scholarly journals Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer‐Generation Drug‐Eluting Stents

Author(s):  
Rayyan Hemetsberger ◽  
Mohammad Abdelghani ◽  
Ralph Toelg ◽  
Nader Mankerious ◽  
Abdelhakim Allali ◽  
...  

Background Percutaneous coronary intervention of calcified lesions was associated with worse outcomes in the era of bare‐metal and first‐generation drug‐eluting stents. Data on percutaneous coronary intervention of calcified lesions with newer‐generation drug‐eluting stents are scarce. Therefore, we investigated the impact of lesion calcification on clinical outcomes in patients undergoing percutaneous coronary intervention with a bioresorbable‐polymer sirolimus‐eluting stent or a durable‐polymer everolimus‐eluting stent. Methods and Results Patients (n=2361) from BIOFLOW II, IV, and V trials were categorized into moderate/severe versus none/mild lesion calcification by a core laboratory. End points were target‐lesion failure (TLF) (cardiac death, target‐vessel myocardial infarction, or target‐lesion revascularization) and probable/definite stent thrombosis at 2 years. The agreement in calcification assessment between the operator and the core laboratory was weak (weighted κ, 0.23). Patients with moderate/severe calcification (n=303; 16%) had higher TLF (13.5% versus 8.4%; P =0.003) and stent thrombosis rates (2.1% versus 0.2%; P <0.0001), whereas target‐lesion revascularization was not different between the groups (5.0% versus 3.9%; P =0.302). After adjustment, calcification did not emerge as an independent predictor of TLF (adjusted hazard ratio [aHR], 1.37; 95% CI, 0.89–2.08; P =0.148) but did for target‐vessel myocardial infarction (aHR, 1.66; 95% CI, 1.03–2.68; P =0.037). TLF rates were similar between bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent (12.6% versus 15.4%, P =0.482) in moderate/severe calcification. In none/mild calcification, the bioresorbable‐polymer sirolimus‐eluting stent showed lower TLF (7.5% versus 10.3%, P =0.045). Conclusions With newer‐generation drug‐eluting stents, moderate/severe lesion calcification was not associated with more TLF after adjustment for the higher risk of patients with coronary calcification, whereas the rate of target‐vessel myocardial infarction was higher. The bioresorbable‐polymer sirolimus‐eluting stent and durable‐polymer everolimus‐eluting stent were equally effective and safe in calcified lesions. Registration URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

2020 ◽  
pp. postgradmedj-2020-138243
Author(s):  
Ratna Andriyati ◽  
Doni Firman ◽  
Yovi Kurniawati ◽  
Amir Aziz Alkatiri ◽  
Raymond Pranata ◽  
...  

BackgroundStudies comparing the clinical outcomes of second-generation biodegradable polymer drug-eluting stents (BP-DES) and second-generation durable polymer drug-eluting stents (DP-DES) in patients with ST-segment elevation myocardial infarction (STEMI) with follow-up duration of more than 1 year are still limited.ObjectiveThis study aimed to compare the 2-year clinical outcome of BP-DES with second-generation DP-DES in patients undergoing primary percutaneous coronary intervention (PPCI).MethodsThis is a retrospective cohort study in patients with STEMI, the primary endpoint was major adverse cardiac events (MACE) defined as recurrent myocardial infarction, total repeat revascularisation and cardiac death. The secondary endpoint was stent thrombosis (ST) defined as definite, probable or possible.ResultsA total of 400 patients were analysed (197 BP-DES groups and 203 DP-DES groups). BP-DES were independently associated with lower incidence of MACE (adjusted HR 0.67, 95% CI 0.21 to 0.91, p=0.005) and ST (adjusted HR 0.62, 95% CI 0.19 to 0.73, p<0.016) within 2 years of follow-up. Subgroup analysis of MACE individual components showed that BP-DES were associated with lower cardiac deaths (HR 0.35; 95% CI 0.18 to 0.94; p<0.001) compared to DP-DES, but not recurrent myocardial infarction and total repeat revascularisation.ConclusionsBP-DES were associated with better clinical outcomes compared to second-generation DP-DES in patients with STEMI undergoing PPCI.


2021 ◽  
Vol 10 (24) ◽  
pp. 5898
Author(s):  
Albert Youngwoo Jang ◽  
Jongwook Yu ◽  
Pyung Chun Oh ◽  
Minsu Kim ◽  
Soon Yong Suh ◽  
...  

Biodegradable polymers (BDPs) and ultrathin struts were recently introduced to drug-eluting stents (DES) to further improve outcomes. In this study, we analyzed and compared the effect of the ultrathin strut BDP-DES (UBDP-DES) with the conventional durable polymer-DES (DP-DES) in patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PPCI). A total of 356 STEMI patients (n = 160 in the UBDP-DES group and n = 196 in the DP-DES group) were enrolled. The primary endpoint was target lesion failure (TLF), including cardiac death, target vessel myocardial infarction, and ischemic-driven, target lesion revascularization (ID-TLR). The mean age was 60.3 ± 12.7 years (male 81.7%), and the median follow-up duration was 63.8 months. TLF was numerically more frequent in the UBDP-DES group (8.1% vs. 4.1%; HR 2.14; 95% CI 0.89–5.18; p = 0.091). Propensity score matching (PSM) was performed to balance discrepancies in the baseline characteristics due to patients in the UBDP-DES group initially having more unstable vital signs. However, after PSM (n = 116 in each group), there was no significant difference in TLF (5.3% vs. 5.3%; HR 1.04, 95% CI 0.34-3.22; p = 0.947) or other secondary endpoints including ID-TLR. In the subgroup analysis, subjects with initial acute heart failure (AHF), defined as Killip class ≥ 3, were associated with 13.6% chance of 30-day mortality (9-fold of those without AHF), although chances of repeat revascularization were low (3.0%). Among patients with AHF, the UBDP-DES group was associated with a numerically higher chance of TLF compared with the DP-DES group. There was no difference in TLF between groups in patients without AHF. This study showed that UBDP-DES has long-term clinical outcomes similar to those of conventional DP-DES in real-world Korean STEMI patients receiving PPCI, especially in those without initial AHF.


Author(s):  
Hyo-Soo Kim ◽  
Jeehoon Kang ◽  
Doyeon Hwang ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  

Background: Large scale randomized comparison of drug-eluting stents (DES) based on durable polymer (DP) versus biodegradable polymer (BP) technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study sought to prove the non-inferiority of the DP-DES compared with the BP-DES in such patients. Methods: The HOST-REDUCE-POLYTECH-ACS trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, non-inferiority trial which compared the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary endpoint was patient oriented composite outcome (POCO, a composite of all-cause death, non-fatal myocardial infarction (MI), and any repeat revascularization) at 12 months. The key secondary endpoint was device oriented composite outcome (DOCO; a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months. Results: A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, POCO occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (Absolute risk difference: -1.2%, P non-inferiority <0.001). The key secondary endpoint, DOCO, occurred less frequently in the DP-DES group (DP-DES vs. BP-DES: 2.6% vs. 3.9%, HR 0.67, 95% CI 0.46-0.98, p=0.038), mostly due to a reduction in target lesion revascularization. The rate of spontaneous non-fatal MI and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% vs. 0.8%; p=0.513 and 0.1% vs 0.4%; p=0.174, respectively). Conclusions: In ACS patients receiving percutaneous coronary intervention (PCI), DP-DES was non-inferior to BP-DES with regard to POCO at 12 months after index PCI. Clinical Trial Registration: URL: clinicaltrials.gov Unique identifier: NCT02193971


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