In patients with unprotected left main disease, clinical outcomes of PCI with an everolimus-eluting stent do not appear to be influenced by high anatomical complexity as defined by a SYNTAX score of at least 33, according to recent study findings.
Researchers evaluated 393 patients (mean age, 72 years; 78% men) enrolled in the Florence ULMD PCI registry, a prospective, single-center registry that includes consecutive patients treated with drug-eluting stent–supported PCI for unprotected left main disease (ULMD).
The researchers identified only patients with ULMD who underwent PCI with an everolimus-eluting stent (EES), either Xience (Abbott Vascular) or Promus (Boston Scientific), between May 2008 and July 2014. PCI was performed rather than surgery due to patient preference or high surgical risk, defined as a logistic EuroSCORE of at least 6. The SYNTAX scoring algorithm was used to score all angiograms, and patients were divided into two groups: those with SYNTAX score of at least 33 (n = 181) and those with SYNTAX score of less than 33 (n = 212).
The study’s primary angiographic endpoint was angiographic restenosis, defined as left main binary angiographic in-segment restenosis greater than 50% on angiographic follow-up. Clinical endpoints included 1-year and 3-year rates of mortality. Also defined as clinical exploratory endpoints were 1-year MACCE, which included cardiac death, nonfatal MI, target vessel revascularization and stroke. Patients underwent routine 6- to 9-month angiographic follow-up, and unscheduled angiography was performed as indicated.
The researchers found the overall rate of binary in-segment restenosis was 4.9%. Comparable restenosis rates were seen in patients with high anatomic complexity (6%) vs. intermediate/low-complexity anatomy (4.1%; P = .399). Multivariate analysis revealed stent length to be the only factor related to restenosis (OR = 1.06; 95% CI, 1.02-1.09).
In terms of 1-year clinical outcomes, all-cause mortality and cardiac death rates were very low (from 0.8% to 1.6%) in patients with a EuroSCORE less than 6, regardless of SYNTAX score. In contrast, a EuroSCORE of at least 6 was correlated with high 1-year cardiac mortality rates (4.4% in patients with SYNTAX score < 33 and 10.2% in patients with SYNTAX score > 33). Although the rates of MI and stroke did not differ among groups, TVR was found to be more prevalent in patients with high EuroSCORE and SYNTAX score of at least 33 (9.3%) vs. those with EuroSCORE less than 6 and SYNTAX score of at least 33 (1.6%; P = .046). The median time toTVR from initial procedure was 187 days (interquartile range, 180-222 days).
At 3-year follow-up, patients with a EuroSCORE less than 6 and SYNTAX score less than 33 had a 99% cardiac survival rate, whereas patients with EuroSCORE less than 6 and SYNTAX score of at least 33 had a 98% cardiac survival rate (P = .63). Patients with EuroSCORE of at least 6 and SYNTAX score less than 33 had a 90% cardiac survival rate at 3 years, whereas patients with EuroSCORE of at least 6 and SYNTAX score of at least 33 had 3-year cardiac survival rates of 87% (P = .211).
Multivariate analysis of 3-year cardiac mortality revealed a strong correlation between EuroSCORE cardiac mortality, but not between SYNTAX score of at least 33, either in patients with EuroSCORE less than 6 or those with EuroSCORE of at least 6.
“SYNTAX score ≥ 33 should be no more considered to determine the optimal revascularization modality agreed that a complete revascularization can be achieved by PCI supported by the use of new-generation DES,” the researchers wrote. “More clinical trials focused on high EuroSCORE and/or SYNTAX ≥ 33 are needed to verify whether completeness of revascularization achieved by PCI in ULMD with complex coronary anatomy is equivalent or superior to coronary surgery.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.