ROTAXUS Published: Rotational Atherectomy Does Not Increase DES Efficacy

Routine lesion preparation using rotational atherectomy does not reduce late lumen loss after drug-eluting stent (DES) implantation, according to a study published online December 19, 2012, ahead of print in JACC: Cardiovascular Interventions. Further, the findings suggest that the superior acute gain obtained by rotablation is counterbalanced by an increased late loss resulting in a neutral effect on restenosis. 

Data from the prospective multicenter ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial were originally presented at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in November 2011 in San Francisco, CA. 

Investigators led by Mohamed Abdel-Wahab, MD, of Herzzentrum (Bad Segeberg, Germany), randomized 240 patients with moderate to severe calcification in a de novo coronary lesion to high-speed rotablation (n = 120) or standard balloon angioplasty (n = 120) followed by paclitaxel-eluting stent implantation (PES; Taxus Liberté; Boston Scientific, Boston, MA). Patients were treated at 3 German centers from August 2006 to March 2010.

At 9 months, the control arm had less in-stent late lumen loss, the primary endpoint, than the atherectomy arm (0.31 ± 0.52 mm vs. 0.44 ± 0.58 mm; P = 0.04). In-segment late lumen loss was numerically higher in the rotablation group (0.36 ± 0.57 mm vs. 0.25 ± 0.57 mm; P = 0.11). QCA data showed similar results but no significant difference in minimal lumen diameter, percent diameter stenosis, or binary restenosis between the 2 arms.

Nine-month rates of death, MI, TVR, TLR, MACE (composite of death, MI, or TVR), and definite stent thrombosis did not differ between the 2 groups (table 1). 

Table 1. Nine-month Clinical Outcomes

 
Intention-to-treat analysis revealed an identical angiographic success rate (96.7%) for both groups. Three cases of stent loss were recorded, all in the standard therapy group; 1 of these developed a periprocedural TIA.

There were 15 (12.5%) crossovers from standard therapy to rotablation because of failure of balloon or stent delivery or suboptimal balloon expansion despite the use of a noncompliant balloon. Five (4.2%) patients from the rotablation group crossed over to standard PCI because of protocol deviation, failure of rotablation wire passage, and total occlusion of the target vessel at the time of PCI. As a result, overall strategy success was higher in the rotablation group (92.5% vs. 83.3%; P = 0.03).

There were 2 deaths during hospitalization, and both occurred in the study arm. Target vessel repeat PCI during hospitalization became necessary in 1 patient in each group. The incidence of periprocedural MI was low in both the study and control groups (1.7% vs. 3.4%; P = 0.68), but access site complications were numerically higher in the rotablation group (5.9% vs. 1.7%; P = 0.17).

No Changes to Current Standard Practice Necessary 

“The principal finding of the study is that [rotational atherectomy] before PES implantation was not superior to PES implantation without prior rotablation in reducing the primary endpoint of in-stent [late lumen loss] at 9 months, indicating that rotablation does not increase the efficacy of DES in this complex group of patients,” Dr. Abdel-Wahab and colleagues write. “[Rotational atherectomy] is an essential technique with growing importance in the current PCI era as increasingly complex patients and lesions are considered for interventional therapy.” 

Two “unexpected observations” that explain the non-superiority of rotablation plus stenting found in the study are that the late lumen loss in the control group was lower than assumed and higher than assumed in the study arm, they write.

According to Dr. Abdel-Wahab and colleagues, the study “emphasizes the importance of careful lesion preparation in complex calcified coronary lesions to ensure stent delivery and complete expansion.” Although routine rotablation does not improve DES efficacy, it “remains an important tool for uncrossable or undilatable lesions and improves overall procedural success in this setting. A strategy of balloon dilation with provisional rotablation before stenting should remain the default strategy for complex calcified lesions in the DES era,” they say. 

Study Details

Baseline characteristics were similar between the 2 arms except for a higher rate of hypertension in the rotablation group (89.1% vs. 79.8%; P = 0.05). Rotablation patients also had longer lesions (20.6 ± 9.3 mm vs. 18.5 ± 9.2 mm; P = 0.04) and were more likely to have grade B2/C lesions (93.8% vs. 86.3%; P = 0.15). 

The control group received predilatation with higher balloon pressure (15.8 ± 4.9 atm vs. 13.6 ± 5.1 atm; P = 0.003). Procedure duration (66.4 ± 44.5 min vs. 57.4 ± 34.5 min; P = 0.05) and fluoroscopy time (22.8 ± 21.9 min vs. 18.1 ± 16.7 min; P = 0.04) were both slightly longer with rotablation. 

 

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Source:
Abdel-Wahab M, Richardt G, Büttner HJ, et al. 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. J Am Coll Cardiol Intv. 2012;Epub ahead of print.

 

 

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