Key result
Stent deployment using a pressure optimization protocol reduced target vessel failure compared to rapid inflation/deflation (10.1% vs 17.8%; HR 0.43; 95% CI 0.29-0.64; P<0.0001).
Why the study?
Does a pressure optimization protocol for stent deployment reduce target vessel failure in patients undergoing PCI compared to rapid inflation/deflation?
Cohort (n=792)
Does a pressure optimization protocol for stent deployment reduce target vessel failure in patients undergoing PCI compared to rapid inflation/deflation?
A standardized pressure optimization protocol for stent deployment significantly reduces long-term target vessel failure compared to the traditional rapid inflation/deflation method.
Pressure optimization protocol was associated with lower target vessel failure in PCI; hypothesis-generating and requires randomized confirmation.
BACKGROUND: High-pressure inflation for coronary stent deployment is universally performed. However, the duration of inflation is variable and does not take into account differences in lesion compliance. We developed a standardized "pressure optimization protocol" (POP) using inflation pressure stability rather than an arbitrary inflation time or angiographic balloon appearance for stent deployment. Whether this approach improves long-term outcomes is unknown. METHODS AND RESULTS: 792 patients who underwent PCI using either rapid inflation/deflation (n = 376) or POP (n = 416) between January 2009 and March 2014 were included. Exclusion criteria included PCI for acute myocardial infarction, in-stent restenosis, chronic total occlusion, left main, and saphenous vein graft lesions. Primary endpoint was target vessel failure [TVF = combined end point of target vessel revascularization (TVR), myocardial infarction, and cardiac death]. Outcomes were analyzed in the entire cohort and in a propensity analysis. Stent implantation using POP with a median follow-up of 1317 days was associated with lower TVF compared with rapid inflation/deflation (10.1 vs. 17.8%, P < 0.0001). This difference was driven by a decrease in TVR (7 vs. 10.6%, P = 0.0016) and cardiac death (2.9 vs. 5.8%, P = 0.017) while there was no difference in myocardial infarction (1 vs. 1.9%, P = 0.19). In the Cox regression model, deployment using POP was the only independent predictor of reduced TVF (HR 0.43; 0.29-0.64; P < 0.0001). In the propensity analysis (330 patients per group) TVF remained lower with POP vs. rapid inflation/deflation (10 vs. 18%, P < 0.0001). CONCLUSIONS: Stent deployment using POP led to reduced TVF compared to rapid I/D. These results recommend this method to improve long-term outcomes.
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Vallurupalli et al. (2017) conducted a cohort in Patients undergoing percutaneous coronary intervention (PCI) (n=792). Pressure optimization protocol (POP) vs. Rapid inflation/deflation was evaluated on Target vessel failure (combined end point of target vessel revascularization, myocardial infarction, and cardiac death) (HR 0.43, 95% CI 0.29-0.64, p=< 0.0001). Stent deployment using a pressure optimization protocol reduced target vessel failure compared to rapid inflation/deflation (10.1% vs 17.8%; HR 0.43; 95% CI 0.29-0.64; P<0.0001).
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