Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study.

OBJECTIVES: To evaluate the safety and efficacy of lesion preparation using rotational atherectomy (RA) with consecutive cutting balloon angioplasty (Rota-Cut). BACKGROUND: Whether the Rota-Cut combination improves stent performance in severely calcified coronary lesions is unknown. METHODS: PREPARE-CALC-COMBO is a single-arm prospective trial in which 110 patients were treated with a Rota-Cut strategy before implantation of sirolimus-eluting stents and compared with patients treated with modified balloon (MB, scoring or cutting) or RA from a historical cohort (the randomized PREPARE-CALC trial). The study had two primary endpoints: in-stent acute lumen gain (ALG) by quantitative angiographic analysis and stent expansion (SE) on optical coherence tomography. RESULTS: In-stent ALG was significantly higher with Rota-Cut compared to RA or MB alone (1.92 ± 0.45 mm vs. 1.74 ± 0.45 mm with MB vs. 1.70 ± 0.42 mm with RA; p = 0.001 and p < 0.001, respectively). SE was comparable between groups (75.1 ± 13.8% vs. 73.5 ± 13.3 with MB vs. 73.1 ± 12.2 with RA; p = 0.19 and p = 0.39, respectively). The Rota-Cut combination resulted in higher minimal stent area (MSA) (7.1 ± 2.2mm2 vs. 6.1 ± 1.7mm2  with MB vs. 6.2 ± 1.9mm2 with RA; p = 0.003 and p = 0.004, respectively). In-hospital death occurred in one patient. Target vessel failure at 9 months was low and comparable between groups (8.2% vs. 8% with MB vs. 6% with RA; p = 1 and p = 0.79, respectively). CONCLUSION: Rota-Cut combination resulted in higher ALG and larger MSA compared with historical control of RA or MB alone, but was not associated with higher SE. Despite extensive lesion preparation, this strategy is safe, feasible, and associated with favorable clinical outcome at 9 months.

Long-Term Outcomes after Rotational Atherectomy for Calcified Chronic Total Occlusion versus Nonchronic Total Occlusion Coronary Lesions.

Background: The role of rotational atherectomy (RA) in contemporary percutaneous coronary intervention (PCI) is expanding to include certain chronic total occlusion (CTO) lesions. However, the long-term outcome of RA in CTOs is still unclear. Objective: To investigate in-hospital and long-term outcomes after RA for CTO compared to non-CTO calcified lesions. Moreover, this report evaluates the role of the elective RA approach in calcified CTOs. Methods and Results: This study enrolled 812 patients (869 lesions; CTO, n = 80 versus non-CTO, n = 789). The mean age of the study population was 73.1 ± 8.6 years, the baseline characteristics were comparable in both groups. Balloon-resistant CTO lesions represented the main indication for RA in CTO patients (61.2%). The mean J-CTO score was 2.42 ± 0.95. The angiographic success rate was lower in CTO patients (88.8% vs 94.9%; p = 0.022). In-hospital major adverse cardiac events (MACE) rate was comparable in both groups (CTO 8.8% vs 7.0% in non-CTO;p = 0.557). At two-year follow-up, a higher target lesion failure (TLF) was observed in CTO group (25.5% vs 15.1%, log rank p = 0.041), driven by higher cardiac mortality while the clinically driven target lesion revascularisation (TLR) was comparable between the study groups. Elective RA for CTO had a shorter procedural time and lower rate of dissection (7.5% vs 25%; p = 0.030) compared to bail-out RA with similar long-term outcomes. Conclusion: Compared to non-CTO, RA for CTO can be performed with a high procedural success rate and comparable in-hospital outcomes. Apart from higher cardiac mortality in the CTO group, the long-term outcomes are comparable in both groups. Elective RA is a feasible and beneficial approach to be used in CTO intervention.

Impact of Prosthetic Valve Regurgitation Assessed by Echocardiography and Magnetic Resonance Imaging on Long-Term Clinical Outcomes after TAVR.

BACKGROUND: Prosthetic valve regurgitation (PVR) impairs early and mid-term outcomes after transcatheter aortic valve replacement (TAVR). We explored the impact of PVR assessed by transthoracic echocardiography (TTE) and magnetic resonance imaging-regurgitation fraction (MRI-RF) on long-term clinical outcomes. METHODS: PVR was assessed by TTE applying the Valve Academic Research Consortium criteria and MRI-RF (from velocity-encoded phase contrast magnetic resonance sequence) in 424 patients. RESULTS: MRI-RF correlated modestly with the echocardiographic grades of PVR (Spearman's rank correlation coefficient = 0.32, p < 0.001). Using an MRI-RF ≥20% to define ≥ moderate PVR, echocardiography and MRI-RF agreed on PVR classification in 412 patients (97.2%; kappa statistic = 0.56, p < 0.001). Five-year mortality or reintervention was higher in patients with echocardiographic ≥ moderate PVR (83.3% vs. 45.0%, log rank p value = 0.002; HR [95% CI]: 3.18 [1.48-6.84]) as well as in patients with MRI-RF ≥20% (79.3% vs. 43.2%, log rank p value <0.001; HR [95% CI]: 2.68 [1.53-4.70]), while the outcomes of patients with echocardiographic mild PVR were not significantly different from those with none-trace PVR. In the two latter groups (echocardiographic < moderate PVR), MRI-RF ≥20% was associated with a significantly higher 5-year mortality or reintervention as compared with MRI-RF <20% (79.5% vs. 42.2%, log rank p value = 0.023; HR [95% CI]: 2.26 [1.10-4.65]). CONCLUSIONS: Greater than mild PVR as defined by TTE or MRI-RF is associated with impaired long-term clinical outcomes after TAVR. MRI-RF can be used to further risk-stratify patients with echocardiographic less-than-moderate PVR.

Impact of Lesion Preparation Technique on Side Branch Compromise in Calcified Coronary Bifurcations: A Subgroup Analysis of the PREPARE-CALC Trial.

OBJECTIVES: To analyze the impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions. BACKGROUND: The impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions is poorly investigated. METHODS: We performed an as-treated analysis on 47 calcified bifurcation lesions treated with scoring/cutting balloons (SCB) and 68 lesions treated with rotational atherectomy (RA) in the PREPARE-CALC trial. Compromised side branch (SB) as assessed in the final angiogram was the primary outcome measure and was defined as any significant stenosis, dissection, or thrombolysis in myocardial infarction flow <3. RESULTS: True bifurcation lesions were present in 49% vs. 43% of cases in the SCB and RA groups, respectively. After stent implantation, SB balloon dilatation was necessary in around one-third of cases (36% vs. 38%; p = 0.82), and a two-stent technique was performed in 21.3% vs. 25% (p = 0.75). At the end of the procedure, the SB remained compromised in 15 lesions (32%) in the SCB group and 5 lesions (7%) in the RA group (p = 0.001). Large coronary dissections were more frequently observed in the SCB group (13% vs. 2%; p = 0.02). Postprocedural levels of cardiac biomarkers were significantly higher in patients with a compromised SB at the end of the procedure. CONCLUSIONS: In the PREPARE-CALC trial, side branch compromise was more frequently observed after lesion preparation with SCB as compared with RA. Consequently, in calcified bifurcation lesions, an upfront debulking with an RA-based strategy might optimize the result in the side branch.

Impact of prosthesis-iteration evolution and sizing practice on the incidence of prosthesis-patient mismatch after transcatheter aortic valve replacement.

OBJECTIVES: To investigate the impact of the introduction of the next generation self-expanding (SE) and balloon-expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). BACKGROUND: PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs. METHODS: PPM was assessed at 30 days post-TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363). RESULTS: The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95-0.99], P = 0.002), history of myocardial infarction (2.09 [1.00-4.34], P = 0.049), annulus maximum diameter (0.84 [0.77-0.92], P < 0.001), and THV oversizing (0.90 [0.87-0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23-8.53], P = 0.017 and 5.79[2.33-14.36], P < 0.001). CONCLUSIONS: The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing.

Human recombinant activated protein C-coated stent for the prevention of restenosis in porcine coronary arteries.

Activated protein C (APC), an endogenous protein, inhibits inflammation and thrombosis and interrupts the coagulation cascade. Here, we investigated the effect of human recombinant APC on the development of neointimal hyperplasia in porcine coronary arteries. Yukon Choice bare metal stents were coated with 2.6 µg APC/mm(2). Under general anesthesia, APC-coated and bare stents were implanted in the left anterior descending and circumflex coronary arteries of 10 domestic pigs. During the 4-week follow-up, animals were treated with dual antiplatelet therapy and neointimal hyperplasia was evaluated via histology. Scanning electron microscopy indicated successful but unequal coating of stents with APC; nearly complete drug release occurred within 4 h. Enzyme-linked immunosorbent assay revealed that intracoronary stent implantation rapidly increased the levels of monocyte chemoattractant protein-1, an effect that was inhibited by APC release from the coated stent. Fibrin deposition and adventitial inflammation were significantly decreased 1 month after implanting APC-coated stents versus bare stents, paralleled by significantly smaller neointimal area (0.98 ± 0.92 vs. 1.44 ± 0.91 mm(2), P = 0.028), higher lumen area (3.47 ± 0.94 vs. 3.06 ± 0.91 mm(2), P = 0.046), and lower stenosis area (22.2 ± 21.2% vs. 32.1 ± 20.1%, P = 0.034). Endothelialization was complete with APC-coated but not bare (90%) stents. P-selectin immunostaining revealed significantly fewer activated endothelial cells in the neointima in the APC group (4.6 ± 1.9 vs. 11.6 ± 4.1%, P < 0.001). Thus, short exposure of coronary arteries to APC reduced inflammatory responses, neointimal proliferation, and in-stent restenosis, offering a promising therapy to improve clinical outcomes of coronary stenting. However, coating stents with APC for prolonged, controlled drug release remains technically challenging.

Valvuloplasty with a paclitaxel-eluting balloon prevents restenosis in an experimental animal model of aortic stenosis.

BACKGROUND AND AIM OF THE STUDY: Restenosis occurs invariably within 12 months following balloon valvuloplasty (BAV) in calcific aortic valve disease (CAVD), and is a limiting factor of this treatment. Cellular proliferation secondary to balloon injury is thought to play a pivotal role in the mechanism of restenosis. The study aim was to investigate the potential role of a paclitaxel-eluting valvuloplasty balloon to mitigate the progression of restenosis in an animal model of CAVD. METHODS: Fifty-three rabbits were fed with an aortic stenosis (AS)-inducing diet (cholesterol 0.5% plus vitamin D3 50,000 IU/day) for three months. The surviving animals (n = 40) underwent echocardiographic and invasive assessments, followed by valvuloplasty, randomly using either a paclitaxel-coated (3 µg/mm2) or a plain balloon. At one month after BAV, the surviving animals (n = 28) underwent repeat assessments, followed by histology and micro-computed tomography (MicroCT) analysis of the aortic valve. RESULTS: The baseline and post-BAV transvalvular gradients, aortic valve area (AVA), left ventricular stroke work loss (SWL) and aortic valve resistance (AVR) were similar between the groups (14 rabbits were assigned to paclitaxel-eluting, and 14 to plain balloon). Significant differences between the groups were observed at one-month post-BAV, which was suggestive of diminished restenosis in the paclitaxel-balloon group (mean maximum transvalvular pressure gradient 7.7 ± 7.7 versus 3.6 ± 3.7 mmHg, p = 0.08; AVA 0.91 ± 0.59 versus 0.55 ± 0.22 cm2, p = 0.04; SWL 3.5 ± 4.0 versus 8.6 ± 8.0%, p = 0.047; AVR 86 ± 71 versus 177 ± 137 dynes/s/cm(-5), p = 0.039). Histology demonstrated decreased leaflet thickness (0.60 ± 0.15 versus 0.71 ± 0.17 mm, p = 0.03), proliferating cell nuclear antigen (PCNA) staining (grade 1.53 ± 0.04 versus 2.24 ± 0.55, p = 0.049), and calcification in the paclitaxel-balloon group. CONCLUSION: Use of a paclitaxel-eluting valvuloplasty balloon in an animal model of AS resulted in attenuated restenosis, secondary to decrease in valve proliferation and calcification.

Calcified coronary lesions: Imaging, prognosis, preparation and treatment state of the art review.

Calcific coronary artery stenosis is a complex disease associated with adverse outcomes and suboptimal percutaneous treatment. Calcium plaque modification has emerged as a key strategy to tackle the issues that accompany calcific stenosis - namely reduced device deliverability, unpredictable lesion characteristics, and difficult dilatation. Atherectomy has traditionally been the treatment modality of choice for heavily calcified coronary stenoses. Contemporary technologies have emerged to aid with planning, preparation, and treatment of calcified coronary stenosis in an attempt to improve procedural success and long-term outcomes. In this State Of The Art Review, we synthesize the body of data surrounding the diagnosis, imaging, and treatment of calcific coronary disease, with a focus on i) intravascular imaging, ii) calcific lesion preparation, iii) treatment modalities including atherectomy, and iv) updated treatment algorithms for the management of calcified coronary stenosis.

The Impact of Body Mass Index on the Mortality of Myocardial Infarction Patients With Nonobstructive Coronary Arteries.

OBJECTIVES: Myocardial infarction without significant stenosis or occlusion of the coronary arteries carries a high risk of recurrent major adverse cardiovascular events and poor prognosis. This study aimed to investigate the association between body mass index and outcomes in patients with a suspected myocardial infarction with nonobstructive coronary artery disease (MINOCA). METHODS: Patients were recruited at Bergmannsheil University Hospital from January 2010 to April 2021. The primary outcomes were in-hospital and long-term mortality. Secondary outcomes consisted of adverse events during hospitalization and during follow-up. RESULTS: A total of 373 patients were included in the study, with a mean follow-up time of 6.2 years. The patients were divided into different BMI groups: < 25 kg/m² (n = 121), 25-30 kg/m² (n = 140), and > 30 kg/m² (n = 112). In-hospital mortality was 1.7% versus 2.1% versus 4.5% (p = 0.368). However, long-term mortality tended to be higher in the < 25 kg/m² group compared to the 25-30 and > 30 kg/m² groups (log-rank p = 0.067). Subgroup analysis using Kaplan-Meier analysis showed a higher rate of cardiac cause of death in the < 25 kg/m² group compared to the 25-30 and > 30 kg/m² groups: 5.7% versus 1.1% versus 0.0% (log-rank p = 0.042). No significant differences were observed in other adverse events between the different BMI groups during hospitalization and long-term follow-up. CONCLUSIONS: Patients with a BMI < 25 kg/m² who experience a suspected myocardial infarction without significant coronary artery disease may have higher all-cause mortality and cardiovascular cause of death. However, further data are needed to confirm these findings.

Clinical outcomes of single- versus two-stent PCI technique in severely calcified true bifurcation lesions after rotational atherectomy.

BACKGROUND: Severely calcified coronary bifurcations complicate percutaneous coronary interventions (PCI) and often necessitate dedicated lesion preparation. We compared the outcomes of single- versus two-stent techniques for treating heavily calcified true bifurcation lesions following rotational atherectomy (RA). METHODS: Among patients receiving RA for severely calcified true bifurcations at a single center, 59 were treated with a single stent, and another 59 received two stents. We analyzed in-hospital adverse outcomes and 1-year rates of the bifurcation-oriented composite endpoint (BOCE), defined as cardiac death, target bifurcation myocardial infarction (TB-MI), or target bifurcation revascularization (TBR). RESULTS: The single-stent arm was associated with more in-hospital adverse outcomes (adj. OR, 6.13; 95% CI, 1.34-28.0; p = 0.019), driven by higher peri-procedural MI rates (18.6% vs. 5.1%, p = 0.043) and more side branch compromise (13.6% vs. 0%, p = 0.006). After 1 year, both techniques had comparable 1-year BOCE (adj. HR, 0.38; 95% CI, 0.12-1.23; p = 0.106). We observed a significant interaction between the treatment technique and the presence of LM bifurcation (p interaction = 0.012), favoring single-stent technique in patients with non-LM bifurcations (HR 0.14, 95% CI 0.03-0.68; p = 0.015). Notably, the single-stent technique had lower rates of TBR (2% vs. 15%, p log-rank = 0.026) after 1 year. CONCLUSION: Patients with severely calcified true bifurcation lesions, treated with RA followed by a single stent implantation, had more in-hospital adverse outcomes compared to those treated with two stents. However, the superior outcomes of the two-stent technique did not translate into improved long-term results. In fact, the two-stent technique was even associated with higher rates of revascularization after 1 year.

Prognostic Implications of Coronary Artery Sclerosis in Troponin-Positive Patients with Non-Obstructive Coronary Arteries.

INTRODUCTION: Coronary sclerosis is a risk factor for the progression to obstructive coronary artery disease (CAD). However, understanding its impact on the outcomes of patients with myocardial infarction and non-obstructive coronary arteries is limited. This study aimed to explore the prognostic influence of coronary sclerosis on in- and out-of-hospital events in troponin-positive patients with non-obstructive coronary arteries. METHODS: This study was a retrospective cohort analysis based on prospectively collected data. A total of 24,775 patients who underwent coronary angiography from 2010 to 2021 in a German university hospital were screened, resulting in a final study cohort of 373 troponin-positive patients with non-obstructive coronary arteries and a follow-up period of 6.2 ± 3.1 years. Coronary sclerosis was defined as coronary plaques without angiographically detectable stenotic lesions of 50% or more in the large epicardial coronary arteries. The primary study endpoint was the occurrence of in-hospital events. Secondary endpoints included events during follow-up. RESULTS: Patients with coronary sclerosis were significantly older (70 ± 12 vs. 58 ± 16 years, p < 0.001), had ST-segment elevation less frequently on electrocardiogram (9.4% vs. 18.7%, p = 0.013), and suffered more often from diabetes mellitus (23.3% vs. 13.1%, p = 0.009), arterial hypertension (79.6% vs. 59.8%, p < 0.001), chronic obstructive pulmonary disease (17.1% vs. 9.4%, p = 0.028), chronic kidney disease (22.2% vs. 8.4%, p < 0.001), atrial fibrillation (19.8% vs. 12.2%, p = 0.045), and valvular diseases than patients without CAD. Patients with coronary sclerosis were more likely to receive medication for primary/secondary prevention on admission and at discharge. The incidence of in- and out-of-hospital events was significantly higher in patients with coronary sclerosis (in-hospital: 42.8% vs. 29.9%, p = 0.010; out-of-hospital: 46.0% vs. 26.1%, p < 0.001). Mortality rates tended to be higher in the coronary sclerosis group (29.4% vs. 20.0%, p = 0.066). CONCLUSION: Patients diagnosed with coronary sclerosis presented a higher incidence of comorbidities and increased medication use, and experienced higher rates of both in-hospital and out-of-hospital events, primarily due to the clustering of cardiovascular risk factors.

Low Bone Mineral Density on Computed Tomography: Association with Poor Survival after Transcatheter Aortic Valve Replacement.

Background: Transcatheter aortic valve replacement (TAVR) has evolved as first-line therapy for severe aortic valve stenosis (AS), with pre-procedural computed tomography (CT) providing critical anatomical information. While primarily used for anatomical planning, TAVR-CT also offers an opportunity to assess low bone mineral density (BMD), a known indicator of frailty. Despite this, the prognostic role of BMD in TAVR patients remains unknown. This study aimed to evaluate BMD on routine TAVR-CT and its impact on long-term survival. Methods: In this retrospective study, 770 consecutive TAVR patients (mean age 80.7 ± 6.7 years, 54.0% males) between November 2015 and March 2022 were included. BMD was measured from a single axial image at the thoracic vertebral level on unenhanced CT scans. Cox regression models assessed the impact of BMD on mortality, and Restricted Cubic Spline models identified potential mortality thresholds. Results: The mean BMD value, as measured on non-contrast CT, was 147.5 ± 5.4 Hounsfield units, demonstrating a noteworthy association with mortality (adjusted hazard ratio per 100 HU decrease: 1.27 [95%CI: 1.01-1.59], p = 0.041). Restricted cubic spline analysis indicated that BMD below 200 HU was linked to a substantial increase in mortality risk. Upon crude Cox regression analysis, every 100 HU decrease was associated with a 32% increase in risk for death (HR 1.32 [95%CI: 1.068-1.65)], p = 0.010). Conclusions: In conclusion, low BMD on TAVR-CT is independently associated with reduced survival, suggesting its potential as a tool for comprehensive frailty assessment and improved risk prediction in TAVR patients.

In-hospital Outcomes of Rotational Atherectomy in ST-Elevation Myocardial Infarction: Results From the Multicentre ROTA-STEMI Network.

BACKGROUND: Although the use of rotational atherectomy (RA) is off-label in the setting of ST-elevation myocardial infarction (STEMI), it can be the only option in severely calcified culprit lesions to achieve procedural success. We sought to investigate the safety and feasibility of RA during primary percutaneous coronary intervention (PPCI). METHODS: This was a retrospective observational study of patients who underwent RA during PPCI from 12 European centres. The main outcomes were procedural success (defined as successful stent implantation with final thrombolysis in myocardial infarction [TIMI] flow 3 and residual stenosis < 30%) and in-hospital mortality. A comparison of patients presenting with and without shock was performed. RESULTS: In 104 patients with RA during STEMI, the mean age was 72.8 ± 9.1 years, and 35% presented with cardiogenic shock. Bailout RA was performed in 76.9% of cases. Mean burr size was 1.42 ± 0.21 mm. Procedural success was achieved in 86.5% of cases, with no difference between shocked and nonshocked patients (94.4% vs 82.4%; P = 0.13). In-hospital stent thrombosis occurred in 0.96%, perforation in 1.9% and burr entrapment in 2.9% of cases. In spite of equally high procedural success, in-hospital mortality was higher in shocked (50%) compared with nonshocked patients (1.5%; P < 0.0001). CONCLUSIONS: Patients presenting with STEMI requiring RA, represent a high-risk population, frequently presenting with cardiogenic shock. In this analysis of selected patients, RA was performed as a bailout strategy in the majority, and, as such, RA seems to be feasible with a high procedural success rate. In the absence of cardiogenic shock, RA-facilitated PCI seems to be associated with low in-hospital mortality.

Incidence and pattern of urgent revascularization in acute coronary syndromes treated with ticagrelor or prasugrel.

BACKGROUND: The ISAR-REACT 5 trial compared the efficacy and safety of ticagrelor and prasugrel in patients with ACS managed invasively. The present study sought to investigate the impact of ticagrelor and prasugrel on the incidence and pattern of urgent revascularization in acute coronary syndromes (ACS) patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: This post-hoc analysis of the ISAR-REACT 5 trial included all ACS patients who underwent PCI. The primary endpoint for this analysis was the incidence of urgent revascularization at 12-month follow-up. Secondary outcome was the pattern of urgent revascularization procedures (namely, urgent target vessel/non-target vessel revascularization - TVR/NTVR). Among 3,377 ACS patients who underwent PCI, 1,676 were assigned to ticagrelor and 1,701 to prasugrel before PCI. After 12 months, the incidence of urgent revascularization was higher among patients assigned to ticagrelor as compared to prasugrel (6.8% vs. 5.2%; hazard ratio [HR] = 1.32, 95% confidence interval [CI] 1.00-1.75; p = 0.051), mostly attributable to significantly more urgent NTVR in the ticagrelor group (3.8% vs. 2.4%; HR = 1.62 [1.09-2.41]; p = 0.017). The risk of urgent TVR did not differ between treatment groups (3.3% vs. 3.0%; HR = 1.13 [0.77-1.65]; p = 0.546). CONCLUSIONS: In ACS patients treated with PCI, the cumulative rate of urgent revascularizations after 12 months is higher with ticagrelor compared to prasugrel, due to a significant increase in urgent revascularizations involving remote coronary vessels.

Short Versus Long-Term Dual Antiplatelet Therapy in Patients at High Bleeding Risk Undergoing PCI in Contemporary Practice: A Systemic Review and Meta-analysis.

INTRODUCTION: Patients at high bleeding risk (HBR patients) represent an important subset of patients undergoing percutaneous coronary intervention (PCI). It remains unclear whether a shortened duration of dual antiplatelet therapy (DAPT) confers benefits compared with prolonged duration of DAPT in this patient population. The aim of this study was to investigate and compare bleeding and ischemic outcomes among HBR patients receiving short- versus long-term DAPT after PCI. METHODS: A meta-analysis of studies comparing short-term (1-3 months) and long-term (6-12 months) DAPT after PCI with second-generation drug-eluting stents in HBR patients was performed. RESULTS: Six studies [1 randomized controlled trial (RCT), 2 RCT subanalyses, and 3 prospective propensity-matched studies] involving 15,908 patients were included in the meta-analysis. During a follow-up of 12 months, short-term DAPT was associated with a reduction in major bleeding events [odds ratio (OR) 0.63, 95% confidence interval (CI) 0.42-0.95; p = 0.03, I2 = 71] and comparable definite/probable stent thrombosis, all-cause mortality, cardiovascular mortality, myocardial infarction (MI), and ischemic stroke, compared with long-DAPT. Single antiplatelet therapy (SAPT) with aspirin was comparable to SAPT with P2Y12 inhibitor, with no treatment-by-subgroup interaction for major bleeding events (p-interaction = 0.27). In studies including patients presenting with MI, a trend of more frequent MI was noted in the short-DAPT arm (OR 1.25, 95% CI 0.98-1.59; p = 0.07; I2 = 0). In a sensitivity analysis comparing 3- and 12-month DAPT, the 3-month DAPT strategy was associated with a higher risk of ischemic stroke (OR 2.37, 95% CI 1.15-4.87; p = 0.02, I2 = 0%). CONCLUSION: Short-term DAPT after PCI in HBR patients was associated a reduction in major bleeding events and similar ischemic outcomes. However, a higher risk of ischemic stroke and MI at 1 year of follow-up was seen in some subsets.

The Target Vessel SYNTAX Score: A Novel Pre-Procedural Predictor for Contrast-Induced Acute Kidney Injury After Rotational Atherectomy.

BACKGROUND: Rotational atherectomy (RA) is a complex procedure often associated with high contrast load. Known risk scores do not predict contrast-induced acute kidney injury (CI-AKI) before RA. We aim to investigate pre-procedural predictors of CI-AKI after RA, and the role of the target vessel SYNTAX score (tvSS). METHODS: Among 295 patients who underwent RA between 01.2010 and 02.2019 at a single center, 49 developed CI-AKI. Those who were on chronic hemodialysis or with no available 48-h' kidney function tests were excluded. Predictors of CI-AKI were assessed in the whole cohort and those with no basal renal impairment. RESULTS: The rate of CI-AKI was 16.6 %. The tvSS was 18 [14-23] vs. 12 [9-18] in patients with vs. without CI-AKI (p < 0.001). The tvSS cut-off value of 15 provided 75 % sensitivity and 60 % specificity for predicting CI-AKI. Consequently, a tvSS ≥15 emerged as an independent pre-procedural predictor for CI-AKI (adjusted OR: 4.94, 95 % CI: 2.38-10.20, p < 0.001), along with left ventricular ejection fraction (LVEF) ≤35 % (p = 0.016) and glomerular filtration rate (GFR) <45 ml/min (p = 0.004). TvSS was the only independent pre-procedural predictor for CI-AKI in patients with GFR ≥60 ml/min (p < 0.001). The contrast volume/GFR ratio and peri-procedural myocardial infarction (MI) were independent procedural predictors for CI-AKI in the whole cohort and in patients with basal GFR ≥60 ml/min. CONCLUSION: CI-AKI after RA is frequent. The tvSS is an efficient pre-procedural predictor for CI-AKI after RA, along with LVEF ≤35 % and GFR <45 ml/min. Contrast volume/GFR ratio and peri-procedural MI emerged as procedural predictors for CI-AKI.

Rotational atherectomy of calcified coronary lesions: current practice and insights from two randomized trials.

With growing experience, technical improvements and use of newer generation drug-eluting stents (DES), recent data showed satisfactory acute and long-term results after rotational atherectomy (RA) in calcified coronary lesions. The randomized ROTAXUS and PREPARE-CALC trials compared RA to balloon-based strategies in two different time periods in the DES era. In this manuscript, we assessed the technical evolution in RA practice from a pooled analysis of the RA groups of both trials and established a link to further recent literature. Furthermore, we sought to summarize and analyze the available experience with RA in different patient and lesion subsets, and propose recommendations to improve RA practice. We also illustrated the combination of RA with other methods of lesion preparation. Finally, based on the available evidence, we propose a simple and practical approach to treat severely calcified lesions.

Patients with higher-atherothrombotic risk vs. lower-atherothrombotic risk undergoing coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials.

BACKGROUND: Patients with atherothrombotic risk are at high hazard of ischemic events. Preventive medicine plays a major role in modifying their outcomes. Whether the choice of a BP-SES or DP-EES can contribute to the occurrence of events remains unclear. We sought to investigate the outcomes of patients with higher atherothrombotic risk (H-ATR) versus lower atherothrombotic risk (L-ATR) undergoing percutaneous coronary intervention (PCI) with either bioresorbable-polymer sirolimus-eluting stent (BP-SES) or durable-polymer everolimus-eluting stent (DP-EES). METHODS: Patients (n = 2361) from BIOFLOW-II, -IV, and -V randomized trials were categorized into H-ATR vs. L-ATR. L-ATR patients had ≤ 1 and H-ATR ≥ 2 of the following criteria: presentation in ACS, diabetes mellitus, previous myocardial infarction, previous PCI/CABG, or previous stroke. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], target lesion revascularization [TLR]) and stent thrombosis (ST) at three years. RESULTS: H-ATR patients (n = 1023) were more morbid than L-ATR patients (n = 1338). TLF rate was significantly higher in H-ATR patients as compared with L-ATR (11.6% vs. 7.0%; HR 1.67, 95% CI 1.27-2.20, p < 0.0001). With BP-SES TLF rates were numerically lower as compared with DP-EES in H-ATR (10.5% vs. 13.5%; HR 0.78, 95% CI 0.54-1.14, p = 0.20) and significantly lower in L-ATR (5.6% vs. 9.8%; HR 0.57, 95% CI 0.38-0.85, p = 0.006). CONCLUSION: In the era of newer-generation DES, patients with H-ATR still are at hazard for ischemic events. Patients with BP-SES had lower TLF rates as compared with DP-EES, most consistent in L-ATR whereas in H-ATR patients most probably secondary preventive strategies are of higher value. CLINICAL TRIAL REGISTRATION: Clinicaltrial.gov. NCT01356888, NCT01939249, NCT02389946. https://clinicaltrials.gov/show/NCT01356888 , https://clinicaltrials.gov/show/NCT01939249 , https://clinicaltrials.gov/show/NCT02389946 .

Peri-Interventional Triple Therapy with Dabigatran Modifies Vasomotion after Bare-Metal Stent Implantation in a Pig Coronary Artery Model.

(1) Background: Coronary artery stenting leads to local inflammation, disturbs vasomotion, and slows endothelialization, increasing vascular thrombus risk. We used a pig stenting coronary artery model to assess how peri-interventional triple therapy with dabigatran ameliorates these effects. (2) Methods: In a total of 28 pigs bare-metal stents were implanted. Four days before the percutaneous coronary intervention (PCI), we started 16 of the animals on dabigatran, maintained through 4 days after the procedure. As controls, the remaining 12 pigs received no therapy. In both groups, dual antiplatelet therapy (DAPT) (clopidogrel, 75 mg plus aspirin, 100 mg) was administered until animals were euthanized. Just after the PCI and on day 3 after the procedure, we performed optical coherence tomography (OCT) in eight animals in the dabigatran group and four controls and euthanized them. We followed the eight remaining animals in each group with OCT and angiography for one month before euthanizing them and performed in vitro myometry and histology on harvested coronary arteries from all animals. (3) Results: The dabigatran group showed a significantly increased vasoconstriction at 3 days after PCI (10.97 ± 3.85 mN vs. 7.32 ± 5.41 mN, p = 0.03), but we found no differences between endothelium-dependent and -independent vasodilatation. We also found no group differences in OCT, quantitative angiography, or histomorphometry findings. (4) Conclusions: Starting a short course of dabigatran just before PCI and continuing for a 3-day window along with usual post-PCI DAPT is associated with enhanced vasoconstriction after bare-metal stent implantation without reducing neointimal formation at one month.