SMART-CASE: Conservative Revascularization Noninferior to Aggressive Approach

San Francisco, CA—In patients with intermediate coronary lesions undergoing revascularization, a conservative approach using a criteria of diameter stenosis >70% was noninferior to an aggressive revascularization approach based on >50% diameter stenosis, according to new data from the SMART-CASE trial.

“These data indicate that revascularization of an angiographically intermediate lesion can be deferred safely,” Hyeon-Cheol Gwon, MD, PhD, of Samsung Medical Center (Seoul, South Korea), said at TCT 2013.

In this multicenter, open label, prospective trial, 899 patients undergoing coronary angiography were randomized to be evaluated for PCI based on either a conservative strategy (revascularization of diameter stenosis >70%) or an aggressive strategy (diameter stenosis >50%). Patients were stratified by enrollment site, diabetes status and measures of left ventricular function. 

“The diameter stenosis >50% was first determined as significant in an animal experiment,” Gwon said. “However, the diameter stenosis between 50% to 70% has been considered intermediate by many operators. In the literature, there is a discrepancy in the indication of PCI for lesions with diameter stenosis >50% as seen in the SYNTAX trial, FAME trial and American guidelines for PCI, and diameter stenosis >70% found in the COURAGE trial and the European guidelines for revascularization.”

According to study results, at 1-year follow-up, both strategies exhibited comparable rates of adverse events: The primary endpoint (all-cause death, MI or any revascularization) occurred in 7.3% of the conservative group and 6.8% of the aggressive group (P=.86). Rates for all-cause death (0.5% in conservative group vs. 2.1% in the aggressive group; P=.06), myocardial infarction (0.9% in both groups; P=.99) and any revascularization (6.8% in conservative group vs. 4.8% in the aggressive group; P=.23) were also similar, although there was a trend towards increased all-cause death in the aggressive group (see Figure).

“The proportion of multivessel disease was found to be similar between the two groups, but the total number of stents per patient and the total stent length per patient were significantly higher in the aggressive strategy group,” Gwon said. “However, it must be noted that no stent was implanted in 213 patients in the conservative group.” 

Study details

San Francisco, CA—In the conservative group, stenting was only performed in lesions with a diameter stenosis of >70% and reference diameter of ≥2.25 mm. A cobalt chromium everolimus-eluting stent was used for all lesions, and no restrictions were made in terms of number of stents or total length of stents. However, Gwon noted, balloon angioplasty for small vessel disease was discouraged in the conservative group. Considerations for the use of IVUS and glycoprotein IIb/IIIa inhibitors were left to the operator’s discretion. In addition, a staged PCI was permitted within 7 days of trial randomization.   

Disclosures:

Gwon reports receiving consultant fees/research support from Abbott Vascular Korea, Medtronic Korea and Medtronic Asia Pacific.