Favourable long-term results with zotarolimus-eluting stents in CTO
Revascularization of chronic total coronary occlusion (CTO) with the new-generation zotarolimus-eluting stents (ZES) using contemporary technique led to a favourable procedural success and improved health status and late-term clinical outcomes, hence lending support to CTO revascularization with ZES in a high-lesion, complex patient population, according to the PERSPECTIVE trial*.
In the prospective, single-centre study, outcomes of 183 consecutive patients (mean age 63 years, 79.8 percent male) who underwent CTO percutaneous coronary intervention (PCI) using ZES were compared with pooled data (n=500, mean age 65 years, 81.8 percent male) from historical drug-eluting stent (DES) trials. [SCAI 2018, abstract 16295]
Among the 183 ZES-treated patients, 93.4 percent had successful guidewire crossing with achievement of at least TIMI* 2 flow. Procedural success rate, defined as achievement of <50 percent diameter stenosis and TIMI >2 flow, was 97.2 percent, comparable to the historical rate of 96.4 percent with DES.
The prespecified performance goal — 1-year major adverse cardiac events (MACE), comprising a composite of myocardial infarction (MI), target lesion revascularization, and death, were significantly lower with ZES vs DES in historical trials (7.6 percent vs 25.2 percent; p<0.001).
Specifically, the component of clinically-driven target lesion revascularization occurred in 1.7 percent of ZES-treated patients vs 2.0 percent of DES-treated patients at 1 year. The 1-year MI rate, according to protocol definition of MI of CK-MB** >10x ULN***, was 2.3 percent with DES vs 2.0 percent with ZES. Death rate was 2.9 percent vs 2.3 percent, respectively.
“Despite high lesion complexity and extensive stent length, treatment with ZES was associated with low rates of repeat revascularization, MI and stent thrombosis comparable to outcomes observed in less complex disease and clinical indications … with clinically-driven target lesion revascularization rate of 1.7 percent and MI rate of 2.3 percent, with no stent thrombosis,” said lead author Dr David Kandzari of Piedmont Heart Institute in Atlanta, Georgia, US.
“Favourable procedural success was achieved exceeding 90 percent and with acceptable procedural and in-hospital safety,” he added.
In addition, treatment with ZES led to significantly improved patient-reported health status from baseline to 1 year in all domains of the Seattle Angina Questionnaire, including angina frequency, physical limitation, and quality of life (all p<0.001). In particular, angina frequency score was significantly improved from baseline (mean score, 96.3 vs 72.3 percent; p<0.001).
“Not only were the success rates favourable but we were also able to demonstrate that patients reported an improved quality of life, which should be considered one of the most important outcomes of any procedure,” said Kandzari.
“The overall findings inform the procedural and clinical effectiveness of contemporary CTO PCI in a highly complex patient population with appropriate clinical indication,” he concluded, noting that the study subjects included patients with diabetes (35.5 percent), prior bypass surgery (26.8 percent), prior MI (32.8 percent), angina class III/IV (79.3 percent), occlusion length >20mm (78.7 percent), and a mean J-CTO score of 2.6.