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

To assess long-term outcome after rotational atherectomy (RA) is followed by drug-eluting stent (DES) implantation in complex calcified coronary lesions. RA can favorably modify heavily calcified coronary lesions, but long-term outcome is poor when it is used as a stand-alone therapy or combined with bare-metal stents. DES have reduced rates of restenosis in a wide range of patient and lesion subsets, but little information is available on long-term clinical outcome when RA is followed by DES implantation (Rota-DES) in complex calcified lesions. Two hundred and five patients with de novo complex calcified coronary lesions treated with Rota-DES were analyzed. Mean age was 69.7 ± 9.3 years, 63 patients (31%) had diabetes mellitus and 21 patients (10%) had chronic renal failure. Total stent length/patient was 32 mm. The majority of patients were treated with paclitaxel-eluting stents (64%) or sirolimus-eluting stents (30%). Angiographic success rate was 98%. The incidence of in-hospital major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR), was 4.4%. Long-term follow-up was available for 188 patients (92%). At a median follow-up period of 15 months (range, 1-84), the cumulative incidence of MACE (Kaplan-Meier estimate) was 17.7%. Death occurred in 4.4%, MI in 3.4%, TVR in 9.9%, and target lesion revascularization (TLR) in 6.8%. One definite (0.5%) and one probable (0.5%) stent thrombosis were observed. In a multivariate analysis, low ejection fraction (<40%) was the only independent predictor of MACE, and both age and diabetes were independent predictors of TLR. This study represents the largest European data set of patients treated with RA in the DES era. RA followed by DES implantation in calcified coronary lesions appears to be feasible and effective, with a high rate of procedural success and low incidence of TLR and MACE at long term considering this complex patient and lesion subset.

Balloon dilatation or debulking seems to be essential to allow successful stent implantation in calcified coronary lesions. Compared with standard balloon predilatation, debulking using high-speed rotational atherectomy (RA) is associated with higher initial procedural success albeit with higher in-stent late lumen loss at intermediate-term follow-up. Whether modified (scoring or cutting) balloons (MB) could achieve similar procedural success compared with RA is not known. In addition, whether new-generation drug-eluting stents could counterbalance the excessive neointimal proliferation triggered by RA remains to be determined. We randomly assigned patients with documented myocardial ischemia and severely calcified native coronary lesions undergoing percutaneous coronary intervention to a strategy of lesion preparation using MB or RA followed by drug-eluting stent implantation. Stenting was performed using a third-generation sirolimus-eluting stent with a bioabsorbable polymer. The trial had 2 primary end points: strategy success (defined as successful stent delivery and expansion with attainment of <20% in-stent residual stenosis in the presence of TIMI [Thrombolysis in Myocardial Infarction] 3 flow without crossover or stent failure; powered for superiority) and in-stent late lumen loss at 9 months (powered for noninferiority). Two hundred patients were enrolled at 2 centers in Germany (n=100 in each treatment group). The mean age of the study population was 74.9±7.0 years; 76% were men, and 33.5% had diabetes mellitus. Strategy success was significantly more common in the RA group (81% versus 98%; relative risk of failure with an MB- versus RA-based strategy, 9.5; 95% CI, 2.3-39.7; P=0.0001), but mean fluoroscopy time was longer (19.6±13.4 versus 23.9±12.2 minutes; P=0.03). At 9 months, mean in-stent late lumen loss was 0.16±0.39 mm in the MB group and 0.22±0.40 mm in the RA group ( P=0.21, P=0.02 for noninferiority). Target lesion revascularization (7% versus 2%; P=0.17), definite or probable stent thrombosis (0% versus 0%; P=1.00), and target vessel failure (8% versus 6%; P=0.78) were low and not significantly different between the MB and RA groups. Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in nearly all patients with severely calcified coronary lesions, is more commonly successful as a primary strategy compared with MB, and is not associated with excessive late lumen loss. A strategy of provisional MB remains feasible, safe, and effective as long as bailout RA is readily available and may offer the advantages of compatibility with smaller sized catheters and less irradiation. Both strategies are associated with excellent clinical outcome at 9 months. URL: https://www.clinicaltrials.gov . Unique identifier: NCT02502851.

ObjectivesTo assess long-term outcome after rotational atherectomy (RA) is followed by long drug-eluting stent (DES) implantation in diffuse calcified coronary lesions.MethodsPatients with diffuse calcified coronary lesions treated with RA following...

In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported. ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA.

Comparison of drug-eluting versus bare-metal stents after rotational atherectomy for the treatment of calcified coronary lesions

Preliminary experience with adjunct directional coronary atherectomy after high-speed rotational atherectomy in the treatment of calcific coronary artery disease

(J Interven Cardiol 2010;23:254–255)

Background and aims: although an association between metabolic syndrome (MS) and cardiovascular disease risk has been documented, the relationship in patients with complex calcified coronary lesions undergoing rotational atherectomy (RA) and drug-eluting stent(DES) insertion remains controversial. Here, the influence of MS on outcomes was assessed. Methods and results: we retrospectively included 398 patients who underwent RA and DES insertion for complex calcified coronary lesions in our institution between June 2015 and January 2019. The modified Adult Treatment Plan III was used to diagnose MS. The endpoint was major adverse cardiovascular events (MACEs), comprising mortality from all causes, myocardial infarction, and target vessel revascularization (TVR). In all, 173 (43.5%) patients had MS. MS was significantly associated with MACE over the 28.32 ± 6.79-month follow-up period (HR 1.783, 95% CI from 1.122 to 2.833) even after adjustment for other possible confounders. Conclusion: MS was frequently observed in patients treated with RA with DES insertion for complex calcified coronary lesions. MS independently predicted MACE in these patients.

High speed rotational atherectomy: Outcome in calcified and noncalcified coronary artery lesions

Introduced >20 years ago,1 coronary artery stents have improved the safety and particularly the efficacy of percutaneous coronary interventions (PCIs).2 Abrupt vessel closure, complicating 6% to 8% of balloon angioplasty procedures, was associated with a 5% mortality, 40% rate of myocardial infarction (MI), and 40% rate of emergency coronary artery bypass grafting.3 Stents significantly reduced these adverse events (Figure 1).4,5 The reduction of restenosis afforded by bare metal stents (BMS) was modest (30% to 40%). Repeat revascularization still occurred in 15% to 20% of cases.6 Drug-eluting stents (DES) with antiproliferative drugs attached via polymers on the stent surface to minimize smooth muscle proliferation have reduced restenosis and rates of target lesion revascularization by 50% to 70% compared with BMS across nearly all lesion and patient subsets.7 Initially8 and again more recently,9–16 safety concerns were raised about DES, particularly about late stent thrombosis (ST). Figure 1. Outcome of 112 patients with abrupt vessel closure in the prestent balloon angioplasty experience of a registry (1985 to 1986; total, 1801 patients)3 and 339 patients with abrupt vessel closure during balloon angioplasty treated with BMS (Palmaz-Schatz) (total, 4596 patients).5 CABG indicates coronary artery bypass grafting. ST was a bane of stent implantation from the beginning. The initial experience with Wallstents in the late 1980s was overshadowed by ST rates approaching 24%.17 Subsequent series with Palmaz-Schatz and Gianturco-Roubin stents (still predominantly bailout stenting) observed ST in 6% to 12% of cases.4,18 The postprocedural antithrombotic regimen at the time consisted of aspirin, often in conjunction with oral anticoagulation. Dual antiplatelet therapy of aspirin and the thienopyridine ticlopidine in conjunction with a shift from bailout to elective stenting resulted in a significant reduction of ST to <2%.5,19 Earlier oral antiplatelet drug loading and …

Calcified coronary lesions may be associated with stent underexpansion, malapposition, and high rates of restenosis. The use of drug-eluting stents (DES) in such lesions has not been fully addressed in the major trials. We sought to examine the outcomes of patients who were treated with plaque modification (PM) to facilitate DES implantation. We analyzed 164 calcified coronary lesions in 145 consecutive patients who underwent aggressive PM with either rotational atherectomy (RA) and/or cutting balloon (CB) before DES implantation. CB was used in moderate calcified lesions and RA alone or followed by CB in severe calcified lesions. Patients were 68.7 +/- 10.1 years old, 47% were diabetic, 34% had left ventricular ejection fraction (LVEF) < or =50%, and 39% had 3-vessel disease. Ninety-five percent of lesions were classified as B2/C, 100% as moderately/severely calcified. PM was achieved by using CB in 57% and by RA alone or followed by CB in 43%. In 100%, a DES was implanted. There was no failure to deliver a stent. At 15 +/- 11 months follow-up, the overall major adverse cardiac events (MACE) rate was 9.6% (3.4% cardiac death, 2.3% myocardial infarction, and 3.4% target lesion revascularization [TLR]). The only independent predictor of MACE was LVEF < or =50% (odds ratio 3.88; 95% confidence interval: 1.15-13.1; P = 0.03). The incidence of stent thrombosis (ST) was 2.1%. There were no significant differences in MACE and TLR based on the type of PM used. In this population at high risk of restenosis, aggressive PM by CB and/or RA before DES implantation provides excellent mid-term outcomes with only 3.4% TLR and 2.1% ST.

Background: The presence of calcified lesions in chronic kidney disease (CKD) patients adversely affects the outcomes of percutaneous coronary interventions (PCIs). Lesion modification using rotational atherectomy (RA) followed by drug-eluting stent (DES) implantation may, therefore, be a suitable strategy to treat heavily calcified coronary lesions in CKD patients. Aim: The aim of the study was to compare the effectiveness and safety of PCI using RA and new-generation DES for treating calcified coronary lesions in patients with mild versus moderate-to-severe CKD. Methods: This was a single-center, retrospective study. Data were collected from the medical records of all CKD patients with calcified coronary artery lesions who underwent RA + DES implantation from November 2014 to October 2019. The primary outcomes were the rates of in-stent restenosis (ISR), repeat revascularization (RR), and major adverse cardiovascular and cerebrovascular events. Secondary outcomes included procedural success, death after intervention, and procedural/in-hospital complications. Results: A total of 77 and 126 patients with mild and moderate-to-severe CKD were treated with RA + DES. Patients with moderate-to-severe CKD were significantly older when compared to patients with mild CKD (mean age: 66.6 ± 8.2 vs. 59.5 ± 7.7 years, respectively, P &lt; 0.0001). Body mass index was significantly lower in moderate-to-severe CKD group compared to the mild CKD group. The number of patients in whom postdilatation was performed after stent implantation was significantly higher in the moderate-to-severe CKD group compared to the mild CKD group (100% vs. 96%, P = 0.025). Overall procedural success was 97.5% with minimal periprocedural complications. The rates of ISR and RR were not significantly different between patients with mild and moderate-to-severe CKD. The two groups did not differ significantly in terms of procedural success, postprocedural complications, and procedural mortality. Conclusion: RA followed by DES implantation is an effective and safe strategy to treat calcified coronary artery lesions in patients with CKD, regardless of the degree of renal dysfunction.

Rational use of rotational atherectomy in calcified lesions in the drug-eluting stent era: Review of the evidence and current practice.

We aimed to evaluate the additional debulking efficacy of low-speed rotational atherectomy (RA) after high-speed RA by using intravascular imaging. A total of 22 severe calcified coronary lesions in 19 patients (age, 74 ± 10years; 74% male) were retrospectively analyzed. All of these lesions underwent RA under optical coherence tomography (OCT) or optical frequency domain imaging (OFDI) guidance. At first, we performed high-speed RA with 220,000rpm until the reduction of rotational speed disappeared; then, low-speed RA with 120,000rpm using the same burr size was performed. OCT or OFDI was performed after both high-speed and low-speed RAs, and the minimum lumen area were compared. The initial and final burr sizes of high-speed RA were 1.5 (1.5-1.75) and 1.75 (1.5-2.0) mm, respectively. The number of sessions, total duration time, and maximum decreased rotational speed during high-speed RA were 11 ± 5 times, 113 ± 47s, and 4000 (3000-5000) rpm, respectively. During low-speed RA, the number of sessions, total duration time, and maximum reduction of rotational speed were 3 ± 1 times, 32 ± 11s, and 1000 (0-2000) rpm, respectively. The minimum lumen area was similar between after high-speed and after low-speed RA [2.61 ± 1.03 mm2 (after high-speed RA) vs. 2.65 ± 1.00 mm2 (after low-speed RA); P = 0.91]. Additional low-speed RA immediately after sufficient debulking by high-speed RA was not associated with increased lumen enlargement. There was no clinical efficacy of low-speed RA after high-speed RA.

Evaluation of calcified lesions by intravascular imaging has revealed that atherectomy devices have only limited impact. However, subsequent use of coronary intravascular lithotripsy (IVL) may increase treatment effectiveness without increasing risk of complications. This study was designed to evaluate the safety and effectiveness of IVL use after atherectomy in severely calcified coronary lesions as pre-treatment for drug-eluting stents (DES). The Dual-Prep registry is a multicenter, prospective registry of consecutive image-guided percutaneous coronary interventions (PCI). The primary effectiveness and safety endpoints were procedural success (residual stenosis < 50% by quantitative coronary angiography) without an in-hospital major adverse cardiac event (MACE) and 30-day freedom from MACE, respectively. Baseline vessel calcification score and final DES expansion were evaluated by optical coherence tomography (OCT). A total of 118 patients with 120 lesions were enrolled at 20 sites. The calcification score of lesions after atherectomy by core-lab assessment was 4.0 in all cases. Rotational atherectomy was applied prior to IVL in 83.9% cases with mean burr size of 1.57 ± 0.20 mm; IVL was subsequently successfully delivered in all cases (mean balloon diameter 3.02 ± 0.45 mm), followed by DES deployment (mean diameter 3.19 ± 0.51 mm, length of 36.3 ± 16.0 mm). The primary efficacy and safety endpoints were met in 98.3% and 98.3% of cases, respectively. A DES expansion index < 0.8 was seen in 42.2%, and an eccentricity index < 0.7 was not observed in any patient. In severely calcified lesions, image-guided atherectomy followed by IVL lesion preparation demonstrated high procedural success rates and satisfactory non-eccentric stent expansion. This approach may be considered for lesions where an ‘IVL-first’ strategy may not be feasible. jRCT1032230384 (Oct 7, 2023).Graphical abstractDual-Prep registry : atherectomy + IVL before DES implantation strategy for calcified lesion (Calc score ≥ 3 after atherectomy)