RESOLUTE All Comers Looks at Simple, Complex Cases in Comparing ZES, EES

Download this article's Factoid (PDF & PPT for Gold Subscribers)

In patients with chronic stable coronary artery disease or acute coronary syndromes, 2 newer-generation zotarolimus- and everolimus-eluting stents appear to be safe and effective for both simple and complex cases through 1 year. The results appear in a paper published in the May 31, 2011, issue of the Journal of the American College of Cardiology.

For the RESOLUTE All Comers trial, investigators led by Stephan Windecker, MD, of Bern University Hospital (Bern, Switzerland), stratified 2,293 patients according to complex (n = 1,520) or simple (n = 772) cases. The definition of ‘complex’ was prespecified using clinical and angiographic characteristics.

Patients were then randomly assigned to treatment with either a Resolute zotarolimus-eluting stent (ZES; Medtronic CardioVascular, Santa Rosa, CA) or a Xience V everolimus-eluting stent (EES; Abbott Vascular, Abbott Park, IL) and randomized to 12-month clinical follow-up with or without active angiographic follow-up at 13 months.

Among complex cases, rates of the primary endpoint of TLF at 12 months (a composite of cardiac death, target-vessel MI, and clinically indicated TLR) were similar for both stent types in the complex group, as were rates of the patient-oriented endpoint (composite of all-cause death, any MI, and any repeat revascularization). However, all-cause death was lower in complex patients treated with ZES than with EES, a difference driven primarily by a higher incidence of noncardiac death (table 1).

Table 1. Outcomes in Complex Cases

Definite or probable stent thrombosis occurred in 1.3% of complex patients with no difference between ZES and EES at 1.7% and 0.9%, respectively (P = 0.26). In-stent percent diameter stenosis, in-stent late loss, and in-segment binary restenosis all were similar for both stent types.

Among simple cases, rates of TLF and the patient-oriented endpoint were comparable for both stent types but about one-third lower than in the complex group (table 2).

Table 2. Outcomes in Simple Cases

Definite or probable stent thrombosis occurred in simple patients at a rate of 1.4% with ZES and 0.3% with EES (P = 0.12). In-stent percentage diameter stenosis and in-stent late loss were lower with EES than with ZES, but the difference failed to reach significance. In-segment binary restenosis, on the other hand, was low and comparable for both stent types.

Outcomes Reflect Real World Population

The study authors point out that the complex patient population encompassed real-world characteristics including acute MI within 72 hours, LVEF less than 30%, renal insufficiency or failure, treatment of bifurcations, saphenous vein grafts, arterial grafts, in-stent restenosis, unprotected left main lesions, more than 2 vessels treated, lesion length greater than 27 mm, more than 1 lesion/vessel, lesion with thrombus, and lesion with total occlusion.

Although the present study does not address the issue of very late stent thrombosis, annual follow-up to 5 years is expected to provide more information on this issue, Dr. Windecker and colleagues note.

Study Details

Unfractionated heparin (5,000 IU or 70 to 100 IU/kg) or bivalirudin (0.75 mg/kg bolus followed by 1.75 mg/kg/h infusion) were used for procedural anticoagulation. Glycoprotein IIb/IIIa inhibitor use was left to the discretion of the operator. Prior to the procedure, all patients received at least 75 mg of aspirin. A 300- to 600-mg loading dose of clopidogrel was given only if clopidogrel had not been administrated daily in the previous 7 days. All patients were discharged on at least 75 mg of aspirin indefinitely and on clopidogrel 75 mg for more than 6 months after the index procedure.

 

---

Source:
Stefanini GG, Serruys PW, Silber S, et al. The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: A substudy of the RESOLUTE All Comers trial (A randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention). J Am Coll Cardiol. 2011;57:2221-2232.

 

 

Related Stories:

• RESOLUTE Published: Outcomes Largely Equivalent for Zotarolimus, Everolimus Stents
• Resolute Zotarolimus-Eluting Stent Noninferior to Xience V
• Positive Findings for Pair of Zotarolimus-Eluting Stents