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European Journal of Vascular and... Jul 2021The efficacy and cost effectiveness of atherectomy for femoropopliteal (FP) arterial diseases have not been determined yet. A systematic review and meta-analysis were... (Comparative Study)
Comparative Study Meta-Analysis
Atherectomy Combined with Balloon Angioplasty versus Balloon Angioplasty Alone for de Novo Femoropopliteal Arterial Diseases: A Systematic Review and Meta-analysis of Randomised Controlled Trials.
OBJECTIVE
The efficacy and cost effectiveness of atherectomy for femoropopliteal (FP) arterial diseases have not been determined yet. A systematic review and meta-analysis were performed to compare the efficacy and safety between atherectomy combined with balloon angioplasty (BA) and BA alone for patients with de novo FP steno-occlusive lesions.
METHODS
The Cochrane Library, Medline, and Embase were used to search for studies evaluating outcomes of atherectomy combined with BA compared with BA alone in FP arterial diseases from inception to July 2020. The methodological quality of the included studies was evaluated with the Cochrane Risk of Bias Tool. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was used to assess the level of evidence for each outcome. The fixed effects model was chosen to combine the data when I < 50%; otherwise, the random effects model was used. Subgroup and sensitivity analyses were performed to further analyse the results.
RESULTS
Four RCTs were included. The meta-analysis showed that atherectomy combined with BA was associated with improved technical success rate (risk ratio [RR] 0.22, 95% confidence interval [CI] 0.13-0.38, p < .001; I = 0; high quality), reduced bailout stenting (RR 0.15, 95% CI 0.07-0.32, p < .001; I = 16%; high quality), and flow limiting dissection (RR 0.24, 95% CI 0.13-0.47, p < .001; I = 0; high quality). No statistically significant difference was found in target lesion revascularisation (TLR), primary patency, mortality, major adverse event (MAE), or ankle brachial index (ABI) after one year follow up.
CONCLUSION
Compared with BA alone, atherectomy combined with BA may not improve primary patency, TLR, mortality rate, or ABI, but may reduce the need for bailout stenting and the incidence of flow limiting dissection and increase the technical success rate in FP arterial diseases. More studies are warranted to further confirm the conclusion.
Topics: Aortic Dissection; Angioplasty, Balloon; Ankle Brachial Index; Atherectomy; Combined Modality Therapy; Femoral Artery; Follow-Up Studies; Humans; Peripheral Arterial Disease; Postoperative Complications; Randomized Controlled Trials as Topic; Stents; Treatment Outcome; Vascular Patency
PubMed: 34112574
DOI: 10.1016/j.ejvs.2021.02.012 -
Journal of Community Hospital Internal... Mar 2021: Coronary artery calcification (CAC) is a pathological deposition of calcium in the intimal and medial layer of the arterial wall. A plethora of therapeutic calcium... (Review)
Review
: Coronary artery calcification (CAC) is a pathological deposition of calcium in the intimal and medial layer of the arterial wall. A plethora of therapeutic calcium debulking techniques is available for the treatment of CAC, including orbital or rotational atherectomy, excimer lasers, cutting, and scoring balloons, which are associated with a soaring rate of complication and low efficacy. To this end, in 2016, the Food and Drug Administration (FDA) posited that shockwave intravascular lithotripsy (S-IVL) technique can be employed with minimal complication. : A retrospective review of cases received lithotripsy for calcified coronary artery disease was performed by using online data from PubMed, Embase, and the Cochrane Central Register of Controlled Trials. The available search results were downloaded into an Endnote library and analyzed into two phases. : Out of 24 participants from case reports and series, Majority were found to be Male. There was no significant difference found in the mortality of patients undergoing IVL for the stenosis of the left main stem, left anterior descending, left circumflex artery, or diagonal branch. The mortality was found to be high among 6 patients with prior comorbidities and underwent more than 3 cycles of IVL (OR 37,95% Cl 1.54-886.04, P 0.02). Out of 24 patients, 2 (8.33%) patients developed complications such as vessel dissection (OR 3.4, 95% Cl 17.87-64.68, P 0.4). : Shockwave intravascular lithotripsy (S-IVL) may be used in cases of the calcified disease to gain vessel lumen in order to deploy drug-eluting stents with PCI. The success of the DES implantation of IVL can be 100% with a minimal complication rate.
PubMed: 33889320
DOI: 10.1080/20009666.2021.1883219 -
The Cochrane Database of Systematic... Sep 2020Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014.
OBJECTIVES
To evaluate the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 August 2019.
SELECTION CRITERIA
We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease.
DATA COLLECTION AND ANALYSIS
Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications.
MAIN RESULTS
We included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency. Six studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events. There was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups. One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively).
AUTHORS' CONCLUSIONS
This review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.
Topics: Acute Coronary Syndrome; Angioplasty, Balloon; Atherectomy; Cause of Death; Heart Failure; Humans; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Stents
PubMed: 32990327
DOI: 10.1002/14651858.CD006680.pub3 -
BioMed Research International 2020The purpose of this article was to compare the efficiency and safety of drug-coated balloon angioplasty (DCB) and atherectomy with percutaneous transluminal angioplasty... (Meta-Analysis)
Meta-Analysis
The purpose of this article was to compare the efficiency and safety of drug-coated balloon angioplasty (DCB) and atherectomy with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal in-stent restenosis (ISR). Pubmed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) (all up to March 2019) were searched systematically. Trial sequential analysis (TSA) was conducted. 5 studies with 599 participants were included. Compared with PTA, DCB significantly increased the rate of patency (6 months: RR 1.65, 95% CI 1.30 to 2.09, < 0.01; 12 months: RR 2.38, 95% CI 1.71 to 3.30, < 0.01) and the rate freedom from target lesion revascularization (TLR) (6 months: RR 1.18, 95% CI 1.09 to 1.28, < 0.01; 12 months: RR 1.56, 95% CI 1.33 to 1.82, < 0.01) at 6 and 12 months follow-up, and the TSA results showed these outcomes were reliable. The rate of clinical improvement by ≥1 Rutherford category in the DCB group was higher than that in the PTA group (6 months: RR 1.35, 95% CI 1.03 to 1.75, = 0.03; 12 months: RR 1.46, 95% CI 1.17 to 1.82, < 0.01) at 6 and 12 months. There is no statistically difference of ABI, all-cause mortality, and incidence of amputation between DCB group and PTA group (MD 0.03, 95% CI -0.03 to 0.08, = 0.40; RR 1.24, 95% CI 0.46 to 3.34, = 0.67; RR 0.32, 95% CI 0.01 to 7.61, = 0.48). Compared with PTA, the rate of patency and freedom from TLR in the laser atherectomy (LD) group was higher than that in the PTA group (patency: 6 months: RR 1.28, 95% CI 1.01 to 1.64, < 0.05, 12 months: RR 2.25, 95% CI 1.14 to 4.44, < 0.05; freedom from TLR: 6 months: RR 1.27, 95% CI 1.05 to 1.53, = 0.01, 12 months: RR 1.59, 95% CI 1.12 to 2.25, = 0.01) at 6 and 12 months follow-up. In conclusion, DCB and LD had superior clinical (freedom from TLR and clinical improvement) and angiographic outcomes (patency rate) compared with PTA for the treatment of femoropopliteal ISR. Moreover, DCB and LD had a low incidence of amputation and mortality and were relatively safe methods.
Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Coated Materials, Biocompatible; Cytoreduction Surgical Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Reoperation; Stents
PubMed: 32596293
DOI: 10.1155/2020/3076346 -
SAGE Open Medicine 2020This review is intended to help clinicians and patients understand the present state of peripheral artery disease, appreciate the progression and presentation of... (Review)
Review
This review is intended to help clinicians and patients understand the present state of peripheral artery disease, appreciate the progression and presentation of critical limb ischemia/chronic limb-threatening ischemia, and make informed decisions regarding inflow and outflow endovascular revascularization and surgical treatment options within the context of current debates in the medical community. A controlled literature search was performed to obtain research on outcomes of critical limb ischemia patients undergoing complete leg revascularization for peripheral artery disease inflow and outflow disease. Data for this review were identified by queries of medical and life science databases, expert referral, and references from relevant papers published between 1997 and 2019, resulting in 48 articles. The literature review herein indicates that endovascular revascularization-including ballooning, stenting, and atherectomy-is an effective peripheral artery disease therapy for both above the knee and below the knee disease, and can safely and effectively treat both inflow and outflow disease. As such, it plays a leading role in the therapy of lower extremity artery disease.
PubMed: 32551113
DOI: 10.1177/2050312120929239 -
Journal of Vascular Surgery Jul 2020Our study aimed to perform a meta-analysis based on current evidence to investigate the efficacy of different debulking devices in the treatment of femoropopliteal... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Our study aimed to perform a meta-analysis based on current evidence to investigate the efficacy of different debulking devices in the treatment of femoropopliteal in-stent restenosis (FP-ISR).
METHODS
We systematically searched for articles reporting treatment of FP-ISR patients in the MEDLINE, Embase, and Cochrane databases. Randomized controlled trials, cohort studies, and retrospective studies were included, and clinical characteristic outcomes were extracted and pooled. The efficacy end points included primary patency and freedom from target lesion revascularization (TLR) at 1 year. Pooled estimates were calculated using the random effects model. For each point, effect size and 95% confidence intervals (CIs) were calculated.
RESULTS
We identified 12 studies with 743 patients that could be included in this meta-analysis. The overall primary patency at 1 year was 58.3% (95% CI, 44.7%-71.9%), and freedom from TLR at 1 year was 67.0% (95% CI, 60.5%-74.6%). Subgroup analysis showed that the laser debulking + percutaneous transluminal angioplasty (PTA) group was associated with a similar primary patency and freedom from TLR compared with the mechanical debulking + PTA group (53.8% vs 52.8; 65.4% vs 62.1%). Subgroup analysis demonstrated that the long lesion and short lesion groups and the occlusive and stenosis groups shared similar results of primary patency and freedom from TLR. Laser + drug-coated balloon was associated with higher primary patency and freedom from TLR compared with laser + PTA (78.5% vs 58.3%; 76.7% vs 66.4%).
CONCLUSIONS
Debulking devices show promising and favorable results for FP-ISR patients with complex lesions. Debulking devices combined with a drug-coated balloon might be an efficacious way to treat FP-ISR complex lesions in the future.
Topics: Angioplasty; Atherectomy; Femoral Artery; Humans; Laser Therapy; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Risk Factors; Thrombectomy; Treatment Outcome; Vascular Patency
PubMed: 32093910
DOI: 10.1016/j.jvs.2019.11.058 -
International Angiology : a Journal of... Dec 2017The aim of this review is to explore the safety and effectiveness of intravascular ultrasound (IVUS) during lower limb endovascular interventions in patients with... (Review)
Review
INTRODUCTION
The aim of this review is to explore the safety and effectiveness of intravascular ultrasound (IVUS) during lower limb endovascular interventions in patients with peripheral arterial disease (PAD).
EVIDENCE ACQUISITION
A systematic review of the PubMed and Scopus databases was performed according to PRISMA guidelines. Clinical studies evaluating IVUS as an adjunct to angiography during revascularization procedures in patients with PAD were included.
EVIDENCE SYNTHESIS
Thirteen studies were identified, with a total number of 2258 patients having had IVUS for PAD intervention. Seven investigated the role of IVUS for angioplasty and stenting, with the majority being retrospective cohorts. Technical success and patency rates ranged from 90-100% and 45-100%, respectively, with a follow-up that ranged from 4.3-63 months. Three of these studies compared IVUS and non-IVUS guided angioplasty and demonstrated a significant difference in the events of amputations or re-interventions in favor of the IVUS group. Furthermore, five studies evaluated IVUS use in true-lumen re-entry, with the technical success ranging between 97-100%. In one study, where IVUS was used for atherectomy, the technical success was 100% and the long-term patency was 90% during a 12-month follow-up. Overall, no significant peri/postoperative IVUS related complications were reported, whereas, 2 studies suggested an IVUS-associated increase in procedure costs that ranged from $1080-$1333.
CONCLUSIONS
There is limited and heterogeneous evidence regarding the use of IVUS for the management of PAD. Further research is required to elucidate the optimal role of IVUS in PAD as well as the cost effectiveness of this approach for routine use in the management of PAD.
Topics: Amputation, Surgical; Angioplasty; Disease Management; Humans; Lower Extremity; Peripheral Arterial Disease; Stents; Ultrasonography, Interventional
PubMed: 28895369
DOI: 10.23736/S0392-9590.17.03866-4 -
Cardiovascular Intervention and... Oct 2018Compared to rotational atherectomy (RA), orbital atherectomy (OA) has been shown to decrease procedure failure and reintervention rates in the treatment of severely... (Comparative Study)
Comparative Study
Compared to rotational atherectomy (RA), orbital atherectomy (OA) has been shown to decrease procedure failure and reintervention rates in the treatment of severely calcified coronary artery lesions. Our objective was to explore the cost-effectiveness of OA compared to RA in the Japanese healthcare system. A decision-analytic model calculated reintervention rates and consequent total 1-year costs. Effectiveness inputs were therapy-specific target lesion revascularization (TLR) rates and all-cause mortality, pooled from clinical studies. Index and reintervention costs were determined based on claims data analysis of n = 33,628 subjects treated in 2014-2016. We computed incremental cost-effectiveness in Japanese Yen (JPY) per life year (LY) gained based on differences in 1-year cost and projected long-term survival, assuming OA device cost between JPY 350,000 and JPY 550,000. OA was found to be associated with improved clinical outcomes (12-month TLR rate 5.0 vs. 15.7%) and projected survival gain (8.34 vs. 8.16 LYs (+0.17), based on 1-year mortality of 5.5 vs. 6.8%). Total 1-year costs were lower for device cost of JPY 430,000 or less, and reached a maximum ICER of JPY 753,445 per LY at the highest assumed device cost, making OA dominant or cost-effective across the tested range, at ICERs substantially below the willingness-to-pay threshold. In conclusion, orbital atherectomy for the treatment of severely calcified coronary artery lesions, compared to rotational atherectomy, is a cost-effective treatment approach in the Japanese healthcare system due to improved clinical performance.
Topics: Aged; Atherectomy, Coronary; Coronary Artery Disease; Cost-Benefit Analysis; Female; Health Care Costs; Humans; Japan; Male; Middle Aged; Survival Rate; Treatment Outcome; Vascular Calcification
PubMed: 28875395
DOI: 10.1007/s12928-017-0488-3 -
BMJ (Clinical Research Ed.) Nov 2015What is the most safe and effective interventional treatment for coronary in-stent restenosis? (Meta-Analysis)
Meta-Analysis Review
STUDY QUESTION
What is the most safe and effective interventional treatment for coronary in-stent restenosis?
METHODS
In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses.
STUDY ANSWER AND LIMITATIONS
Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval -0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a low number of events. Trials had heterogeneity regarding investigation periods, baseline characteristics, and endpoint reporting, with a lack of information at long term follow-up. Direct and indirect evidence was also inconsistent for the comparison between drug eluting stents and drug coated balloons.
WHAT THIS STUDY ADDS
Compared with other currently available interventional treatments for coronary in-stent restenosis, drug coated balloons and drug eluting stents are associated with superior clinical and angiographic outcomes, with a similar comparative efficacy.
FUNDING, COMPETING INTERESTS, DATA SHARING
This study received no external funding. The authors declare no competing interests. No additional data available.
Topics: Bayes Theorem; Coronary Restenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Myocardial Revascularization; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Stents
PubMed: 26537292
DOI: 10.1136/bmj.h5392 -
The Cochrane Database of Systematic... Dec 2012This is an update of the review on 'Percutaneous transluminal rotational atherectomy for coronary artery disease' first published in The Cochrane Library Issue 4, 2003.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an update of the review on 'Percutaneous transluminal rotational atherectomy for coronary artery disease' first published in The Cochrane Library Issue 4, 2003. Percutaneous transluminal coronary rotational atherectomy (PTCRA) debulks atherosclerotic plaque from coronary arteries using an abrasive burr. On rotation, the burr selectively removes hard tissue. PTCRA has been used both as an alternative to and in conjunction with balloon angioplasty to open up blocked coronary arteries. Its ongoing effectiveness and safety compared with other modes of removing atherosclerotic plaques is reviewed.
OBJECTIVES
To assess the effects of PTCRA for coronary artery disease in patients with non-complex and complex lesions (e.g. ostial, long or diffuse lesions or those arising from in-stent re-stenosis) of the coronary arteries.
SEARCH METHODS
For the original review, we searched the Heart Group Specialised Register; The Cochrane Library to Issue 2, 2001; and MEDLINE, CINAHL, EMBASE and Current Contents to December 2002 and reviewed reference lists for relevant articles. For the current review, we searched the same registries from 2002 to 2012 and reviewed reference lists for relevant articles.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials of PTCRA compared with placebo, no treatment or another intervention and excluded cross-over trials.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed the risk of bias of the studies identified. Data were extracted independently by two review authors. We asked authors of trials to provide information when missing data were encountered. Statistical summaries used risk ratios (RR) and weighted mean differences.
MAIN RESULTS
We included 12 trials enrolling 3474 patients. The overall risk of bias was unclear for the majority of articles due to a lack of reported data; however, the authors determined that this would be unlikely to impact negatively as most data outcomes were objective (e.g. death vs. no death). There was no evidence of the effectiveness in improving patient outcomes of PTCRA in non-complex lesions. In complex lesions, there were no statistically significant differences in re-stenosis rates at six months (RR 1.05; 95% confidence interval (CI) 0.83 to 1.33) and at one year (RR 1.21; 95% CI 0.95 to 1.55) in those receiving PTCRA with adjunctive balloon angioplasty (PTCA) (PTCRA/PTCA) compared to those receiving PTCA alone. Morphological characteristics distinguishing complex lesions have not been examined in parallel-arm randomised controlled trials. The evidence for the effectiveness of PTCRA in in-stent re-stenosis is unclearCompared to angioplasty alone, PTCRA/PTCA did not result in a statistically significant increase in the risk of major adverse cardiac events (myocardial infarction (MI), emergency cardiac surgery or death) during the in-hospital period (RR 1.27; 95% CI 0.86 to 1.90). Compared to angioplasty, PTCRA was associated with nine times the risk of an angiographically detectable vascular spasm (RR 9.23; 95% CI 4.61 to 18.47), four times the risk of perforation (RR 4.28; 95% CI 0.92 to 19.83) and about twice the risk of transient vessel occlusions (RR 2.49; 95% CI 1.25 to 4.99) while angiographic dissections (RR 0.48; 95% CI 0.34 to 0.68) and stents used as a bailout procedure (RR 0.29; 95% CI 0.09 to 0.87) were less common.
AUTHORS' CONCLUSIONS
When conventional PTCA is feasible, PTCRA appears to confer no additional benefits. There is limited published evidence and no long-term data to support the routine use of PTCRA in in-stent re-stenosis. Compared to angioplasty alone, PTCRA/PTCA did not result in a higher incidence of major adverse cardiac events, but patients were more likely to experience vascular spasm, perforation and transient vessel occlusion. In certain circumstances (e.g. patients ineligible for cardiac surgery, those with architecturally complex lesions, or those with lesions that fail PTCA), PTCRA may achieve satisfactory re-vascularisation in subsequent procedures.
Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Artery Disease; Coronary Restenosis; Humans; Randomized Controlled Trials as Topic; Stents
PubMed: 23235596
DOI: 10.1002/14651858.CD003334.pub2