Coronary atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions: A systematic review and meta-analysis

Abstract

Background

Severe coronary calcification can impede stent delivery and affect long-term outcomes. Few trials have compared coronary atherectomy with balloon-first strategies for lesion preparation before drug-eluting stent (DES) implantation.

Methods

We searched MEDLINE, Embase, and the Cochrane Library through October 2025 for randomized controlled trials (RCTs) comparing coronary atherectomy with balloon angioplasty for lesion preparation before DES implantation in severely calcified coronary lesions.

Results

Across three RCTs, there was no significant difference in major adverse cardiovascular events between atherectomy and balloon angioplasty (risk ratio [RR] 1.05, 95% confidence interval [CI] 0.85–1.30; I² = 0%). Strategy success trended higher with atherectomy but did not reach statistical significance (RR 1.10, 95% CI 0.99–1.23; I² = 84%). No significant differences were observed for myocardial infarction (RR 1.06, 95% CI 0.80–1.42; I² = 0%), any revascularization (RR 0.68, 95% CI 0.25–1.82; I² = 83%), target lesion revascularization (RR 0.88, 95% CI 0.57–1.37; I² = 83%), target vessel revascularization (RR 0.89, 95% CI 0.64–1.24; I² = 0%), stent thrombosis (RR 2.75, 95% CI 0.94–8.06; I² = 0%), cardiac mortality (RR 1.49, 95% CI 0.93–2.40; I² = 0%), all-cause mortality (RR 1.10, 95% CI 0.79–1.54; I² = 0%), or procedural complications (RR 0.95, 95% CI 0.69–1.30; I² = 3%).

Conclusions

Our meta-analysis showed that routine atherectomy was comparable with balloon angioplasty in severely calcified coronary lesions. These findings support a selective, imaging-guided balloon-first strategy, reserving atherectomy for lesions that remain undilatable or uncrossable. Randomized studies of imaging-guided algorithms and emerging technologies are needed to define optimal lesion-specific strategies.

Keywords

Atherectomy drug-eluting stent balloon angioplasty calcified coronary lesions

Introduction

Coronary artery calcification is commonly observed in patients undergoing percutaneous coronary intervention (PCI) and represents a significant challenge due to its association with increased procedural complexity and higher complication rates.^1,2 Calcified lesions reduce vessel compliance, making balloon dilatation more challenging and predisposing to stent underexpansion and malapposition, which in turn increase the risk of restenosis, stent thrombosis, and adverse cardiovascular outcomes.^3–8 Given these challenges, procedural success in PCI relies heavily on adequate lesion preparation before drug-eluting stent (DES) implantation, especially in severely calcified coronary arteries. Various plaque-modification strategies have been developed to address this, including balloon angioplasty and atherectomy.

Traditionally, balloon angioplasty has been the standard strategy for lesion preparation.⁹ Balloons are widely available, relatively simple to use, and avoid the need for specialized devices. However, in heavily calcified segments, balloon angioplasty often proves insufficient, with risks of inadequate luminal gain, vessel dissection, perforation, or balloon rupture.^10,11 Atherectomy techniques were introduced to address these limitations. Procedural studies have demonstrated that atherectomy enhances luminal gain and reduces the risk of stent underexpansion.¹² Nevertheless, they are associated with increased costs, longer procedure times, and risks of complications such as slow or no flow, perforation, rupture, and periprocedural myocardial infarction (MI).^12–14

Although both balloon angioplasty and atherectomy are widely used strategies, there remains an uncertainty regarding the comparative effectiveness and safety of atherectomy versus balloon angioplasty as the preparatory step before DES implantation. Given the competing considerations, there is a pressing need to consolidate the existing evidence on clinical and procedural outcomes. Previous trials have reported mixed findings, and many were limited by small sample size or heterogeneous lesion characteristics.^15–17 This meta-analysis aims to provide a clearer understanding of the comparative efficacy and safety of atherectomy versus balloon angioplasty in severely calcified lesions, thereby guiding clinical decision-making.

Methods

This meta-analysis was conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.^18,19 The review protocol was prospectively registered with PROSPERO (CRD420251269185).

Data sources and searches

We performed electronic searches of MEDLINE (via PubMed), Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL, via the Cochrane Library) from database inception through October 2025. To identify unpublished or ongoing trials, we searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform Portal. No language or date restrictions were applied. The search strategy combined controlled vocabulary and free-text terms for concepts including “coronary atherectomy,” “rotational atherectomy,” “orbital atherectomy,” “balloon angioplasty,” “scoring balloon,” “cutting balloon,” “calcified coronary lesion,” and “drug-eluting stent.” We screened reference lists of included trials and recent relevant reviews for additional eligible studies.

Eligibility criteria

Studies were eligible for inclusion if they met the following criteria: (1) population: adult patients undergoing DES implantation for severely calcified native coronary lesions; (2) intervention: any type of coronary atherectomy; (3) comparator: balloon angioplasty; and (4) study type: randomized controlled trials (RCTs) only.

Exclusion criteria included non-randomized studies, single-arm series, case reports, and animal studies. There were no restrictions on language or publication status.

Study selection and data abstraction

Rayyan Systems, Inc., a tool for selecting articles, was used to upload all online literature search results. After removing duplicate articles, two reviewers independently screened titles and abstracts for eligibility. Full texts of potentially eligible reports were retrieved and assessed independently by the same reviewers. Discrepancies at any stage were resolved by discussion and, where necessary, adjudication by a third reviewer.

Data regarding study characteristics (including authors, year, trial name, study design, and diagnostic criteria), country and setting, patient population (including age and gender), interventions (including type and procedure), study arms, number of target lesions, number of stents, lesion length, diameter of stenosis, severe calcification (%), follow-up duration, and primary and secondary outcomes were abstracted into a pre-piloted data collection form.

Outcomes

The primary outcomes of interest were major adverse cardiovascular events (MACE) and strategy success at the longest reported follow-up. Secondary outcomes included MI, any revascularization, target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis, cardiac mortality, all-cause mortality, and procedural complications.

Risk of bias assessment

Two reviewers independently assessed risk of bias for each included RCT using the revised Cochrane Risk of Bias tool (RoB 2.0),²⁰ covering (1) bias arising from the randomization process, (2) bias due to deviations from intended interventions, (3) bias due to missing outcome data, (4) bias in measurement of the outcome, and (5) bias in selection of the reported result. Each domain was rated as “low risk,” “some concerns,” or “high risk,” and an overall judgment was made for each trial. Disagreements were resolved by consensus.

Data synthesis and statistical analysis

Review Manager (RevMan, Version 5.4; The Cochrane Collaboration, Copenhagen, Denmark) was used to conduct the meta-analyses. We extracted risk ratios (RRs) and corresponding 95% confidence intervals (CIs) from each trial. We used a random-effects model (Mantel–Haenszel method with DerSimonian–Laird variance estimator) to perform meta-analyses. Statistical heterogeneity was assessed using Cochran's Q test (χ²) and quantified using Higgins’ I² statistic; I² values of approximately 25%, 50%, and 75% were interpreted as low, moderate, and high heterogeneity, respectively. Formal assessment of publication bias was not conducted due to the low number of included studies.

Results

After screening, three RCTs comprising 2445 patients were included in this meta-analysis.^15–17 The PRISMA flowchart depicts the study selection and screening process (Figure S1).

The ROTAXUS, PREPARE-CALC, and ECLIPSE trials compared different lesion preparation strategies before DES implantation. ROTAXUS evaluated rotational atherectomy (RA) plus paclitaxel DES versus direct DES. PREPARE-CALC compared RA plus sirolimus DES with cutting/scoring balloon plus sirolimus DES. ECLIPSE assessed orbital atherectomy plus new-generation DES versus balloon angioplasty plus DES. The detailed characteristics of the included studies and patients are given in Table 1.

Table 1.

Characteristics of included studies.

Study ID	Trial name	Location	Study arms	No. of patients (per arm)	Age (years)	Male, %	Number of target lesions	Number of stents/stents implanted	Mean lesion length (mm)	Diameter of stenosis/reference vessel diameter	Severe calcification, %	Previous MI, %	Previous PCI, %	Previous CABG, %	Follow-up
Kirtane 2025	ECLIPSE	USA	Orbital atherectomy vs. balloon angioplasty	2005 (1008 vs. 997)	70.0 (65.0–76.0) vs. 71.0 (64.0–76.0)	73.6 vs. 72.4	2492 total (1250 OA vs. 1242 BA)	Stents implanted: 1235/1250 lesions (98.8%) OA vs. 1226/1242 lesions (98.7%) BA; total stent count not explicitly reported	28.7 ± 15.1	Reference vessel diameter 3.0 ± 0.4 mm; minimal stent area at maximal calcification 7.67 ± 2.27 mm² (OA) vs. 7.42 ± 2.54 mm² (BA)	26.0 vs. 27.3	43.7 vs. 46.7	NR¹	NR¹	1 year
Abdel-Wahab 2013	ROTAXUS	Germany	RA + PES vs. stenting without prior RA (standard therapy)	240 (120 vs. 120)	70.5 ± 8.2 vs. 71.8 ± 7.2	72.3 vs. 81.7	Lesions: reported as 146 (RA) vs. 176 (Standard)—source phrasing unclear; total lesions NR²	Stents per lesion: 1.3 ± 0.6 (both groups); estimated total stents (derived) ≈ 190 (RA) vs. ≈ 229 (Standard)—see note.	20.6 ± 9.3 vs. 18.5 ± 9.2	Percent diameter stenosis 81.5 ± 10.2% vs. 80.0 ± 10.8%	44.5 vs. 49.1	31.9 vs. 24.4	37.0 vs. 32.8	7.6 vs. 12.6	9 months
Abdel-Wahab 2018	PREPARE-CALC	Germany	Modified balloon (cutting/scoring) vs. high-speed rotational atherectomy + DES	200 (100 vs. 100)	75.0 ± 6.9 vs. 74.8 ± 7.1	75 vs. 77	278 total lesions (137 vs. 141)—1.39 lesions/patient overall	Stents per lesion: 1.71 ± 0.85 vs. 1.52 ± 0.63 (per lesion)	30.07 ± 18.30 vs. 29.81 ± 15.23	Percent diameter stenosis 83.54 ± 8.76% vs. 83.02 ± 10.35%	95.6 (overall; per-arm breakdown not reported)	22 vs. 21 (22% vs. 21%)	55 vs. 47 (55% vs. 47%)	13 vs. 6 (13% vs. 6%)	9 months

BA: balloon angioplasty; CABG: coronary artery bypass grafting; DES: drug-eluting stent; MI: myocardial infarction; NR: not reported; OA: orbital atherectomy; PCI: percutaneous coronary intervention; PES: paclitaxel-eluting stent; RA: rotational atherectomy; SD: standard deviation.

Risk of bias assessment

All trials were of high quality, with low risk of bias across all domains of RoB 2 (Figure S2).

Results of the meta-analysis

Primary outcomes

The pooled analysis showed no statistically significant difference in the risk of MACE between coronary atherectomy and balloon angioplasty (RR 1.05, 95% CI 0.85–1.30; Figure 1). No heterogeneity was observed (I² = 0%).

Our pooled analysis showed a trend toward higher strategy success with coronary atherectomy, but the finding was not statistically significant (RR 1.10, 95% CI 0.99–1.23; Figure 2). A high level of heterogeneity was observed (I² = 84%).

Secondary outcomes

There was no significant difference between atherectomy and balloon angioplasty in the risk of MI (RR 1.06, 95% CI 0.80–1.42; I² = 0%), any revascularization (RR 0.68, 95% CI 0.25–1.82; I² = 83%), TLR (RR 0.88, 95% CI 0.57–1.37; I² = 83%), TVR (RR 0.89, 95% CI 0.64–1.24; I² = 0%), or stent thrombosis (RR 2.75, 95% CI 0.94–8.06; I² = 0%) (Figures S3–S7). There was also no statistically significant difference in cardiac mortality (RR 1.49, 95% CI 0.93–2.40; I² = 0%), all-cause mortality (RR 1.10, 95% CI 0.79–1.54; I² = 0%), or procedural complications (RR 0.95, 95% CI 0.69–1.30; I² = 3%) between the two treatment strategies (Figures S8–S10).

Discussion

Our meta-analysis, including three RCTs with a total of 2445 patients, indicates no significant difference in the risk of MACE between coronary atherectomy and balloon angioplasty. There was a trend toward improved strategy success rates with coronary atherectomy, but this did not attain statistical significance. The secondary outcomes were comparable between the two groups.

The procedural gain from atherectomy is most clearly illustrated by studies such as PREPARE-CALC, in which RA achieved near-universal strategy success compared with the modified balloon arm, mainly due to crossover to atherectomy when faced with balloon-resistant lesions.¹⁵ In the ROTAXUS-AMI trial, along with the other investigations, routine RA reduced bailout rates and was associated with greater acute lumen gain, but was also associated with an increased late lumen loss rate at follow-up, indicating that the procedural benefit could not be sustained.¹⁶ For example, the ECLIPSE trial demonstrated that the orbital atherectomy system device was associated with improved deliverability but did not achieve a metric endpoint (e.g., minimal stent area) or clinical outcomes at 1 year compared with balloon-first.¹⁷ Together, these findings suggest that although adding atherectomy can improve PCI feasibility in challenging anatomic lesions, no additional long-term benefit is achieved when both techniques are technically feasible.

The net benefit of atherectomy on hard clinical endpoints raises important questions regarding the most appropriate utilization of atherectomy in contemporary PCI. Taken as a whole, the data clearly advocate selective rather than routine atherectomy. In lesions in which the balloon is dilatable or crossable, an image-guided balloon first strategy is still the appropriate action with treatment by atherectomy if the lesion is demonstrated to be undilatable or uncrossable by both a standard balloon and a specialty balloon. Atherectomy may be considered in patients who demonstrate inadequate calcium modification, as evidenced by persistent concentric calcification or a lack of calcium fractures, which are usually predictive of insufficient stent expansion.^21,22 The 2021 ACC/AHA/SCAI guidelines on coronary revascularization stated that atherectomy may be an option in heavily calcified lesions requiring balloon pretreatment, but did not support its routine use.²³ Similarly, European guidelines based on practice recommend a calcium-imaging-based approach and reserve atherectomy for cases with a calcium arc >180°, thickness >0.5 mm, or calcium length >5 mm, as these are associated with stent underexpansion.^24,25

It is essential to understand that, while atherectomy remains a critical tool for some complex calcified anatomies, its selective use supports both safety and efficacy.^26,27 In particular, the use of high-pressure non-compliant or scoring/cutting balloons, which are the most widely used, has made balloon angioplasty easier and cheaper, while also leading to fewer device-specific complications.²⁸ Advances in imaging have enabled operators to assess sufficient calcium modification before stent deployment, further enhancing the safety of the balloon-first approach.²⁹ This imaging-guided strategy has been used extensively in ECLIPSE. It has been key to the excellent results in the balloon-only arm, which, in turn, confirms the concept that meticulous lesion preparation guided by imaging can prevent the need for atherectomy.¹⁷

Strengths of our analysis include restricting to randomized data and including the most contemporary large trial (ECLIPSE), which together strengthen the reliability of the pooled inferences. Limitations include the modest number of RCTs, heterogeneity in atherectomy platforms (rotational vs. orbital) and balloon comparators (standard vs. modified), and the dominant influence of a single large trial on pooled estimates. Several outcomes, infrequent events such as stent thrombosis, had limited events and thus imprecise effect estimates. Operator experience, ancillary technologies (e.g., intravascular ultrasound guidance), and evolution in device technique over time may also affect external validity.

For the future, more rigorous selection of lesions for atherectomy must be pursued. Template algorithms using imaging, such as the optical coherence tomography–based calcium scoring algorithm, which assesses arc, thickness, and length, may assist the operator in deciding when balloon strategies will suffice and when upfront atherectomy will be needed.²⁴ In addition, emerging technologies, such as intravascular lithotripsy (IVL), are reshaping the therapeutic landscape. The IVL provides a less abrasive calcium modification and is associated with a lower incidence of no-reflow and a lower risk of perforation.^30,31 Randomized trials comparing IVL, atherectomy, and balloon strategies will be needed to determine the preferred algorithm for different calcific morphologies. There is also a requirement for cost-effectiveness studies, as atherectomy and IVL devices are far more expensive than standard balloons. In the age of value-based care, demonstrating a clear clinical benefit is necessary to justify the widespread use of costly devices.

Conclusion

In this meta-analysis of 2445 patients comparing coronary atherectomy with balloon angioplasty before DES implantation, the rates of MACE, strategy success, and clinical and procedural complications were comparable between the two groups. These results underscore the need to tailor intervention strategies to the patient profile and lesion. Balloon angioplasty remains the default strategy due to its cost-effectiveness, procedural simplicity, shorter procedural time, and lower expertise requirements. Nonetheless, RA remains an important option in selected cases, particularly for severely calcified or undilatable lesions where balloon angioplasty alone might not be sufficient. However, widespread adoption of atherectomy cannot be recommended without more robust evidence. Future research should focus on randomized comparisons of imaging-guided algorithms and emerging technologies such as IVL, include cost-effectiveness analyses, and establish objective lesion-selection thresholds that predict net clinical benefit.

Supplemental Material

sj-docx-1-cvd-10.1177_20480040261446478 - Supplemental material for Coronary atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions: A systematic review and meta-analysis

Supplemental material, sj-docx-1-cvd-10.1177_20480040261446478 for Coronary atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions: A systematic review and meta-analysis by Omar Kasimieh, Yashaswi Guntupalli, Prapti Atul Patel, Lydia Susan Abraham, Thomas Viji Pulickal, Md Arif Hasan Bhuiyan, Milikyas Abera Feyisa, Mohammed Bushnaq, Rohit Mote Reddy, Shiva Mokhtassi, Arooba Ejaz, Asma’a Munasar Ali Alsubari, Vaibhav Vats, Talal Almas and Huzaifa Ahmad Cheema in JRSM Cardiovascular Disease

Footnotes

ORCID iDs

Rohit Mote Reddy

Asma’a Munasar Ali Alsubari

Author contributions

Omar Kasimieh: conceptualization, methodology, validation, formal analysis, investigation, data curation, writing – original draft, visualization. Yashaswi Guntupalli: methodology, investigation, data curation, writing – review & editing. Prapti Atul Patel: methodology, investigation, data curation, writing – review & editing. Lydia Susan Abraham: formal analysis, data curation, writing – original draft, visualization. Thomas Viji Pulickal: investigation, resources, writing – review & editing. Md Arif Hasan Bhuiyan: investigation, resources, writing – review & editing. Milikyas Abera Feyisa: data curation, writing – review & editing. Mohammed Bushnaq: data curation, writing – review & editing. Rohit Mote Reddy: methodology, data curation, writing – original draft. Shiva Mokhtassi: investigation, data curation, writing – review & editing. Arooba Ejaz: investigation, data curation, writing – review & editing. Asma’a Munasar Ali Alsubari: conceptualization, supervision, writing – review & editing. Vaibhav Vats: formal analysis, interpretation, supervision, writing – review & editing. Talal Almas: conceptualization, supervision, writing – review & editing. Huzaifa Ahmad Cheema: conceptualization, supervision, project administration, writing – review & editing.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Supplemental material

Supplemental material for this article is available online.

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