The study sought to assess the procedural success of rotational atherectomy (RA) in coronary chronic total occlusion (CTO) and to investigate the in-hospital and one-year outcomes following RA. From 2015 to 2019, patients undergoing percutaneous coronary intervention for CTO (CTO PCI) were retrospectively included into the hospital database. The primary endpoint was procedural success. Secondary endpoints were in-hospital and one-year major adverse cardiovascular and cerebral event (MACCE) rates. During the study period of 5 years, 2.789 patients underwent CTO PCI. Patients treated with RA (n = 193, 6.92%) had a significantly higher procedural success (93.26% vs. 85.10%, p = 0.0002) compared to those treated without RA (n = 2.596, 93.08%). Despite a significantly higher rate of pericardiocentesis (3.11% vs. 0.50%, p = 0.0013) in the RA group, the in-hospital and one-year MACCE rate was similar in both groups (4.15% vs. 2.77%, p = 0.2612; 18.65% vs. 16.72%, p = 0.485). In conclusion, RA is associated with higher procedural success for CTO PCI, but has higher risks for pericardial tamponade than CTO PCI without the need for RA. Nevertheless, in-hospital and one-year MACCE rates did not differ in-between both groups.
Keywords: coronary chronic total occlusion; CTO; rotational atherectomy; percutaneous coronary intervention; coronary artery disease
The prevalence of coronary chronic total occlusion (CTO) is reported in approximately 15% of all patients undergoing percutaneous coronary interventions (PCI) [[
Therefore, the present study aims to investigate the periprocedural success and one-year outcomes for CTO PCI with and without RA using a large-scaled database from a high-volume CTO center.
All consecutive patients undergoing CTO PCI between January 2015 and December 2019 were retrospectively entered into the hospital database. There were no formal exclusion criteria and all patients who provided informed consent were included consecutively. In this single-centre analysis, the patients were stratified according to whether RA was performed or not during CTO PCI. RA was performed with the Rotablator system (Boston Scientific Corp., Natick, MA, USA) [[
CTOs were defined based on the CTO-ARC criteria (a total occlusion, documented to be ≥3-month-old, with absence of antegrade flow through it and no thrombus, no staining at the proximal cap, and presence of mature collaterals) [[
As part of the quality management program of our institution, baseline demographic, clinical, angiographic, and procedural data, as well as outcome data, were entered routinely into the hospital monitoring database. As part of our routine follow-up, we performed an interview 1 year after any PCI and the results were documented as well in the database. Written informed consent for PCI was obtained from each patient and the collection of data was performed in accordance with the Declaration of Helsinki and approved by the institutional review board (Ethical approval number: EK 21-1100).
The primary endpoint was the procedural success in CTO PCI. The secondary endpoints were the in-hospital and the one-year MACCE.
Baseline and procedural characteristics, as well as lesion characteristics, are shown with means and standard deviations or medians (interquartile range, IQR) unless otherwise specified and were compared between the CTO with RA group and the CTO without RA group using the student t-test. Categorical variables were expressed as percentages and were compared using Pearson's chi-square test or Fisher's exact test. Multivariable analyses were calculated at baseline for the risk of all-cause MACCE by using Cox regression with backward elimination. Crude and adjusted hazard ratios with 95% confidence intervals (95% CI) were calculated after the selection of the confounding variables based on the grounds of univariable association with the given endpoints in the present study (p < 0.05). Cumulative event rates were calculated according to the Kaplan–Meier method, and comparisons were performed with the log-rank test. A p value of <0.05 was considered statistically significant, and all p values were 2-sided. All statistical analyses were performed with JMP 13.0 (SAS, Cary, NC, USA).
A total of 2.789 patients treated with CTO PCI were enrolled during the study period, of whom 193 (6.92%) underwent additional RA (CTO with RA group). The principal baseline characteristics of the CTO with RA group and the non-RA group (CTO without RA group) are listed in Table 1. The population in the atherectomy group was older on average (70.33 ± 8.97 vs. 65.73 ± 10.84 years, p < 0.0001) and had more comorbidities such as diabetes (43.41% vs. 29.85%, p = 0.0002) and hypertension (92.51% vs. 85.86%, p = 0.0081). The number of patients with prior CABG was higher in the RA group (33.52% vs. 16.06%, p = 0.0001), while the number of patients with prior MI was similar in both groups (38.35% vs. 34.50%, p = 0.3290).
The specific lesion characteristics are shown in Table 2 and the procedural characteristics are outlined in Table 3. The lesions in the RA group were more calcified (p < 0.0001) and had higher intra-lesion angulation (p < 0.0001). The CTO lesions treated with RA needed more stents (2.19 ± 1.15 vs. 1.73 ± 1.20, p <0.0001) with an overall larger diameter (4.16 ± 0.53 vs. 3.17 ± 0.04 mm, p 0.05) than the lesion treated with conventional CTO PCI technique. Approximately 30% of the CTO were performed using the retrograde approach, irrespective of the use of RA. We applied more inflation pressure in the RA group both in the pre-dilatation and in the post-dilatation phase (p < 0.0001). The PCI procedure in the RA group took longer fluoroscopic times (p < 0.001) and used more contrast medium volumes (p = 0.0002), as well as higher radiation doses (p < 0.001).
The primary endpoint (i.e., procedural success) occurred significantly more frequent in the CTO with RA group (93.26% vs. 85.10%, p = 0.0002). Accordingly, technical success was achieved more prevalently in the RA group (97.41% vs. 87.87%, p < 0.0001) (Table 4).
There were no significant differences among the two study groups with regard to the secondary clinical endpoints. Despite significantly higher rates of tamponades leading to pericardiocentesis (3.11% vs. 0.50%, p = 0.0013), the in-hospital MACCE rate was similar in both groups (4.15% vs. 2.77%, p = 0.2612). At one year, a total of 491 MACCE events occurred, including 434 (16.72%) and 36 (18.65%) in the RA and non-RA group, respectively (p = 0.48) (Figure 1).
Consistent results were observed regarding the one-year mortality of any causes (3.70% vs. 5.70%, p = 0.1625) and one-year stroke rate (0.65% vs. 0.00%, p = 0.6256). The Kaplan-Maier curve for one-year MACCE is shown in the Figure 2.
In our center, the RA use for CTO increased consistently from 2015 to 2019 (Figure 3).
As shown in Figure 4, the presents study represents the largest ever published cohort of CTO patients treated with RA including a one-year clinical follow-up. Multiple trials demonstrated the prognostic and symptomatic benefits of recanalization of CTO lesions improving survival rate, angina symptoms and heart function [[
Our key finding can be summarized as follows:
- RA is increasingly used in approximately 7% of our CTO cases in the last years, mainly for complex calcified lesions and in patients with prior CABG;
- RA is linked with a significantly higher rate of procedural and technical success;
- Patients treated with RA showed similar in-hospital and one-year MACE rates despite a higher rate of tamponade and pericardiocentesis.
In contrast to previous studies, our results are the first to show significantly higher rates of procedural and technical success in CTO patients treated with RA vs. conventional CTO-techniques. In 2019, Xenogiannis and colleagues reported a large atherectomy cohort with 3.607 CTO cases, including 117 (3.2%) in which atherectomy was used with a similar technical (91% vs. 87%, p = 0.240) and procedural (90% vs. 85%, p = 0.159) success [[
Several alternatives to RA (orbital atherectomy, laser atherectomy, or shockwave therapy) have been introduced to clinical practice to enable adequate lesion preparation by modifying the calcified plaque before stent placement. Some of these devices have been used in terms of CTO lesions. Excimer laser coronary atherectomy therapy has been shown as an effective method for the treatment of in-stent restenosis in CTO [[
The technical aspect of CTO PCI is addressed in our study, and we conclude that technical success is higher in the rotating atherectomy group. However, it is important to note that technical and procedural success does not necessarily mean "patient success". We do see an overall higher perforation rate in the RA group; however, this does not translate into a higher in-hospital or one-year MACCE rate.
Our results should be interpreted in view of several limitations. First, they arise from an observational single center study and, as such, may suffer from limited generalizability. Second, the RA group had higher success rate, despite higher angiographic and clinical complexity. This is probably based on the fact that the Rota Wire has already passed the CTO lesion in most of the cases. Third, the choice of whether to perform a coronary atherectomy was left to the discretion of the operators. Fourth, the Japan-chronic total occlusion (J-CTO) and the Prospective Global Registry of Chronic Total Occlusion Interventions (PROGRESS-CTO) scores are not part of our prospective evaluation focusing on clinical outcome analysis. Furthermore, no information on freedom from angina was available for the present study. Finally, the interventions were performed in a high-volume CTO center by special trained operators, which may restrict extrapolation to less experienced operators and lower volume clinics.
Despite the limitations cited, our study represents the largest register of CTO treated by RA ever published to date. For the first time, CTO treated with RA is shown to be superior to conventional CTO PCI techniques in terms of procedural success. This benefit does not come at the expense of a higher rate of in-hospital or one-year MACCE.
In patients presenting with CTO and undergoing PCI for revascularisation, we found higher rates of procedural success and no difference in the one-year MACCE rate in patients treated with RA despite a higher risk of tamponade and pericardiocentesis. RA is a very effective and useful tool in the armamentarium of a CTO PCI operator, treating complex calcified CTO lesions.
Graph: Figure 1 In-hospital and one-year MACCE classified according to rotational atherectomy use.
Graph: Figure 2 Kaplan–Meier analysis for one-year MACCE according to rotational atherectomy use.
Graph: Figure 3 Temporal evolution of rotational atherectomy use for chronic total occlusion intervention during the study period.
Graph: Figure 4 Percentage of CTO lesions treated with rotational atherectomy in previous studies [[
Table 1 Baseline characteristics in patients undergoing CTO PCI with and without RA.
Patient Characteristics CTO without RA CTO with RA Age (years) 65.73 ± 10.84 70.33 ± 8.97 <0.0001 * Men 82.55% 80.83% 0.56 BMI (kg/m2) 28.44 ± 4.66 28.19 ± 4.47 0.45 eGFR, mL/min/1.73 m2 72.43 66.18 <0.0001 * CAD presentation 0.37 ACS 12.79% 10.36% No ACS 87.21% 89.64% Diabetes mellitus 29.85% 43.41% 0.0002 * Dyslipidemia 89.89% 92.27% 0.37 Hypertension 85.86% 92.51% 0.0081 * Smoking (current) 20.01% 10.99% 0.0024 * LVEF (%) 0.29 >51% 62.24% 58.89% 41–51% 20.31% 25.56% 30–40% 10.89% 11.11% 0–29% 6.56% 4.44% Family History of CAD 43.58% 37.18% 0.13 Prior Myocardial Infarction 38.35% 34.50% 0.33 Prior CABG 16.06% 33.52% <0.0001 * Prior CVD 11.6% 12.3% 0.87 LDL max. 104.75 ± 41.39 91.78 ± 35.71 <0.0001 *
Table 2 Lesion characteristics in patients undergoing CTO PCI with and without RA.
CTO without RA CTO with RA Target vessel <0.0001 * Right coronary 50.35% 55.96% Left circumflex 21.34% 19.17% Left anterior descending 26.93% 20.73% SVG 0.7% 0.0% Number of treated vessels 1.35 ± 0.58 1.41 ± 0.59 0.14 Number of treated segments 6.63 ± 5.41 5.67 ± 4.94 0.009 * Lesion length (mm) 0.15 <10 mm 2.93% 0.52% 0.22 10–20 mm 18.09% 17.28% >20 mm 78.98% 82.20% Ostial lesion 6.69% 7.2% 0.32 Calcification <0.0001 * None 6.49% 0.52% Mild 28.42% 2.07% Moderate 28.80% 11.40% Severe 36.29% 86.01% Eccentric calcification 53.12% 49.41% 0.35 Tortuosity 20.74% 23.83% 0.31 Relevant side brunch 29.58% 23.40% 0.072 * Intra-lesion Angulation 0.13 none 11.98% 11.92% <45% 36.47% 30.05% 45–90% 45.12% 48.19% >90% 6.43% 9.84% <0.0001 *
Table 3 Procedural characteristics in patients undergoing CTO PCI with and without RA.
CTO without RA CTO with RA Balloon diameter pre-dilatation, mm 2.50 ± 1.23 2.99 ± 2.74 <0.0001 * Maximum inflation pressure pre-dilatation, atm 17.63 ± 5.37 22.65 ± 18.59 <0.0001 * Number of stents implanted 1.73 ± 1.20 2.19 ± 1.15 <0.0001 * Diameter of implanted stent, max., mm 3.17 ± 0.04 4.16 ± 0.53 0.05 * Overall stent length, mm 54.18 ± 32.5 50.55 ± 30.21 0.23 Balloon diameter post-dilatation, mm 3.64 ± 2.13 3.96 ± 3.08 <0.0001 * Post-dilatation pressure, atm 20.12 ± 7.04 21.98 ± 6.92 <0.0001 * Burr Size used 1.25 mm 33.14% 1.50 mm 47.34% 1.75 mm 16.57% 2.0 mm 2.96% TIMI flow post PCI 0.0063 * TIMI 0/TIMI I 12.2% 5.79% TIMI II 1.48% 1.05% TIMI III 86.33% 93.16% Access site 0.0027 * Single Radial access 31.08% 20.32% Any Femoral access 68.60% 78.61% Guiding catheter size, Fr <0.0001 * 6 62.82% 32.13% 7 34.25% 60.62% 8 2.93% 7.25% CTO technique 0.29 antegrade 73.42% 69.95% retrograde 26.58% 30.05% Procedural time (minutes) 81 (33–126) 127 (94–186) <0.0001 * Fluoroscopy time (minutes) 35 (20–60) 54 (35–80) <0.0001 * Fluoroscopic Dose Area Product (cGy*cm2) 9710 (5388–16,398) 12,881 (4347–20,632) <0.0001 * Contrast volume used (mL) 260 (190–390) 310 (200–400) 0.0002 *
Table 4 Primary and Secondary endpoints % (n).
CTO without RA CTO with RA one-year MACCE 16.72% (434) 18.65% (36) 0.48 one-year Mortality 3.70% (96) 5.7% (11) 0.16 one-year MI 1.2% (31) 1.04% (2) 0.84 one-year TVR 16.26% (422) 18.65% (36) 0.39 one-year Stroke 0.65% (17) 0,00% (0) 0.63 one-year TLR 14.33% (372) 18.13% (35) 0.16 In-hospital MACCE 2.77% (72) 4.15% (8) 0.26 Mortality 1.04% (27) 1.04% (2) 1.0 MI Type 4a 5.5% (142) 12.5% (24) <0.0004 * TVR 16.35% (475) 18.52% (40) 0.40 Stroke 0.19% (5) 0% (0) 1.0 Technical success 87.87% (2281) 97.41% (188) <0.0001 * Procedural success 85.10% (2209) 93.26% (180) 0.0002 * Procedural time (min) 81 (33.6, 126) 127 (94, 186) <0.0001 * Fluoroscopy time (min) 35 (20, 60) 54 (35, 80) <0.0001 * Contrast volume used (mL) 260 (190, 390) 310 (200, 400) <0.0002 * Fluoroscopic Dose Area Product (cGy*cm2) 9710 (5388–16,398) 12,881 (4347–20,632) <0.0001 * Major Complication % ( Perforation 1.99% (51) 7.94% (15) <0.0001 * Pericardiocentesis 0.5% (13) 3.11% (6) 0.0013 *
Conceptualization, M.A. and K.M.; methodology, M.A., N.C. and M.B.; software, T.S., M.A., J.F. and I.A.; validation, M.B., F.-J.N., D.W. and V.R.; formal analysis, M.A., T.S., M.B. and J.F.; investigation, M.A., M.B., I.A. and K.M.; resources, F.-J.N. and K.M.; data curation: M.B., T.S. and J.F.; writing—original draft preparation, M.A. and K.M.; writing—review and editing, M.B., T.S. and J.F.; visualization, M.A.; supervision, M.A., D.W., M.B., V.R., F.-J.N. and K.M.; project administration, M.A. and K.M. All authors have read and agreed to the published version of the manuscript.
The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the institutional review board (Ethical approval number: EK 21-1100).
Not applicable.
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Kambis Mashayekhi reports consulting/speaker/proctoring honoraria from Abbott Vascular, Abiomed, Ashai Intecc, AstraZeneca, Biotronik, Boston Scientific, Cardinal Health, Daiichi Sankyo, Medtronic, Shockwave Medical, Teleflex, Terumo. Mohamed Ayoub reports consulting/speaker/proctoring honoraria from Ashai Intecc, Biotronik, Boston Scientific, Teleflex, Terumo. The other authors declare no conflicts of interest.
By Mohamed Ayoub; Noé Corpataux; Michael Behnes; Tobias Schupp; Jan Forner; Ibrahim Akin; Franz-Josef Neumann; Dirk Westermann; Volker Rudolph and Kambis Mashayekhi
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