compared with the ScoreFlex Scoring Balloon at a predefined margin of 7% was established.

Figure 4 Procedure success difference between the Wedge and the ScoreFlex groups in the (A) intention-to-treat analysis, (B) per-protocol set analysis. CI, confidence interval.

Of note, device procedural success was successful in all patients in both groups. No cardiac death, target vessel MI, or TLR occurred in either group. Rate of balloon slippage was numerically higher in the ScoreFlex group but was not statistically significant (2.0 vs. 6.1, P=0.28). There were no patients experienced flow-limited dissection, balloon rupture, or perforation in either group (Table 3).

Discussion

The present study was designed to evaluate the effectiveness and safety of the Wedge NC scoring balloon comparing with the Scoreflex scoring balloon during predilation in patients undergoing PCI. The main findings are as follows: (I) the patient-level pooled analysis met its pre-specified noninferiority goal for the primary endpoint of procedure success; (II) the Wedge group received larger balloons, and greater maximal predilation pressure owing to its property, and achieved better MLD, %DS and ALG than the ScoreFlex group; (III) both groups had comparably low rate of procedural complications and satisfactory clinical outcomes.

Heavily resistant coronary lesions pose a significant challenge in the field of interventional cardiology. The mechanical characteristics of the arterial wall are significantly influenced by the thickness, distribution, and attributes of the intimal plaque (15). Severe coronary calcification and thick neointimal hyperplasia primarily contribute to an increase in hoop stress, which may be beyond the capacity of conventional non-compliant balloons to achieve a satisfactory dilatation. Failure to optimally expand rigid coronary plaques may lead to asymmetric stent deployment, thereby increasing the risk of thrombosis and ISR (3).

During the dilation process of heavily resistant coronary lesions, the non-uniform expansion of the balloon results in over-dilation of the more compliant segments at the lesion edges, a phenomenon known as the “dog-boning” effect that increases the risk of vessel wall damage, encompassing edge dissections and coronary perforations (16,17). To address this challenge, various devices and strategies have been developed. Rotational atherectomy is considered to potently offer the most efficient plaque modification. However, it demands superior proficiency in maneuvering the modality and is associated with a high risk of serious complications, including coronary perforation, pericardial effusion, pericardial puncture, pericardiotomy and pericardial tamponade (18-20). Excimer laser has also been reported as a convenient and relatively effective appliance, but it may not be efficient enough when severe calcified lesions are encountered (21,22). Cutting balloons serve as another alternative specifically engineered to relieve vessel hoop stress by creating small, controlled incisions on the vessel wall. Due to the stabilizing effect of the blades, cutting balloons have the unique advantage of remaining stationary during inflation. However, they are often too large to cross heavily resistant lesions. Scoring balloons are developed to overcome the shortcomings of cutting balloon technology in terms of safety and deliverability. Because of the unique out-balloon wire design and lower profile, scoring balloons enable greater lumen gain and enhance stent expansion at a lower pressure with better deliverability (23).

In the present study, we primarily compared the safety and effectiveness of the Wedge NC balloon with the commercially available ScoreFlex balloon, demonstrating non-inferior outcomes with procedure success and favorable clinical outcomes in both groups. The Scoreflex balloon catheter is designed with a focal stress pattern that promotes expansion of resistant lesions at lower pressure. The previous study has shown its good performance in terms of both device procedural success and clinical safety (14). Among 47 patients undergoing unprotected left main interventions, the employment of the AngioSculpt Scoring Balloon (AngioScore, Inc., Fremont, CA, USA) was feasible and safe, with numerically greater lumen area gain (24). In the ISAR-CALC randomized trial, 37 patients were randomly assigned to the scoring balloon (NSE Alpha, B. Braun, Melungeon, Germany) group, the procedural success comprising 30-day MACE was achieved in 89.2% of cases (2). Our results showed that Wedge NC balloon was consistent with prior reports of scoring balloon catheters from other manufactures on clinical performance with a relatively smaller crossing profile (25).

Our study also showed that, comparing with the ScoreFlex group, patients in the Wedge NC group experienced larger balloons as well as greater predilation pressure and gained more lumen area, suggesting lesions were potentially better pre-dilated. The pressure differences observed can be attributed to the distinct properties of the two scoring balloons. Specifically, the Wedge NC scoring balloons are designed with a nominal balloon pressure and rated burst pressure of 12 and 22 atm, respectively. In contrast, the ScoreFlex scoring balloons have corresponding pressure of 6 and 16 atm, respectively. After adjusting the size and maximum pressure of the scoring balloons used in the two groups, the average %DS of the Wedge group was significantly lower than that of the ScoreFlex group (data not shown). In complex and challenging lesions including chronic total occlusions, severely calcified stenoses and ISR, utilization of a non-compliant, low-profile scoring balloons has demonstrated the superiority in achieving greater lesions expansion than conventional balloon. Moreover, adequate lesion preparation is critical to the deployment of DCB and bioresorbable scaffold (BRS), predilation using a scoring balloon probably results in reduced elastic recoil and a blood flow-limited dissection, thus enhancing safe and effective drug transfer in DCB therapy, as well as facilitating symmetric and effective expansion of BRS struts (10,11,26). Although not demonstrated in this study, lesion preparation using Wedge NC balloons at lower pressure may offer a comparable but safer alternative to high-pressure balloon inflation.

Limitations

The results of our trial should be interpreted in light of some limitations. First, although this was a randomized trial and included patients with different presentations of CAD, most of the lesions were simple or of moderate complexity. The application of Wedge NC scoring balloon in highly-complex lesion subsets still needs further study. Second, plaque characteristics such as eccentricity might affect intimal modification, but we did not obtain corresponding intracoronary imaging data to further analyze the difference between the two scoring balloons on stent deployment. Third, because the sample size calculation was based on the primary endpoint and the follow-up was conducted over a limited period of time, the study was not sufficiently powered to detect differences in clinical outcomes. Several large meta-analyses have not demonstrated clear clinical advantages of different types of modified balloons (including both scoring balloons and cutting balloons) (27,28). Larger studies are needed to assess long term safety and efficacy of the Wedge NC scoring balloon.

Conclusions

In this prospective, multicenter, open-label, randomized controlled trial with patients undergoing PCI, the Wedge NC scoring balloon dilatation catheter was noninferior to the ScoreFlex coronary dilatation catheter regarding procedure success, with comparable and low rates of procedural complications for both treatment groups. The Wedge NC scoring balloon dilatation catheter is safe and effective during PCI procedure.

Acknowledgments

We are glad to acknowledge Dr. Nabil Yahya, an exchange interventional cardiology fellow from Lebanon, for carefully reviewing the English writing of our manuscript. We thank all the members who have contributed to this work.

Footnote

Reporting Checklist: The authors have completed the CONSORT reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1457/rc

Trial Protocol: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1457/tp

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1457/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1457/prf

Funding: This work was supported by the National Natural Science Foundation of China (No. 82170332). The study obtained unrestricted grant support from BrosMed Medical Co., Ltd.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1457/coif). H.C. obtained unrestricted grant support from BrosMed Medical Co., Ltd. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The research proposal was approved by the ethics committee at each respective investigating center (leading center: The Second Affiliated Hospital, School of Medicine, Zhejiang University; approval number: A2021001203). All participating institutions were informed and agreed to the study, and all patients provided written informed consent.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

References

1. Writing Committee Members. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2022;79:e21-e129. [Crossref] [PubMed]
2. Rheude T, Rai H, Richardt G, et al. Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial. EuroIntervention 2021;17:481-8. [Crossref] [PubMed]
3. Fujii K, Carlier SG, Mintz GS, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol 2005;45:995-8. [Crossref] [PubMed]
4. Souteyrand G, Amabile N, Mangin L, et al. Mechanisms of stent thrombosis analysed by optical coherence tomography: insights from the national PESTO French registry. Eur Heart J 2016;37:1208-16. [Crossref] [PubMed]
5. Giustino G, Colombo A, Camaj A, et al. Coronary In-Stent Restenosis: JACC State-of-the-Art Review. J Am Coll Cardiol 2022;80:348-72. [Crossref] [PubMed]
6. Barbato E, Shlofmitz E, Milkas A, et al. State of the art: evolving concepts in the treatment of heavily calcified and undilatable coronary stenoses - from debulking to plaque modification, a 40-year-long journey. EuroIntervention 2017;13:696-705. [Crossref] [PubMed]
7. Mody R, Dash D, Mody B, et al. Can Most Calcified Coronary Stenosis Be Optimized With Coronary Intravascular Lithotripsy? JACC Asia 2023;3:185-97. [Crossref] [PubMed]
8. Yerasi C, Case BC, Forrestal BJ, et al. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol 2020;75:1061-73. [Crossref] [PubMed]
9. Joh HS, Kwon W, Shin D, et al. Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention. JACC Asia 2024;4:519-31. [Crossref] [PubMed]
10. Miyazaki T, Latib A, Ruparelia N, et al. The use of a scoring balloon for optimal lesion preparation prior to bioresorbable scaffold implantation: a comparison with conventional balloon predilatation. EuroIntervention 2016;11:e1580-8. [Crossref] [PubMed]
11. Bonaventura K, Schwefer M, Yusof AKM, et al. Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study. Adv Ther 2020;37:2210-23. [Crossref] [PubMed]
12. Thygesen K, Alpert JS, Jaffe AS, et al. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol 2018;72:2231-64. [Crossref] [PubMed]
13. Mintz GS, Popma JJ, Pichard AD, et al. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation 1995;91:1959-65. [Crossref] [PubMed]
14. Kandzari D, Hearne S, Kumar G, et al. Procedural Effectiveness With a Focused Force Scoring Angioplasty Catheter: Procedural and Clinical Outcomes From the Scoreflex NC Trial. Cardiovasc Revasc Med 2022;35:85-90. [Crossref] [PubMed]
15. Vito RP, Dixon SA. Blood vessel constitutive models-1995-2002. Annu Rev Biomed Eng 2003;5:413-39. [Crossref] [PubMed]
16. Raja Y, Routledge HC, Doshi SN. A noncompliant, high pressure balloon to manage undilatable coronary lesions. Catheter Cardiovasc Interv 2010;75:1067-73. [Crossref] [PubMed]
17. Secco GG, Ghione M, Mattesini A, et al. Very high-pressure dilatation for undilatable coronary lesions: indications and results with a new dedicated balloon. EuroIntervention 2016;12:359-65. [Crossref] [PubMed]
18. Al-Lamee R, Ielasi A, Latib A, et al. Incidence, predictors, management, immediate and long-term outcomes following grade III coronary perforation. JACC Cardiovasc Interv 2011;4:87-95. [Crossref] [PubMed]
19. Hoffman SJ, Routledge HC, Lennon RJ, et al. Procedural factors associated with percutaneous coronary intervention-related ischemic stroke. JACC Cardiovasc Interv 2012;5:200-6. [Crossref] [PubMed]
20. Maier A, Gissler MC, Jäckel M, et al. Procedural safety of rotational atherectomy and modified balloon angioplasty: insights from a German national registry. Clin Res Cardiol 2024; Epub ahead of print. [Crossref] [PubMed]
21. Protty MB, Hussain HI, Gallagher S, et al. Excimer laser coronary atherectomy during complex PCI: An analysis of 1,471 laser cases from the British Cardiovascular Intervention Society database. Catheter Cardiovasc Interv 2021;97:E653-60. [Crossref] [PubMed]
22. Sintek M, Coverstone E, Bach R, et al. Excimer Laser Coronary Angioplasty in Coronary Lesions: Use and Safety From the NCDR/CATH PCI Registry. Circ Cardiovasc Interv 2021;14:e010061. [Crossref] [PubMed]
23. Jujo K, Saito K, Ishida I, et al. Intimal disruption affects drug-eluting cobalt-chromium stent expansion: A randomized trial comparing scoring and conventional balloon predilation. Int J Cardiol 2016;221:23-31. [Crossref] [PubMed]
24. Schmidt T, Hansen S, Meincke F, et al. Safety and efficacy of lesion preparation with the AngioSculpt Scoring Balloon in left main interventions: the ALSTER Left Main registry. EuroIntervention 2016;11:1346-54. [Crossref] [PubMed]
25. Sorini Dini C, Nardi G, Ristalli F, et al. Contemporary Approach to Heavily Calcified Coronary Lesions. Interv Cardiol 2019;14:154-63. [Crossref] [PubMed]
26. Kufner S, Joner M, Schneider S, et al. Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial. JACC Cardiovasc Interv 2017;10:1332-40. [Crossref] [PubMed]
27. Danek BA, Karatasakis A, Karacsonyi J, et al. A Meta-Analysis of Contemporary Lesion Modification Strategies During Percutaneous Coronary Intervention in 244,795 Patients From 22 Studies. J Invasive Cardiol 2017;29:E167-76. [PubMed]
28. Scalamogna M, Kuna C, Voll F, et al. Modified balloons to prepare severely calcified coronary lesions before stent implantation: a systematic review and meta-analysis of randomized trials. Clin Res Cardiol 2024;113:995-1005. [Crossref] [PubMed]