A Non-inferiority,Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Cardiovascular Drugs and Therapy - Drug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including...     

Angiographic and Clinical Outcomes After Stent-less Coronary Intervention Using Rotational Atherectomy and Drug-Coated Balloon in Patients with De Novo Lesions

ObjectivesWe investigated angiographic and clinical outcomes in patients with de novo lesions undergoing rotational atherectomy (RA) followed by drug-coated balloon (DCB) dilation (RA/DCB).BackgroundImplantation of drug-eluting stent (DES) has been a mainstay of the interventional treatment of coronary artery disease (CAD); however, there still remain several DES-unsuitable clinical/lesion conditions. Nowadays DCB for de novo lesions has attracted more attention, and RA, which tends not to cause major dissection but to debulk intima, might be one of suitable pre-treatments before DCB.Methods and resultsThirty patients (34 lesions) undergoing RA/DCB for de novo lesions were enrolled. Clinical/lesion background included severe calcification, calcified nodule, inlet/outlet of aneurysm, ostial lesion, severe thrombocytopenia, bleeding tendency, and/or sequelae of Kawasaki disease. The largest burr size used was 1.83 ± 0.23 mm, and the mean DCB diameter was 2.71 ± 0.47 mm. Angiographic success was obtained in 94% of the lesions. No acute closure but 1 no reflow occurred. Repeat angiography (mean, 6.6 months after procedure) was performed for 19 lesions. Frequency of binary restenosis was 21.1%, and late lumen loss was 0.34 ± 0.30 mm. During a mean follow-up period of 13.1 months, 6 deaths (2 sudden deaths, 1 cardiac death, 3 non-cardiac deaths), 2 strokes, and 2 target lesion revascularizations were observed.ConclusionsStent-less PCI using RA/DCB might be an alternative revascularization therapy for CAD patients complicated with DES-unsuitable conditions.     

Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial

ObjectivesThis study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions.BackgroundSmall vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes.MethodsThe PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months.ResultsBetween May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm.ConclusionsIn this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818)     

冠状动脉支架对完全闭塞与非闭塞病变的疗效比较

为比较冠状动脉支架对完全闭塞与非闭塞病变的即时结果和长期疗效,对516例(687处病变)行冠状动脉支架术的患者进行分析.将患者按手术部位的阻塞程度分为完全闭塞组(142例,160处病变)和非闭塞组(374例,527处病变),观察两组患者行冠状动脉支架术后的即时疗效及临床和造影复查的结果.结果显示完全闭塞组术前血管最小腔径显著小于非闭塞组(P<0.001),而术后两组没有统计学差异;临床并发症两组差异无显著性,影像学并发症完全闭塞组显著高于非闭塞组(6.1%比2.5%,P<0.05);完全闭塞组27.8%的病变可见再狭窄,非闭塞组23.7%的病变可见再狭窄,两组比较无显著性差异;随访临床事件完全闭塞组25.2%,非闭塞组22.7%,两组比较无显著性差异.以上结果表明冠状动脉支架对冠状动脉完全闭塞病变的即时结果和长期疗效均与非闭塞病变相近.     

Direct Coronary Stenting in Noncomplex and Noncalcified Lesions: Immediate and Mid-term Results of a Prospective Registry

Stenting of coronary arteries is currently used in clinical practice. The aim of this prospective registry was to assess the feasibility and the safety of stent implantation without balloon predilatation in noncomplex and noncalcifed lesions. One hundred six stents were implanted in 85 patients who underwent percutaneous coronary angioplasty (PTCA) of native vessels (n = 95) or bypass grafts (n = 11). The lesions were type A (21%) or B1 (79%). The stent was a tubular or a coil stent in 71 ± and 29% of the cases, respectively. The angiographic success rate was 94%. The maximal pressure was 12.1 ± 2.1 atm. In only 7 cases, it was not possible to cross the stenosis with the stent, necessitating retrieval of it and predilation with a balloon before stent implantation. Three dissections after stent implantation were treated by a second stent implantation. The primary success rate was 98% (no acute closure or myocardial infarction). A clinical follow-up was obtained in 98% of patients with a mean delay of 6 ± 0.5 months. Eighty-one percent of patients were asymptomatic. The target lesion revascularization rate was 9.4%. Four patients underwent a new PTCA and four patients a coronary artery bypass graft surgery. This technique of stent implantation appears to be safe with good immediate and midterm results. A prospective randomized trial comparing this technique to the standard technique of stent delivery in noncomplex lesions is currently ongoing with an intravascular ultrasound substudy.     

Excimer Laser Angioplasty with Adjunctive Balloon Dilatation Versus Balloon Dilatation Alone for the Treatment of In-Stent Restenosis: Results of a Randomized Single-Center Study

Background: Laser ablation of neointimal tissue prior to balloon dilatation has been shown to be a potential treatment modality for restenosis within previously implanted stents. It remains controversial whether this treatment provides superior acute and long-term results compared to conventional balloon dilatation. Methods and Results: Between November 1995 and November 1996, 96 patients with significant (≥ 50%) in-stent restenosis were randomized to receive excimer laser angioplasty with adjunctive balloon dilatation (ELCA + PTC A, n = 47) or PTCA alone (n = 49). Both groups did not differ with regard to gender, clinical history, location of the lesion, reference diameter, or lesion length. Angiographic success was achieved in 46 patients with ELCA + PTCA (98%) and in 48 patients with PTCA alone (98%). In-hospital complications included acute closure in one patient of each group, one CABG, one repeat PTCA, and one non-Q wave MI with ELCA + PTCA, versus two bleeding and one death with PTCA. Clinical follow-up was obtained in all patients, while angiographic follow-up was available in 35 of 47 (ELCA+PTCA) versus 35 of 49 (PTCA) patients with a mean follow-up time of 163 ± 81 days. With ELCA+PTCA, MLD increased from 0.82 ± 0.38 to 1.99 ± 0.33 mm versus 0.81 ± 0.39 mm to 2.07 ± 0.60 mm with PTCA (P = NS). At follow-up, MLD was 1.32 ± 0.60 mm with ELCA + PTCA versus 1.45 ± 0.75 mm with PTCA (P = NS). Late adverse events included nine repeat PTCA with ELCA +PTCA (19%) versus 12 with PTCA (24%), three CABG with ELCA +PTCA (6%) versus two with PTCA (4%), and one death (2%) with PTCA (P = NS). Angiographic restenosis rate was 52% with ELCA + PTCA versus 47% with PTCA alone (P = NS). Conclusion: Our data suggest that excimer laser angioplasty with adjunctive balloon dilatation for the treatment of in-stent restenosis provides similar acute results as plain balloon dilatation and may offer no advantage over PTCA alone with regard to intermediate-term outcomes.     

Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stenting for the Treatment of Infrapopliteal Long-Segment Arterial Occlusive Disease: The IDEAS Randomized Controlled Trial

ObjectivesThis study sought to report the results of a prospective randomized controlled trial comparing paclitaxel-coated balloons (PCB) versus drug-eluting stents (DES) in long infrapopliteal lesions.BackgroundDES have an established role in the treatment of short infrapopliteal lesions, whereas there is increasing evidence for the use of PCB in longer below-the-knee lesions.MethodsInclusion criteria were patients with Rutherford classes 3 to 6 and angiographically documented infrapopliteal disease with a minimum lesion length of 70 mm. The primary endpoint was target lesion restenosis >50% assessed by digital angiography at 6 months. Secondary endpoints included immediate post-procedure stenosis and target lesion revascularization.ResultsFifty patients were randomized to undergo infrapopliteal PCB angioplasty (25 arteries in 25 limbs; PCB group) or primary DES placement (30 arteries in 27 limbs; DES group). Immediate residual post-procedure stenosis was significantly lower in DES (9.6 ± 2.2% vs. 24.8 ± 3.5% in PCB; p < 0.0001). At 6 months, 5 patients died (2 in PCB vs. 3 in DES; p = 1.00) and 3 suffered a major amputation (1 in PCB vs. 2 in DES; p = 1.00). In total, 44 angiograms were evaluable with quantitative vessel analysis. Binary (>50%) angiographic restenosis rate was significantly lower in DES (7 of 25 [28%] vs. 11 of 19 [57.9%] in PCB; p = 0.0457). There were no significant differences with regard to target lesion revascularization (2 of 26 [7.7%] in DES vs. 3 of 22 [13.6%] in PCB; p = 0.65). Positive vessel wall remodeling was observed in 3 cases in the PCB arm (3 of 19 [(15.8%)] vs. 0 of 19 [0%] in DES; p = 0.07).ConclusionsCompared with PCB in long infrapopliteal lesions, DES are related with significantly lower residual immediate post-procedure stenosis and have shown significantly reduced vessel restenosis at 6 months. PCB may produce positive vessel remodeling. (Infrapopliteal Drug-Eluting Angioplasty Versus Stenting [IDEAS-I]; NCT01517997)     

Randomized Comparison of FFR-Guided and Angiography-Guided Provisional Stenting of True Coronary Bifurcation Lesions: The DKCRUSH-VI Trial (Double Kissing Crush Versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions VI)

ObjectivesThis study sought to compare the outcomes of fractional flow reserve (FFR)–guided and angiography (Angio)–guided provisional side-branch (SB) stenting for true coronary bifurcation lesions.BackgroundAngio-guided provisional SB stenting after stenting of the main vessel provides favorable outcomes for the majority of coronary bifurcation lesions. Whether an FFR-guided provisional stenting approach is superior has not been studied.MethodsA total of 320 patients with single Medina 1,1,1 and 0,1,1 coronary bifurcation lesions undergoing stenting with a provisional SB approach were randomly assigned 1:1 to Angio-guided and FFR-guided groups. SB stenting was performed for Thrombolysis In Myocardial Infarction flow grade <3, ostial SB stenosis >70%, or greater than type A dissection after main vessel stenting in the Angio-guided group and for SB-FFR <0.80 in the FFR-guided group. The primary endpoint was the 1-year composite rate of major adverse cardiac events (cardiac death, myocardial infarction, and clinically driven target vessel revascularization).ResultsComparing the Angio-guided and FFR-guided groups, treatment of the SB (balloon or stenting) was performed in 63.1% and 56.3% of lesions respectively (p = 0.07); stenting of the SB was attempted in 38.1% and 25.9%, respectively (p = 0.01); and, when attempted, stenting was successful in 83.6% and 73.3% of SBs, respectively (p = 0.01). The 1-year composite major adverse cardiac event rate was 18.1% in both groups (hazard ratio: 0.91, 95% confidence interval: 0.48 to 1.88; p = 1.00). The 1-year target vessel revascularization and stent thrombosis rates were 6.9% and 5.6% (p = 0.82) and 1.3% and 0.6% (p = 0.56) in the Angio-guided and FFR-guided groups, respectively.ConclusionsIn this multicenter, randomized trial, angiographic and FFR guidance of provisional SB stenting of true coronary bifurcation lesions provided similar 1-year clinical outcomes. (Randomized Study on DK Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions; ChiCTR-TRC-07000015)