Sex-Based Differences in Acute and Long-Term Outcomes After Orbital Atherectomy for Severely Calcified Coronary Lesions: A Real-World Analysis

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J INVASIVE CARDIOL 2026. doi:10.25270/jic/26.00222. Epub November 9, 2026.

Objectives. Severely calcified coronary lesions pose major challenges in percutaneous coronary intervention (PCI), often linked to procedural complexity and adverse outcomes. Females, historically underrepresented in trials, may face unique risks, yet sex-specific data are limited. Orbital atherectomy (OA) facilitates plaque modification in heavily calcified vessels, but outcomes by sex remain unclear. This study compared acute and long-term outcomes between females and males undergoing OA in a real-world, high-risk cohort.    

Methods. The authors retrospectively analyzed consecutive patients treated with coronary OA for severely calcified lesions at a single, high-volume center. Baseline demographics, lesion characteristics, and procedural outcomes were assessed. The primary endpoint was in-hospital freedom from major adverse cardiac and cerebrovascular events (MACCE): cardiac death, myocardial infarction [MI], stroke). Secondary endpoints included successful stent placement, severe angiographic complications, bleeding, heart failure, and cardiogenic shock. One- and 2-year MACCE rates were evaluated. 

Results. Among 609 patients, 36% were females, with higher representation of Hispanic, Black, and Native American patients compared with males. Females were older (median 77 vs 73 years) with lower rates of prior MI, prior coronary artery bypass graft, and smoking. Lesion characteristics were similar between groups, with 100% successful stent placement. Females had more right coronary artery treatment (32.6% vs 19.3%), while males more often had left anterior descending artery interventions (56% vs 43.8%). In-hospital MACCE rates were low and comparable (1.4% vs 1.6%). Freedom from MACCE was 93.5% at 1 year and 90.5% at 2 years, with no significant sex-based differences.

Conclusions. OA achieved 100% successful stent placement, and safe and durable clinical outcomes in both sexes.

Cardiovascular disease remains a leading cause of morbidity and mortality worldwide,¹ with percutaneous coronary intervention (PCI) playing a central role in the management of coronary artery disease (CAD). Although advances in interventional cardiology have significantly improved patient outcomes, emerging evidence suggests that sex-based differences may influence the safety and effectiveness of PCI techniques.^2,3 A greater understanding of sex-based outcomes following specific interventions is important for optimizing patient care.

Although women make up approximately 50% of the U.S. population,⁴ they account for only 30% of all patients undergoing PCI with or without atherectomy^5-7 and often experience less favorable outcomes than men.^3,8 Prior studies have also reported higher rates of periprocedural complications in women, attributed in part to advanced age, comorbidities, lesion complexity, and delayed presentation.^3,9,10 Severely calcified coronary lesions are commonly associated with aging and comorbidities such as diabetes, hypertension, and renal disease, which may further contribute to poorer clinical outcomes,^11,12 emphasizing the need for effective treatment strategies.

Over the last 3 decades, numerous studies have demonstrated the safety and effectiveness of coronary atherectomy devices, including rotational atherectomy (RA) and orbital atherectomy (OA), in the treatment of severely calcified coronary lesions.^13,14 However, despite the high prevalence of such lesions in the general population (6% to 20% of cases),^11,15 atherectomy is only employed in a small fraction of cases (up to 3%).^5-7 Given the limited use of atherectomy in clinical practice and the underrepresentation of women in prior studies, there exists a significant knowledge gap regarding OA outcomes and potential sex-based differences. This real-world study aimed to address this gap by comparing acute and long-term outcomes following OA between females and males.

Study design

Patients with complex, severely calcified coronary lesions who underwent OA for lesion preparation before PCI at Mount Sinai Medical Center in Miami Beach, Florida (MSMCMB), were identified through electronic health records and the corresponding MSMCMB CathPCI National Cardiovascular Data Registry (NCDR) database; there were no exclusion criteria. CathPCI data were entered by trained hospital registry staff using standardized NCDR definitions. This retrospective analysis included consecutive patients treated between January 2014 and September 2020 and compared outcomes between female and male patients. The study was approved by the MSMCMB Institutional Review Board, and the requirement for informed consent was waived.

Sex and gender considerations

Consistent with the Sex and Gender Equity in Research (SAGER) guidelines, this study reports sex-based analyses. Sex was analyzed as a binary variable (female or male) based on clinical records. Gender identity, gender-related social determinants, and differences of sex development (DSD) were not collected in the source dataset and therefore were not evaluated. Accordingly, the term “sex” in this study refers to the classification recorded in the clinical records.

Study device

The coronary OA device (Diamondback 360 Coronary Orbital Atherectomy System [Abbott]) has been previously described.^14,16 Briefly, the device is a percutaneous OA system that uses an orbiting, diamond-coated crown to sand away and fracture calcific plaques in order to treat severely calcified coronary lesions in preparation for stent delivery.^16,17

Procedural and angiographic assessment

Procedural strategy was determined by the treating operator according to lesion characteristics and clinical judgment. Procedural and angiographic variables were retrospectively obtained from the source clinical and registry records and reflect the information systematically available in these datasets. PCI indication was based on the diagnosis recorded at the time of the procedure, and patients were retained in their originally recorded diagnostic categories. Pre- and post-intervention percent stenosis values were based on site-reported angiographic assessment. Contrast volume was recorded to the nearest 50-mL increment. Stent placement was defined as successful implantation of at least 1 drug-eluting stent following OA during the index procedure.

Study endpoints

The primary study outcome was in‐hospital freedom from major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of cardiac death, periprocedural myocardial infarction (MI), and ischemic or hemorrhagic stroke. Secondary outcomes included successful stent placement, severe angiographic complications (severe dissection type C‐F, perforation, and persistent slow flow/no-reflow), bleeding events, heart failure (HF), and cardiogenic shock during hospitalization. All acute procedural and in-hospital outcomes were site-adjudicated according to NCDR CathPCI version 5 definitions. MACCE at 1- and 2-year follow-up was assessed through retrospective review of the available clinical records.

Statistical analysis

Baseline and procedural characteristics are presented as n (%) for binary variables or median and interquartile range for continuous variables. Missing baseline data were imputed using single imputation approach implemented with a Markov chain Monte Carlo-based algorithm. The starting value for the chain was computed from the expectation‐maximization algorithm. P-values for comparing females vs males were calculated using Fisher’s exact test (if theoretical frequencies were <5) and Pearson’s chi-square test for frequency variables or Wilcoxon rank sum test for continuous variables. A P-value of less than 0.05 was considered statistically significant. All statistical analyses were performed using RStudio (version 4.3.1, R Foundation for Statistical Computing).

Demographics

The most common indication for PCI was acute coronary syndrome (ACS)-unstable angina, accounting for 59.1% (360/609) of cases, followed by stable ischemic heart disease (SIHD) at 26.9% (164/609) and ACS-non-ST-segment elevation myocardial infarction (NSTEMI) at 13.3% (81/609) of cases. The least common indication was ACS-ST-segment elevation myocardial infarction (STEMI), making up 0.7% (4/609) of the overall cohort.

Table 1 presents the baseline characteristics of 609 patients undergoing PCI with OA, focusing on a sex comparison. Within this cohort, 36% (222/609) were females showing a significantly higher median age than males (77 vs 73, P < .001). While the majority of both sexes were White, notable differences appeared. A higher proportion of females were Black (8.1% [18/222] vs 4.1% [16/387], P = .040) and Native American (12% [26/222] vs 0.8% [3/387], P < .001). Ethnicity differences were also apparent (P = .022), with a greater percentage of females identifying as Hispanic (64% [141/222]) compared with males (54% [209/387]). In terms of comorbidities, comparable rates of diabetes, dyslipidemia, and hypertension were observed, along with similar median estimated glomerular filtration rates between females and males. However, disparities in cardiovascular history were noted, as prior MI was less prevalent in females (18% [41/222] vs 27% [103/387], P = .023), and a lower percentage of females had a history of coronary artery bypass grafting (CABG) compared with males (8.6% [19/222] vs 17% [66/387], P = .004). Additionally, fewer females were smokers compared with males (12% [27/222] vs 19% [75/387], P = .022).

Lesion and vessel characteristics

Table 2 summarizes the lesion and vessel characteristics within the study population. Among the 970 included lesions, over 50% (524/970) were classified as Type C lesions via the American College of Cardiology/American Heart Association (ACC/AHA) lesion classification system. The median lesion length was 22 mm, and the pre-intervention percent stenosis was 90%, with no noticeable differences between females and males. The mean number of lesions treated was 1.7 in females and 1.6 in males, with no statistically significant difference between groups. Regarding the target vessel, the left anterior descending artery (LAD) appeared as the most commonly treated vessel for both sexes. However, a notable disparity was observed in the distribution of treated vessels: males showed a significantly higher percentage of LAD treatment compared with females (56% [337/602] vs 43.8% [161/368], P < .001). Conversely, females had a higher proportion of right coronary artery (RCA) treatment compared with males (32.6% [120/368] vs 19.3% [116/602], P < .001).

Procedural results

In total, 656 procedures were performed, with both groups demonstrating a comparable median total fluoroscopy time of 17 minutes and a median total volume of contrast used of 200 mL (Table 2). The mean post-intervention percent residual stenosis was 0.8% (± 6.7).

Table 3 summarizes the procedural outcomes. Successful stent placement was achieved in all patients. Bleeding events remained low, occurring in approximately 2% (12/609) of patients overall, with no Type 3 bleeding events and similar rates between females and males. No significant differences were observed between females and males concerning angiographic complications. Three severe dissections and 5 perforations were reported overall, with no instances of persistent slow flow/no reflow. Cardiogenic shock occurred in 5 patients (0.8% [5/609]) with no differences between females and males. Three patients experienced HF, and all of whom were female, resulting in a statistically significant between-group difference (1.4% [3/222] vs 0% [0/387], P = .048).

In-hospital MACCE

Table 4 shows that both female and male patients experienced low rates of MACCE. The overall freedom from MACCE, which includes cardiac death, MI, ischemic cerebrovascular accident (CVA), and hemorrhagic CVA, was 98.5% (600/609). There were no significant differences between females and males in overall MACCE or any of its components.

MACCE at 1- and 2-year follow-up

Two-year follow-up data were available for 465 patients (76.4% [465/609]). As shown in Table 5, the overall freedom from MACCE at 1- and 2-years post-discharge was 93.5% (435/465) and 90.5% (421/465), respectively. At 1-year follow-up, freedom from MACCE was high and comparable between females and males (92.6% [151/163] vs 94.0% [284/302], P = .56). Similarly, freedom from the individual components of cardiac death, MI, and CVA did not differ significantly by sex. At 2 years, rates remained consistent, with freedom from MACCE of 90.2% (147/163) in females and 90.7% (274/302) in males (P = .87), and no significant differences observed for cardiac death, MI, or CVA.   

This retrospective study highlights several key findings from the comparison of outcomes between females and males undergoing PCI with OA. Despite notable sex differences, including older age, fewer prior MIs and CABG procedures, a lower prevalence of smoking, and more frequent RCA treatment among females, successful stent placement was achieved in 100% of patients in both groups, with low rates of angiographic and bleeding complications and similarly low rates of in-hospital MACCE. Importantly, high freedom from MACCE was maintained at 1 and 2 years, with no significant sex-based differences. These findings add to the evidence regarding sex-based outcomes following OA and may help inform procedural risk assessment and patient counseling.

In our study, females and males exhibited baseline characteristics similar to those of populations described in prior investigations.^3,10,18,19 Females were older than males, with comparable rates of diabetes, hypertension, and renal disease. Males, on the other hand, had a higher prevalence of prior cardiovascular events and smoking. The older age and lower prevalence of prior cardiac events among females could reflect physiologic sex-based differences or differences in the timing of presentation, diagnosis, and treatment of CAD. Females typically experience their first presentation of CAD as many as 10 years later than males, most commonly after menopause.²⁰ In addition,  females  may present with symptoms that are not immediately recognized as cardiac-related, potentially contributing to delayed diagnosis and treatment.²¹ This underscores the importance of recognizing sex-specific symptoms and risk factors to facilitate timely diagnosis and treatment.

A distinctive aspect of our study is the composition of the female cohort, which included substantial racial and ethnic diversity. Notably, 12% of the females were identified as Native American, 8% as Black, and approximately two-thirds as Hispanic. Native American, Black, and Hispanic populations  continue to be underrepresented in clinical trials, and may experience poorer outcomes than White patients following PCI.²² Together with the underrepresentation of females in clinical trials, the diversity of this cohort provides additional real-world outcome data in patients undergoing treatment of severely calcified coronary lesions.

Regarding the target vessel, our results align with previous studies identifying the LAD as the most frequently treated vessel in both sexes.^18,19 Nonetheless, the distribution of treated vessels differed significantly between groups: LAD treatment was more frequent among males, whereas  RCA treatment was more frequent among females. Some studies have hypothesized that calcium deposition occurs earlier in atherosclerotic lesions of the LAD than in lesions of other coronary arteries, including RCA, left circumflex artery, and left main coronary artery.²³ One possible explanation for our findings is that delayed presentation or access to care among female patients may have contributed to more advanced coronary disease, including calcium deposition beyond the LAD; however, this hypothesis could not be evaluated in the present study.

Despite differences in baseline patient and vessel characteristics between females and males, 100% successful stent placement was achieved in all patients, with low observed rates of angiographic complications and bleeding events. The notable stent placement rate in this complex population highlights the potential importance of appropriate lesion preparation and may also reflect the experience of this high-volume center. The overall rate of angiographic complications was 1.3% with no instances of persistent slow flow/no reflow in either cohort, and the rate of bleeding events was around 2% overall with no occurrence of Type 3 bleeding events. The angiographic complications observed in our study are comparable to those reported in another real-world OA study.¹⁹ However, our findings differ from those of the ORBIT II study, which reported a higher rate of severe dissection in females,¹⁸ as well as from those of a multicenter registry, which documented a higher incidence of coronary artery perforation among females undergoing PCI with OA.²⁴ Additionally, our analysis revealed a slightly elevated occurrence of cardiogenic shock among males compared with females, although this remained below 1% across all cases. Females had a higher observed incidence of postprocedural HF than males; however, only 3 HF events occurred in the overall cohort. Given the very small number of events, this exploratory finding should be interpreted with caution and does not permit conclusions regarding a sex-based difference or its potential underlying mechanisms.

Finally, despite the differences in baseline characteristics, comorbidities, and periprocedural outcomes, females and males exhibited similarly high freedom from MACCE during the index hospitalization and at 1- and 2-year follow-up. These findings are consistent with prior OA studies reporting sustained safety and effectiveness beyond the acute phase, including in patients with complex, calcified lesions.^18,19 Our findings extend the available evidence by demonstrating comparable long-term outcomes between females and males in a large, real-world OA cohort.  This observation is particularly relevant given reports of less favorable outcomes among females undergoing other atherectomy procedures, including RA.²⁵ Further studies are needed to identify factors that may contribute to sex-based differences in outcomes and to determine whether these factors should inform procedural planning.

Limitations

This study has several limitations. Its retrospective design is subject to potential biases in data collection and interpretation. In addition, because the study was conducted at a single high-volume PCI center, the findings may not be generalizable to institutions with less experienced operators or different procedural practices. Although intravascular imaging is routinely used in our laboratory for complex, calcified coronary interventions, intravascular ultrasound and optical coherence tomography use were not tracked in this analysis. Acute procedural and in-hospital outcomes were site-adjudicated according to NCDR CathPCI version 5 definitions but were not independently adjudicated by a blinded clinical events committee. Lastly, although 1- and 2-year follow-up data were available for a substantial proportion of patients, loss to follow-up may introduce uncertainty into the long-term findings.

Although prior studies have reported a greater risk of adverse PCI outcomes in females than males, females remain underrepresented in clinical trials evaluating PCI. This study provides real-world evidence supporting the safety and effectiveness of OA for the preparation of severely calcified coronary lesions, with comparable outcomes between females and males despite differences in age and vessel characteristics.  

Benjamin Klein, DO¹; Sri Mandava, MD¹; Amre Ghazzal, MD¹; Karthik Vedantam, MD¹; Zsuzsanna Igyarto, PhD²; Brad J. Martinsen, PhD²; Ajay J. Kirtane, MD³; Martin B. Leon, MD³; Nirat Beohar, MD¹

From the ¹Mount Sinai Medical Center, Miami Beach, Florida; ²Global Clinical Affairs, Abbott Vascular, Santa Clara, California; ³Columbia University Irving Medical Center, New York, New York.

An abstract reporting results from this study was presented at Cardiovascular Research Technologies (CRT) 2026 and subsequently published in JACC: Cardiovascular Interventions. Available at: https://www.jacc.org/doi/10.1016/j.jcin.2026.01.052.

Disclosures: Dr Igyarto and Dr Martinsen and are employed by and own stock in Abbott Vascular. Dr Kirtane, Dr Leon, and Dr Beohar report receiving consulting fees from Abbott Vascular. The remaining authors report no financial relationships or conflicts of interest regarding the content herein.

Address for correspondence: Nirat Beohar, MD, Mount Sinai Medical Center, 4300 Alton Rd, Miami Beach, FL 33140, USA. Email: nirat.beohar@msmc.com; X: @NiratBeoharMD