| Abstract | Introduction: The aim of this study is to assess the efficacy of drug-coated balloons (DCB) in percutaneous coronary artery interventions (PCI) in treatment of de novo coronary artery lesions in diabetic patients.
Materials and Methods: This retrospective study enrolled 225 patients that were treated at the University Hospital Center Zagreb between November 2011 and August 2022. All data were collected from the hospital documentation systems. The patients were divided into two primary groups: diabetics and non-diabetics.
Results: Out of a total of 225 patients, 59 (26.2%) were included in the diabetic group and 166 (73.8%) in the nondiabetic group. The following sociodemographic and clinical characteristics were statistically significantly different between the two groups: arterial hypertension (diabetics 98.3% vs non-diabetics 83.7% p<0.001), smoking status (diabetics 19% vs non-diabetics 34.8%, p<0.030), body mass index -BMI (diabetics 9.7 % vs non-diabetics 27.8 %, CI 27.7-28.9, p< 0.005) and history of prior myocardial infarction (diabetics 45.8% vs non-diabetics 30.1%, p<0.038). There were no significant differences between intervention indications and angiographic findings except for a significantly higher rate of triple vessel disease among diabetics (67.8% vs 40.4%, p<0.001) and single vessel disease in non-diabetics (12% vs 27%, p<0.029). There were no statistically significant differences in early post-procedural findings or procedural complications. The mean clinical follow-up for patients was 30.6 months. The rates of angiographic follow-up were significantly higher in the diabetic group (64.4% vs 34.9%, p<0.001), as were the rates of elective angiographies (59.3% vs 31.9%, p<0.001). Out of our primary end points, only target lesion revascularization (TLR) was statistically significant higher in the diabetic group (18.6% vs 3%, p<0.001). New acute coronary syndrome during follow-up (diabetics 11.9% vs non-diabetics 4.2%, P<0.055) and re-hospitalization rates (diabetics 14% vs non-diabetics 6.1%, p<0.087) were higher in the diabetic group but did not reach statistical significance. Although we don’t have follow-up for all patients (23 were lost for follow-up), there was no death due to cardiac causes.
Conclusion: DCB-only in PCI of de novo coronary artery lesions is associated with higher rates of TLR in diabetic patients. This doesn’t affect clinical outcomes of this patients because MACE (new acute coronary syndrome and rates of re-hospitalization) although higher did not reach statistical significance. Diabetes mellitus is a predictor of worse DCB-only PCI angiographic outcomes in the novo coronary artery lesions, however; this does not render DCBs unsafe for usage. |
| Abstract (croatian) | Uvod: Cilj ovog istraživanja je procijeniti učinkovitost perkutane koronarne intervencije (PCI) pomoću balona oboženim lijekom (drug coated balloon - DCB) u “de-novo” lezijama koronarnih arterija u bolesnika sa šećernom bolesti.
Materijali i metode: Ovo retrospektivno istraživanje uključilo je 225 bolesnika koji su liječeni u Kliničkom bolničkom centru Zagreb od studenog 2011. do kolovoza 2022. Svi podaci su prikupljeni iz bolničkih dokumentacijskih sustava. Bolesnici su podijeljeni u dvije skupine: dijabetičari i ne-dijabetičari.
Rezultati: Od ukupno 225 bolesnika, 59 (26,2%) je bilo uključeno u skupinu s dijabetesom, a 166 (73,8%) u skupinu bez dijabetesa. Sljedeće sociodemografske i kliničke karakteristike značajno su se razlikovale između ove dvije skupine bolesnika: arterijska hipertenzija (dijabetičari 98,3% vs ne-dijabetičari 83,7%, p<0,001), pušenje (dijabetičari 19% vs ne-dijabetičari 34,8%, p<0,030), index tjelesne mase - BMI (dijabetičari 29,7% vs. ne-dijabetičari 27,8%, CI 27,7-28,9, p<0,005) i prethodni infarkt miokarda (dijabetičari 45,8% vs ne-dijabetičari 30,1%, p<0,038). Nije bilo statistički značajnih razlika u indikacijama za intervenciju i u angiografskim nalazima, osim značajno većeg postotka trožilne koronarne bolesti među dijabetičarima (67,8% vs 40,4%, p<0,001) i jednožilne koronarne bolesti kod ne-dijabetičara (12% vs 27%, p<0,029). Nije bilo statistički značajnih razlika u ranom post-proceduralnom angiografskom rezultatu ili proceduralnim komplikacijama. Prosječno kliničko praćenje bilo je 30,6 mjeseci. Stope angiografskog praćenja bile su značajno više u skupini bolesnika s dijabetesom (64,4% vs 34,9%, p<0,001), kao i stope elektivnih koronarografija (59,3% vs 31,9%, p<0,001). Od primarnog ishoda, samo je revaskularizacija ciljne lezije (target lesion revasularization- TLR) bila statistički značajno viša u bolesnika sa šećernom bolesti (18,6% vs 3%, p<0,001). Iako su novi akutni koronarni sindrom (dijabetičari 11,9% vs ne-dijabetičari 4,2%, p<0,055) i rehospitalizacija (dijabetičari 14% vs ne-dijabetičari 6,1%, p<0,087) bili češći u bolesnika sa šećernom bolesti, nisu postigle statističku značajnost. Nitko od bolesnika nije umro tijekom kliničkog praćenja, iako nedostaju podaci za 23 bolesnika.
Zaključak: PCI pomoću DCB-a u “de-novo” lezija koronarnih arterija povezan je s većom učestalosti TLR-a u bolesnika sa šećernom bolesti što međutim, ne utječe na njihov klinički ishod. Naime, MACE (major adverse cardiovascular events) koji se sastoji od novog akutnog koronarnog sindroma i rehospitalizacije, iako viši u bolesnika sa šećernom bolesti nije postigao statističku značajnost. Iako je šećerna bolest prediktor lošijeg angiografskog ishoda u perkutanoj koronarnoj intervencji pomoću DCB-a, njihova primjena je sigurna i efikasna u tih bolesnika. |
