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January 2, 2017

Rotational Atherectomy Evaluated in Two Studies of the ROTATE Registry

January 3, 2017—Two studies of rotational atherectomy followed by stent implantion from the ROTATE multicenter registry were published by Hiroyoshi Kawamoto, MD, et al and Mario Iannaccone, MD, et al in EuroIntervention (2016;12:1448–1456 and 2016;12:1457–1464).

In the first study, Hiroyoshi Kawamoto, MD, et al reported on in-hospital and midterm clinical outcomes of rotational atherectomy followed by metallic stent implantation. In the second study, Mario Iannaccone, MD, et al reported early and midterm outcomes of rotational atherectomy in acute coronary syndrome (non–ST-segment myocardial infarction [NSTEMI]).

Dr. Kawamoto and colleagues assessed 1,176 de novo lesions with calcified coronary lesions treated by rotational atherectomy and metallic stent implantation at nine institutions between 2002 and 2013. The analysis excluded patients with ST-segment elevation myocardial infarction within 30 days, cardiogenic shock before the procedure, lesions with thrombus, and in-stent restenosis.

The investigators reported that in-hospital major adverse cardiac events (MACE) occurred in 8.3% of cases, mainly driven by periprocedural myocardial infarction. The incidence of MACE was 16% and 24.9% at 1- and 2-year follow-up, respectively, both driven by target vessel revascularization (13.5% at 1 year and 19.8% at 2 years).

Multivariate analysis revealed that dialysis was an independent predictor for both in-hospital MACE (odds ratio, 2.33; 95% confidence interval [CI], 1.11–4.87; = .03) and follow-up MACE (hazard ratio [HR], 4.14; 95% CI, 2.87–5.96; P < .001). Drug-eluting stent use was associated with a reduction in follow-up MACE (HR, 0.42; 95% CI, 0.26-0.6; P < .001).

The investigators concluded that rotational atherectomy appears to be safe and effective with acceptable in-hospital and follow-up MACE considering the severity of patient and lesion characteristics. Drug-eluting stent implantation following rotational atherectomy was associated with a reduction in MACE during the follow-up period.

In the second study, Dr. Iannaccone and colleagues assessed the safety and efficacy of rotational atherectomy in patients presenting with NSTEMI with reference to both short- and long-term follow-up.

This observational retrospective registry enrolled all consecutive patients undergoing rotational atherectomy, comparing patients with stable angina and NSTEMI. In addition, NSTEMI patients were matched with NSTEMI patients who did not undergo rotational atherectomy. The primary endpoint was angiographic success. Procedural complications and in-hospital MACE were secondary endpoints, along with MACE during follow-up.

The analysis included 1,308 patients; 37% (484) had an NSTEMI diagnosis and 63% (824) had stable angina.

The investigators reported that angiographic success did not differ between the groups (98.8% vs 99.2%; P = .57). By univariate analysis, procedural complications were more frequent in the NSTEMI group (11.3% vs 8%; P = .04).

In-hospital MACE rates were comparable between groups (5.7% vs 5.8%; P = .93). By multivariate analysis, NSTEMI patients showed a nonsignificant trend toward a higher risk of adverse events (HR, 2.39; CI, 0.96–5.96; P = .061). After a median of 27.9 months, MACE was significantly higher in the NSTEMI group as compared with the stable angina group (32.4% vs 24.2%; log-rank P < .001); the results were confirmed by multivariate analysis.

After propensity score matching, NSTEMI patients undergoing rotational atherectomy had similar outcomes to NSTEMI patients who did not undergo rotational atherectomy (16% vs 13%; log-rank P = .14).

The data demonstrated that rotational atherectomy has similar safety and angiographic outcome in patients with NSTEMI or stable angina. The higher rate of adverse cardiac events at follow-up in NSTEMI patients undergoing rotational atherectomy is comparable with a matched population of NSTEMI patients not undergoing rotational atherectomy, concluded Dr. Iannaccone and colleagues.

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January 3, 2017

Abbott Set to Close Acquisition of St. Jude Medical, Inc.

January 3, 2017

Abbott Set to Close Acquisition of St. Jude Medical, Inc.