Aleksandra Pluta

Treatment of left main coronary artery stenosis with the STENTYS self-expandable drug-eluting stent - a pilot registry

Percutaneous coronary intervention (PCI) of the left main coronary artery (LMCA) for revascularization after stenosis is still considered controversial therapy. Previous studies were performed with balloon-expandable drug-eluting stents (DES). Balloon-expandable stents presented a challenge because they were not able to adapt effectively to variation in the vessel lumen. There are limited data on LMCA therapy with self-expandable DES for treatment of medial and distal lesions. The advantages of a self-apposing stent are adaptation to vessel size, vessel tapering, stent sizing, and good apposition. This was a pilot study to determine safety and device success rate in patients with middle and distal LMCA stenosis treated with the STENTYS self-expanding coronary DES stent. The primary endpoints were device success, acute procedural success and in-hospital and 30-day MACE. Twenty-four patients were included. Median logistic EuroSCORE was 1.6% (1.1–2.6%). Median Syntax score was 20.0 (20.0–27.2) points. Significant stenosis according to the anatomical region was in the middle of the LMCA in 5 cases (21%) and the distal part in 19 (79%). Stent sizes used were: 3.0 × 3.5 mm in 9 (37.5%); 3.5 × 4.0 mm in 3 (12.5%); 3.5 × 4.5 mm in 12 (50%). Device success and acute procedural success were achieved in 23 patients (95.8%), with no edge dissection in any patient. In 1 patient the proximal end of the stent protruded into the aorta. In all patients during their hospitalization and 30-day follow-up there were no adverse events. The data compiled from this small, single-center pilot study suggest that the STENTYS self-expanding coronary stent may be a reasonable approach to treat lesions within the LMCA. These results warrant a larger future clinical trial.

Comparison of First- and Second-Generation Drug-Eluting Stents in an All-Comer Population of Patients with Diabetes Mellitus (from Katowice-Zabrze Registry)

Background This study compared safety and efficacy of first- and second-generation DES in an unrestricted, real-life population of diabetic patients undergoing PCI. Material/Methods The study was a subanalysis of diabetic patients from the all-comer Katowice-Zabrze Registry of patients undergoing PCI with the implantation of either first- (Paclitaxel-, Sirolimus-eluting stents) or second-generation DES (Zotarolimus-, Everolimus-, Biolimus-eluting stents). Efficacy defined as major adverse cardiac and cerebrovascular events (MACCE: death, myocardial infarction, target vessel revascularization, stroke) and safety defined as stent thrombosis (ST) were evaluated at 1 year. Results From the total of 1916 patients, 717 were diabetics. Among them, 257 (36%) were treated with first-generation DES (230 [89%] Paclitaxel-eluting stents, 27 [11%] Sirolimus-eluting stents), 460 with second-generation DES (171 [37%] Zotarolimus-eluting stents, 243 [53%] Everolimus-eluting stents, 46 [10%] Biolimus-eluting stents). Rate of MACCE was equal in both groups (p=0.54). Second-generation DES had a better safety profile than first-generation DES (log-rank for cumulative ST at 1 year p<0.001). First-generation DES was a risk factor for ST (HR 5.75 [1.16–28.47], p=0.03) but not for MACCE (HR 0.89 [0.6–1.32], p=0.57). Conclusions In a real-life setting of diabetic patients undergoing PCI, second-generation DES had lower risk of ST and similar MACCE rate compared to first-generation DES.

Long-Term Percutaneous Coronary Intervention Outcomes of Patients with Chronic Kidney Disease in the Era of Second-Generation Drug-Eluting Stents

Background: The following registry (Katowice-Zabrze retrospective registry) aimed to assess the influence of a chronic kidney disease (CKD) on long-term clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) using either first-generation (DES-I) or second-generation (DES-II) drug-eluting stents. Methods: The study group consisted of 1,908 consecutive patients, of whom 331 (17.3%) had CKD. CKD was defined as an estimated glomerular filtration rate of <60 mL/min/m2. We evaluated the major adverse cardiac and cerebral events (MACCE), i.e., the composite of death, myocardial infarction (MI), stroke, and target vessel revascularization at the 12-month follow-up. Results: CKD patients had a lower left ventricular ejection fraction and more often a history of MI and PCI. Coronary angiography revealed that multivessel coronary artery disease, intracoronary thrombus, and extensive calcifications were more frequent in patients with CKD. However, the SYNTAX score did not vary between patients with or without CKD. There was a higher rate of in-hospital bleedings requiring blood transfusion in patients with CKD. At the 1-year follow-up, MACCE (17.8 vs. 12.6%, HR = 1.46 [95% CI 1.05-2.03], p = 0.009) and death (8.4 vs. 2.3%, HR = 3.9 [95% CI 2.0-7.5], p < 0.001) were more often observed in CKD patients. Multivariable Cox analysis revealed that CKD was an independent risk predictor of death after PCI at the 1-year follow-up (HR = 2.1 [95% CI 1.2-3.6], p = 0.004). In comparison to DES-I, the use of DES-II did not decrease the adverse effect of CKD on MACCE. Conclusion: CKD patients had an increased risk of in-hospital bleeding requiring blood transfusion and a higher risk of MACCE and death at the 12-month follow-up. The use of second-generation DES did not improve clinical outcomes in patients with CKD at the 12-month follow-up.

First- Versus Second-Generation Drug-Eluting Stents in Acute Coronary Syndromes (Katowice-Zabrze Registry)

Background There are sparse data on the performance of different types of drug-eluting stents (DES) in acute and real-life setting. Objective The aim of the study was to compare the safety and efficacy of first- versus second-generation DES in patients with acute coronary syndromes (ACS). Methods This all-comer registry enrolled consecutive patients diagnosed with ACS and treated with percutaneous coronary intervention with the implantation of first- or second-generation DES in one-year follow-up. The primary efficacy endpoint was defined as major adverse cardiac and cerebrovascular event (MACCE), a composite of all-cause death, nonfatal myocardial infarction, target-vessel revascularization and stroke. The primary safety outcome was definite stent thrombosis (ST) at one year. Results From the total of 1916 patients enrolled into the registry, 1328 patients were diagnosed with ACS. Of them, 426 were treated with first- and 902 with second-generation DES. There was no significant difference in the incidence of MACCE between two types of DES at one year. The rate of acute and subacute ST was higher in first- vs. second-generation DES (1.6% vs. 0.1%, p < 0.001, and 1.2% vs. 0.2%, p = 0.025, respectively), but there was no difference regarding late ST (0.7% vs. 0.2%, respectively, p = 0.18) and gastrointestinal bleeding (2.1% vs. 1.1%, p = 0.21). In Cox regression, first-generation DES was an independent predictor for cumulative ST (HR 3.29 [1.30-8.31], p = 0.01). Conclusions In an all-comer registry of ACS, the one-year rate of MACCE was comparable in groups treated with first- and second-generation DES. The use of first-generation DES was associated with higher rates of acute and subacute ST and was an independent predictor of cumulative ST.

Impact of anaemia on long-term outcomes in patients treated with first- and second-generation drug-eluting stents; Katowice-Zabrze Registry

BACKGROUND Coexisting anaemia is associated with an increased risk of major adverse cardiac and cerebrovascular events (MACCE) and bleeding complications after percutaneous coronary intervention (PCI), especially in patients with acute coronary syndrome. AIM To assess the impact of anaemia in patients with coronary artery disease (CAD) treated with first- and second-generation drug-eluting stents (DES) on one-year MACCE. METHODS AND RESULTS The registry included 1916 consecutive patients (UA: n = 1502, 78.3%; NSTEMI: n = 283, 14.7%; STEMI/LBBB: n = 131, 6.8%) treated either with first- (34%) or second-generation (66%) DES. The study population was divided into two groups: patients presenting with anaemia 217 (11%) and without anaemia 1699 (89%) prior to PCI. Anaemia was defined according to World Heart Organisation (haemoglobin [Hb] level < 13 g/dL for men and < 12 g/dL for women). Patients with anaemia were older (69, IQR: 61-75 vs. 62, IQR: 56-70, p < 0.001), had higher prevalence of co-morbidities: diabetes (44.7% vs. 36.4%, p = 0.020), chronic kidney disease (31.3% vs. 19.4%; p < 0.001), peripheral artery disease (10.1% vs. 5.4%, p = 0.005), and lower left ventricular ejection fraction values (50, IQR: 40-57% vs. 55, IQR: 45-60%; p < 0.001). No difference between gender in frequency of anaemia was found. Patients with anaemia more often had prior myocardial infarction (MI) (57.6% vs. 46.4%; p = 0.002) and coronary artery bypass grafting (31.3% vs. 19.4%; p < 0.001) in comparison to patients without anaemia. They also more often had multivessel disease in angiography (36.4% vs. 26.1%; p = 0.001) and more complexity CAD as measured by SYNTAX score (21, IQR: 12-27 points vs. 14, IQR: 8-22 points; p = 0.001). In-hospital risk of acute heart failure (2.7% vs. 0.7%; p = 0.006) and bleeding requiring transfusion (3.2% vs. 0.5%; p < 0.001) was significantly higher in patients with anaemia. One-year follow-up showed that there was higher rate of death in patients with anaemia. However, there were no differences in MI, stroke, target vessel revascularisation (TVR) and MACCE in comparison to patients with normal Hb. There were no differences according to type of DES (first vs. second generation) in the population of patients with anaemia. CONCLUSIONS In patients with anaemia there is a significantly higher risk of death in 12-month follow-up, but anaemia has no impact on the incidence of MI, repeat revascularisation, stroke and MACCE. There is no advantage of II-DES over I-DES generation in terms of MACCE and TVR in patients with anaemia.

Randomized, comparative study of the effectiveness of three different techniques of interscalene brachial plexus block using 0.5% ropivacaine for shoulder arthroscopy

BACKGROUND Interscalene brachial plexus block is an effective regional anesthesia technique for shoulder surgeries. The superiority of the popular ultrasound-guided blocks over peripheral nerve stimulator-confirmed blocks remains unclear. In this study the efficacy of these different block techniques was compared. METHODS This prospective, randomized, clinical study included 109 patients (ASA grades I-III) who receive 20 mL 0.5% ropivacaine with ultrasound-guided blocks (U group), peripheral nerve stimulator-confirmed blocks (N group), or ultrasound-guided and peripheral nerve stimulator-confirmed blocks (dual guidance; NU group) for elective shoulder arthroscopy. Block onset time, duration, and effectiveness on the Lovett rating scale were assessed. RESULTS There was no statistically significant intergroup difference in duration of block performance, irrespective of the technique (P = 0.232). Onset time of complete warmth sensation loss (P < 0.001) and muscle strength abolition (P < 0.001) was significantly longer and mean Lovett rating scale score distribution was significantly higher in the N group than in the other groups (P < 0.001). These findings show a statistically significant correlation between the performance of the used block technique and the necessity of conversion to general anesthesia because of insufficient block in the N group (58.54%) than in the U (24.44%) and NU (19.57%) groups. CONCLUSIONS Peripheral nerve stimulator-confirmed needle placement is not necessary to ensure effectiveness of ultrasound-guided blocks, which is expressed as a lack of necessity of conversion to general anesthesia. Nevertheless, the dual guidance technique is recommended to reduce the risk of complications and might be considered the regional anesthesia of choice for shoulder surgery.

Risk factors for the development of Horner’s syndrome following interscalene brachial plexus block using ropivacaine for shoulder arthroscopy: a randomised trial

BACKGROUND Horners syndrome is comprised of a set of symptoms caused by a permanent or transient ipsilateral sympathetic trunk lesion or paralysis. It may occur after numerous pathologies in the cervical region, epidural, spinal anaesthesia, and interscalene, transscalene, supraclavicular, or infraclavicular brachial plexus block. The aim of this randomised, prospective clinical study was to evaluate the effect of the interscalene brachial plexus block (IBPB) technique on the occurrence rate of Horners syndrome and identify contributing risk factors. METHODS 108 randomly selected patients of ASA I-III status were scheduled for elective shoulder arthroscopy. The patients received 20 mL of 0.5% ropivacaine either with ultrasound (US)-guided IBPB (U), peripheral nerve stimulation (PNS)-confirmation IBPB (N), or US-guided, PNS-confirmed IBPB (dual guidance; NU). RESULTS We observed that Horners syndrome developed in 12% of the N group, 6% of the NU group, and 9% of the U group. The differences in the rates were not statistically significant (P = 0.616). Regardless of the technique used to induce IBPB, our study did not demonstrate any particular anthropometric parameter that predisposed the patients to the development of Horners syndrome. Interestingly, our results showed that NU patients with Horners syndrome were significantly younger than NU patients without Horners syndrome. CONCLUSION The precision of IBPB by use of the dual guidance technique may reduce the rate of Horners syndrome. The higher water concentration in the prevertebral spaces of younger patients may create better conditions for the diffusion of ropivacaine, which may result in a statistically significant higher HS rate.

Gender differences and bleeding complications after PCI on first and second generation DES

Abstract Background. The aim of this study was to evaluate gender differences in the long-term clinical outcomes and safety of patients treated with first- and second generation DES. Methods. The Katowice–Zabrze Registry included 1916 consecutive patients treated with either first or second generation DES. We evaluated major adverse cardiac and cerebrovascular events (MACCE) [composite of death, myocardial infarction (MI), stroke and target vessel revascularization (TVR)] at 12-month follow-up. Safety end point was bleeding complications and stent thrombosis. Results. Registry included [unstable angina (UA) 1500(78%), non-ST-segment elevation myocardial infarction (NSTEMI) 285 (15%), ST-segment elevation myocardial infarction/left bundle branch block (STEMI/LBBB) 131 (7%)]. There were 35.5% females and 64.5% males. Women were older and had higher prevalence of comorbidities. Males more often had multivessel disease and higher Syntax score when comparable to females. We did not observed difference in acute and subacute stent thrombosis in our data, however, females had more in-hospital bleeding complications. Univariable Cox regression analysis revealed that women had similar outcomes when compared to men in terms of a risk of death, MI, TVR, stroke and MACCE at 1-year follow-up. There were no differences between males and females in MACCE when first- and second generation DES were analyzed separately. Conclusion. Despite higher risk profile, women treated with DES have similar outcomes as males in 1-year follow-up. However there is, an increased risk of in-hospital bleedings in women.

Randomised controlled trial of analgesic effectiveness of three different techniques of single-shot interscalene brachial plexus block using 20 mL of 0.5% ropivacaine for shoulder arthroscopy

BACKGROUND Shoulder arthroscopic procedures impose a challenge to anaesthesiologists in terms of postoperative analgesia. Proper pain management after arthroscopic procedures improves patient satisfaction and facilitates early rehabilitation. METHODS We performed a randomized, prospective clinical study to assess the influence of anthropometric parameters and IBPB technique on the quality of postoperative analgesia. A total of 106 randomly selected patients of ASA I-III status scheduled for elective shoulder arthroscopy. Reasons for exclusion were neurological deficit in the upper arm, allergies to amide-type local anesthetics, coagulopathy, and pregnancy.The patients received 20 mL of 0.5% ropivacaine for an ultrasound-guided interscalene brachial plexus block (IBPB) (group U), peripheral nerve stimulation (PNS)-confirmed IBPB (group N), or ultrasound-guided, PNS-confirmed IBPB (dual guidance; group NU). RESULTS We observed that the three groups did not differ in mean time of sensory and motor block terminations. In individual cases in each group, sensory block lasted up to 890-990 minutes, providing satisfactory long lasting postoperative analgesia in patients receiving IBPB. We observed a negative correlation between body mass index and termination of motor block (P = 0.037, Pearsons correlation coefficient) and a positive correlation between age and termination of sensory block (P = 0.0314, Pearsons correlation coefficient) in group U compared to the other two groups. We found a positive correlation between male gender and termination of motor block (P = 0.0487, Pearsons correlation coefficient) in group N compared to the other two groups. CONCLUSION In our study, patients received satisfactory analgesia in the postoperative period regardless of technique used, age, gender, or potentially uncommon anthropometry.

Stents Farmacológicos de Primeira Versus Segunda Geração na Síndrome Coronariana Aguda (Registro Katowice-Zabrze)

Background There are sparse data on the performance of different types of drug-eluting stents (DES) in acute and real-life setting. Objective The aim of the study was to compare the safety and efficacy of first- versus second-generation DES in patients with acute coronary syndromes (ACS). Methods This all-comer registry enrolled consecutive patients diagnosed with ACS and treated with percutaneous coronary intervention with the implantation of first- or second-generation DES in one-year follow-up. The primary efficacy endpoint was defined as major adverse cardiac and cerebrovascular event (MACCE), a composite of all-cause death, nonfatal myocardial infarction, target-vessel revascularization and stroke. The primary safety outcome was definite stent thrombosis (ST) at one year. Results From the total of 1916 patients enrolled into the registry, 1328 patients were diagnosed with ACS. Of them, 426 were treated with first- and 902 with second-generation DES. There was no significant difference in the incidence of MACCE between two types of DES at one year. The rate of acute and subacute ST was higher in first- vs. second-generation DES (1.6% vs. 0.1%, p < 0.001, and 1.2% vs. 0.2%, p = 0.025, respectively), but there was no difference regarding late ST (0.7% vs. 0.2%, respectively, p = 0.18) and gastrointestinal bleeding (2.1% vs. 1.1%, p = 0.21). In Cox regression, first-generation DES was an independent predictor for cumulative ST (HR 3.29 [1.30-8.31], p = 0.01). Conclusions In an all-comer registry of ACS, the one-year rate of MACCE was comparable in groups treated with first- and second-generation DES. The use of first-generation DES was associated with higher rates of acute and subacute ST and was an independent predictor of cumulative ST.