Cardiovascular Revascularization Medicine最新文献

The optimal management of patients with ST-segment elevation myocardial infarction (STEMI) with large thrombus burden (LTB) undergoing primary percutaneous coronary intervention (PCI) remains unsettled. The NATURE (clinicaltrials.gov, NCT04969471) study is a prospective, multicenter, two-arm randomized clinical trial designed to assess the safety and effectiveness of the enVast stent retriever as an adjunctive reperfusion strategy in STEMI patients with LTB undergoing primary PCI. Eligible patients consenting for trial participation are randomly allocated (1:1) to enVast-assisted mechanical thrombectomy followed by conventional PCI (experimental arm) versus standard of care (control arm). Randomization is stratified by site, time from symptom onset (≤ 3 versus >3 h) and intended use of parenteral antiplatelet agents (i.e. glycoprotein IIb/IIIa inhibitors or cangrelor). Scheduled follow-up visits take place at 30 (±7) days, 150 (±60) days, and 365 (±30) days post-randomization. The primary endpoint is the infarct size assessed by the area under the curve for creatin kinase myocardial band (CK-MB) activity. Clinical events will be adjudicated by an independent Clinical Events Committee. A central core-lab will analyse 12‑lead ECG, coronary angiography examinations, cardiac magnetic resonance imaging and echocardiography examinations. A sample size of 148 (74 per arm) STEMI patients with complete primary endpoint assessment will provide a 90% power with a two-sided 5% significance level to detect a decrease in the AUC for CK-MB by 30%. The NATURE trial is the first randomized clinical trial aimed at investigating if enVast-assisted mechanical thrombectomy as adjunctive reperfusion strategy is safe and may reduce infarct size in STEMI patients with LTB undergoing primary PCI. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT04969471.

Introduction: Functionally optimizing percutaneous coronary intervention (PCI) with post-PCI fractional flow reserve (FFR) measurement has been associated with improved outcomes in native vessels. However, its role in in-stent restenosis (ISR) PCI is not well understood.

Methods: Consecutive patients undergoing PCI for stable angina or stabilized acute coronary syndrome enrolled in a PCI registry were included. FFR was measured pre- and post-PCI with the goal of further optimization of the PCI result based on post-PCI FFR. Target vessel revascularization (TVR) was evaluated in those with optimized FFR (≥0.86) in the ISR and native vessel lesions.

Results: There were 675 lesions in 574 patients who underwent pre- and post-PCI FFR with 101 lesions with ISR. ISR group was more likely to present with acute coronary syndrome and to have hypertension and chronic kidney disease. Both groups had long to diffuse disease. Median pre-PCI stenosis (70 %, IQR 60-80 %) and pre-PCI FFR (0.69 vs 0.70) were similar in native and ISR groups. There was similar and modest correlation between angiographic severity and pre-PCI FFR in native and ISR lesions (-0.57[-0.62 to -0.51] and -0.54 [-0.67 to -0.38], both p < 0.0001). Similar proportions of stenosis were functionally optimized to a post-PCI FFR ≥0.86 (66 % vs 71 %, p = 0.7). Despite functional optimization, TVR was significantly higher in ISR compared to native lesions [HR 0.71, 95 % CI 0.08-0.38 Log rank P < 0.001] even when ISR was treated with a drug-eluting stent.

Conclusion: Despite functional optimization by post-PCI FFR, TVR is significantly higher after ISR PCI.