Ten-Year Outcome of Recanalization or Medical Therapy for Concomitant Chronic Total Occlusion After Myocardial Infarction.

BACKGROUND: The EXPLORE (Evaluating Xience and Left Ventricular Function in PCI on Occlusions After STEMI) trial was the first and only randomized trial investigating chronic total occlusion (CTO) percutaneous coronary intervention (PCI) early after primary PCI for ST-segment-elevation myocardial infarction, compared with medical therapy for the CTO. We performed a 10-year follow-up of EXPLORE to investigate long-term safety and clinical impact of CTO PCI after ST-segment-elevation myocardial infarction, compared with no-CTO PCI. METHODS AND RESULTS: In EXPLORE, 302 patients post-ST-segment-elevation myocardial infarction with concurrent CTO were randomized to CTO PCI within ≈1 week or no-CTO PCI. We performed an extended clinical follow-up for the primary end point of major adverse cardiac events, consisting of cardiovascular death, coronary artery bypass grafting, or myocardial infarction. Secondary end points included all-cause death, angina, and dyspnea. Median follow-up was 10 years (interquartile range, 8-11 years). The primary end point occurred in 25% of patients with CTO PCI and in 24% of patients with no-CTO PCI (hazard ratio [HR], 1.11 [95% CI, 0.70-1.76]). Cardiovascular mortality was higher in the CTO PCI group (HR, 2.09 [95% CI, 1.10-2.50]), but all-cause death was similar (HR, 1.53 [95% CI, 0.93-2.50]). Dyspnea relief was more frequent after CTO PCI (83% versus 65%, P=0.005), with no significant difference in angina. CONCLUSIONS: This 10-year follow-up of patients post-ST-segment-elevation myocardial infarction randomized to CTO PCI or no-CTO PCI demonstrated no clinical benefit of CTO PCI in major adverse cardiac events or overall mortality. However, CTO PCI was associated with a higher cardiovascular mortality compared with no-CTO PCI. Our long-term data support a careful weighing of effective symptom relief against an elevated cardiovascular mortality risk in CTO PCI decisions. REGISTRATION: URL: https://www.trialregister.nl; Unique identifier: NTR1108.

Open surgical retrieval of a migrated patent foramen ovale closure device from the descending aorta following failed percutaneous retrieval from the aortic arch: a case report with a word of caution.

Background: Percutaneous patent foramen ovale (PFO) closure is considered safe and has been used widely for over 25 years. A rare but potentially life-threatening complication is device migration, especially to the aorta. Case summary: We present a 30-year-old male with a PFO occlusion device implanted for cryptogenic stroke, which asymptomatically migrated to the aortic arch. A percutaneous retrieval attempt failed at complete removal but relocated the device to the proximal descending aorta. It was then successfully removed by open surgery. Severe intimal damage necessitated resection and interposition grafting. Discussion: Manipulation of migrated intravascular devices can cause intimal damage and subsequent complications, such as local dissections. We advocate caution with percutaneous removal of such large, migrated closure devices to avoid additional intimal damage, especially after endothelialization has occurred. The interventional cardiologist should be aware of the risk of intimal damage as a result, and surgical removal, though invasive, should always be considered.

Predictors and outcomes of procedural failure of percutaneous coronary intervention of a chronic total occlusion-A subanalysis of the EXPLORE trial.

OBJECTIVE: To evaluate predictors of procedural success of percutaneous coronary intervention (PCI) of chronic total coronary occlusions (CTOs) in a non-infarct-related artery following ST-segment elevation myocardial infarction (STEMI), and demonstrate the effect on left ventricular functionality (LVF), infarct size (IS), and pro-arrhythmic electrocardiogram (ECG) parameters. BACKGROUND: Predictors of unsuccessful revascularization of a CTO are numerous, although following STEMI, these are lacking. Besides, effects of failed CTO PCI (FPCI) on the myocardium are unknown. METHODS: This is a subanalysis of the EXPLORE trial, in which 302 STEMI patients with a concurrent CTO were randomized to CTO PCI (n = 147) or no-CTO PCI (NPCI, n = 154). For the purpose of this subanalysis, we divided patients into successful CTO PCI (SPCI, n = 106), FPCI (n = 41), and NPCI (n = 154) groups. Cardiac magnetic resonance imaging and angiographic data were derived from the EXPLORE database, combined with ECG parameters. To gain more insight, all outcomes were compared with patients that did not undergo CTO PCI. RESULTS: In multivariate regression, only CTO lesion length >20 mm was an independent predictor of procedural failure (OR 3.31 [1.49-7.39]). No significant differences in median left ventricular ejection fraction, left ventricular end-diastolic volume, IS, and the pro-arrhythmic ECG parameters such as QT-dispersion, QTc-time, and TpTe-intervals were seen between the SPCI and FPCI groups at 4 months follow-up. CONCLUSION: This subanalysis of the EXPLORE trial has demonstrated that a CTO lesion length >20 mm is an independent predictor of CTO PCI failure, whereas procedural failure did not lead to any adverse effects on LVF nor pro-arrhythmic ECG parameters.

Microtransesophageal Echocardiographic Guidance during Percutaneous Interatrial Septal Closure without General Anaesthesia.

OBJECTIVE: To study the safety and efficacy of microtransesophageal echocardiography (micro-TEE) and TEE during percutaneous atrial septal defect (ASD) and patent foramen ovale (PFO) closure. BACKGROUND: TEE has proven to be safe during ASD and PFO closure under general anaesthesia. Micro-TEE makes it possible to perform these procedures under local anaesthesia. We are the first to describe the safety and efficacy of micro-TEE for percutaneous closure. METHODS: All consecutive patients who underwent ASD and PFO closure between 2013 and 2018 were included. The periprocedural complications were registered. Residual shunts were diagnosed using transthoracic contrast echocardiography (TTCE). All data were compared between the use of TEE or micro-TEE within the ASD and PFO groups separately. RESULTS: In total, 82 patients underwent ASD closure, 46 patients (49.1 ± 15.0 years) with TEE and 36 patients (47.8 ± 12.1 years) using micro-TEE guidance. Median device diameter was, respectively, 26 mm (range 10-40 mm) and 27 mm (range 10-35 mm). PFO closure was performed in 120 patients, 55 patients (48.6 ± 9.2 years, median device diameter 25 mm, range 23-35 mm) with TEE and 65 patients (mean age 51.0 ± 11.8 years, median device diameter 27 mm, range 23-35 mm) using micro-TEE. There were no major periprocedural complications, especially no device embolizations within all groups. Six months after closure, there was no significant difference in left-to-right shunt after ASD closure and no significant difference in right-to-left shunt after PFO closure using TEE or micro-TEE. CONCLUSION: Micro-TEE guidance without general anaesthesia during percutaneous ASD and PFO closure is as safe as TEE, without a significant difference in the residual shunt rate after closure.

A "minimalistic hybrid algorithm" in coronary chronic total occlusion revascularization: Procedural and clinical outcomes.

BACKGROUND: Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual-access and large bore catheters, with trans-femoral approach adoption in most cases. OBJECTIVES: Aim of this manuscript is to describe the outcomes of an alternative hybrid algorithm, called "Minimalistic Hybrid Algorithm," which has the purpose to minimize the use of double access, large bore catheters, and femoral approach in order to minimize the risk of vascular complications and patient's discomfort, without compromising efficacy. METHODS: In this single-center registry, a "minimalistic" approach was attempted in consecutive patients undergoing CTO PCI between March 2016 and October 2017. Data regarding the applicability of this algorithm and the related procedural success rates were collected, together with common demographic and angiographic characteristics. RESULTS: Of the 100 CTO PCI performed in the study period, 91(91%) were successfully approached according to the novel algorithm. Mean J-CTO score of all minimalistic procedures was 1.9 ± 1.2, with 31(34%) patients presenting with J-CTO score ≥3. In 52 procedures, the approach consisted of single-catheter access, 49(94.2%) of which were trans-radial. Out of the 39 patients approached with dual-catheters, 26(69.2%) were biradial, and 8(21%) radial-femoral. Procedural success in patients approached with the minimalistic algorithm was 89%, in line with the results of large-multicenter experiences nowadays available. CONCLUSIONS: Our results show that an alternative algorithm limiting the routine use of large bore catheters and trans-femoral approach is feasible in the clinical practice and yields good procedural outcomes.

Angiographic and clinical outcomes of antegrade versus retrograde techniques for chronic total occlusion revascularizations: Insights from the PRISON IV trial.

OBJECTIVES: Available data indicate mixed outcomes after using retrograde techniques for chronic total occlusion(CTO) recanalization, with generally higher need for repeat revascularization. Aim of this study is to analyze the angiographic and clinical outcome of patients treated with retrograde techniques in the PRISON-IV trial. METHODS AND RESULTS: This is a post-hoc sub-analysis from the randomized PRISON-IV trial. Briefly, 330 patients with a successfully recanalized CTO lesion were randomized 1:1 to receive either hybrid-SES or EES. The hybrid-SES failed to reach the non-inferiority primary endpoint of in-segment late lumen loss at 9-month angiography follow-up. In the present analysis, we divided the population according to the first technical approach, namely antegrade (n = 285) or retrograde approach (n = 45). Demographic characteristics were similar between the two groups, while angiographic features disclosed higher CTO lesion complexity in the group treated with retrograde techniques (J-CTO score: 1.8 ± 1.1 vs 2.6 ± 1.1, respectively, P < 0.001), with longer occlusions (17.6 ± 10 mm vs 28.8 ± 18.7 mm, P < 0.001) and longer stented segment (48.9 ± 24.4 mm vs 73.1 ± 33.2 mm, P < 0.001). Quantitative coronary analysis disclosed similar results at follow-up angiography, with a non-significantly higher in-stent late-lumen loss in the retrograde group (0.08 ± 0.52 mm vs 0.18 ± 0.56 mm, P = 0.32). Clinical follow-up at 12-months showed similar outcome, with a non-significantly higher target-lesions revascularization rate in the retrograde group (6% vs 11.1% respectively, P = 0.2). Significant improvements in angina functional class were observed in both groups. CONCLUSIONS: The present analysis supports the benefits of retrograde techniques in CTO revascularization, with non-significant differences in angiographic and clinical outcomes at late follow-up.

Long-term results of carotid stenting and risk factors in patients with severe carotid artery stenosis undergoing subsequent cardiac surgery.

AIMS: To identify risk factors for composite outcome of mortality, stroke or myocardial infarction in patients with severe carotid stenosis undergoing staged carotid artery stenting (CAS) with subsequent cardiac surgery. METHODS AND RESULTS: In this prospective observational study, we enrolled 643 consecutive patients with both symptomatic (i.e., with history of stroke) and asymptomatic severe carotid artery disease, who required cardiac surgery. Generally, cardiac surgery was planned 30 days after the CAS procedure. The composite outcome consisted of death, stroke and myocardial infarction. The composite outcome rate was 26.3% at 5 years and 47% at 8 years after CAS. Age ≥ 80 years (hazard ratio [HR] = 1.89; 95%CI, 1.18-3.03; P = 0.008), history of stroke (HR = 1.66, 1.16-2.37; P = 0.006), chronic obstructive pulmonary disease (HR = 1.86; 1.07-3.24; P = 0.03) and kidney disease (HR = 1.83, 1.11-3.04; P = 0.02) were independent risk factors for the composite outcome during long-term follow-up. CONCLUSIONS: In this study with staged CAS followed by cardiac surgery, we confirm previously reported event-free survival rates and identify several risk factors for the composite outcome. Future studies are needed to confirm the importance of the identified risk factors and to assess their predictive ability.

Implementing a minimally invasive approach (combining radial approach, small guiding catheters and minimization of double access) for coronary chronic total occlusion intervention according to the hybrid algorithm: The Minimalistic Hybrid Algorithm.

Percutaneous recanalization of coronary chronic total occlusions (CTOs) traditionally relies on the use of dual access and large bore catheters, with trans-femoral approach adoption in most of the cases. Aim of this manuscript is to describe an alternative algorithm, that we called "Minimalistic Hybrid Algorithm", in order to minimize the use of double access, large bore catheters, and femoral approach thus reducing patient's discomfort and possibly procedural complications. This algorithm can be interpreted as an evolution of the classic "Hybrid Algorithm" and requires the operator to be confident with all techniques known in this conventional algorithm. Indeed, all possible techniques and approaches of the conventional hybrid approach to treat CTOs are included in a novel diagram for procedural strategy, which offers an alternative sequence of steps to limit, whenever possible, the invasiveness of the procedure. After dividing the cases in "simple" or "complex" CTO lesions according to the available complexity scores and to the "feeling", knowledge and expertise of the operator, a systematic description of the procedural steps is provided. This includes antegrade and retrograde approaches, as well as sub-intimal and intra-luminal techniques, in order to maintain the simpler single-catheter transradial strategies in the first line for the simple CTO, and the adoption of more complex, double access and transfemoral ones in the further steps. The minimalistic hybrid algorithm herein described is a possible alternative sequence of steps in the setting of CTO recanalization, with the potential of limiting the use of double access, large bore catheters, and femoral approach.

Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient-years of follow up.

OBJECTIVE: To evaluate the safety and efficacy of the Occlutech patent foramen ovale (PFO) device at long-term follow-up (FU). BACKGROUND: The Occlutech device has been proven safe and effective six-months after percutaneous PFO closure. We describe the safety and efficacy after more than 1,300 patient-years of FU. METHODS: All consecutive patients who underwent PFO closure between October 2008 and December 2015 were included. All complications were registered. Residual right-to-left shunt (RLS) was diagnosed using contrast transthoracic echocardiography and graded as minimal, moderate, or severe. RESULTS: In total, 250 patients (mean age 53.5 ± 10.7 years, 46.8% female) underwent percutaneous PFO closure using the Occlutech device. Mean FU was 5.9 ± 1.8 years, a total of 1,345 patient-years. Transient ischemic attack (TIA) or stroke was the main indication for closure (89.6%). Implantation was successful in 100%, no major complications occurred. Minor complications were inguinal hematoma in 16 patients (6.4%), pericardial effusion without the need for intervention in one patient (0.4%) and a supraventricular tachycardia in one patient (0.4%). A moderate or large shunt at one-year follow up was present in 5.9%. A cerebrovascular vascular event occurred in 2.0% at 1-year FU (four TIA, one stroke) and in 7.4% at long-term FU (nine TIA, eight stroke). The total cerebrovascular event rate (TIA and CVA) was 0.02% per patient-year of FU, with a stroke rate of 0.01%. CONCLUSION: The Occlutech device appears to be safe at long-term FU with a very low annual cerebrovascular event rate and a low moderate to large shunt rate at 1-year FU.

The effect of revascularization of a chronic total coronary occlusion on electrocardiographic variables. A sub-study of the EXPLORE trial.

INTRODUCTION: Chronic total coronary occlusions (CTOs) have been associated with a higher prevalence of ventricular arrhythmias compared to patients without a CTO. We evaluated the effect of CTO revascularization on electrocardiographic (ECG) variables. METHODS: We studied a selection of ST-elevation myocardial infarction patients with a concomitant CTO enrolled in the EXPLORE trial. ECG variables and cardiac function were analysed at baseline and at 4 months follow-up. RESULTS: Patients were randomized to percutaneous coronary intervention (PCI) of their CTO (n = 77) or to no-CTO PCI (n = 81). At follow-up, median QT dispersion was significantly lower in the CTO PCI group compared to the no-CTO PCI group (46 ms [33-58] vs. 54 ms [37-68], P = 0.043). No independent association was observed between ECG variables and cardiac function. CONCLUSION: Revascularization of a CTO after STEMI significantly shortened QT dispersion at 4 months follow-up. These findings support the hypothesis that CTO revascularization reduces the pro-arrhythmic substrate in CTO patients.

Impact of collateralisation to a concomitant chronic total occlusion in patients with ST-elevation myocardial infarction: a subanalysis of the EXPLORE randomised controlled trial.

Objective: The impact on cardiac function of collaterals towards a concomitant chronic total coronary occlusion (CTO) in patients with ST-elevation myocardial infarction (STEMI) has not been investigated yet. Therefore, we have evaluated the impact of well-developed collaterals compared with poorly developed collaterals to a concomitant CTO in STEMI. Methods and results: In the EXPLORE trial, patients with STEMI and a concomitant CTO were randomised to either CTO percutaneous coronary intervention (PCI) or no-CTO PCI. Collateral grades were scored angiographically using the Rentrop grade classification. Left ventricular ejection fraction (LVEF) and left ventricular end-diastolic volume (LVEDV) at 4 months were measured using cardiac magnetic resonance imaging. Well-developed collaterals (Rentrop grades 2-3) to the CTO were present in 162 (54%) patients; these patients had a significantly higher LVEF at 4 months (46.2±11.4% vs 42.1±12.7%, p=0.004) as well as a trend for a lower LVEDV (208.2±55.7 mL vs 222.6±68.5 mL, p=0.054) when compared with patients with poorly developed collaterals to the CTO. There was no significant difference in the total amount of scar in the two groups. Event rates were statistically comparable between patients with well-developed collaterals and poorly developed collaterals to the CTO at long-term follow-up. Conclusions: In patients with STEMI and a concomitant CTO, the presence of well-developed collaterals to a concomitant CTO is associated with a better LVEF at 4 months. However, this effect on LVEF did not translate into improvement in clinical outcome. Therefore, the presence of well-developed collaterals is important, but should not solely guide in the clinical decision-making process regarding any additional revascularisation of a concomitant CTO in patients with STEMI. Clinical trial registration: NTR1108.

Impact of ultra-thin struts on restenosis after chronic total occlusion recanalization: Insights from the randomized PRISON IV trial.

OBJECTIVES: The PRISON-IV trial showed inferior outcome in patients with chronic total occlusions (CTOs) treated with the ultrathin-struts (60 µm for stent diameter ≤3 mm, 81µm >3 mm) hybrid-sirolimus eluting stents (SES) compared with everolimus eluting stents (EES, 81 µm). The aim of this study is to investigate if the use of smaller stents (≤3 mm) was responsible for the inferior outcome reported in the trial. METHODS: In the PRISON-IV trial 330 patients with CTO lesion were randomized 1:1 to receive either hybrid-SES or EES. The hybrid-SES failed to reach the non-inferiority primary endpoint of in-segment late lumen loss (LLL) at 9-month angiographic follow-up. In this sub-analysis, we divided the population according to the different size of stents implanted in those receiving only stents with diameter ≤3 mm (Group-A, 178 patients), only stents >3 mm (Group-B, 59 patients), and those receiving stents of both sizes (Group-C, 93 patients). RESULTS: Baseline and procedural characteristics were comparable in the three groups. At angiographic follow-up, most of the adverse outcomes occurred in Group A, with higher incidence of binary restenosis in the Hybrid-SES versus EES (10.3% vs 1.3%, P = 0.03) and augmented in-stent diameter stenosis (26.04 ± 18.59% vs 21.24 ± 12.84, P = 0.06). Similarly, optical coherence tomography (OCT), which was performed in 60 patients at follow-up, documented a mild trend toward lower values of minimum in stent area in Hybrid-SES arm of Group A (4.4 ± 1.02mm2 vs 5.0 ± 1.28mm2, respectively, P = 0.16). CONCLUSIONS: The present analysis suggests that the inferior performance of the ultra-thin hybrid-SES in CTO-PCI is particularly pronounced when smaller stent (≤3 mm diameter) are adopted, if compared with EES.

Long-term impact of chronic total occlusion recanalisation in patients with ST-elevation myocardial infarction.

BACKGROUND: During primary percutaneous coronary intervention (PCI), a concurrent chronic total occlusion (CTO) is found in 10% of patients with ST-elevation myocardial infarction (STEMI). Long-term benefits of CTO-PCI have been suggested; however, randomised data are lacking. Our aim was to determine mid-term and long-term clinical outcome of CTO-PCI versus CTO-No PCI in patients with STEMI with a concurrent CTO. METHODS: The Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) was a multicentre randomised trial that included 302 patients with STEMI after successful primary PCI with a concurrent CTO. Patients were randomised to either CTO-PCI or CTO-No PCI. The primary end point of the current study was occurrence of major adverse cardiac events (MACE): cardiac death, coronary artery bypass grafting and MI. Other end points were 1-year left ventricular function (LVF); LV-ejection fraction and LV end-diastolic volume and angina status. RESULTS: The median long-term follow-up was 3.9 (2.1-5.0) years. MACE was not significantly different between both arms (13.5% vs 12.3%, HR 1.03, 95% CI 0.54 to 1.98; P=0.93). Cardiac death was more frequent in the CTO-PCI arm (6.0% vs 1.0%, P=0.02) with no difference in all-cause mortality (12.9% vs 6.2%, HR 2.07, 95% CI 0.84 to 5.14; P=0.11). One-year LVF did not differ between both arms. However, there were more patients with freedom of angina in the CTO-PCI arm at 1 year (94% vs 87%, P=0.03). CONCLUSIONS: In this randomised trial involving patients with STEMI with a concurrent CTO, CTO-PCI was not associated with a reduction in long-term MACE compared to CTO-No PCI. One-year LVF was comparable between both treatment arms. The finding that there were more patients with freedom of angina after CTO-PCI at 1-year follow-up needs further investigation. CLINICAL TRIAL REGISTRATION: EXPLORE trial number NTR1108 www.trialregister.nl.

First report of the use of long-tapered sirolimus-eluting coronary stent for the treatment of chronic total occlusions with the hybrid algorithm.

BACKGROUND: Coronary chronic total occlusions (CTO) usually coexist with diffusely diseased coronary segments proximal and/or distal to the CTO segment. During percutaneous treatment of CTO, multiple overlapping stents are often needed to treat these long lesions. OBJECTIVES: Aim of this study is to report the first use of long, tapered coronary sirolimus-eluting stents (SES) in this setting. METHODS AND RESULTS: This is a retrospective analysis of 100 consecutive patients undergoing CTO recanalization following the hybrid algorithm. Procedural success rate was 89% (11 failures). Among the successful cases, "conventional" drug-eluting stents(DES) were used in 40(44.9%) patients, while in 49(55%) patients long-tapered SES were attempted with a success rate of 98% (1 cross-over to regular stents). Total stent length in the long-tapered DES group was higher compared to the "conventional" stenting group (76 ± 28 mm vs 46 ± 22 mm, P < .001), with a similar total number of stent (1.6 ± 0.8 vs 1.9 ± 0.8). At quantitative coronary analysis, proximal and distal segment involvement was more extended in patients undergoing long-tapered stenting, with longer overall lesion length. No differences in periprocedural complications and clinical outcomes at a mean follow-up of 303 ± 179 days were observed. CONCLUSIONS: The use of long tapered coronary DES is technically feasible and safe for the percutaneous treatment of CTOs, especially for patients presenting with long lesions.

Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation: An Angiographic and Optical Coherence Tomography TROFI II Substudy.

OBJECTIVES: This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES). BACKGROUND: Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes. METHODS: In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- and EES-treated patients stratified according to post-dilatation status. RESULTS: Primary percutaneous coronary intervention with post-dilatation was performed in 48 (50.5%) BRS- and 25 (25.5%) EES-treated lesions. There were no differences in baseline characteristics and post-procedural minimal lumen diameter between groups. In the BRS group, lesions with post-dilatation were associated with a trend toward a smaller minimal lumen area at 6 months (5.07 ± 1.68 mm2 vs. 5.72 ± 1.77 mm2; p = 0.09) and significantly larger angiographic late lumen loss (0.28 ± 0.34 mm vs. 0.12 ± 0.25 mm; p = 0.02), whereas no difference was observed in the EES arm (5.46 ± 2.18 mm2 vs. 5.55 ± 1.77 mm2; p = 0.85). The neointimal healing score was low and comparable between groups with and without post-dilation (BRS: 1.55 ± 2.61 vs. 1.92 ± 2.17; p = 0.48; EES: 2.50 ± 3.33 vs. 2.90 ± 4.80; p = 0.72). CONCLUSIONS: In the setting of selected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with BRS or EES, post-dilatation did not translate into larger lumen area or improved arterial healing at follow-up. (ABSORB STEMI: The TROFI II; NCT01986803).

Optical coherence tomography findings: insights from the "randomised multicentre trial investigating angiographic outcomes of hybrid sirolimus-eluting stents with biodegradable polymer compared with everolimus-eluting stents with durable polymer in chronic total occlusions" (PRISON IV) trial.

AIMS: The PRISON IV trial investigated the next-generation sirolimus-eluting stent (SES) with ultra-thin struts and biodegradable polymer against the second-generation everolimus-eluting stent (EES) with thin struts and durable polymer in patients with successfully recanalised chronic total occlusions (CTO). In this study, we examined the secondary optical coherence tomography endpoints. METHODS AND RESULTS: The main PRISON IV trial randomised 330 patients to either SES or EES. At nine months, 281 (85%) patients underwent repeat angiography. Of these, 60 consecutive patients received optical coherence tomography divided over both stent groups. The mean number of struts analysed was 750±337 and 633±358 in SES and EES patients, respectively (p=0.07). The minimal lumen area, minimal stent area, maximal neointima area and neointimal thickness were comparable between the groups (4.8±2.1 and 4.4±1.5 mm2; 5.3±1.8 and 5.3±1.4 mm2; 2.5±2.0 and 2.2±1.5 mm2; 0.7±1.7 and 0.4±0.2 mm). The percentage of uncovered struts was higher with EES (6.2±7.5% and 11.9±13.4%, p=0.04), whereas the percentage of malapposed struts and mean number of coronary evaginations were significantly higher with SES (2.9±4.0% and 1.2±2.4%, p=0.02; 18.5±17.7 and 5.3±3.1, p=0.004). CONCLUSIONS: The optical coherence tomography findings of this substudy demonstrated improved strut coverage with ultra-thin strut SES with bioresorbable polymer compared to thin-strut EES with durable polymer in CTO. On the other hand, SES showed a higher rate of stent strut malappositon and coronary evaginations. The clinical relevance of these findings remains to be demonstrated.