Contents
Journal of the American College of Cardiology,
12/2018, Letnik:
72, Številka:
23
Journal Article
Recenzirano
Original Investigations 10-Year Outcomes of Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Artery Disease 2813 Duk-Woo Park, Jung-Min Ahn, Sung-Cheol Yun, Yong-Hoon Yoon, ...Do-Yoon Kang, Pil Hyung Lee, Seung-Whan Lee, Seong-Wook Park, Ki Bae Seung, Hyeon-Cheol Gwon, Myung-Ho Jeong, Yangsoo Jang, Hyo-Soo Kim, In-Whan Seong, Hun Sik Park, Taehoon Ahn, In-Ho Chae, Seung-Jea Tahk, Seung-Jung Park In this 10-year report of the MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty Versus Surgical Revascularization) study comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for unprotected left main coronary artery disease, there was no between-group difference in adjusted risks of death and the composite outcome up to 10 years in the overall cohort. SEE ADDITIONAL CONTENT ONLINEEditorial Comment Coronary Bypass Surgery for Diabetes and Multivessel Disease: Forget the SYNTAX 2838 Paul W.M. Fedak, Deepak L. Bhatt, Subodh VermaStratified Medical Therapy Using Invasive Coronary Function Testing in Angina: The CorMicA Trial 2841 Thomas J. Ford, Bethany Stanley, Richard Good, Paul Rocchiccioli, Margaret McEntegart, Stuart Watkins, Hany Eteiba, Aadil Shaukat, Mitchell Lindsay, Keith Robertson, Stuart Hood, Ross McGeoch, Robert McDade, Eric Yii, Novalia Sidik, Peter McCartney, David Corcoran, Damien Collison, Christopher Rush, Alex McConnachie, Rhian M. Touyz, Keith G. Oldroyd, Colin Berry In patients presenting with angina but no obstructive epicardial coronary artery disease, there is a question of whether outcomes can be improved by identifying and guiding treatment of microvascular and/or vasospastic angina during elective coronary angiography. SEE ADDITIONAL CONTENT ONLINEEditorial Comment Premature Ventricular Complex–Induced Cardiomyopathy: Providing Insights on the Pathogenesis 2883 Francis E. Marchlinski, Cory M. TschabrunnThe Present and Future JACC State-of-the-Art Review Medical Therapy for Long-Term Prevention of Atherothrombosis Following an Acute Coronary Syndrome: JACC State-of-the-Art Review 2886 Guglielmo Gallone, Luca Baldetti, Matteo Pagnesi, Azeem Latib, Antonio Colombo, Peter Libby, Francesco Giannini Apparently stable patients >1 year after an ACS still have persistently elevated risk of recurrent events.
Atherectomy for peripheral arterial disease Twine, Christopher P; Wardle, Bethany G; Ambler, Graeme K ...
Cochrane database of systematic reviews,
09/2020, Letnik:
2020, Številka:
9
Journal Article
Recenzirano
Odprti dostop
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.
Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year ...outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown.
This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions.
We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test.
At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions.
The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease INPACT SFA I; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery SFA and Proximal Popliteal Artery PPA INPACT SFA II; NCT01566461).
Correction to: Leukemia (2012) 26, 2300–2301; doi:10.1038/leu.2012.93 Since the publication of this article, it has been brought to the authors’ attention that there are two instances where the word ...‘bivalirudin’ has been incorrectly spelt as ‘bivaluridin’ (once in the title, the other on page 2). The authors would like to apologize for any inconvenience this may have caused.
Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal ...angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease.
The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA P=0.10). There were no device- or procedure-related deaths and no major amputations.
In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease.
http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and NCT01566461.
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