Drug-Coated Balloon-Only Angioplasty Outcomes in Diabetic and Nondiabetic Patients with De Novo Small Coronary Vessels Disease

Background. The revascularization of small vessels using drug-eluting stents remains challenging. The use of the drug-coated balloon is an attractive therapeutic strategy in de novo lesions in small coronary vessels, particularly in the diabetic group. This study aimed to assess the outcomes of DCB-only angioplasty in small vessel disease. Methods. A total of 1198 patients with small vessel disease treated with DCB-only strategy were followed. Patients were divided into the diabetic and nondiabetic groups. Clinical and angiographical follow-up were organized at 12 months. The primary endpoints were target lesion failure and secondary major adverse cardiac events. Results. There was a significantly higher rate of target lesion failure among diabetic patients compared to nondiabetic [17 (3.9%) vs. 11 (1.4%), P = 0.006 ], taken separately, the rate of target lesion revascularization significantly differed between groups with a higher rate observed in the diabetic group [9 (2%) vs. 4 (0.5%), P = 0.014 ]. Diabetes mellitus remained an independent predictor for TLF (HR: 2.712, CI: 1.254–5.864, P = 0.011 ) and target lesion revascularization (HR: 3.698, CI: 1.112–12.298, P = 0.033 ) after adjustment. However, no significant differences were observed between groups regarding the target vessel myocardial infarction (0.6% vs. 0.1%, P = 0.110 ) and MACE [19 (4.4%) vs. 21 (2.7%), P = 0.120 ]. Conclusion. Drug-coated balloon-only treatment achieved lower incidence rates of TLF and MACE. Diabetes is an independent predictor for target lesion failure and target lesion revascularization at one year following DCB treatment in small coronary vessels. We observed no significant differences between groups regarding MACE in one year.

Managing bifurcations: are two stents better than one?

Introduction Bifurcation percutaneous coronary intervention (PCI) is associated with a higher degree of complexity when compared with non-bifurcation procedures. Although 1-stent PCI remains the standard approach for most bifurcation lesions, data is constantly being published on 2-stent PCI. Aim To evaluate and compare the characteristics and outcomes of patients that underwent bifurcation PCI with one or two stents. Methods Single center, retrospective observational study including all patients who underwent bifurcation PCI between January 2015-December 2018. We defined two groups: 1-stent PCI group (1s-PCI) and 2-stent PCI group (2s-PCI). The 2s-PCI group included PCI patients with all the different techniques used in our center: provisional stenting with 2 stents, Cullote, crushing stent and DK Crush. Results 1s-PCI group included 376 individuals and 2s-PCI group included 26. Overall baseline clinical characteristics were balanced between groups. There was no statistically significant difference in age (mean 64 vs 66; p=0.388), gender (79% vs 85% males; p=0.622) and comorbidities (hypertension, diabetes mellitus, hypercholesterolemia, chronic kidney disease, smoking and previous history of coronary artery disease). Also, there was no difference in clinical status (NSTEMI 36% vs 38%; stable disease 32% vs 42%; STEMI 28% vs 19%; unstable angina 5% vs 0%; p=0.419). Coronary angiography and lesion distribution were similar in both groups (p=0.367). However, radiation dose (median 90.5 [IQR=79] vs 156 [IQR=84] mGy cm2; p<0,001) and contrast volume (median 150 [IQR=100] vs 156 [IQR=83] ml; p<0,001) were significantly higher in 2s-PCI group. At 12-month follow-up, mortality rate was higher in 1s-PCI group, but without statistical significance (8% vs 4%; p=0.71); the same is true for acute myocardial infarction at 12 months (3% vs 0%; p=0.368). Target-lesion failure was only reported in 4 patients in the 1s-PCI group. Survival tests showed no significant difference between groups (χ2(1,n=402)=0.634; p=0.426). Conclusion Individuals that underwent 1s-PCI were overall similar to those who underwent 2s-PCI. Predictably, deploying more than 1 stent required more contrast volume and implied a higher radiation dose. We should note that our studied is greatly limited by the 2s-PCI group size, which may justify the lack of difference in the evaluated outcomes. FUNDunding Acknowledgement Type of funding sources: None.

Five Years Sustained Clinical Safety and Efficacy of An Abluminal Biodegradable-Polymer Coated Sirolimus-Eluting Stent: A Randomized Controlled Trial

Background Drug-eluting stent (DES) with durable polymers have been proven to cause late or very late adverse events. Biodegradable polymer-coated DES was developed to address the risk by avoiding persistent inflammatory irritation from persistent polymers. However, it is unknown whether the benefits of biodegradable polymer DES will occur over longer time. Methods The trial was a prospective, multicenter and randomized non-inferiority clinical trial done in China. Patients with indications for stent implantation were assigned into Cordimax and Xience V group in a 2:1 allocation. The composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularisation (CI-TLR) was the primary endpoint target lesion failure (TLF). The pre-specified endpoint at five years was major adverse cardiac event (MACE) which was defined as a composite of all-cause death, non-fatal myocardial infarction (MI), and CI-TLR. Results 3266 patients (88.3%) completed 5-year follow-up. No difference was observed for TLF between Cordimax (7.5%) and Xience V (8.3%) group (RR: 0.90, 95% CI: 0.70 to 1.15, P = 0.39). MACE occurred in 280 patients (11.4%) in Cordimax group and 162 patients (13.1%) in Xience V group (RR: 0.85, 95% CI: 0.69 to 1.05, P = 0.13). The incidence of definite or probable stent thrombosis did not differ in both groups (Cordimax 0.7%, Xience V 0.9%; RR: 0.78, 95% CI: 0.36 to 1.66; P = 0.51). Conclusion The biodegradable polymer Cordimax stent showed a comparable result to the durable polymer Xience V stent at 5 years, showing its long-term safety and efficacy performance. Trial registration: This study is registered with ClinicalTrials.gov, number NCT03185221 (14/06/2017).

Sex Differences in the Clinical Features and Outcomes of Patients with Acute Coronary Syndrome Treated with Two Generations (Absorb and Magmaris) of Bioresorbable Vascular Scaffolds

Background: Despite the developments in percutaneous coronary interventions (PCI), women are still more likely than men to have unfavorable outcomes after PCI performed in Acute Coronary Syndrome (ACS). The mechanisms of this phenomena are not fully understood. Potential benefits of bioresorbable scaffolds (BRS) may be particularly expressed in the female population. Nevertheless, the data available currently are inconsistent and limited. This study evaluated the gender-related differences in the short-term clinical outcomes in ACS patients treated with implantation of two generations of BRS (first generation, Absorb; second generation, Magmaris). Methods: The study was divided into two arms. To the first one, we qualified 160 patients with ACS treated with PCI who received 210 Absorb scaffolds. The second arm was composed of 193 patients with ACS who underwent PCI with Magmaris implantation. Results: There were no significant sex-related differences in primary endpoints (cardiovascular-death, myocardial infarction, in-stent thrombosis) or principal secondary endpoints (of target-lesion failure, scaffold restenosis, death from any reason, other cardiovascular events) in either generation of BRS in a 1-year follow-up. Conclusions: Both genders tended to have a similar outcome in routine clinical practice following BRS implantation due to ACS. The magnesium bioresorbable scaffold (Magmaris) early outcome seemed to be more favorable in comparison to the Absorb scaffold.

Optical coherence tomography tissue coverage and characterization at six months after implantation of bioresorbable scaffolds versus conventional everolimus eluting stents in the ISAR-Absorb MI trial

Purpose Data regarding vessel healing by optical coherence tomography (OCT) after everolimus-eluting bioresorbable scaffolds (BRS) or everolimus-eluting metallic stent (EES) implantation in acute myocardial infarction (AMI) patients is scarce. We compared OCT findings after BRS or EES implantation in patients with AMI enrolled in a randomized trial. Methods In ISAR-Absorb MI, AMI patients were randomized to BRS or EES implantation, with 6–8 month angiographic follow-up. This analysis includes patients who underwent OCT during surveillance angiography. Tissue characterization was done using grey-scale signal intensity analysis. The association between OCT findings and target lesion failure (TLF) at 2 years was investigated. Results OCT was analyzed in 103 patients (2237 frames, 19,827 struts) at a median of 216 days post-implantation. Of these, 70 were treated with BRS versus 32 with EES. Pre-(92.8 vs. 68.7%, p = 0.002) and post-dilation (51.4 vs. 12.5%, p < 0.001) were more common in BRS as compared to EES. Strut coverage was higher in BRS vs. EES (97.5% vs. 90.9%, p < 0.001). Mean neointimal thickness was comparable in both groups [85.5 (61.9, 124.1) vs. 69.5 (32.7, 127.5) µm, respectively, p = 0.20]. Mature neointimal regions were numerically more common in BRS (43.0% vs. 24.6%; p = 0.35); this difference was statistically significant in ST-elevation myocardial infarction patients (40.9% vs. 21.1%, p = 0.03). At two-years, 8 (7.8%) patients experienced TLF. Mean neointimal area [0.61 (0.21, 1.33) vs. 0.41 (0.11, 0.75) mm2, p = 0.03] and mean neointimal coverage [106.1 (65.2, 214.8) vs. 80.5 (53.5, 122.1) µm, p < 0.01] were higher, with comparable tissue maturity, in lesions with versus without TLF. Conclusions In selected patients who underwent OCT surveillance 6–8 months after coronary intervention for AMI with differing implantation characteristics depending on the device type used, vessel healing was more advanced in BRS compared with EES, particularly in the STEMI subgroup.

Better vascular healing of ultrathin strut biodegradable-polymer sirolimus-eluting stents in patients with acute coronary syndrome

This study aimed to compare the strut coverage between Orsiro ultrathin struts biodegradable polymer sirolimus-eluting stents (O-SES) and Xience thin struts durable polymer everolimus-eluting stents (X-EES) in acute coronary syndrome (ACS) patients using optical coherence tomography (OCT). In BIOSTEMI trial, O-SESs were superior to X-EESs with respect to target lesion failure (TLF) in ACS patients. However, there were few reports comparing intravascular imaging between the two stents in ACS. Between August 2016 and February 2020, 50 lesions from 50 ACS patients who underwent OCT-guided percutaneous coronary intervention (PCI) were enrolled. We compared mid-term vascular healing using OCT between O-SESs and X-EESs at 8-month after stenting. The protocol was approved by the Osaka Rosai Hospiral ethics committee. Among 50 lesions, the X-EES group consisted of 25 lesions and the O-SES of 25 lesions. The percentage of covered strut, the percentage of malapposed strut and mean neointimal thickness at 8-month were evaluated. In the 8-month OCT analysis, the proportion of covered strut was significantly higher in the O-SES group than in in the X-EES group (97.3% vs. 86.0%; p = 0.001). On the other hand, there were no significant differences in the frequency of malapposed strut (0.4% vs 1.0%, p = 0.238). The O-SES group had the tendency of thinner neointima compared to the X-EES group (60µm vs 76µm, p = 0.089). Compared to X-EESs, O-SESs showed better mid-term vascular healing and tended to have thinner neointima in ACS patients. Ultra-thin strut may play a key role in better vascular healing.

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.

Early-, Late-, and Very Late-Term Prediction of Target Lesion Failure in Coronary Artery Stent Patients: An International Multi-Site Study

The main intervention for coronary artery disease is stent implantation. We aim to predict post-intervention target lesion failure (TLF) months before its onset, an extremely challenging task in clinics. This post-intervention decision support tool helps physicians to identify at-risk patients much earlier and to inform their follow-up care. We developed a novel machine-learning model with three components: a TLF predictor at discharge via a combination of nine conventional models and a super-learner, a risk score predictor for time-to-TLF, and an update function to manage the size of the at-risk cohort. We collected data in a prospective study from 120 medical centers in over 25 countries. All 1975 patients were enrolled during Phase I (2016–2020) and were followed up for five years post-intervention. During Phase I, 151 patients (7.6%) developed TLF, which we used for training. Additionally, 12 patients developed TLF after Phase I (right-censored). Our algorithm successfully classifies 1635 patients as not at risk (TNR = 90.23%) and predicts TLF for 86 patients (TPR = 52.76%), outperforming its training by identifying 33% of the right-censored patients. We also compare our model against five state of the art models, outperforming them all. Our prediction tool is able to optimize for both achieving higher sensitivity and maintaining a reasonable size for the at-risk cohort over time.

The 1-Year Safety and Efficacy Outcomes of Magmaris, Novel Magnesium Bioresorbable Vascular Scaffolds in Diabetes Mellitus Patients with Acute Coronary Syndrome

Background: Diabetes mellitus (DM) is one of the major risk factors contributing to Acute Coronary Syndromes (ACS) and is associated with an increased risk of adverse clinical outcomes following percutaneous coronary intervention (PCI), even when the second generation of drug-eluting stents (DES) is used. In order to overcome the disadvantages of permanent caging of a vessel with metallic DES, bioresorbable scaffold (BRS) technology has been recently developed. However, the prognosis of patients with DM and ACS treated with PCI via subsequent implantation of Magmaris (Biotronik, Berlin, Germany)—a novel magnesium-bioresorbable scaffold—is poorly investigated. Methods: A total of 193 consecutive subjects with non-ST elevation acute coronary syndrome (NSTE-ACS) who, from October 2016 to March 2020, received one or more Magmaris scaffolds were enrolled in this study. The diabetic group was compared with non-diabetic subjects. Results: There were no significant differences in the occurrence of primary endpoints (cardiovascular death, myocardial infarction, and in-stent thrombosis) and principal secondary endpoints (target-lesion failure, scaffold restenosis, death from any reason, and other cardiovascular events) between the two compared groups in a 1-year follow-up period. Conclusions: The early 1-year-outcome of magnesium bioresorbable scaffold (Magmaris) seems to be favorable and suggests that this novel BRS is safe and effective in subjects with NSTE-ACS and co-existing DM.