Evaluation of Ultrathin Strut Biodegradable Polymer-Coated Sirolimus-Eluting Stents in an All-Comers Patient Population: 1-Year Results of the S-FLEX Slovakia Registry.

BACKGROUND: Supraflex (Sahajanand Medical Technologies Limited, Surat, India) is a new-generation, biodegradable polymer-coated sirolimus-eluting stent (SES) designed on an ultrathin (60 µm) cobalt-chromium platform with a flexible 'S-link.' The S-FLEX Slovakia registry aimed to assess the safety and effectiveness of Supraflex SES in an all-comers population, with a subgroup of diabetic patients. METHODS: This was a prospective, observational, multi-center, post-market registry conducted between February 2018 and May 2019. All consecutive patients with symptomatic coronary artery disease scheduled for percutaneous coronary intervention with Supraflex SES were enrolled. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR) by percutaneous or surgical methods at 1-year follow-up. Stent thrombosis was a safety endpoint. RESULTS: A total of 413 patients was assessed (145 diabetics and 268 nondiabetics). At 1-year follow-up, the primary endpoint of TLF occurred in 5.1% patients, comprised of 3.9% cardiac deaths, 0.5% TV-MI, and 0.7% CI-TLR. Overall stent thrombosis occurred in 0.5% patients at 1-year follow-up. In the subgroup analysis, TLF occurred in 6.2% diabetics and 4.5% nondiabetics (P =.433) and comprised 4.8% and 3.4% cardiac deaths (P =.447), 0.7% and 0.4% TV-MI (P =.653), and 0.7%, and 0.7% CI-TLR (P =.952) in diabetics and non-diabetics, respectively. Overall stent thrombosis occurred in 0.7% diabetic and 0.4% non-diabetic patient (P =.659). CONCLUSION: This registry demonstrates favourable clinical outcomes after the implantation of the ultrathin biodegradable polymer coated Supraflex SES in an all-comers population, with event rates that were similar in diabetic and nondiabetic patients.

OCT guidance during stent implantation in primary PCI: A randomized multicenter study with nine months of optical coherence tomography follow-up.

AIMS: To assess the possible merits of optical coherence tomography (OCT) guidance in primary percutaneous coronary intervention (pPCI). METHODS AND RESULTS: 201 patients with ST-elevation myocardial infarction (STEMI) were enrolled in this study. Patients were randomized either to pPCI alone (angio-guided group, n=96) or to pPCI with OCT guidance (OCT-guided group, n=105) and also either to biolimus A9 or to everolimus-eluting stent implantation. All patients were scheduled for nine months of follow-up angiography and OCT study. OCT guidance led to post-pPCI optimization in 29% of cases (59% malapposition and 41% dissections). No complications were found related to the OCT study. OCT analysis at nine months showed significantly less in-segment area of stenosis (6% [-11, 19] versus 18% [3, 33]; p=0.0002) in favor of the OCT-guided group. The rate major adverse cardiovascular events were comparable at nine months in both groups (3% in the OCT group versus 2% in the angio-guided group; p=0.87). CONCLUSIONS: This study demonstrates the safety of OCT guidance during pPCI. The use of OCT optimized stent deployment in 1/3 of patients in this clinical scenario and significantly reduced in-segment area of stenosis at nine months of follow-up. Whether such improvements in OCT endpoints will have a positive impact on late clinical outcomes, they demand both a larger and longer-term follow-up study.

Optical coherence tomography-guided primary percutaneous coronary intervention in ST-segment elevation myocardial infarction patients: a pilot study.

BACKGROUND: The objective of our study was to assess whether optical coherence tomography (OCT) guidance could guide intervention to avoid balloon angioplasty and stenting during primary percutaneous coronary intervention. METHODS: One hundred patients with ST-segment elevation myocardial infarction and thrombus-containing lesion were enrolled in this study. Thrombus aspiration was performed in all cases followed by an OCT study. After thrombectomy, no stent was implanted in residual significant stenosis (> 50%) if examination using OCT suggested that the occlusion was mostly thrombotic, provided that the patient was symptom-free and the Thrombolysis in Myocardial Infarction (TIMI) flow was ≥ 2. All patients managed only using thrombectomy underwent 1-week and 9-month angiography and OCT. Patients with significant lesion or those in whom thrombectomy failed to re-establish flow underwent standard treatment. RESULTS: Based on the OCT information, 20 patients (20%) were treated only with aspiration even in the presence of angiographically detected "high-grade stenosis." Angiogram and OCT performed at 1 week and 9 months showed a "normal vessel" without significant stenosis in all 20 cases. There were no cases of major adverse cardiovascular event (including death, myocardial infarction, and target lesion revascularization) during the in-hospital period or at the 12-month follow-up. CONCLUSIONS: The results of our pilot study suggest that ST segment elevation myocardial infarction patients with TIMI 2/3 flow in the angiogram and without significant coronary narrowing using OCT examination (even in the presence of angiographically detected "high-grade stenosis"), in whom thrombus aspiration is performed in addition to optimal medical therapy might benefit only from thrombus aspiration without plain old balloon angioplasty/stenting during primary percutaneous coronary intervention. Validation of these preliminary data in larger randomized studies is warranted.