Clinical and procedural outcomes of percutaneous coronary intervention for de novo lesions involving the ostial left circumflex coronary artery.

BACKGROUND: Percutaneous treatment for ostial left circumflex artery (LCx) lesions is known to be associated with suboptimal results. AIMS: The present study aims to assess the procedural and long-term clinical outcomes of percutaneous coronary intervention (PCI) for de novo ostial LCx lesions overall and according to the coronary revascularization strategy. METHODS: Consecutive patients undergoing PCI with second generation drug eluting stents or drug coated balloons for de novo ostial LCx lesions in three high-volume Italian centers between 2012 and 2021 were retrospectively evaluated. The primary endpoint was target-vessel revascularization (TVR) at 2 years. Secondary endpoints included major adverse cardiovascular and cerebrovascular events (MACCE), target lesion revascularization, myocardial infarction, stroke, all-cause death, and repeat revascularization. RESULTS: A total of 366 patients were included in the analysis with a median follow-up of 901 (IQR: 450-1728) days. 79.5% of the patients were male, 33.6% were diabetic, 49.7% had a previous PCI, and 23.1% a prior surgical revascularization. Very ostial LCx stenting was performed in 34.1%, crossover from left main to LCx in 17.3%, and a two-stent strategy in 48.6% of cases, respectively. In the overall population, the incidence of TVR at 2 years was 19.0% while MACCE rate was 25.7%. No major differences in clinical outcomes were found according to the stenting strategy. Use of intracoronary imaging was associated with fewer MACCE (HR: 0.47, 95% CI: 0.25-1.13, p = 0.01), while the diameter of the stent implanted in the ostial LCx was associated with less TVR (HR: 0.43, 95% CI: 0.25-0.75, p = 0.002). CONCLUSIONS: Percutaneous revascularization of the ostial LCx is associated with a high rate of TVR, regardless of the stenting strategy. Intracoronary imaging and proper stent sizing may reduce the failure rates.

Evolution, Predictors, and Neurocognitive Effects of Silent Cerebral Embolism During Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to assess the characteristics, predictors, evolution, and neurocognitive effects of silent cerebral ischemic lesions (SCILs). BACKGROUND: Most patients undergoing transcatheter aortic valve replacement (TAVR) develop SCILs detectable on magnetic resonance imaging (MRI). The natural history and clinical relevance of SCILs are not well established. METHODS: Cerebral MRI was performed within 7 days before TAVR to assess baseline status and age-related white matter change score. MRI was repeated post-operatively to assess the occurrence, location, number, and dimensions of SCILs. Patients developing SCILs underwent a third MRI examination at 3- to 5-month follow-up. A neurocognitive evaluation was performed before TAVR, at discharge, and at 3-month follow-up. RESULTS: Of the 117 patients enrolled, 96 underwent post-procedural MRI; SCILs were observed in 76% of patients, distributed in all vascular territories, with a median number of 2 lesions, a median diameter of 4.5 mm, and a median total volume of 140 mm3. Independent predictors of SCIL occurrence were higher baseline age-related white matter change score and the use of self-expanding or mechanically expanded bioprostheses. Among 47 patients who underwent follow-up MRI, only 26.7% of post-procedural SCILs evolved into gliotic scar. SCIL occurrence was associated with a more pronounced transient neurocognitive decline early after TAVR and with lower recovery at follow-up. CONCLUSIONS: SCILs occur in the vast majority of patients undergoing TAVR and are predicted by more diffuse white matter damage at baseline and by the use of non-balloon-expandable prostheses. Although most SCILs disappear within months, their occurrence has a limited but significant impact on neurocognitive function.

Left atrial appendage closure with the Ultraseal device: Initial experience and mid-term follow-up.

AIMS: Left atrial appendage (LAA) closure is considered an effective option in patients with non-valvular atrial fibrillation (NVAF) and contraindications to long-term oral anticoagulant (OAC) therapy. However, there are some concerns about safety of currently available devices. Our aim is to provide an initial assessment on feasibility and safety of the novel LAA closure Ultraseal device in patients with NVAF and contraindications to long-term OAC therapy. METHODS: Twenty-three consecutive patients with NVAF undergoing Ultraseal device implantation between July 2016 and February 2018 at two institutions were included. All patients performed transesophageal echocardiography and computed tomography angiography prior to LAA closure. RESULTS: Procedural success was achieved in all patients except two who experienced incorrect device deployment with incomplete LAA closure. Procedure duration halved from first to last procedure performed. The only periprocedural adverse events observed were a myocardial infarction and an in-hospital death due pneumonia. At mean follow-up (166 ± 80 days) all other patients were alive and free from major bleedings and ischaemic strokes. CONCLUSIONS: Our results suggest that the Ultraseal device is a feasible option for LAA occlusion. Notably, the learning curve in this registry was fast, paralleled by extremely low complication rates. These results should be considered hypothesis generating and larger studies are mandatory.

[Two-step strategy for the treatment of complex coronary artery disease and aortic stenosis in a patient with severely impaired left ventricular function]. / Strategia multistep per il trattamento di malattia coronarica complessa e stenosi aortica in un paziente con severa disfunzione ventricolare sinistra.

Coronary artery disease and aortic stenosis frequently coexist. The pathophysiology of both conditions is similar where atherosclerosis is the hallmark feature. Risk factors for aortic stenosis are also similar for coronary artery disease. The standard therapy in the past decades has been coronary artery bypass grafting and aortic valve replacement; however, with the introduction of transcatheter aortic valve implantation their management is probably going to shift towards a percutaneous strategy.

Transcatheter aortic valve implantation in bicuspid anatomy: procedural results with two different types of valves.

BACKGROUND: It is well known that bicuspid valve stenosis can be treated with transcatheter aortic valve implantation (TAVI) even if specific issues can cause problems: dilatation of ascending aorta, possible aorthopathy, eccentricity of the valve and calcium distribution in leaflets and in commissures. We classified Bicuspid aortic valve (BAV) in type 0 (2 cusps and no raphe), and type 1 (2 cusps and one or more raphes). The aim of the present study was to report the results of two types of valve (CoreValve from 2009 to 2016 and Lotus valve from 2014 to 2017) in a consecutive series of BAV patients treated in 2 Italian centers. METHODS: A total of 30 patients with BAV underwent TAVI from September 2009 to March 2017. RESULTS: Mean age was 78±8 years, 54.5% were males and 7.4% had peripheral vasculopathy, 6.5% previous stroke or TIA, 15.6% previous PCI and 9.4% previous coronary artery bypass grafting. Ten patients (30.3%) had a type 1; mean aortic valvular gradient was 57.7±17.7 mmHg; aortic valvular area was 0.7±0.2 mm2, left ventricular ejection fraction was 51.4±10.0% and ascending aorta was 41.0±5.6 mm. Among these 30 patients, 16 of them (group 1) undergone CoreValve implantation and 14 (group 2) undergone Lotus valve implantation. Patients in the first group had a higher Logistic Euroscore (P<0.001) and higher AVA (P=0.026) and valve area CT (P=0.003). Device size in group1 was more often bigger than in group 2 (P<0.001) and postdilatation was never used in the last group. Group 1 had a significant more frequent aortic regurgitation ≥2 assessed with angiography (28.6% vs. 0%; P=0.05). A non-statistically significant higher rate of second valve implantation (6.2% vs. 0%; P=1.00) was also observed. New permanent pacemaker implantation (40.0% vs. 35.7%; P=0.812) was equal in both valves. CONCLUSIONS: Postprocedural aortic regurgitation is still an issue in BAV undergone TAVI when: 1) the annulus is big; 2) when we are using self-expandable valves; and 3) in type 0 valves. Lotus valve, with a higher radial force put in a small annuls seems associated to better procedural outcomes in this subset of patients.

Impact of severe left ventricular dysfunction on mid-term mortality in elderly patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Whether patients with reduced left ventricular function present worse outcome after transcatheter aortic valve implantation (TAVI) is controversial. The aim of this study was to assess the impact of baseline severe impairment of left ventricular ejection fraction (LVEF) on mortality after TAVI. METHODS: Six-hundred-forty-nine patients with aortic stenosis underwent TAVI with the CoreValve system (92.8%) or the Edwards SAPIEN valve system (7.2%). Baseline LVEF was measured by the echocardiographic Simpson method. The impact of LVEF ≤ 30% on mortality was assessed by Cox regression. RESULTS: Patients with LVEF ≤ 30% (n = 63), as compared to those with LVEF > 30% (n = 586), had a higher prevalence of NHYA class > 2 (P < 0.001) and presented with a higher Euroscore (P < 0.001). Procedural success was similar in both groups (98.4% vs. 97.2%, P = 1). After a median follow-up of 436 days (25(th)-75(th) percentile, 357-737 days), all-cause mortality [23.8% vs. 23.7%, P = 0.87, hazard ratios (HR): 0.96, 95% confidence intervals (CI): 0.56-1.63] and cardiac mortality (19.1% vs. 17.6%, P = 0.89, HR: 1.04, 95% CI: 0.57-1.90) were similar in patients with LVEF ≤ 30% as compared to those with LVEF > 30%. Thirty-day all-cause mortality was not significantly different between the two groups (11.1% vs. 6.3%, P = 0.14, HR: 1.81, 95% CI: 0.81-4.06). Patients with LVEF ≤ 30% had a trend toward higher risk of 30-day cardiac mortality (11.1% vs. 5.3%; P = 0.06, HR: 2.16, 95% CI: 0.95-4.90), which disappeared after multivariable adjustment (P = 0.22). CONCLUSIONS: Baseline severe impairment of LVEF is not a predictor of increased short-term and mid-term mortality after TAVI. Selected patients with severe impairment of left ventricular function should not be denied TAVI.

Meta-analysis of comparison between self-expandable and balloon-expandable valves for patients having transcatheter aortic valve implantation.

Two different devices, 1 self-expanding and 1 balloon-expandable, have been developed for patients who underwent transcatheter aortic valve implantation with contrasting data about efficacy and safety. Pubmed, Medline, and Google Scholar were systematically searched for studies of these different devices, with data derived from randomized controlled trial or registries with multivariate analysis. All-cause death at 30 days and at follow-up were the primary end points, whereas postprocedural moderate or severe aortic regurgitation (AR), stroke, major vascular complications, bleedings, and pacemaker implantation the secondary ones. Six studies with 957 self-expanding and 947 balloon-expandable valves were included: 1 randomized controlled trial and 5 observational studies. At 30 days follow-up, rates of death did not differ between self-expanding and balloon-expandable valves (odds ratio [OR] 0.74, 95% confidence interval [CI] 0.47 to 1.17), whereas balloon expandable reduced rates of moderate or severe AR (OR 0.51, 95% CI 0.27 to 0.99) and of pacemaker implantation (OR 0.28, 95% CI 0.17 to 0.47). After a follow-up of 360 days (300 to 390), rates of all-cause death did not differ between the 2 groups. In conclusion, risks of moderate or severe AR and pacemaker implantation were lower with the balloon-expandable devices without an impact on 30 days and midterm mortality.

Impact of diabetes mellitus on early and midterm outcomes after transcatheter aortic valve implantation (from a multicenter registry).

Several clinical and procedural factors have been identified as predictors of early and midterm events after transcatheter aortic valve implantation (TAVI), but incidence and prognostic impact of diabetes mellitus (DM), especially insulin treated, on short- and midterm outcomes remain to be defined. All consecutive patients who underwent TAVI at our institutions were enrolled and stratified according to DM status. All-cause mortality at 30 days or in hospital and at follow-up was the primary end point, whereas periprocedural complications, rates of myocardial infarction, stroke, and reintervention at follow-up were the secondary ones. All end points were adjudicated according to the Valve Academic Research Consortium definitions. In all, 511 patients were enrolled: 361 without DM, 78 with orally treated DM, and 72 with insulin-treated DM. Orally treated DM patients were more frequently women, whereas insulin-treated DM patients were younger. Thirty-day Valve Academic Research Consortium mortality was not significantly higher in patients with orally treated DM and insulin-treated DM compared with patients without diabetes (6.4%, 9.7%, and 4.7%, p = 0.09). Bleedings, vascular complications, postprocedural acute kidney injury, and periprocedural strokes were not significantly different in the 3 groups. At midterm follow-up (median 400 days), patients with insulin-treated DM had a significantly higher mortality rate (33.3% vs 18.6%, p = 0.01) and higher myocardial infarction incidence (8.3% vs 1.4%, p = 0.002) if compared with patients without diabetes. Strokes and reinterventions at follow-up were similar in the 3 groups. After multivariable adjustment, insulin-treated DM was independently correlated with death (hazard ratio 2, 95% confidence interval 1.3 to 3.3) and myocardial infarction (hazard ratio 3.73, 95% confidence interval 1.1 to 13). In conclusion, DM does not significantly affect rates of complications in patients who underwent TAVI. Insulin-treated DM, but not orally treated DM, is independently associated with death and myocardial infarction at midterm follow-up and should be included into future TAVI-dedicated scores.

Impact of female sex on long-term outcomes in patients with ST-elevation myocardial infarction treated by primary percutaneous coronary intervention.

BACKGROUND: Conflicting information exists about whether sex differences affect long-term outcomes in patients undergoing primary percutaneous coronary intervention (PCI). METHODS: This retrospective study enrolled consecutive patients with ST-elevation myocardial infarction undergoing primary PCI within 24 hours from symptom onset. Hazard ratios (HRs) of events with 95% confidence interval (CI) were calculated in the overall population and in a propensity score matched cohort of women and men. RESULTS: Among 481 patients, median age 66 years old, 138 (28.7%) were women. Women were older than men (72 vs 63 years, P<0.001), had a higher prevalence of hypertension (68% vs 54%, P=0.006), diabetes (27% vs 19%, P=0.04), and Killip class≥3 at admission (19% vs 10%, P=0.007). After a median follow-up of 1041 days women experienced a significant higher incidence of the composite of death, nonfatal myocardial infarction, and hospitalization for heart failure (31.9% vs 18.4%, unadjusted HR 1.86; 95% CI, 1.26-2.74; P=0.002), driven mainly by heart failure (unadjusted HR 2.47; 95% CI, 1.12-5.41; P=0.024), without significant differences in death (unadjusted HR 1.49; 95% CI, 0.88-2.53; P=0.13), or nonfatal myocardial infarction (unadjusted HR 1.59; 95% CI, 0.78-3.27; P=0.19) and no increase in target lesion revascularization (9.4% vs 12.5%, unadjusted HR 0.77; 95% CI, 0.42-1.44; P=0.42). After propensity score matching the hazard of the composite endpoint was largely attenuated (HR 1.32; 95% CI, 0.84-2.06; P=0.23). CONCLUSIONS: Women undergoing primary PCI experience worse long-term outcomes than men, but this difference is largely explained by their more adverse baseline cardiovascular profile.

Influence of 9p21.3 genetic variants on clinical and angiographic outcomes in early-onset myocardial infarction.

OBJECTIVES: The purpose of this study was to test whether the 9p21.3 variant rs1333040 influences the occurrence of new cardiovascular events and coronary atherosclerosis progression after early-onset myocardial infarction. BACKGROUND: 9p21.3 genetic variants are associated with ischemic heart disease, but it is not known whether they influence prognosis after an acute coronary event. METHODS: Within the Italian Genetic Study of Early-onset Myocardial Infarction, we genotyped rs1333040 in 1,508 patients hospitalized for a first myocardial infarction before the age of 45 years who underwent coronary angiography without index event coronary revascularization. They were followed up for major cardiovascular events and angiographic coronary atherosclerosis progression. RESULTS: Over 16,599 person-years, there were 683 cardiovascular events and 492 primary endpoints: 77 cardiovascular deaths, 223 reoccurrences of myocardial infarction, and 383 coronary artery revascularizations. The rs1333040 genotype had a significant influence (p = 0.01) on the primary endpoint, with an adjusted hazard ratio of 1.19 (95% confidence interval [CI]: 1.08 to 1.37) for heterozygous carriers and 1.41 (95% CI: 1.06 to 1.87) for homozygous carriers. Analysis of the individual components of the primary endpoints provided no significant evidence that the rs1333040 genotype influenced the hazard of cardiovascular death (p = 0.24) or the reoccurrence of myocardial infarction (p = 0.57), but did provide significant evidence that it influenced on the hazard of coronary revascularization, with adjusted heterozygous and homozygous ratios of 1.38 (95% CI: 1.17 to 1.63) and 1.90 (95% CI: 1.36 to 2.65) (p = 0.00015), respectively. It also significantly influenced the angiographic endpoint of coronary atherosclerosis progression (p = 0.002). CONCLUSIONS: In early-onset myocardial infarction, the 9p21.3 variant rs1333040 affects the progression of coronary atherosclerosis and the probability of coronary artery revascularization during long-term follow-up.

Clinical characteristics and outcome of left ventricular ballooning syndrome in a European population.

We assessed the clinical characteristics and determinants of the prognosis of patients with left ventricular ballooning syndrome (LVBS) in an European population. A total of 128 patients with LVBS (98% women, age 67 ± 11 years) were prospectively followed up for a median of 13 months. A trigger event was identifiable in 58% of the patients. Anterior ST-segment elevation was documented in 38% and negative T waves in 41% of the patients. Apical ballooning was present in 82% and midventricular ballooning in 18%. The initial LV ejection fraction was 41 ± 9%. In-hospital events included the death of 1 patient (0.8%), LV failure in 13 (10%), LV thrombi in 4 (3.1%), sustained ventricular or supraventricular tachyarrhythmias in 6 (4.7%) and asystole in 2 patients (1.6%). The extent of wall motion abnormalities (odds ratio 4.16, p = 0.012), dyspnea at presentation (odds ratio 3.42, p = 0.01), and treatment with nitrates (odds ratio 0.30, p = 0.015) were significant univariate predictors of in-hospital events. The recovery of regional wall motion abnormalities occurred within 1 month of the event in 73% of patients. During follow-up, events occurred in 7 (6%) of 121 patients, including noncardiac death in 1 (0.8%), recurrent LVBS in 2 (1.6%), heart failure in 1 (0.8%), and recurrent chest pain in 3 (2.5%). In conclusion, in a European population, LVBS was characterized by a significant rate of in-hospital events, mainly related to pump failure, and low short-term mortality. The extent of wall motion abnormalities was the best predictor of acute events. Contractile recovery occurred within 1 month in most patients. The long-term prognosis was good, with a recurrence rate of <2%/year.

The first report of late stent thrombosis leading to acute myocardial infarction in patient receiving the new endothelial progenitor cell capture stent.

The endothelial progenitor cell (EPC) capture stent is a stainless steel coronary stent covered with antibodies specific to EPC's surface antigens, designed to promote the faster formation of a functional endothelial lining. This may prevent both stent thrombosis and restenosis as well as reduce the need of prolonged double antiplatelet therapy. Here we report a case of late (156 days after implantation) EPC capture stent thrombosis and re-stenosis of a second EPC capture stent occurring both in the same patient after withdrawal of clopidogrel. Intravascular ultrasound performed during his acute admission showed undersizing of the stent with thrombosis. The present case raises the question about the safety of the EPC capture stent and the need to prolong at least for 6 months double antiplatelet therapy also in patients receiving this new stent.

Inflammatory substrate with eosinophils may be present in bare-metal stent thrombosis.

Coronary stent thrombosis is a rare but life-threatening event after percutaneous revascularization. We report an in-vivo documentation of the pathologic process in the setting of a very late thrombosis within a bare-metal stent, showing eosinophil infiltrates. Interestingly, our case indicates that eosinophil infiltrates might not be a peculiarity of late drug-eluting stent thrombosis.

"Gender paradox" in outcome after percutaneous coronary intervention with paclitaxel eluting stents.

AIMS: To evaluate in-hospital and long-term outcome of women undergoing percutaneous coronary intervention (PCI) with paclitaxel-eluting stents (PES) as compared to men and historic controls treated with bare metal stents. METHODS AND RESULTS: Eight-hundred and ten (810) consecutive patients (642 men and 168 women) with PES were analysed and also compared with 3,515 patients (2,811 men and 704 women) with at least one bare metal stent in the three years previous. In the PES group, women were significantly older than men (mean age of 68+/-10 vs. 63+/-10 years, p<0.001), with more diabetes (39.9 vs. 29.7%, p<0.05), smaller treated vessels (<2.5 mm in 34.9 vs. 24.8%, p=0.003), more left-anterior descending lesions (56.6 vs. 43.2%, p<0.001). More men had multivessel disease (78.8 vs. 62.5%, p<0,001), dyslipidaemia (73.2 versus 65.4%, p<0.05), smoking habit (74.3 versus 34.5%, p<0.001) or prior revascularisation (49.7 versus 36.1%, p<0.05). Compared to bare metal stents, similar higher risk features were recorded in women over time. No gender specific differences in in-hospital outcome were observed. At 12 months the rates of cardiac death, acute myocardial infarction (AMI) and late thrombosis were respectively 2.0%, 3.7% and 0% in women and 2.1%, 3.2%, and 1.2% in men (all p=NS). CONCLUSIONS: Albeit with worse baseline clinical and angiographic characteristics in women, very high immediate success rates and a positive outcome can be achieved in both sexes after PES.

Very late multivessel thrombosis of bare metal stents with concomitant patent drug-eluting stents after withdrawal of aspirin.

Very late stent thrombosis occurs in both drug eluting stent and bare metal stent. Withdrawal of antiplatelet therapy appears to be a potent correlate of late stent thrombosis that leads in majority of cases to acute myocardial infarction or death. A case is reported of very late bare metal stents thrombosis (33 months) in two different vessels after aspirin discontinuation because of a prostatectomy in patient treated simultaneously with bare metal stents and paclitaxel eluting stents, found patent. In conclusion, this case raise the question on the possible need to continue the antiplatelet therapy performing invasive or surgical procedures also in all patients treated with long-standing coronary bare metal stent.

Drug-eluting stents for the percutaneous treatment of the anastomosis of the left internal mammary graft to left anterior descending artery.

BACKGROUND: Data on the treatment of left internal mammary to left anterior descending artery (LIMA-to-LAD) anastomotic disease are scarce and not homogeneous. Both surgery and percutaneous interventions (PCI) have been attempted, but the most effective treatment has not yet been established. In particular, should PCI be performed, the role of stenting seems to be limited by less favorable results than in other subsets of lesions. OBJECTIVE: To assess the clinical impact of drug-eluting stent (DES) use in this particular subset of lesions. METHODS: We describe a cohort of patients treated with PCI on LIMA-to-LAD anastomoses, reporting acute 1-year clinical and angiographic outcomes. The clinical impact of DES use was evaluated as the requirement for target lesion revascularizations (TLR). RESULTS: Fifty-six consecutive patients were evaluated. Acute procedural success was achieved in 52 patients (92.8%). Plain balloon angioplasty allowed acute procedural success in 15 patients (28.8%), whereas stenting was required in 37 patients (71.2%) with suboptimal results or to treat complications. Bare-metal stents (BMS) were used in 17 and DES in 20 patients, without differences in acute results. One-year clinical follow-up was available in 96.1% of patients. TLR were needed in 17.3% of patients. No significant differences were detected in TLR rates after treatment with BMS and DES (26.6% vs. 25%; P=0.99). Two late stent thromboses were observed after DES deployment. CONCLUSION: PCI of the stenoses of LIMA-to-LAD anastomoses with DES did not provide any clinical improvement over BMS use in long-term outcomes; DES use was associated with some cases of late thrombosis.

Immediate removal of femoral-sheath following protamine administration in patients undergoing intracoronary paclitaxel-eluting-stent implantation.

BACKGROUND: Immediate sheath-removal using post-procedural reversal of heparin with protamine reduces groin complications, shortens bed rest and hospital stay after percutaneous coronary intervention (PCI) with bare-metal stents. No data are available with newer and possibly more thrombogenic paclitaxel-eluting stents (PES). AIM: We assessed the safety and efficacy of post-procedural protamine administration after successful coronary PES implantation in elective PCI and in patients with acute coronary syndromes (ACS). METHODS: A consecutive series of 291 patients received 0.5 mg of protamine per 100 units of heparin whenever the post-procedural ACT was > 180 seconds, followed by immediate removal of the sheath (protamine group). Outcomes were compared to a historic control group comprising 291 consecutive patients, who also underwent PCI with PES, but without reversal of anticoagulation by protamine (non protamine group). The incidence of post-procedural vascular complications and bleeding complications, as well as hospital stay, were compared; as were the incidence of major cardiac events at 24 h, 30 days and 6 months. RESULTS: The post-procedural bleeding complications were significantly higher in the non-protamine group. Vascular complications were also more frequent in patients who were not treated with protamine. Hospitalisation length was significantly lower in the protamine group than in the non-protamine group (13.6 +/- 7 h versus 20.41 +/- 3.9 h; p < 0.001). The protamine-group patients also had a significantly reduced bed rest (10.3 h +/- 5.6 h versus 18 h +/- 3.5 h; p < 0.001). During hospitalisation, after PES implantation, no deaths or acute stent thrombosis were observed in either group. The overall incidence of thrombosis and major adverse cardiac events at follow-up were similar in the two groups. CONCLUSIONS: Immediate heparin neutralisation by protamine after successful PES implantation appears to be safe and feasible, also in patients with ACS. Use of protamine and early sheath removal after PCI confers early deambulation and may significantly limit healthcare cost, reduce vascular complications, bedrest, delayed discharge and patient discomfort.