Skip to main content

Comparison of bailout and planned rotational atherectomy for severe coronary calcified lesions

Abstract

Background

To compare outcomes of bailout and planned rotational atherectomy (RA) in the treatment of severe calcified coronary lesions.

Methods

Data of patients treated with RA from 2017 to 2018 at a single-center registry were retrospectively analyzed. All patients were divided into planned RA and bailout RA groups, data between two groups were compared.

Results

A total of 190 patients were included in this study, 138 patients received planned RA and 52 patients received bailout RA. Baseline clinical characteristics had no significant differences between groups. The number of implanted stents and total stents length were similar. But the number of balloon (1.6 ± 0.8 vs. 2.7 ± 1.3, P < 0.001), procedure time (83.5 ± 26.2 vs. 100.8 ± 36.4 min, P = 0.007), fluoroscopy volume (941 ± 482 vs. 1227 ± 872 mGy, P = 0.012] and contrast amount (237 ± 62 vs. 275 ± 90 ml, P = 0.003) were all lower in planned RA group. Planned RA had a higher procedural success rate (99.3% vs. 92.3%, P = 0.007) and a lower complication incidence (4.3% vs. 17.3%, P = 0.009). But the primary outcomes at 3 years (9.2 and 16.6%, log rank p = 0.24) had no difference between groups.

Conclusions

For severe coronary artery calcification, although planned RA did not improved the long term prognosis compared with bailout RA, but it can improve the immediate procedural success rate, reduce the incidence of complications, the procedure time and the volume of contrast.

Peer Review reports

Background

Calcified coronary lesions remain a challenge for percutaneous coronary intervention (PCI). Calcified lesions can lead to stent implantation failure or incomplete stent expansion, thus affecting the long-term efficacy of stents. It also increases the risk of perforation and coronary dissection during procedure [1, 2]. Rotational atherectomy RA plays a key role in the therapy of severe calcified lesions [3, 4]. Although routine RA does not improve the clinical outcomes in the ROTAXUS trial, it can significantly improve the success rate of procedure [5]. However, it should be noted that more than 50% patients in ROTAXUS study were only moderately calcified lesions shown by coronary angiography, and 12.5% of the patients in the conventional balloon pre-expansion group needed to cross over to RA because of balloon failure of devices. Therefore, it is of great clinical significance to explore when to start RA therapy for severe coronary artery calcification. In the Rotate multicenter registry planned RA appears to be safe and was associated with a reduction in procedural and fluoroscopy times, contrast volume, and the number of pre-dilation balloon catheters used [6].

The aim of this study was to investigate in a single high volume PCI center the safety and procedural feasibility of a planned RA strategy for the treatment of severely calcified coronary lesions in comparison to a bailout RA approach following device failure.

Methods

Study design and population

This is a retrospective single-center study of all patients who underwent PCI using RA because of heavily calcified lesions at our hospital from January 2017 to December 2018. Severely calcified lesion was defined as: radiopacities noted without cardiac motion before contrast injection, generally compromising both sides of the arterial lumen. All the patients were divided into 2 groups according to the indication for RA. Planned RA was defined as initial strategy without previous device failure. Bailout RA was defined as RA after incomplete expansion of balloon or failure delivery of any devices. Pre-intervention intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was performed in partial patients, the patients will receive planned RA if the IVUS/OCT showed calcium angle> 270°and calcium length > 5 mm (Fig. 1) or the IVUS/OCT catheter cannot cross the lesions. When discharge from hospital, all the patients were received standard pharmacological treatment (double antiplatelet therapy at least 1 year), and followed-up regularly in clinic.

Fig. 1
figure1

A representative calcification lesion images of IVUS/OCT. a Shows 360° calcium with a minimum lumen area 2.1 mm2. b Shows 360°calcium with maximum calcium thickness 0.58 mm and minimum lumen area1.8 mm2

Data collection

The demographic and clinical characteristics of all patients included age, gender, medical history, left ventricular function on admission, lipid profiles, serum creatinine, hemoglobin and procedual costs. The angiographic and procedural characteristics included number of diseased vessels, target vessel, the size of burr, total number of stents and total length of stents.

The primary outcome (all-cause death, target vessel revascularization and stent thrombosis) at 3 years were collected during follow-up by telephone or electronic record system.

Procedural details

Before procedural, all patients received an oral loading dose of 300 mg aspirin and 300 mg clopidogrel. During procedural, all patients received unfractionated heparin at a dose of 70–100 U/kg to maintain an activated clotting time (ACT) > 300 s. In both groups, the choice of vascular access, burr size, IVUS/OCT was left at the operators’ discretion. The IVUS/OCT catheter was advanced beyond the target lesion using a commercially available IVUS/OCT system (40 MHz IVUS catheter; OptiCross, Boston Scientific. ILUMIEN C7-XR, Abbott). RA was performed by using the Rotablator (Boston Scientific Scimed, Inc., Maple Grove, MN, USA). The burr size was selected to reach a burr/vessel ratio of 0.5–0.6. RA speed ranged between 150,000 and 180,000 rotation per minute. Each RA time was 10–15 s. During RA, A continuous intracoronary infusion of a cocktail with unfractionated heparin and nitroglycerin was employed. Success of RA was defined as complete expansion of balloon of target lesion after RA.

Study endpoints and definitions

Procedural success was defined as a final residual stenosis<30% after stents and grade 3 TIMI flow. Procedural outcomes included total number of balloon and stents used, procedure time, fluoroscopy amount, and volume of contrast used in the two groups. Procedure time was defined as the interval from initial angiography by guiding catheter to final angiography of the target lesion. PCI-related myocardial infarction is defined following the third universal definition of myocardial infarction. Procedure complications included bradycardia, slow-no-reflow, dissection, burr entrapment and perforation. Bradycardia was defined as heart rate less than 45 beats per minute which can influence hemodynamics. Dissection was defined as grades C to F according to National, Heart, Lung, and Blood Institute (NHLBI) criteria [7]. The primary outcome was a composite of all-cause death, target vessel revascularization and stent thrombosis at 3 years.

Statistical analysis

Statistical analysis was performed using SPSS for Windows 18.0 (SPSS, Chicago, IL). Continuous variables areexpressed as mean ± SD, categorical variables are given as frequencies (%). Univariate comparisons between the two groups were performed using Pearson’s chi-square test for categorical variables, and a Student t test for continuous variables. Kaplan-meier was used to analyze the cumulative incidence of clinical events during the follow-up. Difference was considered to be statistically significant at P < 0.05.

Results

Patients characteristics

From January 2017 to December 2018, a total of 190 patients were treated with RA. In 138 patients, RA was performed as a planned procedure, while in other 52 patients, RA was as a bailout procedure. In both groups, patients were old, had a higher proportion of hypertension, Diabetes Mellitus (DM), smoking. Most patients presented as stable coronary artery disease and multi-vessel disease. Baseline clinical characteristics had no significant differences between both groups. But the proportion of IVUS/OCT guided PCI was higher in planned RA group than that in bailout RA group (Table 1).

Table 1 Baseline Clinical Characteristics of the Study Population

Lesion and procedural characteristics

The most common RA-target vessel was left anterior descending artery in both groups (58.4 and 59.2% respectively). The most commonly employed burr size was 1.25 mm (41.6%) and 1.5 mm (54.2%). And the use of more than 1 burr was necessary in 5.3% of all cases. The number of stents and the total stents length had no significant differences between both groups, but the number of balloons in bailout RA group was more than that in planned RA group. In addition, the procedure time, fluoroscopy volume and contrast amount were all lower in planned RA group than bailout RA group (Table 2).

Table 2 Angiographic and Procedural Characteristics

Procedural complication characteristics

The procedural success was achieved in the majority of cases (97.4%), but was lower in the bailout RA group (92.3% vs. 99.3%, P = 0.007). There was no coronary perforation in the two groups. The incidence of complications was higher in bailout RA group (17.3% vs. 4.3%). The most common complications were bradycardia, slow-no-reflow and dissection (Table 3).

Table 3 Complications between groups

Long time outcomes

All patients were followed up for a long period, with a median follow-up time of 36 months (1–84 months). At 3 years, the primary outcomes (a composite of all-cause death, target vessel revascularization and stent thrombosis) had occurred in 9.2% in the planned RA group and 16.6% in the bailout RA group (log rank p 0.24), and the cumulative 3-year incidences of all-cause death were 6.4 and 12.0% (log rank p 0.34), the 3-year cumulative rates of target vessel revascularization were 3.0 and 5.1% (log rank p 0.49), and the 3-year cumulative rates of stent thrombosis were 0.9 and 2.9% (log rank p 0.46) in planed RA and bailout out RA group respectively. There was no significant difference between groups (p > 0.05) (Fig. 2).

Fig. 2
figure2

The primary outcomes between groups

Discussion

The low success rate and high incidence of complications of severe calcification lesions have always been the difficulty during PCI. RA can significantly improve the success rate. Studies showed that the success rate of RA was 95–96.4% [8, 9]. In our study, the success rate of RA was 97.4%. Especially, the success rate in planned RA group was 99.3%, which was significantly higher than that in bailout RA group (92.3%), suggests that planned RA can significantly improve the success rate for severe coronary artery calcification. There were no differences of long term prognosis between groups.

The complications during RA cannot be ignored. Previous studies [10,11,12] have shown that common complications and the incidence during RA were coronary dissection (10.5%), severe coronary spasm (1.6–6.6%), acute vascular occlusion (3.1%), slow-no-reflow (1.2–7.6%) and coronary artery perforation (0–2%). The most common complications in our study were bradycardia (3.2%), coronary dissection (2.6%), slow-no-reflow (1.6%) and burr entrapment (0.5%). The incidence of complication is high in bailout RA group than that in planned RA group (17.3% vs. 4.3%), which shows that planned RA is more safe than bailout RA.

RA is a complicated and time-consuming procedure in the treatment of severe calcified lesions, which may lead to the increase of procedure cost, contrast volume, procedure time and fluoroscopy amount, and thus increase the economic burden of patients and the risk of contrast-induced nephropathy after procedure. However, there are few studies on this issue. Our study showed that compared with bailout RA, planned RA could significantly reduce the procedure time, the volume of contrast used and the fluoroscopy volume during the procedure, which is important for both the interventional cardiologist and the patients. It is consistent with the results of ALLALI et al. [13]. The ROTATE study showed that compared with bailout RA, planned RA did not reduce the adjusted 1-year MACE [6]. The results of ALLALI showed that although planned RA could improve the success rate of the procedure, but the incidence of 2-years MACE did not decrease compared with bailout RA (25.2% vs 28.7%, log rank P = 0.52) [13].

The major limitation of this study is its non randomized design in which operator bias and unmeasured confounders may prohibit definitive conclusions. Limited number of patients, especially in bailout RA group, and not randomized retrospective study design could bias the outcomes.

Conclusions

Overall, our study showed that, for severe coronary artery calcification, although planned RA did not improve the long term prognosis than bailout RA, but it can improve the immediate procedural success rate, reduce the incidence of complications, the procedure time and the volume of contrast compared with bailout RA.

Availability of data and materials

The datasets used during the current study are available from the corresponding author on reasonable request.

Abbreviations

PCI:

Percutaneous coronary interventions

RA:

Rotational atherectomy

IVUS:

Intravascular ultrasound

OCT:

Optical coherence tomography

ACT:

Activated clotting time

DM:

Diabetes mellitus

References

  1. 1.

    Tran T, Brown M, Lasala J. An evidence-based approach to the use of rotational and directional coronary atherectomy in the era of drug-eluting stents: when does it make sense? Catheter Cardiovasc Interv. 2008;72:650–62.

    Article  Google Scholar 

  2. 2.

    Kuriyama N, Kobayashi Y, Yamaguchi M, Shibata Y. Usefulness of rotational atherectomy in preventing polymer damage of everolimus-eluting stent in calcified coronary artery. JACC Cardiovasc Interv. 2011;4:588–9.

    Article  Google Scholar 

  3. 3.

    Hodgson J, Stone G, Lincoff AM, Klein L, Walpole H, Bottner R, et al. Late stent thrombosis: considerations and practical advice for the use of drug-eluting stents: a report from the Society for Cardiovascular Angiography and Interventions Drug-Eluting Stent Task Force. Catheter Cardiovasc Interv. 2007;69:327–33.

    Article  Google Scholar 

  4. 4.

    Barbato E, Carri D, Dardas P, Fajadet J, Gaul G, Haudeet M, et al. European expert consensus on rotational atherectomy. EuroIntervention. 2015;11:30–6.

    Article  Google Scholar 

  5. 5.

    Abdel-Wahab M, Richardt G, Joachim Büttner H, Toelg R, Geist V, Meinertz T, et al. High-speed rotational Atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (rotational Atherectomy prior to Taxus stent treatment for complex native coronary artery disease) trial. JACC Cardiovasc Interv. 2013;6:10–9.

    Article  Google Scholar 

  6. 6.

    Kawamoto H, Latib A, Ruparelia N, Boccuzzi GG, Pennacchi M, Sardella G. Planned versus provisional rotational atherectomy for severe calcified coronary lesions: insights from the ROTATE multi-center registry. Catheter Cardiovasc Interv. 2016;88:881–9.

    Article  Google Scholar 

  7. 7.

    Huber MS, Mooney JF, Madison J, Mooney MR. Use of a morphologic classification to predict clinical outcome after dissection from coronary angioplasty. Am J Cardiol. 1991;68:467–71.

    CAS  Article  Google Scholar 

  8. 8.

    Furuichi S, Sangiorgi GM, Godino C, Airoldi F, Montorfano M, Chieffoet A, et al. Rotational atherectomy followed by drug-eluting stent implantation in calcified coronary lesions. EuroIntervention. 2009;5:370–4.

    Article  Google Scholar 

  9. 9.

    Schwartz BG, Mayeda GS, Economides C, Kloner RA, Shavelle DM, Burstein S. Rotational atherectomy in the drug-eluting stent era: a single-center experience. J Invasive Cardiol. 2011;23:133–9.

    PubMed  Google Scholar 

  10. 10.

    Warth DC, Leon MB, O'Neill W, Zacca N, Polissar NL, Buchbinder M. Rotational atherectomy multicenter registry: acute results, complications and 6-month angiographic follow-up in 709 patients. J Am Coll Cardiol. 1994;24:641–8.

    CAS  Article  Google Scholar 

  11. 11.

    Benezet J, de la Llera LSD, Cubero JM, Villa M, Fernández-Quero M, Sánchez-González A. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011;23:28–32.

    PubMed  Google Scholar 

  12. 12.

    Dardas P, Mezilis N, Ninios V, Tsikaderis D, Theofilogiannakos EK, Lampropoulos S. The use of rotational atherectomy and drug-eluting stents in the treatment of heavily calcified coronary lesions. Hellenic J Cardiol. 2011;52:399–406.

    PubMed  Google Scholar 

  13. 13.

    Allali A, Abdel-Wahab M, Sulimov DS, Jose J, Geist V, Kassner G. Comparison of bailout and planned rotational Atherectomy for heavily calcified coronary lesions: a single-center experience. J Interv Cardiol. 2017;30:124–33.

    Article  Google Scholar 

Download references

Acknowledgements

Not applicable.

Funding

This study was supported by The National Natural Science Foundation of China (No. 81800316). These funds designed the study, collection and analysis of the data.

Author information

Affiliations

Authors

Contributions

CAO CF and LI Q were major contributors in writing the manuscript. MA YL analyzed and interpreted the patient data, LIU J, ZHAO H and LU MY collected patients data, WANG WM was the corresponding author. The authors read and approved the final manuscript.

Corresponding author

Correspondence to Wei-min Wang.

Ethics declarations

Ethics approval and consent to participate

This study was approved by the ethics at Peking University People’s Hospital, all patients provided written informed consent before participation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Cao, Cf., Ma, Yl., Li, Q. et al. Comparison of bailout and planned rotational atherectomy for severe coronary calcified lesions. BMC Cardiovasc Disord 20, 374 (2020). https://doi.org/10.1186/s12872-020-01645-4

Download citation

Keywords

  • Severe coronary calcified lesions
  • Planned rotational atherectomy
  • Bailout rotational atherectomy