Influence of the speed of deflation of the stent delivery system in the myocardial blush and ST-segment resolution in primary angioplasty: a randomized study

Introduction Distal embolization may compromise the results of primary angioplasty. Our aim is to analyze the influence of the speed of deflation of the stent delivery system on the myocardial blush ≥2 and on the ST-Segment resolution ≥70%. Methods From December 2016 to February 2019, all consecutive patients with ST-elevation myocardial infarction who underwent urgent coronary angiography at our institution who were susceptible of thrombectomy, IIB-IIIA inhibitors and direct stenting were randomized 1:1 to fast deflation of the stent delivery system (group 1, n=103) or to slow deflation at 1 atm/second (group 2, n=107). Pre- and postdilatation was not allowed per protocol. The primary outcomes were the myocardial blush ≥2 and the ST-Segment resolution ≥70% while the size of myocardial damage, ejection fraction at discharge and at 12 months and total and cardiovascular mortality at 12 months were the secondary outcomes. A multivariate analysis was performed to analyze the influence of the speed of deflation of the stent delivery system in both primary end-points in case of possible imbalances among groups despite the randomization. Results Both groups represented 47% of the 447 procedures of primary angioplasty performed in that period. Baseline characteristics of the whole cohort: female gender 46 (21.9%), age 59.5±10.6 years, diabetes 35 (16.7%), Killip class IV 5 (2.4%), total ischemic time 177.5 (124–275) minutes and door to balloon time 84 (66–120.5) minutes. There were not differences in clinical or angiographic characteristics between both groups, although there was a non-significant trend towards larger reference vessel diameter in the slow deflation group (2.74±0.42 vs. 2.86±0.47, p=0.07). The study was prematurely stopped with 50% of the calculated sample size due to futility. The primary endpoint of myocardial blush ≥2 occurred in 77 (74.7%) vs. 79 (75.2%), p=0.93 and ST-Segment resolution ≥70% in 54 (53.9%) vs. 59 (55.5%), p=0.75 in group 1 and 2, respectively, without differences in any of the secondary endpoints. The speed of deflation of the stent delivery system did not show any influence on the MB or ST-Segment resolution ≥70% in the multivariate analysis. Predictors of myocardial blush ≥2 were systolic blood pressure at admission, creatinine clearance <60 ml/min and maximal diameter postprocedure. Diabetes, previous infarction, left anterior descending, TIMI ≥2 before intervention, TIMI 3 after intervention and collateral supply grade ≥2 were predictors of ST segment resolution≥70% with an area under the curve of 0.71 (0.63–0.80) and 0.75 (0.68–0.82), respectively. Conclusions In our series, the speed of deflation of the stent delivery system in primary angioplasty did not modified the myocardial blush ≥2 or ST-Segment resolution ≥70% and neither showed any influence in clinical outcomes, size of myocardial infarction by biomarkers and ejection fraction. FUNDunding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Abbott Laboratories

Direct or Direct-Like Stenting in Acute Stemi with High-Grade Thrombus: A Clinical Case Series

We consider herewith acute ST-elevation myocardial infarction cases having high grade thrombus who underwent direct stenting or direct like stenting of the culprit vessel in those a drug-eluting stent was not crossable directly or distal landing zone was not visible directly after successful guidewire navigation in distal true lumen. All the 4 patients had presented with acute STEMI and high-grade thrombus on angiography. All of them were treated with percutaneous coronary intervention incorporating either direct stenting or direct like stenting. All had a very good angiographic outcome with TIMI 3 flow and MBG >/= 2. In most patients with acute STEMI and high-grade thrombus, direct or direct-like stenting is possible, it simplifies the procedure with almost nil on table complications. Twee table abstract Direct and direct-like stenting in patients with high grade thrombus with STEMI is possible in most of the patients. It resulted in TIMI 3 flow and MBG 2 in all our patients. None of them had no-reflow phenomenon. Lay Abstract In any case of ST-elevation MI, time is one of the most important aspects. In this process, it is important to minimize the damage to the heart muscle. Therefore, we need to open the culprit artery in a timely and urgent fashion to restore the blood flow to the heart muscle as quickly as possible. During this restoration of the blood flow, we need to minimize the distal embolization of the clot which may be detrimental to the heart muscle. Here, we describe the cases where we have done stenting directly without touching the clot and that resulted in minimal embolization and better outcomes.

Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study

Background: The SVELTE fixed-wire and rapid exchange bioresorbable-polymer sirolimus-eluting coronary stent systems (SVELTE sirolimus-eluting stent [SES]) are novel, low-profile devices designed to facilitate direct stenting, transradial access, and enhance procedural efficiencies. Methods: Eligible subjects (N=1639) scheduled to undergo percutaneous coronary intervention for non–ST-segment–elevation myocardial infarction or stable coronary artery disease were randomly assigned (1:1) to treatment with either SVELTE SES or a control durable polymer everolimus-eluting coronary stent. The primary end point was 12-month target lesion failure and a noninferiority margin was specified as 3.58% with an expected event rate of 6.5%. Results: Target lesion failure was observed in 10.3% of SVELTE SES and 9.5% of control everolimus-eluting stent subjects under intention to treat analysis (difference=0.8%; P NI =0.034). Clinically indicated target lesion revascularization and stent thrombosis were observed in 1.5% versus 1.9% ( P =0.57) and 0.38% versus 0.51% ( P =0.72) of SVELTE SES versus control everolimus-eluting stent–treated subjects, respectively. Protocol-defined target vessel myocardial infarction (9.4% versus 8.2%) was higher than anticipated and more frequent at sites that utilized troponin versus creatine kinase myocardial band assays. Conclusion: The SVELTE SES did not meet the prespecified threshold for noninferiority. Unexpectedly, high rates of target vessel myocardial infarction in both treatment groups contributed to higher than expected rates of target lesion failure, effectively underpowering the study. No differences between the SVELTE SES and control everolimus-eluting stent were observed for primary clinical or angiographic end point events. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03190473.

Impact of the Result of Continued Thrombolysis After Stenting Following Pharmacomechanical Thrombectomy for Iliofemoral Deep Vein Thrombosis—A Retrospective Study

Objective The aim of this study is to compare the procedure and treatment outcomes of using either direct stenting alone following pharmacomechanical thrombectomy or continued catheter-directed thrombolysis after stenting for treatment of acute left iliofemoral deep vein thrombosis while clot removal degree achieved grade III. Methods From March 2018 to May 2019, 82 patients who underwent iliac venous stenting for treatment of acute left iliofemoral deep vein thrombosis with iliac vein stenosis after pharmacomechanical thrombectomy therapy using the AngioJet system while Clot removal degree achieved grade III were divided into two groups: Direct stenting alone group ( n = 39) and continued catheter-directed thrombolysis after stenting group ( n = 43). Comparisons were made regarding the treatment outcomes, stent patency rate, and Villalta scale between these two groups. Results No serious perioperative complications occurred. The mean urokinase dose and hospitalization time in the stenting alone group and continued catheter-directed thrombolysis after the stenting group were 0.30 million U versus 1.76 ± 0.54 million U and 4.85 ± 0.93 days versus 6.33 ± 1.02 days, ( P < .001). In the first 30 days after the operation, there were 3 recurrent episodes of deep vein thrombosis in the stenting alone group ( P = 0.064). Each patient has completed at least one year of follow-up, the mean follow-up was 15.95 ± 3.44 months. Overall cumulative stent patency rates were 87.2% in stenting alone group and 97.7% in continued catheter-directed thrombolysis after stenting group at 12months ( P = 0.037). The Villalta scores at 12 months had a significant difference between the two groups. The mean Villalta scores in the stenting alone group and continued catheter-directed thrombolysis after the stenting group were 4.44 ± 1.63 and 1.63 ± 1.29, respectively ( P < 0.001). Conclusion When the clot removal degree of pharmacomechanical thrombectomy thrombectomy reaches grade III, both stenting alone and continued catheter-directed thrombolysis after stenting are effective treatment modalities. For young patients with low bleeding risk, continued catheter-directed thrombolysis after stenting has a better patency rate and a lower 1-year post-thrombotic syndrome risk and does not increase major bleeding events. However, it may increase the time and costs of hospitalization accordingly.

Development of a risk score for no-reflow phenomenon after percutaneous coronary interventions in patients with ST-segment elevation myocardial infarction

<p><strong>Background</strong>. No-reflow phenomenon during primary percutaneous coronary intervention (PCI) is a significant clinical problem in patients with ST-elevation myocardial infarction (STEMI), and its predictors remain unclear.</p><p><strong>Aim</strong>. To develop a scoring system to predict the risk of no-reflow in patients undergoing PCI for STEMI.</p><p><strong>Methods</strong>. Data were collected from 1280 consecutive patients with STEMI (59.2±11.4 years, 74.2% men, 5.2% no-reflow) who were admitted to the coronary care unit and underwent PCI. Baseline clinical, angiographic and procedural variables were used to develop the risk score in a training dataset (n=888, 70%) which was then validated in a test dataset (n=392, 30%). A credit risk assessment tool was used to construct a precise screening tool for no-reflow.</p><p><strong>Results</strong>. The model comprised age, pain to revascularisation time, neutrophil count, admission plasma glucose level, initial TIMI flow and direct stenting as the only independent predictors of no-reflow. These factors were weighted and used to develop a risk score ranging from 0 to 7. In the training dataset, the optimal threshold score for predicting no-reflow was ≥35, with 69% sensitivity and 81% specificity (area under the curve (AUC) = 0.84, p &lt; 0.001). When these findings were applied to the test dataset, the AUC was 0.75 (p &lt; 0.001), with 70% sensitivity and 80% specificity.</p><p><strong>Conclusion</strong>. The score developed in this study, based on clinical, angiographic and procedural features, can be used with acceptable accuracy to predict no-reflow in STEMI patients treated by PCI.</p><p>Received 29 August 2019. Revised 25 March 2020. Accepted 16 April 2020.</p><p><strong>Funding:</strong> The study did not have sponsorship.</p><p><strong>Conflict of interest:</strong> Authors declare no conflict of interest.</p>

Mechanical and Pharmacological Revascularization Strategies for Prevention of Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction: Analysis from Index of Microcirculatory Resistance Registry Data

Objectives. We aimed to identify mechanical and pharmacological revascularization strategies correlated with the index of microcirculatory resistance (IMR) in ST-elevation myocardial infarction (STEMI) patients. Background. Microvascular dysfunction (MVD) after STEMI is correlated with infarct size and poor long-term prognosis, and the IMR is a useful analytical method for the quantitative assessment of MVD. However, therapeutic strategies that can reliably reduce MVD remain uncertain. Methods. Patients with STEMI who underwent primary percutaneous coronary intervention (PCI) were enrolled. The IMR was measured with a pressure sensor/thermistor-tipped guidewire immediately after primary PCI. High IMR was defined as values ≥66th percentile of IMR in enrolled patients (IMR > 30.9 IU). Results. A total of 160 STEMI patients were analyzed (high IMR = 54 patients). Clinical factors for Killip class P=0.006, delayed hospitalization from symptom onset P=0.004, peak troponin-I level P=0.042, and multivessel disease P=0.003 were associated with high IMR. Achieving final thrombolysis in myocardial infarction myocardial perfusion grade 3 tended to be associated with low IMR P=0.119, whereas the presence of distal embolization was significantly associated with high IMR P=0.034. In terms of therapeutic strategies that involved adjusting clinical and angiographic factors associated with IMR, preloading of third-generation P2Y12 inhibitors correlated with reducing IMR value (β = −10.30, P<0.001). Mechanical therapeutic strategies including stent diameter/length, preballoon dilatation, direct stenting, and thrombectomy were not associated with low IMR value (all P>0.05), and postballoon dilatation was associated with high IMR (β = 8.30, P=0.020). Conclusions. In our study, mechanical strategies were suboptimal in achieving myocardial salvage. Preloading of third-generation P2Y12 inhibitors revealed decreased IMR value, indicative of MVD prevention.