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Stenting may benefit patients with unprotected left main disease, CAD
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Stenting in patients with unprotected left main coronary artery stenosis and coexisting CAD of low and medium complexity confers quantifiable, but not significant, favorable long-term safety and outcomes up to 10 years, according to recent findings.
These results suggest that stenting may represent an alternative to CABG in this patient population, the researchers wrote.In the prospective, multicenter trial, researchers randomly assigned 105 patients with a minimum of 50% diameter stenosis of the unprotected left main coronary artery to PCI (n = 52) or CABG (n = 53). The groups were comparable in terms of clinical and angiographic characteristics.
The left main was treated with drug-eluting stents in 35% of the PCI group, whereas arterial grafts to the left anterior descending artery were used in 81% of the CABG group. Follow-up data on MACCE were collected from 45 patients in the PCI group (87%) and 48 patients in the CABG group (90.5%). Twenty-three patients in each group underwent ambulatory follow-up. The mean long-term follow-up was 9.8 ± 10 years.
The primary endpoint of the trial was left ventricular ejection fraction evaluated by echocardiography at 1 year. Secondary endpoints at 10-year follow-up included MACCE.
Favorable trends
At the 10-year follow-up, the researchers observed a trend toward higher ejection fraction with stenting vs. surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; P = .07).
At 10 years, the incidence of MACCE was numerically lower, but not significantly lower, in the PCI group vs. CABG (51.1% vs. 64.4%; P = .28). However, the researchers observed a trend toward higher very long-term MACCE-free survival in the PCI group vs. CABG (HR = 1.57; 95% CI, 0.9-2.73).
Additionally, researchers observed a nonsignificant decrease in mortality in PCI vs. CABG (21.6% vs. 30.2%; P = .41).
They found no difference in the rates of MI in PCI vs. CABG (8.7% vs. 10.4%; P = .62) or in long-term MI-free survival between the groups (HR = 1.14; 95% CI, 0.3-4.25). Similar results were seen regarding the rate of cerebrovascular in PCI vs. CABG (4.3% vs. 6.3%; HR = 2.85; 95% CI, 0.4-20.4). There was a similar rate of repeat revascularizations between PCI and CABG (26.1% vs. 31.3%; P = .64), which was largely propelled by the increase in these events in the CABG group beyond 2 years.
Although the likelihood of very long-term survival out to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; HR = 1.45; 95% CI, 0.67-3.13), there was a trend toward higher very long-term, major adverse event-free survival years in the PCI group (34.7% vs. 22.1%; HR = 1.71; 95% CI, 0.97-2.99), according to the researchers.
Definitive trial needed
“This is the longest observation of patients who underwent randomization to left main stenting and surgical revascularization. At 10 years, there were no differences in the incidence of MACCE, including stroke and repeated revascularization rates,” the researchers wrote. “A definitive, statistically powered trial showing noninferiority of PCI and CABG in patients with left main disease and low and medium complexity of coexisting [CAD], with results extending to 5-year follow-up is required.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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