Key result
Routine noncompliant balloon postdilatation fails to reduce 2-year major adverse events after everolimus-eluting stenting.
Why the study?
There are limited data on the clinical value of routine postdilatation using noncompliant balloons after contemporary drug-eluting stent implantation.
RCT (n=810)
Open-label
1:1 ratio
Yes
Absolute Event Rate: 3.6% vs 4.4%
p-value: p=0.537
Routine postdilatation offers no clear benefit after everolimus-eluting stents; early termination leaves open efficacy in larger trials.
BACKGROUND: There are limited data on the clinical value of routine postdilatation using noncompliant balloons after contemporary drug-eluting stent implantation. HYPOTHESIS: Additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation could provide better clinical outcomes. METHODS: We randomly assigned 1774 patients with coronary artery disease to undergo additional high-pressure postdilatation using noncompliant balloons and moderate-pressure dilatation using stent balloons after everolimus-eluting stent implantation. The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization. RESULTS: The study was discontinued early owing to slow enrollment. In total, 810 patients (406 patients in the high pressure group and 404 in the moderate pressure group) were finally enrolled. At 2 years, the primary endpoint occurred in 3.6% of patients in the high pressure group and in 4.4% of those in the moderate pressure group (P = .537). In addition, no significant differences were observed between the two groups in the occurrence of an individual end point of death (0.8% in the high pressure group vs 1.5% in the moderate group, P = .304), MI (0.2% vs 0.5%, P = .554), stent thrombosis (0% vs 0.2%, P = .316), or TVR (2.8% vs 2.6%, P = .880). CONCLUSIONS: The strategy of routine postdilatation using noncompliant balloons after everolimus-eluting stent implantation did not provide incremental clinical benefits.
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Park et al. (2020) conducted an RCT in Coronary artery disease (n=810). Additional high-pressure postdilatation using noncompliant balloons vs. Moderate-pressure dilatation using a stent balloon was evaluated on Composite of death, myocardial infarction, stent thrombosis, and target vessel revascularization at 2 years (p=0.537). Routine postdilatation using noncompliant balloons after everolimus-eluting stent implantation did not significantly improve the 2-year composite of death, MI, stent thrombosis, and TVR (3.6% vs 4.4%).
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