Latin American randomized trial of balloon angioplasty versus coronary stenting in diabetic patients with small vessel reference size (Latin American Small Vessel [LASMAL II] Trial): Immediate and long-term results

Rodríguez, Alfredo E.; Alemparte, Máximo Rodriguez; Pereira, Carlos Fernández; Vigo, Cesar F.; Sampaolesi, Alberto; Bernardi, Víctor; Marchand, Eugenio; Trongé, Jorge; Palacios, Igor F.

doi:10.1016/j.ahj.2005.05.013

Cited by 11 publications

(5 citation statements)

References 27 publications

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“…[2][3][4] In the early 2000s, several randomized controlled trials (RCT), have compared PCI with bare-metal stents (BMS) to balloon angioplasty for the treatment of small vessel CAD. [5][6][7][8][9][10][11][12] Drug-coated balloons (DCB) have been shown to be a valuable option for the treatment of in-stent restenosis after BMS or drug-eluting stents (DES) and have been tested as an alternative strategy to DES for the treatment of native small vessel CAD. 13,14 DCB provide a fast and high-dose delivery of antiproliferative drugs to the vessel wall, and carry several anticipated benefits over DES such as the lack of permanent scaffold and the need for a shorter duration of dual antiplatelet therapy.…”

Section: Introductionmentioning

confidence: 99%

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Drug‐Coated balloons vs drug‐eluting stents for the treatment of small coronary artery disease: A meta‐analysis of randomized trials

Sánchez

Chiarito

Cortese

et al. 2020

Cathet Cardio Intervent

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Objectives and background There is conflicting evidence about the effects of drug‐coated balloons (DCB) compared with drug‐eluting stents (DES) in patients with native small vessel coronary artery disease (CAD). Methods The PubMed, Embase, Cochrane Central Register of Controlled Trials, and http://ClinicalTrials.gov databases and main international conference proceedings were searched for randomized controlled trials (RCT) comparing DCB versus DES in patients with native small vessel CAD. Data were pooled by meta‐analysis using a random‐effects model. The primary endpoint was target vessel revascularization (TVR). Secondary clinical endpoints were: myocardial infarction (MI), target lesion revascularization (TLR), all‐cause death, cardiac death, and stent thrombosis or target vessel thrombosis. Secondary angiographic outcomes were: in‐segment restenosis, in‐segment percentage‐diameter stenosis, in‐segment late lumen loss, in‐segment net luminal gain, and in‐segment minimal lumen diameter. Results Five trials enrolling 1,459 patients were included. Mean clinical follow‐up was 10.2 months. The use of DCB, compared with DES, was associated with similar risk of TVR (odds ratio [OR]: 0.97; 95% confidence interval [CI] 0.56 to 1.68; p = .92), TLR (OR: 1.74; 95% CI: 0.57 to 5.28; p = .33), all‐cause death (OR: 1.03; 95% CI: 0.14 to 7.48; p = .98), with a trend toward a lower risk of MI (OR: 0.49; 95% CI: 0.23 to 1.03; p = .06), and with significant lower risk of vessel thrombosis (OR: 0.12; 95% CI: 0.01 to 0.94; p = .04). DCB use was associated with similar risk of angiographic restenosis (OR: 1.12; 95% CI 0.69 to 1.84; p = .64), comparable late luminal loss (standardized mean difference (SMD): –0.18; 95% CI: −0.39 to 0.03; p = .09), while leading to significant higher percentage diameter stenosis (SMD: 0.27; 95% CI 0.12 to 0.41; p < .01) and smaller minimal luminal diameter (SMD: ‐0.52; 95% CI: −0.86 to −0.18; p = .003). Conclusion Compared with DES, the use of DCB for the treatment of native small vessel CAD is associated with similar TVR and restenosis and reduces the risk of vessel thrombosis, although DES implantation yields slightly better angiographic surrogate endpoints.

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Section: Introductionmentioning

confidence: 99%

“…Its interventional treatment remains challenging owing to an increased risk of technical failure, restenosis and need of repeated revascularization 2‐4 . In the early 2000s, several randomized controlled trials (RCT), have compared PCI with bare‐metal stents (BMS) to balloon angioplasty for the treatment of small vessel CAD 5‐12 …”

Section: Introductionmentioning

confidence: 99%

Drug‐Coated balloons vs drug‐eluting stents for the treatment of small coronary artery disease: A meta‐analysis of randomized trials

Sánchez

Chiarito

Cortese

et al. 2020

Cathet Cardio Intervent

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“…In an effort to decrease the periprocedural thromboembolic complications, phosphorilcholine (PC) coated stents were developed and assessed in cardiology. 5 However, this experience cannot be fully translated to neuroendovascular procedures due to differences in vessel size (parent vessel and side branches), hemodynamic environment, and overall device engineering.…”

Section: Introductionmentioning

confidence: 99%

Acute thrombus formation on phosphorilcholine surface modified flow diverters

Marosfői

Clarençon

Langan

et al. 2017

J NeuroIntervent Surg

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PurposeThromboembolic complications remain a limitation of flow diverting stents. We hypothesize that phosphorilcholine surface modified flow diverters (Pipeline Flex with Shield Technology, sPED) would have less acute thrombus formation on the device surface compared with the classic Pipeline Embolization device (cPED).MethodsElastase-induced aneurysms were created in 40 rabbits and randomly assigned to receive cPED or sPED devices with and without dual antiplatelet therapy (DAPT) (four groups, n=10/group). Angioplasty was performed to enhance apposition and create intimal injury for a pro-thrombotic environment. Both before and after angioplasty, the flow diverter was imaged with intravascular optical coherence tomography. The outcome measure was the number of predefined segments along the implant relative to the location of the aneurysm with a minimum of 0 (no clot formation) and maximum of 3 (all segments with thrombus). Clot formation over the device at ostia of branch arteries was assessed as either present or absent.ResultsFollowing angioplasty, the number of flow diverter segments with clots was significantly associated with the flow diverter (p<0.0001), but not with DAPT (p=0.3872) or aneurysm neck size (p=0.8555). The incidence rate for clots with cPED was 1.72 times more than with sPED. The clots on the flow diverter at the location corresponding to side branch ostia was significantly lower with sPED than with cPED (OR 0.180; 95% CI 0.044 to 0.734; p=0.0168), but was not associated with DAPT (p=0.3198).ConclusionIn the rabbit model, phosphorilcholine surface modified flow diverters are associated with less thrombus formation on the surface of the device.

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“…SES significantly reduced the odds of TLR compared to PES (OR: 0.39; 95% CI: 0.16 to 0.93), DCB (OR: 0.34; 95% CI: 0.10 to 0.97), BMS (OR: 0.21; 95% CI: 0.13 to 0.36), and BA (OR: 0.16; 95% CI: 0.09 to 0.29) (Figures 2C and 3, Online Figure S2, OnlineTable S5). Findings between direct and indirect estimates were in agreement; there was no evidence of considerable heterogeneity among trials.Eighteen trials (4,576 patients) contributed to the analysis of myocardial infarction(18)(19)(20)(21)(22)(23)(24)(25)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37).OnlineTable S4presents the numbers of events separately for each included trial. In summary, 218 patients experienced myocardial infarction during the entire follow-up.…”

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confidence: 99%

Percutaneous Coronary Interventions for the Treatment of Stenoses in Small Coronary Arteries

Siontis

Piccolo

Praz

et al. 2016

JACC: Cardiovascular Interventions

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Latin American randomized trial of balloon angioplasty versus coronary stenting in diabetic patients with small vessel reference size (Latin American Small Vessel [LASMAL II] Trial): Immediate and long-term results

Cited by 11 publications

References 27 publications

Drug‐Coated balloons vs drug‐eluting stents for the treatment of small coronary artery disease: A meta‐analysis of randomized trials

Drug‐Coated balloons vs drug‐eluting stents for the treatment of small coronary artery disease: A meta‐analysis of randomized trials

Acute thrombus formation on phosphorilcholine surface modified flow diverters

Percutaneous Coronary Interventions for the Treatment of Stenoses in Small Coronary Arteries

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