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Background: Coronary artery calcification is a strong predictor for procedural failure and is independently associated with adverse events after percutaneous coronary intervention (PCI). An important contributor to the impaired outcome is the inability to achieve optimal results due to stent underexpansion or stent deformation/fracture. Intravascular lithotripsy (IVL) has emerged as an alternative technique to change the integrity of calcified plaques., Aims: Our aim was to investigate if pre-treatment with IVL in severely calcified lesions increases stent expansion, assessed by optical coherence tomography (OCT), when compared to predilatation with conventional and/or specialty balloon strategy., Methods: EXIT-CALC was a prospective, single-centre, randomised controlled study. Patients with an indication for PCI and severe calcification of the target lesion were allocated to predilatation with conventional angioplasty balloons or pre-treatment with IVL, followed by drug-eluting stenting and mandatory postdilatation. Primary endpoint was stent expansion assessed by OCT. Secondary endpoints were the occurrence of peri-procedural events and major adverse cardiac events (MACE) in hospital and during follow-up., Results: A total of 40 patients were included. The minimal stent expansion in the IVL-group (n = 19) was 83.9 ± 10.3% and 82.2 ± 11.5% in the conventional group (n = 21) (p = 0.630). Minimal stent area was 6.6 ± 1.5 mm 2 and 6.2 ± 1.8 mm 2 , respectively (p = 0.406). No peri-procedural, in-hospital and 30-day follow-up MACE were reported., Conclusions: In severely calcified coronary lesions we found no significant difference in stent expansion measured by OCT when comparing IVL, as plaque modification, with conventional and/or specialty angioplasty balloons., Competing Interests: Declaration of Competing Interest All authors declare that they have no conflicts of interest., (Copyright © 2023. Published by Elsevier B.V.)

Objectives: This study sought to assess the efficacy and safety of a drug-coated balloon (DCB) strategy versus drug-eluting stent (DES) in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)., Background: In primary percutaneous coronary intervention for STEMI, stenting has proved to be beneficial with regard to repeat revascularization, but not recurrent myocardial infarction or death, compared with balloon angioplasty alone. A strategy of DCB angioplasty without stenting might abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty., Methods: In the prospective, randomized, single-center REVELATION trial, we compared DCB with DES in patients presenting with STEMI. Patients with a new, nonseverely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after pre-dilatation were randomized to treatment with a DCB or DES. The primary endpoint was fractional flow reserve at 9 months, allowing for a functional measurement of the infarct-related lesion., Results: A total of 120 patients were included. At 9 months after enrolment, the mean fractional flow reserve value was 0.92 ± 0.05 in the DCB group (n = 35) and 0.91 ± 0.06 in the DES group (n = 38) (p = 0.27). One abrupt vessel closure requiring treatment occurred after treatment with DCB. Up to 9-months follow-up, 2 patients required nonurgent target lesion revascularization (1 in each group)., Conclusions: In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months. Furthermore, it seemed to be a safe and feasible strategy. (Revascularization With Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial Infarction [REVELATION]; NCT02219802)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Hypertension is a well known risk factor for atherosclerosis. However, data on the prognostic impact of hypertension in patients with ST elevation myocardial infarction (STEMI) are inconsistent and mainly related to studies performed in the thrombolytic era, with very few data in patients undergoing primary angioplasty. Therefore, the aim of the current study was to evaluate the impact hypertension on clinical outcome in STEMI patients undergoing primary PCI with BMS or DES., Methods: Our population is represented by 6298 STEMI patients undergoing primary angioplasty included in the DESERT database from 11 randomized trials comparing DES vs BMS for STEMI., Results: Hypertension was observed in 2764 patients (43.9%), and associated with ageing (p<0.0001), female gender (p<0.001), diabetes (p<0.0001), hypercholesterolemia (p<0.0001), previous MI (p=0.002), previous revascularization (p=0.002), longer time-to-treatment (p<0.001), preprocedural TIMI 3 flow, and with a lower prevalence of smoking (41% vs 53.9%, p<0.001) and anterior MI (42% vs 45.9%, p=0.002). Hypertension was associated with impaired postprocedural TIMI 0-2 flow (Adjusted OR [95% CI]=1.22 [1.01-1.47], p=0.034). At a follow-up of 1,201 ± 440 days, hypertension was associated with higher mortality (adjusted HR [95% CI]=1.24 [1.01-1.54], p=0.048), reinfarction (adjusted HR [95% CI]=1.31 [1.03-1.66], p=0.027), stent thrombosis (adjusted HR [95% CI]=1.29 [0.98-1.71], p=0.068) and TVR (adjusted HR [95% CI]=1.22 [1.04-1.44], p=0.013)., Conclusions: This study showed that among STEMI patients undergoing primary angioplasty with DES or BMS, hypertension is independently associated with impaired epicardial reperfusion, mortality, reinfarction and TVR, and a trend in higher ST., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: Several studies have found that among patients with ST-segment elevation myocardial infarction (STEMI) treated by thrombolysis, female sex is associated with a worse outcome. However, still controversial is the prognostic impact of gender in primary angioplasty, especially in the era of drug-eluting stents (DES). Therefore, the aim of this study was to investigate sex-related differences in clinical outcome in patients with STEMI treated with primary angioplasty with Bare-Metal Stent (BMS) or DES., Methods: Our population is represented by 6298 STEMI patients undergoing primary angioplasty and stent implantation included in the DESERT database. Follow-up data were collected from 3 to 6 years after primary angioplasty., Results: Female gender was observed in 1466 (23.2%) out of 6298 STEMI patients. Women were older (65.3 ± 12.4 vs 59.3 ± 11.4 years, p < 0.001), with higher prevalence of diabetes (18.6% vs 14.5%, p < 0.001), hypertension (52.4% vs 41.4%, p < 0.001), slightly longer ischemia time (272 ± 247 vs 258 ± 220 min, p = 0.06). No difference was observed in terms of angiographic and procedural characteristics. Follow-up data were available at a mean of 1201 ± 441 days. At long-term follow-up female gender was associated with a significantly higher rate of death (11.7% vs 8.5%, HR [95% CI] = 1.45 [1.18-1.78], p < 0.001), while no difference was observed in terms of reinfarction (HR [95% CI] = 1.14 [0.89-1.45], p = 0.3), ST (HR [95% CI] = 1.12 [0.85-1.48], p = 0.4), with similar temporal distribution (acute, subacute, late and very late) between male and female patients, and no difference in TVR (HR [95% CI] = 1.11 [0.95-1.3], p = 0.2, p = 0.2). These results were confirmed in both patients receiving BMS or DES. The impact of female gender on mortality disappeared after correction for baseline confounding factors (HR [95% CI] = 0.88 [0.71-1.09], p = 0.25)., Conclusions: This study shows that in patients with STEMI treated by primary angioplasty, female gender is associated with higher mortality rate in comparison with men, and this is mainly due to their higher clinical and angiographic risk profiles. In fact, female sex did not emerge as an independent predictor of mortality., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Objectives: This study sought to investigate which factors are associated with failure of thrombus aspiration (TA) and if this has prognostic implications., Background: The pathophysiological mechanism and clinical benefit of TA during primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction is still in debate., Methods: Between August 2001 and October 2007, TA was attempted in 1,399 patients. Failure of TA was defined as the inability to reach and/or cross the occlusion with the aspiration catheter for effective thrombus removal. In addition, we analyzed patients in which no material could be obtained. We examined baseline clinical and angiographic variables related to failure of TA or to the lack of aspirate. Follow-up on vital status was obtained at 1 year., Results: In 144 (10.3%) patients, the aspiration catheter failed to cross the lesion. After multivariable adjustment, marked proximal tortuosity (odds ratio [OR]: 2.88, 95% confidence interval [CI]: 1.92 to 4.31, p < 0.001), the presence of a calcified lesion (OR: 2.70, 95% CI: 1.77 to 4.13, p < 0.001), and a bifurcation lesion (OR: 1.97, 95% CI: 1.15 to 3.37, p = 0.013) were independent predictors of failed TA. Age over 60 years and the circumflex as infarct-related artery were associated with the lack of aspirate. Mortality rates at 1 year were 6.2% in patients with failed TA and 6.4% with successful TA (hazard ratio: 0.98, 95% CI: 0.49 to 1.95, p = 0.95)., Conclusions: The presence of marked proximal tortuosity of the infarct-related artery, a calcified lesion, and a bifurcation lesion are independent predictors of failure of thrombus aspiration. We found that unsuccessful TA did not affect 1-year mortality., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to evaluate the long-term outcomes of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial., Background: In primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction (STEMI), the use of drug-eluting stents (DES) is still controversial. Several randomized controlled trials of DES, compared with bare-metal stents (BMS), with short-term follow-up showed a reduction in target lesion revascularization (TLR), but no differences in rates of cardiac death or recurrent myocardial infarction. Moreover, the occurrence of (very) late stent thrombosis (ST) continues to be of major concern, and, therefore, long-term follow-up results are needed., Methods: We randomly assigned 619 patients presenting with STEMI to a paclitaxel-eluting stent (PES) or the similar BMS. The primary end point was the composite of cardiac death, recurrent myocardial infarction, or TLR. We performed clinical follow-up at 5 years., Results: At 5 years, the occurrence of the composite of cardiac death, recurrent myocardial infarction, or TLR was comparable at 18.6% versus 21.8% in PES and BMS, respectively (hazard ratio [HR]: 0.82, 95% confidence interval [CI]: 0.58 to 1.18, p = 0.28). The incidence of definite or probable ST was 12 (4.2%) in the PES group and 10 (3.4%) in the BMS group (HR: 1.19, 95% CI: 0.51 to 276, p = 0.68)., Conclusions: In the present analysis of PES compared with BMS in primary percutaneous coronary intervention for STEMI, no significant difference in major adverse cardiac events was observed. In addition, no difference in the incidence of definite or probable ST was seen, although very late ST was almost exclusively seen after the use of PES. (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation [PASSION]; ISRCTN65027270)., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)