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AUTAX: Multiple paclitaxel-eluting stents safe for implantation in patients with multivessel disease
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The implantation of a paclitaxel-eluting stent with the aim of complete revascularization is safe in patients with multivessel coronary artery disease.
Researchers included 441 consecutive patients with two-vessel or three-vessel disease who either had or did not have prior percutaneous coronary intervention in the AUTAX registry. Patients were implanted solely with multiple paclitaxel-eluting stents (Taxus Express, Boston Scientific). The primary endpoint of the registry was the incidence of major adverse cardiac and cerebrovascular events, defined as all-cause mortality, nonfatal acute MI, target lesion revascularization and cerebrovascular event, within the two-year follow-up period.
Complete revascularization was achieved in 90.5% of all study patients. According to the results, a total of 78 patients experienced major adverse cardiac and cerebrovascular events during the study period, including TLR (13.1%), which occurred in 60 of the patients. Other major adverse cardiac and cerebrovascular events identified included acute MI (1.4%), death (3.6%) and stroke (0.2%) with a cumulative composite event rate of 18.3%. The researchers also identified age (HR=1.03, 95% CI, 1.00-1.05) and unstable angina/non-STEMI (HR=2.10; 95% CI, 1.34-3.28) as predictors of major adverse cardiac or cerebrovascular events in the patient population, with diabetes trending towards being a predictor (HR=1.50; 95% CI, 0.94-2.36). Incomplete revascularization (HR=3.84; 95% CI, 1.60-9.11) and unstable angina/non-STEMI (HR=2.40; 95% CI, 1.01-5.75) were predictors of mortality and/or acute MI.
“With the aim of complete revascularization, multiple paclitaxel-eluting stent implantation is safe for patients with multivessel CAD, with low incidence of late stent thrombosis, even with off-label indications or complex coronary anatomy unfavorable for [CABG],” concluded the researchers.
In an accompanying editorial, William Wijns, MD, PhD, noted that while the information collected in the registry was helpful, particularly because it did not exclude patients with prior PCI, it ultimately did not provide additional evidence beyond the results of the SYNTAX trial.
“More than the actual outcome results, the AUTAX registry usefully draws the attention to the importance of completeness of revascularization and tight follow-up (including angiography as felt desirable) in patients with multivessel disease of low-to-moderate complexity,” Wijns wrote. “No conclusions can be drawn regarding equivalence or superiority of the preferred approach vs. [CABG]. With all due respect for our excellent Austrian colleagues, the level of evidence provided by the AUTAX registry is not beyond, but rather behind, the SYNTAX study.”
Gyongyosi M. J Am Coll Cardiol Intv. 2009;2:718-727.