Effectiveness and safety of optical coherence tomography-guided PCI in Indian patients with complex lesions: A multicenter, prospective registry

光学相干断层扫描引导下经皮冠状动脉介入治疗(PCI)在印度复杂病变患者中的有效性和安全性:一项多中心前瞻性注册研究

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Abstract

BACKGROUND: Optical coherence tomography (OCT) is reported to be a feasible and safe imaging modality for the guidance of percutaneous coronary intervention (PCI) of complex lesions. METHODS: This multicenter, prospective registry assessed the minimum stent area (MSA) achieved under OCT guidance. A performance goal of 24% improvement in MSA over and above the recommendation set by the European Association of Percutaneous Cardiovascular Interventions Consensus 2018 (4.5 mm(2) MSA for non-left main and 3.5 mm(2) for small vessels). The incidence of contrast-induced nephropathy was also assessed. Core lab analysis was conducted. RESULTS: Five hundred patients (average age: 59.4 ± 10.1 years; 83% males) with unstable angina (36.8%), NSTEMI (26.4%), and STEMI (22%) were enrolled. The primary endpoint was achieved in 93% of lesions with stent diameter ≥2.75 mm (average MSA: 6.44 mm(2)) and 87% of lesions with stent diameter ≤2.5 mm (average MSA: 4.56 mm(2)). The average MSA (with expansion ≥80% cutoff) was 6.63 mm(2) and 4.74 mm(2) with a stent diameter ≥2.75 mm and ≤2.5 mm, respectively. According to the core lab analysis, the average MSA achieved with a stent diameter ≥2.75 mm and ≤2.5 mm was 6.23 mm(2) and 3.95 mm(2), respectively (with expansion ≥80% cutoff). Clinically significant serum creatinine was noted in two patients (0.45%). Major adverse cardiac events at 1 year were noted in 1.2% (n = 6) of the patients; all were cardiac deaths. CONCLUSION: PCI under OCT guidance improves procedural and long-term clinical outcomes in patients with complex lesions not just in a controlled trial environment but also in routine clinical practice.

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