|Year : 2017 | Volume
| Issue : 4 | Page : 115-120
Clinical outcomes of patients undergoing rotational atherectomy followed by drug-eluting stent implantation: A single-center real-world experience
Lucky R Cuenza1, Ada Cherryl Jayme2, James Ho Khe Sui3
1 National Heart Center, Philippines
2 Philippine Heart Center, Metro Manila, Philippines
3 Department of Invasive Cardiology, Philippine Heart Center, Metro Manila, Philippines
|Date of Web Publication||20-Dec-2017|
Dr. Lucky R Cuenza
Department of Adult Cardiology, Philippine Heart Center, East Avenue Quezon City, 1100 Metro Manila
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Rotational atherectomy (RA) is used to improve procedural success of percutaneous catheter interventions (PCIs) of complex and heavily calcified coronary lesions. We report the clinical experience and outcomes in our institution with the use of RA, followed by drug-eluting stent implantation.
Materials and Methods: Data of 81 patients treated with PCI and adjunctive RA were analyzed. Clinical follow-up for the occurrence of major adverse events (MAEs) was obtained in all patients and correlated with significant variables using multivariate Cox proportional hazards analysis.
Results: Mean age was 67.9 ± 9.2 years, 61.7% had diabetes, 20.9% had chronic kidney disease, and 48.1% had previous acute coronary syndrome (ACS). Mean SYNTAX score was 29.8 ± 12.2, with a 92.5% angiographic success rate achieved. In-hospital MAEs rate was 7.4% while mortality rate was 8.6%. On median follow-up of 12.2 months, incidence of MAEs of 13.5% with a 75% free incidence from MAEs at 34 months. Multivariate analysis revealed that a history of previous ACS, ejection fraction, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, SYNTAX score, burr to artery ratio, and attainment of angiographic success were significant predictors of MAEs.
Conclusion: RA followed by drug-eluting stent implantation is a safe and effective method in improving procedural success as well as short- and long-term outcomes of PCI in our center. A combination of clinical and procedural factors is predictive for the occurrence of MAEs and should be taken into account in the application of this technique.
Keywords: Drug-eluting stents, percutaneous catheter intervention, rotational atherectomy, rotablation
|How to cite this article:|
Cuenza LR, Jayme AC, Khe Sui JH. Clinical outcomes of patients undergoing rotational atherectomy followed by drug-eluting stent implantation: A single-center real-world experience. Heart Views 2017;18:115-20
|How to cite this URL:|
Cuenza LR, Jayme AC, Khe Sui JH. Clinical outcomes of patients undergoing rotational atherectomy followed by drug-eluting stent implantation: A single-center real-world experience. Heart Views [serial online] 2017 [cited 2019 Dec 15];18:115-20. Available from: http://www.heartviews.org/text.asp?2017/18/4/115/221231
| Introduction|| |
Rotational atherectomy (RA) refers to mechanical debulking using delivery of high-speed burrs to facilitate deployment of stents in heavily calcified lesions. The technique was first invented at the start of the 1980s by David Auth et al. and has been used for more than 20 years as an adjunct for percutaneous catheter interventions (PCIs). Calcified coronary lesions are associated with decreased likelihood of procedural success as well as increased short- and long-term outcomes. In these subsets of patients, the use of RA can help prepare the complex coronary lesion by differentially ablating hard calcified tissue or fibrotic plaque that cannot be crossed by a balloon or be adequately dilated for better stent deployment. Despite the initial enthusiasm for its use, studies have revealed high rates of adverse events and restenosis rates when combined with bare metal stents. The advent of the newer drug-eluting stents as well as more aggressive treatment has sparked renewed enthusiasm for its use. Many reports have suggested improved outcomes and procedural success from many high-volume centers. In our setting in the Philippines, we have been recently increasing the utilization of this tool to achieve there are currently no studies that have ever been done describing the outcomes and predictors of events in the use of RA in our local setting. Our objectives for this study were to describe the outcomes of patients who underwent PCI with adjunctive RA in our institution as well as to determine the predictors of major adverse events.
| Materials and Methods|| |
This was a retrospective study based on patients seen at the Philippine Heart Center who underwent PCI with drug-eluting stents coupled with RA. The patients signed written informed consent and our Institutional Ethics Board approved the study. Relevant information was derived through review of outpatient department records and admissions along with electronic data. Clinical, angiographic, and procedural characteristics were reviewed and characterized.
RA was performed using a Rotablator device (Boston scientific). Clinical follow-up was determined through telephonic inquiry and spanned from the index procedure to the date of whether or not there was any occurrence of any major adverse event (MAE) defined as a composite of any occurrence all-cause mortality, cardiovascular (CV) mortality, myocardial infarction (MI), target vessel revascularization, stent thrombosis, coronary artery revascularization, and new onset of cerebrovascular events as well as any procedural-related complication. All-cause mortality included both CV deaths and non-CV related deaths.
Definition of terms
- All-cause mortality - Mortality in the catheterization laboratory and during hospital stay as well as on follow-up after PCI from any cause which can be CV or non-CV
- MI - An outcome of MI was defined by documentation of new abnormal Q-waves on electrocardiogram and a CK-MB five times the upperlimit of normal in the 1st 7 days after PCI. Eight or more days following PCI, MI will be defined by the presence of new abnormal Q-waves on electrocardiogram and an elevated troponin and/or CK-MB levels
- Cerebrovascular accident - It includes transient ischemic attack, reversible neurologic deficits, intracranial hemorrhage, or ischemic stroke
- Stent thrombosis - Sudden occlusion of a stented coronary artery due to formation of thrombosis
- Target vessel revascularization - Any repeat PCI in the target vessel
- Burr to artery ratio - The ratio of burr size to the reference vessel lumen
- Angiographic success - Successful PCI described as attainment of <50% residual diameter stenosis using angioplasty or <20% using drug-eluting stents
- Procedural success - Successful PCI angiographic success (attainment of residual diameter <50% accompanied by relief of ischemia) without major hospital clinical complications within 30 days of the procedure.
Data analysis was done using STATA SE Version 13 (StataCorp, Texas, USA). Quantitative variables were summarized and presented as mean ± standard deviation, while qualitative variables are presented as frequency and percent distribution. Kaplan–Meier curves were used to show the rate of MAEs and mortality among patients who underwent PCI with RA. Factors associated with MAEs were determined and tested using univariate and multivariate Cox-proportional hazards regression. The level of significance was set at P = 0.05.
| Results|| |
Between January 2013 and December 2015, 81 patients were included in the study. The baseline clinical characteristics of the patients are listed in [Table 1]. The patients' mean age were 67.9 ± 9.2, most were male and hypertensive (75.3% and 85.1%, respectively), 39 (48.1%) had a history of a previous acute coronary syndrome (ACS), and 4 (4.9%) had previous PCI. The mean ejection fraction (EF) was 55.6 ± 11.3. The mean neutrophil to lymphocyte ratio (NLR) was 3.6 ± 2.7, while the mean platelet to lymphocyte ratio (PLR) was 161 ± 80.5. Only two patients underwent the procedure through radial access while 97.5% was through the femoral route. The mean SYNTAX score was 29.8 ± 12.2. Seventy-nine lesions (97.5%) were diffusely calcified and 53 patients (65.4%) had type C/B2 lesions. The rest of the angiographic characteristics are summarized in [Table 2].
Procedural characteristics are listed in [Table 3]. Seventy (86.4%) were primary ad hoc rotablation procedures, with the rest being bail out or nonplanned procedures. One patient had procedural success with the use of intravascular ultrasound. All patients were treated using second-generation drug-eluting stents. Twenty-six percent of patients were treated with multiple burrs (mean 1.27 ± 0.5). Final burr size was 1.5 ± 0.3 mm, and the final burr to vessel ratio was 0.54 ± 0.11. Balloon predilation was performed in most lesions with a mean balloon size of 2.3 ± 0.48 mm and mean inflation pressure of 16.1 ± 4.4 atm. The mean stent length was 28.9 ± 7.2 mm with a maximum length of 38 mm. After stenting, postballoon dilatation was done in 27 (33%). Angiographic success was achieved in 92.5% of patients.
Complete clinical follow-up was obtained in 100% of the patients. There were 17 patients (20.9%) who experienced MAEs [Table 4]. Periprocedural complications include one patient with coronary artery dissection, one had no reflow, and another had a trapped burr that required surgical intervention. In-hospital MAEs rate was 7.4%. Two patients had acute kidney injury (2.5%) and two had vascular complications (2.5%). There were four who died in the hospital postprocedure (4.9%) Overall, there were seven patients who died (8.6%) with 6 (7.4%) from cardiac causes. Four had nonfatal MI (4.9%), one patient had a stroke, one had definite stent thrombosis, while another had probable stent thrombosis. At a median follow-up of 12.2 months, Kaplan–Meier survival curves showed a cumulative incidence of MAEs of 13.5%. At around 34 months, patients were 75% free from MAEs [Figure 1].
|Figure 1: Kaplan–Meier (median follow up 12.2 months) curves showing the occurrence of major adverse events|
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The comparison of the different variables between those who developed MAEs and those who did not is tabulated in [Table 5]. Patients who experienced MAEs were more likely to have has a history of previous ACS (hazard ratio [HR] 6.1, P = 0.005), lower EF (HR 0.93, P = 0.000), higher NLR (HR 1.5, P = 0.000), higher PLR (HR 1.3, P = 0.000), and a higher burr to artery ratio (HR 1.3 P = 0.004). The SYNTAX score (HR 1.7, P = 0.001) and attainment of angiographic success (HR 0.12, P = 0.009) were also shown to be significant predictors of MAEs.
|Table 5: Comparison of variables of those who developed major adverse events versus those without major adverse events with multivariate Cox proportional hazard analysis|
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| Discussion|| |
This study sought to describe the contemporary use of RA in the drug-eluting stent era in our institution. Most of the patients were elderly (mean age 67.9 ± 9.2 years), with significant comorbidities (75.3% hypertensive, 61.7% diabetic) and with high-risk features (48% with previous ACS, nearly 30% with EF <50%). In 98.7% of the patients, the indication for the use of RA was to modify severely calcified lesions in the attempt to improve procedural success.
The lesions that were intervened on were mostly classified as ACC/AHA Type B2/C. Importantly, 86.4% were primary ad hoc rotablation procedures with less than 13% classified as bailout procedures. RA facilitated DES implantation and angiographic success in almost 93% of patients. This is consistent with the literature as most reports on RA with DES implantation focused on calcified lesions. Successful RA results in the creation of a smooth vessel lumen, suitable for the successful performance of balloon angioplasty and stenting at the site of the lesion.
Along with a high rate of angiographic success, procedural complication rates were relatively low (one patient with no reflow, one patient with dissection, and another had a trapped burr and was eventually sent for surgery). An important message of this study was the technique that the operators used to achieve these results. Seventy-four percent of the procedures were accomplished with one burr (mean, 1.27 ± 0.5); the average final burr size was 1.5 ± 0.3 mm with a low burr to artery ratio (0.5 ± 0.1). Our data are similar to the single-center study of Schwartz et al., which further confirms the state-of-the-art approach to RA in the use of small burrs for plaque modification in highly calcified lesions to facilitate stent delivery and achieve adequate expansion and apposition.
Despite the favorable procedural results, in-hospital mortality was 4.9%, and at a median follow-up of 12.2 months, the cumulative incidence of major adverse cardiovascular event (MACE) was 13.5%. Similarly, in a study by Furuichi et al., the incidence of cumulative MACE was 15.8% at an average follow-up period of 14.7 months. In that study, death occurred in four patients (4.2%), non-Q-wave MI occurred in three patients (3.2%), and Q-wave MI occurred in two patients (2.1%). In our study, the operators handled some of the most complicated and sickest patients who likely would have been excluded from prospective trials and this most likely contributed to these procedural and outcome characteristics. Long-term follow showing decreasing rates of MAEs is reflective of the efficacy of this procedure in improving outcomes on follow-up which has also been shown in previous studies.
In our study, a history of previous ACS was a significant predictor of MAEs (HR 6.1, P = 0.005). This variable likely contributed to decreased EF, another significant predictor (HR 0.9, P = 0.000). Nearly 30% of our patients had an EF of <50%. In the study of 145 patients who underwent plaque modification with RA by Vaquerizo et al., an EF < 50% was the only independent predictor of MACE.
The NLR has been shown to predict long-term mortality and outcomes in patients undergoing PCI, while the PLR has been shown to be correlated with the SYNTAX score, which was also statistically significant (HR 1.7, P = 0.001) and when related to the severity and complexity of coronary artery disease may affect both angiographic and procedural success. Both the NLR (HR 1.5, P = 0.000) and the PLR (HR 1.3, P = 0.000) were significant variables in our study. These comparative ratios are inexpensive, readily available on assessment and have the potential to provide incremental prognostic value.
The burr to artery ratio is defined as the ratio of the burr size with the reference vessel diameter. In our study, the mean burr to artery ratio was 0.5 ± 0.1 and was a significant predictor of events (HR 1.4, P = 0.004). Using a burr to balloon strategy, it has been postulated that the use of a smaller burr makes a region of calcified plaque smoother so that angioplasty can be performed. The optimal burr to artery ratio is unknown, but Kaplan et al. noted that the need for revascularization was lowest in burr to artery ratios of 0.6–0.85 while Brown et al. noted that a low burr to artery ratio is associated with high procedural success and low complication rates. Similar to the study by Eftychiou et al., patients who developed MAEs also had a higher SYNTAX score (mean 27.6 ± 15.2) reflecting increased lesion complexity. All these clinical and procedural variables contributed to the attainment of angiographic success, which was also a significant predictor of events (HR 0.12, P = 0.009).
Our study is limited by its single-center, retrospective design with possible selection bias as well as a lack of control group. The relatively small number of patients may not be representative of the larger cohort of patient populations making it difficult to ascertain the generalizability of the results. However, this was a real-world study in patients who receive RA in the current drug-eluting stent era, reflecting how our interventionists routinely apply this technique in practice. In this series with 19 (23.4%) bifurcation lesions, 15 (18.5%) ostial, and 19 (23.4%) totally occluded lesions, RA has been shown to benefit not only patients with severely calcified lesions but also those with complex coronary artery disease  as well as to facilitate successful interventions in patients deemed as high risk, and our results are consistent with available literature.
With all the advances in antiplatelet and pharmacological treatments in interventional cardiology, RA has maintained its role in the armamentarium of the interventionist. The combined approach of RA has a favorable effect when dealing with heavily calcified lesions in both angiographic and clinical outcomes. Reviews of patient registries have revealed no decrease in procedural success with RA despite increasing complexity in patients' medical illness or in its use in coronary lesions such as chronic total occlusions and bifurcation lesions., Aside from description of clinical outcomes, the studies that examine the predictors of outcomes in patients undergoing RA are limited. As the use and expertise of this procedure continue to evolve, it is important that the clinician will take into consideration not only the complexity of the anatomy but also the clinical and procedural characteristics that determine outcomes in the application of this technique.
| Conclusion|| |
In this real-world study, the use of RA followed by drug-eluting stent implantation is a safe and feasible procedure associated with a high rate of procedural success and improved short- and long-term outcomes. Aside from lesion complexity affecting angiographic success, the factors that are predictive for the occurrence of MAEs are related to a combination of both clinical and procedural factors. All these variables must be taken into account to aid the interventionist to predict and improve outcomes with continued use and evolution of this adjunctive strategy in the current drug-eluting stent era.
We would like to thank the Philippine Heart Center Department of Education Training and Research for the general and technical support they provided.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]