High-Speed Rotational Atherectomy Versus Modified Balloons Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions

Abstract

Background: 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. Methods and Results: 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. Conclusions: 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. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02502851.

Comparison of Bailout and Planned Rotational Atherectomy for Heavily Calcified Coronary Lesions: A Single‐Center Experience

“…In experienced RA centers, immediate bailout RA procedures are commonly performed, although safety, feasibility, and long-term outcome of bailout RA are not well known. Furuichi et al 12 previously reported a rate of 63.1% for bailout cases, whereas a rate of 27% of unplanned RA was reported in a series of Abdel-Wahab et al 11 In the ROTAXUS study, crossover to RA was necessary in 12.5% of patients in the group randomized to a standard balloon dilatation before stenting. Remarkably, both bailout and elective cohorts were well balanced in their baseline characteristics in our study, with an age of around 71 years, about one-third with diabetes and one-third with acute coronary syndromes.…”

Percutaneous Coronary Intervention of Complex Calcified Lesions With Drug‐Coated Balloon After Rotational Atherectomy

“…In studies using DES after RA in complex calcified lesions, the cumulative TLR rate has varied between 2 and 12%. 5,[23][24][25][26][27][28] In the only RCT (ROTAXUS trial) assessing routine RA before Taxus DES implantation, the TLR rate was high (12% at 9 months) but this is likely explained by the fact that control angiographies tend to increase the TLR rate. 6 The differences in the patient population and lesions treated may also contribute to the variation in the results.…”

“…The overall MACE rate (14%) at 12 months after RA þ DCB was similar as compared to published registries using RA þ DES. [23][24][25][26][27][28] Approximately, half of the MACE rate in our data was driven by CV deaths. As expected, the risk of CV death was higher in patients presenting with ACS than in patients with stable CAD.…”

Feasibility and clinical outcome of rotational atherectomy in patients presenting with an acute coronary syndrome

“…More bare metal stents (BMS) were implanted in ACS patients (15.3% vs. 6.8%, P = 0.003), whereas more second generation DESs were implanted in SCAD population (24.6% vs. 38.9%; P = 0.004). Both fluoroscopy time and contrast load were higher in the ACS group (27.5 min[18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] vs. 22 min…”

“…One might expect an even better outcome of RA in contemporary practice with the routine use of the new generation DES. The combination of RA with implantation of a DES has been suggested to be associated with reduced rates of TLR and MACE compared to BMS18,19 . This finding has been further confirmed in the present study, as treatment with BMS or early generation DES was among the independent predictors of MACE at two years after PCI.Although no safety or acute efficacy differences could be identified between patients with ACS or SCAD undergoing RA, the intermediateterm prognosis of ACS patients remained significantly worse.…”