A Comparison of Peri-Procedural Myocardial Infarction between Paclitaxel-Coated Balloon and Drug-Eluting Stent onDe NovoCoronary Lesions

Abstract

PurposeThis study compared the impact of paclitaxel-coated balloons (PCB) or drug eluting stents (DES) on peri-procedural myocardial infarction (PMI) on de novo coronary lesion in stable patients.Materials and MethodsIn this observational study, we compared the incidence of PMI amongst patients with single vessel de novo coronary lesions who underwent treatment with a PCB or DES. Propensity score-matching analysis was used to assemble a cohort of patients with similar baseline characteristics. PMI was classified as myocardial infarction occurring within 48 hours after percutaneous coronary intervention with a threshold of 5 x the 99th percentile upper reference limit of normal for creatine kinase-myocardial band (CK-MB) or troponin T (TnT).ResultsOne hundred four patients (52 receiving PCB and 52 receiving DES) were enrolled in this study. The peak mean values of CK-MB and TnT were significantly higher in the DES group. There was a significantly higher rate of PMI in the DES group (23.1% vs. 1.9%, p=0.002). Total occlusion of the side-branch occurred in two patients treated with DES, while no patients treated with PCB. In multivariable analysis, DES was the only independent predictor of PMI compared with PCB (odds ratio 42.85, 95% confidence interval: 3.44–533.87, p=0.004).ConclusionTreatment with a PCB on de novo coronary lesion might be associated with a significant reduction in the risk of PMI compared to DES.

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

“…[21][22][23][24] Clinical experience in hundred thousand of critically ill patients and the experience especially in coronary trials confirm that no consequences may be expected. [25][26][27] Finally, DCB have been used in intracranial vessels without causing neural deficits. 28,29 In contrast, consideration of the release of embolic debris with lower solubility and by a far larger mass and volume as an unavoidable consequence of angioplasty and stent implantation has been widely neglected 30 because in most interventions and vessel territories it remains with no clinical consequence.…”

Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review

“…Longer-term data is also needed. The finding of a reduced risk of thrombosis and peri-procedural MI in comparative observational studies is also of interest [ 26 , 27 ]. Although reasons for why these results were seen have been speculated, further investigation in a randomized setting would be of use.…”

“… TLR: DCB 0% vs. DES/BMS 5%, p N.S. (12 months, 100%) DCB 1.5 months, bailout BMS 6 months, DES 12 months Sinaga et al (2016) [ 25 ] SeQuent Please (2nd/3rd-Gen DES) NR MACE: DCB 11.6% vs. DES 11.7%, p = 1.000 TLR: DCB 5.2% vs. DES 3.7%, p = 0.601 (12 months, 100%) DCB 6 months, DES 12 months Giannini et al (2017) [ 22 ] IN.PACT Falcon (2nd-Gen DES) NR MACE*: DCB 12.2% vs. DES 15.4%, p = 0.538 TLR: DCB 5.6% vs. DES 4.4%, p = 0.720 (12 months, 100%) DCB 1 month, Bailout BMS 3 months, DES 12 months Her et al (2017) [ 27 ] SeQuent Please (1st/2nd Gen DES) NR Pericprocedural MI: DCB 1.9% vs. DES 23.1% p = 0.002 TLR: DCB 1% vs. DES 0%, p = 1.00 (12 months, 100%) DCB 1.5 months, DES 12 months Venetsanos et al (2018) [ 26 ] SeQuent Please, Pantera Lux, IN.PACT Falcon (2nd/3rd-Gen DES) NR TLR: DCB 0.2% vs. DES 1.1%, HR: 1.05; (95% CI 0.72–1.53) TLT: DCB 7.0% vs. DES 6.2%, HR: 0.18 (95% CI 0.04–0.82) (30 months, 100%) DCB 1 month, DES 6 months Single-armed observational studies Unverdorben et al PEPCAD I (2010, 2013) [ 17 , 18 ] SeQuent Please In-Segment LLL: 0.28 ± 0.53 (6 months, 89%) MACE: 15.3% TLR: 11.9% (36 months, 100%) DCB 1 month, bailout BMS 3 months Cuculi et al (2012) [ 44 ] IN.PACT Falcon NR TLR: 4.8% (12 months, 95%) 1.5 months Woehrle et al SeQuent Please World Wide Registry (2012) [ 35 ] SeQuent Please NR …”

“…However, 88.5% of DES patients were given only a first-generation device, which may explain the poorer outcomes seen. Periprocedural MI is a complication of up to 30% of DES procedures and troponin release after PCI is classically associated with worse outcomes [ 27 ].…”