Clinical Research in Cardiology最新文献

Background: Limited data is available for long-term outcomes after percutaneous coronary intervention (PCI) of coronary drug-eluting stent (DES) in-stent restenosis (ISR) in diabetics.

Aims: Thus, the aim of this observational, retrospective study was to close this lack of evidence.

Methods: Between January 2007 and February 2021, a total of 3511 patients with 5497 ISR lesions were treated at two large-volume centers in Munich, Germany, of which 1242 (35.4%) were diabetics. Endpoints of interest were the rates of cardiac death, repeat revascularization, and myocardial infarction (MI). Survival was analyzed using the Kaplan-Meier method. Differences between the groups were tested with the log-rank test. Conventional multivariable analysis with adjustment for relevant variables was performed.

Results: After 10 years, the rates of cardiac death were 42.8% for diabetics and 32.8% for nondiabetics (HR_adj 1.55 [95% CI, 1.31-1.81], p < 0.001). MI occurred in 15.9% of diabetics and in 9.7% of non-diabetics (HR_adj 1.70 [95% CI, 1.36-2.11], p < 0.001). The rates of repeat revascularization of target lesion (HR_adj 1.17 [95% CI, 1.02-1.34], p = 0.028), target vessel, and nontarget vessel were significantly higher in diabetics as compared to nondiabetics. No statistically relevant difference was found regarding the rate of stent thrombosis. Compared to non-insulin-dependent diabetics, insulin-dependent diabetics show higher rates of cardiac death and MI, but comparable revascularization rates in both diabetic groups.

Conclusions: In the long term, the rates of cardiac death, MI, and repeat revascularization after PCI of DES-ISR are significantly higher in diabetics, particularly in insulin-dependent diabetics, than in nondiabetics.

Background: Transradial access (TRA) is recommended as the primary route for coronary angiography (CAG) and percutaneous coronary intervention (PCI). In recent years, a more distal puncture site in the area of the anatomical snuffbox (distal radial access; dRA) has been established. In this randomized multicenter trial, we aim to demonstrate the superiority of dRA with respect to the rate of radial artery occlusion (RAO) compared with the traditional proximal radial access (pRA).

Methods: Patients scheduled for CAG or PCI in five cardiology centers in Germany were randomized for standard pRA or dRA. The primary endpoint was a reduced rate of RAO (superiority) after 30 days. Secondary endpoints included crossover rate, hand function assessed by QuickDASH test, duration of the puncture and procedure, and the puncture success rate. Proximal and distal radial artery patency was examined by ultrasound within 48 h and after 30 days.

Results: A total of 254 patients were enrolled (mean age: 66 ± 10 years, 71% male gender, 48% PCI). The trial was halted prematurely after 50% of the planned population. The primary endpoint was numerically reduced in the dRA group (N = 1/128; 0.9%) compared with the pRA group (N = 3/126, 2.8%), but the difference was not statistically significant (P = 0.36). Puncture success was high in both arms (N = 240/254, 94%) and no statistically significant difference between the two puncture sites (dRA: 91%; pRA: 98%) was observed. Major complications were not encountered.

Conclusion: The rate of radial artery occlusion after dRA for coronary intervention was not significantly reduced compared with pRA.

Trial registration: This study is registered in ClinicalTrials: NCT04194606.

Background: The use of drug-coated balloons (DCB) in percutaneous coronary interventions (PCI) is increasing due to potential benefits mainly by avoiding foreign material although a widespread application area beyond in-stent restenosis lacks robust clinical data to date. As such, we aimed to assess the safety and efficacy of DCBs in treating de novo lesions.

Methods: For this analysis, we included all patients treated with DCB in a de novo lesions from 2010 to 2019 at our institution. We performed a 1:1 propensity score matching to pair each DCB intervention with a comparable DES intervention. Follow-up continued until 09/2022 to assess clinical outcomes.

Results: A total of 303 patients with de novo lesion were matched to 303 patients with comparable baseline characteristics. The median follow-up time was 5.7 years (IQR 2.7-9.3). There were no significant differences in cardiovascular (CV) mortality (HR 1.01 [95% CI 0.87-1.19], p value 0.874), all-cause mortality (HR 1.05 [95% CI 0.91-1.22], p value 0.491), MACE (HR 1.10 [95% CI 0.96-1.26], p value 0.170), acute myocardial infarction (HR 1.08 [95% CI 0.90-1.19], p value 0.308), or any revascularization (HR 1.03 [95% CI 0.90-1.19], p value 0.671) between both groups. However, we observed a trend toward lower rates of target lesion revascularization in patients with small vessel disease (HR 0.84 [95% CI 0.68-1.02], p value 0.072), and in side branch lesions (HR 0.79 [95% CI 0.58-1.04], p value 0.096).

Conclusion: DCBs demonstrated long-term safety and efficacy in de novo lesions, with promising trends in reducing target lesion revascularization in small vessel disease and side branches.

Background: Drug-coated balloons (DCBs) are increasingly used to treat coronary artery disease, and their safety and efficacy profile can vary based on the eluted drug and excipient. Head-to-head comparisons of paclitaxel-coated balloons (PCBs) according to contemporary excipient formulations are scant.

Methods: Consecutive patients undergoing DCB angioplasty with either urea PCB (Prevail, Medtronic, Dublin, Ireland) or iopromide PCB (Sequent Please / NEO, B. Braun, Melsungen, Germany) at two Italian institutions from 2021 to 2024 were retrospectively enrolled. The primary endpoint was target lesion failure (TLF), a composite including target lesion revascularization, target vessel myocardial infarction, and cardiac death, at 1 year. Clinical endpoints were compared through propensity score adjustment for clinical and angiographic variables.  RESULTS: A total of 448 patients were included, with 211 patients (240 lesions) treated with urea PCB and 237 patients (287 lesions) treated with iopromide PCB. The prevalence of in-stent restenosis (ISR) was 30% in the urea PCB group and 23% in the iopromide PCB (p = 0.070). At 1 year, the cumulative incidence of TLF was 8.1% in both groups (adjusted hazard ratio (HR): 0.90, 95% CI: 0.27-3.00). Rates of secondary endpoints were also similar. Subgroup analyses showed no significant interaction between treatment groups and any of the prespecified subgroups, including lesion type (de novo vs. in-stent restenosis; p_interaction = 0.848).  CONCLUSIONS: In this first head-to-head comparison, the Prevail urea PCB and Sequent Please / NEO iopromide PCB demonstrated comparable clinical safety and efficacy profiles at 1 year.

Background: Intravascular ultrasound (IVUS) plays a central role in complex percutaneous coronary interventions (PCI). While guidance for stenting and optimization is the most common reason for IVUS use, the technical application of IVUS for greater procedural efficiency is becoming increasingly important. The impact of IVUS has been only partially investigated in its technical aspect.

Methods: We analyzed 15,226 CTO-PCIs from the EuroCTO registry between January 2022 and December 2023. We compared CTO PCI procedures performed with or without IVUS and further categorized IVUS use based on its application (technical reasons or stent optimization).

Results: IVUS was used in 22% (n = 3393) of cases and increased consistently from 12 to 24% between 2016 and 2023. Guidance for stenting and optimization remained the most common indication (86.4% of IVUS cases). Importantly, IVUS was utilized in 7.2% (n = 1092) of cases for technical reasons, mainly to identify the proximal cap (55.7% of technical indications, n = 608). IVUS-guided CTO-PCIs showed higher J-CTO scores (2.46 ± 1.20 vs. 2.19 ± 1.25; p < 0.001) and greater use of the retrograde approach (28% vs. 19%; p < 0.001). Technical success rates were comparable between the IVUS and angiographic groups (90% vs. 92%; p = ns). High-experience IVUS users achieved greater technical success compared to low- and intermediate-experience users (p < 0.010). On multivariable analysis, IVUS use was an independent predictor of technical success (odds ratio 1.39, 95% CI from 1.07 to 1.82, p value = 0.016).

Conclusions: IVUS in CTO PCI is primarily used for stent optimization. However, there is an increasing use of IVUS for technical reasons resulting in similar technical success rates even in more complex lesions and standing out as an independent predictor of success. Experience seems to play a role, with an advantage for highly experienced users.

Background: Modern contemporary percutaneous coronary intervention (PCI) techniques with drug-eluting stents (DES) have high procedural success rates in chronic total occlusion (CTO) but with a high prevalence of repeat revascularization. The use of drug-coated balloons (DCBs) in CTO is an alternative treatment strategy. The evidence for DCBs in CTO is, therefore, of interest, and we provide a structured and comprehensive review of the evidence available in terms of the use of DCBs in CTO, including de novo and in-stent (IS) CTO lesions.

Objectives: We conducted a systematic review and meta-analysis on the use of DCBs in the management of coronary CTO.

Methods: Electronic databases (PubMed, Embase and Ovid) were systematically searched from inception to April 2024 for DCB CTO studies. A meta-analysis was undertaken using a random-effects inverse-variance method due to heterogeneity. The primary outcome is target lesion revascularization (TLR). Secondary outcomes are major adverse cardiac events (MACE) as a composite of target lesion revascularization (TLR), cardiac death (CD), and any myocardial infarction (MI) including procedural and non-procedural MI, target vessel revascularization (TVR), angiographic outcomes such as late lumen loss (LLL), binary restenosis, and reocclusion.

Results: A total of 10 studies consisting of 1,695 patients were systematically reviewed. This showed that late luminal changes in terms of lumen gain and minimal lumen loss were consistently seen in CTO cohorts 7-12 months after DCB treatment. Five studies were included for meta-analysis with 1,474 patients. There were no significant differences in TLR between treatment strategies such as DCB, DES, and hybrid (DES + DCB) in both de novo and IS-CTO populations as follows: DCB vs DES [OR, 0.71; 95% CI 0.49-1.02], DCB vs DES in IS-CTO [OR, 0.78; 95% CI 0.45-1.34], DCB vs Hybrid [OR, 0.96; 95% CI 0.39-1.43], and hybrid vs DES [OR, 0.76; 95% CI 0.15-3.84]. Similar findings were seen with the MACE outcome. A sensitivity analysis showed no difference between the above-mentioned groups in terms of MI, CD, and TVR.

Conclusion: The limited initial evidence on DCB in coronary CTO-PCI suggests a safe and effective alternative treatment strategy and suggests RCTs are, therefore, required.

Background: Cardiac implantable electronic devices (CIEDs) are increasingly implanted in older patients with multiple comorbidities. The impact of comorbidities on procedural complications and clinical outcomes during and after defibrillator implantation remains a subject of ongoing debate.

Aim: To investigate the associations of the comorbidity burden on baseline characteristics, periprocedural complications, and on outcomes in patients with implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy with defibrillator (CRT-D) implantations or revisions.

Methods: Patients who underwent ICD or CRT-D implantations or revisions at 50 centers were prospectively enrolled in the German Device Registry. Data on patient characteristics, periprocedural complications, and outcomes were collected. Patients were categorized into four groups based on cardiometabolic comorbidities (stroke, chronic kidney disease (CKD), diabetes, hypertension): group I (no comorbidities), group II (one), group III (two), and group IV (three or four). Primary outcomes included 1-year all-cause mortality, major adverse cardiac and cerebrovascular events (MACCE), and arrhythmic/non-arrhythmic events. The Kaplan-Meier analysis was used to determine 1-year mortality.

Results: Overall, 5329 patients (mean age 65.2 years) underwent 3794 ICD and 1535 CRT-D implantations. Median follow-up was 17 months. Periprocedural complications (group I: 2.1%, group II: 1.5%, group III: 2.1%, group IV: 2.4%; p = 0.91) and in-hospital MACCE (group I: 0.2%, group II: 0.4%, group III: 0.6%, group IV: 0.4%; p = 0.25) were not related to comorbidity burden. Higher comorbidity burden was associated with a higher 1-year all-cause mortality (p < 0.001), but ICD shocks did not differ between groups (p = 0.97). The MADIT-ICD non-arrhythmic mortality score increased with comorbidities (p < 0.001), while the VT/VF score remained unchanged.

Conclusions: Periprocedural complications do not appear to be affected by cardiometabolic comorbidities in patients undergoing ICD or CRT-D implantation in Germany. As expected, multimorbidity was associated with a higher risk of mortality and MACCE without detectable effects on ventricular arrhythmias.